New Medications and Drugs

The Safety of the HPV Vaccine

2009-11-20T04:44:00.000-08:00

From the U.S. Department of Health and Human Services, I’m Ted Pestorius with HHS HealthBeat.

A survey finds that a new vaccine against cervical cancer is about as safe as any other vaccine.

At the Centers for Disease Control and Prevention, Barbara Slade reviewed national health data through a database of voluntary reports on vaccines.
[Barbara Slade speaks] "For 23 million doses that were sent out, we’ve received 12,424 reports."

Of those reports, only about 6 percent were considered serious. Those include 20 verified deaths of widely varying causes, and two cases of Lou Gehrig’s disease. The researchers say they can’t tell if those resulted in some way from the vaccine. So the researchers conclude that the vaccine looks safe for the girls and young women who should get it. So far, more than 7 million have.

The study is in the Journal of the American Medical Association.

Learn more at hhs.gov.

HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ted Pestorius.

Food and Drug Administration has approved the H1N1 Influenza Virus Vaccine additional

2009-11-18T04:43:00.000-08:00

The U.S. Food and Drug Administration announced that it has approved a fifth vaccine for protection against the 2009 H1N1 influenza virus. The vaccine is manufactured by ID Biomedical Corp. of Quebec, Canada, owned by GlaxoSmithKline PLC.

As with the four previous H1N1 influenza vaccines licensed by the FDA on Sept.15, 2009, ID Biomedical Corporation will manufacture its H1N1 vaccine using the established, licensed egg-based manufacturing process used for producing seasonal flu vaccine.

Potential side effects of this H1N1 vaccine are expected to be similar to those of the seasonal and H1N1 flu vaccines. The most common side effect is soreness at the injection site. Others may include mild fever, body aches and fatigue for a few days after the inoculation.

As with any medical product, unexpected or rare serious adverse events may occur. The FDA is collaborating with other government agencies to enhance adverse event safety monitoring during and after the H1N1 2009 vaccination program.

ID Biomedical’s H1N1 monovalent vaccine will be produced in multi-dose vials, in a formulation that contains thimerosal.

As with any medical product, unexpected or rare serious adverse events may occur. FDA is collaborating with the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention, and other government agencies to enhance the capacity for adverse event safety monitoring during and after the 2009 H1N1 vaccination program.

Influenza A (H1N1) 2009 Monovalent

FDA approved these vaccines as a strain change to each manufacturer’s seasonal influenza vaccine. There is considerable experience with seasonal influenza vaccine development and production and influenza vaccines produced by this technology have a long and successful track record of safety and effectiveness in the United States. The Influenza A (H1N1) 2009 Monovalent vaccines will undergo the usual testing and lot release procedures that are in place for seasonal influenza vaccines.

Injectable Vaccines
Intranasal Vaccines

know more about this vaccines - click here

Alzheimer's Disease Awareness Month

2009-11-10T06:17:00.000-08:00

Nearly 4.5 million Americans suffer from Alzheimer's disease, a brain disorder that affects memory, thinking, and reasoning skills. Early symptoms of Alzheimer's are sometimes mistaken for normal aging, so according to National Institute on Aging about the topic of Forgetfulness, you should know when to ask for help.

Diagnosis

Maria has been a teacher for 35 years. Teaching fills her life and gives her a sense of accomplishment, but recently she has begun to forget details and has become more and more disorganized. At first, she laughed it off, but her memory problems have worsened. Her family and friends have been sympathetic but are not sure what to do. Parents and school administrators are worried about Maria’s performance in the classroom. The principal has suggested she see a doctor. Maria is angry with herself and frustrated, and wonders whether these problems are signs of Alzheimer’s disease or just forgetfulness that comes with age.

Many people worry about becoming forgetful. They think forgetfulness is the first sign of Alzheimer’s disease (AD). Over the past few years, scientists have learned a lot about memory and why some kinds of memory problems are serious but others are not.

Age-Related Changes in Memory

Forgetfulness can be a normal part of aging. As people get older, changes occur in all parts of the body, including the brain. As a result, some people may notice that it takes longer to learn new things, they don’t remember information as well as they did, or they lose things like their glasses. These usually are signs of mild forgetfulness, not serious memory problems.
Some older adults also find that they don’t do as well as younger people on complex memory or learning tests. Scientists have found, though, that given enough time, healthy older people can do as well as younger people do on these tests. In fact, as they age, healthy adults usually improve in areas of mental ability such as vocabulary.

Keeping Your Memory Sharp

People with some forgetfulness can use a variety of techniques that may help them stay healthy and maintain their memory and mental skills. Here are some tips that can help:

Plan tasks, make “to do” lists, and use memory aids like notes and calendars. Some people find they remember things better if they mentally connect them to other meaningful things, such as a familiar name, song, book, or TV show.
Develop interests or hobbies and stay involved in activities that can help both the mind and body.
Engage in physical activity and exercise. Several studies have associated exercise (such as walking) with better brain function, although more research is needed to say for sure whether exercise can help to maintain brain function or prevent or delay symptoms of Alzheimer’s.
Limit alcohol use. Although some studies suggest that moderate alcohol use has health benefits, heavy or binge drinking over time can cause memory loss and permanent brain damage.
Find activities, such as exercise or a hobby, to relieve feelings of stress, anxiety, or depression. If these feelings last for a long time, talk with your doctor.

Other Causes of Memory Loss

Some memory problems are related to health issues that may be treatable. For example, medication side effects, vitamin B12 deficiency, chronic alcoholism, tumors or infections in the brain, or blood clots in the brain can cause memory loss or possibly dementia (see more on dementia, below). Some thyroid, kidney, or liver disorders also can lead to memory loss. A doctor should treat serious medical conditions like these as soon as possible.

Emotional problems, such as stress, anxiety, or depression, can make a person more forgetful and can be mistaken for dementia. For instance, someone who has recently retired or who is coping with the death of a spouse, relative, or friend may feel sad, lonely, worried, or bored. Trying to deal with these life changes leaves some people confused or forgetful.

The confusion and forgetfulness caused by emotions usually are temporary and go away when the feelings fade. The emotional problems can be eased by supportive friends and family, but if these feelings last for a long time, it is important to get help from a doctor or counselor. Treatment may include counseling, medication, or both.

Treatment for Dementia

A person with dementia should be under a doctor’s care. The doctor might be a neurologist, family doctor, internist, geriatrician, or psychiatrist. He or she can treat the patient’s physical and behavioral problems (such as aggression, agitation, or wandering) and answer the many questions that the person or family may have.
People with dementia caused by Alzheimer’s disease may be treated with medications. Four medications are approved by the U.S. Food and Drug Administration to treat AD. Donepezil (Aricept®), rivastigmine (Exelon®), and galantamine (Razadyne®) are used to treat mild to moderate AD (donepezil has been approved to treat severe AD as well). Memantine (Namenda®) is used to treat moderate to severe AD. These drugs may help maintain thinking, memory, and speaking skills, and may lessen certain behavioral problems for a few months to a few years in some people. However, they don’t stop AD from progressing. Studies are underway to investigate medications to slow cognitive decline and to prevent the development of AD.
People with vascular dementia should take steps to prevent further strokes. These steps include controlling high blood pressure, monitoring and treating high blood cholesterol and diabetes, and not smoking. Studies are underway to develop medicines to reduce the severity of memory and thinking problems that come with vascular dementia. Other studies are looking at the effects of drugs to relieve certain symptoms of this type of dementia.
Family members and friends can help people in the early stages of dementia to continue their daily routines, physical activities, and social contacts. People with dementia should be kept up-to-date about the details of their lives, such as the time of day, where they live, and what is happening at home or in the world. Memory aids may help. Some families find that a big calendar, a list of daily plans, notes about simple safety measures, and written directions describing how to use common household items are useful aids.

What You Can Do

If you’re concerned that you or someone you know has a serious memory problem, talk with your doctor. He or she may be able to diagnose the problem or refer you to a specialist in neurology or geriatric psychiatry. Health care professionals who specialize in Alzheimer’s can recommend ways to manage the problem or suggest treatment or services that might help. More information is available from the organizations listed below.
People with AD, MCI, or a family history of AD, and healthy people with no memory problems and no family history of AD may be able to take part in clinical trials. Participating in clinical trials is an effective way to help in the fight against Alzheimer’s. To find out more about clinical trials, call the Alzheimer’s Disease Education and Referral (ADEAR) Center toll-free at 800-438-4380 or visit the ADEAR Center website at www.nia.nih.gov/Alzheimers. More information is available at www.ClinicalTrials.gov.

For More Information

Here are some helpful Federal and non-Federal resources:
Alzheimer’s Disease Education and Referral (ADEAR) Center
P.O. Box 8250
Silver Spring, MD 20907-8250
800-438-4380 (toll-free)
www.nia.nih.gov/Alzheimers
A service of the National Institute on Aging (NIA), the ADEAR Center offers information and publications in English and Spanish for families and caregivers on diagnosis, treatment, patient care, caregiver needs, long-term care, and research related to AD.
Alzheimer’s Association
225 North Michigan Avenue, Floor 17
Chicago, IL 60601-7633
800-272-3900 (toll-free)
866-403-3073 (TDD/toll-free)
www.alz.org
Eldercare Locator
800-677-1116 (toll-free)
www.eldercare.gov
National Library of Medicine
MedlinePlus
www.medlineplus.gov
For more information on health and aging, contact:
National Institute on Aging
Information Center
P.O. Box 8057
Gaithersburg, MD 20898-8057
800-222-2225 (toll-free)
800-222-4225 (TTY/toll-free)
www.nia.nih.gov
www.nia.nih.gov/Espanol
Visit NIHSeniorHealth (www.nihseniorhealth.gov), a senior-friendly website from the National Institute on Aging and the National Library of Medicine. This website has health information for older. Special features make it simple to use. For example, you can click on a button to have the text read out loud or to make the type larger.
National Institute on Aging
National Institutes of Health
U.S. Department of Health and Human Services
October 2008

Although there isn't yet a cure for Alzheimer's, early diagnosis can help to treat the symptoms. Learn more about Alzheimer's disease by checking out some questions and answers from the National Institutes of Health.

Important Information: The Use of Expired Tamilfu for Oral Suspension Authorization

2009-10-21T23:19:00.000-07:00

This article is based on the FDA News about authorizing the use of certain lots of expired Tamiflu for Oral Suspension as part of the federal government's response to 2009 H1N1 Influenza public health emergency in July 2009 for the use that is beyond their labeled expiration dates. FDA has now authorized a lot to ensure that the Tamiflu for Oral suspension is available for patients during public health emergency. The authorization part for the Tamiflu for Oral Suspension are part of the Strategic National Stockpile and have been tested through the federal government's Shelf-Life Extension Program also known as (SLEP).

FDA evaluates comprehensively in every testing to assure the quality and the stability of the product because FDA conducts scientific testing and analysis to dermine if certain drugs are acceptable for use beyond their expiration date, under SLEP.

So as of now this drug is authorized by the FDA for use beyond their expiration dates are not required to be relabeled with information about the use of the products beyond their expiration dates. So health care professionals and patients might receive Tamiflu for Oral Suspension that is beyond its expiration date.

For Healthcare Professionals things to consider:

Be aware that specific lots of Tamiflu for Oral Suspension have been authorized for use beyond their expiration dates.
Understand that FDA has determined that data supports the use of certain lots of Tamiflu for Oral Suspension beyond their expiration dates.
It is good if you discuss this information with your patients with regards to any concerns they may have about using this product.
Any Tamiflu that is beyond its expiration date, you can verify it to this website in the FDA site: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm154962.htm
Consider discussing with patients, families, and caregivers the benefits of taking antiviral medications in relation to the potential risks of untreated illness.

Information for Patients, Families and Caregivers:

FDA has determined that certain lots of Tamiflu for Oral Suspension are authorized for use beyond their expiration dates based on scientific testing and analysis
Discuss any concerns you have about using Tamiflu for Oral Suspension with your healthcare professionals.
Make sure to follow all directions given by your healthcare professional when using Tamiflu for Oral Suspension
If you want to look up the lot number for your Tamiflu to see if it is authorized for use beyond its expiration date, go to http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm154962.htm and look for your lot number in the table under “Tamiflu Lots Whose Expiration Date Has Been Extended”.

Note: This contents of this article has been referred to the FDA website.

Guidance for Industry: Helicobacter pylogi-Associated Duodenal Ulcer Diseas for Adults for develop drugs treatment

2009-10-14T22:26:00.000-07:00

This article is only to serve as a guidance to share with you for comment purposes only and to assist sponsors in clinical drug development for treatment of adults with duodenal ulcers that is caused by the helicobacter pylogi (H. pylori) for the reduction of the duodenal ulcer recurrence. This is applicable to the development of drugs for treatment of adults with duodenal ulcers and is not addressed for treatment of children or those conditions that is associated with H. pylori, including gastric ulcers and non-ulcer dyspepsia.

There are about 95% of patients with peptic ulcer disease. Following bacterial eradication, ulcer recurrence rates have been shown to be significantly and reproducibly reduced compared to long-term acid suppressive therapy. In the year 1994, the National Institutes of Health consensus panel has recommended that "Since cure of the H.pylori decreases ulcer recurrence and facilitates healing, antibiotic therapy is definitely indicated for all H.pylori infected ulcer patients.

This program for development according to them that sponsors should conduct at least two adequate and well-controlled trials for purpose of establish safety and efficacy of antimicrobial-containing regiments to treat the H.pylori-associated duodenal ulcer disease.

To know more about the specific efficacy trial considerations, the study design, efficacy endpoints, clinical pharmacology and microbiology considerations, visit

Please Note: This references are from the FDA news release updates.

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Hepatology 2009

2009-10-08T22:00:00.000-07:00

This book is an Award winning in 2009 and is now available for free download for you.

This book is the winner of the second 25,000 Euro Amedeo Challenge Award who are Stefan Mauss, Thomas Berg, Jurgen Rockstroh, Christoph Sarrazin, Heiner Wedemeyer, et al.

What this book is about:

Hepatology is a rapidly evolving medical field that will continue to grow and maintain our excitement over the next few decades. Viral hepatitis is not unlike HIV was 10 or 15 years ago when the retrovirus began to be better understood and treatable. Today, Hepatitis B viral replication can be suppressed by potent antiviral drugs, although there are risks regarding the emergence of resistance. Strategies to enhance the eradication rates of HBV infection still need to be developed. On the other hand, hepatitis C virus infection can be eradicated by treatment with pegylated interferon plus ribavirin. However, particularly in those infected by HCV genotype 1, the sustained virologic response rates are still suboptimal. Many new antiviral drugs, especially protease and polymerase inhibitors, are currently in preclinical and clinical development and the first data from larger clinical trials provide some optimism that the cure rates for patients with chronic hepatitis C will be enhanced with these new agents. In other areas of hepatology like for example the hereditary and metabolic liver diseases, our knowledge is rapidly increasing and new therapeutic options are on the horizon.

This book is helpful in this rapid growing world that changes from time to time. This issue about viral hepatitis and other liver diseases are a global burden and timely information which is important for physicians, scientists, patients and other health care officials from all over the world.

This book has become an international standard and therefore can help a lot of health care providers out there. If you would like to read this book, you can download it for free here in pdf format in courtesy of Hepatologytextbook.com.

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Basic Principles of Drugs

2009-10-06T00:27:00.001-07:00

This are the Basic Principles of Drugs:

Identify the five basic principles of drug action.
Explain nursing assessments necessary to evaluate potential problems associated with the absorption of mediations.
Describe nursing interventions that can enhance drug absorption.
List three categories of drug administration and state the routes of administration for each category.
Differentiate between general and selective types of drug distribution mechanisms.
Name the process that inactivates drugs.
Identify the meaning and significance to the nurse of the term half-life when used in relation to drug therapy.

Drugs for people suffering from migraine

2008-11-28T01:39:00.000-08:00

Migraine is merely similar with headache, the difference is that migraine is more painful wherein you will experience visual disturbances including distorted vision, zigzag patterns or flashing lights. Symptoms of migraine includes intense aching of head, often on one side of the head only, vomiting, sensitivity to light, smell and sounds. Migraine normally last between 3 to 72 hours. It is still a subject for research if what causes migraine, but for many people suffering from it says that migraine could be a cause of stress, lack of food intake or irregular meals, overtiredness, sleepless nights, extreme emotions, environmental factors and climatic conditions.

Migraine attacks to different people. So if you suffer from this kind of very painful headache better take Midrin, or Maxalt (rizatriptan). Midrin is used to ease tension and migraine headaches. For migraine headaches, take midrin at the first sign when headache occurs as prescribed by your doctor. You will usually take one capsule every hour only as needed until headache is relieved. You should not take more than five capsules in a 12 hour period; just follow the prescription of the doctor. This kind of drug should be used only as needed and not as a usual basis.

You can also use Maxalt (rizatriptan) to treat migraines. It helps patients to relieve headaches, nausea and vomiting. If the first dosage you take will only partially relieved you, then you can take a second dose after 2 hours or as prescribed by your doctor. Do not take more than 30 milligrams in a 24 hour period. For more dosage considerations read the Patient Information Leaflet for more information.

Over the Counter and Cold Medications

2008-11-06T08:59:00.000-08:00

The Food and Drug Administration has notified healthcare professionals and their consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying product labels for over the counter drugs for consumers for cough and cold medicines to state “do not use” in children under 4 years of age.

That is why the FDA supports the CHPA members to help the prevention and the reduction for the misuse and to better give more information to consumers about the safe and the effective use of these products for children. What is FDA has done is to continue to assess the safety and efficacy of these products and to revise its Over the Counter list of approved ingredients and amounts for these medicines. Elders, parents and caregivers should be given notice and should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to their children and should therefore is deemed important to consult their healthcare professionals first if they have any questions or concerns.

Drug therapy treatment, how can it help you?

2008-10-28T20:08:00.000-07:00

It is important to take good care of ourselves especially when one of our family members needs drug therapy, mental illness, alcohol abuse, anxiety disorder, substance abuse. Like for instance, substance abuse can lead to mental illness and of course we care about our family, and he/she needs our help, therefore we can suggest that it is important for him to find successful drug treatment. And at that in receiving drug treatment, we have to find one that gives good service, reputable company and one where our family can receive affordable drug therapy wherein they are reliable. We can find that on Cliffside Malibu, a drug treatment center that provides one of the best services you can find.

Patients can receive different kinds of therapy, so they have to help their own selves first, involve in individual or a group therapy. Especially when a patient is experiencing depression, an affordable drug treatment can help them on the process, as it cannot obviously be resolved overnight, it takes a lot of time, effort and patience to undergo the treatment. So with this services, to undergo with the drug treatment, they can be supportive, always be there for you as you move on the process of healing yourself. And when you’re treated, you’ll become a more better person, and experience a joy that is difficult to explain.

Cinryze

2008-10-18T21:51:00.002-07:00

As has been previously discussed with this drug: Cinryze. It has been announced by the Lev Pharmaceuticals, Inc. that the US FDA has approved a new drug called: Cinryze according to New York's Business Wire Last October 10 2008. A CI inhibitor for routine prophylaxis against any angioedema attacks for adolescent and adult patients that has a hereditary angioedema which is also known as CI inhibitor deficiency. Expecting thatt this drug will be out and available for prophylaxis against HAE later this year.

An opinion from an MD professor Michael Frank in Pediatric Allergy and Immunology Division at the Duke University of Medicine states that such illness has been life-threatening, constraining and truly debilitating. He also added that with the approval of this therapy, shown to safely decrease HAE attacks, represents the potential for patients for longer life and health assurance.

Nonetheless, considered as the first and only FDA drug approved CI inhibitor therapy, the US Hereditary angioedema is characterized by these symptoms such as painful, distracting, and sometimes fatal swelling of the extremities, face, genitals, abdomen, and laryngeal tact. Usually this attack affects an estimation of about 10,000 people and are often unpredictable, spontaneous or precipitated by either emotional or physical stress.

Patients with the illness will have access to a therapy that helps reduce the requency and severity o such debilitating and potentially life threatening attacks. and as mentioned by a CEO Chief Executive Officer Joshua Schein, Cinryze drug can help patients live, healthier, more productive and predictable lives.

Having the provision of support services like benefit coverage investigations, pior authorizations and broad-based reimbursement assistance for patients and health care providers, will helpthe program excel and assist patients by securing an adequate insurance coverage for Cinryze drug.

Cinryze approved by the FDA for Prophylaxis against Hereditary Angioedema attacks

2008-10-14T05:23:00.000-07:00

It has been announced by the Lev Pharmaceuticals, Inc. that the U.S. FDA has approved the drug called: Cinryze according to New York’s Business Wire last October 10, 2008 which is a C1 inhibitor (human) for routine prophylaxis against any angioedema attacks for adolescent and adults patients that has a Hereditary Angioedema (HAE) which is also called as C1 inihibitor deficiency. It is expected that this drug will be out and available for prophylaxis against HAE later this year.

This is the first and only FDA drug approved C1 inhibitor therapy for routine prophylaxis against HAE attacks in the U.S. Hereditary angioedema is characterized by these symptoms such as that it is painful, debilitating and sometimes fatal swelling of the extremities, face, genitals, abdomen and laryngeal tract. Usually this attacks affect with an estimation of about 10,000 people in the United States that are often unpredictable and may also be spontaneous or precipitated by either emotional or physical stress.

An opinion from Michael Frank, MD, professor, Pediatric Allergy and Immunology Division, Duke University School of Medicine said that “Until now, living with HAE has been a life-altering, constraining and truly debilitating experience” and also added that “The approval of this therapy – which has been shown to safely decrease HAE attacks in these patients – represents the potential for patients to live a more normal life.”

Patients with HAE will have access to a therapy that helps reduce the frequency and severity of such debilitating and potentially life-threatening HAE attacks, as mentioned by Joshua Schein who is a (CEO) Chief Executive Officer” of Lev. He also said that Cinryze can help these patients live healthier, more productive and predictable lives.

There will be a provision of support services like benefit coverage investigations, prior authorizations and broad-based reimbursement assistance for patients and health care providers. With the help of this program it will assist patients and health care providers by helping to secure adequate insurance coverage for Cinryze C1 inhibitor. The company assures that all patients may benefit from this therapy.

Learn how to stitch up wounds from Apprenticedoctor.com

2008-09-22T20:53:00.000-07:00

When you are a medical student and you are required to have skills especially in thetarget=new" hospital, in emergency cases and more, one of the skills that is important in becoming a doctor especially in surgery is to learn how to stitch up wounds. Of course, at first it is not that easy at all, it takes a lot of practice and become good at what you are doing.

So with this one you need to practice more everyday not just once but several times to make it perfect. In the Apprenticedoctor.com they can guarantee your own suturing course and kit with all the course materials you need for this one. Included are interactive CD-ROM that gets to teach you the most basic principles in suturing a wound and caring for the wound, with illustrations, detailed instructions and more. Not only that but they also have an e-book for this one at the most affordable price and with good services and good products that can teach you how to learn to become a good surgeon and medical professional. Since we very well know that it is not easy, they help you with all the materials that you need and with more tutorial from them through their CD-ROM and more instructional materials. As the saying goes: Practice makes perfect.

Mitral Valve of the heart - what about it?

2008-09-21T07:13:00.000-07:00

Mitral valve is an inflow for the main pumping chamber of the heart, on our left ventricle. It functions to pressure from the superior surface of the valve wherein it allows blood to flow into the left ventricle during left systole or known as the contraction and then it closes at the end of atrial contraction to prevent the blood to back flow into the atria during the left ventricle systole.

Its normal cardiac cycle is that the atria contracts first then it fills in the ventricle. And at the end of ventricular diastole is that the bicuspid valve shuts down that then prevents backflow as the ventricle begins its systolic phase.

So the importance of this when abnormality occurs in the mitral valve of the heart is that it needs to undergo mitral valve surgery or mitral valve replacement.

The process of this is important that is done by cardiac surgeries by the Maryland Heart Center where they specialize in this areas. Mitral valve repair is a procedure to treat the narrowing and the leakage of the mitral valve.

Health-pedia - taking care of our health

2008-09-21T05:59:00.000-07:00

It is deemed important when we get to take good care of our own health. Of course, prevention is better than cure. Not only general terms of health but specifically like men’s health, colon, oral care, our skin and more.

Health-pedia.com gives on of the products that is highly recommended for us in terms of losing weight. One of their weight loss products are the Alli Weight loss pill, it is safe when used as directed because it does not work in your heart and brain but rather in the digestive system. Suppressing ones appetite is also good like the one they call the Caralluma Burn, it is just simply natural since it has clinical research that helps suppress ones appetite. The Dietrine Carb Blocker is 100% safe and stimulant free natural product. This kind of product is research-supported with botanical ingredients. It works by which the body breaks down the carbohydrate molecule with alpha amylase, which is known as an enzyme that is produced in the pancreas. It is an all-natural nutritional ingredient which is extracted from white kidney beans. It is absolutely safe and effective. Not only this product but the same goes with their other products as well.

As when it comes to women’s health products, usually women during the time of their menstrual period they tend to get agitated because of the changes in their hormones. When women wants to have mood stabilizer during their menstrual period, it is good to have Native Remedies Femalite that supports the feelings of well-being that is addressed to what we call the “blues” that is experienced by women during their pre menstrual period. Not only that but it also relieves cramps and aches felt by the person itself. But when it comes to monthly bleeding during menstruation what helps are the Native Remedies Mens-reduce.

When one takes good care of his/her own skin, to maintain its soft, supple appearance and to have trouble free skin from Native Remedies Clearskin-e cream is good. A lot of things in life we learn, it is better to take good care of it now, and experience good health since it is hard when a person has to do the cure and to undergo surgeries and treatments. Supplements are vital in our body and can help us a lot, not only the present but also for the future, for it is true that health is wealth.

How Medical Alarm is important for safety and protection of our home

2008-09-14T10:38:00.000-07:00

If there is one thing that your home needs, that is protection and safety. In cases of emergency, and you need help, but your grandma is helpless because she is only the one left at home and she can barely move herself anymore, so how can she get help? These are instances in life where we rarely expect to happen, but in reality, it does happen. And it even occurs at the most unexpected times of our life.

So when we want safety not only for our parents or grandparents but also for us and our kids at home, we need one that can detect especially with major cases like intruders inside the house, if your grandmother is lost or does not know where she is going. There is what we call the GPS Bracelet that tracks her wherever she is, this device is very useful so when she is lost, it can track her wherever she is at that very moment.

Medical Alarm is indeed a lot of help especially nowadays that life is tough and everybody is busy with work and all that. One good uses also is Tele-Assist from Brickhouse Alert, they provide free brochure from their items from which this Tele-Assist is good for your home safety, for intruders, and when grandma falls and is not able to push that panic button, it can get you help immediately. To make it simple, it is like having a helper at home that gets to watch you just in case of any emergency.

Magnetic Therapy Products

2008-09-07T18:33:00.000-07:00

As the saying goes: Health is wealth. Yes it is indeed, when one get to takes good care of one self, staying a healthy lifestyle is the best way to live and enjoy life. We sometimes experience a lot of stresses in our life that we feel our neck and our back strains, there are times that we cannot even go to sleep right away at night. Supplements really does help a lot like Magnetic therapy from which they are relief organics that helps our body to naturally heal and relieve the pain from our back, to have a restful sleep. Magnet therapy is a supplement that helps our body to perform well despite the strenuous life we experience.

There are such Magnetic Therapy Products like the Natural HGH Support Supplement which performs by decreasing our blood cholesterol up to 8.5% and increases our good cholesterol and decreases by 15% our bad cholesterol simply within two weeks. They are therapies certified health magnets for immediate healing of inflamed joints, sleeping problems, sports injuries, controlling our weight, or when we experience ear ringing. As this products gives one a lifetime guarantee with no need of repurchasing such as the large magnetic wafers. The effectivity is simply good and tested as it supports the body’s normal healing.

Kaiser Health Plans

2008-09-01T20:16:00.000-07:00

California Kaiser health plans is known for its good service, low-cost and affordable health plans. Time is gold. The earlier you got your health insurance, the more secured you are since health is wealth especially for your kids, in short, your family. It depends upon the health insurance that a person choose to have like individual, family or senior health plans.

It is important to provide protection against any injury or illness. Since Kaiser Permanente health plans is one of America’s largest non-profit health plans where the provision of their services aside from Kaiser health plans are Health savings accounts, Medicare, Managed care, Long term care and Medicare and a lot more. They are the only California health plan to make the National Committee for Quality Assurance list of the best health plan serving 8 million people in 9 states already. A good health insurance company is one that best gives good service and render truthfulness, privacy and confidentiality to their members.

Drug treatment center

2008-08-31T06:09:00.000-07:00

When a person who is into drugs has finally decided to undergo the Drug Rehab Program, we already know that this process is not easy neither to be treated is not overnight. It is a process that one has to undergo under a lot of challenges, but with support from their family, naturally that does help a lot.

Of course, a person who is into Drug abuse has to choose the right Drug Treatment Center, with good support and services and definitely with the right training and assistance from the center. Certainly Addiction Treatment is the best way to get treated for a patient who is into drugs. Through all of this, the patient itself must have to understand his/her own situation and definitely not to be come too much dependent on the staff, the trained personnel, but the person itself has to understand the nature of addiction itself because this one is a trying process indeed. Not only that but also the patient must have to understand the full functional dynamics of the treatment so its on road to recovery, there is a brighter future that lay ahead of him. Overcoming it may be hard, it may be a lot of struggle but at the end of every tunnel, there is light.

Colloidal Silver

2008-08-31T05:55:00.000-07:00

Colloidal Silver are known for maintaining a good immune system, the importance of the immune system in our body is that it is to help ourselves be prevented from having any kind of disease in a short period of time. Collid means silver particles, it is not silver ions. When we have a good immune system, it helps a lot. This may take various concentrations of ionic silver, silver colloids and silver proteins that is purified in water. It helps by killing bacteria through the oligodynamic effect (this means that this are effects of toxicity of metal-ions on living cells, algae, spores, fungus, virus and many more) by inhibiting the expression of enzymes and other proteins that is essential to ATP (Adenosine triphosphate) production same as goes with the Liquid Colloidal Silver.

The highest particle surface are for maximum effectivity is the True Colloidal Silver, it is a mineral supplement. It is known as a natural mineral supplement which is 500 times greater than other products with no any adverse side effects that surely depends on the product like the one known as Mesosilver. It contains only pure water and pure silver that is made by using the highest purity, sterile reagent grade deionized water. With regards to all of this, it is very important to really take good care of your body.

Stavzor – drug treatment for Bipolar Disorders, Epilepsy, Seizures and Migraine prophylaxis.

2008-08-24T20:58:00.000-07:00

Over the past decades, more and more drugs have been discovered as response to the increasing rate of diseases. People have been getting problems through migraine prophylaxis, bipolar disorders, epilepsy, and seizures. It’s a good thing that Noven Pharmaceuticals, Inc. has answered by producing a drug that will cure these illnesses. This new drug is known as Stavzor, a valporic acid capsule that is made to minimize the adverse events associated with bipolar disorders.

Stavzor was approved on July 29, 2008 by the U.S. Food and Drug Administration (FDA). It is available in various strengths, including 500 mg, 250 mg, and 125 mg. Because it is made of soft gel capsule, this drug is easier to swallow. Not only that, Stavzor is also made of an advanced enteric technology that is primarily designed to greatly minimize gastric irritability and reduce reflux from patients suffering. Remember to always have a check with your doctor about the dosage before you get to decide to take the drug so that you will not have any problems with it. If the medication is prescribed by your doctor into taking Stavzor, see to it that you take the medicine at a scheduled time. It is also important not to commit a mistake by stop taking the medication unless the doctor tells you to do so. Otherwise, you may experience having physical problems if you stop taking the doses suddenly and experience some kind of side effects upon taking this drug.

Taking Stavzor will somehow create some side effects. Some of the most common side effects associated in taking this medicine include vomiting, nausea, drowsiness, and dizziness. Another important thing to remember: do not take Satvzor if you have been diagnosed with significant hepatic dysfunction or hepatic disease, urea cycle and disorders. Do not also use this drug if you are pregnant, as it could cause some teratogenic effects on your offspring. Remember also to call your doctor immediately if you are having enlarged lymph nodes, fever or rashes because you may be hypersensitive to your medication.

Information about New drugs and/or medications

2008-08-15T05:58:00.000-07:00

The medical world is now flooded with various advancements such as the creation of new drug and medications. Pharmaceutical companies have several releases of medicines under different brands and packaging. To regulate this situation and to ensure that these medicines cannot risk or hard human health, the United States Food and Drug Administration set out the IND or the Investigational New Drug. Under this program pharmaceutical companies are required to seek permission to ship an experimental drug to clinical investigators before its sale and marketing application can be approved. In addition this program also required if the drug has a new indication, change in the approved route of administration or dosage level, changed in the approved patient population or increase of risk and its significant change in the promotion of an approved drug.

If new drugs and medications will be subject for IND application the three main broad areas which are animal pharmacology and toxicology studies, chemistry and manufacturing information and clinical protocols and investigator information have to be passed. On the first area, which is the animal pharmacology and toxicology studies, the initial testing of the drug are made with animals or humans. The efficiency and safeness of the drug is assessed under this area. The next area that has to be satisfied is the chemistry and manufacturing information, under this the chemical composition, manufacturing methods and stability of the product is considered. This is done to ensure that the company can adequately produce supply whenever the demand on the market grows. The last area that has to be satisfied is the clinical protocols and investigator information wherein clinical trials have to be fulfilled. Here professional medical practitioners oversee the administration of the experimental compounds. This aims to ensure the overall effectiveness of the drug.

Once these three major areas are passed by the new drugs and medications, the result will be reviewed under the IRB or the Institutional Review Board. Another qualifying exam is a must to double check the result made in the IND. If you are a manufacturer or a consumer, you have to be thankful of these government policies. It’s not a strategy to just give you an inconvenience, but it only assures the well being and health of all the citizens.

RX Medications Affiliate

2008-07-09T04:56:00.000-07:00

When gas creates a big problem in our economy because it never cease for the price of the oil to lower down. Same goes with the price Medications because nothing is cheap nowadays. For consumers, their privacy is important for them and a desire for convenience has driven millions of consumers to order online through the internet to buy their own pharmaceutical needs.

Being an RX Affiliate gives a good commission and they are one of the most competitive affiliates in Medicine online. Those who are affiliated with them get to receive of up to 40% commission on the initial order value and not only that because they also give Full Commissions for affiliates for future purchases.

RX Affiliate Resources you can see have lots of advantages because aside from their prompt customer support, they have a 40% commission like mentioned above for every order and their commission percentage is based on the product type and sales volume. They have the highest payout in the industry and weekly payouts from offshore account. They have a provision of own campaign tracking, a top converting templates, and an impressive traffic reports. A very good one, highly recommended Affiliate company for those who would like to join them.

Sunset Malibu - Drug Rehabilitation Center

2008-07-03T06:36:00.000-07:00

Sunset Malibu is one of the top California drug rehabilitation centers, they are highly acclaimed top notch treatment for individuals and families that seeks treatment from pain of alcoholism or drug abuse, hoping that they can find sanctuary.

It is necessary also to undergo addiction treatment which could lead to addiction recovery because through this it could save lives of those people who needs and who are determined to be treated. Those who are drug dependent would have to learn their lesson since it is important that they do and at that undergoing such treatment takes a lot of effort, it is not easy at all but eventually when addiction treatment patients want it to work, it will work that is why it is known to be a labor of love.

Hardwork is important to undergo drug abuse treatment, since it is a fact that only patients who get the proper drug treatment from a qualified rehabilitation center stands a chance of achieving a meaningful drug recovery because when you are on Prescription drug abuse, it is really hard to beat it alone. It entails commitment and a thorough understanding of such treatment. Here, in Sunset Malibu is one of the most private and luxurious drug and alcohol treatment center located in Malibu, California. They promote long-term sobriety and addiction recovery with a wide variety of treatments and holistic care and medications such as yoga, massage, acupuncture, herbology and more.

Lipitor

2008-06-28T10:22:00.000-07:00

Lipitor which its generic name is Atorvastatin calcium and the brand name as Lipitor is prescribed to lower cholesterol. Your own doctor may be prescribing a special diet if you have high cholesterol or high triglyceride level and you’ve not been able to lower your readings by diet alone. The drug helps to clear harmful low-density lipoprotein which is also known as LDL cholesterol out of the blood and it does help limit the body’s ability to form new LDL cholesterol. This drug is known as HMG-CoA Reductase Inhibitors which is the newest antilipemic agents available which is also known as statins. The statins which competitively inhibit the enzyme responsible for converting HMG-CoA to mevalonate in the biosynthetic pathway to cholesterol in the liver. So this drug indicates the reduction in liver cholesterol that increases the removal of LDL may from the circulating blood.

Your doctor, however may prescribe this drug to reduce any chances of having a heart attack or developing a heart disease if you have this following factors such as at age of 55 years or older, smoking, having a high blood pressure and have a family history of early heart disease including having low levels of high density lipoprotein also known as HDL or good cholesterol.

This drug is prescribed only if the diet, exercise and weight loss fail to bring your cholesterol level under control. It is important to remember that this drug is a supplement and not a substitute for other kind of measures.

It is advised that the drug is taken once a day either with food or without a food. May be taken in the morning or in the evening but should hold to the same time each day. Generally, the drug begins working within 2 weeks. It should be stored at room temperature. Some common side effects includes abdominal pain, abnormal heartbeat, allergic reaction, arthritis, back pain, chest pain, constipation, diarrhea, flu symptoms. But it is not advised to take the drug during pregnancy or even while breastfeeding or if you have liver disease and it gives you an allergic reaction.

Ambrosia – a treatment center for substance abuse, addiction and alcohol treatment

2008-06-20T07:33:00.000-07:00

Ambrosia is a world-class treatment center for drug rehabilitation, addiction and alcohol treatment located in the quaint but a modern town of Port St. Lucie, Florida from which they tend to accept clients from 18 years old and older.

It can help the client in a spiritually, mentally and physically kind of way that would exactly for them to lead a new way of life. The treatment center is licensed by the State of Florida to treat patients of all types specifically in drug abuse and alcoholism. Their service is essentially guaranteed, one of a kind because of the fact that they have 20 years of experience treating patients with substance abuse and drug addiction treatment from all walks of life.

When it comes to the addiction treatment they have a known service is called: Day/Night \Treatment with a community housing. Clients at this point are well monitored 24 hours, and let the clients to live in a community that is very supportive while on treatment. They render services like Individual counseling, groups counseling, counseling with families, substances abuse and education, anger management, communication skills development. It also involves non-verbal therapies like the music therapy, recreation therapy and more to provide clients a means of self-expression. They also have an Intensive Outpatient treatment and simply an Outpatient treatment. Whether you choose what kind of service you’d like to receive, it can help clients to achieve stability in regards to their disorders, they would be able to cope up with it.

In addition, when one decides to undergo on the family program has been known to be free of charge and also available to family and significant others of the client treatment in Ambrosia. Naturally, the progress of the client may not be exactly fast, and cannot be achieve in a rush, it should be expected for the family members that their client will undergo the treatment slowly and yet the effectivity of the treatment has a promising results and depends upon each client itself. It is important to be aware of the facts that when you see your love one that needs this treatment for those who are substance abuse, drug addiction, you don’t have to turn a blind eye, instead why not just face the facts and do the right thing for the benefit of your love ones because it can make a great change for your love one’s benefit, that cannot only make a great change at the present, but the future as well.

At this, the Ambrosia Substance Abuse Treatment Center provides good education, guidance and a well-established support for families and their loved ones to the impact that has resulted to their very own family member that’s been affected by substance abuse and chemical dependency since this problem create more harm than it can do you any good. It is very beneficial for clients when they tend to undergo such kind of treatment to achieve a good life in the future and for their own future to come.

Treatment for Pain – Remoxy, a new drug application announced by Pain Therapeutics and King Pharmaceuticals.

2008-06-16T10:39:00.000-07:00

On June 10, 2008 Pain Therapeutics, Inc. and King Pharmaceuticals Inc announced that there is a New Drug Application and has already been submitted to the U.S. Food and Drug Administration (FDA). The drug is known as a unique long-acting formulation of oral oxycodone from moderate to severe chronic pain that is exactly designed to resist common methods of prescription of drug misuse and abuse.

Both the companies have believed that the New Drug Application (NDA) that the drug, Remoxy has benefits from years of rigorous and independent scientific and clinical testing. The NDA includes animal and human data from extractability, pharmacokinetic, toxicology and clinical studies.

According to the King’s chairman, President and CEO, Brian A. Markison said that “The NDA submission for Remoxy is an important advance in meeting the pain management needs of patients and prescribers concerned with addressing the risks of prescription pain medicine misuse and abuse within our communities.”

The thing with this is that there is a priority review designated that is given to drugs that has in reality, undergoes advances in treatment or may be providing a treatment where there are no adequate therapy existing. So when they say Priority Review, it simply defines the time that it takes for the FDA to review an NDA which is reduced from 12 months to about 6 months.

New Drugs: TREXIMET - migraine relief drug

2008-04-22T07:41:00.000-07:00

Migraine headaches tend to continue to be an important problem wherein an estimated 29.5 million Americans has nearly have half of which are not diagnosed. According to the International Headache Society's diagnostic criteria, migraine is characterized by recurrent headaches from which if it is untreated, typically would last from 4 to 72 hours, with symptoms including moderate to severe headache pain, throbbing head pain, head pain located on on side of the head and also a head pain aggravated by routine activity, sensitivity to the light and sound, nausea and vomiting.

The generic name of Treximet is sumatriptan and naproxen sodium. There was a clinical studies that showed that Treximet has relieved the pain of more patients compared to the drug sumatriptan 85mg. It has provided a greater percentage of patients with migraine pain to have been relieved at two hours compared to that drug. Also, Treximet has provided more patients sustained migraine relief from 2 to 24 hours compared to the individual components.

Treximet has been well studied where more than 3,700 migraine sufferers of nearly 30,000 migraine attacks in clinical studies. The product is expected to be available in U.S. pharmacies in the middle of May 2008. The approval of this drug was based on that data from two identical double-blind, randomized, placebo-controlled, parallel-group, multicenter studies of more than 2,900 migraine sufferers.

The drug was generally well-tolerated in these pivotal studies. The most common related adverse events that has been reported within 24 hours of taking the drug Treximet were dizziness; nausea; somnolence; chest discomfort and chest pain; neck, throat and jaw pain, tightness and pressure; numbness/tingling; upset stomach and also dry mouth. The drug was known to be studied in a one-year open-label tolerability and safety study of 565 patients who treated of about nearly 24,500 migraine patients with the active drug. Recent study shows that according to a one-year study treated an average of five migraine attacks per month with Treximet.

rescription Treximet is indicated for the acute treatment of migraine attacks, with or without aura, in adults. Treximet should only be used where a clear diagnosis of migraine headache has been established. Treximet may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Treximet contains a non- steroidal anti-inflammatory drug (NSAID). NSAID-containing products cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. Treximet is contraindicated in patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes and in patients with other significant underlying cardiovascular diseases. Treximet should not be given to patients in whom unrecognized coronary artery disease is predicted by the presence of risk factors without a prior cardiovascular evaluation. Treximet should not be given to patients with uncontrolled hypertension because the components have been shown to increase blood pressure.

FDA newly approved drug for Major Depressive Adult Patients: Pristiq

2008-03-19T08:13:00.000-07:00

The new drug approved by FDA: Pristiq (desvenlafaxine) on February 29, 2008 which is a structurally novel, once-daily serotonin-norepinephrine reuptake inhibitor (SNRI) to treat adult patients with the major depressive disorder by Wyeth Pharmaceuticals. Wyeth expects for it to begin its shipping on the second quarter of 2008.

According to the President and CEO of Wyeth, Pristiq is Wyeth's 4th new drug to receive approval in the last twelve months which demonstrates their ability to achieve success through rigorous scientific process of discovery and development. He said that they look forward to working with the FDA and other regulatory authorities around the world to continue to bring important new medicines to patients who needs them.

Philip Ninan, M.D. who is the Vice President of Wyeth Medical Affairs says that Pristiq is an important new therapeutic option for patients and clinicians since that there is no single therapy that works for all people with major depression. He said that the drug is approved at a once-daily 50-mg dose that does not require titration, allowing physicians to start their patients at the recommended therapeutic dose.

The efficacy of the drug Pristiq as a treatment for major depression on patients was establish in a four 8-week, randomized, double-blind, placebo-controlled, fixed-dose studies in adult outpatients who met the Diagnostic and Statistic Manual of Mental Disorders (DSM-IV) criteria for MDD. At the recommended dose of the 50 mg, the discontinuation rate due to an adverse experience for Pristiq was similar to the rate for placebo.

Side effects of a lot of antidepressant therapies can cause some patients to stop taking their medication. The most common observed adverse effects in patients who takes the drug Pristiq for MDD were anxiety, hyperhidrosis, constipation, nausea, dizziness, decreased appetite, somnolence (sleepiness), specific male sexual function disorders, and insomnia.

Prstiq is contraindication for patients with known hypersensitivity to the drug or venlafaxine. And must not be used concomitantly with an MAOI or within 14 days or stopping the MAOI drug. Allow 7 days after stopping Pristiq before starting a MAOI.

FDA Approves Aloxi injection for the Prevention of Postoperative Nausea and Vomiting

2008-03-10T03:24:00.000-07:00

In New Jersey on March 2, 2008 by PRNewswire the company named: Eisai Coroporation of North America, its U.S. subsidiary, MGI Pharma, Inc. and Helsinn Healthcare SA announced on that day that the US FDA has approved Aloxi which the medical term is palonosetron hydrochloride which is an injection for the prevention of postoperative nausea and vomiting known as PONV for up to 24 hours following surgery. But the study of its efficacy beyond 24 hours has not been demonstrated as of yet.

Aloxi, is a receptor antagonist that is approved by the FDA for the prevention of acute and delayed nausea and vomiting which is associated with initial and repeat course of moderately emetogenic chemotherapy, and for the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy.

The incidence of adverse reactions was indistinguishable among all treatment groups from which it includes placebo. According to Hajime Shimizu, the Chairman and the CEO of Eisai Corporation of North America "This new indication is in keeping with our human health care mission to address the unmet medical needs of patients, a single intravenous dose of Aloxi can provide anesthesiologists with an effective option for the prevention of PONV for up to 24 hours".

This is considered as an important milestone for the drug Aloxi, given that the increasing use of antiemetic prophylaxis during surgical procedures" according to Riccardo Braglia, CEO of Helsinn Healthcare SA.

Aloxi is the first and the only 5-HT3 receptor antagonist to be indicated for the prevention of acute and delayed nausea and vomiting which is associated with initial and repeat course of a moderate emetogenic chemotherapy, and for the prevention of acute nausea and vomiting associated with initial repeat courses of highly emetogenic chemotherapy.

The drug Aloxi is contraindicated to patients who have hypersensitivity to the drug of any of its components. The most common adverse reactions of the drug Aloxi are chemotherapy-induced nausea and vomiting trials which include headache and constipation.

For more information about the drug go to: http://www.aloxi.com

A new study conducted for target therapies of Breast Cancer which has established a model for Global Clinical Trials.

2008-03-01T06:45:00.000-08:00

On Feb. 29, 2008 there are two targeted medications that is designed to treat an aggressive form of breast cancer which are now being tested in a new study which involves of about 8,000 participants in 50 countries across six continents – a clinical trial that investigators does hope can provide a new model for the global cancer research. As known, this trial, which is dubbed ALTTO which means Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization study, will be one of the first global initiatives from which there are two large, academic breast cancer research networks that covers different parts of the world that have jointly developed a study in which all the care and the collected data are standardized regardless of where patients are treated.

ALTTO is designed to answer the most pressing questions with regards to the use of two widely used cancer agents: from where whether one agent is more effective, which agent is safer for patients, and what benefit will be derived by taking the drugs separately, in tandem order, or together? The trial has been known to be randomized, Phase III study which is considered a gold standard method for proving drug effectiveness.

The trial is unusual from where it has two different designs which surely depends on whether patients with stage I or stage II breast cancer have already been treated with chemotherapy. The study will be compared with four different regiments of targeted therapy which is administered over a 52-week period. Patients will be randomized to receive either trastuzumab or lapatinib alone, or trastuzumab followed by lapatinib, or the two treatments are combined.

“It has been heard that there have been major improvements on the management of patients with early breast cancer in the last few years, so on this new study it has build on this knowledge and sets an example of the new era: good science, and a good worldwide collaboration” said Edith Perez M.D., oncologist in North Central Cancer Treatment Group at Mayo Clinic, in Jacksonville, Florida.

Clinical Trials: Stemcyte on application of Plasma – Depleted Umbilical Cord Blood Stem Cell Products

2008-02-22T23:12:00.000-08:00

According to PRNewswire in San Diego, California last February 21, 2008 the benefits of the plasma-depleted cord blood stem cell products were the actual subjects of about six abstracts that is presented on that week by StemCyte, Inc and its associates at the Bone Marrow Transplant (BMT) Tandem Meetings held in San Diego, California.

It has been reported that the abstracts obtained with the data is both for pediatric and adult patient populations which as known, were treated with StemcCyte’s mbilical cord blood (UCB) stem cell transplant products for multiple diseases from which of these diseases includes non-malignant diseases, blood cancers and thalassemia. StemCyte has submitted five abstracts from which three were already presented orally and the sixth abstract submitted by the researchers from the University of California, Los Angeles.

According to Kenneth J.Giacin, chairman and chief executive officer of StemCyte he said that “The BMT Tandem Meetings were an excellent opportunity for StemCyte to demonstrate its strength and its breadth of applications of our UCB stem cell products for treating patients with multiple diseases” and he also added that “We are pleased that our research associates were able to present this important data.”

StemCyte is a known company, a global leader in stem cell therapeutics with a marketed umbilical cord blood stem cell transplantation product. Its proprietary plasma depleted cord blood stem cell product have been used to cure hundreds of patients which has a life-threatening diseases. The company with its partners is actively involved in the development of a new umbilical cord blood based cell therapies and has the larges clinical study for using unrelated cord blood transplantation for thalassemia, one of the most common genetic diseases in the world.

HIV/AIDS: Epivir tablets for Pediatrics

2008-02-14T07:07:00.000-08:00

FDA has approved the new formulation of the Epivir tablets on February 7, 2008 which is specifically designed on appropriate pediatric patients who can swallow the tablets reliably. It is available in 150 mg scored tablets which allows for dosing recommendation in pediatric patients.

However, the recommended oral dose of the drug named is Epivir Oral Solution in HIV-1-infected pediatric patients 3 months to 16 years of age is 4 mg/kg twice daily (up to a maximum of 150 mg twice a day), which is administered in combination with antiretroviral agents. As the drug itself has also been made available for those who can take the solid dosage form as a scored tablet HIV-1-infected pediatric patients who weigh >=14 kg. But then if the child is unable to swallow the tablet reliably then it is advised that the formulation of the oral solution is prescribed.

Ortho Evra Contraceptive Transdermal Patch

2008-01-24T09:12:00.000-08:00

Audience: Reproductive healthcare professionals, patients: FDA modified the prescribing information for the Ortho Evra Contraceptive Transdermal (Skin) Patch to include the results of a new epidemiology study that is found wherein users of the birth control partch were at higher risk of developing serious blood clots, which is also known as venous thromboembolism (VTE), than women using birth control pills.

The changes of label is based on a study that is conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson. The patch was studied in women with the range of age from 15 to 44 years old. These findings supports an earlier study that has also said in women of this groups were at a higher risk for VTE. FDA has believed that Ortho Evra is a safe and it is an effective method of contraception when used according to the labeling, which really does recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about the use of Ortho Evra versus other contraceptive options.

View more on this on FDA

Stanford Study Finds Transplant Patient Thrives 2 Years After Stopping Immunosuppressive Drugs

2008-01-24T09:08:00.000-08:00

STANFORD, Calif., Jan. 23, 2008 - Luck smiled on Larry Kowalski when his brother agreed to donate a kidney Kowalski needed to live. He was even luckier that his brother's kidney was such a good match.

That last stroke of luck led Kowalski to connect with a team of researchers at the Stanford University School Medicine, whose efforts have enabled him for two years to live free of the heavy-duty drugs that transplant patients normally have to take for the rest of their lives.
The researchers describe Kowalski's case in a brief report to be published in the Jan. 24 issue of The New England Journal of Medicine on the technique they developed, based on 25 years of research by Samuel Strober, MD, professor of immunology and rheumatology. The journal issue also includes two reports from other research groups, describing their efforts to achieve organ transplantation without long-term immunosuppressive drugs.
Kowalski, now 50, was 3 years old when doctors discovered he had been born with only one kidney. His single kidney held out until he was 47. Then a blood test indicated that it was beginning to fail.

Kowalski's 49-year-old brother agreed to help, and that turned out to be crucial. His brother was a perfect fit of the six proteins most important in matching the immune systems of transplant donors with recipients.

Transplant recipients are matched as closely as possible with the donor organs to minimize the body's normal response to reject the organs. The biggest danger with organ transplantation lies not in the surgery, but in the recipient's own body rejecting the organ as a foreign invader. Without drugs to suppress that reaction, usually the recipient's immune system encounters unfamiliar proteins on the transplanted organ, attacks the organ and eventually destroys its function.

But unless the recipient has an identical twin, there will always be some minor differences between the organs, so even close matches require a lifetime of immunosuppressive drugs. Long-term use of these drugs can cause cancer, bothersome side effects and, most ironic for kidney transplant recipients, kidney damage.

The ultimate goal for transplant patients is to get their bodies to tolerate their donor organs without drugs. Transplant doctors have been trying to develop ways to do this for years, with little success.

The fact that Kowalski had such a good match with his brother's kidney made him an ideal candidate for the Stanford clinical study. The researchers were investigating whether a procedure that involved adjusting Kowalski's immune system, plus infusing blood cells from the brother who donated the kidney, could allow Kowalski's body to tolerate his brother's kidney.
The therapy was first developed in mice by Strober, the senior author of the study. In the last few years, Strober worked with Robert Lowsky, MD, associate professor of blood and marrow transplantation, to adapt this strategy from mice for human lymphoma and leukemia patients. The procedure combines localized blasts of irradiation and antibody treatments to tweak the recipient's immune cells. Then the recipient gets an infusion of blood cells from the donor. The procedure boosts levels of a type of immune cell called regulatory T cells. These cells function as the immune system's "peacekeepers" and can avert the attack that causes rejection.

When the Stanford transplant team approached Kowalski with the offer, he jumped at the chance that might allow him to forego a lifetime of immunosuppressive drugs.

In February 2005, Kowalski received his brother's kidney at Stanford Hospital. He was started on an immunosuppressive drug with the intention that it would be temporary. His only notable complication came about a month after his transplant, when Kowalski had to be hospitalized briefly for a fever. He returned to work as a restaurant owner three months after the transplant.
Doctors began to taper the use of the immunosuppressive drug and, after six months, Kowalski was drug-free.

"Essentially, my immune system contains half my brother's immune cells and half of my own," said Kowalski. "It's enough that my body thinks my brother's kidney is mine."

After all the mouse studies leading up to testing in patients, Kowalski's case is rewarding for Strober. "It's been a long, long road that ends up with clinical trials that could lead to somebody's benefit," he said. "Tolerance has been the goal for decades, and we are just now beginning to see the fruits of all that labor."

Kowalski could be called the poster child of the procedure so far, but others in the same research study haven't fared as well. Six other patients treated before him haven't been able to go off of their drugs, but their kidneys came from donors not as perfectly matched as Kowalski's was.
He was the first patient in a new iteration of the technique that is being tried only in perfectly matched donors and recipients. So far, one patient that followed Kowalski is showing promising results but is not yet off the drugs, said lead author John Scandling, MD, professor of nephrology and Kowalski's kidney transplant specialist.

The research team found Kowalski "remains in good health" 34 months after he stopped taking the immunosuppressive drugs. An interview with Kowalski shows this to be an understatement. Not only does he run four restaurants in California, but he bikes, snowboards, scuba dives, goes to the gym regularly and, most taxing of all, is the father of a 3-year-old. By anyone's definition, he is in great health.

"The idea of getting off drugs holds tremendous appeal for patients," said Scandling. "So far, there is hope, but we still have a long way to go."

This study was supported by a grant from the National Heart, Lung, and Blood Institute.
Others from Stanford who contributed to this work are: Stephan Busque, MD, associate professor of surgery; Sussan Dejbakhsh-Jones, research associate in immunology and rheumatology; Claudia Benike, research associate in pathology; Maria Millan, MD, adjunct professor of surgery; Judith Shizuru, MD, PhD, associate professor of blood and marrow transplantation; Richard Hoppe, MD, professor and chair of radiation oncology, and Edgar Engleman, MD, professor of pathology and of medicine.

Stanford University Medical Center integrates research, medical education and patient care at its three institutions - Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children's Hospital at Stanford. For more information, please visit the Web site of the medical center's Office of Communication & Public Affairs at http://mednews.stanford.edu/.

Contact: Mitzi Baker
mabaker@stanford.edu
650-725-2106
Stanford University Medical Center

Prilosec and Nexium Drugs: Studies of increased rates of cardiac events has no evidence according to FDA's safety reviews

2007-12-11T01:30:00.000-08:00

ROCKVILLE, Md., Dec. 10, 2007-Background: On May 29, 2007 AstraZeneca, the maker of Prilosec (omeprazole) and Nexium (esomeprazole), sent FDA data from two long-term studies in patients with severe gastroesophageal reflux disease (GERD) that were being treated with either Prilosec or Nexium. The studies were designed to assess the effectiveness of treatment with Prilosec, or Nexium, or surgery for severe GERD. Participants were randomly assigned to receive treatment with either a drug (Prilosec in one study and Nexium in the other) or surgery. During the studies, cardiovascular events raised a question about whether long-term use of these drugs increases the risk of heart attacks, heart failure, and heart-related sudden death in patients taking either one of the prescribed drugs compared to patients who received surgical treatment. On Aug. 9, 2007 FDA released an "Early Communication of an Ongoing Safety Review" of these drugs. The agency’s initial review determined that there was no increased risk of heart problems associated with long-term use of these drugs. At FDA’s request, AstraZeneca submitted a large amount of additional information about these and other studies and FDA undertook a comprehensive review of all available data regarding this potential safety concern. The following represents the agency’s current analysis of available data on these medications.

Current Information: FDA has completed a comprehensive, scientific review of known safety data for the drugs Prilosec and Nexium. While both of the long-term studies reported to FDA on May 29, 2007 collected safety data, the study protocols did not specify how heart problems, such as heart attacks, were defined or verified. As a result, evaluating the information that was gathered about the safety of both drugs in these studies was challenging. FDA’s assessment of the information from the data gathered was further supported by an additional analysis of 14 comparative studies of Prilosec, four of which were placebo-controlled. Although these studies were not specifically conducted to assess the risk of heart problems, and patient follow-up was incomplete, they do not suggest an increased risk of heart problems with the use of Prilosec or its newer formulation Nexium.

Based on everything now known at the agency, the reported difference in the frequency of heart attacks and other heart-related problems seen in the earlier analyses of the two small long-term studies does not indicate the presence of a true effect. Therefore, FDA continues to conclude that long-term use of these drugs is not likely to be associated with an increased risk of heart problems. FDA recommends that health care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs.

FDA approves the non-prescription of the drug : Zyrtec-D for Allergies

2007-11-13T20:58:00.000-08:00

In November 9, 2007 in Rockville, Md., the Food and Drug Administration (FDA) has approved the drug called: Zyrtec-D (cetirizine HCl 5mg and pseudoephedrine HCl 120mg), it is an allergy drug that is nonprescription used in adults and children 12 years of age and older. This drug is a combined antihistamine with a nasal decontestant.

Zyrtec-D has been available as a prescription drug since 2001 and it is now approved by the FDA as a noonprescription drug for the relief of symptoms that is due to hay fever and other upper respiratory allergies such as itchy, watery eyes, sneezing, runny nose, itching of the nose or throat, and also nasal congestion. The drug is also used for reducing the swelling of nasal passages and for relief of sinus congestion and pressure, and also for restoring freer breathing through the nose.

Hay fever and other allergies are the sixth leading causes of chronic disease. According to Andrea Leonard-Segal, M.D., Director, Division of Nonprescription Clinical Evaluation in the Fda's Center for Drug Evaluation and Research, "The approval of this widely-used drug for nonprescription use will enable many people to have access to another effective treatment for their allergy symptoms, this approval reflects FDA's commitment to bringing the prescription drugs to the over-the-counter market when they can be safely used without a prescription".

It is important that when you get to use this drug, you must also be aware of its common side effects which includes drowsiness, fatigue, and dry mouth. Sales of the drug are subject to certain restrictions in the Combat Methamphetamine Epidemic Act. This law places restrictions on the sale of products that contains pseudoephedrine, such as limiting the amount that an individual can purchase, and imposing record keeping requirements on the retail establisments that sell the product. Zyrtec-D is distributed by McNeil Consumer Healthcare, Fort Washington, Pa.

The U.S. FDA has approved: Abilify (aripiprazole) for adolescent patients with Schizophrenia

2007-11-07T07:12:00.000-08:00

On Nov 6, 2007 the place in Tokyo, Japan and Princeton, N.J. according to PRNewswire/Otsuka Pharmaceutical Co. Ltd., and Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration has approved the supplemental New Drug Application for the atypical antipsychotic Abilify (aripiprazole) and this serves as the treatment for schizophrenia in adolescents where the age ranges from 13-17 years old. Abilify in adolescents treats positive and negative symptoms of schizophrenia. This drug has been first approved by the FDA for the treatment of schizophrenia in adults on November 15, 2002.

Even now, it has been heard that the FDA has limited approval when it comes to treatment options for the adolescent patients with schizophrenia that is according to Robert Findling, M.D., Director of Child and Adolescent Psychiatry, University Hospitals Case Medical Center, Cleveland, Ohio. According to him "the approval of this new indication for Abilify provides an additional effective treatment option for these patients with schizophrenia".

It has been approved because their basis is the result of a six-week, it is randomized, double-blind, placebo-controlled study that has demonstrated significant improvement with Abilify as when compared to placebo on the primary efficacy endpoint, Positive and Negative Syndrome Scale (PANSS) Total Score.

According to Elliott Sigal, M.C., Ph.D., Executive Vise President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb "Schizophrenia is one of the most complex of all mental health disorders". He also added that "We remain committed to providing innovative therapies, such as Abilify, to help patients, including adolescents, living with schizophrenia".

About Abilify

The first and only available dopamine partial agonist, Abilify is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults. Abilify is also indicated for the treatment of schizophrenia in adults and adolescents (13-17 years old). Abilify Injection is indicated for the treatment of adults with agitation associated with schizophrenia or Bipolar I Disorder, manic or mixed.

Initially approved in November 2002, over 12.5 million prescriptions have been written for Abilify in the U.S.(3) through June 2007.

Abilify is available by prescription only. Abilify tablets should be taken once daily with or without food and are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg strengths. Abilify Discmelt Orally Disintegrating Tablets are available in 10 mg and 15 mg strengths. In addition, Abilify is available in a 1 mg/mL nonrefrigerated oral solution and as a single-dose ready-to-use solution for intramuscular injection 7.5 mg/mL. In adult patients, the recommended Abilify oral target dose is 15 mg to 30 mg/day in Bipolar I Disorder and 10 mg to 15 mg/day in schizophrenia. In adolescent patients with schizophrenia, the recommended Abilify oral target dose is 10 mg/day (with a starting dose of 2 mg/day which was titrated to 5 mg after 2 days and to the target dose of 10 mg after 2 additional days). The 30 mg/day dose was not shown to be more efficacious than the 10 mg/day dose. In adult patients with agitation associated with bipolar mania or schizophrenia, the Abilify Injection initial dose is 9.75 mg/1.3 mL. If ongoing Abilify therapy is clinically indicated, oral Abilify in a range of 10 mg to 30 mg/day should replace Abilify Injection as soon as possible. The safety of doses of Abilify oral or Abilify Injection above 30 mg/day has not been evaluated in clinical trials.

Important Safety Information and Indications for Abilify

Indications:

* Abilify is indicated for acute and maintenance treatment of schizophrenia in adults

* Abilify is indicated for the treatment of schizophrenia in adolescents 13 to 17 years of age

* Abilify is indicated for acute and maintenance treatment of bipolar disorder with or without psychotic features

Abilify Injection is indicated for the treatment of adults with agitation associated with schizophrenia or bipolar disorder, manic or mixed.

Important Safety Information

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Abilify is not approved for the treatment of patients with dementia-related psychosis (see Boxed WARNING).

Cerebrovascular adverse events (eg, stroke, transient ischemic attack), including fatalities, have been reported at an increased incidence in clinical trials of elderly patients with dementia-related psychosis treated with Abilify
# Neuroleptic malignant syndrome (NMS) -- As with all antipsychotic medications, a rare and potentially fatal condition known as NMS has been reported with Abilify. NMS can cause hyperpyrexia, muscle rigidity, diaphoresis, tachycardia, irregular pulse or blood pressure, cardiac dysrhythmia, and altered mental status. If signs and symptoms appear, immediate discontinuation is recommended

# Tardive dyskinesia (TD) -- The risk of developing TD and the potential for it to become irreversible may increase as the duration of treatment and the total cumulative dose increase. Prescribing should be consistent with the need to minimize TD. If signs and symptoms appear, discontinuation should be considered since TD may remit, partially or completely

# Hyperglycemia and diabetes mellitus -- Hyperglycemia, in some cases associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics including Abilify. Patients with diabetes should be monitored for worsening of glucose control; those with risk factors for diabetes should undergo baseline and periodic fasting blood glucose testing. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. There have been few reports of hyperglycemia with Abilify

Abilify may be associated with orthostatic hypotension and should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions which would predispose them to hypotension.

As with other antipsychotic drugs, Abilify should be used with caution in patients with a history of seizures or with conditions that lower the seizure threshold.

Like other antipsychotics, Abilify may have the potential to impair judgment, thinking, or motor skills. Patients should not drive or operate hazardous machinery until they are certain Abilify does not affect them adversely.

Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotics. Appropriate care is advised for patients who may exercise strenuously, be exposed to extreme heat, receive concomitant medication with anticholinergic activity, or be subject to dehydration.

Esophageal dysmotility and aspiration have been associated with antipsychotic drug use, including Abilify; use caution in patients at risk for aspiration pneumonia.

The possibility of a suicide attempt is inherent in psychotic illnesses and bipolar disorder, and close supervision of high-risk patients should accompany drug therapy.

Physicians should advise patients to avoid alcohol while taking Abilify.

Strong CYP3A4 or CYP2D6 inhibitors increase Abilify drug concentrations when used concomitantly.

CYP3A4 inducers decrease Abilify drug concentrations when used concomitantly.

Commonly observed adverse events (greater than or equal to 5 percent incidence and at least twice the rate of placebo for Abilify vs placebo, respectively):

* Adult patients with schizophrenia: akathisia (8 percent vs 4 percent)
* Pediatric patients (13 to 17 years) with schizophrenia: extrapyramidal disorder (17 percent vs 5 percent), somnolence (16 percent vs 6 percent), and tremor (7 percent vs 2 percent)
* Adult patients with bipolar mania: constipation (13 percent vs 6 percent), akathisia (15 percent vs 3 percent), sedation (8 percent vs 3 percent), tremor (7 percent vs 3 percent), restlessness (6 percent vs 3 percent), and extrapyramidal disorder (5 percent vs 2 percent)
* Adult patients with agitation associated with schizophrenia or bipolar mania: nausea (9 percent vs 3 percent)

References
(1) Data on file at Otsuka America Pharmaceutical, Inc.

(2) Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76.

(3) IMS Auditrac NGPS: Abilify total monthly retail prescriptions: Data accessed July 2007.

CONTACT: Debra Kaufmann, Otsuka America Pharmaceutical, Inc.,+1-240-683-3568, ; Hideki Shirai, OtsukaPharmaceutical Co., Ltd., +81-3-6717-1400, ; David M.Rosen, Communications, Bristol-Myers Squibb Company, +1-609-252-5675,; John Elicker, Investor Relations, Bristol-MyersSquibb Company, +1-212-546-3775,

New Innovation in Treatment of Eczema

2007-10-27T07:20:00.001-07:00

There is a new drug that is going to be used for the treatment of Eczema which is the Tacrolimus ointment, at present this is an investigational ointment that is being tested currenly in the U.S. for the treatment of Eczema. It suppresses the part of the immune system that is responsible for the eczema rash and itching. It is showing great promise, and will hopefully be available soon. It appears to be just as effective as steroid creams, but does not have many of the side effects that the steroids have.

Tacrolimus was developed in the 1990s as a topical immunomodulatory therapy for atopic eczema (alternatively termed atopic dermatitis). Tacrolimus was originally developed as a systemic immunosuppressant to prevent rejection of organ transplants, and continues to be used in this way. As a topical formulation, tacrolimus exhibits minimal systemic absorption and no system accumulation. This property ensures an excellent tolerability profile, with side-effects limited to mild local irritation. The most common adverse events are sensations of skin burning and itching and these symptoms tend to disappear as the skin heals, generally within a matter of days. Clinical trials conducted over the short- and long-term in both adults and in children aged over 2 years have shown that tacrolimus provides rapid and prolonged relief of the major symptoms of eczema (e.g. pruritus, erythema, oedema, induration/papulation, excoriations, lichenification and oozing or crusting). Tacrolimus was shown to be particularly effective in treating eczema of the head and neck. Moreover, other studies have demonstrated that skin atrophy is not induced with tacrolimus treatment. This represents an important advantage over traditional topical corticosteroid therapy, which can cause skin atrophy as a result of the inhibition of collagen synthesis. Consequently, topical corticosteroids must be used with caution in areas of thinner skin such as the face, neck and flexors and when applied over longer periods of time. Tacrolimus is available in two strengths of ointment (0.1 and 0.03%) licensed for twice-daily treatment of atopic eczema in adults and children. The 0.03% dose is licensed to treat both children over 2 years and adults, whilst the higher dose is reserved for adults only.

Conversions and Calculations

2007-10-21T00:36:00.002-07:00

Accurate conversions and calculations are crucial to ensuring safe drug administration. Use the tables below when you need to convert one unit to another, find equivalent measures, convert temperatures between Celsius and Fahrenheit, or calculate dosages or administration rates.

click on it once again for clearer image.

Patient Teaching Aids

2007-10-07T02:59:00.000-07:00

Teach your patients about drugs. Download the drug name for each that you choose. This content is on how to teach your patient about that particular drug. You can give this to your patient on discharge, home visits and whenever you deem they need it.

Be sure to review the instructions verbally with patients before giving out the handout to them. Below are the most commonly used drugs.

This is downloadable by Adobe reader (pdf). It is found on the left side.

Note: Only the Letter A available

I.V. Injections

2007-09-01T08:49:00.002-07:00

I.V. drugs can be injected into the veins of the arms and hands. The illustration at right shows commonly used sites.

Locate the vein using a tourniquet.
Insert the catheter at a slight angle (about 10 degrees).
Release the tourniquet when blood appears in the syringe or tubing.
Slowly inject the drug into the vein.

Subcutaneous Injections

2007-09-01T08:49:00.001-07:00

S.C. drugs can be injected into the fat pads on the abdomen, buttocks, upper back, and lateral upper arms and thighs (shaded in the illustrations below). If your patient requires frequent S.C. injections, make sure to rotate injection sites.

Gently gather and elevate or spread S.C. tissue.
IInsert the needle at a 45- or 90-degree angle, depending on the drug or the amount of S.C. tissue at the site.

I.M. Injections

2007-09-01T08:39:00.000-07:00

You can administer an I.M. injection into the muscles shown below. In these illustrations, specific injection sites are shaded.

Dorsogluteal site

Draw an imaginary line from the posterior superior iliac spine to the greater trochanter.
Insert the needle at a 90-degree angle above and outside the drawn line.
You can administer a Z-track injection through this site. After drawing up the drug, change the needle, displace the skin lateral to the injection site, withdraw the needle, and then release the skin.

Deltoid site

Locate the lower edge of the acromial process.
Insert the needle 1" to 2" below the acromial process at a 90-degree angle

Vastus lateralis and rectus femoris sites

Find the lateral quadriceps muscle for the vastus lateralis, or the anterior thigh for the rectus femoris.
Insert the needle at a 90-degree angle into the middle third of the muscle, parallel to the skin surface.

Ventrogluteal site

With the palm of your hand, locate the greater trochanter of the femur.
SSpread your index and middle fingers posteriorly from the anterior superior iliac spine to the furthest area possible. This is the correct injection site.
Remove your fingers and insert the needle at a 90-degree angle.

Aseptic Technique Guidelines

2007-09-01T08:06:00.000-07:00

A direct path must be maintained between the filter and the area inside the hood where the manipulations are being performed. Air downstream from non-sterile objects (such as solution containers, hands etc.) becomes contaminated from particles blown off these objects. To best illustrate this very important point click on the two examples of proper aseptic technique: (manipulation of a vial and an ampule). The hands should never obstruct airflow around the area where the needle enters the vial or ampoule. Also, when pulling back the plunger of a syringe, the fingers should not come in contact with any part of the plunger--except the flat part at the end. Poor manipulation of the syringe is the most frequent cause of contamination.

Always minimize clutter. Waste and other items should never enter the hood. All calculations should be done before entering the hood.

Wash hands and arms before compounding or re-entering the hood. Also, remove any jewelry from the hands and wrists. It is important that you keep your hands within the cleaned area of the hood as much as possible. Do not touch your hair, face or clothing.

Excess dust should be removed from items before introducing them into the hood.

Arrange objects in a manner to get full benefit of the laminar flow of air. Critical items should be placed as close to the air source as possible. In a horizontal hood, items should be placed no closer than 3 inches from the very back of the hood (nothing should touch the filter). Occasionally, you may stack a few items (eg IVPB's), however they must be stacked from lower to higher starting from the back of the hood. Also, it should be limited to a maximum of 3 to 4 items.

When working in a horizontal laminar flow hood, all work must be performed at a distance of no less than 6 inches from the front edge of the work surface. At a distance of less than 6 inches, laminar flow air begins to mix with the outside air and contamination is possible. Never become so engrossed in your work that you forget this basic rule.

Avoid spraying or squirting solutions onto the HEPA filter. Always aim away from the filter when opening ampoules or adjusting syringes.

Outer pouches and wraps should be removed at the edge of the work area as the sterile contents are pulled into the work area. Never bring these items into the main work area.

Large objects should never be placed near the back of the hood. Not only do these objects contaminate everything downstream, but they also disrupt the laminar flow pattern of air which normally suspends the contaminants and removes them from the area.

Remember that hand cleanliness is further reduced each time more bottles and other non-sterile items are handled.

Before and after preparing a series of IV admixtures, or anytime something is spilled, the work surface of the laminar flow hood should be thoroughly cleaned with alcohol. A long side to side motion should be used starting at the back of the hood and then working forward. The acrylic plastic sides should also be cleaned periodically.

It is possible to overcome the established airflow velocity by a strong reverse current produced by coughing, quick movements, talking etc. Keep all of these to a minimum in order to maintain a sterile environment. Do not talk, cough or sneeze into the hood!

The contents of glass ampoules should always be filtered before adding to an IV admixture.

Needles should be used for a maximum of 8 to 10 punctures. It may be necessary to change the needle more frequently if it becomes increasingly difficult to enter a vial.

Always disinfect all rubber stoppers and ampoule necks with alcohol before entering with a needle.

New Drugs 2007 (approved by FDA)

2007-09-01T07:55:00.000-07:00

CARDIOLOGY/VASCULAR DISEASES

Fenofibrate; For the treatment of hyperlipidemia, dyslipidemia and hypertriglyceridemia; LifeCycle Pharma; Approved August 2007
Letairis (ambrisentan); For the treatment of pulmonary arterial hypertension; Gilead; Approved June 2007
Soliris (eculizumab); For the treatment of paroxysmal nocturnal hemoglobinuria; Alexion Pharm; Approved March 2007
Tekturna (aliskiren); For the treatment of hypertension; Novartis Pharms; Approved March 2007

DERMATOLOGY/PLASTIC SURGERY

Altabax (retapamulin); For the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes; Glaxo; Approved April 2007
Extina (ketoconazole); For the treatment of seborrheic dermatitis; Stiefel; Approved June 2007
Xyzal (levocetirizine dihydrochloride); For the treatment of seasonal and perennial allergic rhinitis and urticaria; UCB Inc.; Approved May 2007

ENDOCRINOLOGY

Evamist (estradiol); For the treatment of moderate to severe vasomotor symptoms due to menopause; Vivus; Approved July 2007
Fenofibrate; For the treatment of hyperlipidemia, dyslipidemia and hypertriglyceridemia; LifeCycle Pharma; Approved August 2007
Supprelin LA (histrelin acetate); For the treatment of central precocious puberty; Indevis Pharms; Approved May 2007

HEMATOLOGY

Soliris (eculizumab); For the treatment of paroxysmal nocturnal hemoglobinuria; Alexion Pharm; Approved March 2007

IMMUNOLOGY/INFECTIOUS DISEASES

Altabax (retapamulin); For the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes; Glaxo; Approved April 2007
AzaSite (azithromycin); For the treatment of bacterial conjunctivitis; InSite Vision; Approved April 2007
Extina (ketoconazole); For the treatment of seborrheic dermatitis; Stiefel; Approved June 2007
Selzentry (maraviroc); For the treatment of CCR5-tropic HIV-1; Pfizer; Approved August 2007
Veramyst (fluticasone furoate); For the treatment of seasonal and perennial allergic rhinitis; GlaxoSmithKline; Approved April 2007
Xyzal (levocetirizine dihydrochloride); For the treatment of seasonal and perennial allergic rhinitis and urticaria; UCB Inc.; Approved May 2007

MUSCULOSKELETAL

Reclast (zoledronic acid); For the treatment of Paget's disease; Novartis Pharms; Approved April 2007

NEPHROLOGY/UROLOGY

Torisel (temsirolimus); For the treatment of renal cell carcinoma; Wyeth Pharms; Approved May 2007

NEUROLOGY

Exelon (rivastigmine tartrate); For the treatment of Alzheimer's and Parkinson's disease-related dementia; Novartis Pharms; Approved July 2007
Neupro (rotigotine); For the treatment of Parkinson's disease; Schwarz; Approved May 2007
Nuvigil (armodafinil); For the treatment of excessive sleepiness; Cephalon; Approved June 2007
Vyvanse (Lisdexamfetamine Dimesylate); For the treatment of Attention-Deficit/Hyperactivity Disorder; New River; Approved February 2007

OBSTETRICS/GYNECOLOGY

Evamist (estradiol); For the treatment of moderate to severe vasomotor symptoms due to menopause; Vivus; Approved July 2007

ONCOLOGY

Torisel (temsirolimus); For the treatment of renal cell carcinoma; Wyeth Pharms; Approved May 2007
Tykerb (lapatinib); For the treatment of breast cancer; GlaxoSmithKline; Approved March 2007

OPTHALMOLOGY

AzaSite (azithromycin); For the treatment of bacterial conjunctivitis; InSite Vision; Approved April 2007

OTOLARYNGOLOGY

Veramyst (fluticasone furoate); For the treatment of seasonal and perennial allergic rhinitis; GlaxoSmithKline; Approved April 2007
Xyzal (levocetirizine dihydrochloride); For the treatment of seasonal and perennial allergic rhinitis and urticaria; UCB Inc.; Approved May 2007

PEDIATRICS/NEONATOLOGY

Altabax (retapamulin); For the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes; Glaxo; Approved April 2007
Supprelin LA (histrelin acetate); For the treatment of central precocious puberty; Indevis Pharms; Approved May 2007
Veramyst (fluticasone furoate); For the treatment of seasonal and perennial allergic rhinitis; GlaxoSmithKline; Approved April 2007
Vyvanse (Lisdexamfetamine Dimesylate); For the treatment of Attention-Deficit/Hyperactivity Disorder; New River; Approved February 2007
Xyzal (levocetirizine dihydrochloride); For the treatment of seasonal and perennial allergic rhinitis and urticaria; UCB Inc.; Approved May 2007

PSYCHOLOGY

Vyvanse (Lisdexamfetamine Dimesylate); For the treatment of Attention-Deficit/Hyperactivity Disorder; New River; Approved February 2007

PULMONARY/RESPIRATORY DISEASES

Letairis (ambrisentan); For the treatment of pulmonary arterial hypertension; Gilead; Approved June 2007
Xyzal (levocetirizine dihydrochloride); For the treatment of seasonal and perennial allergic rhinitis and urticaria; UCB Inc.; Approved May 2007

Monitoring Blood Levels

2007-09-01T07:05:00.000-07:00

What you can see on this table are the therapeutic and the toxic blood levels for the selected drugs. These levels may vary slightly among laboratories.

Drug	Therapeutic blood level	Toxic blood level
acetaminophen	10 to 20 mcg/ml	> 150 mcg/ml
alprazolam	0.025 to 0.102 mcg/ml	Not defined
amikacin	Peak: 25 to 35 mcg/ml Trough: 5 to 10 mcg/ml	> 35 mcg/ml > 10 mcg/ml
aminophylline	10 to 20 mcg/ml	> 20 mcg/ml
amiodarone	1 to 2.5 mcg/ml	> 2.5 mcg/ml
amitriptyline	120 to 250 ng/ml	> 500 ng/ml
amobarbital	1 to 5 mcg/ml	> 10 mcg/ml
atenolol	0.2 to 0.7 mcg/ml	35 mcg/ml
bepridil	1 to 2 ng/ml	1 to 2 ng/ml
calcium	9 to 10.5 mg/dl	> 12 mg/dl
carbamazepine	4 to 14 mcg/ml	> 15 mcg/ml
clonazepam	10 to 80 ng/ml	> 100 ng/ml
creatinine	0.6 to 1.2 mg/dl	> 4 mg/dl
cyclosporine	50 to 300 ng/ml	> 400 ng/ml
desipramine	115 to 300 ng/ml	> 400 ng/ml
diazepam	0.5 to 2 mcg/ml	> 3 mcg/ml
digoxin	0.8 to 2 ng/ml Trough (> 12 hours after dose): Heart failure: 0.8 to 1.5 ng/ml Arrhythmias: 1.5 to 2 ng/ml	Adults: > 2.5 ng/ml Children: > 3 ng/ml
diltiazem	0.05 to .40 mcg/ml	3.7 to 6.1 mcg/ml
diphenylhydantoin	10 to 20 mcg/ml	20 to 50 mcg/ml
disopyramide	2 to 8 mcg/ml	> 8 mcg/ml
ethchlorvynol	2 to 8 mcg/ml	> 20 mcg/ml
ethosuximide	40 to 100 mcg/ml	> 100 mcg/ml
flecainide	0.2 to 1 mcg/ml	> 1 mcg/ml
fluconazole	5 to 15 mcg/ml	Not defined
fluoxetine	0.09 to 0.40 mcg/ml	Not defined
gentamicin	Peak: 4 to 12 mcg/ml Trough: 1 to 2 mcg/ml	> 12 mcg/ml > 2 mcg/ml
glucose	70 to 110 mg/dl	> 300 mg/dl
glutethimide	2 to 6 mcg/ml	> 5 mcg/ml
haloperidol	5 to 20 ng/ml	> 20 ng/ml
hydromorphone	0.008 to 0.049 mcg/ml	Not defined
imipramine	225 to 300 ng/ml	> 500 ng/ml
kanamycin	Peak: 25 to 35 mcg/ml Trough (mild to moderate infection): 1 to 4 mcg/ml Trough (severe infection): 4 to 8 mcg/ml	> 35 to 40 mcg/ml > 10 to 15 mcg/ml > 10 to 15 mcg/ml
lidocaine	1.5 to 6 mcg/ml	> 6 mcg/ml
lithium	0.6 to 1.2 mEq/L	> 1.5 mEq/L
lorazepam	50 to 240 ng/ml	300 to 600 ng/ml
magnesium	12 to 32 mcg/ml	80 to 120 mcg/ml
meperidine	100 to 550 ng/ml	> 1,000 ng/ml
meprobamate	6 to 12 mcg/ml	> 60 mcg/ml
methsuximide	10 to 40 mcg/ml	> 44 mcg/ml
metoprolol	0.03 to 0.27 mcg/ml	Not defined
mezlocillin	35 to 45 mcg/ml	> 45 mcg/ml
milrinone	150 to 250 ng/ml	> 250 ng/ml
nifedipine	0.025 to 0.1 mcg/ml	> 0.1 mcg/ml
nortriptyline	50 to 140 ng/ml	> 300 ng/ml
oxazepam	0.2 to 1.4 mcg/ml	> 2 mcg/ml
paroxetine	0.031 to 0.062 mcg/ml	Not defined
phenobarbital	10 to 40 mcg/ml	> 40 mcg/ml
phenytoin	10 to 20 mcg/ml	> 20 mcg/ml
potassium	3.5 to 5.0 mEq/L	> 6 mEq/L
primidone	4 to 12 mcg/ml	> 12 mcg/ml
procainamide	4 to 8 mcg/ml	> 10 mcg/ml
propofol	2 to 16 mcg/ml	Not defined
propranolol	50 to 200 ng/ml	> 200 ng/ml
quinidine	2 to 5 mcg/ml	> 5 mcg/ml
salicylates	100 to 300 mcg/ml	> 300 mcg/ml
sertraline	0.055 to 0.25 mcg/ml	Not defined
sodium	135 to 145 mEq/L	> 160 mEq/L
streptomycin	25 mcg/ml	> 25 mcg/ml
theophylline	10 to 20 mcg/ml	> 20 mcg/ml
tobramycin	Peak: 4 to 12 mcg/ml Trough: 1 to 2 mcg/ml	> 12 mcg/ml > 2 mcg/ml
tocainide	4 to 10 mcg/ml	Not defined
valproic acid	50 to 100 mcg/ml	> 100 mcg/ml
vancomycin	Peak: 20 to 40 mcg/ml Trough: 5 to 15 mcg/ml > 15 mcg/ml	> 40 mcg/ml > 15 mcg/ml
verapamil	0.08 to 0.3 mcg/ml	Not defined
zolpidem	0.003 to 0.018 mcg/ml	Not defined

Drug Tabulation 3: Mefenamic Acid

2007-09-01T06:29:00.000-07:00

NAME OF DRUG

-Generic name Mefenamic Acid

-Brandname Mefenamic

-Dosage 500mg.

-Frequency q6h

-Route oral

-Timing q6h

ACTION/MECHANISM OF ACTION (MOA):

Pain reliever

- Mefenamic acid reduces inflammation and pain by blocking production and release of chemicals that produces it and inhibits prostaglandin biosynthesis.

INDICATION

- It decreases inflammation (swelling).

- This medicine is used for the treatment of mild to moderate pain, inflammation, and fever

CONTRAINDICATION

Contraindicated to patient who has:

Renal Failure

Active peptic ulcers

Inflammatory intestinal diseases.

Hypersensitivity to aspirin (acetylsalicylic acid) or other non-steroidal anti-inflammatory agents.

ADVERSE EFFECTS

diarrhea
fever
skin rash
Feeling sleepy or unable to think clearly
Belly pain, heartburn, cramps, diarrhea, gas.

Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard candy, or chewing gum may help

NURSING CONSIDERATIONS:

1. If patient have had a stomach ulcer or bleeding, tell healthcare provider.

2. Instruct patient to avoid alcohol (includes wine, beer, and liquor) when taking this medicine since it can cause increases in stomach irritation.

3. Use caution if the patient has a weakened heart. It may cause increased shortness of breath or weight gain. Then recommend to talk with healthcare provider or its own physician.

4. Avoid aspirin, aspirin-containing products, other pain medicines, other blood thinners (warfarin, ticlopidine, clopidogrel), garlic, ginseng, ginkgo, and vitamin E while taking. Talk with healthcare provider.

5. If patient is allergic to any medicine, especially aspirin, or have asthma. Make sure to tell about the allergy and how it affected the patient by consulting its attending physician.

Drug Tabulation 2: Metronidazole

2007-09-01T06:22:00.000-07:00

NAME OF DRUG CONTENT

-Generic name Metronidazole Trichomonacide ambecide

-Brandname Flagyl

-Dosage 500mg.

-Frequency 8am-1pm-6pm

-Route oral

-Timing tid

ACTION/MECHANISM OF ACTION (MOA)

Antibacterial

-Effective against anaerobic bacteria and protozoa. Specifically inhibits growth of trichomonae and amoebae by binding to DNA, resulting in loss of helical structure, strand breakage, inhibition of nucleic acid synthesis and cell death.

INDICATION:

- Skin and skin structure infections due to Bacteroides species.

- To reduce postoperative anaerobic infection following emergency appendectomy.

CONTRAINDICATION:

- Hypersensitivity to metronidazole.

- SPECIAL CONCERNS: Metronidazole is carcinogenic in rats; avoid unnecessary use.

- Use with caution in those with evidence or history of blood dyscrasias.

ADVERSE EFFECTS:

GI: Nausea, dry mouth, metallic taste, vomiting, diarrhea, abdominal discomfort, constipation, epigastric distress, abdominal cramping/pain.

CNS: Headache, dizziness, vertigo, incoordination, ataxia, confusion, irritability, depression, weakness.

GU: burning, dysuria, cystitis, polyuria, incontinence.

Allergic: Urticaria, pruritus, erythematous rash, flushing, fever.

Misc.: Glossitis, flu-like symptoms, bacterial infection.

NURSING CONSIDERATIONS:

1. Drug has a high sodium content.

2. Reduce the dose in those with hepatic disease. Dosage reduction may be necessary in geriatric clients.

3. Avoid alcoholic drinks while the patient is taking metronidazole and for three days afterwards. Alcohol may make patient feel dizzy, sick, or flushed. Drinking alcohol while taking metronidazole may also give you headaches or stomach pains.

4. Patient’s mouth may get dry. Instruct to chew sugarless gum, sucking hard candy, and drinking plenty of water will help.

5. Tell the health care professional if patient’s symptoms do not improve in 2 or 3 days.

Drug Tabulation 1: Cefuroxime

2007-09-01T06:06:00.000-07:00

NAME OF DRUG CONTENT

Generic name Cefuroxime Cefuroxime axetil

-Brandname Ceftin

-Dosage 500 mg.

- Frequency: 8am - 6pm

-Route oral

- Timing: bid

ACTION/MECHANISM OF ACTION (MOA)

Bactericidal/Antibacterial

- Bactericidal: inhibits synthesis of bacterial cell wall, causing cell death.

INDICATION

-For dermatologic infections, caused by S. aureus, S. pyogenes

-fights bacteria in the body.

- is used to treat many different types of bacterial infections.

CONTRAINDICATION

CNS: Headache, dizziness, lethargy, paresthesias

GI: Nausea, vomiting, diarrhea, anorexia, abdominal pain, flatulence, pseudomembranous colitis, liver toxicity

Hematologic: Bone marrow depression: decreased WBC, decreased platelets, decreased Hct

GU: Nephrotoxicity

Hypersensitivity: Ranging from rash to fever to anaphylaxis, serum sickness reaction

Other: Superinfections, disulfiram-like reaction with alcohol

ADVERSE EFFECTS

-an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, face, or tongue; hives; or a rash).

-rash, redness or itching.

- severe nausea, vomiting, or diarrhea;

NURSING CONSIDERATIONS:

1. Cefuroxime axetil for PO use is available in tablet and suspension forms. Swallow tablets whole and not crush, crushed tablet has a strong, bitter, persistent taste. The tablets may be taken without regard for food. Protect tablets from excessive moisture.

2. Tablet are not bio-equivalent and not substitutable on a mg-per-mg basis.

3. Prior to reconstitution, protect drug from light. The power and reconstituted drug may darken without affecting potency.

4. Continue therapy for at least 10 days in infections due to Streptococcus pyogenes.

5. Do not take cefuroxime if patient have ever had an allergic reaction to another cephalosporin or to a penicillin unless the doctor is aware of the allergy and monitors their therapy.

Tablets and Capsules not to CRUSH!

2007-08-29T07:13:00.000-07:00

Accutane	Nexium
Aciphex	Nia-Bid
Adalat CC	Niaspan
Aerolate	Nicotinic Acid
Aggrenox	Nitro-Bid
Allegra D	Nitroglyn
Artane Sequels	Nitrong
Arthrotec	Nitrostat
Asacol	Norflex
Bayer EC	Norpace CR
Bellergal-S	Novafed A
Biaxin XL	Oramorph SR
Boniva	OxyContin
Calan SR	Pancrease MT
Carbatrol	PCE
Carbiset-TR	Pentasa
Cardene SR	Perdiem
Cardizem CD, LA, SR	Phazyme
Carter’s Little Pills	Phyllocontin
Cartia XT	Plendil
Ceclor CD	Pneumomist
CellCept	Prelu-2
Choledyl SA	Prevacid
Claritin-D	Prilosec
Colace	Pro-Banthine
Colestid	Procainamide HCL SR
Compazine Spansules	Procardia
Concerta	Proscar
Cotazym-S	Protonix
Covera-HS	Proventil Repetabs
Creon	Prozac
Cytovene	Quibron-T/SR
Cytoxan	Quinaglute Dura-Tabs
Deconamine SR	Quinidex Extentabs
Depakene	Respaire SR
Depakote	Respbid
Desoxyn Gradumets	Reyataz
Dexedrine Spansule	Ritalin-SR
Diamox Sequels	Roxanol SR
Dilacor XR	Ru-Tuss
Dilatrate-SR	Sinemet CR
Disobrom	Slo-bid Gyrocaps
Ditropan XL	Slo-Niacin
Donnatal Extentabs	Slo-Phyllin GG, Gyrocaps
Donnazyme	Slow FE
Drixoral	Slow-K
Dulcolax	Slow-Mag
DynaCirc CR	Sorbitrate SA
Easprin	Striant
Ecotrin	Sudafed 12 Hour
Effexor XR	Sular
Entex LA	Sustaire
Erythromycin Base	Tavist-D
Eskalith CR	Tegretol-XR
Factive	Teldrin
Feocyte	Ten-K
Feosol	Tenuate Dospan
Ferro-Sequel	Tessalon Perles
Feratab	Theobid Duracaps
Flomax	Theochron
Glucotrol XL	Theoclear LA
Guaifed	Theo-Dur
Ilotycin	Theolair-SR
Imdur	Theo-Sav
Inderal LA	Theospan-SR
Inderide LA	Theo-24
Indocin SR	Theovent
Isoptin SR	Theo-X
Isordil Sublingual, Tembids	Thorazine Spansules
Isosorbide Dinitrate Sublingual	Tiazac
Kadian	Toprol XL
Kaon-Cl	T-Phyl
K-Dur	Tranxene-SD
Klor-Con	Trental
Klotrix	Triaminic
K-Tab	Trilafon Repetabs
Levbid	Trinalin Repetabs
Levsinex Timecaps	Tuss-Ornade Spansules
Lexxel	Tylenol Extended Relief
Lithobid	Ultrase MT
Lodine XL	Uniphyl
Lodrane LD	Verelan
Macrobid	Volmax
Mestinon Timespans	Voltaren, XR
Methylin ER	Wellbutrin SR, XL
Micro-K Extencaps	Xanax-XR
Monafed	ZORprin
MS Contin	Zyban
Naldecon	Zymase
Naprelan

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Tablets and Capsules not to CRUSH!