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Carbamazepine is an excellent drug for many medical conditions. Like many drugs, it can cause potentially serious birth defects. Any woman of the child-bearing age should take appropriate precautions when taking any medicine. There is always the potential of harming a developing fetus.
COPYRIGHT 1989 Pediatrics for Parents, Inc.
COPYRIGHT 2004 Gale Group

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WARNINGS
Serious Dermatologic Reactions
SJS/TEN and HLA-B*1502 Allele
Aplastic Anemia and Agranulocytosis
Patients with a history of adverse hematologic reaction to any drug may be particularly at risk of bone marrow depression.
PRECAUTIONS
Laboratory Tests
For genetically at-risk patients [see WARNINGS], high-resolution ‘HLA-B*1502 typing’ is recommended. The test is positive if either one or two HLA-B*1502 alleles are detected and negative if no HLA-B*1502 alleles are detected.
ADVERSE REACTIONS
Initial Section
The most severe adverse reactions have been observed in the hemopoietic system and skin (see BOXED WARNING), the liver and the cardiovascular system.
COPYRIGHT 2008 Washington Information Source, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

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Tegretol-XR is a new formulation of Tegretol that will allow many patients to switch from 3 or 4 daily doses to a more convenient twice-daily regimen. Available only by prescription in 100mg, 200mg and 400mg tablets, Tegretol-XR is indicated as a first-line monotherapy for the treatment of partial, secondarily generalized, and generalized tonic-clonic seizures. It is expected to be available in August.
The most frequently observed adverse reactions with Tegretol-XR therapy - particularly during the initial phases of therapy - are dizziness, drowsiness, unsteadiness, nausea and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the lowest possible dose. Although reports of transient or persistent decreased platelet or white blood cells are not uncommon in association with the use of Tegretol, the vast majority of cases of leukopenia have not progressed to the more serious conditions of aplastic anemia or agranulocytosis. When initiating therapy with Tegretol-XR, physicians should obtain complete pretreatment hematologic testing as a baseline. As with all anticonvulsant therapy, periodic hematologic evaluations are recommended at the physician’s discretion. Physicians should monitor patient’s plasma levels during conversion to Tegretol-XR or whenever any anticonvulsant therapy formulation is changed.
Tegretol-XR will be marketed by CibaGeneva Pharmaceuticals, a marketing alliance between Ciba-Geigy Corp. of Tarrytown, N.Y., and the corporation’s wholly-owned subsidiary, Geneva Pharmaceuticals, Inc. Ciba is a leading developer and manufacturer of healthcare and agricultural products and speciality chemicals for industry. Ciba is dedicated to discovering, developing, manufacturing and marketing innovative pharmaceuticals that meet unmet medical needs and improve patients’ quality of life. The company has been dedicated to research, drug development and continuing education in the neurosciences for more than 25 years. -0- Note to Editors: Full prescribing information is available by calling 908/277-5758.
CONTACT: Ciba Public Relations
Doug Arbesfeld, 908/277-5758
COPYRIGHT 1996 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Clonazepam (marketed as Klonopin)
Clorazepate (marketed as Tranxene)
Divalproex sodium (marketed as Depakote, Depakote ER, Depakene)
Ethosuximide (marketed as Zarontin)
Ethotoin (marketed as Peganone)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Lacosamide (marketed as Vimpat)
Levetiracetam (marketed as Keppra)
Mephenytoin (marketed as Mesantoin)
Methosuximide (marketed as Celontin)
Oxcarbazepine (marketed as Trileptal) Phenytoin (marketed as Dilantin Suspension)
Pregabalin (marketed as Lyrica)
Primidone (marketed as Mysoline)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Trimethadione (marketed as Tridione)
Zonisamide (marketed as Zonegran)
Some of these medications are also available as generics.
Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

– Online : www.fda.gov/MedWatch/report.htm
– Regular Mail : use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
and mail to MedWatch, 5600 Fishers Lane , Rockville , MD 20852-9787
– Fax: (800) FDA-0178
– Phone: (800) FDA-1088
For more information
Information for Health Care Professionals and Public Health Advisory: http://www.fda.gov/cder/drug/infopage/antiepileptics/default.htm
Media Inquiries:
Sandy Walsh, 301-796-4669
Consumer Inquiries:
888-INFO-FDA

The Food and Drug Administration supposes bioequivalence a substitute for therapeutic equivalency - the equal capacity of two formulations of drugs to cure disease or relieve symptoms. Doctors and pharmacists say that some drugs imitation, demonstrating bioequivalence with the source drug is not sufficient proof that similar drug will produce similar results.

There are a number of possible gaps in the rules of the FDA comparison, specialists say.

1. The FDA tolerance for the difference in the capacity, the release of an active component of the drug, the complex of healing, can be too wide.

2. The agency does not require realistic different formulations of the tests in big group of patients.

3. The FDA might be mistaken by the measurement of a generic medication in the capability to deliver the medication mixture to the blood. Most of the drugs act, in the organs, cell, tissues, not in the bloodstream.

Though the formula of brand-name and generic drug is the same, they could differ in some details. Although the two amounts equal share similar active component, usually look different. These differences can lead to minor variations in the way they act in people.

A branded drugs and their generic equivalent in almost any cases are devised with different dyes, fill materials and binding. Despite all these should come from list of pharmaceutical components approved by FDA, which are, in almost any cases, set up differently in each producer’s product. A version of a medication may use sugar or lactose as an inactive component, other may not. However incidental components such as those can affect the method patients metabolize a drug and dissolve the active component slower or faster. And that may lead to variations in the 2 structures of the effects.

In general, the FDA allows a generic medication to release the eighty and one hundred and twenty five of the active component into the blood, compared with freedom in a single draught of medication original. Range that would be impractical different in the sense that most of the drugs are. Generic manufacturers and the FDA are defending the permissible range of variability as it is permitted between “lots” of the brand.

However, doctors and specialists in pharmacology notify that the FDA range could be too wide for some meds, especially if a medication has a “narrow therapeutic index” thin line between a dose that is ineffective or dangerous.

The variation in the rate at which a brand and generic release his freedom of active component could court tragedy with some meds, too. From this point of view, the experts said that “the formulas extended release” - the doses no more than once a day usually - can place specific problems.

If released formulating its therapeutic agent over twenty hours and other released a large percent in the first 5 hours and too little in the past 5, a patient can have a toxic density of the drug in the morning and gimp along with a dosage dangerously ineffective at the end of the day. In laboratory tests, and in small samples of human subjects, the FDA measures release rates at regular intervals. Pharmacologist, but warn that the intervals might not always be sufficiently fine.

Borgheini reviewed medical lit documenting differences in the effects of psychoactive drugs generic and branded twin. In the case of 3 anti-seizure drugs - valproic acid, phenytoin, carabamazepine (marketed under the trade name Tegretol, Cerebyx, Felbatol), the study found that generic preparations or not to release the correct dosage to patients or blood happened in higher paces of “breakthrough seizures.”

Eventually, the agency requires not a lot of clinical evidence that generic drugs from a proposed work will be similar as the first drug in a wide cross slice of real patients. The FDA carries out quality control on the samples periodically generic post-marketing begins, and doctors and patients can provide issues with a generic medication to the contrary event monitoring system of the FDA. However neither manufacturers of generic drugs, nor does the FDA post-market studies that could indicate the patients are reacting to a different way that the generic brand counterparts.

In the approval process for generic drugs, the FDA usually requires a producer to administer a single dosage of their proposed production to a group of twenty four to forty eight healthy volunteers and then shows blood levels of them periodically to measure the concentrations of substance active. The generic performance is compared then to the first drug in the same category.

However it may be not a good indicator of how big populations of ill patients will permit or respond to an alternative medication that has already been, approval process critics say.

Written for online pharmacy.

What Causes Epilepsy?

This is a tricky question with no clear-cut answer. Often doctors can’t pinpoint exactly what causes epilepsy in a particular individual. But scientists do know that these are some of the things that can make a person more likely to develop epilepsy:

A brain injury, such as from a car crash or bike accident

An infection or illness that affected the developing brain of a fetus during pregnancy

Epilepsy can arise as a result of many different conditions that affect the brain. Examples of these conditions include stroke (resulting from a blockage of the blood supply to parts of the brain), complications during childbirth, infections (such as meningitis, encephalitis, cysticercosis, or brain abscess), head trauma, and certain genetic disorders.

Epilepsy Symptoms

Eyes are generally open.

The person may not appear to be breathing. The person is often breathing deeply after an episode.

The return to consciousness is gradual and should occur within a few moments.

Simple partial - person fully aware; abnormal twitching movement of part of the body, for example, head, eyes, hand or arm, or tingling sensation; person may sense odd smells, sounds or tastes

Complex partial - person experiences odd tastes or smells or dj-vu; dream-like state follows; during an attack, lip smacking, grimacing or fidgeting may occur; can be followed by generalised seizure

How Is Epilepsy Treated?

Drug Therapy

Many drugs are available to treat epilepsy, several of which have only recently been released.

Older, classic medications used to treat epilepsy include:

Dilantin or Phenytek

Phenobarbital

Tegretol or Carbatrol

Vagus nerve stimulation — This procedure involves minor surgery and is a relatively new treatment that helps prevent or lessen the severity of seizures. An electrical stimulator is placed beneath the skin of the upper chest. The stimulator, which emits electrical impulses, is connected to an electrode that is attached to a nerve in the neck through a small incision. A patient with a vagus nerve stimulator continues to take medication but sometimes can reduce the amount or number of medications.

Surgery

Surgery is an option for a small number of patients whose epilepsy cannot be controlled with medication. A good candidate for surgery has seizures that always begin in the same cerebral location, which can be removed (resected) without creating deficits. Neurosurgeons generally avoid performing surgery in areas of the brain responsible for speech, hearing, and other important functions.

What is the prognosis?

Most people with epilepsy lead outwardly normal lives. While epilepsy cannot currently be cured, for some people it does eventually go away. Most seizures do not cause brain damage. It is not uncommon for people with epilepsy, especially children, to develop behavioral and emotional problems, sometimes the consequence of embarrassment and frustration or bullying, teasing, or avoidance in school and other social setting. For many people with epilepsy, the risk of seizures restricts their independence (some states refuse drivers licenses to people with epilepsy) and recreational activities.

Causes of Fabry Disease

The gene that encodes a-Gal A has been isolated and sequenced, and more than 245 different mutations (missense, nonsense, splice, deletion, and insertion errors) have been reported. Attempts to correlate genotype with clinical presentation have been confounded by the fact that very few recurrent mutations have been reported. The typical interfamilial variability of the disease phenotype may be due to other modifying factors, which may be genetically or environmentally derived.

Fabry disease is inherited as an X-linked disorder, meaning that the defective gene is carried on the X (female) chromosome. This means that for a mother who carries the defective gene, each of her sons has a 50% chance of inheriting the disorder and each of her daughters has a 50% chance of being a carrier

All of our hereditary information is contained on genes. We have genes that determine our physical characteristics like our hair color, eye color, height, etc. We also have genes that are responsible for specific functions such as our metabolism and growth.

The deficiency in this enzyme causes certain lipid molecules, called glycosphingolipids, to accumulate in the body’s tissues, particularly the heart, kidneys, eyes and nerve tissue.

Symptoms of Fabry Disease

Symptoms usually begin during childhood or adolescence and include burning sensations in the hands that gets worse with exercise and hot weather and small, raised reddish-purple blemishes on the skin. Some boys will also have eye manifestations, especially cloudiness of the cornea.

The symptoms depend on an individual’s level of enzyme deficiency. If the deficiency is severe, symptoms may develop during childhood or adolescence. If it’s less severe, they’ll probably develop later in life.

Red, raised lesions known as angiokeratomas occur on the skin and within the mouth. The ability to sweat is decreased. The cornea and lens of the eye become clouded. Later, kidney failure occurs which secondarily causes hypertension. Heart function can also be impaired.

The pain in the hands and feet usually responds to medications such as Tegretol (carbamazepine) and dilantin. Gastrointestinal hyperactivity may be treated with metoclopramide or Lipisorb (a nutritional supplement). Early experiments have indicated that enzyme replacement may be useful.

Kidney complications are a common and serious effect of the disease; renal insufficiency and renal failure may worsen throughout life. Proteinuria is often the first sign of kidney involvement. Cardiac complications occur when Gb3 builds up in different heart cells; heart related effects worsen with age and may lead to increased risk of heart disease.

Symptoms of Fabry disease may include the appearance of clusters of wart-like discolorations on the skin (angiokeratomas), abdominal pain, and/or visual impairment. Later in the course of the disease, kidney failure, heart irregularities, and/or progressive neurological abnormalities may cause serious complications. Fabry disease, which is inherited as an X-linked recessive trait, primarily affects males. A milder form of the disease has been identified in females.

Medical scientists haven’t yet been able to find a cure for lupus. In the absence of a specific cure, doctors can only control the symptoms produced by the disease and prevent the occurrence of further complications. With the appropriate treatment, the majority of patients diagnosed with lupus can live healthy and active lives. The progression of lupus is fluctuant and unpredictable, the disease alternating between periods of symptomatic exacerbation and periods of remission. The main goal of the existing treatments of lupus is to prolong the periods of remission and to ease the phases of relapse. Medical scientists hope that in the near future they will be able to come up with an efficient cure for lupus, a treatment that can gradually reverse the effects produced by the disease and prevent the occurrence of flares. The ongoing research upon this matter will probably result in finding the specific cure for lupus in the following couple of years.

The term “Lupus” comprises a variety of distinctive types that can be classified as follows:

Systemic Lupus Erythematosus, (SLE), the most common type of lupus, has a pronounced polyvalent character. The systemic form of lupus can affect multiple parts of the body and cause a wide variety of unspecific symptoms, ranging from mild to severe. Despite the fact that SLE commonly affects people with ages between 15 and 40, it can also affect the very young or the elderly. Systemic lupus is considered a highly problematic disease, being difficult to diagnose and often requiring ongoing combination treatments.

Discoid Lupus Erythematosus is a type of lupus that primarily affects the skin. In the absence of the appropriate treatment, discoid lupus can become systemic over the course of time. In its first stages of progression, discoid lupus produces inflammation and rashes on the face, scalp, or other body regions. In time, the rashes become prominent, thickened and may even increase in size. The skin lesions caused by discoid lupus may also involve scaling and blistering. Although lupus rashes may ameliorate or even completely clear up with the aid of treatment, they tend to recur after a certain amount of time.

Drug-induced lupus is a rare form of the disease that occurs as a result of medication intolerance. This type of lupus produces symptoms that are very similar to systemic lupus erythematosus: rash, unexplained fever, pulmonary and coronary affections, and arthritis. However, unlike the systemic form of the disease, drug-induced lupus doesn’t involve kidney impairments and often disappears as soon as the causative drugs are no longer administered. The most common medications that have been identified to cause drug-induced lupus are: hydralazine (Apresoline), methyldopa (Aldomet), procainamide (Procan), isoniazid (INH), quinidine (Quinaglute), phenytoin (Dilantin) and carbamazepine (Tegretol).

The last type of lupus refers to the neonatal form of the disease. Neonatal lupus is a very rare disease that affects newborn babies of mothers diagnosed with systemic lupus erythematosus or other similar autoimmune diseases. Infants affected by this type of lupus often suffer from congenital heart and circulatory problems. Sometimes, infants with neonatal lupus may also suffer from liver conditions and skin affections. When the disease is promptly diagnosed, the young patients’ life expectancy and overall condition can be improved with treatment. Prompt medical intervention is crucial for patients with suspected neonatal lupus.

So if you want to find more about Lupus or more details about lupus treatment please follow this link http://www.lupus-guide.com

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In some cases, injections of botulinum toxin A (Oculinum) into the eyelids can help; the tiny doses of botulinum temporarily paralyze the affected muscle or muscles. The effects last for 3-4 months, and the injections can be repeated if needed. A number of oral medications may help, including low doses of tranquilizers such as diazepam (Valium), antiseizure drugs like carbamazepine (Tegretol), such anti-Parkinson’s medications as levodopa (Sinemet, Modopar), and other drugs that affect nerve function such as benztropine (Cogentin). In severe cases, surgery to remove some of the affected nerves and muscles can be done. For more information, check www. blepharospasm.org
My mother recently died of Alzheimer’s disease at age 87 after suffering with the disease for years. I read that loss of your sense of smell may be a warning sign of Alzheimer’s and that there’s a home test. I heard on the news that more people are now getting Alzheimer’s. I just turned and am worried I might get it, too, since I can be forgetful at times. Should I buy this home test?
We understand your concern. The increase in the number of people with Alzheimer’s reflects the fact that people are dying less often of other ills, such as heart disease or cancer. Age is the biggest risk factor for Alzheimer’s. New data published in March show that one in eight Americans age 65 and older are living with Alzheimer’s; the number rises to nearly one in two after age 85.
However, familial cases of Alzheimer’s usually occur at a much younger age. Having one affected family member, especially one who is much older, is not usually an indication of genetic risk. A number of studies suggest that loss of smell may precede Alzheimer’s disease. Over the years there have been observations that the brain damage that occurs in dementia frequently affects the sense of smell. However, having an impaired sense of smell and taste (or losing the ability to smell) can occur in older people after a severe viral infection, among other causes. We cannot recommend using a home test for Alzheimer’s disease risk. If you have concrete signs of memory loss (or loss of smell) that are causing you to worry, you should ask your doctor about appropriate testing at a center specializing in memory problems and Alzheimer’s disease.
COPYRIGHT 2007 Belvoir Media Group, LLC
COPYRIGHT 2008 Gale, Cengage Learning