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treatment & management

Drug Profiles:
Topiramate & Topiramate Capsules
AKA: Topamax® Tablets and Topamax® Sprinkle Capsules

CAUTION: Federal law prohibits dispensing without prescription.

topamaxtopamax sprinkle

Trade Name Pronounced: TOW-pah-macks
Generic Pronounced Name: TOW-pir-mate

   

About the Drug:

TOPAMAX ® is also proving to be a most effective preventive or prophylactic Migraine regiment. After careful testing and a good anti-migraine program by this drug company, this existing Epilepsy medication is administered in a dose appropriate to Migraine prophylaxis. As Migraine and Epilepsy are Related diseases, this is actually a sound approach. Recent clinical trials of Topamax® as a Migraine preventive have been quite successful, and are moving this medication closer to FDA approval for this use..

Description:

Topamax® is an antiepileptic drug, prescribed to control both the mild attacks known as partial seizures and the severe tonic-clonic convulsions known as grand mal seizures. It is typically added to the treatment regimen when other drugs fail to fully control a patient's attacks.

Caution:

Do not abruptly stop taking Topamax®. If the drug isn't withdrawn gradually, seizures may be caused, even in patients who do not normally experience seizures.

How one should take this medication:

It is important to take this medication exactly as prescribed. It can be taken with or without food. Avoid breaking the tablets; the medication has a bitter taste.

Topamax® increases your risk of developing kidney stones. To prevent this problem, be sure to take this medication with plenty of fluids.

--If you miss a dose...

Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Never take two doses

at once.

--Storage instructions...

Store Topamax® at room temperature in a tightly-closed container. Protect the tablets from moisture.

When Indicated for Migraine:

Since this is a relatively new way to use some of the newer neuronal stabilizers (anticonvulsants) such as Topamax® (topiramate) (As well as others like Neurotin® (gabapentin), Lamictal® (lamotrigine) and Gabatril® (tiagabine)) prophylactically for Migraine disease, the dosage will be directed by your physican. Having noted that we will post recommend clinical practice guidelines for use as soon as we get that information from the manufacturer, FDA or AHS. For now, data from a Phase III study recently completed offers excellent information.

At the Migraine Trust's 14th biennial International Research Symposium, noted Migraine specialist Dr. Stephen Silberstein noted:

  • The best results were achieved at a dosage of 100 or 200 milligrams of topiramate per day, a lower dosage than that used to treat epilepsy.
  • The most commonly experience side effects were nausea and tingling of the extremities.
  • "What was amazing in this trial was the effect on weight. The patients who got topiramate lost, on average, 3.8 percent of their body weight."

During a recent interview with MAGNUM, Dr. Silberstein elaborated:

  • "The key to success with Topamax is a very slow titration up to the therapeutic dose. Patients should begin taking only 15 mg, once a day, and taper up slowly from there, being sure to take it in a split dose."
  • The effective dosages are lower than you might think. Many patients achieve good results at only 50 mg per day."

 

Possible Side Effects:

Some side effects, such as fatigue, are more likely to surface with high doses of Topamax®. Others occur regardless of dosage. While many tend to disappear after the first 8 weeks of therapy, it's still important to report them to your doctor. Only your doctor can determine if it is safe for you to continue taking Topamax®.

More common side effects may include:

Abdominal pain, abnormal coordination, abnormal vision, agitation, anxiety, appetite loss, back pain, breast pain, chest pain, confusion, constipation, depression, difficulty with concentration, difficulty with memory, dizziness, double vision, drowsiness, fatigue, flu-like symptoms, indigestion, involuntary eye movement, language problems, leg pain, loss of coordination, menstrual problems, mood problems, nausea, nervousness, rash, sinusitis, slowing of movements, sore throat, speech problems, tingling or burning sensations, tremors, upper respiratory infection, weakness, weight loss

Less common side effects may include:

Abnormal gait, abnormal menstrual bleeding, acne, aggressiveness, apathy, bladder infection, changes in taste, bloody urine, body odor, bronchitis, cough, decreased awareness, decreased mobility, decreased sensitivity, diarrhea, digestive inflammation, dry mouth, exaggerated sense of well being, eye pain, feelings of illness, feelings of unreality, fever, fluid retention, frequent urination, gas, gum inflammation, hair loss, hallucinations, headache, hearing difficulties, heart palpitations, hot flushes, hyperactivity, impotence, increased sweating, irritable bladder, joint pain, kidney stones, loss of balance, loss of consciousness, low sex drive, mood swings, muscle ache, muscle tension, muscle weakness, nosebleeds, painful or difficult urination, personality problems, pinkeye, ringing in the ears, sensitivity to touch, severe itching, shivers, shortness of breath, sleeplessness, suicidal tendencies, swelling, vaginal infection, vomiting, weight gain,

Topamax® has also been known to cause a number of very rare side effects (typically striking less than one person in a hundred). If you develop any unfamiliar problems while taking Topamax®, report them to your doctor.

When should this drug not be prescribed:

If Topamax® gives you an allergic reaction, you'll be unable to use the drug.

Special warnings about this medication

Because Topamax® sometimes causes confusion, dizziness, fatigue, and problems with machinery, or participate in any hazardous activity that requires full mental alertness until you are certain how the drug affects you.

Tell your doctor if you have kidney problems or if you are on hemodialysis. Your dosage of Topamax® may need adjustment. Also make sure the doctor is aware of any liver disorder you may have. Topama® must be used cautiously by individuals with impaired liver function.

Possible food and drug interactions when taking this medication:

If Topamax® is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Topamax® with:

  • Acetazolamide (Diamox)
  • Carbamazepine (Tegretol)
  • Dichlorphenamide (Daranide)
  • Digoxin (Lanoxin)
  • Phenytoin (Dilantin)
  • Oral contraceptives
  • Valproic acid (Depakene)

Topamax® can depress the central nervous system. Be extremely cautious about combining it with alcohol, sedatives, tranquilizers, and other central nervous system depressants.

Special Information if You Are Pregnant or Breastfeeding:

In animal studies, Topamax® has caused harm to the developing fetus, and its safety has not been verified in pregnant humans. It is recommended for use during pregnancy only if the doctor feels that its potential benefit outweighs the potential risk to the infant.

This medication may appear in breast milk, and its possible effect on the nursing infant remains unknown. Check with your doctor if you plan to breastfeed your baby.

Recommended dosage:

ADULTS

Topamax® therapy usually begins with a dose of 15 milligrams once daily during the first week. The daily dosage is then increased each week until, by the eighth week, the patient is taking 100 milligrams twice a day. Some patients achieve adequate results at 50 milligrams twice a day.

For people with poor kidney function, the dosage is usually cut in half. On the other hand, those undergoing hemodialysis may need a supplemental dose.

If you are also taking Dilantin or Tegretol, the dosage of Topamax® may need adjustment. Likewise, the doctor may adjust your dosage if you have liver problems.

CHILDREN

The safety and effectiveness of Topamax® in children have not been established.

Overdose:

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

For more information you can visit the manufacture’s (Ortho-McNeil) WebPage at http://www.ortho-mcneil.com/topamax/index.htm .