Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
topiramate (UNII: 0H73WJJ391) (topiramate - UNII:0H73WJJ391)
Rebel Distributors Corp
topiramate
topiramate 25 mg
ORAL
PRESCRIPTION DRUG
TOPAMAX® (topiramate) Tablets and TOPAMAX® (topiramate capsules) Sprinkle Capsules are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see Clinical Studies (14.1)] . TOPAMAX® (topiramate) Tablets and TOPAMAX® (topiramate capsules) Sprinkle Capsules are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome [see Clinical Studies (14.2)] . TOPAMAX® (topiramate) Tablets and TOPAMAX® (topiramate capsules) Sprin
TOPAMAX® Tablets TOPAMAX® (topiramate) Tablets are available as debossed, coated, round tablets in the following strengths and colors: 25 mg cream tablet (debossed "OMN" on one side; "25" on the other) and are available in bottles of 15 and 60 count 50 mg light yellow tablet (debossed "OMN" on one side; "50" on the other) and are available in bottles of 15 count 100 mg yellow tablet (debossed "OMN" on one side; "100" on the other) and are available in bottles of 15 count Storage and Handling TOPAMAX® (topiramate) Tablets should be stored in tightly-closed containers at controlled room temperature (59° to 86°F, 15° to 30°C). Protect from moisture.
New Drug Application
TOPAMAX- TOPIRAMATE TABLET, COATED Rebel Distributors Corp ---------- MEDICATION GUIDE TOPAMAX® (Toe-pa-max) (topiramate) Tablets and Sprinkle Capsules Read this Medication Guide before you start taking TOPAMAX® and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about TOPAMAX®, talk to your healthcare provider or pharmacist. What is the most important information I should know about TOPAMAX®? • TOPAMAX® may cause eye problems. Serious eye problems include: • any sudden decrease in vision with or without eye pain and redness, • a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma). • These eye problems can lead to permanent loss of vision if not treated. You should call your healthcare provider right away if you have any new eye symptoms. • TOPAMAX® may cause decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition • Like other antiepileptic drugs, TOPAMAX® may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping (insomnia) • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood Do not stop TOPAMAX® without first talking to a healthcare provider. • Stopping TOPAMAX® suddenly can cause serious problems. • Suicida Прочитайте повний документ
TOPAMAX- TOPIRAMATE TABLET, COATED REBEL DISTRIBUTORS CORP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TOPAMAX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOPAMAX TOPAMAX (TOPIRAMATE) TABLETS INITIAL U.S. APPROVAL: 1996 RECENT MAJOR CHANGES • Warnings and Precautions (5.8) [12/2009] INDICATIONS AND USAGE TOPAMAX is an antiepileptic (AED) agent indicated for: Monotherapy epilepsy: Initial monotherapy in patients ≥10 years of age with partial onset or primary generalized tonic- clonic seizures (1.1). Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2). Migraine: Treatment for adults for prophylaxis of migraine headache (1.3). DOSAGE AND ADMINISTRATION See DOSAGE AND ADMINISTRATION, Epilepsy: Adjunctive Therapy Use for additional details (2.1). Initial Dose T itration Recommended Dose Epilepsy monotherapy: adults and pediatric patients ≥10 years (2.1) 50 mg/day in two divided dose s The dosage should be increased weekly by increments of 50 mg for the first 4 weeks then 100 mg for weeks 5 to 6. 400 mg/day in two divided dose s Epilepsy adjunctive therapy: adults with partial onset seizures or LGS (2.1) 25 to 50 mg/day The dosage should be increased weekly to an effective dose by increments of 25 to 50 mg. 200–400 mg/day in two divided doses Epilepsy adjunctive therapy: adults with primary generalized tonic-clonic seizures (2.1) 25 to 50 mg/day The dosage should be increased weekly to an effective dose by increments of 25 to 50 mg. 400 mg/day in two divided dose s Epilepsy adjunctive therapy: pediatric patients with partial onset seizures, primary generalized tonic-clonic seizures or LGS (2.1) 25 mg/day (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week The dosage should be inc Прочитайте повний документ