Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)
Aidarex Pharmaceuticals LLC
TOPIRAMATE
TOPIRAMATE 25 mg
ORAL
PRESCRIPTION DRUG
Topiramate Tablets USP 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) ]. Topiramate Tablets USP 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 (14.1) ] None. [see Warnings and Precautions (5.6)] Topiramate can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate in utero
Topiramate Tablets USP are available as circular, biconvex, film coated, tablets in the following strengths and colors: 25 mg white (engraved “G” on one side; “25” on the other) They are supplied as follows: 25 mg tablets - bottles of 7 count with desiccant (NDC 33261-106-07) 25 mg tablets - bottles of 14 count with desiccant (NDC 33261-106-14) 25 mg tablets - bottles of 28 count with desiccant (NDC 33261-106-28) 25 mg tablets - bottles of 30 count with desiccant (NDC 33261-106-30) 25 mg tablets - bottles of 45 count with desiccant (NDC 33261-106-45) 25 mg tablets - bottles of 60 count with desiccant (NDC 33261-106-60) 25 mg tablets - bottles of 90 count with desiccant (NDC 33261-106-90) Storage and Handling Topiramate Tablets USP should be stored in tightly-closed containers at 20-25o C (68-77°F) [See USP Controlled Room Temperature]. Protect from moisture.
Abbreviated New Drug Application
TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED Aidarex Pharmaceuticals LLC ---------- MEDICATION GUIDE Topiramate ( TOE-pee-rah-mate) Tablets USP Read this Medication Guide before you start taking topiramate 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 topiramate talk to your healthcare provider or pharmacist WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT TOPIRAMATE TABLETS ? • Topiramate tablets 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. • Topiramate tablets 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, topiramate 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 topiramate without first talking to a healthcare provider. • Stopping topiramate suddenly can cause serious Đọc toàn bộ tài liệu
TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED AIDAREX PHARMACEUTICALS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TOPIRAMATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOPIRAMATE TABLETS. TOPIRAMATE TABLETS USP FOR ORAL USE INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Topiramate Tablets USP are an antiepileptic (AED) agent indicated for: (1) 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) DOSAGE AND ADMINISTRATION See DOSAGE AND ADMINISTRATION, Epilepsy: Adjunctive Therapy Use for additional details (2.1) (2) Initial Dose Titration Recommended Dose Epile psy monotherapy: (2) adults and pediatric patients ≥10 years (2.1) (2) 50 mg/day in two divided doses (2) 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 doses (2) 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 doses Epilepsy adjunctive therapy: pediatric patients with partial onset seizures, primary generalized tonic-clonic seizures or LGS (2.1) (2) 25 mg/day (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week (2) The dosage should be increased at 1- or 2-week intervals by increments of 1 to 3 mg Đọc toàn bộ tài liệu