Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)
Lake Erie Medical DBA Quality Care Products LLC
TOPIRAMATE
TOPIRAMATE 50 mg
ORAL
PRESCRIPTION DRUG
Topiramate tablets, USP and topiramate Capsules (Sprinkle) 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 and topiramate Capsules (Sprinkle) 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)] None. Pregnancy Category D.[see WARNINGS AND PRECAUTIONS (5.6)] Topiramate can cause fetal harm when administered to a pregn
Topiramate Tablets, USP Topiramate Tablets USP, 25 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with 'ZD 16' on one side and plain on the other side and are supplied as follows: Topiramate Tablets USP, 50 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with 'ZD 15' on one side and plain on the other side and are supplied as follows: Bottles of 30 55700-0210-30 Topiramate Tablets, USP 100 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with 'ZD 14' on one side and plain on the other side and are supplied as follows: Topiramate Tablets USP, 200 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with 'ZD 13' on one side and plain on the other side and are supplied as follows: Topiramate Capsules (Sprinkle) Topiramate Capsules (Sprinkle), 15 mg are white to off-white pellets filled in size ‘2’ empty hard gelatin capsules with white opaque cap imprinted with 'ZA63' and white opaque body imprinted with '15 mg' in black ink and are supplied as follows: Topiramate Capsules (Sprinkle), 25 mg are white to off-white pellets filled in size ‘1’ empty hard gelatin capsules with white opaque cap imprinted with 'ZA64' and white opaque body imprinted with '25 mg' in black ink Storage and Handling Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.
Abbreviated New Drug Application
TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED Lake Erie Medical DBA Quality Care Products LLC ---------- MEDICATION GUIDE Topiramate Tablets, USP Topiramate Capsules (Sprinkle) 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? • Topiramate 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 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 Læs hele dokumentet
TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TOPIRAMATE SAFELYAND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOPIRAMATE.TOPIRAMATE TABLETS, USPTOPIRAMATE CAPSULES (SPRINKLE) "INITIAL U.S. APPROVAL:". 1996 INDICATIONS AND USAGE Topiramate is 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 sizures. (1.1) (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) (1) DOSAGE AND ADMINISTRATION See DOSAGE AND ADMINISTRATION, Epilepsy: Adjunctive Therapy Use for additional details (2.1) (2) Initial Dose (2) Titration (2) Recommended Dose (2) Epilepsy monotherapy: (2) 50 mg/day in two (2) The dosage should (2) 400 mg/day in two (2) adults and pediatric (2) divided doses (2) be increased weekly (2) divided doses (2) patients ≥ 10 years (2.1) (2) by increments of 50 (2) mg for the first 4 (2) weeks then 100mg (2) for weeks 5 to 6. (2) Epilepsy adjunctive (2) 25 to 50 mg/day (2) The dosage should (2) 200 to 400 mg/day in (2) therapy: adults with (2) be increased weekly (2) two divided doses (2) partial onset seizures or (2) to an effective dose (2) LGS (2.1) (2) by increments of 25 (2) to 50 mg. (2) Epilepsy adjunctive (2) 25 to 50 mg/day (2) The dosage should (2) 400 mg/day in two (2) therapy: adults with (2) be increased weekly (2) divided doses (2) primary generalized (2) to an effective dose (2) tonic-clonic seizures. (2) by increments of 25 (2) (2.1) (2) to 50 mg. (2) Epilepsy adjunctive (2) 25 mg/day (or less, (2) The doseage should (2) 5 to 9 mg/kg/day in (2) therapy: pediatric (2) based on a Læs hele dokumentet