Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)
State of Florida DOH Central Pharmacy
TOPIRAMATE
TOPIRAMATE 25 mg
ORAL
PRESCRIPTION DRUG
Topiramate tablets, USP and topiramate capsules (sprinkle) are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. 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 (5.7)] Topiramate can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft
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. 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. 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. 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. They are supplied by State of Florida DOH Central Pharmacy 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. 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.
Abbreviated New Drug Application
TOPIRAMATE - TOPIRAMATE TABLET, FILM COATED State of Florida DOH Central Pharmacy ---------- 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, including any new problems with your vision. 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. Call your healthcare provider right away if you have a high fever, a fever that does not go away, or decreased sweating. Topiramate can increase the level of acid in your blood (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will: • feel tired • not feel hungry (loss of appetite) • feel changes in heartbeat • have trouble thinking clearly Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with t Прочетете целия документ
TOPIRAMATE - TOPIRAMATE TABLET, FILM COATED STATE OF FLORIDA DOH CENTRAL PHARMACY ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TOPIRAMATE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOPIRAMATE. INITIAL U.S. APPROVAL-1996 RECENT MAJOR CHANGES Warnings and Precautions, Visual Field Defects (5.2) 01/2014 INDICATIONS AND USAGE Topiramate is an antiepileptic (AED) agent indicated for: Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 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: Monotherapy and Adjunctive Therapy Use for additional details (2.1) INITIAL DOSE TITRATION RECOMMENDED DOSE Epile psy monothe rapy: children 2 to < 10 years (2.1) 25 mg/day administe re d nightly for the first week The dosage should be titrated over 5 to 7 weeks Daily doses in two divided doses based on weight (Table 2) Epilepsy monothe rapy: adults and pediatric patients ≥ 10 years (2.1) 50 mg/day in two divide d 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 to 400 mg/day in two divided doses Epile psy adjunctive therapy: adults with primary ge ne ralize d 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 o Прочетете целия документ