Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)
Sun Pharmaceutical Industries, Inc.
TOPIRAMATE
TOPIRAMATE 25 mg
ORAL
PRESCRIPTION DRUG
Topiramate tablets, USP 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 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 palate (oral clefts). When multiple species of pregnant animals received
Topiramate tablets, USP are available as debossed, film-coated, circular tablets in the following strengths and colors: 25 mg white (coded “S” on one side; “707” on the other) 50 mg yellow (coded “S” on one side; “710” on the other) 100 mg yellow (coded “S” on one side; “711” on the other) 200 mg brown (coded “S” on one side; “712” on the other) They are supplied as follows: 25 mg tablets Bottles of 30’s with Child Resistant Cap…………...NDC 62756-707-83 Bottles of 60’s with Child Resistant Cap…………...NDC 62756-707-86 Bottles of 100’s with Child Resistant Cap …............NDC 62756-707-88 Bottles of 100’s with Non Child Resistant Cap ……NDC 62756-707-08 Bottles of 500’s with Non Child Resistant Cap ……NDC 62756-707-13 Bottles of 1000’s with Non Child Resistant Cap …..NDC 62756-707-18 50 mg tablets Bottles of 30’s with Child Resistant Cap…..............NDC 62756-710-83 Bottles of 60’s with Child Resistant Cap…………..NDC 62756-710-86 Bottles of 100’s with Child Resistant Cap …...........NDC 62756-710-88 Bottles of 100’s with Non Child Resistant Cap …...NDC 62756-710-08 Bottles of 500’s with Non Child Resistant Cap …...NDC 62756-710-13 Bottles of 1000’s with Non Child Resistant Cap ….NDC 62756-710-18 100 mg tablets Bottles of 30’s with Child Resistant Cap…..............NDC 62756-711-83 Bottles of 60’s with Child Resistant Cap…………...NDC 62756-711-86 Bottles of 100’s with Child Resistant Cap …............NDC 62756-711-88 Bottles of 100’s with Non Child Resistant Cap ……NDC 62756-711-08 Bottles of 500’s with Non Child Resistant Cap …....NDC 62756-711-13 Bottles of 1000’s with Non Child Resistant Cap …..NDC 62756-711-18 200 mg tablets Bottles of 30’s with Child Resistant Cap…...............NDC 62756-712-83 Bottles of 60’s with Child Resistant Cap…………...NDC 62756-712-86 Bottles of 100’s with Child Resistant Cap …............NDC 62756-712-88 Bottles of 100’s with Non Child Resistant Cap …....NDC 62756-712-08 Bottles of 500’s with Non Child Resistant Cap …....NDC 62756-712-13 Bottles of 1000’s with Non Child Resistant Cap …..NDC 62756-712-18 Storage and Handling Store topiramate tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.
Abbreviated New Drug Application
TOPIRAMATE - TOPIRAMATE TABLET, FILM COATED Sun Pharmaceutical Industries, Inc. ---------- MEDICATION GUIDE Topiramate Tablets, USP (toe-PEER-uh-mate) Read this Medication Guide before you start taking topiramate tablets 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 tablets, 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, including any new problems with your vision. 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. Call your healthcare provider right away if you have a high fever, a fever that does not go away, or decreased sweating. Topiramate tablets 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 Lugege kogu dokumenti
TOPIRAMATE - TOPIRAMATE TABLET, FILM COATED SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- 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, USP. TOPIRAMATE TABLETS, USP FOR ORAL USE 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 T ITRATIO N RECO MMENDED DO SE Epilepsy monotherapy: children 2 to <10 years (2.1) 25 mg/day administered 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 monotherapy: adults and pediatric patients ≥10 years (2.1) 50 mg/day in two divided doses 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 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 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 adjuncti Lugege kogu dokumenti