Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)
NuCare Pharmaceuticals, Inc.
TOPIRAMATE
TOPIRAMATE 100 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 tablets can cause fetal harm when administered to a pregnant woman. Data from
Topiramate tablets USP Topiramate tablets USP are available in the following strengths and colors: 100 mg, Orange colored, circular, biconvex, film-coated tablets, debossed with "124" on one side and "Cipla" on the other side and are available in Bottles of 30 NDC 68071-3088-3 Bottles of 60 NDC 68071-3088-6 Bottles of 90 NDC 68071-3088-9 PHARMACIST: Dispense in a tight container as defined in the USP. Use child-resistant closure (as required). Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.
Abbreviated New Drug Application
TOPIRAMATE- TOPIRAMATE TABLET NuCare Pharmaceuticals, Inc. ---------- Advise the patient to read the FDA-approved patient labeling (Medication Guide). Eye Disorders Instruct patient taking topiramate tablets should be told to seek immediate medical attention if they experience blurred vision, visual disturbances, or periorbital pain [see Warnings and Precautions ( 5.1), ( 5.2)] . Oligohidrosis and Hyperthermia Closely monitor topiramate tablets-treated pateints, especially pediatric patients, for evidence of decreased sweating and increased body temperature, especially in hot weather. Counsel patient to contact their healthcare professionals immediately if they develop a high or persistent fever, or decreased sweating [see Warnings and Precautions ( 5.3)] . Metabolic Acidosis Warn patients about the potential significant risk for metabolic acidosis that may be asymptomatic and may be associated with adverse effects on kidneys (e.g., kidney stones, nephrocalcinosis), bones (e.g., osteoporosis, osteomalacia, and/or rickets in children), and growth (e.g., growth delay/retardation) in pediatric patients, and on the fetus [see Warnings and Precautions ( 5.4) and Use in Specific Populations ( 8.1)] . Suicidal Behavior and Ideation Counsel patients, their caregivers, and families that AEDs, including topiramate tablets, may increase the risk of suicidal thoughts and behavior, and advise of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior or the emergence of suicidal thoughts, or behavior or thoughts about self-harm. Instruct patients to immediately report behaviors of concern to their healthcare providers [see Warnings and Precautions ( 5.5)] . Interference with Cognitive and Motor Performance Warn patients about the potential for somnolence, dizziness, confusion, difficulty concentrating, or visual effects, and advise patients not to drive or operate machinery until they have gained sufficient experience on topiramate tablets to gauge w Lestu allt skjalið
TOPIRAMATE- TOPIRAMATE TABLET NUCARE PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TOPIRAMATE TABLETS, USP 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 tablets USP 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 INITIAL DOSE TITRATION RECOMMENDED DOSE Epilepsy monotherapy: children 2to<10years (2.1) 25mg/day administered nightly for the first week The dosage should betitratedover5–7 weeks Daily doses in two divided doses based on weight(Table2) Epilepsy monotherapy: adults and pediatric patients≥10years (2.1) 50mg/day in two divided doses The dosage should be increased weekly by increments of 50mg for the first 4 weeks then100mgfor weeks 5to6. 400 mg/day in two divided doses Epilepsy adjunctive therapy :adults with partial onset seizures or LGS( 2.1) 25to50mg/day The dosage should be increased weekly to an effective dose by incrementsof25to50mg. 200–400 mg/day in two divided doses Epilepsy adjunctive therapy: adults with primary generalized tonic- clonic seizures (2.1) 25to50mg/day The dosage should be increased weekly to an effective dose by incrementsof25to50mg. 400 mg/day in two divided doses Epilepsy adjunctive therapy: pediatric Patients with partial o Lestu allt skjalið