Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)
Preferred Pharmaceuticals, Inc.
TOPIRAMATE
TOPIRAMATE 200 mg
ORAL
PRESCRIPTION DRUG
Topiramate tablets are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Topiramate tablets are indicated as 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 and older with seizures associated with Lennox-Gastaut syndrome. Topiramate tablets are indicated for patients 12 years of age and older for the prophylaxis of migraine headache. 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) and for being small for gestational age. When multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofaci
Topiramate tablets, USP are available as debossed, film-coated, circular tablets in the following strengths and colors: 200 mg brown (coded “S” on one side; “712” on the other) 200 mg tablets; Bottles of 15’s with Child Resistant Cap…...............NDC 68788-6824-5 Bottles of 30’s with Child Resistant Cap…...............NDC 68788-6824-3 Bottles of 60’s with Child Resistant Cap…...............NDC 68788-6824-6 Bottles of 90’s with Child Resistant Cap…...............NDC 68788-6824-9 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 Preferred Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Topiramate Tablets, USP (toe-PEER-uh-mate) What is the most important information I should know about topiramate tablet? 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 tablet 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. If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away. Topiramate tablet 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 topiramate tablets. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis. Like other antiepileptic drugs, topiramate tablet 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 Прочетете целия документ
TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED PREFERRED PHARMACEUTICALS, 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. TOPIRAMATE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Topiramate is indicated for: • Epilepsy: initial monotherapy in patients ≥2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1); adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and for patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (1.2) • Prophylaxis of migraine in patients 12 years of age and older (1.3) (1) DOSAGE AND ADMINISTRATION Topiramate initial dose, titration, and recommended maintenance dose varies by indication and age group. See Full Prescribing Information for recommended dosage, and dosing considerations in patients with renal impairment, geriatric patients, and patients undergoing hemodialysis (2.1, 2.2, 2.3, 2.4, 2.5, 2.6) (2) DOSAGE FORMS AND STRENGTHS • Tablets: 25 mg, 50 mg, 100 mg, and 200 mg (3) (3) CONTRAINDICATIONS None (4) (4) WARNINGS AND PRECAUTIONS • Acute myopia and secondary angle closure glaucoma: can lead to permanent visual loss; discontinue topiramate as soon as possible (5.1) • Visual field defects: consider discontinuation of topiramate (5.2) • Oligohidrosis and hyperthermia: monitor decreased sweating and increased body temperature, especially in pediatric patients (5.3) • Metabolic acidosis: baseline and periodic measurement of serum bicarbonate is recommended; consider dose reduction or discontinuation of topiramate if clinically appropriate (5.4) • Suicidal behavior and ideation: antiepileptic drugs increase the risk of suicidal behavior or ideation (5.5) • Cognitive/neuropsychiatric adverse reactions: use caution when oper Прочетете целия документ