Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)
Cipla USA Inc.
TOPIRAMATE
TOPIRAMATE 25 mg
ORAL
PRESCRIPTION DRUG
Topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. Topiramate tablets are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older. Topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older. None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334. Information about the North American Drug Pregnancy
Topiramate tablets, USP are available containing 25 mg, 50 mg, 100 mg or 200 mg of topiramate USP. The 25 mg tablets are white, film coated, round, biconvex tablets debossed with IG on one side and 278 on other. They are available as follows: NDC 69097-816-03 bottles of 60 tablets NDC 69097-816-12 bottles of 500 tablets NDC 69097-816-15 bottles of 1000 tablets The 50 mg tablets are yellow, film coated, round, biconvex tablets debossed with IG on one side and 279 on other. They are available as follows: NDC 69097-817-03 bottles of 60 tablets NDC 69097-817-12 bottles of 500 tablets NDC 69097-817-15 bottles of 1000 tablets The 100 mg tablets are light yellow, film coated, round, biconvex tablets debossed with IG on one side and 280 on other. They are available as follows: NDC 69097-818-03 bottles of 60 tablets NDC 69097-818-12 bottles of 500 tablets NDC 69097-818-15 bottles of 1000 tablets The 200 mg tablets are pink, film coated, round, biconvex tablets debossed with IG on one side and 281 on other. They are available as follows: NDC 69097-819-03 bottles of 60 tablets NDC 69097-819-12 bottles of 500 tablets NDC 69097-819-15 bottles of 1000 tablets Topiramate tablets Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Protect from moisture.
Abbreviated New Drug Application
TOPIRAMATE- TOPIRAMATE TABLET Cipla USA Inc. ---------- MEDICATION GUIDE Topiramate Tablets, USP (toe pir’a mate) Tablets, for oral use 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. If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away. 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 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 tablets 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 Прочитајте комплетан документ
TOPIRAMATE- TOPIRAMATE TABLET CIPLA USA 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 RECENT MAJOR CHANGES Warnings and Precautions (5.1, 5.4, 5.7, 5.9, 5.10, 5.13) 10/2022 INDICATIONS AND USAGE Topiramate is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial- onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2) Preventive treatment of migraine in patients 12 years of age and older (1.3) 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) DOSAGE FORMS AND STRENGTHS Tablets: 25 mg, 50 mg, 100 mg, and 200 mg (3) CONTRAINDICATIONS None (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 operating Прочитајте комплетан документ