Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)
Direct_Rx
ORAL
PRESCRIPTION DRUG
1.1 Monotherapy Epilepsy 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. 1.2 Adjunctive Therapy Epilepsy 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. 1.3 Migraine Topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older. None. 8.1 Pregnancy 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
16.1 How Supplied 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…………... Bottles of 60’s with Child Resistant Cap…………... Bottles of 100’s with Child Resistant Cap …............ Bottles of 100’s with Non Child Resistant Cap … Bottles of 500’s with Non Child Resistant Cap …… Bottles of 1000’s with Non Child Resistant Cap ….. 50 mg tablets Bottles of 30’s with Child Resistant Cap….............. Bottles of 60’s with Child Resistant Cap………….. Bottles of 100’s with Child Resistant Cap …........... Bottles of 100’s with Non Child Resistant Cap …... Bottles of 500’s with Non Child Resistant Cap …... Bottles of 1000’s with Non Child Resistant Cap …. 100 mg tablets Bottles of 30’s with Child Resistant Cap….............. Bottles of 60’s with Child Resistant Cap………….. Bottles of 100’s with Child Resistant Cap …............ Bottles of 100’s with Non Child Resistant Cap …… Bottles of 500’s with Non Child Resistant Cap ….... Bottles of 1000’s with Non Child Resistant Cap ….. 200 mg tablets Bottles of 30’s with Child Resistant Cap…............... Bottles of 60’s with Child Resistant Cap…………... Bottles of 100’s with Child Resistant Cap …............ Bottles of 100’s with Non Child Resistant Cap ….... Bottles of 500’s with Non Child Resistant Cap ….... Bottles of 1000’s with Non Child Resistant Cap ….. 16.2 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
Direct_Rx ---------- 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 have any of these symptoms, especially if they are new, worse, or worry you: • t Lestu allt skjalið
TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED DIRECT_RX ---------- TOPIRAMATE 1.1 Monotherapy Epilepsy 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. 1.2 Adjunctive Therapy Epilepsy 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. 1.3 Migraine Topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older. 2.1 Dosing in Monotherapy Epilepsy Adults and Pediatric Patients 10 Years of Age and Older The recommended dose for topiramate monotherapy in adults and pediatric patients 10 years of age and older is 400 mg/day in two divided doses. The dose should be achieved by titration according to the following schedule (Table 1): Table 1: Monotherapy Titration Schedule for Adults and Pediatric Patients 10 years and older Morning Dose Evening Dose Week 1 25 mg 25 mg Week 2 50 mg 50 mg Week 3 75 mg 75 mg Week 4 100 mg 100 mg Week 5 150 mg 150 mg Week 6 200 mg 200 mg Pediatric Patients 2 to 9 Years of Age Dosing in patients 2 to 9 years of age is based on weight. During the titration period, the initial dose of topiramate is 25 mg/day nightly for the first week. Based upon tolerability, the dosage can be increased to 50 mg/day (25 mg twice daily) in the second week. Dosage can be increased by 25 to 50 mg/day each subsequent week as tolerated. Titration to the minimum maintenance dose should be attempted over 5 to 7 weeks of the total titration period. Based upon tolerability and clinical response, additional titration to a higher dose (up to the maximum maintenance dose) can be attempted at 25 to 50 mg/day weekly increments. The total daily dose should not exceed the maximum maintenance dose for each range of body weight (Table 2). Table 2: Monotherapy Target Total Daily M Lestu allt skjalið