Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)
medsource pharmaceuticals
ORAL
PRESCRIPTION DRUG
Topiramate tablets and topiramate capsules 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 and topiramate capsules are indicated as adjunctive therapy for 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 and topiramate capsules 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-f
Topiramate Tablets, USP Topiramate Tablets USP, 25 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 16" on one side and plain on the other side and are supplied as follows: NDC 68382-138-14 in bottle of 60 tablets NDC 68382-138-16 in bottle of 90 tablets NDC 68382-138-01 in bottle of 100 tablets NDC 68382-138-05 in bottle of 500 tablets Topiramate Tablets USP, 50 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 15" on one side and plain on the other side and are supplied as follows: NDC 68382-139-14 in bottle of 60 tablets NDC 68382-139-16 in bottle of 90 tablets NDC 68382-139-01 in bottle of 100 tablets NDC 68382-139-05 in bottle of 500 tablets Topiramate Tablets USP, 100 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 14" on one side and plain on the other side and are supplied as follows: NDC 68382-140-14 in bottle of 60 tablets NDC 68382-140-16 in bottle of 90 tablets NDC 68382-140-01 in bottle of 100 tablets NDC 68382-140-05 in bottle of 500 tablets Topiramate Tablets USP, 200 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 13" on one side and plain on the other side and are supplied as follows: NDC 68382-141-14 in bottle of 60 tablets NDC 68382-141-16 in bottle of 90 tablets NDC 68382-141-01 in bottle of 100 tablets NDC 68382-141-05 in bottle of 500 tablets Topiramate Capsules, USP Topiramate Capsules USP, 15 mg are white to off-white pellets filled in size '2' empty hard gelatin capsules with white opaque cap imprinted with "ZA63" and white opaque body imprinted with "15 mg" in black ink and are supplied as follows: NDC 68382-004-14 in bottle of 60 capsules NDC 68382-004-16 in bottle of 90 capsules NDC 68382-004-01 in bottle of 100 capsules NDC 68382-004-05 in bottle of 500 capsules NDC 68382-004-10 in bottle of 1000 capsules Topiramate Capsules USP, 25 mg are white to off-white pellets filled in size '1' empty hard gelatin capsules with white opaque cap imprinted with "ZA64" and white opaque body imprinted with "25 mg" in black ink and are supplied as follows: NDC 68382-005-17 in bottle of 28 capsules NDC 68382-005-14 in bottle of 60 capsules NDC 68382-005-16 in bottle of 90 capsules NDC 68382-005-01 in bottle of 100 capsules NDC 68382-005-05 in bottle of 500 capsules NDC 68382-005-10 in bottle of 1000 capsules Store at 20 o to 25 o C (68 o to 77 o F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.
Abbreviated New Drug Application
TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED medsource pharmaceuticals ---------- MEDICATION GUIDE Topiramate (toe-PIR-a-mate) Tablets, USP Topiramate (toe-PIR-a-mate) Capsules, USP What is the most important information I should know about Topiramate? Topiramate 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 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 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. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis. Like other antiepileptic drugs, topiramate 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 o Belgenin tamamını okuyun
TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED MEDSOURCE PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TOPIRAMATE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOPIRAMATE. TOPIRAMATE TABLETS, FOR ORAL USE TOPIRAMATE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL-1996 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) Sprinkle Capsules: 15 mg and 25 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 oper Belgenin tamamını okuyun