TOPIRAMATE- topiramate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

TOPIRAMATE

Composition:

TOPIRAMATE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.                                                                  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). When multiple species of pregnant animals received topiramate at clinically relevant doses, structural malfo

Product summary:

Topiramate tablets USP Topiramate tablets USP are available in the following strengths and colors:                                                                    25 mg, White colored, circular, biconvex film-coated tablets, debossed with "122" on one side and "C" on the other side and are available in Bottles of 60's (NDC 69097-122-03) Bottles of 500's (NDC 69097-122-12) Bottles of 1000's (NDC 69097-122-15) 50 mg, Light orange colored, circular, biconvex, film-coated tablets, debossed with "123" on one side and "C" on the other side and are available in Bottles of 60's (NDC 69097-123-03) Bottles of 500's (NDC 69097-123-12) Bottles of 1000's (NDC 69097-123-15) 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 60's (NDC 69097-124-03) Bottles of 500's (NDC 69097-124-12) Bottles of 1000's (NDC 69097-124-15) 200 mg, Pink colored, capsule shaped, biconvex, film-coated tablets, debossed with "125" on one side and "Cipla" on other side and are available in Bottles of 60's (NDC 69097-125-03) Bottles of 500's (NDC 69097-125-12) Bottles of 1000's(NDC 69097-125-15) 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Preferred Pharmaceuticals Inc.
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MEDICATION GUIDE
Revised: 8/2017
Document Id: 2b1a4e21-5a41-456a-81a5-2814a9a11ab3
34391-3
Set id: 2b1a4e21-5a41-456a-81a5-2814a9a11ab3
Version: 1
Effective Time: 20170828
Preferred Pharmaceuticals Inc.

Summary of Product characteristics

TOPIRAMATE- TOPIRAMATE TABLET
PREFERRED PHARMACEUTICALS INC.
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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
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INDICATIONS AND USAGE
Topiramate tablets USP is indicated for:
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DOSAGE AND ADMINISTRATION
Topiramate tablets 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
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ADVERSE REACTIONS
Epilepsy: Most common (>10% more frequent than placebo or low-dose
topiramate tablets) adverse reactions in adult and
pediatric patients were: paresthesia, anorexia, weight loss, speech
disorders/related speech problems, fatigue, dizziness,
somnolence, nervousness, psychomotor slowing, abnormal vision and
fever (6.1)
Migraine: Most common (≥5% more frequent than placebo) adverse
reactions in adult and pediatric patients were:
paresthesia, anorexia, weight loss, difficulty with memory, taste
perversion, diarrhea, hypoesthesia, nausea, abdominal pain
and upper respiratory tract infection (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT CIPLA LTD, AT
1-866-604-3268 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 8/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Monotherapy Epilepsy
1.2 Adjunctive Therapy Epilepsy
1.3 Migraine
2 DOSAGE AN