TOPIRAMATE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Lake Erie Medical DBA Quality Care Products LLC

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 malformations, including craniofacial defects, and reduced fetal weights

Descriptif du produit:

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 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 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 55700-217-30 55700-217-60 55700-217-90 200 mg, Pink colored, capsule shaped, biconvex, film-coated tablets, debossed with "125" on one side and "Cipla" on other side and are available in 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.

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

Lake Erie Medical DBA Quality Care Products LLC
----------
MEDICATION GUIDE
Revised: 8/2022
Document Id: 5f7dfb59-773a-4d27-8c13-b812f489b135
34391-3
Set id: 40b11fee-1e7c-4ad8-bc44-6494ea4791a5
Version: 9
Effective Time: 20220822
Lake Erie Medical DBA Quality Care Products LLC

Résumé des caractéristiques du produit

TOPIRAMATE- TOPIRAMATE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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
Indications and Usage (1) 05/2017
Dosage and Administration (2) 05/2017
Dosage and Administration,
Geriatric Patients
(Ages 65 Years and Over)
Removed 05/2017
Patients with Hepatic Disease
Removed 05/2017
Warnings and Precautions (5.4, 5.6, 5.9, 5.10) 05/2017
Warnings and Precautions
Sudden Unexplained Death in
Epilepsy (SUDEP)
Removed 05/2017
Paresthesia Removed
05/2017
Adjustment of Dose in Renal Failure Removed
05/2017
Decreased Hepatic Function
Removed 05/2017
Monitoring: Laboratory Tests
Removed 05/2017
INDICATIONS AND USAGE
Topiramate tablets USP is indicated for:
Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of
age with partial onset or primary
generalized tonic-clonic seizures (1.1)
Adjunctive therapy epilepsy: 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
with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2)
Prophylaxis of migraine in patients 12 years of age and older (1.3)
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
Acute myopia and secondary angle closure glaucoma: can lead to
permanent visual loss; discontinue
topiramate tablets as soon as possibl