TOPIRAMATE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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)

leaflet_short:

Topiramate tablets USP Topiramate tablets USP are available in the following strengths and colors: 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 30's (NDC 70934-133-30) 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.

מצב אישור:

Abbreviated New Drug Application

עלון מידע

Denton Pharma, Inc. DBA Northwind Pharmaceuticals
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MEDICATION GUIDE
Revised: 1/2021
Document Id: b9be8998-6c0f-d2df-e053-2995a90ad762
34391-3
Set id: 70a7a4bf-2f02-6deb-e053-2991aa0ae87f
Version: 3
Effective Time: 20210125
Denton Pharma, Inc. DBA Northwind Pharmaceuticals

מאפייני מוצר

TOPIRAMATE- TOPIRAMATE TABLET
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
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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
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 a