CARISOPRODOL tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

CARISOPRODOL (UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H)

Disponible depuis:

Wallace Pharmaceuticals Inc.

DCI (Dénomination commune internationale):

CARISOPRODOL

Composition:

CARISOPRODOL 250 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use Carisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)] . Carisoprodol tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. Risk Summary Data over many decades of carisoprodol use in pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Data on meprobamate, the primary metabolite of carisoprodol, also do not show a consistent association between maternal use of meprobamate and an increased risk of major birth defects (see Data). In a published

Descriptif du produit:

250 mg Tablets: round, convex, white tablets, inscribed with WP 5901; available in bottles of 100 (NDC 51525-5901-1), and bottles of 30 (NDC 51525-5901-3). Storage Store at controlled room temperature 20°-25°C (68°-77°F).

Statut de autorisation:

New Drug Application Authorized Generic

Résumé des caractéristiques du produit

CARISOPRODOL- CARISOPRODOL TABLET
WALLACE PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CARISOPRODOL TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CARISOPRODOL
TABLETS.
CARISOPRODOL TABLETS, FOR ORAL USE CIV
INITIAL U.S. APPROVAL: 1959
INDICATIONS AND USAGE
Carisoprodol tablets are a muscle relaxant indicated for the relief of
discomfort associated with acute, painful
musculoskeletal conditions in adults. (1)
Limitations of Use
•
DOSAGE AND ADMINISTRATION
•
DOSAGE FORMS AND STRENGTHS
Tablets: 250 mg (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence > 2%) are drowsiness,
dizziness, and headache (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WALLACE PHARMACEUTICALS
INC. AT 1-800-619-6344 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic
antidepressants) - additive sedative effects ( 5.1, 7.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Sedation
5.2 Abuse, Dependence, and Withdrawal
Should only be used for acute treatment periods up to two or three
weeks (1)
Recommended dose is 250 mg to 350 mg three times a day and at bedtime.
(2)
Acute intermittent porphyria (4)
Hypersensitivity reactions to a carbamate such as meprobamate (4)
Due to sedative properties, may impair ability to perform hazardous
tasks such as driving or operating machinery
(5.1)
Additive sedative effects when used with other CNS depressants
including alcohol (5.1)
Cases of abuse, dependence and withdrawal, (5.2, 9.2,9.3)
Seizures (5.3)
5.3 Seizures
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
6.2 Post-marketing Experience
7 DRUG INTERACTIONS
7.1 CNS Depressants
7.2 CYP2C19 In