Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
CARISOPRODOL (UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H)
Altura Pharmaceuticals, Inc.
CARISOPRODOL
CARISOPRODOL 350 mg
ORAL
PRESCRIPTION DRUG
Carisoprodol Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. 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 reactions to a carbamate such as meprobamate There are no data on the use of Carisoprodol Tablets during human pregnancy. Animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival. The primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic. Retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an increase
Carisoprodol Tablets, USP 350 mg, are white, round, unscored tablets; imprinted "WW 176". They are supplied by Altura Pharmaceuticals, Inc. as follows: Store at 20-25o C (68-77o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Abbreviated New Drug Application
CARISOPRODOL - CARISOPRODOL TABLETS TABLET ALTURA 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. CARISIOPRODOL TABLETS, USP FOR ORAL USE. INITIAL U.S. APPROVAL: 1959 RECENT MAJOR CHANGES Indications and Usage (1) 9/2007 Dosage and Administration (2) 9/2007 INDICATIONS AND USAGE Carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions. (1) (1) Important Limitations: (1) Should only be used for acute treatment periods up to two or three weeks (1) Not recommended in pediatric patients less than 16 years of age (8.4) DOSAGE AND ADMINISTRATION Recommended dose is 350 mg three times a day and at bedtime. (2) (2) DOSAGE FORMS AND STRENGTHS Tablets 350 mg (3) (3) CONTRAINDICATIONS Acute intermittent porphyria (4) Hypersensitivity reactions to a carbamate such as meprobamate (4) WARNINGS AND PRECAUTIONS 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 Drug Dependence, Withdrawal, and Abuse (5.2) Seizures (5.3) ADVERSE REACTIONS Most common adverse reactions (incidence > 2%) are drowsiness, dizziness, and headache (6.1) (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WEST-WARD PHARMACEUTICALS AT 1-877-233-2001 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6) DRUG INTERACTIONS CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) -additive sedative effects (5.1 and 7.1) (7) SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 4/2010 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 DRUG DEPENDENCE, WITHDRAWAL, AND ABUSE 5.3 SEIZURES 6 ADVERSE REA Les hele dokumentet