Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
CARISOPRODOL (UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H)
Keltman 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 reaction to a carbamate such as meprobamate. Pregnancy Category C. There are no data on the use of carisoprodol 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
350 mg Tablets: white, round, unscored tablets debossed "WW 176" on one side and plain on the reverse side. They are supplied by Keltman Pharmaceuticals Inc. as follows: Storage: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
CARISOPRODOL - CARISOPRODOL TABLET KELTMAN PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CARISOPRODOL TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CARISOPRODOL TABLETS, USP. CARISOPRODOL TABLETS 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 Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions. (1) Important Limitations: 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) DOSAGE FORMS AND STRENGTHS Tablets: 350 mg (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) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT VINTAGE PHARMACEUTICALS, LLC AT 1 800 444-4011 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 and 7.1) SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 1/2011 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 REACTIONS 6.1 Clinic Прочетете целия документ