Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
CARISOPRODOL (UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H)
Vensun Pharmaceuticals, Inc.
CARISOPRODOL
CARISOPRODOL 350 mg
ORAL
PRESCRIPTION DRUG
Carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use Carisoprodol 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 tablet is 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 animal reproduc
Carisoprodol Tablets, USP 350 mg: round, convex, white tablets, debossed with SG 109 on one side; available in bottles of 100 tablets (NDC 42543-700-01), bottles of 500 tablets (NDC 42543-700-05), and the bottles of 1000 tablets (NDC 42543-700-10). Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
CARISOPRODOL- CARISOPRODOL TABLET VENSUN 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 INITIAL U.S. APPROVAL: 1959 INDICATIONS AND USAGE Carisoprodol is a muscle relaxant indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. (1) Limitation of Use Should only be used for acute treatment periods up to two or three weeks (1) DOSAGE AND ADMINISTRATION Recommended dose is 250 mg to 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 abuse, dependence and withdrawal (5.2, 9.2, 9.3) Seizures (5.3) ADVERSE REACTIONS Most common adverse reactions (incidence > 2%) are drowsiness, dizziness, and headache (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT VENSUN PHARMACEUTICALS, INC. AT 1-800-385-1540 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: 11/2018 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 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 Inhibitors and Inducers 8 USE IN SPECIFIC POPULA Lue koko asiakirja