Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
CARISOPRODOL (UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H)
Oxford Pharmaceuticals, LLC
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 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 reproductio
350 mg Tablets: round, convex, white tablets, inscribed with 111 on one side and “O” on the other side; available in bottles of 100 (NDC 69584-111-10), bottles of 500 (NDC 69584-111-50) and bottles of 1000 (NDC 69584-111-90). Storage Store at controlled room temperature 20° - 25°C (68° - 77°F).
Abbreviated New Drug Application
CARISOPRODOL- CARISOPRODOL TABLET OXFORD PHARMACEUTICALS, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CARISOPRODOL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CARISOPRODOL. CARISOPRODOL TABLETS FOR ORAL USE, CIV 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) Limitations of Use Should only be used for acute treatment periods up to two or three weeks (1) 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 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 OXFORD PHARMACEUTICALS LLC AT 1-844 508 1455 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: 9/2019 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 5.3 Seizures 6 ADVERSE REACTIONS 6.1 Clinical Studies Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 CNS Depressants 7.2 CYP2C19 Inhibitors and Inducers 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 La Baca dokumen lengkap