Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
CARISOPRODOL (UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H)
Method Pharmaceuticals, LLC
ORAL
PRESCRIPTION DRUG
Carisoprodol Tablets USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets USP 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. 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 matern
Carisoprodol Tablets USP, 350 mg: white, round, unscored tablets debossed “2410 V” on one side and plain on the reverse side; available as follows: • Bottles of 100: NDC 58657-645-01 • Bottles of 500: NDC 58657-645-50 • Bottles of 1000: NDC 58657-645-10 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
CARISOPRODOL- CARISOPRODOL TABLET METHOD PHARMACEUTICALS, LLC ---------- 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 Tablets are 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 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 METHOD PHARMACEUTICALS AT 1-877-250- 3427 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) 9040431 SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 6/2019 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS CIV 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 Lees het volledige document