Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
CARISOPRODOL (UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H)
Unit Dose Services
ORAL
PRESCRIPTION DRUG
Carisoprodol tablets, USP is 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, USP is 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 maternal use of meprobamate and an increase
Product: 50436-1090 NDC: 50436-1090-1 30 TABLET in a BOTTLE NDC: 50436-1090-2 60 TABLET in a BOTTLE NDC: 50436-1090-3 90 TABLET in a BOTTLE NDC: 50436-1090-4 120 TABLET in a BOTTLE
Abbreviated New Drug Application
CARISOPRODOL- CARISOPRODOL TABLET UNIT DOSE SERVICES ---------- 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, USP FOR ORAL USE CIV INITIAL U.S. APPROVAL: 1959 INDICATIONS AND USAGE Carisoprodol tablets, USP is 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 SCIEGEN PHARMACEUTICALS, INC. AT (855) 724-3436 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 Belgenin tamamını okuyun