দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
Carisoprodol (UNII: 21925K482H) (Carisoprodol - UNII:21925K482H)
Wilshire Pharmaceuticals, Inc.
Carisoprodol
Carisoprodol 250 mg
ORAL
PRESCRIPTION DRUG
Carisoprodol Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use 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. 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 publi
Carisoprodol Tablets, USP are available containing 250 mg or 350 mg of carisoprodol, USP. The 250 mg tablets are white to off-white, round, unscored tablets debossed with I43 on one side of the tablet and plain on the other side. They are available as follows: The 350 mg tablets are white to off-white, round, unscored tablets debossed with I44 on one side of the tablet and plain on the other side. Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Abbreviated New Drug Application
CARISOPRODOL- CARISOPRODOL TABLET WILSHIRE 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 USP, FOR ORAL USE, CIV INITIAL U.S. APPROVAL: 1959 INDICATIONS AND USAGE Carisoprodol Tablets, USP are 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: 250 mg, 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 WILSHIRE PHARMACEUTICALS, INC. AT 1-877-495-6856 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: 7/2019 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 Post-marketing Experience 7 DRUG INTERACTIONS 7 DRUG INTERACTIONS 7.1 CNS Depressants 7.2 সম্পূর্ণ নথি পড়ুন