CARISOPRODOL tablet

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

CARISOPRODOL (UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H)

থেকে পাওয়া:

Unit Dose Services

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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

পণ্য সারাংশ:

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

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

CARISOPRODOL- CARISOPRODOL TABLET
UNIT DOSE SERVICES
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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