CARISOPRODOL tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Aphena Pharma Solutions - Tennessee, LLC

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 increased

Produktsammanfattning:

Carisoprodol Tablets, USP 350 mg: round, convex, white tablets, debossed with SG 109 on one side; available in bottles of 100 tablets (NDC 42543-700-01),  bottles of 500 tablets (NDC 42543-700-05), and the bottles of 1000 tablets (NDC 42543-700-10). Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

CARISOPRODOL- CARISOPRODOL TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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
•
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
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence > 2%) are drowsiness,
dizziness, and headache (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT VENSUN PHARMACEUTICALS,
INC. AT 1-800-385-1540 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: 11/2016
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
Recommended dose is 250 mg to 350 mg three times a day and at bedtime.
(2)
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)
6.1 Clinical Studies Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 CNS Depressants
7.2 CY