CARISOPRODOL tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

STAT Rx USA LLC

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Carisoprodol Tablets are indicated for the relief of discomfort associated with acute, painful musculoskietal conditions in adults.  Carisprodol Tablets should only be used for short periods (up to two or three weeks) brcause adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculosketal 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 maternal use of meprobamate and an increased risk for parti

Produkt oppsummering:

Carisoprodol Tablets, USP 350 mg, are white, round, unscored tablets; imprinted "WW 176", are available in: Bottles of 28 tablets Bottles of 30 tablets Bottles of 40 tablets Bottles of 56 tablets Bottles of 60 tablets Bottles of 90 tablets Store at 20-25o C (68-77o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CARISOPRODOL - CARISOPRODOL TABLET
STAT RX USA LLC
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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.
CARISIOPRODOL TABLETS, USP FOR ORAL USE.
INITIAL U.S. APPROVAL: 1959
RECENT MAJOR CHANGES
Indications and Usage (1) 9/2007
Dosage and Administration (2) 9/2007
INDICATIONS AND USAGE
Carisoprodol is indicated for the relief of discomfort associated with
acute, painful musculoskeletal conditions. (1) (1)
Important Limitations: (1)
Should only be used for acute treatment periods up to two or three
weeks (1)
Not recommended in pediatric patients less than 16 years of age (8.4)
DOSAGE AND ADMINISTRATION
Recommended dose is 350 mg three times a day and at bedtime. (2) (2)
DOSAGE FORMS AND STRENGTHS
Tablets 350 mg (3) (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 Drug Dependence, Withdrawal, and Abuse (5.2)
Seizures (5.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence > 2%) are drowsiness,
dizziness, and headache (6.1) (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WEST-WARD
PHARMACEUTICALS AT 1-877-233-2001 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6)
DRUG INTERACTIONS
CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic
antidepressants) -additive sedative effects (5.1 and 7.1)
(7)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2010
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 DRUG DEPENDENCE, WITHDRAWAL, AND ABUSE
5.3 SEIZURES
6 ADVERSE REACTIONS
6.1 CLINICAL S