CARISOPRODOL tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Rebel Distributors Corp.

DCI (Dénomination commune internationale):

CARISOPRODOL

Composition:

CARISOPRODOL 350 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. 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 mep

Descriptif du produit:

350 mg Tablets: white, round, unscored tablets debossed "2410 V" on one side and plain on the reverse side; available in bottles of 15, 20, 21, 30, 42, 60, 90 and 120. Storage: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

CARISOPRODOL- CARISOPRODOL TABLET
REBEL DISTRIBUTORS CORP.
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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)
INDICATIONS AND USAGE
Carisoprodol Tablets are indicated for the relief of discomfort
associated with acute, painful musculoskeletal conditions. (1)
Important Limitations:
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)
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 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)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT VINTAGE
PHARMACEUTICALS, LLC AT 1 800 444-4011 OR
FDA AT 1-800-FDA-1088 OR _www.fda.gov/medwatch_.
DRUG INTERACTIONS
CNS depressants (e.g., alcohol, benzodiazepines,