CARISOPRODOL tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Aidarex Pharmaceuticals LLC

INN (Nome Internazionale):

CARISOPRODOL

Composizione:

CARISOPRODOL 350 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Carisoprodol Tablets, USP 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 meprobamate. There are no data on the use of Carisoprodol Tablets 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 incre

Dettagli prodotto:

Carisoprodol Tablets USP, 350 mg, are White, Round, Unscored Tablets imprinted “WW 176”, are available in: Bottles of 60 tablets Storage :  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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

CARISOPRODOL- CARISOPRODOL TABLET
AIDAREX PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
CARISOPRODOL TABLETS, USP C-IV
RX ONLY
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
Warnings and Precautions, Sedation (5.1) 10/2009
Warnings and precautions, Drug Dependence, Withdrawal, and Abuse (5.2)
10/2009
INDICATIONS AND USAGE
Carisoprodol Tablets, USP 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 WEST-WARD
PHARMACEUTICAL CORP. AT 1-877-233-2001 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 and 7.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 8/2012
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS