CARISOPRODOL- carisoprodol tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Preferred Pharmaceuticals, Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

CARISOPRODOL is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. CARISOPRODOL 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 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 risk for particular congenital malfor

Resumen del producto:

350 mg Tablets: White to off white, Round convex tablets, debossed with ‘CL’ above ‘022’ on one side available in: Bottle of 14 - 68788-9976-5 Bottle of 15 - 68788-9976-1 Bottle of 20 - 68788-9976-2 Bottle of 30 - 68788-9976-3 Bottle of 60 - 68788-9976-6 Bottle of 90 - 68788-9976-9 Bottle of 100 - 68788-9976-0 Storage: Store at controlled room temperature 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature]

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

CARISOPRODOL- CARISOPRODOL TABLET
PREFERRED PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CARISOPRODOL SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR CARISOPRODOL
CARISOPRODOL TABLETS FOR ORAL USE CIV
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 is indicated for the relief of discomfort associated with
acute, painful musculoskeletal conditions. (1)
Important Limitations:
•
•
DOSAGE AND ADMINISTRATION
•
DOSAGE FORMS AND STRENGTHS
Tablets: 350 mg (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence > 2%) are drowsiness,
dizziness, and headache (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT INGENUS PHARMACEUTICALS
NJ AT 1-877-748-1970 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORM AND STRENGTH
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)
Recommended dose is 350 mg three times a day and at bedtime.(2)
Acute intermittent porphyria (4)
Hypersensitivity reactions to a carbamate such as meprobamate (4)
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)
CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic
antidepressants) – additive sedative effects ( 5.1
and 7.1)
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Sedation
5.2 Drug Dependence, With