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.

Designació comuna internacional (DCI):

CARISOPRODOL

Composición:

CARISOPRODOL 350 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Carisoprodol Tablets USP are 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 are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. Pregnancy Category C.  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 meprobamat

Resumen del producto:

Carisoprodol Tablets USP, 350 mg: white, round, unscored tablets debossed "2410 V" on one side and plain on the reverse side; available as follows: Bottle of 14 - 68788-2582-5 Bottle of 15 - 68788-2582-1 Bottle of 20 - 68788-2582-2 Bottle of 30 - 68788-2582-3 Bottle of 60 - 68788-2582-6 Bottle of 90 - 68788-2582-9 Bottle of 100 - 68788-2582-0 Bottle of 120 - 68788-2582-8 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

CARISOPRODOL- CARISOPRODOL TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
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.
CARISOPRODOL TABLETS, FOR ORAL USE CIV
INITIAL U.S. APPROVAL: 1959
INDICATIONS AND USAGE
Carisoprodol Tablets are indicated for the relief of discomfort
associated with acute, painful musculoskeletal conditions in
adults. (1)
Limitations of Use:
•
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 PAR PHARMACEUTICAL AT
1-800-828-9393 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 FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
Should only be used for acute treatment periods up to two or three
weeks (1)
Recommended dose is 250 mg to 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 abuse, dependence, and withdrawal (5.2, 9.2, 9.3)
Seizures (5.3)
CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic
antidepressants) - additive sedative effects (5.1,
7.1)
5.1 Sedation
5.2 Abuse, Dependence, and Withdrawal
5.3 Seizures
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 CNS Depressants
7.2 CYP2C19 Inhibitors and Inducer