CARISOPRODOL tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

RedPharm Drug, Inc.

DCI (Dénomination commune internationale):

CARISOPRODOL

Composition:

CARISOPRODOL 350 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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. 8.1 Pregnancy: Category Pregnancy 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 meprobamate and an increased r

Descriptif du produit:

350 mg Tablets: White to off white, Round convex tablets, debossed with ‘CL’ above ‘022’ on one side available in: Bottles of 100 NDC 64980-174-01. Bottles of 500 NDC 64980-174-05. Bottles of 1000 NDC 64980-174-10. Storage: Store at controlled room temperature 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
REDPHARM DRUG, INC.
----------
CARIS OPRODOL
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:
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 Ingenus Pharmaceuticals
NJ at 1-877-748-
1970 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: 12/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORM AND STRENGTH
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Sedation
5.2 Drug Dependence, Withdrawal, and Abuse
5.3 Seizures
6 ADV