CARISOPRODOL tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Aidarex Pharmaceuticals LLC

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Carisoprodol tablets USP is 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 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-

Produkt oppsummering:

Carisoprodol tablets USP, 350 mg : White to off-white circular biconvex tablets, debossed with logo-mark "OP" and product number "35" on one side and no mark on the other side; Repackaged by Aidarex Pharmaceuticals, LLC Corona, CA 92880 Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CARISOPRODOL- CARISOPRODOL TABLET
AIDAREX PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CARISOPRODOL TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CARISOPRODOL TABLETS
USP.CARISOPRODOL TABLETS USP FOR
ORAL USE, CIV INITIAL U.S. APPROVAL: 1959
INDICATIONS AND USAGE
Carisoprodol tablets USP is indicated for the relief of discomfort
associated with acute, painful musculoskeletal conditions in
adults ( 1 )
Limitations of Use :
Should only be used for acute treatment periods up to two or three
weeks ( 1 )
DOSAGE AND ADMINISTRATION
Recommended dose is 250 mg to 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 abuse, dependence, and withdrawal ( 5.2 , 9.2 , 9.3 )
Seizures ( 5.3 )
ADVERSE REACTIONS
Most common adverse reactions (incidence > 2%) are drowsiness,
dizziness, and headache ( 6.1 )
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ORIENT PHARMA CO., LTD.
AT 1-855-314-2853 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 , 7.1 )
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1. INDICATIONS AND USAGE
2. DOSAGE AND ADMINISTRATION
3. DOSAGE FORMS AND STRENGTHS
4. CONTRAINDICATIONS
5. WARNINGS AND PRECAUTIONS
5.1 Sedation
5.2 Abuse, Dependence, and Withdrawal
5.3 Seizures
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
6.2 Post-marketing Experience
7 DRUG INTERACTIONS
7.1 CNS Depressants
7.2 CYP2C19 Inhibit