CARISOPRODOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Carisoprodol (UNII: 21925K482H) (Carisoprodol - UNII:21925K482H)

Available from:

Proficient Rx LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 malformations. Teratogenic effects: Animal studies have not adequately evaluated the teratogenic effects of carisoprodol. There was no increase in the incidence of congenital malformations noted in reproductive studies in rats, rabbits, and mice treated with meprobamate. Retrospective, post-marketing studies of meprobamate during human pregnancy were equivocal for demonstrating an increased risk of congenital malformations following first trimester exposure. Across studies that indicated an increased risk, the types of m

Product summary:

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; available in bottles of 20, 30, 60, 90, 120. Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CARISOPRODOL- CARISOPRODOL TABLET
PROFICIENT RX LP
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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
Limitations of Use :
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
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
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 6/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1. INDICATIONS AND USAGE
2. DOSAGE AND ADMINISTRATION
3. DOSAGE FORMS AND STRENGTHS
Carisoprodol tablets USP is indicated for the relief of discomfort
associated with acute, painful musculoskeletal
conditions in adults ( 1 )
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 )
Tablets: 350 mg ( 3 )
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 )
Most common adverse reactions (incidence > 2%) are drowsiness,
dizziness, and headache ( 6.1 )
CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic
antidepressants) - additive sedative effects ( 5.1 ,
7.1 )
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 CY