CARISOPRODOL tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

RedPharm Drug, Inc.

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 tablets, USP is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. 8.1 Pregnancy: 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

製品概要:

Carisoprodol Tablets, USP 350 mg: round, convex, white tablets, debossed with SG 109 on one side; available in bottles of 100 tablets (NDC 42543-700-01), bottles of 500 tablets (NDC 42543-700-05), and the bottles of 1000 tablets (NDC 42543-700-10). Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

認証ステータス:

Abbreviated New Drug Application

製品の特徴

CARISOPRODOL- CARISOPRODOL TABLET
REDPHARM DRUG, INC.
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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
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 Vensun Pharmaceuticals,
Inc. at
1-800-385-1540 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: 7/2014
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 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 CNS Depressants
7.2 CYP2C19 Inhibitors and I