CARISOPRODOL tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Physicians Total Care, Inc.

INN (שם בינלאומי):

CARISOPRODOL

הרכב:

CARISOPRODOL 350 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Carisoprodol Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets 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 meprobamate and a

leaflet_short:

350 mg Tablets: white, round, unscored tablets debossed "2410 V" on one side and plain on the reverse side; available in: bottles of 10 - NDC 54868-0816-7 bottles of 20 - NDC 54868-0816-2 bottles of 30 - NDC 54868-0816-3 bottles of 40 - NDC 54868-0816-9 bottles of 50 - NDC 54868-0816-5 bottles of 60 - NDC 54868-0816-4 bottles of 90 - NDC 54868-0816-8 bottles of 100 - NDC 54868-0816-6 bottles of 120 - NDC 54868-0816-0 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

CARISOPRODOL - CARISOPRODOL TABLET
PHYSICIANS TOTAL CARE, 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 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 Tablets are 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 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 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 QUALITEST
PHARMACEUTICALS AT 1 800 444-4011 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: 3/2012
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 Drug Dependenc