CARISOPRODOL tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Mutual Pharmaceutical Company, Inc.

INN (Международно Name):

Carisoprodol

Композиция:

Carisoprodol 350 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 USP are 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-marketing studies do not show a consistent association between maternal use of meprobamate and an increased risk for

Каталог на резюме:

Carisoprodol tablets USP, 350 mg are white, round, debossed MP 58 on one side and blank on the other side. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

CARISOPRODOL- CARISOPRODOL TABLET
MUTUAL PHARMACEUTICAL COMPANY, INC.
----------
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.
CARISOPRODOL TABLETS, USP FOR ORAL USE, C-IV
INITIAL U.S. APPROVAL: 1959
INDICATIONS AND USAGE
Carisoprodol tablets are 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 MUTUAL PHARMACEUTICAL
COMPANY, INC. AT 1-888-351-
3786 OR [e-mail] 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: 2/2014
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 Post-marketing Experience
7 DRUG INTERACTIONS
7.1 CNS Depressants
7.2 CYP2C19 Inhib