CARISOPRODOL tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Proficient Rx LP

DCI (Dénomination commune internationale):

CARISOPRODOL

Composition:

CARISOPRODOL 350 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Carisoprodol 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 are 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, postmarketing studies do not show a consistent association between maternal use of meprobamat

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

CARISOPRODOL- CARISOPRODOL TABLET
PROFICIENT RX LP
----------
INDICATIONS AND USAGE
Carisoprodol 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)].
DOSAGE AND ADMINISTRATION
The recommended dose of carisoprodol is 350 mg three times a day and
at bedtime. The recommended
maximum duration of carisoprodol tablets use is up to two or three
weeks.
DOSAGE FORMS AND STRENGTHS
350 mg Tablets: round, convex, white tablets, inscribed with “446”
on one side and plain on other side
CONTRAINDICATIONS
Carisoprodol tablets are contraindicated in patients with a history of
acute intermittent porphyria or a
hypersensitivity reaction to a carbamate such as meprobamate.
WARNINGS AND PRECAUTIONS
5.1 Sedation
Carisoprodol has sedative properties (in the low back pain trials, 13%
to 17% of patients who received
carisoprodol experienced sedation compared to 6% of patients who
received placebo) [see ADVERSE
REACTIONS (6.1)] and may impair the mental and/or physical abilities
required for the performance of
potentially hazardous tasks such as driving a motor vehicle or
operating machinery. There have been
postmarketing reports of motor vehicle accidents associated with the
use of carisoprodol.
Since the sedative effects of carisoprodol and other CNS depressants
(e.g., alcohol, benzodiazepines,
opioids, tricyclic antidepressants) may be additive, appropriate
caution should be exercised with
patients who take more than one of these CNS depressants
simultaneously.5.2 Drug Dependence,
Withdrawal, and Abuse
In the postmarketing experience with carisoprodol, cases of
dependence, withdrawal, and abuse have
been reported with prolonged use. Most cases of dependence,
withdrawal, and a