CARISOPRODOL tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Oxford Pharmaceuticals, LLC

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use Carisoprodol 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 is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. Risk Summary Data over many decades of carisoprodol use in pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Data on meprobamate, the primary metabolite of carisoprodol, also do not show a consistent association between maternal use of meprobamate and an increased risk of major birth defects (see Data). In a published animal reproductio

leaflet_short:

350 mg Tablets: round, convex, white tablets, inscribed with 111 on one side and “O” on the other side; available in bottles of 100 (NDC 69584-111-10), bottles of 500 (NDC 69584-111-50) and bottles of 1000 (NDC 69584-111-90). Storage Store at controlled room temperature 20° - 25°C (68° - 77°F).

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

CARISOPRODOL- CARISOPRODOL TABLET
OXFORD PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CARISOPRODOL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CARISOPRODOL.
CARISOPRODOL TABLETS FOR ORAL USE, CIV
INITIAL U.S. APPROVAL: 1959
INDICATIONS AND USAGE
Carisoprodol is a muscle relaxant 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 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 OXFORD PHARMACEUTICALS
LLC AT 1-844 508 1455 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: 9/2019
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 Inducers
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 La