HIGHLIGHTS OF PRESCRIBING INFORMATION

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Method Pharmaceuticals, LLC

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

      Carisoprodol Tablets USP are 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.       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 matern

Περίληψη προϊόντος:

      Carisoprodol Tablets USP, 350 mg: white, round, unscored tablets debossed “2410 V” on one side and plain on the reverse side; available as follows:       •       Bottles of 100: NDC 58657-645-01       •       Bottles of 500: NDC 58657-645-50       •       Bottles of 1000: NDC 58657-645-10       Storage:       Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

CARISOPRODOL- CARISOPRODOL TABLET
METHOD PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CARISOPRODOL TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CARISOPRODOL TABLETS.
CARISOPRODOL TABLETS, FOR ORAL USE
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 METHOD PHARMACEUTICALS
AT 1-877-250-
3427 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)
9040431
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 6/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
CIV
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