CARISOPRODOL- carisoprodol tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Preferred Pharmaceuticals Inc.

INN (Διεθνής Όνομα):

Carisoprodol

Σύνθεση:

Carisoprodol 350 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 particular congenital malformations. There is no information about the effects of carisoprodol on the mother and the fetus during labor and delivery. Very limited data in humans show that carisoprodol is present in breast milk and may reach concentrations two to four times the maternal plasma concentrations. In one case report, a breast-fed infant received about 4-6% of the maternal daily dose through breast milk and experienced no adverse effects. However, milk production was inadequate and the baby was supplemented with formula. In lactation studies in mice, female pup survival and pup weight at

Περίληψη προϊόντος:

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
PREFERRED PHARMACEUTICALS 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 TABLETS
USP.CARISOPRODOL TABLETS USP FOR
ORAL USE. CIV
INITIAL U.S. APPROVAL
19 59
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ORIENT PHARMA CO., LTD.
AT 1-855-642-2594 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH .
DRUG INTERACTIONS
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
Carisoprodol tablets USP is 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 )
Recommended dose is 250 mg to 350 mg three times a day and at bedtime.
( 2 )
Tablets: 350 mg ( 3 )
Acute intermittent porphyria ( 4 )
Hypersensitivity reactions to a carbamate such as meprobamate ( 4 )
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 )
Most common adverse reactions (incidence > 2%) are drowsiness,
dizziness, and headache ( 6.1 )
CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic
antidepressants) - additive sedative effects ( 5.1 ,
7.1 )
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 Depres