PRAZOLAMINE- carisoprodol, gaba kit

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Physician Therapeutics LLC

INN (International Name):

CARISOPRODOL

Sammensetning:

CARISOPRODOL 350 mg

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

1 INDICATIONS AND USAGE 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)]. 4 CONTRAINDICATIONS Carisoprodol Tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. 5 WARNINGS AND PRECAUTIONS 5.1 Sedation Carisoprodol Tablets may have sedative properties (in the low back pain trials, 13% to 17% of patients who received Carisoprodol Tablets 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

Produkt oppsummering:

16 HOW SUPPLIED/STORAGE AND HANDLING Carisoprodol Tablets, USP 350 mg, are white, round, unscored tablets; imprinted “WW 176”, are available in: Bottles of 100 tablets Bottles of 500 tablets Bottles of 1000 tablets How Supplied Theramine is supplied in purple and white, size 0 capsules in bottles of 60 or 90 capsules. Physician Supervision Theramine is a Medical Food product available by prescription only and must be used while the patient is under ongoing physician supervision. U.S. patent pending. Manufactured by Arizona Nutritional Supplements, Inc. Chandler AZ 85225 Distributed by Physician Therapeutics LLC, Los Angeles, CA 90077. www.ptlcentral.com Copyright 2003-2006, Physician Therapeutics LLC, all rights reserved NDC: 68405-1008-02 NDC: 68405-1008-03

Autorisasjon status:

unapproved drug other

Preparatomtale

PRAZOLAMINE - CARISOPRODOL, GABA
PHYSICIAN THERAPEUTICS LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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HIGHLIGHTS OF PRESCRIBING INFORMATION
CARISOPRODOL TABLETS, USP RX ONLY REV. 09/09 THESE HIGHLIGHTS DO NOT
INCLUDE ALL THE INFORMATION NEEDED TO
USE CARISOPRODOL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR CARISOPRODOL TABLETS.
INITIAL U.S. APPROVAL CARISOPRODOL TABLETS FOR ORAL USE
RECENT MAJOR CHANGES
Indications and Usage (1) 9/2007
Dosage and Administration (2) 9/2007
INDICATIONS AND USAGE
Carisoprodol Tablets are indicated for the relief of discomfort
associated
with acute, painful musculoskeletal conditions. (1)
Important Limitations:
• Should only be used for acute treatment periods up to two or three
weeks (1)
• Not recommended in pediatric patients less than 16 years of age
(8.4)
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 Drug Dependence, Withdrawal, and Abuse (5.2)
• Seizures (5.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence > 2%) are drowsiness,
dizziness, and headache (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact West-ward
Pharmaceutical Corp. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or
www.fda.gov/me dwatch.
DRUG INTERACTIONS
• CNS depressants (e.g., alcohol, benzodiazepines, opioids,
tricyclic
antidepressants) – additive sedative effects ( 5.1 and 7.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2010
FULL PRESCRI