TIZANIDINE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

TIZANIDINE HYDROCHLORIDE (UNII: B53E3NMY5C) (TIZANIDINE - UNII:6AI06C00GW)

Tilgængelig fra:

Bryant Ranch Prepack

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Tizanidine Tablets, USP is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with Tizanidine Tablets, USP should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration(2.1) ]. Tizanidine Tablets, USP is contraindicated in patientstaking potent inhibitors of CYP1A2, such as fluvoxamine or ciprofloxacin [see Drug Interactions (7.1 , 7.2 ) ]. Pregnancy Category C Tizanidine Tablets, USP has not been studied in pregnant women. Tizanidine Tablets, USP should be given to pregnant women only if the benefit outweighs the risk to the unborn fetus. Reproduction studies performed in rats at a dose of 3 mg/kg, equal to the maximum recommended human dose on a mg/m2 basis, and in rabbits at 30 mg/kg, 16 times the maximum recommended human dose on a mg/m2 basis, did not show evidence of teratogenicity. Tizanidine at doses that are equal to and up to 8 times th

Produkt oversigt:

16.2 Tizanidine Tablets, USP Tizanidine Tablets, USP 4 mg are available as; white to off-white, round, flat beveled, uncoated tablets debossed with product code “503” on one side, and quadrisecting score on the other. NDC: 72162-1642-0: 1000 Tablets in a BOTTLE Store at 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in containers with child resistant closure. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

TIZANIDINE- TIZANIDINE TABLET
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TIZANIDINE TABLETS, USP
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TIZANIDINE TABLETS, USP.
TIZANIDINE TABLETS, USP (TIZANIDINE HYDROCHLORIDE) TABLETS, FOR ORAL
USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Tizanidine Tablets, USP is a central alpha-2-adrenergic agonist
indicated for the management of spasticity.
Because of the short duration of therapeutic effect, treatment with
Tizanidine Tablets, USP should be
reserved for those daily activities and times when relief of
spasticity is most important [_see Dosage and_
_Administration (1)_].
DOSAGE AND ADMINISTRATION
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•
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DOSAGE FORMS AND STRENGTHS
Tablets 2 mg and 4 mg. (3)
CONTRAINDICATIONS
Concomitant use with potent inhibitors of CYP1A2, such as fluvoxamine
or ciprofloxacin (4, 5.5, 7.1, 7.2)
WARNINGS AND PRECAUTIONS
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•
•
•
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ADVERSE REACTIONS
The most common adverse reactions (greater than 2% of 264 patients
taking tizanidine and greater than
in placebo-treated patients in three multiple dose, placebo-controlled
studies) were dry mouth,
somnolence, asthenia, dizziness, urinary tract infection,
constipation, liver function tests abnormal,
vomiting, speech disorder, amblyopia, urinary frequency, flu syndrome,
SGPT/ALT increased, dyskinesia,
nervousness, pharyngitis, and rhinitis. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SUN PHARMACEUTICAL
INDUSTRIES, INC. TOLL
FREE AT 1-800-818-4555 OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
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•
Recommended starting dose: 2 mg; dose can be repeated at 6 to 8 hour
intervals, up to a maximum
of 3 doses in 24 hours (2.1)
Dosage can be increased by 2 mg to 4 mg per dose, with 1 to 4 days
between increases; total daily
dose should not exceed 36 mg (2.1)
Tizanidine pharmacokinetics differs between tablets and capsules, and
when taken with or without
food. These differe