TIZANIDINE- tizanidine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Tizanidine Hydrochloride (UNII: B53E3NMY5C) (Tizanidine - UNII:6AI06C00GW)

Available from:

Preferred Pharmaceuticals, Inc

INN (International Name):

Tizanidine Hydrochloride

Composition:

Tizanidine 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tizanidine tablet 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 should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1) ]. Tizanidine hydrochloride is contraindicated in patients taking potent inhibitors of CYP1A2, such as fluvoxamine or ciprofloxacin [see Drug Interactions (7.1, 7.2) ]. Pregnancy Category C Tizanidine hydrochloride has not been studied in pregnant women. Tizanidine hydrochloride 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 the maximum

Product summary:

Tizanidine Tablets USP, 2 mg  are white to off white, oval, flat, beveled edged tablets debossed with “R179” on one side and “bisecting score” on other side. Bottle of 28 – 68788-9091-2 Bottle of 30 - 68788-9091-3 Bottle of 60 - 68788-9091-6 Bottle of 90 - 68788-9091-9 Bottle of 120 - 68788-9091-8 Tizanidine Tablets USP, 4 mg are white to off white, oval, flat, beveled edged tablets debossed with “R180” on one side and “quadrisecting score” on other side. Bottle of 30 - 68788-9092-3 Bottle of 60 - 68788-9092-6 Bottle of 90 - 68788-9092-9 Bottle of 120 - 68788-9092-8 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].  Dispense in containers with child resistant closure.   Rx Only Manufactured by: Dr. Reddy’s Laboratories Limited Bachepalli – 502 325 INDIA Revised: 0909 Repackaged by Preferred Pharmaceuticals, Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TIZANIDINE- TIZANIDINE TABLET
PREFERRED PHARMACEUTICALS, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO
USETIZANIDINE HYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TIZANIDINE
HYDROCHLORIDE.
TIZANIDINE TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
PHARMACOKINETIC DIFFERENCES BETWEEN TIZANIDINE CAPSULES AND TIZANIDINE
TABLETS:TIZANIDINE CAPSULES ARE NOT BIOEQUIVALENT TO TIZANIDINE
TABLETS IN THE FED
STATE. THE PRESCRIBER SHOULD BE THOROUGHLY FAMILIAR WITH THE COMPLEX
EFFECTS OF FOOD
ON TIZANIDINE PHARMACOKINETICS (SEE PHARMACOKINETICS AND DOSAGE AND
ADMINISTRATION).
INDICATIONS AND USAGE
Tizanidine tablet is a central alpha-2-adrenergic agonist indicated
for the management of spasticity. Because of the short
duration of therapeutic effect, treatment with tizanidine tablet
should be reserved for those daily activities and times when
relief of spasticity is most important. (1)
DOSAGE AND ADMINISTRATION
1.
2.
3.
4.
DOSAGE FORMS AND STRENGTHS
1.
CONTRAINDICATIONS
1.
WARNINGS AND PRECAUTIONS
1.
2.
3.
4.
5.
6.
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 DR. REDDY’S
LABORATORIES INC., AT 1-888-375-3784 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
Recommended starting dose: 2 mg; dose can be repeated at 6 to 8
hourintervals, 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
daysbetween increases; total daily dose should not
exceed 36 mg (2.1)
Tizanidine pharmacokinetics