TIZANIDINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

INN (International Name):

TIZANIDINE HYDROCHLORIDE

Composition:

TIZANIDINE 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)]. Tizanidine 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 has not been studied in pregnant women. Tizanidine 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 recommended human dose on a mg/m2 basis increased g

Product summary:

Tizanidine Tablets, USP 4 mg are available for oral administration as white to off-white, round, scored tablets, imprinted “APO” over “TI-4” on one side and plain with a quadrisect score on the other side. They are supplied as follows: Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6418-61 Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TIZANIDINE- TIZANIDINE TABLET
MAJOR PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TIZANIDINE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TIZANIDINE TABLETS.
TIZANIDINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Tizanidine is a central alpha-2-adrenergic agonist indicated for the
management of spasticity. Because of
the short duration of therapeutic effect, treatment with tizanidine
should be reserved for those daily
activities and times when relief of spasticity is most important. (1)
DOSAGE AND ADMINISTRATION
5.
6.
7.
8.
DOSAGE FORMS AND STRENGTHS
2.
CONTRAINDICATIONS
2.
WARNINGS AND PRECAUTIONS
7.
8.
9.
10.
11.
12.
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 APOTEX CORP. AT
1-800-706-5575 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
USE IN SPECIFIC POPULATIONS
3.
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 differences could result in a change in tolerability and
control of symptoms (2.1, 12.3)
To discontinue tizanidine, decrease dose slowly to minimize the risk
of withdrawal and rebound
hypertension, tachycardia, and hypertonia (2.2)
Tablets 2 mg and 4 mg (3)
Concomitant use with potent inhibi