Tizanidine (Tizanidine Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE:

Tizanidine is a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION).

DOSAGE AND ADMINISTRATION:

A single oral dose of 8 mg of tizanidine reduces muscle tone in patients with spasticity for a period of several hours. The effect peaks at approximately 1 to 2 hours and dissipates between 3 to 6 hours. Effects are dose-related.

Although single doses of less than 8 mg have not been demonstrated to be effective in controlled clinical studies, the dose-related nature of tizanidine’s common adverse events make it prudent to begin treatment with single oral doses of 4 mg. Increase the dose gradually (2 to 4 mg steps) to optimum effect (satisfactory reduction of muscle tone at a tolerated dose).

The dose can be repeated at 6 to 8 hour intervals, as needed, to a maximum of three doses in 24 hours. The total daily dose should not exceed 36 mg.

Experience with single doses exceeding 8 mg and daily doses exceeding 24 mg is limited. There is essentially no experience with repeated, single, daytime doses greater than 12 mg or total daily doses greater than 36 mg (see WARNINGS).

Food has complex effects on tizanidine pharmacokinetics. These pharmacokinetics differences may result in clinically significant differences when switching administration of the tablet between the fed or fasted state. This change may result in increased adverse events or delayed/more rapid onset of activity, depending upon the nature of the switch. For this reason, the prescriber should be thoroughly familiar with the changes in kinetics associated with these different conditions (see Pharmacokinetics).

HOW SUPPLIED:

Tizanidine Hydrochloride Tablets are available containing tizanidine base, as follows:

2 mg:	Each white to off-white, round, flat-faced, beveled-edge, scored tablet debossed with stylized b 131 on one side and scored on the other side, contains 2.288 mg tizanidine HCl. Available in bottles of:
	150 Tablets	NDC 0555-0131-72

4 mg:	Each white to off-white, round, flat-faced, beveled-edge, cross-scored tablet debossed with stylized b 132 on one side and cross-scored on the other side, contains 4.576 mg tizanidine HCl. Available in bottles of:
	150 Tablets	NDC 0555-0132-72

Store at controlled room temperature, 20° to 25°C (68° to 77°F); with excursions permitted between 15° to 30°C (59° to 86°F) [See USP].

Dispense in containers with child-resistant closure.