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 DOSING AND ADMINISTRATION).

A single 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, which differ with the different formulations. These pharmacokinetic differences may result in clinically significant differences when [1] switching administration of the tablet between the fed or fasted state, [2] switching administration of the capsule between the fed or fasted state, [3] switching between the tablet and capsule in the fed state, or [4] switching between the intact capsule and sprinkling the contents of the capsule on applesauce. These changes 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 CLINICAL PHARMACOLOGY: Pharmacokinetics).

Zanaflex Capsules™

Zanaflex Capsules™(tizanidine hydrochloride) are available in three strengths as two-piece hard gelatin capsules containing tizanidine hydrochloride 2 mg, 4 mg or 6 mg. The 2 mg capsules have a standard blue opaque body with a standard blue opaque cap with “2 MG” printed on the cap. The 4 mg capsules have a white opaque body with a standard blue opaque cap with “4 MG” printed on the cap. The 6 mg capsules have a light blue opaque body with a white stripe and light blue opaque cap with “6 MG” printed on the capsules. The capsules are provided as follows:

Zanaflex Capsules™(tizanidine hydrochloride), 2 mg, bottles of 150 capsules
(NDC 10144-602-15)

Zanaflex Capsules™(tizanidine hydrochloride), 4 mg, bottles of 150 capsules
(NDC 10144-604-15)

Zanaflex Capsules™(tizanidine hydrochloride), 6 mg, bottles of 150 capsules
(NDC 10144-606-15)

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

Zanaflex® tablets

Zanaflex® (tizanidine hydrochloride) tablets are available in two strengths as white, uncoated tablets containing tizanidine hydrochloride 2 mg or 4 mg. The 2 mg tablets have a bisecting score on one side and debossed with “A592” on the other side. The 4 mg tablets have a quadrisecting score on one side and are debossed with “A594” on the other side. Tablets are provided as follows:

Zanaflex® (tizanidine hydrochloride) tablets, 2 mg, bottles of 150 tablets
(NDC 10144-592-15)

Zanaflex® (tizanidine hydrochloride) tablets, 4 mg, bottles of 150 tablets
(NDC 10144-594-15)

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
Zanaflex® is the registered trademark of Elan Pharmaceuticals Inc. Zanaflex Capsules™is the trademark of Elan Pharmaceuticals Inc.
Manufactured by: Elan Pharma International, Ltd., Athlone, Ireland
Marketed and Distributed by: Acorda Therapeutics Inc. Hawthorne, NY 10532
©2006, Acorda Therapeutics Inc., All rights reserved.
Rev. 7/06
FDA rev date: 7/28/2006

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