A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Zanaflex Indications, Dosage, Storage, Stability - Tizanidine
Zanaflex Indications, Dosage, Storage, Stability - Tizanidine
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 DOSING 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).
HOW SUPPLIED
Zanaflex® (tizanidine hydrochloride) is available as 2 mg white tablets, with a bisecting score on one side and debossed with "A592" on the other. The tablets are available in bottles of 150 (NDC 10144-592-15).
Zanaflex® (tizanidine hydrochloride) is available as 4 mg white tablets, with a quadrisecting score on one side and debossed with "A594" on the other. The tablets are available in bottles of 150 (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.
Marketed by: Acorda Therapeutics, Inc Hawthorne, New York 10532, AcordaZanaflexTab001, Rev. 08-30-04
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