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Zanaflex

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Zanaflex

INDICATIONS

Zanaflex is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with Zanaflex should be reserved for those daily activities and times when relief of spasticity is most important [see DOSAGE AND ADMINISTRATION].

DOSAGE AND ADMINISTRATION

Dosing Information

Zanaflex Capsules® or Zanaflex® tablets may be prescribed with or without food. Once the formulation has been selected and the decision to take with or without food has been made, this regimen should not be altered.

Food has complex effects on tizanidine pharmacokinetics, which differ with the different formulations. Zanaflex Capsules and Zanaflex tablets are bioequivalent to each other under fasting conditions (more than 3 hours after a meal), but not under fed conditions (within 30 minutes of a meal). These pharmacokinetic differences may result in clinically significant differences when switching administration of tablet and capsules and when switching administration between the fed or fasted state. These changes may result in increased adverse events, or delayed or 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].

The recommended starting dose is 2 mg. Because the effect of Zanaflex peaks at approximately 1 to 2 hours post-dose and dissipates between 3 to 6 hours post-dose, treatment can be repeated at 6 to 8 hour intervals, as needed, to a maximum of three doses in 24 hours.

Dosage can be gradually increased by 2 mg to 4 mg at each dose, with 1 to 4 days between dosage increases, until a satisfactory reduction of muscle tone is achieved. The total daily dose should not exceed 36 mg. Single doses greater than 16 mg have not been studied.

Dosing in Patients with Renal Impairment

Zanaflex should be used with caution in patients with renal insufficiency (creatinine clearance < 25 mL/min), as clearance is reduced by more than 50%. In these patients, during titration, the individual doses should be reduced. If higher doses are required, individual doses rather than dosing frequency should be increased [see WARNINGS AND PRECAUTIONS].

Dosing in Patients with Hepatic Impairment

Zanaflex should be used with caution in patients with any hepatic impairment. In these patients, during titration, the individual doses should be reduced. If higher doses are required, individual doses rather than dosing frequency should be increased. Monitoring of aminotransferase levels is recommended for baseline and 1 month after maximum dose is achieved, or if hepatic injury is suspected. [see Use In Specific Populations]

Drug Discontinuation

If therapy needs to be discontinued, particularly in patients who have been receiving high doses (20 mg to 36 mg daily) for long periods (9 weeks or more) or who may be on concomitant treatment with narcotics, the dose should be decreased slowly (2 mg to 4 mg per day) to minimize the risk of withdrawal and rebound hypertension, tachycardia, and hypertonia [see Drug Abuse and Dependence].

HOW SUPPLIED

Dosage Forms And Strengths

Capsules
  • 2 mg: Light blue opaque body with a light blue opaque cap with “2 MG” printed on the cap
  • 4 mg: White opaque body with a blue opaque cap with “4 MG” printed on the cap
  • 6 mg: Blue opaque body with a white stripe and blue opaque cap with “6 MG” printed on the cap
Tablets
  • 4 mg white, uncoated tablets with a quadrisecting score on one side and debossed with “A594” on the other side

Storage And Handling

Zanaflex Capsules®

Zanaflex Capsules® (tizanidine hydrochloride) capsules are available in three strengths as two-piece hard gelatin capsules containing tizanidine hydrochloride 2.29 mg, 4.58 mg and 6.87 mg, equivalent to 2 mg, 4 mg and 6 mg tizanidine base.

  • The 2 mg capsules have a light blue opaque body with a light blue opaque cap with “2 MG” printed on the cap: bottles of 150 capsules (NDC 10144-602-15)
  • The 4 mg capsules have a white opaque body with a blue opaque cap with “4 MG” printed on the cap: bottles of 150 capsules (NDC 10144-604-15)
  • The 6 mg capsules have a blue opaque body with a white stripe and blue opaque cap with “6 MG” printed on the capsules: 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 as 4 mg white, uncoated tablets containing tizanidine hydrochloride 4.58 mg, equivalent to 4 mg tizanidine base. The tablets have a quadrisecting score on one side and are debossed with “A594” on the other side. Tablets are provided as follows: 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 .

Marketed and Distributed by: Acorda Therapeutics Inc. Ardsley, NY 10502. Revised: November 2013.

Last reviewed on RxList: 11/22/2013
This monograph has been modified to include the generic and brand name in many instances.

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