zanaflex warning

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Zanaflex (tizanidine hydrochloride) Tablets and Capsules

Audience: Healthcare professionals

[Posted 04/11/2007] Acorda Therapeutics and FDA informed healthcare

professionals of changes to the CONTRAINDICATIONS and WARNINGS Sections

of the product labeling for Zanaflex, a drug used to treat spasticity.

In pharmacokinetic studies where tizanidine was coadministered with

either fluvoxamine or ciprofloxacin (CYP1A2 inhibitors), the serum

concentration of tizanidine was significantly increased and potentiated

its hypotensive and sedative effects. Although there are no clinical

studies evaluating the effects of other CYP1A2 inhibitors on tizanidine,

coadministration of tizanidine with other CYP1A2 inhibitors (zileuton,

other fluroquinolones, antiarrythmics, cimetidine, famotidine, oral

contraceptives, acyclovir and ticlopidine) should be avoided.

[March 27, 2007 - Letter

<http://www.fda.gov/medwatch/safety/2007/Zanaflex_DHCP_3-27-2007.pdf> -

Acorda Therapeutics]

[July 2006 - Label

<http://www.fda.gov/medwatch/safety/2007/Zanaflex_PI_apr07.pdf> -

Acorda Therapeutics]

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