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Thread: Zanaflex warning

  1. #1

    Zanaflex warning

    FDA - MedWatch - Zanaflex (tizanidine hydrochloride) Tablets and Capsules - Changes to the CONTRAINDICATIONS and WARNINGS Sections of the Approved Product Labeling
    MedWatch - The FDA Safety Information and Adverse Event Reporting Program

    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.

    Read the complete MedWatch 2007 Safety summary, including a link to the manufacturer's Dear Healthcare Provider Letter regarding this issue at:
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  2. #2
    Razzle, thanks. Wise.

    Quote Originally Posted by razzle51
    FDA - MedWatch - Zanaflex (tizanidine hydrochloride) Tablets and Capsules - Changes to the CONTRAINDICATIONS and WARNINGS Sections of the Approved Product Labeling
    MedWatch - The FDA Safety Information and Adverse Event Reporting Program

    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.

    Read the complete MedWatch 2007 Safety summary, including a link to the manufacturer's Dear Healthcare Provider Letter regarding this issue at:

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