Tizanidine Hydrochloride Capsules

CONTRAINDICATIONS

• Concomitant use with strong CYP1A2 inhibitors ( 4, 7.1)
• Patients with a history of hypersensitivity to tizanidine or the ingredients in tizanidine hydrochloride capsules ( 4, 5.5)

WARNINGS AND PRECAUTIONS

• Hypotension: monitor for signs and symptoms of hypotension, in particular in patients receiving concurrent antihypertensives; tizanidine should not be used with other α 2-adrenergic agonists ( 5.1, 7.7)
• Risk of liver injury: monitor ALTs; discontinue tizanidine if liver injury occurs ( 5.2)
• Sedation: tizanidine may interfere with everyday activities; sedative effects of Tizanidine, alcohol, and other central nervous system (CNS) depressants are additive ( 5.3, 7.4)
• Hallucinations: consider discontinuation of tizanidine ( 5.4)

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ADVERSE REACTIONS

The most common adverse reactions (greater than 10% of patients taking tizanidine and greater than in patients taking placebo) were dry mouth, somnolence, asthenia and dizziness. ( 6.1)

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To report SUSPECTED ADVERSE REACTIONS, contact Trifluent Pharma at 1-210-944-6920 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Full Safety and Prescribing Information: DailyMed