Tizanidine Hcl
Generic Name: tizanidine hcl
Brand Names:
Tizanidine Hcl
11. Description Tizanidine hydrochloride is a central alpha2-adrenergic agonist. Tizanidine hydrochloride, USP is a white to slightly yellow crystalline powder. Tizanidine is slightly soluble in water and methanol. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride.
Overview
11. Description Tizanidine hydrochloride is a central alpha2-adrenergic agonist. Tizanidine hydrochloride, USP is a white to slightly yellow crystalline powder. Tizanidine is slightly soluble in water and methanol. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride.
Uses
1. Indications and Usage Section 1 INDICATIONS AND USAGE Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important [SEE DOSAGE AND ADMINISTRATION (2.1)].
Dosage
2. Dosage and Administration Section 2.1 Dosing Information Tizanidine hydrochloride Capsules 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. Tizanidine hydrochloride Capsules and tizanidine 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.
Side Effects
6. Adverse Reactions The following adverse reactions are described elsewhere in other sections of the prescribing information: Hypotension [SEE WARNINGS AND PRECAUTIONS (5.1)] Liver Injury [SEE WARNINGS AND PRECAUTIONS (5.2)] Sedation [SEE WARNINGS AND PRECAUTIONS (5.3)] Hallucinosis/Psychotic-Like Symptoms [SEE WARNINGS AND PRECAUTIONS (5.4)] Hypersensitivity Reactions [SEE WARNINGS AND PRECAUTIONS (5.6)] 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
Interactions
7. Drug Interactions 7.1 Fluvoxamine Concomitant use of fluvoxamine and tizanidine is contraindicated. Changes in pharmacokinetics of tizanidine when administered with fluvoxamine resulted in significantly decreased blood pressure, increased drowsiness, and increased psychomotor impairment [see CONTRAINDICATIONS (4) AND CLINICAL PHARMACOLOGY (12.3)]. 7.2 Ciprofloxacin Concomitant use of ciprofloxacin and tizanidine is contraindicated. Changes in pharmacokinetics of tizanidine when administered with ciprofloxacin resulted in significantly decreased blood pressure, increased drowsiness, and increased psychomotor impairment [see CONTRAINDICATIONS (4) and CLINICAL PHARMACOLOGY (12.3)].
Warnings
5. Warnings and Precautions 5.1 Hypotension Tizanidine is an α2-adrenergic agonist that can produce hypotension. Syncope has been reported in the post marketing setting. The chance of significant hypotension may possibly be minimized by titration of the dose and by focusing attention on signs and symptoms of hypotension prior to dose advancement. In addition, patients moving from a supine to fixed upright position may be at increased risk for hypotension and orthostatic effects. Monitor for hypotension when tizanidine is used in patients receiving concurrent antihypertensive therapy. It is not recommended that tizanidine be used with other α2-adrenergic agonists. 4. Contraindications Tizanidine hydrochloride capsules are contraindicated in patients taking potent inhibitors of CYP1A2, such as fluvoxamine or ciprofloxacin [see DRUG INTERACTIONS (7.1, 7.2)].
Storage
16. How Supplied/Storage and Handling 16.1 Tizanidine Hydrochloride 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 4 mg tizanidine base.
Frequently Asked Questions
What is Tizanidine Hcl used for?▼
1. Indications and Usage Section 1 INDICATIONS AND USAGE Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important [SEE DOSAGE AND ADMINISTRATION (2.1)].
What are the side effects of Tizanidine Hcl?▼
6. Adverse Reactions The following adverse reactions are described elsewhere in other sections of the prescribing information: Hypotension [SEE WARNINGS AND PRECAUTIONS (5.1)] Liver Injury [SEE WARNINGS AND PRECAUTIONS (5.2)] Sedation [SEE WARNINGS AND PRECAUTIONS (5.3)] Hallucinosis/Psychotic-Like Symptoms [SEE WARNINGS AND PRECAUTIONS (5.4)] Hypersensitivity Reactions [SEE WARNINGS AND PRECAUTIONS (5.6)] 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
What are the important warnings for Tizanidine Hcl?▼
5. Warnings and Precautions 5.1 Hypotension Tizanidine is an α2-adrenergic agonist that can produce hypotension. Syncope has been reported in the post marketing setting. The chance of significant hypotension may possibly be minimized by titration of the dose and by focusing attention on signs and symptoms of hypotension prior to dose advancement. In addition, patients moving from a supine to fixed upright position may be at increased risk for hypotension and orthostatic effects. Monitor for hypotension when tizanidine is used in patients receiving concurrent antihypertensive therapy. It is not recommended that tizanidine be used with other α2-adrenergic agonists. 4. Contraindications Tizanidine hydrochloride capsules are contraindicated in patients taking potent inhibitors of CYP1A2, such as fluvoxamine or ciprofloxacin [see DRUG INTERACTIONS (7.1, 7.2)].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.