Tizanidine hydrochloride

TIZANIDINE HYDROCHLORIDE

Manufacturer: Cadila Pharmaceuticals Limited

Score: 142.0

Quick Summary

Tizanidine hydrochloride is a central alpha-2-adrenergic agonist used for the management of spasticity. It is available in capsule form and should be taken with or without food, with a recommended starting dose of 2 mg and a maximum daily dose of 36 mg. The drug has several contraindications, including use with potent inhibitors of CYP1A2, and may cause adverse reactions such as dry mouth, somnolence, and dizziness. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use, with careful monitoring and dose adjustments recommended as needed.

Key Clinical Findings and Indications

Tizanidine hydrochloride is a central alpha-2-adrenergic agonist
Used for the management of spasticity
Available in capsule form
Recommended starting dose of 2 mg
Maximum daily dose of 36 mg

Important Safety Information

Warning

Concomitant use with potent inhibitors of CYP1A2 is contraindicated

Contraindications

Potent inhibitors of CYP1A2, such as fluvoxamine or ciprofloxacin
Hypersensitivity to tizanidine or any of its ingredients

Adverse Reactions

Dry mouth
Somnolence
Dizziness
Urinary tract infection
Constipation
Liver function tests abnormal
Vomiting
Speech disorder
Amblyopia
Urinary frequency
Flu syndrome
Dyskinesia
Nervousness
Pharyngitis
Rhinitis

Dosing Recommendations

General Guidance

Dose adjustments should be made gradually, with careful monitoring of the patient's response to therapy

Spasticity

Adult Dose

2 mg, repeated at 6 to 8 hour intervals, up to a maximum of 3 doses in 24 hours

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

There are no adequate data on the developmental risk associated with use of tizanidine in pregnant women
Animal studies have shown embryofetal and postnatal offspring mortality and growth deficits at doses less than those used clinically

Nursing Mothers

It is not known whether tizanidine is excreted in human milk
Caution should be exercised when tizanidine is administered to a nursing woman

Pediatric Use

Safety and effectiveness in pediatric patients have not been established

Geriatric Use

Tizanidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function
Care should be taken in dose selection, and it may be useful to monitor renal function in elderly patients

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