Novartis Healthcare




Concise Prescribing Info
Tizanidine HCl
Painful muscle spasms associated w/ static & functional disorders of the spine (cervical & lumbar syndromes) &/or following surgery eg, for herniated intervertebral disc or OA of the hip. Spasticity due to neurological disorders eg, multiple sclerosis, chronic myelopathy, degenerative spinal cord diseases, CVA & cerebral palsy.
Dosage/Direction for Use
Relief of painful muscle spasms 2-4 mg tid. Severe cases 2 or 4 mg extra dose. Spasticity due to neurological disorders Initially 6 mg daily in 3 divided doses, may increase stepwise at half-wkly or wkly intervals by 2-4 mg. Optimum therapeutic response: 12 & 24 mg daily in 3 or 4 equally spaced doses. Max: 36 mg daily. Renal impairment (CrCl <25 mL/min) Initially 2 mg once daily.
May be taken with or without food.
Hypersensitivity. Severely impaired hepatic function. Concomitant use w/ strong CYP1A2 inhibitors eg, fluvoxamine or ciprofloxacin.
Special Precautions
Drugs known to increase QT interval. Hypotension. Avoid abrupt w/drawal. Discontinue use if SGPT/SGOT levels are persistently >3x the upper limit of normal; monitor liver function test (≥12 mg dose). Renal impairment (CrCl <25 mL/min). May impair ability to drive or operate machinery. Pregnancy & lactation. Not recommended in childn ≤18 yr. Elderly ≥65 yr.
Adverse Reactions
Somnolence, dizziness; GI disorder, dry mouth; muscular weakness; fatigue. Insomnia, sleep disorder; hypotension; nausea; decreased BP, increased transaminases.
Drug Interactions
Increased plasma levels & QT(c) prolongation w/ CYP1A2 inhibitors [eg, fluvoxamine or ciprofloxacin, antiarrhythmics (amiodarone, mexiletine, propafenone), cimetidine, fluoroquinolones (enoxacin, pefloxacin, norfloxacin), rofecoxib, OCs & ticlopidine]. Decreased plasma levels w/ CYP1A2 inducers. Drugs known to prolong QT interval (eg, cisapride, amytriptyline & azithromycin). May occasionally cause hypotension & bradycardia w/ antihypertensives including diuretics. Decreased conc w/ rifampicin. Decrease systemic exposure in smokers (>10 cigarettes/day). May enhance CNS depressant effects of alcohol. May enhance sedative action w/ sedatives, hypnotics (eg, benzodiazepines or baclofen) & antihistamines. Potential additive hypotensive effect w/ α-2 adrenergic agonists (eg, clonidine).
MIMS Class
ATC Classification
M03BX02 - tizanidine ; Belongs to the class of other centrally-acting muscle relaxants.
Sirdalud tab 2 mg
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