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Sirdalud

Sirdalud

tizanidine

Manufacturer:

Novartis Healthcare

Distributor:

Zuellig

Marketer:

Sandoz
Concise Prescribing Info
Contents
Tizanidine HCl
Indications/Uses
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. Extra dose of 2 or 4 mg may be taken, preferably at night, in severe cases. 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. Elderly ≥65 yr Start at the lowest dose, increase in small steps according to tolerability & efficacy. Patient w/ renal impairment (CrCl <25 mL/min) Initially 2 mg once daily, increase dose in small steps according to tolerability & efficacy. Patient w/ moderate hepatic impairment Start w/ the lowest dose, increase carefully according to tolerability.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Severely impaired hepatic function. Concomitant use w/ strong CYP1A2 inhibitors eg, fluvoxamine or ciprofloxacin.
Special Precautions
Immediately discontinue in case of anaphylaxis or angioedema w/ anaphylactic shock or difficulty of breathing. Hypotension may occur. Rebound HTN & tachycardia w/ sudden w/drawal; do not stop treatment abruptly. Reports of association w/ hepatic dysfunction. Monitor LFTs mthly for the 1st 4 mth in patients receiving doses ≥ 12 mg & in patients who develop clinical symptoms suggestive of hepatic dysfunction. Discontinue treatment if SGPT/SGOT levels are persistently >3 times the ULN. Not recommended w/ moderate CYP1A2 inhibitors. Caution when given w/ drugs known to increase QT interval. Systemic exposure may be increased in patients w/ renal impairment (CrCl <25 mL/min). May impair ability to drive or operate machinery. Sexually-active females of reproductive potential should use effective contraception during treatment & for 1 day after stopping treatment. Do not use during pregnancy unless benefit clearly outweighs the risk. Do not give to women who are breast-feeding. Not recommended in childn <18 yr. Limited experience in 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 & overdose symptoms eg, 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. Potential additive effect on QT interval w/ drugs known to prolong QT interval (eg, cisapride, amytriptyline & azithromycin). May occasionally cause hypotension & bradycardia w/ antihypertensives including diuretics. Decreased conc w/ rifampicin. Decreased systemic exposure in smokers (>10 cigarettes/day). May enhance CNS depressant effects of alcohol. Possible enhanced sedative action w/ sedatives, hypnotics (eg, benzodiazepines or baclofen) & antihistamines. Potential additive hypotensive effect w/ α-2 adrenergic agonists (eg, clonidine).
MIMS Class
Muscle Relaxants
ATC Classification
M03BX02 - tizanidine ; Belongs to the class of other centrally-acting muscle relaxants.
Presentation/Packing
Form
Sirdalud tab 2 mg
Packing/Price
50's
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