Source: Health Products Regulatory Authority (IE) Revision Year: 2016 Publisher: Teva Pharma B.V., Swansweg 5, 2031GA, Haarlem, Netherlands
Treatment of spasticity associated with multiple sclerosis or with spinal cord injury or disease.
For oral use.
The effect of tizanidine on spasticity is maximal within 2-3 hours of dosing g and it has a relatively short duration of action. The timing and frequency of dosing should therefore be tailored to the individual, and tizanidine should be given in di vide d doses, up to 3-4 times daily, depending on the patient’s needs. There is considerable variation in response between patients so careful titration is necessary. Care should be taken not to exceed the dose producing the desired therapeutic effect.
It is usual to start with a single dose of 2 mg increasing by 2 mg increments at no less than half-weekly intervals. The optimum the rapeutic response is gene rally achieved with a daily dose of between 12 an d 24 mg, administered in 3 or 4 equally spaced doses. Single doses should not exceed 12 mg. The total daily dose should not exceed 36 mg.
Adverse events (see section 4.8) m a y occur at therapeutic doses but these can be minimised by slow titration so that in the large majority of patients they are not a limiting factor.
If therapy needs to be discontinued, particularly in patients who have been receiving high doses for long periods, the dose should be decreased slowly (se e section 4.4).
Experience in the elderly is limited and use of tizanidine is not recommended unless the benefit of treatment clearly outweighs the risk. Pharmacokinetic data suggest that renal clearance in the elderly may be decreased by up to three fold.
Experience with tizanidine in patients under the age of 18 y ears is limited. Tizanidine is not recommended for use in this population.
In patients with renal insufficiency (creatinine clearance < 25 m l/min) treatment should be started with2 m g once daily with slow titration to achieve the effective dose. Dosage increases should be in increments of no more than 2 mg according to tolerability and effectiveness. It is advisable to slowly increase the once-daily dose before increasing the frequency of administration. Renal function should be monitored as appropriate in these patients (see section 4.4).
Tizanidine is contraindicated in patients with significantly impaired hepatic function (see sections 4.3 and 4.4).
Clinical experience is limited. In one adult case, who ingested 400 mg tizanidine, recovery was uneventful. This patient received mannitol and frusemide.
Nausea, vomiting, hypotension, bradycardia, QT prolongation, dizziness, miosis, respiratory distress, coma, restlessness, somnolence.
General supportive measures are indicated and an attempt should be made to remove uningested substance from the gastro-intestinal tract using gastric lavage or by repeated administration of high doses of activated charcoal. The patient should be well hydrated. Further treatment should be symptomatic.
3 years.
Do not store above 30°C.
Blister PVC/PVDC/Aluminium.
Blister packs of 15, 20, 30, 50, 100, 120 and clinical pack 500 (10x 50) tablets.
Not all pack-sizes may be marketed.
No special requirements.
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