Each tablet contains: Tizanidine……………..2mg and Tizanidine……………..4mg as Hydrochloride.

Tizanidine (Musidin®) is a centrally acting skeletal muscle relaxant; its major site of action is in the spinal cord. Tizanidine (Musidin®) preferentially, inhibits polysynaptic mechanisms responsible for excessive muscle tone, mainly by reducing the release of excitator amino acids from interneurons. The drug does not affect neuromuscular transmission. Tizanidine (Musidin®) is well tolerated and effective against both acute painful muscle spasms and chronic spasticity of spinal and cerebral origin.

Tizanidine (Musidin®) is rapidly and almost completely absorbed. Peak plasma concentration is reached within 1 to 2 hours. Metabolism is largely hepatic. The metabolites have no significant activity. Both parent drug and metabolites are excreted mainly via the kidneys (approximately 70%). The substance is eliminated with a half-life of 2.1 to 4.2 hours. Plasma protein binding is low (30%).

Painful muscle spasms associated with static and functional disorders of the spine (cervical and lumbar syndromes), following surgery, e.g. for herniated intervertebral disc or osteoarthritis of the hip. Spasticity due to neurological disorders e.g. multiple sclerosis, chronic myelopathy, degenerative diseases of the spinal cord, cerebrovascular accidents, and cerebral palsy.

Relief of painful muscle spasms 2 to 4mg three times daily in tablet form. In severe cases an extra dose of 2 or 4mg may be taken at night. Spasticity due to neurological disorders The dosage should be adjusted to the needs of the individual patient. The initial daily dose should not exceed 6mg given in three divided doses. It may be increased stepwise at half-weekly or weekly intervals by 2 to 4mg. The optimum therapeutic response is generally achieved with a daily dose of between 12 and 24mg, administered in 3 or 4 equally spaced doses. The daily dose of 36mg should not be exceeded.

Hypersensitivity to the drug, severe hepatic dysfunction.

In patients with renal insufficiency (creatinine clearance less than 25 ml/min), it is recommended to start treatment at 2mg once daily. Dosage increase should be done in small steps according to tolerability and efficacy. If efficacy has to be improved, it is advisable to increase first the once-daily dose before increasing the frequency of administration. Patients experiencing drowsiness at the beginning of treatment should be advised against activities requiring a high degree of alertness, e.g. driving a vehicle or operating machinery. Tizanidine (Musidin®) has no teratogenic effects in animals, but its safety in pregnancy has not yet been established. Experience with drug in children is still limited and its safety in breast-fed infants of mothers receiving Tizanidine (Musidin®) is unknown.

Concomitant use of Tizanidine (Musidin®) with antihypertensives, including diuretics, may occasionally cause hypotension and bradycardia. Alcohol or sedatives may enhance the sedative action of Tizanidine (Musidin®), its clearance has been reported to be lower in women receiving hormonal contraceptives.

With low doses, as recommended for the relief of painful muscle spasms, side effects are rare and usually mild and transient. They include drowsiness, fatigue, dizziness, dry mouth, nausea, gastrointestinal disturbances and slight reduction in blood pressure. With higher doses, as recommended for spasticity, the above side effects are more frequent and more pronounced, but seldom severe enough to require discontinuation of treatment. In addition, muscle weakness and insomnia may occur and instances of hypotension and bradycardia have been observed. Transient increase in serum transaminases have occurred in a few patients.

Clinical experience is limited. In one adult case, who ingested 400mg Tizanidine (Musidin®), recovery was uneventful. Symptoms: nausea, vomiting, hypotension, dizziness, miosis, respiratory distress, coma, restlessness, somnolence. Treatment: It is recommended to eliminate the ingested drug by repeated administration of high doses of activated charcoal. Forced diuresis is expected to accelerate the elimination of Tizanidine (Musidin®). Further treatment should be symptomatic.

· Protect from heat, sunlight and moisture. · Keep all medicines out of the reach of children. · Store below 30oC.

Musidin Tablets 2mg: Blister pack of 10 tablets. Musidin Tablets 4mg: Blister pack of 10 tablets.

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