Composition
Each tablet contains: Tizanidine (as HCL): 4 mg.
Properties
Tizanidine (Roysan®) is a centrally acting skeletal muscle relaxant, its major site of action is in the spinal cord. It preferentially inhibits polysynaptic mechanisms responsible for excessive muscle tone, mainly by reducing the release of excitatory amino acids from interneurons.
The drug does not affect neuromuscular transmission.
Roysan® is well tolerated and effective against both acute painful muscle spasms and chronic spasticity of spinal and cerebral origin.
Pharmacokinetics
Tizanidine is rapidly and completely absorbed after oral administration; peak plasma concentration is reached within 1 to 2 hours. The half-life is approximately 3-5 hours.
Tizanidine is metabolized in the liver to inactive metabolities; it is widely distributed throughout the body and is excreted mainly through the kidneys.
Indications
- Painful muscle spasms in the cervical or lumbar regions and postoperative as in herniated intervertebral disc or osteoarthritis of the hip.
- Spasticity due to neurological disorders, e.g, multiple sclerosis, degenerative disease of spinal cord, myelopathy, cerebrovascualr accidents and cerebral palsy.
Contraindications
Hypersensitivity to tizanidine
Precautions
- Renal insufficiency ( creatinine clearance < 25 ml/min)
- Severely impaired liver function
- Patients who have to drive or operate machinery
- Patients suffering from hypotension or who are receiving concurrent antihypertensive drugs.
N.B.: Experience with tizanidine in children is still limited
Side Effects
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.
Drug Interaction
- Concomitant use with antihypertensives
- Alcohol or sedatives may enhance the sedative action of tizanidine
Pregnancy and lactation
Tizanidine has no teratogenic effects in animals but its safety in pregnancy has not yet been established.
Experience in breast-fed infants of mothers receiving tizanidine is unknown
Dosage
Relief of painful muscle spasms: ½ to 1 tablet 3 times daily. In severe cases an extra dose may be taken in night.
Spasticity due to neurological disorders: The dosage should be adjusted to the needs of the individual patient. The initial daily dose (6 mg) may be increased stepwise to reach 12 or 24 mg dialy.
Daily dose should not exceed 36 mg ( 9 tablets)
How Supplied
Strips of 10 tablets in pack of 1 strip.
Keep all medicaments out of reach of children
Product of: AMOUN PHARMACEUTICAL CO. El-Obour City, Cairo, Egypt. ATC Code: M03BX02