DE-PAIN 4
-
Chemical Name:
Tizanidine (HCl) -
Therapeutic Category:
Neuromuscular drugs -
Pharmacologic Category:
Alpha2-Adrenergic Agonist -
Pharmaceutical Form:
Tablets -
Composition:
Tizanidine (HCl) 4mg
DE - PAIN
Tablets
Tizanidine (Hydrochloride)
1. PHARMACOLOGY:
DE PAIN is a centrally acting skeletal muscle relaxant. Its principle site of action is the spinal cord.
It preferentially inhibits polysynaptic mechanisms responsible for excessive muscle tone. It does not affect neuromuscular transmission.
DE PAIN is well tolerated and effectively relieves both acute, painful muscle spasms and chronic spasticity of spinal and cerebral origin.
It reduces resistance to passive movement, alleviates spasm and clonus, and improves voluntary strength.
2. PHARMACOKINETICS:
Absorption: Tizanidine HCl is rapidly and almost completely absorbed.
Peak plasma concentration is attained within 1 - 2 hours.
Metabolism and Elimination:
- Metabolism is mainly hepatic.
- Excretion is mainly (~ 70 %) via the kidneys.
- Elimination half – life is around 3 - 5 hours.
- Food intake has no effect on the pharmacokinetics of Tizanidine HCl.
3. INDICATIONS:
- Painful muscle spasms: Associated with postural or functional disorders of the spine (cervical and lumbar syndromes) following surgery i.e. for herniated intervertebral disc, or for osteoarthritis of the hip.
- Spasticity due to multiple sclerosis.
- Spasticity due to diseases of the spinal cord such as chronic myelopathy etc …
- Muscle spasms and spasticity due to neurological disorders, i.e. following cerebrovascular accident or head injury, or due to infantile cerebral palsy.
4. CONTRAINDICATIONS:
Hypersensitivity to the drug.
5. PRECAUTIONS:
- Impaired kidney or liver function: Dosage should be adjusted as necessary.
- Pregnancy and lactation: As per the advice of the physician.
6. ADVERSE REACTIONS:
Adverse reactions are rare and usually mild and transient, they include:
Drowsiness, fatigue, dry mouth, nausea and slight reduction in blood pressure.
7. DRUG INTERACTIONS:
- Concomitant use of Tizanidine HCl with antihypertensives (including diuretics) may occasionally cause hypotension and bradycardia.
- Tizanidine HCl may potentiate the effects of alcohol and sedatives.
8. DOSAGE & ADMINISTRATION:
- Relief of painful muscle spasms:
2 - 4 mg three times daily.
In severe cases, an additional dose of 2 mg or 4 mg may be taken at night.
- Spasticity due to neurological disorders:
The dosage is adjusted to the needs of the individual patient.
The initial daily dose should not exceed 6 mg given in three divided doses.
It may be increased stepwise by 2 to 4 mg at 3 days or 7 days intervals.
The optimum therapeutic response is generally achieved with a daily dose of between 12 mg to 24 mg divided into 3 or 4 doses.
Maximum dose: a daily dose of 36 mg should not be exceeded.
9. PACKAGING & COMPOSITION:
- DE - PAIN 2 Tablets: A pack of 20 tablets in blisters. Each tablet contains Tizanidine (Hydrochloride) 2 mg.
- DE - PAIN 4 Tablets: A pack of 20 tablets in blisters. Each tablet contains Tizanidine (Hydrochloride) 4 mg.
10. STORAGE CONDITIONS:
Store DE - PAIN Tablets at temperature between (15-30)°C.
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