MYLOBAC 10& 25 MG TABLET

Description

PROPERTIES:
MYLOBAC contains baclofen which inhibits both mono-synaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of afferent terminals, although actions at supraspinal sites may also contribute to its clinical effect.
Pharmacokinetic:
ϖ Baclofen is rapidly and completely absorbed from the gastro-intestinal tract.
ϖ The bioavailability of oral baclofen is 70 to 80%.
ϖ Baclofen is bound to plasma protein to the extent of about 30%.
ϖ About 15% of a dose of baclofen is metabolized in the liver.
ϖ Approximately 70% of baclofen is eliminated in the urine in the unchanged form.
INDICATIONS:
MYLOBAC is indicated for the relief of painful spasticity of voluntary muscles associated with many conditions such as:
• Spinal cord injuries and diseases, e.g. traumatic partial section of the cord, transverse myelitis, meningitis and tumors of the cord.
• Traumatic head injury and cerebral palsy.
• Trigeminal neuralgia and post-herpetic neuralgia.
• Low back pain and sciatica.
• Multiple sclerosis.
• Tardive dyskinesia.
• Intractable hiccups.
DOSAGE:
Adults:
The initial dose is 5 mg ( ½ tablet of MYLOBAC 10 mg ) 3 times daily for 3 days, then increased by increments of 5 mg per dose every 3 days until the desired response is achieved. The maximum dose is 20 mg or 25 mg 3 times a day.
Doses of 80 mg 100 mg daily may be given to carefully supervised patients.
Children:
0.75 to 2.5 mg/kg/day in three divided doses. The recommended initial dose is 2.5 mg three times daily. The dose should be increased gradually at 3-day intervals until the desired improvement of symptoms is achieved or as directed by the physician.
CONTRAINDICATIONS:
Hypersensitivity to baclofen.
SIDE EFFECTS:
MYLOBAC tablets are well tolerated. Side effects are often mild and transient and may be minimized by increasing doses gradually. Sedation, drowsiness, nausea, dizziness, confusion, hypotension and skin rashes may occur.
DRUG INTERACTIONS:
Concomitant use of CNS depressants with baclofen may produce additive CNS effects.
Pregnancy & lactation:
The safety in lactation has not been established. The drug should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus.
Precautions & warning:
Patients with renal impairment may need a reduced dose. Patients should be cautioned regarding operating dangerous machinery due to possibility of sedation. It should be used cautiously in patients with convulsive disorders.
PACKING:
A carton box containing 1 (Aluminium/Transparent PVC) strip containing 10 tablets of Mylobac (10 mg or 25 mg) and a pamphlet.
STORAGE:
Keep at a temperature not exceeding 30C, in dry place.
Keep out of reach of children.
instruction to patients:
• Abrupt discontinuation of treatment should be avoided.
• MYLOBAC should be taken during meals with a little liquid.