Baclotin 10 – 25  (Tablets)

Composition:
Each tablet contains 10 or 25mg Baclofen.

Indications:
Baclotin is a skeletal muscle relaxant, it acts centrally, Baclotin is indicated for relief of spasms resulting from disorders such as multiple sclerosis, spinal lesions. It is also indicated in adults and children for relief of spasticity of voluntary muscles arising from cerebrovascular accidents, tumors of the spinal cord, motor neuron diseases, cerebral palsy, meningitis, and traumatic head injuries. Baclotin is likely to be mostly effective in patients whose spasticity constitutes a handicap to activities and/or physiotherapy.

Dosage:
Children up to 10 years: 0.75 – 2mg/Kg daily. The recommended daily maintenance doses are as follows:

Age

Dosage

12months – 2years

10 – 20mg

2 – 6 years

20 – 30mg

6 – 10 years

30 – 60mg

Children over 10 years: 2.5mg/Kg daily.
The usual starting dose is 2.5mg 4 times daily increased about every 3 days until the desired therapeutic effect is obtained.
Adults: The initial dose is 5mg 3 times daily. 5mg increase the total daily dose every fourth day. i.e. the dosage regimen is: 5mg 3 times a day for 3 days, 10mg 3 times a day for next 3 days, 15mg 3 times a day for next 3 days, 20mg 3 times a day for next 3 days, or until the desired therapeutic effect is obtained. Dose over 100mg daily is not recommended.
Doses should be reduced in renal failure. If no benefit is apparent within 6 – 8 weeks of achieving the maximum dosage, therapy should be gradually withdrawn.

Side Effects:
Side Effects occur with initial treatment, with large doses, or if the dose increased too quickly, such as: Drowsiness, nausea, vomiting, fatigue, dizziness, hypotension, hallucination, depression, headache, tinnitus, dysphasia, constipation or diarrhea, tremor, insomnia, nystagmus, pruritus, urinary disorders, deterioration in liver function.

Contraindications:
Peptic ulcer or hypersensitivity to the drug.

Drug Interactions:
When Baclotin is taken with other drugs acting on CNS or with alcohol, increased sedation may occur. Since concomitant treatment with Baclotin and antihypertensive agent is likely to increase hypotensive effect, dosage of antihypertensive medication should be adjusted accordingly. In patients with Parkinson's disease receiving treatment with Baclotin and levodopa plus carbidopa, there have been reports of mental confusion, hallucination, and agitation. During concurrent treatment with tricyclic antidepressants, the drug may result in muscular hypotonia. The drug in patients receive Lithium may produce sever aggravation of hyperkinetic symptoms.

Precautions:
The drug should be used with caution in patients with: Sever psychiatric disorders, convulsive disturbances or epilepsy, disorder in renal or hepatic function, patients receiving antihypertensive therapy and elderly. Patients with stroke may be more susceptible to Baclotin. Elevation of blood sugar concentrations may occur in diabetics. During treatment, patients should avoid driving or operating machines. Therapy must be gradually discontinued.

Use in Pregnancy or Lactation:
The drug should not be used during pregnancy, especially during the first 3 months. In mothers taking Baclotin, active substance passes into breast milk in small quantities that no undesirable effects on infant are expected.

Presentation:
Carton pack contains 2 blisters of 10 tablets in each, with leaflet.

 
 
 

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