Generic
Baclofen
Pharmacology
Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABAB receptors, which inhibits the release of glutamate and aspartate. It may also act at intraspinal sites producing CNS depression. Baclofen also exerts an antinociceptive effect.
Dosage Administration
Adult & children over 10 years: 5 mg 3 times daily, preferably with or after food, gradually increased; max. 100 mg daily. Children <10 years: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose- 12 month-2 years: 10-20 mg (10-20 ml) 2 years-6 years: 20-30 mg (20-30 ml) 6 years-10 years: 30-60 mg (30-60 ml)
Contraindications
Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established. Baclofen crosses the placental barrier. Baclofen should only be administered to pregnant women when in the judgement of the physician concludes that the potential benefits outweigh the possible hazards. Baclofen is excreted in breast milk however evidence to date suggests that the quantities are so small that no undesirable effects on the infant would be expected.
Side Effects
Lower doses (approximately 5 mg per day) should be used for patients with impaired renal function or those undergoing chronic haemodialysis. Patients suffering not only from spasticity but also from psychotic disorders, schizophrenia, depressive or manic disorders or confusional states should be treated cautiously and closely monitored as exacerbations of these disorders may occur. In patients with epilepsy and muscle spasticity, Baclofen may be used under appropriate supervision and provided that adequate anticonvulsive therapy is continued. Lowering of the convulsion threshold may occur and seizures have been reported after the cessation of Baclofen therapy or with overdose. Baclofen should be used with caution in patients with or with a history of peptic ulcers, cerebrovascular diseases, or hepatic, renal or respiratory failure. Careful monitoring of respiratory and cardiovascular function is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness. During treatment with Baclofen, neurogenic disturbances affecting emptying of the bladder may improve. However in patients with preexisting sphincter hypertonia, acute retention of urine may occur. Baclofen should be used with caution in these circumstances. Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerance to the medicine. Appropriate laboratory tests should be performed periodically in patients with hepatic diseases or diabetes mellitus to ensure that no medicine induced changes in these underlying diseases have occurred.
Pregnancy And Lactation
Gastric lavage is important in case of severe overdose.
Therapeutic
Keep below 30�C temperature, away from light & moisture. Keep out of the reach of children.
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