| DESCRIPTION |
| Fenobac® the preparation of Baclofen. Baclofen is an effective muscle relaxant and antispasfic agent with a spinal site of action. Baclofen is structurally similar to the inhibitory neurotransmitter gamma-amino-butyric acid, though its actions are different. It binds stereospecifically to GAIBAB receptors. It is thought that activation of the GAIBAB receptors on presynaptic terminal reduces evoked transmitter release, perhaps through reduced presynaptic Ca2 influx. Baclofen can inhibit the function of inward calcium currents in some cells. The drug is rapidly absorbed after oral administration and is widely distributed throughout the body. |
| INDICATIONS |
- The control of spasticity caused by multiple sclerosis and spinal cord lesions.
- The control of spasticity in children caused by cerebral palsy.
- The adjunctive management of neurogenic bladder.
- The management of refractory trigeminal neuralgia.
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| DOSAGE AND ADMINSTRATION |
- The dose should be titrated to gain maximum benefit and minimize adverse reactions.
- Tablets should be taken with food or milk to reduce gastrointestinal intolerance.
- Baclofen should be withdrawn gradually if cessation of therapy is indicated.
Adult:
The usual starting dose of Baclofen for adults is 5 mg given three times daily. Based on the response, the dose can be increased gradually every three days by 5 mg to a maximum of 80 mg/day in several doses. It benefits are not evident after a 6 to 8 weeks trial period, patients should be slowly withdrawn from the drug. Children:
In children aged 12-24 months, the recommended daily dose is10-20 mg, and in children aged 2-10 years, 20-60 mg per day (from starting dose 0.3 -0.75 mg/kg body weight per day up-to 2 mg/kg body weight per day). Elderly:
Dosages should be cautiously administered and the patient kept under appropriate surveillance. Toxicity due to Baclofen may be mistaken for uraemic encephalopathy. Impaired Renal Function:
Baclofen should be used with caution. Lower doses (approximately 5 mg per day) should be used for patients with impaired renal function or those undergoing chronic haemodialysis. |
| CONTRAINDICATIONS |
| Baclofen is contraindicated in epilepsy, spasticity of functional significance, rheumatic muscle spasm and patients who are hypersensitive to any component of this product. |
| ADVERSE REACTIONS |
| Common adverse reactions include sedation, lethargy, vertigo, headache, nausea and diarrhea. Other infrequent side-effects are muscular hypotonia, urinary disturbances, confusion, speech disturbance, ataxia, hallucination, nightmares, euphoria, insomnia, depression, anxiety, agitation, tremor, nystagmus, paraesthesias, seizures, myalgia, fever, respiratory of cardiovascular depression, hypotension, dry mouth, gastrointestinal disorder, sexual dysfunction, visual disorders, rash, pruritis, urticaria, hyperhidrosis, angioedema, rarely taste alterations, blood sugar changes and paradoxical increase in spasticity. Some of the CNS and genitourinary symptoms may be related to the underlying disease rather than to drug therapy. |
| PRECAUTIONS |
| Baclofen should be used with caution in patients who use their spasticity to maintain posture or to increase function. In patient with epilepsy, the clinical slate and electroencephalogram should be monitored at regular intervals, since deterioration in seizure control and EEG have bean reported occasionally in patient laking Baclofen. Because of possibility of sedation, patient should be cautioned regarding the operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness. Patient should be cautioned that the CNS depressant effects of Baclofen may be additive to those of alcohol and other CNS depressants. |
| USE IN PREGNANCY AND LACTATION |
| Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Baclofen should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In mothers treated with oral Baclofen in therapeutic doses, the active substance passes into the breast milk. Therefore, administration to nursing mothers is not recommended. |
| DRUG INTERACTIONS |
a) Antihypertensives - Baclofen has an occasional hypotensive effect and should be used with care in conjunction with antihypertensive agents.
b) CNS depressant - The CNS depressant effects of Baclofen may be additive to those of CNS depressants.
c) Lithium- Baclofen may produce severe aggravation of hyperkinetic symptoms in patients receivinglithium.. |
| PHARMACEUTICAL PRECAUTION |
| Store in a cool dry place, away from light. Keep out of reach of children. |
| PACKAGING |
| Fenobac® Tablets: Box containing 3 strips of 10 Tablets each. Each tablet contains Baclofen USP 10 mg. |
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