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
Baclofen is contraindicated in patients with hypersensitivity to any component of this product.
Side Effects
The most common adverse reactions associated with Baclofen are transient drowsiness, daytime sedation, dizziness, weakness and fatigue. Central Nervous System: Headache (<10%), insomnia (<10%), and rarely, euphoria, excitement, depression, confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus, slurred speech, co-ordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizures, respiratory depression. Cardiovascular: Hypotension (<10%), rare instances of dyspnoea, palpitation, chest pain, syncope. Gastrointestinal: Nausea (approximately 10%), constipation (<10%) and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhoea and positive test for occult blood in stool. Genitourinary: Urinary frequency (<10%) and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, haematuria. Other: Instances of rash, pruritus, ankle oedema, excessive perspiration, weight gain, nasal congestion, visual disturbances, hepatic function disorders and paradoxical increase in spasticity. Muscular hypotonia of a degree sufficient to make walking or movement difficult may occur but is usually relieved by readjusting the dosage. For this purpose, the daytime dosage may be reduced and the evening dosage increased.
Pregnancy And Lactation
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.
Therapeutic
Centrally acting Skeletal Muscle Relaxants
Storage Conditions
Keep below 30�C temperature, away from light & moisture. Keep out of the reach of children.
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