Relofen-10mg.

Category:

COMPOSITION

Relofen 10 Tablet: Each tablet contains Baclofen BP 10 mg.

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.

INDICATION

Relofen (Baclofen) is effective in the symptomatic treatment of spasticity caused by multiple sclerosis or other diseases of the spinal cord, such as traumatic lesions.

DOSAGE AND ADMINISTRATION

Treatment should be initiated with an oral dose of 5 mg, given two or three times daily. After three days the individual dose is increased to 10 mg. The maximum dosage is 20 mg four times daily. Do not exceed 80 mg daily.

CONTRAINDICATION

Patients with a history of epilepsy or convulsive disorders.

PRECAUTION

Relofen (Baclofen) should be used with caution in patients with a history of gastric and duodenal ulcer, severe psychiatric disorders, or impaired cerebrovascular system, in pulmonary insufficiency, renal impairment and in patients receiving anti-hypertensive therapy.

SIDE EFFECTS

Nausea, vomiting, drowsiness, confusion, dizziness, fatigue and hypotonia may occur. Other side-effects include giddiness, hypotension, euphoria, hallucinations, depression, headache, diarrhoea or constipation, tremors, insomnia, visual disturbances, allergic skin reactions, pruritis, urinary disturbances and hepatic impairment.

USE IN PREGNANCY AND LACTATION

Relofen (Baclofen) is teratogenic in animals and should therefore not be administered to pregnant and lactating women.

DRUG INTERACTION

Increased sedation may occur if Relofen (Baclofen) is taken with agents acting on the central nervous system, alcohol or synthetic opiates. The risk of respiratory depression is also increased. Combined treatment with Relofen (Baclofen) and antihypertensives is likely to increase the fall in blood pressure; therefore the dosage of antihypertensive medication should be adjusted accordingly. The concomitant administration of Relofen (Baclofen) and tricyclic antidepressants may potentiate the pharmacological effects of Relofen (Baclofen) resulting in pronounced muscular hypotonia. The concurrent use of MAO inhibitors and Relofen (Baclofen) may result in increased CNS depressant effects.

OVERDOSE

Gastric lavage is important in case of severe overdose.

STORAGE

Protect from light and store below 25°C. Keep out of the reach of children.

PACKING

Relofen 10 Tablet: Box containing 10 X 3 tablets in blister pack.

Relofen-10mg.
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