Skelofen 5 mg Tablet

Skelofen 5 mg Tablet

DESCRIPTION

SKELOFEN (Baclofen) is an effective muscle relaxant and antispastic agent with a spinal site of action. SKELOFEN

(Baclofen) inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABA-receptors, which inhibits the release of glutamate and aspartate. It may also act at intraspinal sites producing CNS depression. Neuromuscular transmission is not affected by Baclofen. SKELOFEN (Baclofen) also exerts an antinociceptive effect.

COMPOSITION

SKELOFEN 5 : Each film-coated tablet contains Baclofen USP 5 mg.

SKELOFEN 10 : Each film-coated tablet contains Baclofen USP 10 mg.

INDICATIONS

™ Spasm of skeletal muscle

™ Reflex muscle contractions

™ Spasticity resulting from multiple sclerosis, spinal cord injuries and other spinal cord diseases

™ Muscle spasm of cerebral origin especially infantile cerebral palsy

™ Indirect effects of treatment with SKELOFEN include, improvement of sleep patterns, improvement in bladder and sphincter function and helps in the prevention and healing of decubitus ulcers

™ Cerebrovascular accidents or neoplastic or degenerative brain disease

™ Tension-type headache

DOSAGE AND ADMINISTRATION

SKELOFEN (Baclofen) should be taken during meals with a little

liquid.

SKELOFEN (Baclofen) should be given in divided doses preferably 3 times daily for adults and 4 times daily for children. The lowest dose compatible with an optimal response is recommended.

If benefits are not evident after 6 to 8 week trial period, patients should be slowly withdrawn from the drug.

Adults:

Start therapy at low dosage and increase gradually until optimum effect is achieved (usually between 30 – 80 mg daily).

The following dosage titration schedule is suggested:

5 mg three times a day for 3 days

10 mg three times a day for 3 days

15 mg three times a day for 3 days

20 mg three times a day for 3 days

Thereafter additional increases may be necessary, but the total daily dose should usually not be exceeded a maximum of 80 mg, although in hospitalized patients, daily doses of 100 - 120 mg may occasionally be given.

Children:

Treatment should be started at a very low dose e.g. 0.3 mg/kg per day in divided doses. The dosage should be raised cautiously at 1- 2 week intervals until it is sufficient for the child's individual needs.

The usual dosage range for maintenance therapy is 0.75 to 2mg/kg body weight per day. In children, aged over 10 years, a maximum daily dose of 2.5 mg/kg bodyweight may be given.

OR, AS DIRECTED BY THE PHYSICIAN.

SIDE-EFFECTS

The most common adverse reactions associated with SKELOFEN are transient drowsiness, daytime sedation, dizziness, weakness and fatigue. Others reported:

Neuropsychiatric: headache (<10%), insomnia (<10%), and rare instance of euphoria, excitement, depression, confusion, hallucinations, paresthesia, nightmares, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizures, lowered convulsion threshold, and respiratory depression.

Cardiovascular: hypotension (<10%), rare instances of dyspnea, palpitation, chest pain, syncope.

Gastrointestinal: nausea (approx. 10%), constipation (<10%), and rare instance of dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, positive test for occult blood in stool.

Genitourinary: urinary frequency (<10%), and rare instance of enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria.

Other: instances of rash, pruritus, ankle edema, 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 may be increased.

CONTRAINDICATIONS

SKELOFEN is contraindicated in patients with hypersensitivity to any component of this product.

SPECIAL PRECAUTIONS

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, SKELOFEN 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 SKELOFEN therapy or with overdose.

SKELOFEN 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 SKELOFEN, neurogenic disturbances affecting emptying of the bladder may improve. However in patients with preexisting sphincter hypertonia, acute retention of urine may occur. SKELOFEN should be used with caution in these circumstances.

SKELOFEN 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.

USE IN 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.

DRUG INTERACTIONS

Increased sedation may occur if SKELOFEN 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 SKELOFEN and antihypertensive is likely to increase the fall in blood pressure; therefore the dosage of antihypertensive medication should be adjusted accordingly. The concomitant administration of SKELOFEN and tricyclic antidepressants may potentiate the pharmacological effects of SKELOFEN resulting in pronounced muscular hypotonia. In patients with Parkinsons disease receiving treatment with SKELOFEN and levodopa and carbidopa, there have been several reports of mental confusion, hallucinations, headaches, nausea and agitation. The concurrent use of MAO inhibitors and SKELOFEN may result in increased CNS depressant effects.

Caution is advised and the dosage of one or both agents should be adjusted accordingly. Caution should be exercised when administering SKELOFEN and magnesium sulphate or other neuromuscular blocking agents since a synergistic effect may theoretically occur.

SUPPLY

SKELOFEN 5 : Each box contains 3x10 tablets in blister strips.

SKELOFEN 10 : Each box contains 3x10 tablets in blister strips.