Flexifen Tablet 5mg

PRESENTATION

Flexifen 5: Each tablet contains Baclofen BP 5 mg.

Flexifen 10: Each tablet contains Baclofen BP 10 mg.

DESCRIPTION

Baclofen is a centrally acting skeletal muscle relaxant and an antispastic agent with a spinal site of action.

INDICATIONS

Flexifen is indicated for:

– Spasm.

– Spinal cord diseases.

– Cerebrovascular accidents or neoplastic or degenerative brain disease.

– Muscle spasm of cerebral origin especially infantile cerebral palsy.

– The alleviation of spasticity resulting from multiple sclerosis

DOSAGE & ADMINISTRATION

Adults:

Treatment should be started with low dose and increased gradually until optimum effect is achieved. The following dosage titration

schedule is suggested:

5 mg 3 times daily for 3 days,

10 mg 3 times daily for 3 days,

15 mg 3 times daily for 3 days,

20 mg 3 times daily for 3 days,

25 mg 3 times daily for 3 days.

Thereafter, additional increases may be necessary. The optimum dosage generally ranges from 30 – 80 mg daily in 3 – 4 divided

doses. Daily doses of 100 – 120 mg may be given to carefully supervised patients in hospitals.

Children:

Treatment should be started at a very low dose, e.g., 0.3 mg/kg per day in divided (preferably 4) 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 2 mg/kg body weight per day. In children aged over 10 years a maximum daily dose of 2.5 mg/kg body

weight may be given.

Renal Insufficiency:

Baclofen is excreted principally in urine as unchanged drug. So it may be necessary to reduce the dosage in patients with impaired

renal function.

SIDE EFFECTS

The most common side effects include drowsiness, nausea, dizziness, lassitude, lightheadedness, confusion, fatigue, muscular pain

& weakness and hypotension.

PRECAUTIONS

Patients suffering from psychotic disorders, schizophrenia, depressive or manic disorders, confusional states or Parkinson\’s

disease, should be treated cautiously with Baclofen. Baclofen stimulates gastric acid secretion and should be used with caution in

patients with a history of peptic ulcer and avoided in those with active peptic ulcer disease . Liver function should be monitored

in patients with liver disease; patients with renal impairment need a reduced dose. Baclofen should be used with caution in

patients with respiratory impairment. Observations of increased blood sugar concentrations suggest caution in patients with

diabetes mellitus. Care is also required in the elderly, in whom adverse effects may be more common, and in patients with

cerebrovascular disease (who tolerate Baclofen poorly). Baclofen may cause drowsiness; patients affected should not drive or

operate machinery. Abrupt withdrawal of Baclofen may result in a withdrawal syndrome and exacerbation of spasticity; dosage should

be reduced gradually over at least 1 to 2 weeks, or longer if symptoms occur.

USE IN PREGNANCY & LACTATION

There are no adequate and well controlled studies of Baclofen in pregnant women. So it should be used during pregnancy only if the

potential benefit outweighs the potential risk to the fetus.

Baclofen is excreted in breast milk. However, evidence suggests that the quantities are so small that no undesirable effect on the

infant would be expected.

DRUG INTERACTION

Alcohol and other CNS depressants may exacerbate the CNS effects of Baclofen and should be avoided. There may be increased

weakness if Baclofen is given to patients taking a tricyclic antidepressant and an increased hypotensive effect if it is given to

patients receiving antihypertensive therapy.

OVER DOSE

Prominent features are signs of central nervous system depression. No specific antidote of Baclofen is known. Elimination of the

agent from GI tract, artificial respiration, administration of fluid with a diuretic and dialysis should be considered.

COMMERCIAL PACK

Flexifen 5: Each box contains 5 blister strips of 10 tablets.

Flexifen 10: Each box contains 3 blister strips of 10 tablets.