LIOSAL Baclofen 10mg Film-Coated Tablet 1's

Name: LIOSAL Baclofen 10mg Film-Coated Tablet 1's
Brand: Liosal
SKU: RXDRUG-DR-XY40693-1pc
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Description

Indications/Uses

Baclofen (Liosal) is a prescription medicine used to treat the symptoms of spasticity from multiple sclerosis, in particularity for the relief of spasm and concomitant pain clonus and muscular rigidity. Baclofen (Liosal) is also indicated for the treatment of Dystonia; Spasticity associated with cerebral palsy; And trigeminal neuralgia.

Dosage/Direction for Use

Baclofen (Liosal) is given orally in divided doses, preferably with or after food or milk. The initial dose of baclofen is 5 mg three times daily for 3 days, increased to 10 mg three times daily for 3 days, then in similar increments and intervals until either a dose of 20 mg three times daily is reached or until the desired therapeutic effect is obtained. Higher doses have been used. Doses of more than 80 to 100 mg daily are not generally recommended although doses of up to 150 mg daily have been given to carefully to supervised patients.
In the UK a dosage range of 0.75 to 2 mg/kg daily has been used for children; in children over 10 years a maximum daily dosage of 2.5 mg/kg may be given. It is usual to start with a low dose of 2.5 mg given four times daily, increased cautiously about 3 days until the desired therapeutic effect is obtained. The recommended daily maintenance doses are: 12 months to 2 years, 10 to 20 mg; 2 to 6 years, 20 to 30 mg; 6 to 10 years, 30 to 60 mg.

Overdosage

Symptoms of Baclofen overdose include vomiting, weakness, drowsiness, slow breathing, seizures, unusual pupil size and coma.

Administration

Should be taken with food.

Contraindications

Baclofen is contraindicated in epilepsy, rheumatic muscle spasm, pre-existing bladder sphincter hypertonia and patients who are known sensitive to Baclofen or to any of the excipients.

Special Precautions

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. It should also be used with caution in patients with severe psychiatric disorders or epilepsy or convulsive disorders since these disorders may be exacerbated by baclofen. 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). It should be used with caution in patients who use their spasticity to maintain posture or to increase function. Urine retention may be exacerbated in patients with hypertonic bladder sphincters.
Baclofen may cause drowsiness; patients affected should not drive or operate machine.
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

Pregnancy Category C. Safe use of Baclofen during pregnancy has not been established. Baclofen crosses the placental barrier. Potential benefits should be weighed against the possible hazards. Use of Baclofen in lactating women is not recommended. If therapy is considered essential, alternative feeding arrangements should be made.

Adverse Reactions

The most common adverse effects include drowsiness, nausea, dizziness, lassitude, lightheadedness, confusion, fatigue, muscular pain and weakness, and hypotension. Other adverse effects include euphoria, hallucinations, depression, headache, tinnitus, convulsions, paraesthesias, slurred speech, dry mouth, taste alterations, vomiting, diarrhea or constipation, ataxia, nystagmus, tremors, insomnia, visual disturbances, skin rashes, pruritus, increased sweating, urinary disturbances, respiratory or cardiovascular depression, blood sugar changes, alterations in liver function values, and a paradoxical increase in spasticity. Problems with erection and ejaculation have also been reported with intrathecal baclofen; these are usually reversible on withdrawal of therapy.
Overdosage may lead to muscular hypotonia, hypothermia, drowsiness, respiratory depression, coma and convulsion.

Drug Interactions

Alcohol and other CNS depressants may exacerbate the CNS effects of baclofen and should be avoided; severe aggravation of hyperkinetic symptoms may possibly occur in patients taking lithium. There may be increased weakness if baclofen is given to patients taking a tricyclic antidepressant and there may be an increased hypotensive effect if it is given to patients receiving antihypertensive therapy. Ibuprofen and other drugs that produce renal insufficiency may reduce baclofen excretion leading to toxicity.

Storage

Store at a temperature not exceeding 30°C.
Keep in a dry place away from light and moisture.

Action

Pharmacology: Pharmacokinetics: Baclofen is rapidly and almost completely absorbed from the gastrointestinal tract after an oral dose. Peak plasma concentrations occur after 0.5 to 3 hours after ingestion, but the rate and extent of absorption vary between patients, and may vary inversely with the dose. After oral doses, some baclofen crosses the blood-brain barrier, with concentrations in CSF about 12% of those in the plasma. About 30% of baclofen is bound to plasma proteins. About 70 to 80% of a dose is excreted in the urine mainly as unchanged drug; about 15% is metabolized in the liver. The elimination half-life of baclofen is about 3 to 4 hours in plasma and about 1 to 5 hours in the CSF. Baclofen crosses the placenta and is distributed into breast milk.

MedsGo Class

Muscle Relaxants