LIORESAL 25/MG TAB 50/TAB

Indications

Approved Uses

Spasticity resulting from multiple sclerosis, spinal cord injuries, spinal cord diseases, cerebral palsy (in some regions)

Dosage & Administration

Dosing by Condition

Spasticity (adults, oral): start 5 mg three times daily; increase by 5 mg per dose every ~3 days as tolerated; usual maintenance 40-80 mg/day in divided doses; typical maximum 80 mg/day (20 mg four times daily).

Initial Dose

5mg three times daily (15mg/day), titrated upward every 3 days

Maintenance Dose

40-80 mg/day in divided doses

Maximum Dose

80 mg per day (maximum recommended dose); doses above 80 mg/day are not recommended in standard prescribing information

Dose Adjustment Notes

Titrate gradually to effect and tolerability (often every ~3 days); use lower doses/caution in renal impairment and in older adults; avoid abrupt discontinuation-taper gradually.

How to Take

Oral tablet: swallow with water; may be taken with or without food (taking with food/milk can reduce GI upset); doses are typically given in divided doses 3-4 times daily as prescribed.

Side Effects

Common Side Effects

Common: drowsiness/somnolence, dizziness, weakness/fatigue, nausea; may also cause confusion and constipation (and other anticholinergic-like GI effects) in some patients.

Side Effect Frequency

Very common (≥10%): somnolence/drowsiness, dizziness, weakness/fatigue. Common (1-10%): headache, nausea, hypotension, confusion, constipation, dry mouth.

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to baclofen (or excipients).

Warnings & Precautions

Do not stop abruptly (taper to avoid severe withdrawal); caution in renal impairment/elderly, epilepsy/seizure disorders, psychiatric illness, respiratory insufficiency/sleep apnea risk, and with other CNS depressants; may impair driving/operating machinery due to sedation/dizziness.

Age Restriction

Oral baclofen: pediatric use is established for spasticity; commonly referenced labeling supports use in children ≥12 years, while use <12 years is not well established and should be specialist-directed (no absolute SFDA age limit provided in the verified data).

Driving Warning

Avoid Driving

Drug Interactions

Drug Interactions

Clinically important interactions: additive CNS depression with alcohol and other CNS depressants (e.g., opioids, benzodiazepines); enhanced hypotension with antihypertensives; increased sedation/hypotonia reported with tricyclic antidepressants; neuropsychiatric effects reported with levodopa/carbidopa; caution with lithium (neurotoxicity/hyperkinesia reported).

Interaction Severity

Major/clinically significant: additive CNS/respiratory depression with alcohol, opioids, benzodiazepines, and other sedatives/hypnotics; caution with other CNS depressants. Additional clinically relevant interactions include enhanced hypotension with antihypertensives and increased neuropsychiatric effects with levodopa/dopaminergics (reported).

Food Interaction

No clinically significant food restriction; may take with food or milk to reduce gastrointestinal upset.

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

C

Kidney Impairment

Yes-reduce dose and titrate cautiously in renal impairment; avoid or use very low doses with close monitoring in severe CKD/ESRD, and baclofen is dialyzable (no single universally accepted CrCl-based regimen).

Liver Impairment

No specific adjustment required; use with caution in severe hepatic impairment

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly - taper dose gradually over 1 to 2 weeks to avoid withdrawal symptoms like seizures and hallucinations.

Overdose

Overdose may cause profound CNS/respiratory depression (somnolence to coma), hypotonia, hyporeflexia, bradycardia/hypotension, seizures, and respiratory failure; management is supportive (airway/ventilation, hemodynamic support), consider activated charcoal if early, and hemodialysis can enhance elimination in severe toxicity/renal impairment.

Patient Counseling

May cause drowsiness/dizziness-avoid driving/machinery until effects are known; avoid alcohol and other sedatives; take as prescribed in divided doses and titrate gradually; do not stop suddenly-taper to avoid withdrawal (e.g., agitation, hallucinations, seizures); may take with food/milk if stomach upset occurs; rise slowly to reduce dizziness/fall risk.

Monitoring Requirements

Monitor clinical response (spasticity, function) and CNS adverse effects (sedation, confusion, falls); monitor renal function and watch for toxicity in renal impairment; monitor for withdrawal symptoms if dose is reduced/stopped.

Pharmacology

Mechanism of Action

Acts as a GABA-B receptor agonist, inhibiting mono- and polysynaptic reflexes at the spinal cord level, which reduces the release of excitatory neurotransmitters and relieves muscle spasticity.

Half-Life

Approximately 2-6 hours (typical ~3-4 hours in normal renal function).

Bioavailability

Approximately 70%-85% (oral).

Metabolism

Minimal hepatic metabolism (about ~15%); most of the dose is excreted unchanged.

Excretion

Primarily renal: ~70-85% excreted unchanged in urine; remainder as metabolites with a small fecal component.

Protein Binding

Low protein binding: ~30%.

Product Information

Available Dosage Forms

For this SFDA product: oral tablet only (25 mg). Baclofen is also available in some markets as intrathecal solution/kit (for pump use); other oral forms (solution/granules) are market-dependent and not supported by the verified SFDA record for LIORESAL 25 mg tablets.

Composition per Dose

Each tablet: 25mg baclofen

Generic Availability

Yes

Pain Type

Muscular

Nsaid

No

Opioid

No

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