LIORESAL 10/MG TAB 50/TAB

Indications

Approved Uses

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

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 individualized in divided doses; maximum commonly 80 mg/day (20 mg four times daily). Pediatric dosing is weight/age-based and should follow specialist/local labeling.

Initial Dose

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

Maintenance Dose

15-80 mg/day in 3-4 divided doses

Maximum Dose

80 mg/day (up to 100 mg/day under strict medical supervision)

Children's Dosage

Not recommended under 12 years per LIORESAL tablets label; pediatric use per specialist guidance for granules/solution in children >=12 years same as adults

Dose Adjustment Notes

Titrate upward slowly (commonly every ~3 days) to effect/tolerability; use lower starting doses and slower titration in older adults; reduce dose/extend interval in renal impairment; avoid abrupt discontinuation-taper gradually (often over 1-2 weeks or longer depending on dose/duration).

How to Take

Oral tablet: swallow with water; may be taken with or without food, but taking with food or milk can reduce gastrointestinal upset; doses are typically given in divided doses (e.g., 3-4 times daily) per prescriber titration.

Side Effects

Common Side Effects

Common: drowsiness/somnolence, dizziness, weakness/fatigue, nausea, headache, confusion; constipation can occur.

Side Effect Frequency

Very common (>10%): somnolence/drowsiness, dizziness, weakness/fatigue. Common (1-10%): headache, nausea, confusion, hypotension, insomnia, ataxia, dry mouth, urinary disturbances.

Safety & Warnings

Contraindications

Hypersensitivity to baclofen (or excipients).

Warnings & Precautions

Do not stop abruptly-taper to avoid withdrawal; caution in renal impairment (high toxicity risk), seizure disorders, psychiatric illness, elderly, and respiratory compromise; may impair driving/operating machinery; additive sedation with alcohol/CNS depressants; monitor for excessive weakness and mental status changes.

Age Restriction

Oral baclofen: pediatric use is permitted; safety/efficacy are not established in children <12 years (label-dependent), so use in <12 years only if specialist-directed; not specifically restricted to <2 years.

Driving Warning

Avoid Driving

Drug Interactions

Drug Interactions

Clinically important: additive CNS depression with alcohol and other CNS depressants (opioids, benzodiazepines, sedatives); enhanced hypotension with antihypertensives; TCAs may increase muscle weakness/hypotonia; levodopa/carbidopa may increase confusion/hallucinations; lithium may exacerbate neurotoxicity/hyperkinesia-monitor/avoid as appropriate.

Interaction Severity

MAJOR/clinically significant: alcohol and other CNS depressants (e.g., opioids, benzodiazepines) due to additive sedation/respiratory depression; MODERATE: antihypertensives (additive hypotension), tricyclic antidepressants (may increase weakness/hypotonia), levodopa/dopaminergics (may worsen confusion/hallucinations).

Food Interaction

No clinically significant food interaction; may be taken with or without food, but taking with food or milk may lessen stomach upset.

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Not assigned FDA category (animal data show adverse effects; use in pregnancy only if benefit outweighs risk)

Children

Not recommended under 12 years per LIORESAL tablets label; pediatric use per specialist guidance for granules/solution in children >=12 years same as adults

Elderly

Start at lower doses (5 mg once or twice daily), titrate slowly, monitor closely for CNS depression, confusion, and hypotension

Kidney Impairment

Dose reduction and slow titration are recommended in renal impairment; avoid or use very low doses with close monitoring when eGFR/CrCl <30 mL/min, and baclofen is dialyzable (toxicity risk is high in CKD).

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if it is almost time for the next dose; do not double the dose

Stopping the Medicine

Do not stop abruptly - taper dose gradually over 1-2 weeks or longer to avoid withdrawal symptoms including seizures and hallucinations

Overdose

Symptoms: marked CNS depression (somnolence/coma), respiratory depression, hypotonia, hypotension/bradycardia, seizures, nausea/vomiting; Management: urgent supportive care (airway/ventilation), consider activated charcoal if early, treat seizures, and consider hemodialysis in severe toxicity especially with renal impairment.

Patient Counseling

May cause drowsiness/dizziness-avoid driving/operating machinery until effects are known; avoid alcohol and other sedatives; take with food or milk if stomach upset occurs; do not stop abruptly-taper under medical supervision to avoid withdrawal (e.g., agitation, hallucinations, seizures); report severe confusion, breathing problems, or marked weakness.

Monitoring Requirements

Monitor clinical response (spasticity, function) and CNS adverse effects (sedation, dizziness, confusion); monitor for withdrawal symptoms during taper; assess renal function in at-risk patients and adjust dose accordingly; monitor blood pressure if symptomatic or on antihypertensives; in patients with seizure disorders, monitor seizure control (EEG only if clinically indicated).

Pharmacology

Mechanism of Action

GABA-B receptor agonist acting primarily at the spinal cord to inhibit excitatory neurotransmitter release and reduce mono- and polysynaptic reflex activity, thereby decreasing muscle tone/spasticity.

Half-Life

Approximately 3-4 hours (typical range ~2-6 hours).

Bioavailability

Oral bioavailability is approximately 70-85% (often cited ~70-80%).

Excretion

Primarily renal: ~70-85% excreted in urine largely unchanged; remainder (~15-30%) via feces.

Product Information

Available Dosage Forms

Tablet

Composition per Dose

Each tablet: 10 mg baclofen

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Pain Type

Muscular

Nsaid

No

Opioid

No

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