BACLON 25/MG TAB 50/TAB

Indications

Approved Uses

Spasticity resulting from multiple sclerosis, spinal cord injuries, spinal cord diseases, cerebral palsy

Off-Label Uses

Commonly cited off-label uses include alcohol use disorder (craving reduction in some protocols), intractable hiccups, trigeminal neuralgia, and gastroesophageal reflux disease (GERD) (selected cases).

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; maximum commonly recommended is 80 mg/day (some references allow higher under specialist supervision).

Initial Dose

5mg three times daily (15mg/day), titrated upward gradually

Maintenance Dose

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

Maximum Dose

80 mg daily (20 mg four times a day).

Children's Dosage

Children ≥12 years: Initial 5mg three times daily, titrate by 5mg every 3 days; Max 60mg/day. Children <12 years: Not recommended for oral use

Dose Adjustment Notes

Titrate gradually to minimize CNS adverse effects (commonly increase by 5 mg per dose every ~3 days as tolerated); reduce dose in renal impairment; avoid abrupt discontinuation-taper gradually to prevent withdrawal (e.g., agitation, hallucinations, seizures, rebound spasticity).

How to Take

Oral tablet: swallow with water; may be taken with or without food, but taking with food or milk can reduce GI upset; doses are typically given in divided doses (usually 3 times daily) per the prescribed regimen.

Side Effects

Common Side Effects

Drowsiness, dizziness, weakness, fatigue, nausea, headache, hypotension, confusion, insomnia

Side Effect Frequency

Very common (>10%): drowsiness/somnolence, dizziness, weakness (asthenia). Common (1-10%): fatigue, nausea, headache, hypotension, confusion.

Safety & Warnings

Contraindications

Hypersensitivity to baclofen (or excipients).

Warnings & Precautions

Do not stop abruptly-taper to avoid withdrawal (agitation, hallucinations, seizures, hyperthermia/rebound spasticity); caution in renal impairment, epilepsy/seizure history, psychiatric disorders, elderly, and respiratory insufficiency; may impair driving/operating machinery; additive effects with CNS depressants/alcohol.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

CNS depressants (including alcohol, opioids, benzodiazepines, sedating antihistamines) → additive sedation/respiratory depression; antihypertensives → increased hypotension; tricyclic antidepressants may increase muscle weakness/hypotonia; lithium may increase neurotoxicity/hyperkinesia; caution with other sedatives/psychotropics.

Interaction Severity

MAJOR: additive CNS/respiratory depression with alcohol, opioids, benzodiazepines, and other sedatives. MODERATE: enhanced hypotension with antihypertensives; increased weakness/hypotonia with tricyclic antidepressants. Other interactions (e.g., lithium-related neurotoxicity/hyperkinesia) are reported but are less consistently classified and require close monitoring if combined.

Food Interaction

No clinically significant food interaction; taking with food or milk may reduce nausea/GI upset.

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Category C

Children

Children ≥12 years: Initial 5mg three times daily, titrate by 5mg every 3 days; Max 60mg/day. Children <12 years: Not recommended for oral use

Elderly

Start at lowest dose (5mg once or twice daily), titrate slowly with careful monitoring for CNS depression, confusion, and falls

Kidney Impairment

Yes-reduce dose and titrate slowly in renal impairment; avoid or use very low doses with close monitoring in severe CKD (e.g., eGFR/CrCl <30 mL/min) and consider avoidance in dialysis unless specialist-directed.

Liver Impairment

No specific hepatic dose adjustment; use caution in severe hepatic impairment.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if near next dose. Do not double the dose.

Stopping the Medicine

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

Overdose

Symptoms: marked CNS depression (drowsiness to coma), respiratory depression, hypotonia, bradycardia/hypotension, seizures (can occur), nausea/vomiting; Management: urgent emergency care, supportive/airway-ventilation, consider activated charcoal if early, treat seizures/support hemodynamics; hemodialysis can enhance elimination 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 unless prescriber approves; take with food or milk if stomach upset occurs; do not stop abruptly-taper under medical supervision to avoid withdrawal (including hallucinations/seizures/rebound spasticity); rise slowly to reduce dizziness and report severe confusion, breathing difficulty, or marked weakness.

Monitoring Requirements

Monitor clinical response (spasticity, function) and adverse effects (sedation, dizziness, weakness, confusion); monitor renal function especially in older adults or renal impairment; monitor for withdrawal symptoms during dose reduction/discontinuation.

Pharmacology

Mechanism of Action

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

Onset of Action

Oral: symptomatic benefit may begin within hours, but optimal effect often requires several days to weeks due to titration.

Duration of Effect

Oral: approximately 4-8 hours per dose (variable by patient).

Half-Life

Approximately 2.5-4 hours (commonly cited around 3-4 hours) in adults with normal renal function.

Bioavailability

70-85%.

Metabolism

Minimal hepatic metabolism; approximately 15% is metabolized (majority excreted unchanged in urine).

Excretion

Primarily renal elimination, with most of the dose excreted unchanged in urine (commonly ~70-85%); a smaller fraction is eliminated via feces/metabolism.

Protein Binding

Approximately 30% protein bound (low-to-moderate binding).

Product Information

Available Dosage Forms

For baclofen in general: oral tablets; oral solution (in some markets); intrathecal solution/injection for pump use (specialist use). For this SFDA product specifically: Tablet (oral).

Composition per Dose

Each tablet: 25mg baclofen

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Pain Type

Muscular

Nsaid

No

Opioid

No

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