BACLON 10/MG TAB 50/TAB

Indications

Approved Uses

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

Off-Label Uses

Commonly cited off-label uses include intractable hiccups, trigeminal neuralgia/neuropathic pain syndromes, and gastroesophageal reflux disease (GERD) (via reduced transient LES relaxations); it has also been studied for alcohol use disorder.

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 (e.g., 5 mg TID → 10 mg TID → 15 mg TID → 20 mg TID); usual maintenance 40-80 mg/day in divided doses; maximum commonly 80 mg/day.

Initial Dose

5mg three times daily (titrate upward every 3 days)

Maintenance Dose

40-80mg daily, given in divided doses.

Maximum Dose

80mg per day (oral)

Children's Dosage

Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Dose Adjustment Notes

Titrate gradually to effect; use lower starting doses and slower titration in older adults; reduce dose/extend interval in renal impairment; avoid abrupt discontinuation-taper gradually to prevent withdrawal (e.g., agitation, hallucinations, seizures).

How to Take

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

Side Effects

Common Side Effects

Drowsiness, dizziness, weakness, fatigue, nausea, headache, hypotension, confusion, constipation, urinary frequency

Side Effect Frequency

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

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to baclofen or any component; other conditions (e.g., epilepsy, peptic ulcer disease) are precautions, not absolute contraindications.

Warnings & Precautions

Key precautions: taper to discontinue (avoid withdrawal); caution in epilepsy/seizure risk, psychiatric illness, respiratory impairment, renal impairment, elderly; may cause sedation/dizziness and impair driving; monitor for CNS depression and hypotension.

Age Restriction

Oral baclofen is used in pediatrics; labeling varies by region, but it is generally not recommended in children <12 years unless specialist-directed (and many references avoid use <2 years due to limited data).

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Additive CNS depression with alcohol and other CNS depressants (opioids, benzodiazepines, sedating antihistamines); levodopa/carbidopa may increase confusion/hallucinations; hypotension may be enhanced with antihypertensives-use caution.

Interaction Severity

MAJOR/clinically significant: additive CNS and respiratory depression with alcohol, opioids, benzodiazepines and other sedatives; use caution with other hypotensive agents (may increase dizziness/hypotension) and with levodopa/dopaminergics (may worsen confusion/hallucinations in some patients).

Food Interaction

No clinically significant food interaction; taking with food or milk may improve gastrointestinal tolerability.

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Category C (animal studies show adverse effects; use only if benefit outweighs risk)

Children

Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Elderly

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

Kidney Impairment

Dose reduction is required in renal impairment; use very low doses and slow titration in severe impairment (e.g., CrCl <30 mL/min) and consider avoidance/close monitoring in dialysis (baclofen is dialyzable).

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper gradually (commonly over 1-2 weeks, longer if high dose/long duration) to reduce withdrawal (e.g., hallucinations, seizures, rebound spasticity).

Overdose

Symptoms: CNS depression (drowsiness/coma), respiratory depression, hypotonia, seizures, bradycardia/hypotension; management is supportive (airway/ventilation), consider activated charcoal if early, and urgent emergency evaluation.

Patient Counseling

Take exactly as prescribed and titrate only per clinician; may take with food/milk if stomach upset occurs; causes drowsiness/dizziness-avoid driving/operating machinery until effects are known; avoid alcohol and other sedatives unless approved; rise slowly to reduce dizziness; do not stop suddenly-taper to avoid withdrawal (including hallucinations/seizures); seek help for severe weakness, confusion, breathing problems, or withdrawal symptoms.

Monitoring Requirements

Monitor clinical response (spasticity, function) and adverse effects (sedation, dizziness, weakness); assess renal function in patients with renal impairment/older adults; in patients with seizure disorders, monitor for seizure control (clinical monitoring ± EEG per specialist).

Pharmacology

Mechanism of Action

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

Half-Life

Approximately 3-6 hours (range 2.5-6.8 hours in adults with normal renal function)

Bioavailability

Rapidly and extensively absorbed; absorption may be dose-dependent, being reduced with increasing doses.

Metabolism

Minimal hepatic metabolism (~10-15%); the majority is excreted unchanged in urine

Excretion

Primarily renal elimination: about 70-85% excreted unchanged in urine; the remainder is eliminated via feces/minor metabolism.

Product Information

Available Dosage Forms

Baclofen is available as oral tablets and oral liquid formulations (solution/suspension depending on market) and as intrathecal solution for pump administration; this specific SFDA product is an oral tablet.

Composition per Dose

Each tablet: 10mg baclofen

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Pain Type

Muscular

Nsaid

No

Opioid

No

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