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Other · GABA-B receptor agonist — centrally acting antispastic agent

Lioresal (Baclofen)

Also sold as: Lioresal, Bacloren, Bacpas, Baqofen, Gabafen

Pregnancy

Cat C

Lactation

Caution

Schedule

H

Forms

Tablet 5mg, 10mg, 25mg +1

Indications

Adult Dosing

Spasticity (MS, SCI)

Start 5 mg PO TDS; increase by 5 mg per dose every 3 days as tolerated. Usual: 30–75 mg/day. Max: 100 mg/day (oral).

Slow titration essential. Individual variation large — some patients need 80–100 mg; others respond to 20 mg.

Intractable hiccups

5–10 mg PO TDS

Short-course; review at 2 weeks

Maximum daily dose: 100 mg/day (oral adult)

Pediatric Dosing

Age Range: ≥1 year
Dose: Start 0.3 mg/kg/day in 3 divided doses; titrate to max 2.5 mg/kg/day (< 8 years: max 40 mg/day; ≥ 8 years: max 60 mg/day). Intrathecal: specialist only.

Cerebral palsy: intrathecal baclofen pump (specialist) for severe refractory spasticity

Renal Dose Adjustment

CrCl / eGFRDose Adjustment
CrCl < 15 mL/minReduce dose significantly — renally excreted; severe accumulation risk in renal failure. Consider intrathecal route.
Calculate eGFR / CrCl →

Hepatic Adjustment

No specific dose adjustment — not significantly hepatically metabolised

Pregnancy & Lactation

Pregnancy: Category C

Use only when benefit outweighs risk — spasticity management in pregnancy challenging. Neonatal withdrawal syndrome reported with maternal baclofen use (hypotonia, respiratory depression, seizures — manage in NICU). Avoid if possible in 1st trimester.

Lactation: Caution

Excreted in small amounts in breast milk — generally considered acceptable if medically necessary. Monitor infant for hypotonia and sedation.

Top Drug Interactions

Interacting DrugEffectSeverity
CNS depressants (benzodiazepines, opioids, alcohol, antipsychotics)Additive CNS and respiratory depression — significant risk of overdose and comaMajor
AntihypertensivesAdditive hypotensionModerate
TCAs (amitriptyline, imipramine)Additive CNS depression; hypotoniaModerate

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Side Effects

Common

  • Drowsiness (most common — dose-dependent)
  • Fatigue and weakness (especially legs — can worsen functional ability)
  • Dizziness
  • Nausea
  • Confusion (elderly)
  • Dry mouth
  • Urinary retention

Serious / Discontinue If

  • ⚠️ ABRUPT WITHDRAWAL — LIFE-THREATENING: baclofen withdrawal causes severe rebound spasticity, hallucinations, seizures, hyperthermia, multi-organ failure, DEATH. NEVER stop suddenly after prolonged use. Taper gradually.
  • Respiratory depression (high doses — especially intrathecal)
  • Coma (overdose or rapid dose increase)
  • Seizures (paradoxical — overdose)
  • Intrathecal pump failure (catastrophic withdrawal or overdose)

Contraindications

Available Indian Brands

BrandManufacturerPrice (approx)
Lioresal 10mgNovartis30 tab ₹185
Bacloren 10mgSun Pharma30 tab ₹75
Bacpas 10mgCipla30 tab ₹68
Gabafen 10mgTorrent30 tab ₹72

Monitoring Required

Patient Counseling Points

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Clinically reviewed by: Dr. Arun Hegde, MS (Orthopaedics), Consultant Orthopaedic Surgeon

Last reviewed: 2026-04-01

References

  • NICE MS Spasticity Guidelines
  • BNF — Baclofen
  • FDA Baclofen Prescribing Information
  • Cochrane — Baclofen for Spasticity
  • Neurological Society of India — Spasticity Management
Disclaimer: This information is for clinical reference only. It is not exhaustive and does not substitute clinical judgement. Always verify current dosing against the manufacturer's prescribing information and current treatment guidelines. Drug prices are approximate and may vary.