Schedule H

Oral, Intrathecal

• Tablet: 5 mg, 10 mg, 20 mg

• Intrathecal injection: 0.05 mg/mL, 0.5 mg/mL, 2 mg/mL (available through specialist centres/hospital supply)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Spasticity Due to Multiple Sclerosis, Spinal Cord Injury, or Cerebral Origin

Oral Route:

Parameter Recommendation

Starting dose 5 mg orally three times daily

Titration Increase by 5 mg per dose every 3 days based on response and tolerability

Usual maintenance dose 40–80 mg/day in 3–4 divided doses

Maximum dose 120 mg/day

Intrathecal Route (Refractory Spasticity — Specialist Only):

Parameter Recommendation

Starting dose (Test dose) 50 mcg as single bolus via lumbar puncture

Titration Increase by 25–50 mcg every 24 hours during screening phase; subsequent pump programming based on response

Usual maintenance dose 300–800 mcg/day via continuous intrathecal infusion

Maximum dose 1000 mcg/day

Key Clinical Notes:

• Abrupt withdrawal (particularly intrathecal) may cause life-threatening complications: seizures, hyperthermia, rhabdomyolysis, multi-organ failure

• Monitor for sedation, hypotonia, and falls during dose escalation

• Intrathecal therapy requires implantable pump system and is restricted to specialist rehabilitation/neurology centres

Secondary Indications — Adults (Off-label)

Indication Dose Duration Evidence Basis Remarks

Intractable hiccups Starting: 5 mg TID; Titration: up to 20 mg TID based on response; Max: 60 mg/day Short-term (3–7 days); reassess need Small RCTs; Indian neurologist practice OFF-LABEL. Specialist only.

Alcohol use disorder (craving reduction) Starting: 10 mg TID; Maintenance: 10–20 mg TID; Max: 60 mg/day 4–8 weeks, occasionally longer International RCTs; limited Indian data; Indian psychiatry practice OFF-LABEL. Specialist (psychiatrist) only. Practice variability exists.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Spasticity Due to Cerebral Palsy or Spinal Cord Pathology

• Minimum age: Not recommended below 1 year of age

• Ages 1–2 years: Use only under specialist supervision with extreme caution

Oral Baclofen — Weight-Based Dosing:

Weight Starting Dose Titration Maximum Dose

<8 kg 0.3 mg/kg/day divided TID Increase by 0.3 mg/kg/day every 3–5 days 0.75 mg/kg/dose TID

8–20 kg 2.5 mg TID Increase by 2.5 mg/dose every 3–5 days 20–30 mg/day

20 kg 5 mg TID Increase by 5 mg/dose every 3–5 days 60 mg/day

Intrathecal Baclofen:

• Considered only in refractory spasticity in children ≥4 years

• Initiation exclusively in hospital setting after screening test dose

• Managed only by paediatric neurologist/rehabilitation specialist

Safety Monitoring:

• Hypotonia, somnolence, respiratory depression

• Seizure threshold (especially if pre-existing epilepsy)

• Growth parameters on long-term therapy

• Signs of withdrawal if doses are missed

Secondary Indications — Paediatric Doses (Off-label)

Not applicable.

Haemodialysis:

• Baclofen is dialysable

• Administer dose after dialysis session

• Reduce frequency; monitor closely for sedation, confusion, hypotonia

• Known hypersensitivity to baclofen or any excipient

• Active peptic ulcer disease (oral formulation)

• Intrathecal formulation: infection at injection site, systemic infection, unstable epilepsy

• Epilepsy — baclofen may lower seizure threshold

• Psychiatric disorders — may precipitate or worsen confusion, hallucinations, psychosis

• Elderly patients — increased sensitivity to sedation and fall risk

• Chronic renal impairment — high risk of drug accumulation

• Abrupt discontinuation — risk of withdrawal syndrome (seizures, hallucinations, hyperthermia, rebound spasticity)

• Respiratory disease — may exacerbate respiratory depression, especially with intrathecal route

• Autonomic dysreflexia in spinal cord injury patients — monitor closely

Parameter Details

Safety category Limited human data; animal studies suggest risk at high doses

When it may be used Only when benefit clearly outweighs risk; preferably in 2nd–3rd trimester

Preferred alternatives Consider physiotherapy first; if drug required, consult obstetric neurology

What to monitor Maternal CNS effects, fetal movements; avoid abrupt discontinuation near term (risk of neonatal withdrawal)

Parameter Details

Compatibility Compatible with breastfeeding at doses ≤40 mg/day

Expected drug levels in milk Low

Preferred alternatives None if baclofen specifically indicated

What to monitor in infant Sedation, poor feeding, inadequate weight gain

• Starting dose: 5 mg once or twice daily

• Titration: Increase slowly every 5–7 days based on tolerability

• Extra risks:

• Increased sensitivity to sedation and CNS depression

• Higher risk of falls, confusion, dizziness

• Reduced renal function predisposes to accumulation

• Monitoring: Renal function, mental status, gait stability

Interacting Drug(s) Effect Mechanism Management

CNS depressants (benzodiazepines, opioids, sedating antihistamines) Additive sedation; respiratory depression Pharmacodynamic synergy Avoid combination if possible; if necessary, use lowest doses with close monitoring

Alcohol Enhanced CNS depression Additive effect Advise strict avoidance

Intrathecal morphine Severe respiratory depression, hypotension Additive CNS and respiratory depressant effects Use only under specialist supervision with continuous monitoring

Interacting Drug(s) Effect Management

Antihypertensives Enhanced hypotensive effect Monitor blood pressure; adjust antihypertensive dose if needed

Tricyclic antidepressants Additive CNS depression; muscle weakness Use cautiously; monitor for excessive sedation

NSAIDs May worsen renal function and baclofen accumulation Use with caution in renal impairment

Antiepileptics May alter seizure control Monitor seizure frequency; adjust antiepileptic dose if required

Levodopa Possible worsening of parkinsonian symptoms; confusion Monitor motor and mental status

• Drowsiness, sedation

• Dizziness

• Weakness, fatigue

• Nausea

• Headache

• Hypotonia

• Constipation

• Confusion (especially in elderly)

Adverse Effect Clinical Notes

Withdrawal syndrome Especially with intrathecal route: seizures, high fever, altered mental status, rhabdomyolysis — requires urgent hospitalisation; do NOT stop abruptly

Respiratory depression Risk in overdose or with intrathecal use; monitor respiratory status

Seizures May occur on initiation, dose escalation, or abrupt withdrawal

Hallucinations / Psychosis Especially in elderly or psychiatric comorbidity

Hepatotoxicity Rare; discontinue if unexplained LFT elevation

Phase Parameter Frequency

Baseline Renal function, liver function (if hepatic disease), seizure history, psychiatric history Before initiation

After initiation/dose change Spasticity response, sedation level, muscle tone, blood pressure Weekly during titration

Long-term (oral) Renal function, mental status, gait, adverse effects Every 3–6 months

Long-term (intrathecal) Pump function, catheter integrity, infection signs, withdrawal/overdose symptoms Per pump manufacturer protocol; minimum every 1–3 months

• Liofen (Sun Pharma)

• Baclosign (Signature)

• Baclof (Intas)

• Lioresal (Novartis — limited availability)

• Intrathecal formulations: Available through specialist hospital supply; not routinely stocked in retail pharmacies

• Not included in NLEM

• May be available under government disability rehabilitation schemes in select centres

1. Titrate slowly: Gradual dose escalation minimises sedation and hypotonia, especially in elderly and paediatric patients.

1. Never stop abruptly: Sudden discontinuation (oral or intrathecal) can precipitate life-threatening withdrawal — always taper over 1–2 weeks minimum.

1. Renal caution: Baclofen is renally excreted unchanged; even modest renal impairment can cause significant accumulation and toxicity — reduce dose and monitor closely.

1. Intrathecal is last resort: Reserve for refractory spasticity unresponsive to oral therapy; requires multidisciplinary team and pump infrastructure.

1. Off-label uses require specialist input: Intractable hiccups and alcohol dependence are off-label; use only under neurologist or psychiatrist supervision.

1. Falls prevention: Counsel patients and caregivers about fall risk due to muscle weakness and sedation, particularly during initiation.

spasticity; muscle relaxant; cerebral palsy; multiple sclerosis; intrathecal therapy; GABA-B agonist; renal-adjust; withdrawal-risk; elderly-caution; specialist-use

RxIndia v0.9 — 08 May 2025

• CDSCO product inserts

• Indian Pharmacopoeia (Baclofen monograph)

• NFI 2021

• API Textbook of Medicine

• AIIMS Adult and Paediatric Drug Formulary

• ICMR guidelines for Cerebral Palsy rehabilitation

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine

• IAP Guidelines (supportive)

• WHO EML (paediatrics — supportive)

• International RCTs for off-label indications (hiccups, alcohol use disorder — clearly marked)