Schedule H

Oral

• Tablet 10 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Bronchial Asthma (Adjunctive or Maintenance Therapy)

Parameter Recommendation

Starting dose 10 mg twice daily

Titration May increase based on clinical response and tolerability

Usual maintenance dose 10 mg twice to three times daily

Maximum dose 30 mg/day

Clinical Notes:

• Used as adjunct to inhaled corticosteroids and bronchodilators

• Not indicated for acute bronchospasm or rescue therapy

• Reassess benefit if no improvement after 4–6 weeks

1. Chronic Obstructive Pulmonary Disease — Stable Phase (Adjunctive Therapy)

Parameter Recommendation

Starting dose 10 mg twice daily

Titration May increase to 10 mg three times daily if tolerated

Usual maintenance dose 20–30 mg/day in divided doses

Maximum dose 30 mg/day

Clinical Notes:

• Provides anti-inflammatory benefit via inhibition of inflammatory cell recruitment

• Not for acute exacerbations

• Use alongside standard COPD therapy (bronchodilators, inhaled corticosteroids)

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Notes Evidence

Post-stroke dizziness/vertigo 10 mg twice daily Short-term (as clinically indicated) OFF-LABEL, Specialist only Limited supportive data; used in Japanese and Indian specialist practice for cerebral vasodilation

Neuropathic pain 10 mg twice to three times daily As clinically indicated OFF-LABEL, Specialist only Small international trials; research interest in chronic pain modulation; no Indian RCT data

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Bronchial Asthma (Under Paediatric Pulmonologist Supervision Only)

≥6 years 0.4 mg/kg/dose twice daily 10 mg 20 mg

<6 years Not recommended except under specialist supervision — —

Clinical Notes:

• Limited clinical trial data in Indian paediatric population

• Use only as adjunct to inhaled therapy

Safety Monitoring:

• Monitor for gastrointestinal intolerance (nausea, abdominal pain)

• Observe for behavioural changes or irritability

• Periodic hepatic function assessment in prolonged use

Secondary Indications — Paediatrics (Off-label)

• NOT RECOMMENDED for off-label use in children for any indication outside bronchial asthma

• No established safety data for neurological or pain-related uses below 18 years of age

• Known hypersensitivity to ibudilast or any excipient

• Severe hepatic impairment (Child-Pugh C)

• Acute asthma exacerbation or status asthmaticus (not effective as rescue therapy)

• History of peptic ulcer disease or active dyspepsia (may exacerbate GI symptoms)

• History of seizure disorder (potential CNS effects; use under close monitoring)

• Pre-existing psychiatric illness including depression, anxiety, or psychosis (rare mood disturbances reported)

• Mild to moderate renal or hepatic insufficiency (limited clearance data; monitor)

• Concurrent use of other CNS-active agents

Parameter Details

Safety Not well established; insufficient human data

Risk category No formal category assigned in India; use only if benefit clearly outweighs risk

Preferred alternatives Inhaled corticosteroids (budesonide), salbutamol for asthma; standard bronchodilators for COPD

When may be used Only if no safer alternative available; under specialist supervision

Monitoring Maternal hepatic function; fetal growth monitoring if prolonged use

Parameter Details

Drug levels in milk Unknown in humans; low transfer reported in animal studies

Compatible with breastfeeding Use cautiously; prefer alternatives if available

Preferred alternatives Inhaled therapies (salbutamol, budesonide)

Infant monitoring Observe for GI symptoms (vomiting, diarrhoea), unusual sedation, or feeding difficulty

Parameter Recommendation

Starting dose 10 mg once daily or twice daily

Titration More gradual than in younger adults due to reduced hepatic/renal reserve

Specific risks Dizziness (increased fall risk), GI upset, mood changes

Monitoring Baseline and periodic hepatic and renal function; clinical assessment for CNS effects

Interacting Drug Effect / Risk Recommendation

Theophylline Additive CNS stimulation and GI adverse effects; potential for toxicity Avoid combination unless closely monitored; consider dose reduction of either agent

CNS stimulants (e.g., pseudoephedrine, amphetamines) Enhanced agitation, anxiety, palpitations Avoid concurrent use

Interacting Drug Effect / Risk Recommendation

Antiepileptics (phenytoin, carbamazepine, phenobarbital) Potential interaction via hepatic enzyme induction; may reduce ibudilast levels Monitor clinical response; dose adjustment may be needed

Macrolide antibiotics (erythromycin, clarithromycin) Possible increased ibudilast exposure via CYP3A4 inhibition Monitor for increased adverse effects

Antidepressants (SSRIs, TCAs) Potential for additive mood disturbance Use with caution; monitor for psychiatric symptoms

Strong CYP3A4 inhibitors/inducers May alter ibudilast metabolism No formal interaction data; use cautiously

• Nausea

• Dyspepsia / epigastric discomfort

• Headache

• Dizziness

• Palpitations

• Diarrhoea

• Irritability or mild agitation

Adverse Effect Notes

Seizures Rare; discontinue immediately if occurs

Hepatic enzyme elevation Monitor LFTs; discontinue if significant elevation

Mood disturbance / suicidal ideation Rare; screen patients; discontinue if psychiatric symptoms emerge

Hypersensitivity reactions (rash, angioedema, anaphylaxis) Discontinue immediately; manage appropriately

Timepoint Parameters

Baseline Hepatic function tests (LFTs), renal function, seizure history assessment, psychiatric history screening

2–4 weeks after initiation Clinical assessment for CNS side effects, mood changes, GI tolerance

Long-term (every 3–6 months) Repeat LFTs; assess clinical efficacy and GI tolerability

• Ketas (Sun Pharma)

• Ibudilast (generic manufacturers)

Note: Brand availability may vary regionally. Verify current market availability before prescribing.

Additional Notes:

• Not included in NLEM 2022; price not NPPA-controlled

• Limited availability in government supply; primarily available in private sector

1. Adjunctive role only: Ibudilast should never replace inhaled corticosteroids or bronchodilators; use as add-on therapy in patients with suboptimal control

1. Not for acute relief: Educate patients that this is not a rescue medication; ensure they have appropriate reliever inhalers

1. GI tolerability: Take with food to minimise nausea and dyspepsia; consider dose reduction if GI symptoms persist

1. Psychiatric screening: Screen for history of depression or mood disorders before initiation; counsel patients and caregivers to report mood changes

1. Reassess efficacy: Discontinue if no clinical benefit observed within 4–6 weeks

1. Hepatic monitoring: Periodic LFT monitoring is essential, particularly in patients on long-term therapy or with baseline liver disease

ibudilast; asthma; COPD; phosphodiesterase inhibitor; PDE4; nonsteroidal bronchodilator; adjunctive therapy; hepatic-caution; not-for-acute-relief; Schedule H

RxIndia v1.0 — 20 Jan 2025

• CDSCO approved prescribing information

• Indian Pharmacopoeia

• AIIMS Drug Formulary

• API Textbook of Medicine

• Indian specialist prescribing practices for asthma/COPD

• Manufacturer product inserts (India-marketed formulations)

• Limited international RCT data for off-label indications (clearly marked as such)