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Authoritative Clinical Reference
Schedule H
Oral
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
➤ Chronic Obstructive Pulmonary Disease (COPD)
Parameter Recommendation
Starting dose 100 mg orally once daily after food (preferably at night)
Titration May increase to 100 mg twice daily after 1–2 weeks if tolerated and symptoms persist
Usual maintenance dose 100 mg twice daily
Maximum dose 200 mg per day
Key Clinical Notes:
➤ Chronic Bronchitis
Parameter Recommendation
Starting dose 100 mg orally once daily after food
Titration Increase to 100 mg twice daily based on clinical response and tolerability
Usual maintenance dose 100 mg twice daily
Maximum dose 200 mg per day
Key Clinical Notes:
➤ Bronchial Asthma (Add-on therapy)
Parameter Recommendation
Starting dose 100 mg orally once daily after food
Titration Increase to 100 mg twice daily if additional bronchodilation required
Usual maintenance dose 100 mg once or twice daily
Maximum dose 200 mg per day
Key Clinical Notes:
Secondary Indications – Adults (Off-label)
Not applicable. No established off-label indications documented in Indian clinical practice or specialist references.
PAEDIATRIC DOSING (Specialist Only)
Primary Indications
Regulatory status: Use in children is not formally approved in Indian national guidelines. Use below is based on Indian specialist practice and should be considered off-label.
➤ Chronic Respiratory Conditions with Mucus Hypersecretion (OFF-LABEL — Specialist Only)
| Age Group | Dose (mcg/kg/day) | Typical Total Daily Dose | Clinical Notes |
|---|
6–12 years 2.5–5 mL (25–50 mg) twice daily after food Oral syrup 100 mg/day
12 years 100 mg once daily, may increase to twice daily Capsule or syrup 200 mg/day
Safety Monitoring:
Age Restrictions:
Secondary Indications – Paediatrics (Off-label)
Not applicable. No established off-label paediatric indications with documented evidence.
| eGFR (ml/min/1.73m²) | Recommendation |
|---|---|
| ≥60 | mL/min/1.73m² No adjustment required |
| 30–59 | mL/min/1.73m² Use with caution; consider 100 mg once daily |
| <30 | mL/min/1.73m² Avoid or use with extreme caution — risk of xanthine accumulation |
| Haemodialysis | Limited data; avoid if possible |
Note: If co-prescribed with other methylxanthines, monitor serum theophylline levels.
| Severity | Recommendation |
|---|---|
| Mild impairment | No dose adjustment required; monitor tolerability |
| Moderate impairment | Start with 100 mg once daily; do not exceed this dose; monitor LFTs |
| Severe impairment | Avoid use — significant risk of drug accumulation |
Parameter Details
Risk Category Generally not recommended; limited human safety data
Concerns Xanthine derivatives cross placenta; potential fetal tachycardia and CNS effects
Preferred alternatives Inhaled salbutamol, ipratropium, or budesonide for respiratory symptoms
When may be used Only if potential benefit clearly outweighs risk and alternatives unsuitable; specialist input required
Monitoring Fetal heart rate monitoring; observe for signs of preterm labour in third trimester
Parameter Details
Compatibility Not recommended during breastfeeding
Drug levels in milk Xanthine component likely excreted in breast milk (moderate levels expected)
Infant concerns Potential CNS stimulation, irritability, feeding disturbance in nursing infant
Preferred alternatives Inhaled salbutamol or budesonide (lower systemic exposure)
Infant monitoring If use unavoidable: monitor for irritability, poor feeding, sleep disturbance
Parameter Recommendation
Starting dose 100 mg once daily
Titration Increase cautiously after 2 weeks; do not rush to maximum dose
Special risks Increased sensitivity to CNS stimulation (anxiety, insomnia), cardiac effects (palpitations, tachycardia), gastrointestinal intolerance
Additional considerations Assess renal and hepatic function before initiation; monitor for falls secondary to dizziness
Interacting Drug Effect Recommendation
Other methylxanthines (theophylline, aminophylline) Additive toxicity — CNS stimulation, arrhythmias, seizures Avoid concurrent use
Fluoroquinolones (ciprofloxacin, norfloxacin) Inhibit xanthine metabolism; increased toxicity risk Avoid combination or reduce acebrophylline dose and monitor closely
Lithium Xanthines may increase lithium excretion Monitor lithium levels; may need lithium dose adjustment
Beta-agonists (salbutamol, salmeterol) Synergistic tachycardia and hypokalaemia Use together with cardiac monitoring
Interacting Drug Effect Recommendation
Macrolides (erythromycin, clarithromycin) May increase xanthine plasma levels Monitor for signs of toxicity; consider dose reduction
Phenytoin, Carbamazepine Enzyme induction may reduce acebrophylline efficacy Monitor therapeutic response; may need dose increase
Cimetidine Inhibits xanthine metabolism Monitor for toxicity; avoid if possible
Rifampicin Induces metabolism; reduced efficacy Monitor response; consider alternative mucolytics
Warfarin Potential interaction with clotting parameters Monitor INR if co-prescribed
Corticosteroids No direct pharmacokinetic interaction but additive GI irritation Administer after food; monitor for dyspepsia
Adverse Effect Action Required
Seizures (xanthine-related) Discontinue immediately; manage seizure as per protocol
Tachyarrhythmias or angina Discontinue; ECG evaluation; cardiology referral if needed
Severe hypersensitivity (rash, bronchospasm, angioedema) Discontinue; supportive management
Hepatotoxicity (elevated transaminases) Discontinue; monitor LFTs; hepatology referral if severe
Phase Parameters
Baseline Liver function tests (especially if hepatic disease); serum creatinine; ECG if cardiac history; blood glucose in diabetics
After initiation (1–2 weeks) Assess tolerability (GI symptoms, palpitations); pulse rate
Long-term (every 3–6 months) LFTs; renal function; ECG in elderly or cardiac patients; symptom control assessment
Note: Several FDCs available with montelukast (e.g., Acemont®) or levosalbutamol — verify exact composition before prescribing.
| Formulation | Approximate Price (per tablet) |
|---|---|
| Capsule 100 mg (SR) | ₹8–15 per capsule |
| Syrup (100 mL bottle) | ₹50–80 per bottle |
FDC preparations Higher than single-agent formulations
Note: Not currently included in NLEM 2022; prices not under NPPA ceiling control.
Acebrophylline; bronchodilator; xanthine derivative; mucoregulator; COPD; chronic bronchitis; asthma adjunct; renal-caution; hepatic-caution; Schedule H
RxIndia v1.0 — 10 Jul 2025
This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
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