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Authoritative Clinical Reference
Schedule H
Oral
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
➤ Bronchial Asthma (Maintenance therapy — NOT for acute relief)
Parameter Recommendation
Starting dose 10 mg orally once daily at bedtime
Titration May increase to 20 mg once daily after 1–2 weeks if inadequate response and tolerated
Usual maintenance dose 10–20 mg once daily at bedtime
Maximum dose 20 mg once daily
Key Clinical Notes:
➤ Chronic Obstructive Pulmonary Disease (COPD) — Mild to Moderate
Parameter Recommendation
Starting dose 10 mg orally once daily at bedtime
Titration Increase to 20 mg once daily after 1–2 weeks if required
Usual maintenance dose 10–20 mg once daily
Maximum dose 20 mg once daily
Key Clinical Notes:
Secondary Indications – Adults (Off-label)
Not applicable. No widely accepted off-label indications documented in Indian clinical practice.
PAEDIATRIC DOSING (Specialist Only)
Primary Indications (Asthma – Maintenance therapy)
| Age Group | Dose (mcg/kg/day) | Typical Total Daily Dose | Clinical Notes |
|---|
2–5 years 0.05–0.1 mg/kg once daily at bedtime Oral solution preferred Maximum 10 mg/day
6–12 years 5–10 mg once daily at bedtime Tablets or oral solution Titrate based on response
12 years 10 mg once daily at bedtime Tablets May increase to 20 mg as per adult dosing
Safety Monitoring:
Age Restrictions:
Secondary Indications – Paediatrics (Off-label)
Not applicable. No commonly used off-label paediatric indications in Indian practice.
| eGFR (ml/min/1.73m²) | Recommendation |
|---|---|
| ≥50 | mL/min/1.73m² No dose adjustment required |
| 30–49 | mL/min/1.73m² Initiate at 5 mg once daily; titrate cautiously |
| <30 | mL/min/1.73m² Initiate at 5 mg once daily; use with caution — risk of terbutaline accumulation |
| Haemodialysis | Limited data; use lowest effective dose with close monitoring |
| Severity | Recommendation |
|---|---|
| Mild impairment | Start at 5 mg once daily; titrate slowly based on response |
| Moderate impairment | Use with caution; start at 5 mg; monitor closely for accumulation and adverse effects |
| Severe impairment | Avoid use — bambuterol undergoes extensive hepatic metabolism; risk of significant accumulation of active metabolite |
| Note: Consider inhaled LABAs (e.g., salmeterol, formoterol) | as preferred alternatives in hepatic impairment. |
Parameter Details
Risk Category Use with caution; avoid in first trimester unless clearly necessary
Concerns Beta-2 agonists may cause uterine relaxation (tocolytic effect); may affect fetal heart rate near term
Preferred alternatives Inhaled salbutamol (SABA) or inhaled corticosteroids (budesonide) for asthma control
When may be used Only if inhaled therapy not feasible and maternal benefit outweighs fetal risk; specialist input advised
Monitoring Monitor uterine tone and fetal heart rate if used near delivery
Parameter Details
Compatibility Likely compatible with breastfeeding
Drug levels in milk Terbutaline (active metabolite) excreted in breast milk in low concentrations
Infant monitoring Observe for restlessness, tremor, feeding difficulties, tachycardia
Preferred alternatives Inhaled salbutamol preferred due to lower systemic exposure
Parameter Recommendation
Starting dose 5 mg once daily at bedtime
Titration Increase slowly; monitor after each dose change
Special risks Increased sensitivity to tremor, palpitations, tachycardia, insomnia, and falls
Monitoring Regular assessment of renal function, cardiovascular status, and electrolytes
Interacting Drug Effect Recommendation
Non-selective beta-blockers (e.g., propranolol) Antagonise bronchodilator effect; risk of bronchospasm Avoid combination
MAO inhibitors Potentiation of sympathomimetic effects; hypertensive crisis, arrhythmias Avoid use within 14 days of MAOI
Tricyclic antidepressants Enhanced cardiovascular effects (tachycardia, arrhythmias) Avoid or use with extreme caution
Interacting Drug Effect Recommendation
Theophylline Additive beta-agonist effects (tachycardia, tremor, hypokalaemia) Use together with caution; monitor
Corticosteroids Additive hypokalaemia risk Monitor serum potassium regularly
Loop/thiazide diuretics Additive hypokalaemia Monitor serum potassium
Digoxin Increased arrhythmia risk due to hypokalaemia Monitor ECG and electrolytes
Antidiabetic agents Bambuterol may raise blood glucose Monitor glycaemic control closely
Adverse Effect Action
Significant tachycardia or arrhythmias Consider dose reduction or discontinuation
Paradoxical bronchospasm Discontinue immediately; treat with alternative bronchodilator
Severe hypokalaemia Check electrolytes; supplement potassium; review concurrent medications
Hyperglycaemia May unmask latent diabetes; monitor blood glucose
Seizures (rare, dose-related) Discontinue; evaluate for alternative causes
Phase Parameters
Baseline Blood pressure, pulse rate, ECG (if cardiac history), fasting blood glucose, serum potassium, renal and hepatic function
After initiation/titration (1–2 weeks) Heart rate, blood pressure, serum potassium, blood glucose
Long-term (every 3–6 months) Symptom control review, serum electrolytes, renal function, glycaemic status in diabetics
| Formulation | Approximate Price (per tablet) |
|---|---|
| Tablets 10 mg | ₹3–6 per tablet |
| Tablets 20 mg | ₹5–9 per tablet |
| Oral solution (100 mL) | ₹30–60 |
Note: Not included in NLEM; prices vary across brands and retailers.
Bambuterol; LABA; oral beta-agonist; asthma maintenance; COPD; prodrug; terbutaline; hepatic metabolism; renal adjustment; paediatric bronchodilator; 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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