Schedule H

Oral, Inhalation, Subcutaneous, Intravenous

• Tablets: 2.5 mg, 5 mg

• Syrup: 1.5 mg/5 mL

• Metered Dose Inhaler (MDI): 250 mcg/actuation

• Respules/Nebuliser solution: 2.5 mg/2.5 mL, 5 mg/2 mL

• Injection: 0.5 mg/mL (1 mL ampoule)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Bronchial Asthma — Acute Exacerbation and Maintenance

A. Oral Route (Adults)

Step Dose Clinical Notes

Starting dose 2.5 mg twice or thrice daily Take with or without food

Titration Increase to 5 mg thrice daily based on response Assess after 1–2 weeks

Usual maintenance dose 2.5–5 mg two to three times daily Individualise based on symptom control

Maximum dose 15 mg/day (in divided doses) Higher doses increase adverse effects without added benefit

B. Inhalation — MDI (Adults)

Step Dose Clinical Notes

Starting dose 250–500 mcg (1–2 puffs) as needed Use spacer device for optimal delivery

Usual maintenance dose 250–500 mcg every 4–6 hours PRN Not for scheduled regular use as monotherapy

Maximum dose 1.5 mg/day (6 puffs) Exceeding suggests poor control — review therapy

C. Nebulisation (Adults)

Step Dose Clinical Notes

Starting dose 2.5–5 mg diluted in 2–3 mL normal saline Nebulise over 10–15 minutes

Frequency Every 4–6 hours as needed Can give more frequently in acute severe exacerbation

Maximum dose 20 mg/day Higher doses under specialist/ICU supervision only

D. Parenteral — Acute Severe Asthma (Hospital/Specialist Only)

Route Dose Clinical Notes

Subcutaneous 0.25 mg; may repeat after 15–30 minutes Maximum 0.5 mg in 4 hours

IV infusion 1.5–5 mcg/min initially; titrate to response Maximum 20 mcg/min; continuous cardiac monitoring required

1. Chronic Obstructive Pulmonary Disease (COPD) — Acute Exacerbation

Route Dose Clinical Notes

Nebulisation 2.5–5 mg every 4–6 hours Combine with ipratropium for enhanced bronchodilation

Oral 2.5–5 mg twice or thrice daily Less preferred than inhaled route

Maximum dose As per asthma dosing

Key point: Long-acting bronchodilators (LAMA/LABA) preferred for maintenance in COPD; terbutaline mainly for acute relief

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Preterm Labour (Tocolysis) IV infusion: Start 5 mcg/min; increase by 2.5 mcg/min every 10–20 min; maximum 20 mcg/min Maximum 48–72 hours OFF-LABEL; Specialist obstetric use only; Requires continuous maternal and fetal monitoring; Evidence: Indian obstetric practice; Limited to short-term delay for corticosteroid administration

Note: Oral terbutaline for maintenance tocolysis is NOT recommended due to lack of efficacy and safety concerns

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Acute Asthma / Wheezing Episodes

A. Oral Dosing (Age-based)

6 months–2 years 0.075 mg/kg/dose TID 2.5 mg/dose Use syrup formulation

2–6 years 1.25–2.5 mg TID 2.5 mg/dose Adjust based on weight and response

6–12 years 2.5 mg TID 5 mg/dose Tablet or syrup

12 years Adult dosing 15 mg/day

B. Nebulisation (Weight-based)

Weight/Age Dose Frequency Clinical Notes

<20 kg 0.1–0.15 mg/kg/dose Every 4–6 hours PRN Dilute in 2–3 mL NS

≥20 kg 2.5–5 mg/dose Every 4–6 hours PRN Maximum 5 mg/dose

C. MDI via Spacer

Age Dose Clinical Notes

All ages (with appropriate spacer) 250 mcg (1 puff) every 4–6 hours PRN Use valved holding chamber; face mask for <4 years

D. Subcutaneous (Emergency — Hospital Only)

Weight Dose Clinical Notes

All weights 0.005–0.01 mg/kg/dose Maximum 0.25 mg/dose; may repeat every 4–6 hours

Safety monitoring:

• Monitor heart rate (tachycardia common)

• Observe for tremor, irritability, agitation

• Check oxygen saturation during acute treatment

Secondary Indications — Paediatrics (Off-label)

Not applicable.

No routine off-label paediatric indications supported by Indian guidelines.

Minimum age: Not recommended below 6 months of age except under paediatric pulmonologist supervision

Severe impairment (eGFR <30) Use with caution; start at lower doses

Dialysis Not significantly removed by haemodialysis; no supplemental dose needed

• Known hypersensitivity to terbutaline or any excipients

• Tachyarrhythmias (uncontrolled atrial fibrillation, ventricular tachycardia)

• Severe hypertrophic obstructive cardiomyopathy

• For tocolysis: Antepartum haemorrhage requiring immediate delivery, eclampsia/severe pre-eclampsia, significant maternal cardiac disease, intrauterine fetal death, chorioamnionitis

• Cardiovascular disease (ischaemic heart disease, hypertension, arrhythmias) — may cause tachycardia, palpitations

• Diabetes mellitus — can induce hyperglycaemia; monitor blood glucose

• Hyperthyroidism — may exacerbate thyrotoxic symptoms

• Hypokalaemia or concurrent use of potassium-depleting drugs

• Seizure disorders — rare reports of seizures with high-dose IV use

• Elderly patients — increased sensitivity to cardiac effects

• Prolonged or excessive use — risk of tolerance and paradoxical bronchospasm

Parameter Recommendation

Safety category Generally considered safe for asthma management (extensive clinical experience)

Preferred alternatives Inhaled salbutamol is first-line for asthma in pregnancy; inhaled route preferred over oral

When it may be used Asthma: Use inhaled terbutaline if salbutamol unavailable; Tocolysis: Short-term use (≤48–72 hours) under specialist supervision only

Monitoring Maternal: Heart rate, BP, blood glucose, serum potassium, fluid balance, ECG; Fetal: Continuous fetal heart rate monitoring during IV tocolysis

Note: IV terbutaline for tocolysis carries risk of pulmonary oedema — strict fluid restriction required

Parameter Recommendation

Compatibility Compatible with breastfeeding

Drug levels in milk Low (minimal amounts excreted)

Preferred alternatives Inhaled salbutamol preferred if available

Infant monitoring Observe for irritability, jitteriness, poor feeding (rare)

• Recommended starting dose: 2.5 mg orally twice daily; inhaled route preferred

• Titration: Slower titration advised; assess cardiovascular tolerance

• Additional risks:

• Increased susceptibility to tachycardia and arrhythmias

• Tremor more pronounced and distressing

• Risk of hypokalaemia especially with concurrent diuretics

• Urinary retention in males with prostatic hypertrophy

• Monitoring: Heart rate, ECG if parenteral use, serum potassium with repeated dosing

Drug Interaction Management

Non-selective beta-blockers (propranolol, carvedilol) Antagonise bronchodilator effect; may precipitate severe bronchospasm AVOID combination; use cardioselective beta-blockers (bisoprolol, metoprolol) if essential

MAO inhibitors Potentiate cardiovascular effects (hypertension, tachycardia) Avoid concurrent use or use with extreme caution

Tricyclic antidepressants Potentiate cardiac effects of beta-agonists Use with caution; monitor for arrhythmias

Digoxin Hypokalaemia from terbutaline increases digoxin toxicity risk Monitor serum potassium and digoxin levels

Drug Interaction Management

Thiazide/Loop diuretics Additive hypokalaemia Monitor serum potassium; supplement if needed

Systemic corticosteroids Additive hypokalaemia risk Monitor potassium especially with high-dose or prolonged use

Theophylline/Aminophylline Additive tachycardia, arrhythmia risk; additive hypokalaemia Monitor heart rate and potassium

Antidiabetic agents (insulin, OHAs) Beta-agonists may cause hyperglycaemia Monitor blood glucose; adjust antidiabetic dose if needed

Halogenated anaesthetics Increased risk of arrhythmias Inform anaesthetist; discontinue if possible before surgery

• Fine tremor (especially hands) — most common, dose-related

• Palpitations and tachycardia

• Nervousness, restlessness, anxiety

• Headache

• Muscle cramps

• Nausea

• Dizziness

Reaction Action Required

Severe hypokalaemia Monitor potassium; supplement as needed; may precipitate arrhythmias

Cardiac arrhythmias (atrial fibrillation, ventricular tachycardia) Discontinue; ECG monitoring; cardiology review

Myocardial ischaemia Discontinue parenteral use; supportive care

Paradoxical bronchospasm Stop administration immediately; use alternative bronchodilator

Pulmonary oedema (with IV tocolysis) Discontinue immediately; supportive care; ICU management

Seizures (rare, with IV overdose) Discontinue; supportive management

During acute treatment Pulse rate, oxygen saturation, clinical response, tremor assessment

During IV infusion Continuous ECG, pulse, BP; hourly fluid balance; serum potassium every 6–12 hours

Long-term oral/inhaled use Periodic assessment of symptom control; serum potassium if on diuretics; review for tolerance/overuse

Single-ingredient:

• Bricanyl (AstraZeneca)

• Terbulin (Cipla)

• Asthalin-T (Cipla) — Note: Verify as this may be salbutamol combination

• Terbutol (Lupin)

Fixed-dose combinations (FDCs):

NLEM status: Not included in NLEM 2022 (Salbutamol is the preferred beta-2 agonist in NLEM)

• Inhaled route preferred: Oral terbutaline has slower onset and more systemic side effects; salbutamol MDI/nebulisation is generally first-choice for acute bronchospasm

• Tremor management: Fine tremor is dose-dependent and often improves with continued use or dose reduction; reassure patients

• Beta-blocker caution: Non-selective beta-blockers can cause life-threatening bronchospasm — always verify concurrent medications

• Hypokalaemia risk: Monitor potassium with frequent nebulisation, IV use, or concurrent diuretics/steroids — low K+ can precipitate arrhythmias

• Not for maintenance tocolysis: Oral terbutaline for ongoing prevention of preterm labour is ineffective and potentially harmful

• Paradoxical bronchospasm: If wheezing worsens after administration, discontinue and switch to alternative bronchodilator

asthma; COPD; bronchodilator; beta-2 agonist; nebulisation; tocolysis; hypokalaemia risk; pregnancy-use; paediatric bronchospasm; not-NLEM

RxIndia v1.1 — 14 Jun 2025

• CDSCO Approved Product Information

• Indian Pharmacopoeia 2022

• API Textbook of Medicine (11th Edition)

• IAP Guidelines on Childhood Asthma

• AIIMS Hospital Formulary

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (13th Edition)

• Harrison's Principles of Internal Medicine (21st Edition)

• WHO Model List of Essential Medicines for Children (supportive reference)