Schedule H

Inhalation (via DPI/MDI)

• Salmeterol 25 mcg/actuation inhaler (MDI)

• Salmeterol 50 mcg per blister (DPI/Rotacaps)

• Fixed-dose combinations (FDC) with fluticasone propionate:

• Salmeterol 25 mcg + Fluticasone 50 mcg (MDI)

• Salmeterol 25 mcg + Fluticasone 125 mcg (MDI)

• Salmeterol 25 mcg + Fluticasone 250 mcg (MDI)

• Salmeterol 50 mcg + Fluticasone 100 mcg (DPI)

• Salmeterol 50 mcg + Fluticasone 250 mcg (DPI)

• Salmeterol 50 mcg + Fluticasone 500 mcg (DPI)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Bronchial Asthma (Maintenance Therapy ONLY)

⚠️ MANDATORY: Must ALWAYS be co-prescribed with inhaled corticosteroid (ICS)

Parameter DPI (Rotacaps/Diskus) MDI

Starting dose 50 mcg twice daily 25 mcg (1 puff) twice daily

Titration Based on symptom control; assess after 2–4 weeks Based on symptom control; assess after 2–4 weeks

Usual maintenance dose 50 mcg twice daily 25 mcg twice daily

Maximum dose 100 mcg twice daily (rarely required) 50 mcg twice daily

Key Clinical Notes:

• NOT for acute bronchospasm relief — always prescribe a rescue SABA concurrently

• Risk of asthma-related mortality increases when used without concurrent ICS

• Prefer fixed-dose combination inhalers (salmeterol + fluticasone) to ensure ICS adherence

1. Chronic Obstructive Pulmonary Disease (COPD)

May be used as monotherapy or combined with ICS ± LAMA based on GOLD phenotype and exacerbation risk

Parameter Dosing Details

Starting dose 50 mcg twice daily (DPI) OR 25 mcg twice daily (MDI)

Titration Based on symptomatic response and spirometry; evaluate at 4–8 weeks

Usual maintenance dose 50 mcg twice daily

Maximum dose 100 mcg twice daily (monitor for tremor, tachycardia)

Key Clinical Notes:

• Monotherapy acceptable in COPD (unlike asthma)

• Consider adding ICS if frequent exacerbations (≥2/year) or eosinophil count ≥300 cells/μL

• Combine with LAMA (e.g., tiotropium) for GOLD Group D patients

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Notes

Exercise-induced bronchospasm prophylaxis (OFF-LABEL) 50 mcg via DPI, 30 minutes before exercise Single-use prophylaxis Not first-line; SABA preferred. Evidence from international RCTs; limited Indian data. Specialist guidance advised.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Bronchial Asthma (Maintenance Therapy Only — Always with ICS)

4–11 years MDI with spacer 25 mcg twice daily 50 mcg/day

4–11 years DPI (if capable) 50 mcg twice daily 100 mcg/day

≥12 years MDI or DPI Same as adult dosing 100 mcg twice daily

Key Clinical Notes:

• Minimum age: 4 years (under paediatric pulmonologist supervision)

• MUST be combined with ICS (e.g., fluticasone) — use FDC inhalers to ensure adherence

• Assess inhaler technique at each visit; spacer mandatory for MDI in children

• Monitor linear growth with prolonged ICS+LABA therapy

1. COPD in Children

Not applicable

Secondary Indications — Paediatric (Off-label)

• No established off-label paediatric indications beyond asthma in Indian practice

• Not to be used below 4 years of age except in clinical trials or under specialist pulmonologist guidance

• Known hypersensitivity to salmeterol or any formulation excipients (e.g., lactose in DPI)

• Use as monotherapy in asthma (without concurrent ICS) — associated with increased mortality risk

• Acute asthma exacerbation or status asthmaticus (not a rescue medication)

• Severe milk protein allergy (for lactose-containing DPI formulations)

• Cardiovascular disease: ischaemic heart disease, arrhythmias, hypertension

• Hyperthyroidism or thyrotoxicosis

• Diabetes mellitus — may cause transient hyperglycaemia

• Hypokalaemia — risk increased with concurrent diuretics, corticosteroids, or xanthines

• Seizure disorders — may lower seizure threshold at high doses

• Prolonged QTc interval

• Phaeochromocytoma (rare)

• History of paradoxical bronchospasm with inhaled therapy

Parameter Details

Risk Category Generally considered compatible (no formal FDA category post-2015; animal studies reassuring; limited human data)

Preferred alternatives ICS monotherapy (budesonide preferred) for mild-moderate asthma

When may be used If asthma remains uncontrolled on ICS alone; benefit of controlled asthma outweighs theoretical risk

Monitoring Fetal growth surveillance; maternal peak flow and symptom diary

Parameter Details

Compatibility Compatible with breastfeeding

Preferred alternatives ICS monotherapy (budesonide) if asthma mild

Drug levels in milk Low (minimal systemic absorption from inhaled route)

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

Parameter Recommendation

Starting dose Standard adult dose (no routine reduction)

Titration Slower dose escalation if underlying cardiac disease

Special risks Increased susceptibility to hypokalaemia, tremor, palpitations, tachyarrhythmias; reduced renal reserve may delay potassium recovery

Monitoring ECG if cardiac history; serum potassium if on diuretics

Interacting Drug Effect Management

Non-selective beta-blockers (propranolol, carvedilol) Antagonise bronchodilator effect; risk of severe bronchospasm Avoid concomitant use; use cardioselective beta-blockers (bisoprolol) if essential

MAO inhibitors Risk of hypertensive crisis Avoid salmeterol within 14 days of MAOI use

Tricyclic antidepressants Potentiate cardiovascular effects Avoid or use with extreme caution

Other sympathomimetics (oral beta-agonists, pseudoephedrine) Additive adrenergic effects; risk of arrhythmia, hypertension Avoid concurrent use

Potassium-wasting diuretics (furosemide, thiazides) Additive hypokalaemia risk Monitor serum potassium; correct before initiating

Interacting Drug Effect Management

Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin) Increased systemic salmeterol levels → tremor, palpitations, QT prolongation Avoid if possible; if essential, use with caution and monitor

Theophylline/aminophylline Additive bronchodilation; increased arrhythmia and hypokalaemia risk Monitor heart rate, potassium

Systemic corticosteroids Additive hypokalaemia Monitor serum potassium during acute exacerbations

QT-prolonging drugs (fluoroquinolones, ondansetron, antipsychotics) Additive QT prolongation risk ECG monitoring if combination unavoidable

• Headache (most common)

• Tremor (dose-related)

• Palpitations

• Throat irritation/pharyngitis

• Muscle cramps

• Cough after inhalation

• Oral candidiasis (with ICS combination)

Adverse Effect Clinical Action

Paradoxical bronchospasm Discontinue immediately; treat with SABA; switch to alternative LABA

Tachyarrhythmias / atrial fibrillation Discontinue; cardiology evaluation

Severe hypokalaemia Discontinue; correct potassium; review concurrent drugs

QT prolongation / Torsades de pointes Discontinue; ECG monitoring; avoid other QT-prolonging drugs

Anaphylaxis / angioedema Discontinue permanently; emergency management

Asthma-related death (with LABA monotherapy) Black box warning internationally — never use without ICS in asthma

After 2–4 weeks Symptom control assessment, peak expiratory flow, inhaler technique review

Long-term Spirometry every 6–12 months; adherence to ICS co-therapy; monitor for tremor, tachycardia; serum potassium annually if on diuretics

Paediatrics Linear growth monitoring (with ICS combination); developmental milestones

Plain Salmeterol:

• Serevent® Rotacaps/Accuhaler (GSK)

• Salmec Rotacaps® (Cipla)

Fixed-Dose Combinations (Salmeterol + Fluticasone):

• Seroflo® Rotacaps/Inhaler (Cipla)

• Combitide® (Sun Pharma)

• Seretide® (GSK)

• Salbair-F® (Lupin)

• Flohale-S® (Mankind)

Note: Salmeterol + Fluticasone FDC is included in NLEM 2022; prices are controlled under NPPA ceiling price regulations.

1. Never prescribe salmeterol alone for asthma — always co-prescribe ICS or use fixed-dose combination inhalers to prevent mortality risk

1. Not a rescue medication — onset of action is 15–20 minutes; always ensure patient has a separate SABA (salbutamol) for acute relief

1. Device technique matters — poor inhaler technique is a leading cause of treatment failure; demonstrate and reassess at every visit

1. Prefer FDC inhalers in asthma — improves ICS adherence and simplifies regimen

1. Step-down when controlled — after 3–6 months of good control, consider stepping down to ICS monotherapy per ICMR/GINA stepwise approach

1. COPD differs from asthma — monotherapy acceptable in COPD; consider triple therapy (ICS + LABA + LAMA) for frequent exacerbators

asthma; COPD; LABA; bronchodilator; inhalation; ICS-mandatory; fluticasone-combination; NLEM-India; paediatric-4years; respiratory; Salmeterol

RxIndia v1.0 — 06 Jun 2025

• CDSCO Approved Formulations List

• Indian Pharmacopoeia 2022

• National List of Essential Medicines (NLEM) 2022

• API Textbook of Medicine (11th Edition)

• ICMR Guidelines for Management of Bronchial Asthma (2023)

• ICMR-COPD Management Guidelines (2023)

• AIIMS Treatment Protocols — Pulmonary Medicine

• IAP Guidelines for Paediatric Asthma Management

• GINA 2023 (referenced for off-label indication only; not primary source)