Schedule H

Inhalation (Dry Powder Inhaler, Metered Dose Inhaler, Nebulisation)

• Dry Powder Inhaler (DPI): 6 µg, 12 µg per actuation

• Metered Dose Inhaler (MDI): 6 µg, 12 µg per actuation

• Nebuliser Solution: 20 µg/mL (2 mL ampoules)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Bronchial Asthma (Maintenance Therapy — NEVER as Monotherapy)

Must be used in combination with inhaled corticosteroids (ICS).

Clinical Setting Dosing Key Notes

Step 3–5 Asthma (Moderate to Severe)

Starting dose 12 µg BID via DPI or MDI (with ICS) Always as fixed-dose combination

Titration Not applicable Adjust ICS component based on control

Usual maintenance dose 12 µg BID Onset of action within 5 minutes

Maximum dose 24 µg/day Do NOT use for acute relief

SMART Regimen (Single Maintenance and Reliever Therapy)

• Only with Budesonide-Formoterol combination

• Starting dose: 6 µg PRN as reliever + 6–12 µg BID as maintenance

• Usual maintenance dose: 6–12 µg BID with PRN doses as needed

• Maximum dose: 48 µg/day (combined maintenance + reliever doses)

• Use in moderate-to-severe persistent asthma

1. Chronic Obstructive Pulmonary Disease (COPD)

Can be used as monotherapy or combined with LAMA/ICS.

Parameter Dose

Starting dose 12 µg via DPI or MDI once to twice daily

Titration Not routinely required

Usual maintenance dose 12 µg BID

Maximum dose 24 µg/day

• Consider combination therapy (with Tiotropium or ICS) based on GOLD classification, symptom burden, and exacerbation history

• Duration of action: approximately 12 hours

Secondary Indications — Adults (Off-label)

Not applicable.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Bronchial Asthma (Controller Therapy — Only with ICS)

≥6 to 12 years 6 µg BID via DPI (with ICS) 6 µg BID 12 µg/day Use fixed-dose ICS-LABA combinations only

12 years 6–12 µg BID via DPI (with ICS) 12 µg BID 24 µg/day Same as adult dosing

Safety Notes:

• Never use LABA monotherapy in children — black box warning for asthma-related mortality

• Available combinations: Budesonide-Formoterol

• Assess inhaler technique at each visit

• Minimum age: 6 years

Children <6 years: Not recommended except under paediatric pulmonologist supervision with compelling indications.

Secondary Indications — Paediatrics (Off-label)

Not applicable.

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

• Monotherapy in asthma without concomitant ICS (increased risk of asthma-related deaths)

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

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

• Cardiovascular disorders: ischaemic heart disease, cardiac arrhythmias, hypertrophic cardiomyopathy, uncontrolled hypertension

• Diabetes mellitus: may cause transient hyperglycaemia; monitor blood glucose

• Hyperthyroidism: may exacerbate symptoms

• Seizure disorders: beta-2 agonists may lower seizure threshold

• Hypokalaemia: risk increased with concurrent diuretics, theophylline, or systemic corticosteroids

• Phaeochromocytoma: use with extreme caution

• Paradoxical bronchospasm: discontinue immediately if occurs

• QT prolongation: caution with pre-existing QT interval prolongation

Parameter Recommendation

Risk category Generally considered low risk when inhaled (limited systemic absorption)

Preferred alternatives ICS monotherapy (Budesonide preferred) for mild asthma

When may be used In moderate-to-severe asthma when ICS alone is insufficient; continue ICS-LABA if already established pre-pregnancy

Monitoring required Maternal oxygenation, asthma control, fetal growth monitoring; poorly controlled asthma carries greater risk than medication

Parameter Recommendation

Compatible with breastfeeding Yes — minimal systemic absorption from inhaled route

Preferred alternatives Salbutamol (SABA), Budesonide (ICS)

Expected drug levels in milk Low (negligible systemic levels)

Infant monitoring Observe for irritability, feeding difficulties, or changes in sleep pattern

• Starting dose: 12 µg BID (same as adult dose)

• Titration: Slower titration recommended if cardiovascular comorbidities present

• Additional risks:

• Increased susceptibility to tachyarrhythmias

• Higher risk of hypokalaemia if on diuretics or digoxin

• Monitor for tremor, palpitations, and CNS stimulation

• Monitoring: Baseline ECG if cardiac history; periodic serum potassium if on concurrent hypokalaemia-inducing agents

Interacting Drug Effect Recommendation

Non-selective beta-blockers (e.g., Propranolol, Carvedilol) Antagonises bronchodilatory effect; may precipitate severe bronchospasm Avoid; use cardioselective beta-blockers (e.g., Metoprolol) if essential

MAO inhibitors / Tricyclic antidepressants Potentiation of cardiovascular effects; risk of hypertensive crisis Avoid Formoterol within 14 days of MAOI use

QT-prolonging drugs (e.g., Haloperidol, Erythromycin, Ondansetron, Fluoroquinolones) Additive QT prolongation; risk of torsades de pointes Avoid combination or use with ECG monitoring

Non-potassium-sparing diuretics (e.g., Furosemide, Hydrochlorothiazide) Increased risk of severe hypokalaemia Monitor serum potassium; correct deficits

Interacting Drug Effect Recommendation

Theophylline Additive bronchodilation; increased risk of hypokalaemia and arrhythmias Monitor serum theophylline levels and potassium

Systemic corticosteroids Additive hypokalaemia risk Monitor potassium periodically during acute exacerbations

Digoxin Hypokalaemia-induced digitalis toxicity; increased arrhythmia risk Monitor ECG and serum potassium

Xanthine derivatives Synergistic effects but increased adverse effect risk Use with caution; adjust doses as needed

• Tremor (most common)

• Palpitations

• Headache

• Throat irritation or dryness

• Muscle cramps

• Tachycardia

• Insomnia (particularly with evening doses)

• Oropharyngeal candidiasis (when used with ICS combinations)

• Paradoxical bronchospasm — discontinue immediately; administer SABA

• Severe hypokalaemia — particularly with concurrent diuretics/steroids; may require potassium supplementation

• Cardiac arrhythmias — including atrial fibrillation, ventricular ectopics, supraventricular tachycardia

• QT prolongation — rare; risk of torsades de pointes

• Angioedema and anaphylaxis — rare; requires immediate discontinuation

• Asthma-related death — increased risk with LABA monotherapy (without ICS)

After initiation/dose change Review symptom control and inhaler technique within 1–2 weeks

Long-term Periodic assessment of asthma/COPD control; serum potassium if on chronic steroids or diuretics; spirometry/PEFR for objective disease monitoring

• Foracort® (with Budesonide)

• Symbicort® (with Budesonide)

• Formonide®

• Budamate® (with Budesonide)

• Airtec FB® (with Budesonide)

• Oxyplus®

• Ezicort-F® (with Budesonide)

Note: Formoterol is most commonly available as fixed-dose combinations with Budesonide in India.

NLEM Status: Included as combination with Budesonide (Budesonide 200 µg + Formoterol 6 µg)

• Never prescribe Formoterol as monotherapy in asthma — always combine with ICS to prevent asthma-related mortality.

• SMART regimen (Single Maintenance and Reliever Therapy) is only approved with Budesonide-Formoterol, not with other ICS-LABA combinations.

• Rapid onset (within 5 minutes) differentiates Formoterol from Salmeterol and makes it suitable for PRN use in SMART.

• Inhaler technique is a major determinant of treatment success — demonstrate and verify at each visit.

• Avoid evening doses in patients reporting insomnia or sleep disturbance.

• Pre-treatment cardiovascular assessment is advisable in elderly patients or those with known cardiac disease.

formoterol; LABA; asthma; COPD; SMART regimen; ICS-LABA; inhaled bronchodilator; respiratory; NLEM India; budesonide-formoterol

RxIndia v1.0 — 07 Apr 2025

• CDSCO product inserts

• Indian Pharmacopoeia (IP)

• National List of Essential Medicines (NLEM 2022)

• GINA India adaptation — ICS-LABA recommendations

• IAP Guidelines on Bronchial Asthma (Paediatric use)

• API Textbook of Medicine (Asthma and COPD chapters)

• AIIMS Adult Asthma Management Protocol