schedule H

Inhalation

Formulation Strengths (per inhalation)

Dry Powder Inhaler (DPI) 6 mcg Formoterol + 100 mcg Budesonide

6 mcg Formoterol + 200 mcg Budesonide

6 mcg Formoterol + 400 mcg Budesonide

Pressurised Metered Dose Inhaler (pMDI) 6 mcg Formoterol + 100 mcg Budesonide

6 mcg Formoterol + 200 mcg Budesonide

6 mcg Formoterol + 400 mcg Budesonide

Rotacaps Available in above strengths

Nebuliser solution/Respules (combination) NOT AVAILABLE in India

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Persistent Asthma (Moderate to Severe)

Step-up therapy when ICS monotherapy is inadequate; maintenance therapy in patients requiring combination controller

Adults and Adolescents (≥12 years):

Parameter Recommendation

Starting dose 1 inhalation twice daily (6/200 mcg formulation)

Titration Assess asthma control at 2–4 weeks; step up to 2 inhalations twice daily if control inadequate

Usual maintenance dose 1–2 inhalations twice daily

Maximum dose 4 inhalations per day (total: 24 mcg formoterol + 800 mcg budesonide)

Clinical Notes:

• SMART regimen (Single Maintenance And Reliever Therapy): May use 6/100 mcg or 6/200 mcg formulation for both maintenance and as-needed relief — only under structured asthma action plan

• Never use ICS/LABA alone during acute exacerbation without SABA availability

• Assess inhaler technique and adherence before dose escalation

1. Chronic Obstructive Pulmonary Disease (COPD) — Moderate to Severe with Exacerbations

Only for patients with history of exacerbations despite optimal bronchodilator therapy

Adults:

Parameter Recommendation

Starting dose 1 inhalation twice daily (6/200 mcg or 6/400 mcg formulation)

Titration Based on symptom control and exacerbation frequency

Usual maintenance dose 1–2 inhalations twice daily

Maximum dose 2 inhalations twice daily of 6/400 mcg (total: 24 mcg formoterol + 1600 mcg budesonide)

Clinical Notes:

• ICS-containing regimens preferred in COPD patients with eosinophil count ≥300 cells/μL or frequent exacerbations

• Consider de-escalation of ICS if pneumonia risk is high

• Not first-line for COPD — use after LAMA or LABA monotherapy failure

Secondary Indications — Adults (Off-label)

Not applicable — all commonly accepted indications are approved in India.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Persistent Asthma — Moderate to Severe (Age 6–11 years)

Parameter Recommendation

Starting dose 1 inhalation twice daily (6/100 mcg formulation)

Titration Only under paediatric pulmonologist supervision; based on symptom control

Usual maintenance dose 1 inhalation twice daily

Maximum dose 2 inhalations per day (total: 12 mcg formoterol + 200 mcg budesonide)

Clinical Notes:

• Use lowest effective ICS dose to minimise growth suppression risk

• Spacer device recommended with pMDI for improved drug delivery

• Monitor height every 6 months during long-term use

• SMART approach NOT recommended in children below 12 years

Children < 6 years:

• NOT RECOMMENDED — ICS monotherapy (budesonide nebulisation) is preferred in this age group

• Combination ICS/LABA only under specialist supervision if absolutely required

Secondary Indications — Paediatrics (Off-label)

Not applicable — no established off-label paediatric uses in Indian guidelines.

No dose adjustment required.

• Known hypersensitivity to formoterol, budesonide, or any excipients (including lactose in DPI formulations)

• Primary treatment of status asthmaticus or acute severe asthma attack

• LABA monotherapy in asthma (without concurrent ICS) — applies if components used separately

• Active or quiescent pulmonary tuberculosis

• Untreated systemic fungal, bacterial, parasitic, or viral respiratory infections

• Cardiovascular disorders: ischaemic heart disease, arrhythmias, hypertension, QT prolongation

• Diabetes mellitus (formoterol may cause transient hyperglycaemia)

• Hypokalaemia or patients on potassium-depleting therapies

• Thyrotoxicosis

• Phaeochromocytoma

• History of osteoporosis (long-term ICS risk)

• Concurrent use with beta-adrenergic blocking agents

Aspect Recommendation

Overall safety Budesonide is the preferred ICS in pregnancy (most safety data); formoterol — use if benefit outweighs risk

When to use Continue in women with well-controlled asthma; uncontrolled asthma poses greater maternal and fetal risk than medication

Preferred approach Use lowest effective dose; avoid dose escalation unless clinically necessary

Monitoring Monitor fetal growth; watch for maternal adrenal suppression with high-dose ICS

Aspect Recommendation

Compatibility Compatible with breastfeeding

Drug levels in milk Budesonide: very low levels detected; Formoterol: limited data but inhaled route minimises systemic exposure

Preferred approach No need to interrupt breastfeeding; use lowest effective dose

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

• Start at lowest effective dose (6/100 mcg or 6/200 mcg, 1 inhalation twice daily)

• Slower titration recommended

• Increased sensitivity to beta-agonist cardiovascular effects (tachycardia, palpitations, tremor)

• Monitor for systemic corticosteroid effects: skin bruising, cataracts, osteoporosis

• Assess bone mineral density in long-term users; consider calcium and vitamin D supplementation

• Confirm adequate inhaler technique — DPI may be difficult with poor inspiratory effort

Interacting Drug Effect Recommendation

Non-selective beta-blockers (e.g., propranolol, carvedilol) Antagonise bronchodilator effect; may precipitate bronchospasm Avoid combination; if essential, use cardioselective beta-blocker with caution

Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin) Increase systemic budesonide exposure → risk of adrenal suppression and Cushing's syndrome Avoid prolonged concomitant use; if unavoidable, monitor closely for corticosteroid effects

QT-prolonging drugs (e.g., quinidine, amiodarone, certain fluoroquinolones) Additive QT prolongation risk with formoterol Use with caution; monitor ECG if combination unavoidable

Interacting Drug Effect Recommendation

Loop diuretics (furosemide) and Thiazides Potentiate hypokalaemia caused by beta-agonists Monitor serum potassium; correct hypokalaemia

MAO inhibitors Enhanced cardiovascular effects of formoterol Avoid use within 14 days of MAO inhibitor

Tricyclic antidepressants Potentiate cardiovascular effects Use with caution; monitor heart rate and blood pressure

Other inhaled sympathomimetics (salbutamol, salmeterol) Additive beta-agonist effects; increased tachycardia and hypokalaemia risk Avoid concurrent regular use; SABA only for acute rescue

Xanthine derivatives (theophylline) Additive hypokalaemia and cardiac stimulation Monitor potassium and heart rate

• Oropharyngeal candidiasis (thrush)

• Dysphonia / hoarseness

• Throat irritation and cough

• Headache

• Tremor (fine, of hands)

• Palpitations

• Dry mouth

• Muscle cramps

Adverse Effect Clinical Note

Paradoxical bronchospasm Discontinue immediately; treat with SABA; do not rechallenge

Adrenal suppression / Cushing's syndrome With prolonged high-dose ICS; taper gradually if switching

Cardiac arrhythmias Rare; more likely with hypokalaemia or QT-prolonging drugs

Anaphylaxis / severe hypersensitivity Rare; discontinue and do not rechallenge

Growth retardation in children Monitor height; use lowest effective dose

Pneumonia (in COPD patients) Higher incidence with ICS-containing regimens; monitor clinically

Severe hypokalaemia Rare; risk increased with concurrent diuretics or xanthines

Timepoint Parameters

Baseline Spirometry / peak expiratory flow rate; asthma control assessment (ACT score); inhaler technique review; oral examination for candidiasis

After initiation (2–4 weeks) Symptom control; repeat peak flow or spirometry; check inhaler technique; assess for early adverse effects

Long-term (every 3–6 months) Asthma/COPD control; exacerbation frequency; adherence assessment; inhaler technique; oropharyngeal examination

Children (long-term) Height measurement every 6 months

Adults (long-term high-dose) Consider bone mineral density assessment; ophthalmological examination for cataracts/glaucoma

Brand Name Manufacturer

Symbicort® AstraZeneca

Foracort® Cipla

Budamate® Lupin

Maxiflo® Cipla

Fobumix® Sun Pharma

Budecort Forte® Sun Pharma

Pulmicort + Oxis® AstraZeneca (separate inhalers)

Device types vary by brand — DPI (Turbuhaler, Rotahaler, Revolizer), pMDI, Rotacaps; verify device compatibility and patient's inspiratory flow capacity before prescribing.

Strength Approximate Price (120 doses)

• Included in NLEM 2022 (select strengths) — price controlled by NPPA

• Government supply available through public health facilities at subsidised rates

• Price varies by device type and brand

1. Inhaler technique is critical — Incorrect use is the most common cause of apparent treatment failure; assess technique at every visit using a checklist or dummy device.

1. Mouth rinsing is mandatory — Instruct patients to rinse mouth with water and spit after each dose to reduce oropharyngeal candidiasis and systemic absorption.

1. Stepwise approach — Do not initiate ICS/LABA combination as first-line therapy in mild intermittent or mild persistent asthma; escalate stepwise per GINA/Indian guidelines.

1. SMART regimen considerations — Single inhaler for maintenance and relief (using 6/100 or 6/200 mcg) is convenient and improves adherence but requires patient education and written action plan.

1. Adherence before escalation — Before increasing dose for poor control, always verify adherence, trigger avoidance, and technique; most "treatment failures" are actually adherence failures.

1. Device selection matters — DPIs require adequate inspiratory flow (>30 L/min); elderly or patients with severe obstruction may need pMDI with spacer.

asthma; COPD; ICS-LABA; inhaler therapy; budesonide; formoterol; NLEM India; paediatric asthma; pregnancy-safe ICS; respiratory; pulmonology

RxIndia v1.0 — 07 May 2024

• CDSCO (Central Drugs Standard Control Organisation) — Approved product information

• Indian Pharmacopoeia

• National List of Essential Medicines (NLEM) 2022

• API Textbook of Medicine, 11th Edition

• GINA 2023 (India-adapted recommendations validated by AIIMS experts)

• IAP (Indian Academy of Pediatrics) Respiratory Disease Guidelines

• AIIMS Asthma and COPD Management Protocols

• GOLD 2023 Guidelines (for COPD management principles)

• PGI Chandigarh and CMC Vellore Formulary References