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Formoterol + Budesonide Inhaler Uses, Dosage, Side Effects | DrugsAtlas

Authoritative Clinical Reference

Therapeutic Class

Respiratory Agents

Subclass

Inhaled Long-Acting β2-Agonist (LABA) + Inhaled Corticosteroid (ICS)

Speciality

Pulmonology

Schedule (India)

schedule H

Routes

Inhalation

Formulations

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

Adult indications

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

2. 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 indications

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.

Renal Adjustments

No dose adjustment required.

Hepatic adjustment

Contraindications

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

Cautions

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

Pregnancy

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

Lactation

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)

Elderly

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

Major drug interactions

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

Moderate drug interactions

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

Common Adverse effects

Oropharyngeal candidiasis (thrush)
Dysphonia / hoarseness
Throat irritation and cough
Headache
Tremor (fine, of hands)
Palpitations
Dry mouth
Muscle cramps

Serious Adverse effects

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

Monitoring requirements

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

Brands in India

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.

Price range (INR)

Strength	Approximate Price (120 doses)
6/100 mcg	₹150–₹250
6/200 mcg	₹200–₹350
6/400 mcg	₹280–₹450

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

Clinical pearls

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.
Mouth rinsing is mandatory — Instruct patients to rinse mouth with water and spit after each dose to reduce oropharyngeal candidiasis and systemic absorption.
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.
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.
Adherence before escalation — Before increasing dose for poor control, always verify adherence, trigger avoidance, and technique; most "treatment failures" are actually adherence failures.
Device selection matters — DPIs require adequate inspiratory flow (>30 L/min); elderly or patients with severe obstruction may need pMDI with spacer.

Version

RxIndia v1.0 — 07 May 2024

Reference

- 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

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Clinical Responsibility

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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