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