Budesonide (Inhaled) Schedule (India)

Schedule H

Budesonide (Inhaled) Routes

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

Budesonide (Inhaled) Formulations

Dry Powder Inhaler (DPI): 100 mcg, 200 mcg, 400 mcg per actuation

Metered Dose Inhaler (MDI): 100 mcg, 200 mcg per actuation

Respules/Nebuliser Suspension: 0.25 mg/mL, 0.5 mg/mL, 1 mg/mL (2 mL ampoule/respule)

Budesonide (Inhaled) Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Bronchial Asthma — Maintenance Therapy

Adults and Adolescents (≥12 years) — Inhaler (DPI/MDI):

Mild Persistent Asthma:

Parameter Recommendation

Starting dose 200–400 mcg/day in 1–2 divided doses

Titration Increase by 200 mcg/day every 2–4 weeks if control inadequate

Usual maintenance dose 200–400 mcg/day

Maximum dose 800 mcg/day

Moderate Persistent Asthma:

Parameter Recommendation

Starting dose 400–800 mcg/day in 2 divided doses

Titration Adjust every 2–4 weeks based on symptom control

Usual maintenance dose 400–800 mcg/day

Maximum dose 1600 mcg/day

Severe Persistent Asthma:

Parameter Recommendation

Starting dose 800–1600 mcg/day in 2 divided doses

Titration Step-down by 25–50% every 3 months once asthma well-controlled

Usual maintenance dose 800–1200 mcg/day

Maximum dose 1600 mcg/day

Clinical Notes:

Administer via spacer device when using MDI to improve drug delivery

Rinse mouth with water after each use to prevent oropharyngeal candidiasis

Not a rescue medication — always ensure patient has access to SABA for acute symptoms

Onset of clinical effect may take 1–2 weeks; maximum benefit in 4–8 weeks

Chronic Obstructive Pulmonary Disease (COPD) — Maintenance Therapy

Adults — In Combination with Long-Acting Bronchodilator (LABA):

Parameter Recommendation

Starting dose 400 mcg twice daily (usually as FDC with formoterol)

Titration Not applicable for ICS component; adjust based on exacerbation frequency

Usual maintenance dose 400–800 mcg/day in 2 divided doses

Maximum dose 800 mcg/day

Clinical Notes:

Indicated ONLY for COPD patients with frequent exacerbations (≥2/year or ≥1 hospitalisation) despite LABA/LAMA therapy

Typically prescribed as fixed-dose combination with formoterol (budesonide/formoterol)

Monotherapy with ICS NOT recommended in COPD

Consider blood eosinophil count >300 cells/μL as predictor of ICS response

Monitor for pneumonia risk with prolonged ICS use in COPD

Acute Asthma Exacerbation — Nebulised (Alternative to Systemic Steroids)

Adults:

Parameter Recommendation

Starting dose 1–2 mg via nebuliser every 6–12 hours

Titration Not applicable

Usual maintenance dose 1–2 mg twice daily

Maximum dose 4 mg/day

Duration 5–7 days

Clinical Notes:

May be used as alternative to oral prednisolone in mild-moderate exacerbations

Not a substitute for systemic corticosteroids in severe exacerbations

Can be mixed with nebulised bronchodilators (salbutamol, ipratropium) in same nebuliser chamber

Secondary Indications – Adults Only (Off-label)

Indication Dose Duration Supervision Evidence Basis

Eosinophilic Bronchitis — OFF-LABEL 400–800 mcg/day inhaled in 2 divided doses 4–8 weeks; reassess response Specialist only (Pulmonology) Small RCTs; Indian pulmonology practice

Allergic Bronchopulmonary Aspergillosis (ABPA) — as adjunct — OFF-LABEL 800–1600 mcg/day inhaled in 2 divided doses Long-term with systemic steroids/antifungals Specialist only Limited evidence; tertiary centre practice

Budesonide (Inhaled) Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Persistent Asthma — Maintenance Therapy

Age Restriction: May be used from 6 months of age via nebulisation. DPI/MDI use from age 5–6 years depending on technique.

Nebulised Budesonide (6 months – 5 years):

Severity Starting Dose Titration Usual Maintenance Maximum Dose

Mild persistent 0.25 mg once or twice daily Increase to 0.5 mg BD if inadequate control 0.25–0.5 mg/day 1 mg/day

Moderate persistent 0.5 mg twice daily Adjust based on symptom control 0.5–1 mg/day 1 mg/day

Severe persistent 0.5–1 mg twice daily Step-down once controlled ≥3 months 1 mg/day 2 mg/day (short-term)

Inhaled Budesonide — DPI/MDI (6–11 years):

Severity Starting Dose Titration Usual Maintenance Maximum Dose

Mild persistent 100–200 mcg/day in 1–2 doses Increase by 100 mcg every 2–4 weeks if needed 100–200 mcg/day 400 mcg/day

Moderate persistent 200–400 mcg/day in 2 doses Adjust based on response 200–400 mcg/day 800 mcg/day

Severe persistent 400–800 mcg/day in 2 doses Step-down once controlled 400–800 mcg/day 800 mcg/day

Adolescents (≥12 years):

Use adult dosing

Clinical Notes:

Use spacer device with MDI in all children

Nebulisation preferred in children <5 years or those unable to use inhaler correctly

Monitor height velocity every 6 months — growth suppression possible with high doses

Titrate to lowest effective dose once asthma controlled for ≥3 months

Acute Asthma Exacerbation — Nebulised

Children (≥6 months):

Parameter Recommendation

Starting dose 0.5–1 mg via nebuliser every 12 hours

Titration Not applicable

Usual dose 0.5–1 mg twice daily

Maximum dose 2 mg/day

Duration 3–7 days

Clinical Notes:

Effective alternative to oral prednisolone for mild-moderate exacerbations in children

Particularly useful when oral corticosteroid administration is difficult (vomiting, non-compliance)

May be combined with nebulised salbutamol

Secondary Indications – Paediatric (Off-label)

Indication Age Dose Duration Notes Evidence Basis

Croup (Moderate-Severe Laryngotracheobronchitis) — OFF-LABEL ≥6 months 2 mg nebulised as single dose Single dose; may repeat once after 30–60 minutes if needed Emergency department setting; adjunct to dexamethasone IAP guidelines; WHO; multiple RCTs

Viral-Induced Wheeze (Recurrent) — OFF-LABEL ≥12 months 0.5–1 mg nebulised twice daily during episodes During acute episodes (3–7 days) Specialist paediatric pulmonology supervision Indian paediatric practice; limited RCT support

Minimum Age Statement:

Not recommended below 6 months of age except under specialist paediatric pulmonology supervision.

Safety Monitoring:

Height and weight at baseline and every 6 months

Assess inhaler/nebuliser technique at every visit

Monitor for oral candidiasis and dysphonia

Annual ophthalmologic assessment if on high-dose ICS >1 year

Budesonide (Inhaled) Renal Adjustments

No dose adjustment required.

Budesonide undergoes extensive first-pass hepatic metabolism with minimal renal excretion. Renal impairment does not significantly affect systemic exposure from inhaled budesonide.

Budesonide (Inhaled) Hepatic adjustment

Severity	Recommendation
Mild impairment (Child-Pugh A)	No dose adjustment required
Moderate impairment (Child-Pugh B)	Use with caution; standard doses generally acceptable; monitor for systemic corticosteroid effects
Severe impairment (Child-Pugh C)	Use with caution; risk of increased systemic exposure; monitor for adrenal suppression; consider dose reduction if prolonged high-dose therapy
Note: Systemic absorption from inhaled route is low (~10–20%)	; hepatic impairment primarily affects oral budesonide formulations.

Budesonide (Inhaled) Contraindications

Known hypersensitivity to budesonide or any excipient (including lactose in DPI formulations)

Primary treatment of status asthmaticus or acute severe asthma attack requiring emergency intervention (ICS is not rescue therapy)

Active or quiescent pulmonary tuberculosis (unless on adequate anti-TB therapy)

Untreated systemic fungal, bacterial, or viral infections

Budesonide (Inhaled) Cautions

Active or latent pulmonary tuberculosis — may reactivate; ensure TB status assessed before initiating long-term ICS

Systemic fungal infections

Ocular herpes simplex

History of oropharyngeal candidiasis — emphasise mouth rinsing

Transferring from systemic corticosteroids — risk of adrenal insufficiency; taper systemic steroids gradually

Patients previously requiring oral corticosteroids for asthma — may have adrenal suppression

Prolonged high-dose use — risk of systemic effects (adrenal suppression, osteoporosis, cataracts, glaucoma)

Growth monitoring essential in children — may cause temporary reduction in growth velocity

Paradoxical bronchospasm — discontinue and use alternative if occurs

Pneumonia risk in COPD patients on ICS

Diabetes mellitus — may affect glycaemic control at high doses

Budesonide (Inhaled) Pregnancy

Parameter Details

Risk category Generally considered safe; extensive human data support use

Preferred status Inhaled budesonide is the PREFERRED inhaled corticosteroid during pregnancy in India and internationally

When may be used Should be continued in pregnant women with asthma; uncontrolled asthma poses greater risk to mother and fetus than ICS use

Monitoring Monitor maternal asthma control (peak flow, symptoms); fetal growth monitoring as per routine antenatal care

Note: Poorly controlled asthma during pregnancy is associated with pre-eclampsia, preterm birth, and low birth weight — risks far outweigh theoretical concerns of ICS use.

Budesonide (Inhaled) Lactation

Parameter Details

Compatibility Compatible with breastfeeding

Drug levels in milk Very low; minimal systemic absorption from inhaled route; estimated infant exposure <0.3% of maternal dose

Preferred status Budesonide is the preferred ICS for breastfeeding mothers

Infant monitoring No specific monitoring required; observe for general wellbeing, normal feeding pattern, and growth

Budesonide (Inhaled) Elderly

Parameter Recommendation

Starting dose Start at lower end of dosing range (200–400 mcg/day for asthma)

Titration Titrate gradually based on response and tolerability

Special risks Increased risk of osteoporosis, cataracts, glaucoma with prolonged high-dose use; monitor bone density if high-dose ICS >5 years; assess fall risk

Additional considerations Higher prevalence of comorbidities (diabetes, osteoporosis); check inhaler technique — cognitive/motor impairment may affect use; consider nebulisation if inhaler technique poor

Budesonide (Inhaled) Major drug interactions

Drug/Class Mechanism/Effect Recommendation

Strong CYP3A4 inhibitors (ketoconazole, itraconazole, voriconazole, posaconazole) Marked increase in budesonide systemic exposure → risk of Cushing syndrome, adrenal suppression Avoid combination if possible; if unavoidable, use lowest budesonide dose and monitor for systemic steroid effects

Ritonavir, cobicistat (potent CYP3A4 inhibitors) Significant increase in budesonide exposure Avoid inhaled budesonide in HIV patients on ritonavir-boosted regimens; consider alternative ICS (beclomethasone) or alternative antiretroviral

Systemic corticosteroids (prednisolone, dexamethasone) Additive adrenal suppression risk Use with caution; taper systemic steroids when initiating ICS; monitor for adrenal insufficiency

Budesonide (Inhaled) Moderate drug interactions

Drug/Class Effect Recommendation

Moderate CYP3A4 inhibitors (erythromycin, clarithromycin, diltiazem, verapamil, fluconazole) Modest increase in budesonide systemic exposure Monitor for systemic corticosteroid effects (Cushingoid features, hyperglycaemia); generally acceptable at standard inhaled doses

Grapefruit juice Inhibits intestinal CYP3A4; minimal effect on inhaled route No significant clinical interaction with inhaled budesonide

Live vaccines Potential reduced immune response with high-dose prolonged ICS Avoid live vaccines if on high-dose ICS (≥800 mcg/day) for >1 month; consult immunisation guidelines

Budesonide (Inhaled) Common Adverse effects

Oropharyngeal candidiasis (oral thrush)

Dysphonia (hoarseness of voice)

Throat irritation / pharyngitis

Cough after inhalation

Headache

Upper respiratory tract infection

Budesonide (Inhaled) Serious Adverse effects

Adverse Effect Clinical Action

Paradoxical bronchospasm Discontinue immediately; treat with SABA; switch to alternative ICS or delivery device

Adrenal suppression / Adrenal crisis Risk with prolonged high-dose use or rapid withdrawal after transferring from systemic steroids; monitor for fatigue, hypotension; may require stress-dose steroids during illness/surgery

Hypersensitivity reactions (angioedema, urticaria, rash, bronchospasm) Rare; discontinue and avoid future use

Growth retardation in children Monitor height; use lowest effective dose; generally reversible effect

Posterior subcapsular cataracts / Glaucoma Risk with prolonged high-dose use; periodic ophthalmologic examination recommended

Reduced bone mineral density / Osteoporosis Risk with prolonged high-dose use (≥800 mcg/day for years); consider calcium/vitamin D supplementation and bone densitometry in at-risk patients

Pneumonia (in COPD patients) Monitor for symptoms; higher risk with ICS in COPD than asthma

Budesonide (Inhaled) Monitoring requirements

Baseline:

Asthma/COPD severity assessment (symptom frequency, FEV1/peak flow if available)

Inhaler technique assessment

Height (mandatory in children)

Rule out active TB in endemic areas

Blood glucose if diabetic

After Initiation / Dose Change:

Reassess symptom control at 2–4 weeks

Review rescue inhaler use

Recheck inhaler technique

Assess for local adverse effects (oral thrush, dysphonia)

Long-term Monitoring:

Height velocity every 6 months in children

Symptom control and peak flow/spirometry at each visit

Annual review of step-down possibility

Ophthalmologic examination if on high-dose ICS >2 years

Bone mineral density if on high-dose ICS ≥5 years (especially elderly, postmenopausal women)

Screen for oral candidiasis

Periodic assessment of adrenal function if on high-dose ICS with systemic steroid history

Budesonide (Inhaled) Brands in India

Single-Ingredient Inhalers:

Budecort (Cipla) — DPI, MDI, Respules

Pulmicort (AstraZeneca) — DPI, Respules

Budesal (Lupin) — Respules

Budez (Sun Pharma) — DPI

Ribufort (Intas) — DPI

Fixed-Dose Combinations (FDCs) with Formoterol:

Foracort (Cipla) — DPI, MDI

Budamate (Lupin) — DPI

Symbicort (AstraZeneca) — DPI

Fomtide (Cipla) — DPI

Fixed-Dose Combinations with Salbutamol:

Aerocort (Cipla) — MDI

Fixed-Dose Combinations with Formoterol + Tiotropium (Triple Therapy):

Triohale (Cipla) — DPI

Budesonide (Inhaled) Price range (INR)

Formulation	Approximate Price (per tablet)
DPI 100 mcg (60–200 doses) ₹150–₹350 per inhaler
DPI 200 mcg (60–200 doses) ₹180–₹400 per inhaler
DPI 400 mcg (60 doses) ₹250–₹450 per inhaler
MDI 100 mcg (200 doses) ₹100–₹200 per inhaler
MDI 200 mcg (200 doses) ₹150–₹280 per inhaler
Respules 0.5 mg/mL (10 respules) ₹150–₹250 per pack
Respules 1 mg/mL (10 respules) ₹200–₹350 per pack

Included in NLEM 2022 (100 mcg, 200 mcg inhalers)

NPPA price ceiling applicable for scheduled strengths

Available through government supply for asthma/COPD programmes

Significant brand-to-brand price variation

Budesonide (Inhaled) Clinical pearls

Rinse mouth after every use — simple intervention dramatically reduces oral candidiasis and dysphonia; instruct all patients at initiation and reinforce at follow-up

Inhaler technique is critical — poor technique is the most common cause of apparent ICS failure; reassess technique at every visit; use spacer with MDI in all patients

Not a rescue medication — patients must understand that ICS is for prevention, not acute relief; always prescribe SABA (salbutamol) for breakthrough symptoms

Pregnancy-preferred ICS — budesonide has the most extensive safety data of all ICS during pregnancy; do not discontinue in pregnant asthmatics

Step-down when controlled — after 3 months of good asthma control, attempt to reduce ICS dose by 25–50%; maintain on lowest effective dose to minimise long-term risks

COPD requires justification — unlike asthma, ICS in COPD is reserved for frequent exacerbators with eosinophilic phenotype; avoid routine ICS in stable COPD without exacerbation history

Monitor growth in children — temporary reduction in growth velocity possible in first 1–2 years of ICS use; effect on final adult height is minimal (≤1 cm) with standard doses

Budesonide (Inhaled) Tags

inhaled-corticosteroid; ICS; asthma; COPD; nebuliser; DPI; MDI; paediatric-use; pregnancy-safe; lactation-compatible; NLEM India; Schedule H

Budesonide (Inhaled) Version

RxIndia v1.0 — 05 Jun 2025

Budesonide (Inhaled) Reference

CDSCO approved product inserts

Indian Pharmacopoeia

National List of Essential Medicines (NLEM) 2022

API Textbook of Medicine

ICMR Guidelines on COPD Management

IAP Guidelines on Childhood Asthma

GINA Global Strategy for Asthma Management (supportive)

GOLD COPD Guidelines (supportive)

AIIMS Pulmonology Treatment Protocols

WHO Model Formulary (paediatric dosing support)

1.

RxIndia

The Drug Registry

Budesonide (Inhaled)

Ciclesonide