Schedule H

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

• 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)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. 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

1. 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

1. 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

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. 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

1. 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

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.

• 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

• 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

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.

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

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

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

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

• Oropharyngeal candidiasis (oral thrush)

• Dysphonia (hoarseness of voice)

• Throat irritation / pharyngitis

• Cough after inhalation

• Headache

• Upper respiratory tract infection

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

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

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

• 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

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

1. 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

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

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

1. 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

1. 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

1. 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

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

RxIndia v1.0 — 05 Jun 2025

• 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)

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