Schedule H

Inhalation, Oral, Rectal, Nasal

• Inhalation (DPI/MDI): 100 mcg, 200 mcg, 400 mcg per actuation

• Nebulizer suspension (Respules): 0.5 mg/2 mL, 1 mg/2 mL

• Oral capsules (enteric-coated/delayed-release): 3 mg

• Rectal enema: 2 mg/100 mL

• Nasal spray: 100 mcg per actuation

Note: Rectal foam formulation is NOT AVAILABLE in India.

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Bronchial Asthma — Maintenance Therapy (Inhaled)

Adults:

Parameter Details

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

Titration Adjust every 2–4 weeks based on asthma control; step up if uncontrolled, step down after 3 months of good control

Usual maintenance dose 200–800 mcg/day in 1–2 divided doses

Maximum dose 1600 mcg/day

Clinical Notes:

• Use DPI or MDI with spacer device for optimal drug delivery

• Nebulization reserved for severe exacerbations or young children

• NOT for acute bronchospasm relief — ensure patient has rescue SABA

• Rinse mouth after each inhalation to prevent oral candidiasis

1. Chronic Obstructive Pulmonary Disease (COPD) — Maintenance Therapy

(As component of ICS/LABA combination)

Parameter Details

Starting dose 200–400 mcg twice daily (as ICS component in FDC)

Titration Not applicable — fixed-dose combination

Usual maintenance dose 200–400 mcg twice daily

Maximum dose 400 mcg twice daily (as ICS component)

Clinical Notes:

• Do NOT use budesonide monotherapy for COPD — must be combined with LABA (formoterol)

• Indicated for patients with frequent exacerbations (≥2/year) or eosinophilic phenotype

• Common FDC: Budesonide + Formoterol (Symbicort®, Budamate®)

1. Crohn's Disease — Mild to Moderate Ileocaecal or Right-sided Colonic Disease

(Oral delayed-release capsule)

Parameter Details

Starting dose 9 mg orally once daily (morning)

Titration Not applicable

Usual maintenance dose 9 mg once daily for 8 weeks

Maximum dose 9 mg/day

Clinical Notes:

• Take in the morning, preferably before breakfast

• Taper after 8 weeks: reduce to 6 mg daily for 2 weeks, then 3 mg daily for 2 weeks before discontinuation

• Not recommended for maintenance beyond 3 months due to adrenal suppression risk

• Less effective for left-sided colonic or pancolonic Crohn's disease

1. Allergic Rhinitis — Seasonal and Perennial

Adults (Nasal Spray):

Parameter Details

Starting dose 100 mcg (1 spray) per nostril once daily (total 200 mcg/day)

Titration May increase to 100 mcg per nostril twice daily if inadequate response

Usual maintenance dose 100–200 mcg per nostril daily

Maximum dose 400 mcg/day (200 mcg per nostril twice daily)

Clinical Notes:

• Onset of action: 24–48 hours; maximum effect in 1–2 weeks

• Assess response at 2 weeks; if no improvement, consider alternative diagnosis

• Prime nasal spray before first use

1. Ulcerative Colitis — Distal Disease and Proctitis

(Rectal Enema)

Parameter Details

Starting dose 2 mg (one enema) rectally once daily at bedtime

Titration Not applicable

Usual maintenance dose 2 mg once daily at bedtime

Maximum dose 2 mg/day

Duration 4–6 weeks; taper based on clinical response

Clinical Notes:

• Retain enema for at least 30 minutes (preferably overnight)

• Effective for left-sided colitis extending up to splenic flexure

• Combine with oral mesalamine for optimal response

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Bronchial Asthma — Maintenance Therapy (Inhaled)

Nebulization (Age 6 months to 5 years):

Age Starting Dose Titration Usual Maintenance Maximum Dose

6 months – 5 years 250 mcg twice daily via nebulizer Adjust every 2–4 weeks based on symptom control 250–500 mcg twice daily 1000 mcg/day

DPI/MDI with Spacer (Age >5 years):

Age Starting Dose Titration Usual Maintenance Maximum Dose

6–11 years 100–200 mcg twice daily Adjust every 2–4 weeks 100–400 mcg twice daily 800 mcg/day

≥12 years 200 mcg twice daily Adjust as per adult protocol 200–400 mcg twice daily 800 mcg/day (up to 1600 mcg in severe asthma)

Clinical Notes:

• Use face mask with nebulizer or spacer with MDI in young children

• Monitor growth velocity annually — linear growth suppression possible with high-dose ICS

• Step-down therapy after 3 months of well-controlled asthma

1. Allergic Rhinitis (Nasal Spray)

Age Starting Dose Usual Maintenance Maximum Dose

6–11 years 50 mcg (1 spray) per nostril once daily 50–100 mcg per nostril once daily 200 mcg/day

≥12 years 100 mcg per nostril once daily 100 mcg per nostril once or twice daily 400 mcg/day

Monitoring: Epistaxis, nasal septum irritation, growth parameters

Secondary Indications — Paediatric (Off-label)

Indication Age Dose Duration Remarks

Crohn's disease (mild-moderate ileocaecal) — OFF-LABEL >8 years (weight >25 kg) 9 mg orally once daily; taper to 6 mg after 4 weeks 8–12 weeks Specialist only (Paediatric Gastroenterologist); used in Indian tertiary paediatric GI centres

Eosinophilic oesophagitis — OFF-LABEL >10 years 1 mg daily as viscous slurry 8–12 weeks Specialist only; limited paediatric data

⚠️ Not recommended below 6 months of age for inhaled formulations except under paediatric pulmonologist supervision with documented justification.

Safe in all stages of chronic kidney disease.

• Hypersensitivity to budesonide or any formulation excipient

• Acute status asthmaticus or acute severe bronchospasm (requires systemic corticosteroids)

• Untreated systemic fungal, bacterial, or viral infections

• Active or quiescent pulmonary tuberculosis (untreated)

• Nasal formulation: Recent nasal surgery, nasal trauma, or nasal septal ulceration (until healed)

• Active or latent tuberculosis — screen before initiating inhaled corticosteroids

• Systemic fungal infections — may worsen with immunosuppression

• Ocular herpes simplex — risk of exacerbation

• Long-term high-dose inhaled use — monitor for hypothalamic-pituitary-adrenal (HPA) axis suppression

• Growth suppression in children — monitor height velocity with chronic ICS use

• Glaucoma and cataracts — chronic corticosteroid exposure increases risk

• Osteoporosis risk — with prolonged high-dose use

• Diabetes mellitus — corticosteroids may impair glycaemic control

• Immunocompromised patients — increased infection susceptibility

• Transfer from systemic corticosteroids — risk of adrenal insufficiency; taper systemic steroids slowly

Parameter Details

Safety Category Inhaled/nasal: Generally considered safe (minimal systemic absorption); Oral/rectal: Use only if benefit outweighs risk

Preferred ICS Budesonide is the preferred inhaled corticosteroid during pregnancy (most safety data available)

When to use Continue inhaled budesonide for asthma control throughout pregnancy — uncontrolled asthma poses greater risk to fetus

Monitoring Maternal adrenal function if prolonged oral use; routine fetal growth monitoring

Parameter Details

Compatibility Compatible with breastfeeding (inhaled and nasal forms)

Drug levels in milk Inhaled: Negligible; Oral: Low to moderate (variable first-pass metabolism)

Preferred alternatives Budesonide is preferred ICS during lactation; oral use should be limited to short-term if possible

Infant monitoring Growth parameters; signs of adrenal suppression unlikely with inhaled/nasal routes

Parameter Recommendation

Starting dose Lower end of dose range for oral budesonide; standard doses for inhaled/nasal

Titration Slower titration and reassessment to avoid overtreatment

Special considerations Increased susceptibility to systemic corticosteroid effects; monitor for osteoporosis, hyperglycaemia, adrenal suppression with prolonged use

Additional risks Falls risk with muscle weakness; ensure adequate calcium and vitamin D intake

Drug Mechanism Clinical Effect Recommendation

Ketoconazole Strong CYP3A4 inhibitor Markedly increased budesonide systemic exposure (6–8 fold) Avoid combination; if essential, use lowest budesonide dose and monitor for corticosteroid toxicity

Itraconazole Strong CYP3A4 inhibitor Significantly increased budesonide levels Avoid or reduce budesonide dose; monitor closely

Ritonavir, Cobicistat Potent CYP3A4 inhibitors Profound increase in systemic budesonide exposure Avoid combination — high risk of Cushing syndrome and adrenal suppression

Clarithromycin CYP3A4 inhibitor Increased budesonide systemic effects Use with caution; monitor for adverse effects

Drug Interaction Recommendation

Rifampicin, Phenytoin, Carbamazepine, Phenobarbital CYP3A4 inducers — may reduce budesonide efficacy Monitor for reduced therapeutic effect; dose increase may be required

Oral contraceptives (estrogen-containing) May modestly increase budesonide exposure Rarely clinically significant; monitor if adverse effects emerge

Grapefruit juice Weak CYP3A4 inhibitor May modestly increase oral budesonide levels; avoid large quantities

Potassium-depleting agents (diuretics, laxatives) Additive hypokalaemia risk Monitor potassium with high-dose corticosteroid use

Inhaled Route:

• Oropharyngeal candidiasis (oral thrush)

• Hoarseness/dysphonia

• Throat irritation

• Cough during inhalation

Nasal Route:

• Epistaxis

• Nasal dryness and irritation

• Pharyngitis

Oral Route:

• Nausea, dyspepsia

• Headache

• Acne

• Mood changes

• Mild fluid retention

Rectal Route:

• Local discomfort

• Rectal urgency

• Flatulence

• Adrenal suppression — with chronic high-dose use (especially oral); may manifest as fatigue, hypotension, hypoglycaemia during stress; requires gradual tapering

• Growth suppression in children — monitor height velocity annually with long-term ICS use

• Osteoporosis and fractures — with prolonged systemic exposure

• Posterior subcapsular cataracts — with chronic use

• Glaucoma — increased intraocular pressure with prolonged use

• Immunosuppression — increased susceptibility to infections; reactivation of latent TB

• Anaphylaxis — rare hypersensitivity reaction; discontinue immediately

• Paradoxical bronchospasm — rare; discontinue inhaled form and treat with SABA

Phase Parameters

Baseline Spirometry (asthma/COPD); symptom scores; nasal mucosal examination (nasal spray); stool inflammation markers and colonoscopy (IBD); screen for TB if risk factors

After initiation Symptom control assessment at 2–4 weeks; spirometry at 4–8 weeks for asthma; adverse effects evaluation

Long-term (>3 months) Annual height velocity in children; annual ophthalmology review for cataracts/glaucoma; bone mineral density if prolonged high-dose use; adrenal function assessment if on oral form >8 weeks; HbA1c in diabetics

Inhalers (DPI/MDI):

• Budecort® (Cipla)

• Pulmicort® (AstraZeneca)

• Budetrol® (Lupin)

• Vent FB® (Mankind) — FDC with formoterol

Nebulizer Suspension:

• Budecort Respules® (Cipla)

• Pulmicort Respules® (AstraZeneca)

• Budesal® (Glenmark)

Oral Capsules:

• Budenofalk® (Dr. Falk/Abbott)

• Entocort® (AstraZeneca — limited availability)

Nasal Spray:

• Rhinocort® (Johnson & Johnson)

• Budenase® (Cipla)

• Budelin® (Sun Pharma)

Rectal Enema:

• Budenema® (Sun Pharma)

• Entocort Enema® (limited availability)

Common Fixed-Dose Combinations:

Note: Not under NPPA price control as monotherapy; some FDCs may have controlled pricing.

• Spacer device essential: Always prescribe spacer with MDI to improve drug delivery and reduce oropharyngeal deposition — significantly reduces oral candidiasis risk

• Mouth rinsing: Counsel patients to rinse mouth and spit after each inhalation — simple measure that prevents most cases of oral thrush

• Pregnancy safety: Budesonide has the best safety profile among ICS during pregnancy — do not discontinue inhaled therapy in pregnant asthmatics

• Oral budesonide advantage: First-pass hepatic metabolism (~90%) limits systemic effects compared to prednisolone — preferred for mild-moderate Crohn's disease

• Tapering required: Do not abruptly discontinue oral budesonide after >2 weeks of use — gradual taper prevents adrenal crisis

• ICS/LABA in COPD: Never use budesonide monotherapy for COPD — always in combination with LABA; ICS indicated only for exacerbation-prone patients

budesonide; inhaled corticosteroid; ICS; asthma; COPD; Crohn's disease; allergic rhinitis; ulcerative colitis; pregnancy-safe; paediatric asthma; CYP3A4 substrate; Schedule H; India

RxIndia v1.0 — 27 Apr 2025

• CDSCO approved product information

• Indian Pharmacopoeia/NFI 2021

• API Textbook of Medicine — Bronchial Asthma, Inflammatory Bowel Disease

• ICMR IBD Consensus Statement

• Indian Academy of Pediatrics Asthma Guidelines

• AIIMS Drug Formulary

• Indian Society of Allergy, Asthma & Immunology Guidelines

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• RCT/meta-analysis — off-label microscopic colitis and eosinophilic oesophagitis indications