Schedule H

Inhalation (MDI), Intranasal

• Metered-dose inhaler (MDI): 80 mcg, 160 mcg per actuation

• Nasal spray: 50 mcg per spray (120 metered doses per bottle)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

▶ 1. Bronchial Asthma — Maintenance Therapy (Inhalation Route)

Used as controller inhaled corticosteroid (ICS) in persistent asthma.

Asthma Severity Starting Dose Titration Usual Maintenance Dose Maximum Dose

Mild persistent 80 mcg once daily Assess response every 2–4 weeks; step up if uncontrolled 80–160 mcg once daily 160 mcg/day

Moderate persistent 160 mcg once daily May increase to 160 mcg twice daily if inadequate control 160–320 mcg/day 320 mcg/day

Severe persistent 160 mcg twice daily Consider add-on LABA if uncontrolled on max ICS 320 mcg/day 640 mcg/day (specialist supervision only)

Key Clinical Notes:

• Not for acute bronchospasm or rescue therapy

• Regular daily use required for therapeutic benefit

• Use with spacer device to improve lung deposition and reduce oropharyngeal side effects

• Rinse mouth after each use to prevent oral candidiasis

▶ 2. Allergic Rhinitis — Seasonal and Perennial (Intranasal Route)

Parameter Adults & Adolescents ≥12 years

Starting dose 2 sprays per nostril once daily (200 mcg/day total)

Titration Reduce to maintenance once symptom control achieved (usually 1–2 weeks)

Usual maintenance dose 1 spray per nostril once daily (100 mcg/day)

Maximum dose 200 mcg/day (2 sprays per nostril once daily)

Key Clinical Notes:

• Onset of action: 24–48 hours; maximum benefit within 1–2 weeks

• Typical treatment duration: 2–8 weeks, adjust per seasonal requirements

• Prime nasal spray before first use or if not used for >4 days

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Nasal Polyposis — OFF-LABEL 2 sprays per nostril once daily (200 mcg/day) 3–6 months Specialist only; Evidence: International RCTs; used in Indian ENT specialist practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

▶ 1. Bronchial Asthma — Maintenance Therapy (Inhalation)

Approved for children ≥4 years

4–11 years 80 mcg once daily Assess every 4 weeks; increase only if necessary 80–160 mcg/day 160 mcg/day

≥12 years 160 mcg once daily As per adult dosing 160–320 mcg/day 640 mcg/day (specialist supervision)

Safety Monitoring:

• Mandatory use of spacer device in all children <12 years

• Monitor linear growth every 6 months if used >3 months

• Annual height velocity assessment recommended

⚠️ Not recommended for children <4 years

▶ 2. Allergic Rhinitis (Intranasal)

Approved for children ≥6 years

Parameter Children 6–11 years Adolescents ≥12 years

Starting dose 1 spray per nostril once daily (100 mcg/day) 2 sprays per nostril once daily (200 mcg/day)

Titration Maintain lowest effective dose Reduce to 1 spray per nostril after symptom control

Usual maintenance dose 1 spray per nostril once daily 1–2 sprays per nostril once daily

Maximum dose 200 mcg/day 200 mcg/day

⚠️ Not recommended for children <6 years except under paediatric ENT supervision

Secondary Indications — Paediatrics (Off-label)

Indication Age Dose Duration Notes

Nasal Polyposis — OFF-LABEL ≥12 years 2 sprays per nostril once daily Up to 3 months Specialist only; Evidence: Limited; adapted from adult data

Ciclesonide undergoes hepatic metabolism; negligible renal excretion of active metabolite.

• Known hypersensitivity to ciclesonide or any formulation component

• Primary treatment of acute bronchospasm or status asthmaticus (not a rescue medication)

• Untreated localized fungal, bacterial, or viral infections of the respiratory tract

• Nasal route: Active untreated nasal infections, recent nasal surgery, or nasal trauma (risk of impaired healing)

• Risk of oropharyngeal candidiasis — advise rinsing mouth after inhalation

• Hypothalamic-pituitary-adrenal (HPA) axis suppression with prolonged high-dose use

• Growth retardation in children on long-term ICS therapy

• History of pulmonary tuberculosis or other chronic respiratory infections

• Nasal mucosal ulceration or recurrent epistaxis

• Patients transferring from systemic corticosteroids — risk of adrenal insufficiency

• Glaucoma or cataracts — monitor with prolonged use

• Immunocompromised patients — increased infection risk

Aspect Details

Safety Low systemic bioavailability; generally considered low risk with inhaled route

Preferred alternative Budesonide (more extensive pregnancy safety data available)

When to use May be used if benefit outweighs risk; continue if well-controlled on ciclesonide prior to conception

Monitoring Fetal growth surveillance with high-dose or prolonged use; maternal symptom control

Aspect Details

Compatibility Compatible with breastfeeding

Preferred alternative Budesonide (more lactation data available)

Drug levels in milk Negligible due to low systemic absorption

Infant monitoring Growth, feeding pattern, signs of infection with prolonged maternal use

Aspect Recommendation

Starting dose Same as younger adults; use lower end of dose range initially

Titration Gradual; assess response before dose escalation

Extra risks Increased susceptibility to oropharyngeal candidiasis; bone loss with chronic high-dose use; posterior subcapsular cataracts and glaucoma with prolonged use

Monitoring Bone mineral density if prolonged high-dose therapy; periodic eye examination

Interacting Drug Mechanism / Effect Management

Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, cobicistat) Inhibit metabolism of des-ciclesonide (active metabolite); increased systemic corticosteroid exposure Avoid combination or use lowest effective ciclesonide dose; monitor for Cushingoid features

Systemic corticosteroids Additive HPA axis suppression Avoid unnecessary combination; taper systemic steroids carefully when switching to inhaled route

Interacting Drug Mechanism / Effect Management

CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, phenobarbital) Increased metabolism; reduced ciclesonide efficacy May require higher ICS dose; monitor asthma control

Other inhaled corticosteroids Duplication of therapy; increased systemic steroid burden Avoid concurrent use

Prolonged topical nasal decongestants (oxymetazoline) Additive nasal mucosal effects; rebound congestion Limit decongestant use to <5 days

Inhalation route:

• Oropharyngeal candidiasis

• Dysphonia / hoarseness

• Cough

• Throat irritation

• Headache

Intranasal route:

• Epistaxis

• Nasal dryness and irritation

• Headache

• Nasopharyngitis

Adverse Effect Clinical Action

HPA axis suppression (adrenal insufficiency) Usually with high-dose prolonged use; taper gradually if stopping; stress-dose steroids may be needed during illness/surgery

Growth suppression in children Monitor height velocity; use minimum effective dose

Paradoxical bronchospasm Discontinue immediately; treat with SABA; do not rechallenge

Glaucoma / raised intraocular pressure Periodic eye examination with prolonged use

Posterior subcapsular cataract Periodic eye examination with prolonged use

Nasal septal perforation Rare; discontinue if suspected; ENT referral

Hypersensitivity reactions (urticaria, angioedema) Discontinue; avoid re-exposure

After initiation (2–4 weeks) Symptom control; oral cavity examination for candidiasis; voice changes

Periodic (every 3–6 months) Asthma Control Test (ACT) score or spirometry; inhaler technique review

Long-term Annual growth monitoring (children); eye examination if prolonged use (>12 months); bone mineral density if high-dose chronic use in at-risk patients

Brand Name Formulation Manufacturer

Alvesco MDI 80 mcg, 160 mcg Altus/Covis

Omnaris Nasal spray 50 mcg/spray Covis

Cicleflow MDI 80 mcg, 160 mcg —

NLEM Status Not included in NLEM; not under price control

Government Supply Limited availability in public sector

• Prodrug advantage: Ciclesonide is activated to des-ciclesonide only in the lungs, resulting in lower oropharyngeal deposition and reduced local side effects (candidiasis, dysphonia) compared to budesonide or beclomethasone

• Once-daily dosing improves adherence, particularly beneficial in school-going children and working adults

• Spacer use is essential in all patients using MDI to maximise lung deposition and minimise oropharyngeal adverse effects

• Step-down therapy: Once asthma control is achieved for 3 months, attempt dose reduction to the minimum effective maintenance dose

• Not interchangeable with rescue inhalers: Always ensure patient has separate SABA (salbutamol) for acute symptoms

• Preferred in ICS-intolerant patients: Consider ciclesonide for patients experiencing significant dysphonia or candidiasis on other ICS

Ciclesonide; ICS; inhaled corticosteroid; asthma; allergic rhinitis; nasal spray; respiratory; pulmonology; paediatric-safe; low systemic absorption; prodrug; once-daily

RxIndia v1.0 — 23 May 2025

• CDSCO approved product information

• Indian Pharmacopoeia

• API Textbook of Medicine, 11th Edition

• AIIMS Drug Formulary

• IAP Respiratory Chapter Guidelines

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Indian ENT clinical protocols

• International RCTs (for off-label nasal polyposis indication only)