Schedule H (for inhaled/intranasal formulations)

Inhalation (DPI, MDI), Intranasal, Topical (dermatological)

• Fluticasone propionate DPI: 50 mcg, 100 mcg, 250 mcg, 500 mcg per actuation

• Fluticasone propionate MDI: 50 mcg, 125 mcg, 250 mcg per actuation

• Fluticasone furoate DPI: 100 mcg, 200 mcg per actuation

Intranasal Spray:

• Fluticasone propionate: 50 mcg/spray (120 sprays/bottle)

• Fluticasone furoate: 27.5 mcg/spray (120 sprays/bottle)

Topical:

• Fluticasone propionate cream: 0.05% (10g, 15g, 30g)

• Fluticasone propionate ointment: 0.005% (15g, 30g)

• Fluticasone propionate lotion: 0.05%

Fixed-Dose Combinations (FDC) with LABA:

• Fluticasone propionate + Salmeterol (various strengths)

• Fluticasone furoate + Vilanterol (100/25 mcg, 200/25 mcg)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Bronchial Asthma (Inhaled Corticosteroid – Maintenance Therapy)

Fluticasone Propionate (DPI/MDI):

Parameter Mild-Moderate Asthma Moderate-Severe Asthma

Starting dose 100–250 mcg twice daily 250–500 mcg twice daily

Titration Adjust based on symptom control and spirometry every 2–4 weeks Step down once controlled for 3 months

Usual maintenance dose 100–250 mcg twice daily 250–500 mcg twice daily

Maximum dose 1000 mcg/day (500 mcg twice daily) 2000 mcg/day in severe cases (specialist only)

Fluticasone Furoate (DPI) – Once-daily formulation:

Parameter Dosing

Starting dose 100 mcg once daily

Titration Increase to 200 mcg once daily if inadequate control after 2 weeks

Usual maintenance dose 100–200 mcg once daily

Maximum dose 200 mcg once daily

Key Clinical Notes:

• Assess and correct inhaler technique at every visit

• Rinse mouth with water after inhalation to prevent oral candidiasis

• Consider ICS+LABA combination if not controlled on ICS monotherapy

• Step down to lowest effective dose after 3 months of stable control

1. Allergic Rhinitis (Intranasal)

Fluticasone Propionate Nasal Spray:

Parameter Dosing

Starting dose 100 mcg/nostril once daily (2 sprays each nostril) OR 50 mcg/nostril twice daily

Titration Reduce to 50 mcg/nostril once daily once symptoms controlled

Usual maintenance dose 50–100 mcg/nostril once daily

Maximum dose 200 mcg/day (100 mcg per nostril)

Fluticasone Furoate Nasal Spray:

Parameter Dosing

Starting dose 55 mcg/nostril once daily (2 sprays each nostril)

Titration Reduce to 27.5 mcg/nostril once symptoms controlled

Usual maintenance dose 27.5–55 mcg/nostril once daily

Maximum dose 110 mcg/day

Key Clinical Notes:

• Onset of action: 12–24 hours; maximum effect within 3–7 days

• Regular daily use more effective than as-needed dosing

• Prime spray before first use and if unused for >7 days

1. Chronic Rhinosinusitis with Nasal Polyps

Parameter Dosing

Starting dose Fluticasone furoate 110 mcg/day (2 sprays each nostril once daily)

Titration Not applicable

Usual maintenance dose 110 mcg/day

Maximum dose 110 mcg/day

Key Clinical Notes:

• Long-term therapy usually required

• Reassess efficacy every 3–6 months

• Combine with saline irrigation for optimal benefit

1. Steroid-Responsive Dermatoses (Topical)

Indications: Atopic dermatitis, eczema, contact dermatitis, psoriasis (non-facial), discoid lupus erythematosus

Parameter Fluticasone Propionate 0.05% Cream/Ointment

Starting dose Apply thin layer to affected area once or twice daily

Titration Reduce frequency as condition improves

Usual maintenance dose Once daily application

Maximum duration 2–4 weeks continuously; reassess if no improvement

Key Clinical Notes:

• Classified as medium-high potency topical corticosteroid

• Avoid use on face, axillae, groin for >7 days

• Do not use under occlusive dressings unless directed

• Use lowest potency and shortest duration effective

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Bronchial Asthma (ICS Maintenance Therapy)

Fluticasone Propionate:

Age Formulation Starting Dose Usual Maintenance Maximum Dose

4–11 years DPI or MDI with spacer 50–100 mcg twice daily 50–100 mcg twice daily 200 mcg/day

≥12 years DPI or MDI 100–250 mcg twice daily 100–250 mcg twice daily 500–1000 mcg/day

Fluticasone Furoate:

Age Formulation Dose Maximum

≥12 years DPI 100 mcg once daily 200 mcg once daily

Key Clinical Notes:

• Minimum age: 4 years (under paediatric pulmonologist/allergist supervision)

• Spacer device mandatory for MDI use in children

• Monitor linear growth velocity annually during long-term therapy

• Use lowest effective dose; step down after 3 months of control

1. Allergic Rhinitis (Intranasal)

Fluticasone Propionate Nasal Spray:

Age Dose Maximum

4–11 years 50 mcg/nostril once daily (1 spray each nostril) 100 mcg/day

≥12 years Adult dosing 200 mcg/day

Fluticasone Furoate Nasal Spray:

Age Dose Maximum

2–11 years 27.5 mcg/nostril once daily (1 spray each nostril) 55 mcg/day

≥12 years 55 mcg/nostril once daily 110 mcg/day

Secondary Indications — Paediatric (Off-label)

• Eosinophilic esophagitis: NOT recommended in routine paediatric practice; specialist gastroenterology input required

• Use below 4 years (asthma): Only under paediatric pulmonologist supervision with nebulised alternatives preferred

• Use below 2 years (intranasal): NOT recommended except under specialist guidance

Clear Statement: Not recommended below age 4 years for inhaled use and below age 2 years for intranasal use except under specialist supervision.

No dose adjustment required for any route of administration (minimal systemic absorption with inhaled, intranasal, and topical formulations).

• Known hypersensitivity to fluticasone or any formulation excipient (including lactose in DPI)

• Primary treatment of status asthmaticus or acute bronchospasm (ICS not for rescue)

• Untreated active pulmonary tuberculosis

• Untreated systemic fungal, bacterial, or viral infections

• Recent nasal surgery or nasal trauma (for intranasal spray) — defer until healed

• Presence of nasal septal ulceration (for intranasal spray)

• Primary bacterial, viral, or fungal skin infections (for topical use)

• Rosacea, acne vulgaris, perioral dermatitis (for topical use on face)

• Risk of adrenal suppression with high-dose or prolonged ICS therapy, particularly when combined with other corticosteroids

• Growth retardation in children on prolonged ICS — monitor height annually

• Increased risk of glaucoma and posterior subcapsular cataracts with long-term inhaled or intranasal use

• Paradoxical bronchospasm (rare) — discontinue and treat with SABA

• Immunocompromised patients: increased susceptibility to infections

• Patients with active or quiescent tuberculosis — use with caution under appropriate anti-TB cover

• Skin atrophy, striae, telangiectasia with prolonged topical use

• Systemic absorption increased with occlusive dressings, application to large body surface area, or broken skin

• Diabetes mellitus — may worsen glycaemic control at high doses

• Osteoporosis risk with long-term high-dose ICS

Parameter Details

Risk Category Generally considered safe for inhaled/intranasal forms; low systemic absorption

Preferred alternatives Budesonide (inhaled) is preferred ICS in pregnancy for asthma (most safety data); fluticasone acceptable if already well-controlled

When may be used When asthma/rhinitis control required; uncontrolled asthma poses greater risk to fetus than ICS exposure

Topical use Use lowest potency; avoid large areas or prolonged duration

Monitoring Fetal growth (if high-dose ICS or systemic absorption concern); maternal symptom control

Parameter Details

Compatibility Compatible with breastfeeding for inhaled/intranasal/topical forms

Preferred alternatives None required; fluticasone acceptable

Drug levels in milk Low (minimal systemic absorption from inhaled/topical routes)

Infant monitoring Monitor for oral thrush if topical used on breast/nipple area; otherwise no specific monitoring required

Parameter Recommendation

Starting dose Start at lowest effective dose

Titration Slow titration; reassess need periodically

Special risks Increased risk of skin thinning, bruising, purpura with topical use; higher susceptibility to glaucoma/cataracts with inhaled/nasal use; assess inhaler technique and manual dexterity; bone density concerns with prolonged high-dose ICS

Monitoring Annual ophthalmology review if prolonged use; bone health assessment if high-dose therapy

Interacting Drug Mechanism & Effect Management

Ritonavir, Cobicistat (strong CYP3A4 inhibitors) Markedly increased systemic fluticasone levels → adrenal suppression, Cushing syndrome Avoid combination; if unavoidable, use lowest fluticasone dose and monitor closely for systemic effects

Ketoconazole, Itraconazole (strong CYP3A4 inhibitors) Similar mechanism; significant increase in systemic exposure Avoid prolonged concurrent use; consider alternative antifungal or alternative ICS

Other potent CYP3A4 inhibitors (clarithromycin, telithromycin, nefazodone) Increased fluticasone systemic levels Use with caution; monitor for Cushingoid features

Interacting Drug Effect Management

Moderate CYP3A4 inhibitors (erythromycin, diltiazem, verapamil) May modestly increase systemic fluticasone levels Monitor for systemic corticosteroid effects with prolonged use

Other inhaled/systemic corticosteroids Additive HPA axis suppression Avoid overlapping high-dose therapy; use lowest effective doses

Beta-agonists (oral) Additive hypokalaemia risk Monitor potassium if high-dose combination used

Rifampicin (CYP3A4 inducer) May reduce fluticasone efficacy Monitor symptom control; may need dose adjustment

Inhaled:

• Oropharyngeal candidiasis (oral thrush)

• Dysphonia/hoarseness

• Throat irritation, dry mouth

• Cough after inhalation

• Headache

Intranasal:

• Epistaxis (most common)

• Nasal irritation, dryness, burning

• Headache

• Unpleasant taste/smell

Topical:

• Local burning, stinging, pruritus

• Skin dryness

• Folliculitis

Adverse Effect Clinical Notes

Adrenal suppression (ICS) Risk with high doses (>1000 mcg/day fluticasone propionate) or CYP3A4 inhibitor co-administration; may present as adrenal crisis during stress

Growth suppression (Paediatric ICS) Monitor height annually; use lowest effective dose

Glaucoma/Cataracts (ICS/Intranasal) Risk with prolonged high-dose use; annual ophthalmology screening recommended

Osteoporosis (long-term high-dose ICS) Consider bone density monitoring

Nasal septal perforation (Intranasal) Rare; avoid directing spray at septum

Paradoxical bronchospasm (ICS) Requires immediate discontinuation and SABA treatment

Anaphylaxis Rare; discontinue permanently

Skin atrophy, striae, telangiectasia (Topical) Risk with prolonged use, especially on thin skin

Secondary skin infections (Topical) Tinea incognito; masked bacterial infection

HPA axis suppression (Topical) Risk with large surface area application or occlusion

After initiation (2–4 weeks) Symptom control; oral cavity inspection for candidiasis (ICS); nasal mucosa inspection (intranasal)

Long-term (ICS) Annual height measurement in children; ophthalmology review if prolonged use; bone density if high-dose >6 months; adrenal function if symptoms of suppression

Long-term (Topical) Skin integrity; signs of atrophy, striae, infection

Fluticasone Propionate Inhalers:

• Flohale® (Cipla)

• Flutihale® (Cipla)

• Flixotide® (GSK)

Fluticasone Furoate Inhalers:

• Flutiflo® (Cipla)

Fluticasone + Salmeterol (FDC):

• Seroflo® (Cipla)

• Combitide® (Sun Pharma)

• Seretide® (GSK)

• Salbair-F® (Lupin)

Fluticasone + Vilanterol (FDC):

• Relvar® Ellipta (GSK)

• Airzenta® (Cipla)

Fluticasone Nasal Sprays:

• Flixonase® (GSK)

• Flonase® (GSK)

• Fluticone® (Cipla)

• Fluticasone FT® (furoate formulation)

Fluticasone Topical:

• Flutivate® Cream/Ointment (GSK)

• Flucos® (Glenmark)

• Futop® (Ranbaxy/Sun)

Note: Inhaled corticosteroids (including fluticasone) are listed under NLEM 2022 as essential medicines for asthma; prices regulated under NPPA for scheduled formulations.

1. Always teach and verify inhaler technique — incorrect technique is the commonest cause of treatment failure with ICS

1. Mouth rinsing after ICS is mandatory — reduces oral candidiasis and dysphonia; instruct patient to rinse and spit (not swallow)

1. Fluticasone propionate vs furoate: Furoate has longer duration allowing once-daily dosing and higher receptor binding affinity; propionate is more established with broader paediatric data

1. For allergic rhinitis, consistent daily use is more effective than intermittent/as-needed dosing — educate patients that full benefit may take 1 week

1. Step-down therapy in asthma: Once controlled for 3 months, attempt 25–50% dose reduction; aim for lowest effective maintenance dose

1. Avoid CYP3A4 inhibitors with high-dose fluticasone — ritonavir/cobicistat combination particularly dangerous; can cause iatrogenic Cushing syndrome

1. Topical use on face: Limit to 5–7 days maximum; prefer lower potency alternatives (hydrocortisone) for facial dermatoses

asthma; ICS; inhaled-corticosteroid; allergic-rhinitis; nasal-polyps; topical-steroid; NLEM-India; CYP3A4-interaction; paediatric-4years; budesonide-alternative; Fluticasone

RxIndia v1.0 — 06 Jun 2025

• CDSCO Approved Drug Formulations List

• Indian Pharmacopoeia 2022

• National List of Essential Medicines (NLEM) 2022

• API Textbook of Medicine (11th Edition)

• ICMR Guidelines for Management of Bronchial Asthma (2023)

• AIIMS Treatment Protocols — Pulmonary Medicine

• IAP Guidelines for Paediatric Asthma Management

• IAP Textbook of Paediatrics

• Indian Association of Dermatologists (IADVL) Guidelines on Topical Corticosteroids

• GINA 2023 (supportive reference for stepwise therapy concepts)