FLUSORT 0.05% NASAL SPRAY

Indications

Approved Uses

Management of nasal symptoms of seasonal allergic rhinitis and perennial allergic rhinitis; may also be used for non-allergic rhinitis depending on local labeling.

Dosage & Administration

Maximum Dose

Adults/adolescents: up to 2 sprays per nostril once daily (total 200 mcg/day); children 4-11 years: 1 spray per nostril once daily (total 100 mcg/day).

Side Effects

Common Side Effects

Epistaxis (nosebleed), nasal irritation/burning or dryness, headache, unpleasant taste/smell, sore throat/pharyngitis.

Side Effect Frequency

Very common/common: epistaxis, nasal irritation/burning/dryness, headache, unpleasant taste/smell, sore throat/pharyngitis. Uncommon/rare: nasal ulceration or septal perforation, hypersensitivity reactions, and with prolonged/high-dose use possible increased intraocular pressure/glaucoma and cataracts.

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to fluticasone propionate or any excipients.

Warnings & Precautions

Precautions: avoid use/monitor with nasal ulcers, recent nasal surgery/trauma until healed; monitor nasal mucosa for epistaxis/ulceration/perforation; caution with infections (incl. TB) and ocular herpes; avoid eye contact; monitor for glaucoma/cataracts and for systemic steroid effects (esp. with other steroids or strong CYP3A4 inhibitors); monitor growth in children on long-term therapy.

Age Restriction

Approved for adults and children aged ≥4 years; not recommended/indicated under 4 years.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Avoid/closely monitor with strong CYP3A4 inhibitors (especially ritonavir/cobicistat; also ketoconazole/itraconazole/clarithromycin) due to increased systemic exposure and risk of adrenal suppression/Cushing’s; additive risk with other corticosteroids.

Food Interaction

No clinically meaningful food restrictions; grapefruit is not a relevant interaction for intranasal fluticasone at usual doses.

Special Populations

Pregnancy

Category C

Storage & Patient Advice

Stopping the Medicine

Generally can be stopped without tapering when used at recommended intranasal doses; if used for a prolonged period at higher-than-recommended doses or if systemic corticosteroid exposure is suspected, consider gradual dose reduction and monitor for adrenal suppression. Symptoms may recur after discontinuation.

Overdose

Acute intranasal overdose is unlikely to cause significant systemic toxicity; chronic excessive use may cause systemic corticosteroid effects (e.g., adrenal suppression/Cushingoid features)-manage by reducing/stopping and monitoring if symptomatic.

Patient Counseling

Use regularly (preferably daily) as benefit is not immediate and may take several days to 1-2 weeks for maximal effect. Prime before first use and re-prime if not used for a prolonged period per product leaflet; shake gently, blow nose, aim the nozzle slightly outward away from the nasal septum, and avoid spraying into eyes. Use the lowest effective dose and do not exceed labeled daily sprays; wipe/clean the nozzle after use. Seek medical advice for persistent/severe epistaxis, nasal ulceration/pain, signs of infection, or any vision changes; use in children with adult supervision. Tell a clinician about strong CYP3A4 inhibitors (e.g., ritonavir/cobicistat, ketoconazole/itraconazole) due to increased systemic corticosteroid exposure.

Monitoring Requirements

Monitor for local nasal adverse effects with prolonged use (epistaxis, mucosal ulceration, Candida, and rare septal perforation) and for growth suppression in children on long-term therapy; consider periodic eye assessment (cataract/glaucoma) in long-term/high-dose use or in at-risk patients.

Pharmacology

Mechanism of Action

Fluticasone propionate is a synthetic glucocorticoid that binds glucocorticoid receptors in the nasal mucosa to downregulate inflammatory gene transcription and inhibit mediator/cell recruitment (e.g., histamine, leukotrienes, cytokines; eosinophils/mast cells), reducing edema and nasal secretions.

Onset of Action

Some symptom improvement may occur within ~12 hours, but maximal benefit typically requires several days and may take 1-2 weeks of regular daily use.

Bioavailability

Less than 2% systemic bioavailability after intranasal administration.

Metabolism

Extensive hepatic first-pass metabolism predominantly via CYP3A4 to inactive metabolites (major: 17β-carboxylic acid derivative).

Product Information

Available Dosage Forms

Nasal spray.

Composition per Dose

Each actuation (spray): 50 mcg fluticasone propionate (0.05%)

Generic Availability

Yes

OTC Alternatives

Saline nasal spray/irrigation; oral second-generation antihistamines (e.g., cetirizine, loratadine); intranasal antihistamine where available OTC; other OTC intranasal corticosteroids such as budesonide or triamcinolone (availability depends on country).

Symptom Target

Allergy, Congestion, Runny Nose

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 26-05-2026