DEFONEX NASAL SPRAY

Indications

Approved Uses

Seasonal allergic rhinitis and perennial allergic rhinitis; prophylaxis of seasonal allergic rhinitis; nasal polyps in adults.

Off-Label Uses

Adjunctive therapy in acute/chronic rhinosinusitis (including post-viral/acute bacterial rhinosinusitis) and symptomatic adenoid hypertrophy; sometimes used for non-allergic rhinitis/eustachian tube dysfunction symptom relief.

Dosage & Administration

Dosing by Condition

Allergic Rhinitis (Adults & Children ≥12 years): Initial: 2 sprays (100 mcg) in each nostril once daily. Maintenance: 1 spray (50 mcg) in each nostril once daily. Max: 4 sprays (200 mcg) in each nostril once daily.
Allergic Rhinitis (Children 3-11 years): 1 spray (50 mcg) in each nostril once daily (total 100 mcg).

Initial Dose

For Allergic Rhinitis (Adults & Children ≥12 years): Two sprays (50 mcg/spray) in each nostril once daily (total dose 200 mcg).

Maintenance Dose

For Allergic Rhinitis (Adults & Children ≥12 years): One spray in each nostril once daily (total dose 100 mcg) once symptoms are controlled.

Maximum Dose

For Allergic Rhinitis (Adults & Children ≥12 years): Four sprays in each nostril once daily (total dose 400 mcg). For Nasal Polyps (Adults ≥18 years): Two sprays in each nostril twice daily (total dose 400 mcg).

Children's Dosage

For Allergic Rhinitis (3-11 years): One spray (50 mcg) in each nostril once daily (total dose 100 mcg). Not approved for nasal polyps in children under 18 years.

Dose Adjustment Notes

No specific dose adjustment is generally required for renal or hepatic impairment; use the lowest effective dose for maintenance and follow age-appropriate dosing (children typically require lower doses).

How to Take

Blow the nose gently before use. Shake well. Prime the pump before first use (typically 10 sprays) and re-prime if not used for ≥1 week (typically 2 sprays) until a fine mist appears. Keep the bottle upright with head slightly forward; insert the nozzle into one nostril, aim away from the nasal septum, and spray while breathing in gently through the nose; breathe out through the mouth. Repeat for the other nostril as prescribed. Avoid spraying into the eyes; wipe the nozzle and replace the cap after use.

How to Prepare

Prime before first use until a fine mist appears (commonly ~10 actuations); if not used for about 1 week, re-prime with ~2 sprays; shake gently and avoid spraying into eyes.

Side Effects

Common Side Effects

Epistaxis, headache, pharyngitis/sore throat, nasal irritation/burning, sneezing; upper respiratory tract infection/viral infection and cough can also occur.

Side Effect Frequency

Very common: headache. Common: epistaxis, pharyngitis/upper respiratory symptoms, nasal irritation/burning/sneezing. Less common/rare but clinically important: nasal ulceration and (rare) septal perforation; hypersensitivity reactions; increased intraocular pressure/cataract/glaucoma.

Safety & Warnings

Contraindications

Hypersensitivity to mometasone furoate or any excipient.

Warnings & Precautions

Avoid/use with caution after recent nasal surgery/trauma or with septal ulcers until healed; monitor for local nasal effects (epistaxis, irritation, Candida), consider infection risks (e.g., TB, untreated fungal/bacterial/viral infections), caution with ocular herpes simplex and monitor for glaucoma/cataracts; monitor growth in children on long-term therapy; systemic steroid effects/adrenal suppression possible with excessive dosing and when switching from systemic steroids.

Age Restriction

Allergic rhinitis: approved for children ≥2 years (not recommended <2 years). Nasal polyps: adults ≥18 years.

Drug Interactions

Drug Interactions

Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir/cobicistat) may increase systemic mometasone exposure; additive systemic corticosteroid effects are possible with other steroids at high doses.

Interaction Severity

MODERATE: Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir/cobicistat) may increase systemic corticosteroid exposure and risk of adrenal suppression/Cushingoid effects; avoid or monitor. Additive corticosteroid effects may occur with concurrent high-dose/prolonged use of other corticosteroids.

Food Interaction

No clinically relevant food interaction (not applicable for intranasal administration).

Special Populations

Children

For Allergic Rhinitis (3-11 years): One spray (50 mcg) in each nostril once daily (total dose 100 mcg). Not approved for nasal polyps in children under 18 years.

Elderly

Standard adult dosing.

Kidney Impairment

No adjustment needed

Liver Impairment

No routine dose adjustment; use with caution in severe hepatic impairment.

Storage & Patient Advice

Preparation Instructions

Prime before first use until a fine mist appears (commonly ~10 actuations); if not used for about 1 week, re-prime with ~2 sprays; shake gently and avoid spraying into eyes.

Overdose

Acute intranasal overdose is unlikely to cause toxicity; chronic excessive use may cause systemic corticosteroid effects (e.g., hypercorticism/adrenal suppression)-manage with observation/supportive care and return to prescribed dosing, with adrenal assessment if clinically indicated.

Patient Counseling

Use regularly as prescribed (daily, same time) and not just PRN; benefit may start within 1-2 days but maximal effect often takes 1-2 weeks. Blow nose before use; shake gently; prime before first use and re-prime if unused; aim away from the nasal septum; avoid eyes; clean nozzle periodically; do not exceed dose or share. Seek medical advice for persistent epistaxis/nasal ulceration, severe irritation, signs of infection, or vision changes; children should be supervised.

Monitoring Requirements

Periodically examine nasal mucosa for irritation, ulceration, epistaxis, Candida infection, or septal perforation (especially with long-term use). Monitor growth in children on prolonged therapy. Consider periodic eye assessment (cataract/glaucoma) in long-term use or at-risk patients.

Pharmacology

Duration of Effect

Approximately 24 hours (supports once-daily dosing).

Half-Life

Approximately 5.8 hours (reported after intravenous administration; not clinically meaningful for nasal use due to minimal systemic absorption).

Bioavailability

<1% systemic bioavailability after intranasal administration (negligible systemic absorption).

Metabolism

Extensive hepatic first-pass metabolism, primarily via CYP3A4, to inactive metabolites.

Excretion

Primarily excreted as metabolites via bile/feces, with a minor urinary component.

Protein Binding

Approximately 98-99% protein bound.

Product Information

Available Dosage Forms

Nasal spray (aqueous suspension) only for DEFONEX 0.05% NASAL SPRAY.

Composition per Dose

Each actuation (spray): 50 mcg mometasone furoate (0.05% w/w) in aqueous suspension

Symptom Target

Allergy, Congestion, Runny Nose

Sedating

No

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