TABUNEX 0.05% AQUA NASAL SP 120/SPRAYS

Indications

Approved Uses

Treatment of seasonal and perennial allergic rhinitis in adults and children, prophylaxis of seasonal allergic rhinitis, treatment of nasal polyps in adults

Off-Label Uses

Adjunctive therapy in acute rhinosinusitis (often with antibiotics when bacterial infection is suspected) and symptomatic treatment of non-allergic rhinitis are commonly used off-label; other ENT inflammatory conditions may be treated based on clinician judgment.

Dosage & Administration

Dosing by Condition

Allergic rhinitis: Adults/adolescents ≥12 years: 2 sprays in each nostril once daily (total 200 mcg/day); once controlled, may reduce to 1 spray each nostril once daily (100 mcg/day). Children: 1 spray in each nostril once daily (100 mcg/day) (age cutoffs depend on local labeling; commonly ≥2 years). Nasal polyps (adults ≥18 years): 2 sprays in each nostril once daily (200 mcg/day); may increase to 2 sprays in each nostril twice daily (400 mcg/day) if inadequate response, then reduce to lowest effective dose. Seasonal allergic rhinitis prophylaxis (where labeled): start 2-4 weeks before season at 2 sprays each nostril once daily (200 mcg/day).

Initial Dose

2 sprays (50 mcg each) per nostril once daily (total 200 mcg/day) for adults and adolescents ≥12 years

Maintenance Dose

For allergic rhinitis in adults, 1-2 sprays in each nostril once daily (total dose 100-200 mcg).

Maximum Dose

For nasal polyps, 2 sprays in each nostril twice daily (total dose 400 mcg).

Children's Dosage

Children 3-11 years: 1 spray (50 mcg) per nostril once daily (100 mcg/day). Not recommended in children under 3 years

Dose Adjustment Notes

No routine dose adjustment is required in renal impairment; in hepatic impairment, systemic exposure is generally low but use the lowest effective dose and use caution in severe hepatic impairment due to potential increased systemic corticosteroid effects.

How to Take

For intranasal use only. Shake well before each use. Gently blow the nose, keep head slightly forward, insert the nozzle into one nostril while occluding the other, aim the spray away from the nasal septum, and actuate while breathing in gently. Wipe/clean the nozzle after use and replace the cap. Prime the pump before first use (typically 10 sprays until a fine mist appears) and re-prime if not used for ≥1 week (typically 2 sprays).

How to Prepare

Prime before first use with 10 actuations (or until a fine mist appears); if not used for 14 days or longer, re-prime with 2 actuations.

Side Effects

Common Side Effects

Epistaxis (nosebleed), headache, nasal irritation/burning/stinging, sneezing, pharyngitis/sore throat, and upper respiratory tract infection.

Side Effect Frequency

Very common/common: epistaxis, headache, pharyngitis/sore throat, nasal irritation/burning, sneezing; upper respiratory tract infection may occur. Uncommon/rare but clinically important: nasal ulceration or septal perforation, hypersensitivity reactions, Candida (white patches), and ocular effects (e.g., increased intraocular pressure/cataract/glaucoma) with prolonged use.

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to mometasone furoate or any excipients; do not use in the presence of untreated localized infection involving the nasal mucosa; avoid use after recent nasal surgery/trauma until healing is complete.

Warnings & Precautions

Monitor for epistaxis/irritation and periodically examine nasal mucosa (risk of ulceration/septal perforation); avoid use until healing after nasal surgery/trauma; use caution with tuberculosis or untreated fungal/bacterial/viral infections (may mask infection); consider ocular monitoring with long-term use (glaucoma/cataracts); monitor for adrenal suppression and growth in children on prolonged therapy, especially when switching from systemic steroids.

Age Restriction

Allergic rhinitis: approved for children ≥2 years; Nasal polyps: adults only (≥18 years).

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically significant interactions are uncommon, but caution with strong CYP3A4 inhibitors (e.g., ritonavir/cobicistat, ketoconazole) which can increase systemic corticosteroid effects; additive systemic effects may occur with other corticosteroids.

Interaction Severity

Clinically relevant interactions are mainly with strong CYP3A4 inhibitors (e.g., ritonavir/cobicistat, ketoconazole, clarithromycin), which can increase systemic corticosteroid exposure and risk of adrenal suppression/Cushingoid effects; manage by avoiding when possible or monitoring for systemic steroid effects.

Food Interaction

No restriction

Alcohol Interaction

Safe

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Children

Children 3-11 years: 1 spray (50 mcg) per nostril once daily (100 mcg/day). Not recommended in children under 3 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

Storage Conditions

Store below 30°C. Do not freeze. No reconstitution required.

Preparation Instructions

Prime before first use with 10 actuations (or until a fine mist appears); if not used for 14 days or longer, re-prime with 2 actuations.

Missed Dose

Use the missed dose as soon as remembered the same day; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Do not stop abruptly if used long-term at high doses or if the patient has been on systemic corticosteroids; taper gradually and monitor for adrenal insufficiency. For typical intranasal use at recommended doses, tapering is generally not required, but consider a short taper if symptoms rebound.

Overdose

Acute overdose is unlikely to cause toxicity; chronic excessive use may suppress the HPA axis-management is observation/supportive care and return to recommended dosing, with adrenal function assessment if systemic effects are suspected.

Patient Counseling

Use TABUNEX (mometasone furoate) nasal spray regularly as prescribed (often once daily); benefit may start within 1-2 days but maximum effect can take 1-2 weeks. Shake well before each use. Prime before first use until a fine mist appears; re-prime if not used for a period (see product instructions). Blow nose gently, aim the nozzle slightly outward away from the nasal septum, and avoid spraying into eyes. Clean the applicator/nozzle regularly. Do not exceed the prescribed dose; do not share. Seek medical advice for persistent/frequent nosebleeds, nasal pain/ulceration, white patches (possible Candida), or vision changes; use caution with strong CYP3A4 inhibitors. Store below 30°C and do not freeze; prescription-only.

Monitoring Requirements

Long-term use: periodically examine nasal mucosa for irritation, ulceration, candidiasis, and (rare) septal perforation; monitor for epistaxis. In children on prolonged therapy, monitor growth. In patients at risk, consider periodic eye evaluation for glaucoma/cataracts and monitor for signs of systemic corticosteroid effects if high doses or interacting drugs are used.

Pharmacology

Mechanism of Action

Mometasone furoate binds glucocorticoid receptors in nasal mucosa to downregulate inflammatory gene transcription and inhibit release of pro-inflammatory mediators (e.g., cytokines, leukotrienes, histamine), reducing mucosal inflammation, edema, and secretions.

Onset of Action

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

Duration of Effect

Approximately 24 hours, supporting once-daily dosing for most patients.

Half-Life

Approximately 5.8 hours (terminal half-life after intravenous administration); systemic exposure after intranasal use is minimal.

Bioavailability

Systemic bioavailability is <1% after intranasal administration.

Metabolism

Extensive hepatic first-pass metabolism primarily via CYP3A4 to inactive metabolites (for the swallowed/absorbed fraction).

Excretion

Excreted mainly as metabolites via bile/feces, with a small fraction in urine (e.g., ~74% feces and ~8% urine reported after systemic dosing).

Protein Binding

Approximately 98-99% protein bound.

Product Information

Available Dosage Forms

Nasal spray, suspension.

Composition per Dose

Each spray (100 mg suspension): 50 mcg mometasone furoate (as monohydrate)

Generic Availability

Yes

OTC Alternatives

In Saudi Arabia, TABUNEX (mometasone) is SFDA-listed as Prescription, so an OTC equivalent mometasone product is not applicable; OTC options for symptom relief include saline nasal sprays/irrigation. Availability of OTC intranasal steroid alternatives (e.g., fluticasone, budesonide, triamcinolone) depends on local Saudi scheduling and cannot be assumed as OTC without SFDA confirmation.

Symptom Target

Allergy, Congestion, Runny Nose

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 07-05-2026