AVAMYS NASAL SP 120/SPRAYS

Indications

Approved Uses

Treatment of symptoms of seasonal allergic rhinitis (including ocular symptoms) and treatment of symptoms of perennial allergic rhinitis.

Dosage & Administration

Dosing by Condition

Allergic rhinitis (seasonal or perennial): Adults/adolescents ≥12 years: 2 sprays per nostril once daily initially (total 110 µg/day), then reduce to 1 spray per nostril once daily (55 µg/day) when controlled. Children 2-11 years: 1 spray per nostril once daily (55 µg/day); may increase to 2 sprays per nostril once daily (110 µg/day) if inadequate response, then step back down to 1 spray per nostril once daily for maintenance.

Initial Dose

Adults and adolescents (≥12 years): Two sprays (27.5 mcg per spray) in each nostril once daily (total daily dose of 110 mcg).

Maintenance Dose

1 spray into each nostril once daily (55 mcg/day) once symptoms are controlled

Maximum Dose

Two sprays in each nostril once daily (total daily dose of 110 mcg).

Children's Dosage

Children 2-11 years: 1 spray (27.5 mcg) per nostril once daily (55 mcg/day). Not approved under 2 years of age.

Dose Adjustment Notes

No dose adjustment is generally required in elderly patients or in renal impairment; use caution in hepatic impairment (potential increased systemic exposure) and use the lowest effective dose once controlled.

Side Effects

Common Side Effects

Epistaxis, headache, nasal irritation/discomfort (including dryness), and nasal ulceration; nasopharyngitis can also occur.

Side Effect Frequency

Very common: epistaxis. Common: headache, nasal ulceration/irritation/discomfort, nasopharyngitis. Rare/uncommon but clinically important: hypersensitivity reactions; nasal septal perforation; ocular effects (cataract/glaucoma) with prolonged use; systemic corticosteroid effects are uncommon at recommended doses.

Safety & Warnings

Contraindications

Hypersensitivity to fluticasone furoate or to any excipients.

Warnings & Precautions

Use caution/monitor when switching from systemic steroids (risk of adrenal insufficiency); monitor for systemic corticosteroid effects (adrenal suppression, growth in children) with high dose/prolonged use; monitor for nasal mucosal effects (epistaxis, ulceration, septal perforation-especially after nasal surgery/trauma); monitor ocular symptoms/IOP in patients with vision changes or glaucoma/cataracts; use caution in patients with untreated infections (including TB) or ocular herpes simplex.

Age Restriction

Not recommended/approved for children under 2 years of age; indicated from age ≥2 years.

Drug Interactions

Drug Interactions

Avoid/not recommended with strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat, ketoconazole) due to increased systemic corticosteroid exposure; additive systemic effects may occur with other corticosteroids.

Interaction Severity

MAJOR: Strong CYP3A4 inhibitors (especially ritonavir/cobicistat; also ketoconazole/itraconazole/clarithromycin) can markedly increase systemic fluticasone exposure with risk of adrenal suppression/Cushingoid effects; avoid or monitor closely. ADDITIVE: Concurrent corticosteroids (inhaled/oral/other intranasal) may increase cumulative systemic steroid burden.

Special Populations

Children

Children 2-11 years: 1 spray (27.5 mcg) per nostril once daily (55 mcg/day). Not approved under 2 years of age.

Kidney Impairment

No adjustment needed.

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly if used regularly for long periods or at higher-than-recommended doses; tapering may be needed to avoid rebound rhinitis symptoms and, rarely, systemic corticosteroid withdrawal. At usual recommended intranasal doses, systemic withdrawal is unlikely, but symptoms may recur after stopping-follow prescriber direction for step-down/maintenance.

Overdose

Acute intranasal overdose is unlikely to require treatment beyond observation/supportive care; chronic excessive use may cause systemic corticosteroid effects (e.g., adrenal suppression) and warrants clinical assessment/monitoring.

Patient Counseling

Use Avamys (fluticasone furoate) regularly once daily as prescribed; benefit may start within a few days but maximal effect can take up to 1-2 weeks. Shake well before each use. Prime before first use (and re-prime if not used for a prolonged period per product instructions) and use correct technique: blow nose, aim the nozzle slightly outward away from the nasal septum, sniff gently while spraying. Wipe/clean the nozzle and replace the cap after use. Do not exceed the prescribed sprays; seek medical advice for persistent/recurrent epistaxis, nasal pain/ulceration, or any visual changes (e.g., blurred vision). Keep out of reach of children. Store below 25°C.

Monitoring Requirements

Monitor for local nasal adverse effects (epistaxis, ulceration, Candida, and rare septal perforation) and ensure correct spray technique; monitor growth in children with long-term use; consider ophthalmic evaluation/IOP monitoring if visual symptoms occur or in patients with glaucoma/cataract risk.

Pharmacology

Mechanism of Action

Binds glucocorticoid receptors in the nasal mucosa, downregulating inflammatory gene transcription and mediators (e.g., cytokines/chemokines/eicosanoids), reducing mucosal edema, mucus production, and inflammatory cell infiltration.

Onset of Action

Some symptom improvement may occur within ~8 hours; maximal benefit typically requires several days and may take 1-2 weeks of regular daily use.

Duration of Effect

Approximately 24 hours (supports once-daily dosing).

Bioavailability

<0.5% systemic bioavailability after intranasal administration (negligible).

Metabolism

Extensive hepatic metabolism via CYP3A4 to largely inactive metabolites (high first-pass metabolism).

Excretion

Primarily fecal excretion; urinary excretion is minimal (typically reported as <~2%).

Product Information

Available Dosage Forms

Nasal spray, suspension.

Composition per Dose

Each actuation: 27.5 mcg fluticasone furoate in aqueous suspension

OTC Alternatives

In Saudi Arabia this product is prescription-only (per verified API legal status). OTC symptomatic alternatives include nasal saline irrigation/sprays; other OTC options depend on local scheduling but commonly include non-sedating oral antihistamines (e.g., cetirizine/loratadine) and, where available OTC, some intranasal corticosteroids (e.g., fluticasone propionate/budesonide).

Symptom Target

Allergy, Congestion, Runny Nose

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 03-05-2026