RHINCORT AQUA 64/MCG/DOSE NASAL SP 120/DOSES

Indications

Approved Uses

Treatment of nasal symptoms of seasonal allergic rhinitis and perennial allergic rhinitis.

Off-Label Uses

Adjunctive therapy in chronic rhinosinusitis (including post-operative care) and symptom management in non-allergic rhinitis (practice-dependent).

Dosage & Administration

Dosing by Condition

Allergic rhinitis (adults and adolescents ≥12 years): usual starting dose 256 mcg/day (2 sprays/nostril once daily) or 128 mcg/day (1 spray/nostril once daily) depending on symptom severity; maximum 256 mcg/day; maintenance typically 128 mcg/day (1 spray/nostril once daily). Children 6-11 years: 128 mcg/day (1 spray/nostril once daily); maximum 128 mcg/day.

Initial Dose

256 mcg/day (2 sprays per nostril once daily)

Maintenance Dose

128 mcg/day (1 spray per nostril once daily)

Maximum Dose

Adults and adolescents (≥12 years): 256 mcg/day intranasally (e.g., 4 sprays/day of 64 mcg; may be given as 2 sprays per nostril once daily or 1 spray per nostril twice daily). Children (6 to <12 years): 128 mcg/day intranasally (e.g., 2 sprays/day of 64 mcg; may be given as 1 spray per nostril once daily).

Children's Dosage

For children 6 to <12 years, the recommended starting dose is 64 mcg per day (one spray per nostril). The maximum dose is 128 mcg per day (two sprays per nostril).

Dose Adjustment Notes

Titrate to the lowest effective dose once symptoms are controlled; no routine renal dose adjustment is needed. Use caution in moderate-to-severe hepatic impairment because systemic exposure to budesonide may increase.

How to Prepare

No reconstitution is needed (ready-to-use nasal spray suspension); shake well and prime the pump before first use (and re-prime if unused for several days) until a fine mist is produced.

Side Effects

Common Side Effects

Epistaxis, nasal irritation/burning/stinging, nasal dryness, sneezing, headache, and pharyngitis.

Side Effect Frequency

Common (≥1% to <10%): epistaxis, nasal irritation/burning/stinging, dryness, sneezing, pharyngitis, headache. Uncommon/rare: nasal septal perforation, hypersensitivity reactions; very rare: glaucoma/cataract or increased intraocular pressure; systemic corticosteroid effects (e.g., HPA-axis suppression, growth effects) are uncommon at recommended intranasal doses but possible with prolonged/high-dose use or interactions.

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to budesonide or any excipients.

Warnings & Precautions

Precautions: recent nasal ulcers/surgery/trauma (delay use until healed); monitor for epistaxis, mucosal irritation and Candida; use caution with untreated local infections and in patients with TB/ocular herpes; monitor growth in children with long-term use; monitor for glaucoma/cataracts with prolonged therapy or risk factors; consider adrenal suppression risk when combined with strong CYP3A4 inhibitors or other steroids.

Age Restriction

Not approved/recommended for children under 6 years (use in ≥6 years per labeling).

Driving Warning

Safe

Drug Interactions

Food Interaction

No restriction

Alcohol Interaction

Safe

Special Populations

Children

For children 6 to <12 years, the recommended starting dose is 64 mcg per day (one spray per nostril). The maximum dose is 128 mcg per day (two sprays per nostril).

Elderly

Standard adult dosing. No overall differences in safety or effectiveness were observed, though epistaxis frequency may increase with age.

Kidney Impairment

No adjustment needed.

Storage & Patient Advice

Preparation Instructions

No reconstitution is needed (ready-to-use nasal spray suspension); shake well and prime the pump before first use (and re-prime if unused for several days) until a fine mist is produced.

Stopping the Medicine

At usual intranasal doses, tapering is generally not required; however, if used at high doses or for prolonged periods, consider gradual dose reduction to minimize potential systemic corticosteroid effects and monitor for symptom recurrence.

Overdose

Acute intranasal overdose is unlikely to be clinically significant; chronic excessive use may cause systemic corticosteroid effects (e.g., hypercorticism/HPA-axis suppression); manage by reducing to recommended dosing (taper generally not required, but consider gradual reduction if prolonged very high exposure).

Patient Counseling

Use RHINOCORT AQUA (budesonide) exactly as prescribed and regularly (daily) for best control; symptom relief may start within 1-2 days but full benefit can take up to ~2 weeks. Shake well before each use; prime the pump before first use (and if not used for several days) until a fine mist appears. Blow your nose gently, keep head slightly forward, insert nozzle and aim slightly away from the nasal septum, then spray while gently breathing in; repeat for the other nostril and wipe the nozzle after use. Avoid spraying into eyes; do not exceed the prescribed dose and do not use for immediate relief of a common cold. Seek medical advice for severe/frequent nosebleeds, persistent nasal ulceration/crusting/whistling, signs of local infection (e.g., thrush), or vision changes; tell your clinician if using other corticosteroids or strong CYP3A4 inhibitors, and monitor growth in children on long-term therapy. Store below 25°C and keep the bottle upright; do not freeze.

Monitoring Requirements

Periodically examine nasal mucosa for irritation, ulceration, epistaxis, Candida infection, or septal perforation; monitor growth in children with long-term use; counsel to report visual changes and consider intraocular pressure/cataract assessment in at-risk patients or prolonged high-dose use.

Pharmacology

Mechanism of Action

Budesonide is a corticosteroid that binds glucocorticoid receptors in the nasal mucosa, downregulating pro-inflammatory gene transcription and mediator release, thereby reducing mucosal edema, secretions, and nasal hyperreactivity.

Onset of Action

Some improvement may occur within 8-24 hours, but maximal benefit typically requires several days and up to 1-2 weeks of regular daily use.

Duration of Effect

Approximately 24 hours (supports once-daily dosing).

Product Information

Available Dosage Forms

Nasal spray, suspension (metered-dose spray container).

Composition per Dose

Each actuation (dose): 64 mcg budesonide as suspension in aqueous medium

OTC Alternatives

In Saudi Arabia this product is prescription-only (SFDA legal status: Prescription); OTC alternatives for symptom relief include oral second-generation antihistamines (e.g., cetirizine, loratadine), saline nasal sprays/irrigation, and (where locally available OTC) intranasal antihistamines or decongestants for short-term use.

Symptom Target

Allergy, Congestion, Runny Nose

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 15-08-2026