Product Description:

• Rhinocort Aqua Nasal Spray is a corticosteroid indicated for the treatment of nasal symptoms of seasonal or perennial allergic rhinitis in adults and children six years of age and older.


• It contains budesonide, a synthetic corticosteroid that reduces swelling of the nasal lining, helping to relieve symptoms such as stuffy nose, runny nose, itching, and sneezing.


• Safety and effectiveness have not been established in children under 6 years of age.

How To Use:

• For intranasal use only.


• The recommended starting dosage for adults and children 6 years of age and older is 64 mcg per day, administered as one spray per nostril of Rhinocort Aqua Nasal Spray 32 mcg once daily.


• Maximum dosages are 256 mcg per day (four sprays per nostril once daily) for adults 12 years and older, and 128 mcg per day (two sprays per nostril once daily) for pediatric patients 6 to under 12 years.


• Prior to initial use, shake the container gently and prime the pump by actuating eight times.


• If used daily, no repriming is needed; if not used for two consecutive days, reprime with one spray or until a fine spray appears; if not used for more than 14 days, rinse the applicator and reprime with two sprays or until a fine spray appears.


• Shake gently before each use.

Warnings And Precautions:

• Local Nasal Effects: May cause epistaxis, Candida albicans infections, nasal septal perforation, and impaired wound healing.


• Monitor for adverse effects on the nasal mucosa and avoid use in patients with recent nasal ulcers, surgery, or trauma.


• Hypersensitivity Reactions: May include anaphylaxis, urticaria, rash, dermatitis, angioedema, and pruritus; discontinue if reactions occur.


• Immunosuppression: Potential worsening of infections (e.g., tuberculosis, fungal, bacterial, viral, or parasitic infections; ocular herpes simplex).


• Use with caution in patients with these infections; more serious courses of chickenpox or measles may occur in susceptible patients.


• Hypercorticism and Adrenal Suppression: May occur with high dosages or in susceptible individuals; reduce dosage slowly if changes occur. Effect on Growth: Monitor growth in pediatric patients; may cause reduction in growth velocity.


• Glaucoma and Cataracts: Close monitoring warranted, especially in patients with vision changes or history of increased intraocular pressure, glaucoma, and/or cataracts.


• Most common adverse reactions (incidence ≥ 2%): epistaxis, pharyngitis, bronchospasm, coughing, nasal irritation. Post-marketing reports include immediate and delayed hypersensitivity reactions, glaucoma, increased intraocular pressure, cataracts, nasal septum perforation, anosmia, pharynx disorders, wheezing, palpitations, and growth suppression.

Ingredients:

• Active: Budesonide 32 mcg per spray. Inactive: Microcrystalline cellulose, carboxymethylcellulose sodium, anhydrous dextrose, polysorbate 80, disodium edetate, potassium sorbate, purified water, and hydrochloric acid.