NASOFLO NASAL SPRAY 50MCG (BOTTLE)

Dosage / Direction for Use Adult & childn ≥12 yr Usual dose: 2 sprays in each nostril once daily, preferably in the morning, or 1 spray in each nostril bid. Max: 4 sprays in each nostril daily. Maintenance: 1 spray in each nostril once daily. Start maintenance dose a few days after (4-7 days) initial therapy. Childn 4-11 yr Usual dose: 1 spray in each nostril once daily, preferably in the morning. If necessary, 2 sprays in each nostril once daily or 1 spray in each nostril bid. Then, patient may shift to usual dose once adequate control is achieved. Max: 2 sprays in each nostril daily. Contraindications Hypersensitivity. Special Precautions May cause growth velocity reduction in childn. Avoid taking higher than recommended doses. Patients who receive systemic corticosteroids for prolonged periods & transferred to topical corticosteroids. Possibility of Cushing's syndrome in patients sensitive to corticosteroid effects or when usual doses are exceeded. Avoid exposure to allergens during treatment to prevent occurrence of severe allergic symptoms in the eyes &/or lower resp tract. Caution use in patient w/ clinical TB or asymptomatic M. tuberculosis infection of the resp tract, untreated fungal or bacterial infection, ocular herpes simplex or untreated systemic viral infection. Examine nasal passages periodically for mucosal changes & signs of candidiasis during long-term therapy. Increased susceptibility to infections (eg, chickenpox, varicella). Concomitant use w/ other inhaled steroids. Pregnancy & lactation. Elderly. Childn <4 yr. Side Effects / Adverse Reactions Immediate hypersensitivity reactions & anaphylaxis/anaphylactoid reaction; epistaxis, nasal burning/irritation, pharyngitis, cough, asthma symptoms, nasal secretion containing blood, nasal discharge, bronchitis, sneezing, rhinorrhea, sinusitis, sore throat, throat irritation & dryness, hoarseness, voice changes, alteration or loss of sense of taste &/or smell, nasal congestion, nasal dryness, nasal septum perforation, nasal septum crusting, nasal ulcer & localized candidal infection of the nose &/or pharynx; nausea, vomiting, abdominal pain, diarrhea; dryness & irritation of the eyes, conjunctivitis, blurred vision, glaucoma, increased IOP & cataract; headache, dizziness, drowsiness, lethargy, fatigue or arthralgia, fever, flu-like symptoms, menstrual cramps, aches & pains, growth suppression. Interactions Increased risk of hypercorticism &/or suppression of HPA axis function w/ other inhaled or systemic corticosteroids. Increased peak plasma conc & AUC w/ ritonavir. Increased plasma conc w/ ketoconazole & other CYP3A4 inhibitors.