Sonicort Nasal Spray

Allergic Rhinitis, nasal polyp, seasonal and perennial allergic rhinitis, vasomotor rhinitis

Nasal Allergic rhinitis Indicated for seasonal or perennial allergic rhinitis Adult: As metered-dose spray (100 mcg/dose): Initially, 1 spray into each nostril once daily. The maximum recommended dose is 400 mcg per day administered as four sprays per nostril once daily. Nasal polyps Adult: As metered-dose spray (100 mcg/dose): 1 spray into each nostril once daily for up to 3 months.

Nasal Allergic rhinitis Indicated for seasonal or perennial allergic rhinitis Child: >6 yr: As metered-dose spray (100 mcg/dose): Initially, 1 spray into each nostril once daily. Nasal polyps Child: >6 yr: As metered-dose spray (100 mcg/dose): 1 spray into each nostril once daily for up to 3 months <6 years: Safety and efficacy not established

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, except for an adverse reaction reporting frequency of epistaxis that increased with age.

Prior to initial use, the container must be shaken gently and the pump must be primed by actuating eight times. If used daily, the pump does not need to be reprimed. 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 the container gently before each use.

Hypersensitivity to any of the ingredients of this preparation.

Local Nasal Effects: Epistaxis, Candida albicans infections, nasal septal perforation, impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma. Hypersensitivity reactions: Anaphylaxis, urticaria, rash, dermatitis, angioedema and pruritus may occur after administration of Budesonide Nasal Spray. Immunosuppression: Potential worsening of infections (e.g., existing tuberculosis, fungal bacterial, viral, or parasitic infections; or ocular herpes simplex). Use with caution in patients with these infections. More serious or even a fatal course of chickenpox or measles can occur in susceptible patients. Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dose in susceptible individuals. If such changes occur, reduce treatment with Budesonide Nasal Spray slowly. Effect on growth: Monitor the growth of pediatric patients. Glaucoma and cataracts: Close monitoring is warranted.

Not Classi Pregnancy Adverse events (eg, hypoadrenalism) observed with systemic corticosteroids in animal reproduction studies Increased risk of abnormalities has not been demonstrated in pregnant women using intranasal budesonide Clinical considerations: Intranasal corticosteroids are recommended for allergic rhinitis during pregnancy Lactation Excreted in breast milk after oral inhalation (~0.3-1% of the maternal dose) Plasma budesonide levels obtained from infants after breast-feeding were below the limit of quantification

The main route of metabolism of corticosteroids, including budesonide, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Concomitant administration of CYP3A4 may inhibit the metabolism of, and increase the systemic exposure to, budesonide. Caution should be exercised when considering the co-administration of Budesonide Nasal Spray with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin).

1-10% Epistaxis (8%),Pharyngitis (4%),Bronchospasm (2%),Cough (2%),Nasal irritation (2%)

Budesonide is a corticosteroid that has mainly glucocorticoid activity. It prevents and controls inflammation by controlling the rate of protein syntheis, decreasing the migration of polymorphonuclear leucocytes/fibroblasts and reversing capillary permeability.

Sonicort 100mcg Nasal Spray manufactured by OSL Pharma Limited.. Its generic name is Budesonide 0.1% Nasal spray.