Budesonide 0.1% Nasal spray

Indications

Budesonide 0.1% Nasal spray is used for: Hay fever, nasal polyposis, seasonal and perennial allergic rhinitis, vasomotor rhinitis

Adult Dose

Nasal Nasal polyps Adult: As metered-dose spray (64 mcg or 100 mcg/dose): 1 spray into each nostril bid up to 3 mth; alternatively, 2 sprays into each nostril once daily for preparations containing 64 mcg/dose. Allergic rhinitis Adult: As metered-dose spray (64 mcg or 100 mcg/dose): Initially, 2 sprays into each nostril daily or 1 spray into each nostril bid, reduce to 1 spray into each nostril daily until symptoms are controlled.

Child Dose

Nasal Nasal polyps Child: >6 yr: As metered-dose spray (100 mcg/dose): 1 spray into each nostril bid up to 3 mth. Nasal Allergic rhinitis Child: >6 yr: As metered-dose spray (100 mcg/dose): Initially, 2 sprays into each nostril daily or 1 spray into each nostril bid, reduce to 1 spray into each nostril daily until symptoms are controlled. <6 years: Safety and efficacy not established

Renal Dose

Administration

Contra Indications

Hypersensitivity to any of the ingredients of this preparation.

Precautions

Budesonide nasal spray should be used with caution in patients with active or quiescent tuberculous infection, untreated fungal, bacterial, or systemic viral infections, or ocular herpes simplex infection. Patients with recent nasal septal ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid. Lactation: Distributed in breast milk; estimated total daily oral dose of budesonide available in breast milk to infant is ~0.3-1% of dose inhaled by mother

Pregnancy-Lactation

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

Interactions

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).

Adverse Effects

Side effects of Budesonide 0.1% Nasal spray : 1-10% Epistaxis (8%), Pharyngitis (4%), Bronchospasm (2%), Cough (2%), Nasal irritation (2%)

Mechanism of Action

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.