Indications

Budesonide nasal spray is indicated in- Prophylaxis and treatment of seasonal and perennial allergic rhinitis. Prophylaxis and treatment of vasomotor rhinitis. Symptomatic relief of nasal polyposis. Prevention against nasal polyps after polypectomy.

Composition

Pharmacology

Budesonide is a synthetic corticosteroid having potent glucocorticoid activity and weak mineralocorticoid activity. It has approximately a 200-fold higher affinity for the glucocorticoid receptor and a 1000-fold higher topical anti-inflammatory potency than cortisol. Corticosteroids have been shown to have a wide range of inhibitory activities against multiple cell types (e.g. mast cell, eosinophil, neutrophil, macrophage, and lymphocyte) and mediators (e.g. histamine, eicosanoids, leukotriene, and cytokine) involved in allergic mediated inflammation.

Dosage & Administration

Adults and children 6 years of age and older : 100 mcg per day administered as one spray per nostril once daily. Adults (12 years of age and older) : The maximum recommended dose is 400 mcg per day administered as four sprays per nostril once daily. Pediatric Use : Safety and effectiveness in pediatric patients below 6 years of age have not been established.

Contraindications

Side Effects

Adverse local reactions following budesonide use are mild and usually transient. Systemic side effects have not been reported during clinical studies of budesonide nasal preparations. Sneezing, headache, sore throat, dry mouth, nausea etc. have been reported as the common side effects.

Pregnancy & Lactation

Pregnancy : Inhaled budesonide has been assigned to pregnancy category B by the FDA. Budesonide has not been shown to be teratogenic in animals when given in high doses by inhalation. Despite the animal findings, it would appear that the possibility of fetal harm is remote if the inhaled drug is used during pregnancy. Nevertheless, because the studies in humans cannot rule out the possibility of harm, inhaled budesonide should be used during pregnancy only if clearly needed. Lactation : The amounts of inhaled budesonide excreted into breastmilk are minute and infant exposure is negligible. Reviewers and an expert panel consider inhaled corticosteroids acceptable to use during breastfeeding. When taken by mouth, budesonide is only about 9% bioavailable; bioavailability in the infant is likely to be similarly low for any budesonide that enters the breastmilk.

Precautions & Warnings

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.

Therapeutic Class

Nasal Decongestants & Other Nasal Preparations, Respiratory corticosteroids

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.