Budicort
Budesonide BP

Presentation
Budicort Nasal Spray: Each bottle contains 120 metered doses of Budesonide BP. Each actuation delivers Budesonide BP 100 mcg

Description
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

Indications and Uses
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

Contraindications
Hypersensitivity to any of the ingredients of this preparation

Dosage And Administration
Adults and children 6 years of age and older: 100 mcg per day administered as one spray per nostril once daily.

The maximum recommended dose for adults (12 years of age and older) is 400 mcg per day administered as four sprays per nostril once daily


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.

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.

Use in pregnancy & lactation
Pregnancy: There are no adequate and well-controlled studies in pregnant women. Budesonide nasal spray, like other corticosteroids, should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether Budesonide is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exercised when Budesonide nasal spray is administered to nursing women

Overdosage
Like any other nasally administered corticosteroids, acute overdosing is unlikely in view of the total amount of active ingredient present. Clinically significant systemic adverse events would most likely not occurs if the entire contents of the bottle were administered all at once, via either oral or nasal application. Chronic overdosage may result in signs/symptoms of hypercorticism.

Commercial Pack
Budicort Nasal Spray: Each bottle contains 120 metered dose spray.;