Drug information of Budesonide

Budesonide

Drug group:

Budesonide is a steroid. It prevents the release of substances in the body that cause inflammation. Budesonide nasal is used to treat nasal symptoms such as congestion, sneezing, and runny nose caused by seasonal or year-round allergies. Budesonide is also used to keep nasal polyps from coming back after surgery to remove them.

Mechanism of effect

The precise mechanism of corticosteroid actions on inflammation in seasonal and perennial allergic rhinitis is not well known. These anti-inflammatory actions of corticosteroids may contribute to their efficacy in seasonal and perennial allergic rhinitis

Pharmacodynamic

Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity.

Pharmacokinetics

After intranasal administration of a single dose of Budesonide Nasal Spray (128 mcg), the mean peak plasma concentration of approximately 0.3 nmol/L occurs about 0.5 hours post-dose. Compared to an intravenous dose, approximately 34% of the delivered intranasal dose reaches the systemic circulation, most of which is absorbed through the nasal mucosa. While budesonide is well absorbed from the GI tract, the oral bioavailability of budesonide is low (~10%) primarily due to extensive first pass metabolism in the liver. The terminal half-life, 2 to 3 hours, was the same for both epimers and was independent of dose. Budesonide was excreted in urine and feces in the form of metabolites. Approximately 2/3 of an intranasal radiolabeled dose was recovered in the urine and the remainder in the feces.

Drug indications

Allergic Rhinitis

Dosage

Usual Adult Dose for Allergic Rhinitis Nasal aerosol: 2 sprays (32 mcg/spray) in each nostril in the morning and evening or 4 sprays in each nostril in the morning. Maximum recommended dose is 8 sprays (256 mcg)/day. Nasal Spray: 1 spray (32 mcg) in each nostril once daily. Maximum dose: 4 sprays (128 mcg) in each nostril once daily. Usual Pediatric Dose for Allergic Rhinitis 6 years or older: Nasal aerosol: 2 sprays (32 mcg/spray) in each nostril in the morning and evening or 4 sprays in each nostril in the morning. Maximum recommended dose is 8 sprays (256 mcg)/day. Nasal spray: 1 spray (32 mcg) in each nostril once daily. Maximum dose: less than 12 years: 2 sprays (64 mcg) in each nostril once daily; 12 years or older: 4 sprays (128 mcg) in each nostril once daily.

Alerts

1-Intranasal corticosteroids, including budesonide may cause a reduction in growth velocity when administered to pediatric patients. 2-Glaucoma, increased intraocular pressure and cataracts have been reported following the intranasal application of corticosteroids, including budesonide. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts 3-Local Nasal Effects(Epistaxis, Candida Infection, Nasal Septal Perforation, Impaired Wound Healing), Hypersensitivity Reactions Including Anaphylaxis, Immunosuppression, Hypothalamic-Pituitary-Adrenal Axis Effects may occur.

Points of recommendation

1-Patients should use Budesonide Nasal Spray at regular intervals since its effectiveness depends on its regular use. 2-A decrease in symptoms may occur as soon as 24 hours after onset of treatment but generally it takes 3 to 7 days to reach maximum benefit. If no improvement has been obtained by the third week of treatment, the nasal inhaler treatment should be discontinued.

Pregnancy level

B


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