Budesonide nasal spray is indicated for:

• Prevention and treatment of seasonal and perennial allergic rhinitis
• Management of vasomotor rhinitis
• Symptomatic relief of nasal polyps
• Prevention of recurrence of nasal polyps following polypectomy

Budesonide is a synthetic corticosteroid with strong glucocorticoid activity and minimal mineralocorticoid effect. It has a very high affinity for glucocorticoid receptors and exhibits significantly greater topical anti-inflammatory potency compared to cortisol. Corticosteroids exert their effects by inhibiting multiple inflammatory cells (including mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and inflammatory mediators (such as histamine, eicosanoids, leukotrienes, and cytokines), thereby reducing allergic inflammation.

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.

Administration

How to use the Nasal Spray-

• Shake the bottle gently and remove the dust cover.
• Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
• Gently blow the nose to clear the nostrils.
• Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
• Breathe out through your mouth.
• Repeat the above steps in the same/ other nostril for consecutive doses.

Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-

• Remove the dust cover.
• Gently pull off the nasal applicator.
• Wash the applicator and dust cover in warm water.
• Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
• Gently push the applicator back on the top of the bottle and re-fix the dust cover.

No clinically significant drug interactions have been reported.

Local adverse effects are generally mild and temporary. Systemic side effects have not been observed in clinical studies. Commonly reported reactions include sneezing, headache, sore throat, dry mouth, and nausea.

Pregnancy: Inhaled budesonide is classified as pregnancy category B. Animal studies have not shown teratogenic effects at high doses, and the risk of fetal harm appears low. However, due to limited human data, it should be used during pregnancy only when clearly necessary.

Lactation: Only very small amounts of budesonide are excreted into breast milk, and exposure to the infant is minimal. Inhaled corticosteroids are generally considered safe during breastfeeding.

Budesonide nasal spray should be used cautiously in patients with active or latent tuberculosis, untreated fungal, bacterial, or systemic viral infections, or ocular herpes simplex. It should also be avoided in patients with recent nasal septal ulcers, nasal surgery, or nasal trauma.

Acute overdose is unlikely due to the low systemic exposure of intranasal corticosteroids. Even if a large amount is administered at once, significant systemic adverse effects are unlikely. Chronic overuse may lead to symptoms of hypercorticism.

Nasal Decongestants & Other Nasal Preparations, Respiratory corticosteroids

Store below 30°C, away from light and moisture. Keep out of reach of children.