Generic
Budesonide 0.1% Nasal Spray
3 brands available in the market
At a glance
Budesonide 0.1% Nasal Spray is a corticosteroid nasal spray used for the prophylaxis and treatment of seasonal and perennial allergic rhinitis, vasomotor rhinitis, and symptomatic relief of nasal polyposis. It reduces nasal inflammation and helps control allergy symptoms.
Description
Budesonide Nasal Spray is a synthetic corticosteroid with 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.
Budesonide Nasal Spray is indicated for the prophylaxis and treatment of seasonal and perennial allergic rhinitis, vasomotor rhinitis, symptomatic relief of nasal polyposis, and prevention against nasal polyps after polypectomy.
Indications
- 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
Therapeutic class
Respiratory corticosteroids
Pharmacological class
Nasal Corticosteroid
Pharmacology
Budesonide is a synthetic corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity. Corticosteroids have been shown to have wide-ranging inhibitory activities against multiple cell types (mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (histamine, eicosanoids, leukotrienes, cytokines) involved in allergic-mediated inflammation.
Mechanism of action
Budesonide inhibits inflammatory cells and mediators in the nasal mucosa, controlling symptoms of allergic rhinitis and nasal polyposis.
Dosage
Adults and children 6 years and older: 100 mcg per day (1 spray per nostril) once daily.
Adults (12 years and older): Maximum recommended dose: 400 mcg per day (4 sprays per nostril) once daily.
Children below 6 years: Safety and efficacy have not been established.
Note: Use the lowest effective dose and reduce dose once symptoms are controlled.
Administration
Shake the bottle gently and remove the dust cover. Clear the nostrils. Close one nostril and insert the nasal applicator into the open nostril. Tilt head slightly forward and keep the spray upright. Breathe in through the nose and press the spray while breathing in. Breathe out through the mouth. Replace the dust cover after each use. Clean the applicator with warm water at least once a week and allow to dry.
Missed dose
If you miss a dose, apply it as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not double the dose.
Side effects
Common side effects: Sneezing, headache, sore throat, dry mouth, nausea.
Local reactions are usually mild and transient. Systemic side effects have not been reported in clinical studies.
Long-term use may cause nasal septal perforation, epistaxis (rare).
Precautions & warnings
- Use with caution in patients with active or quiescent tuberculosis, 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.
- Reduce to the lowest effective dose once symptoms are controlled.
- Use during pregnancy and lactation only if clearly needed.
Contraindications
- Hypersensitivity to budesonide or any ingredients
Drug interactions
- Strong CYP3A4 inhibitors (ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin): May increase systemic exposure to budesonide; caution required.
- No other significant drug interactions reported.
Food interactions
Alcohol consumption does not cause harmful effects, but general caution is advised.
Use in pregnancy
Safe during pregnancy (Category B). Animal studies at high doses showed no teratogenicity. Human studies suggest remote possibility of fetal harm; use only if clearly needed.
Pregnancy Category: B — always consult a doctor before taking during pregnancy.
Use in lactation
Minute amounts of inhaled budesonide are excreted into breast milk, and infant exposure is negligible. Reviewers and expert panels consider inhaled corticosteroids acceptable during breastfeeding.
Pediatric use
Safety and efficacy in children below 6 years have not been established.
Geriatric use
No specific dose adjustment required for elderly; consult your physician.
Renal / hepatic impairment
No special precautions required for patients with liver or kidney impairment (minimal systemic absorption with topical application).
Overdose effects
Acute overdose is unlikely (total amount in bottle). Chronic overuse may cause signs/symptoms of hypercorticism.
Storage conditions
Store below 30°C, away from light and moisture. Keep out of reach of children.
Chemical structure
Budesonide 0.1% (Synthetic Corticosteroid)