Jewim Pharma


Global Pharmatrade
Full Prescribing Info
Each dose (actuation) contains: Budesonide 64 mcg.
Budesonide is indicated in the treatment of allergic and non-allergic rhinitis, nasal polyps, and prevention of nasal polyps after polypectomy and reversal of allergic rhinitis.
Dosage/Direction for Use
Dosage varies depending on the severity of asthma. Patients should be started on a higher dose range, and then gradually tapered to the lower possible level to maintain control. Initial dose for adults and children over 6 years is 1 spray into each nostril once daily (64 micrograms daily), increasing as necessary up to a maximum of 256 micrograms daily for adults and 128 micrograms daily for children aged less than 12 years or as prescribed by the physician.
Directions for Use: Blow the nose gently. With the head upright, spray the medicine into each nostril. For best results, spray once into each nostril, wait 3 to 5 minutes to allow the medicine to work, then blow the nose gently and thoroughly. Repeat until the complete dose is used.
Rinse the tip of the spray bottle with hot water, taking care not to suck water into the bottle, and dry with a clean tissue. Replace the cap right after use.
To avoid spreading infection, do not use the container for more than one person.
Acute overdosage with Budesonide should not be a clinical problem. Habitual overdosing may cause hypercorticism and adrenal suppression. Withdrawal of Budesonide or a decrease in dose will abolish these effects, although the normalization of the Hypothalamic-Pituitary-Adrenal axis may be slow. If oropharyngeal candidiasis develops, it may be treated with appropriate anti-fungal therapy and still continuing Budesonide. The incidence can be kept to minimum by asking patients to rinse their mouth after each inhalation.
Contraindicated in patients with recent sinus infection, nasal bleeding or surgery, patients with active pulmonary tuberculosis and in patients with hypersensitivity to the drug or any of its components.
Special Precautions
Adrenal suppression may occur in some patients treated with high-dose long term inhalation therapy. In prolonged use, nasal passages should be examined periodically for mucosal changes. It should be used with extreme caution, or not at all in patients with clinical tuberculosis or asymptomatic Mycobacterium tuberculosis infections of the respiratory tract, untreated fungal or bacterial infection or ocular Herpes simplex or untreated systemic viral infections. Caution should be taken in children who are receiving long-term treatment and they should have their height regularly monitored, since high doses of corticosteroids taken for long periods of time can impair growth in children.
Adverse Reactions
Budesonide is generally well tolerated. Mild irritations in the throat, coughing, hoarseness and candida infection in the oropharynx have been reported. Skin reactions, urticaria, rash, dermatitis. Facial skin irritations occurred in some cases.
Store at temperatures not exceeding 30°C.
ATC Classification
R01AD05 - budesonide ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
Nasal spray 64 mcg/dose x 1's.
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