Negara: Selandia Baru
Bahasa: Inggris
Sumber: Medsafe (Medicines Safety Authority)
Budesonide 100ug
Douglas Pharmaceuticals Limited
Budesonide 100 µg
100 mcg/dose
Nasal spray solution
Active: Budesonide 100ug Excipient: Butylated hydroxyanisole Citric acid monohydrate Disodium edetate dihydrate Hydrochloric acid Hypromellose Macrogol 400 Microcrystalline cellulose Potassium sorbate Purified water Sodium citrate dihydrate Sodium laurilsulfate
Spray bottle, glass, metered, 200 dose units
Prescription
Prescription
Sicor (Societa Italiana Corticosteroidi) Srl
Package - Contents - Shelf Life: Spray bottle, glass, metered, - 200 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 3 months opened stored at or below 25°C protect from light
1989-02-27
DATA SHEET ELTAIR FORTE AQUEOUS BUDESONIDE 100 ΜG/DOSE PRESENTATION ELTAIR FORTE AQUEOUS nasal spray is a uniform, white, liquid suspension packed in a 12mL amber glass bottle fitted with a metered dose pump. USES _ACTIONS _ Budesonide is a non-halogenated corticosteroid. In investigations in animals and man, budesonide has shown a favourable relationship between local anti-inflammatory activity and systemic glucocorticoid side effects over a wide dose range. This favourable relation between therapeutic effect and systemic side effects is due to budesonide's high glucocorticoid receptor affinity and high first-pass metabolism with a short half-life. The mechanism of action of intranasally administered budesonide has not yet been completely defined, however, budesonide has been shown to counteract the mainly IgE mediated lung anaphylaxis in guinea pigs. Pre-treatment for one week with intranasal budesonide 400mcg daily in asymptomatic patients with seasonal rhinitis significantly inhibited the immediate reaction to allergen challenge. _PHARMACOKINETICS _ Due to extensive first pass metabolism in the liver, the oral bioavailability of budesonide is low (approximately 10%). After nasal administration of a large dose (1mg) of budesonide from a metered dose aerosol the systemically available fraction is approximately 15%. Negligible biotransformation occurs in human nasal mucosa. After nasal application of 100mcg, budesonide peak plasma concentrations of approximately 1nmol/L were observed with 45 minutes. The volume of distribution of budesonide in adult man is 301.3 41.7L and in children is 3.1 to 4.8L/kg indicating a high tissue affinity. Plasma protein binding is 88.3 1.5% in humans. Budesonide is metabolised in the liver to more polar metabolites with low glucocorticoid activity (ie. 100 fold lower than the parent compound). The plasma half-life of budesonide in humans Baca dokumen lengkapnya