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Rhinocort® Aqua (Budesonide). Aqueous nasal spray 32 mcg/ dose and 64 mcg/ dose. Abbreviated Prescribing Information: See local Prescribing Information for full details, as Prescribing Information may vary from country to country. Properties: Nasally administered glucocorticosteroid with high local anti-inflammatory effect. Full clinical effect of Rhinocort is usually achieved within one to two weeks. Indications: Seasonal allergic and allergic/non-allergic perennial rhinitis. Treatment of nasal polyps. Prevention of nasal polyps after polypectomy. Contra-indications: Hypersensitivity to any of the ingredients. Dosage: Dosage is individual and should be tapered to the smallest dose maintaining symptom control. Rhinitis. Adult, the elderly and children 6 years and older: In general, recommended starting dose is 256 mcg once daily in the morning or divided into two administrations morning and evening. Treatment of seasonal rhinitis should if possible start before exposure to the allergens. Treatment and prevention of nasal polyps: In general, recommended dose is 128 mcg twice daily. Warnings and Precautions: Excessive doses of, or long-term treatment with glucocorticosteroids may lead to signs or symptoms of hypercorticism, suppression of HPA function and/or suppression of growth in children. The long term effects of glucocorticosteroids in children are not fully known. The growth of children taking glucocorticosteroids in long term treatment by any route should be monitored and the benefits of the therapy weighed against the possibility of growth suppression. Reduced liver function may affect the elimination of corticosteroids. Special consideration in patients with lung tuberculosis. Pregnancy and lactation: As with other drugs administered during pregnancy, the benefits for the mother should be weighed against the risks for the foetus. There is no information regarding the passage of budesonide into human milk. Interactions: Budesonide has not been observed to interact with any drug used for the treatment of rhinitis. Oral ketoconazole may increase systemic exposure to budesonide. Undesirable effects: Nasal irritation, slight haemorrhagic secretion and epistaxis. Immediate and delayed hypersensitivity reactions including urticaria, rash, dermatitis, angioedema and pruritus . In extremely rare cases, ulcerations of mucous membrane and nasal septal perforation. Legal category: On Medical Prescription. Further information is available on request from AstraZeneca or local AstraZeneca subsidiaries. Rhinocort® is a registered trademark owned by the AstraZeneca group of companies. Other names of the product are Budecort® Nasal, Pulmicort® Nasal, Rhinocortol®, Pulmicort® Topinasal®, Nasocort®. Date: June 2000 |
