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September 1, 2014

Budesonide Teva

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Company: Teva Pharmaceuticals Ireland.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Budesonide 0.5mg/2ml.
Description: White to off-white nebuliser suspension.
Presentation: 0.5mg/2ml-20, €23.95.
Indication: Treatment of bronchial asthma in patients where use of a pressurised inhaler or dry powder formulation is unsatisfactory or inappropriate.
Pharmacology: Budesonide is a glucocorticosteroid with a powerful local anti-inflammatory action. The precise mechanism of action of glucocorticosteroids in the treatment of asthma is not fully understood. Anti-inflammatory effects (including T-cells, eosinophilic cells and mast cells) such as inhibition of the release of inflammatory mediators and inhibition of cytokine-mediated immune response, are considered important.
Dosage: Twice daily, by inhalation. Administration once daily may be considered in mild to moderate stable asthma. Adult: Initiation and maintenance: 0.5-2mg daily. May be increased in very severe cases. Elderly: As per adults. Children: Over 12 years: As per adults. 6 months – 12 years: Initially 0.25-1mg daily; consider higher initial dose up to 2mg daily for patients on maintenance therapy with oral steroids. Maintenance: 0.25-1mg daily. Patients on maintenance therapy with oral steroids: See SPC. Under 6 months, safety and efficacy not established.
Contraindications: Hypersensitivity to budesonide or any of the excipients.
Special precautions: Not indicated for acute dyspnoea or status asthmaticus. Caution: Pulmonary tuberculosis, viral infections of the airways, transferring from oral therapy, hepatic impairment, patients with impaired adrenal function during periods of stress (e.g. surgery, infections or worsening asthma attacks). Systemic effects (including Cushing’s syndrome) may occur at high doses over prolonged periods. Regularly monitor growth of children receiving prolonged treatment – use lowest effective dose. Reassess therapy if severe paradoxical bronchospasm occurs. Pregnancy, lactation (if benefits outweigh risks).
Drug interactions: Avoid: Potent CYP3A4 inhibitors (erythromycin, clarithromycin, itraconazole, ketoconazole, ritonavir, saquinavir). Systemic or intranasal steroids.
Adverse drug reactions: Oropharyngeal candidiasis, hoarseness, cough, oral mucosal irritation, difficulty in swallowing.
Full prescribing information and references available from Teva Pharmaceuticals Ireland. Telephone: 1800 201700.