Company: Clonmel Healthcare Ltd.
Legal category: Prescription. GMS. Sport-declaration required.
Active ingredient: Budesonide 0.5mg/2ml, 1mg/2ml.
Description: White to off-white suspension.
Presentation: 0.5mg/2ml-20, €25.49; 1mg/2ml-20, €36.78.
Indication: Persistent 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 probably important.
Dosage: Twice daily, by inhalation. Administration once daily may be considered in cases of mild to moderate stable asthma. Adult: Initiation and maintenance: 0.5-2mg daily. May be increased further in very severe cases. Elderly: As per adults. Children: Adolescents over 12 years: As per adults. 6 months and above: Initially, 0.25-1mg daily. Consider a higher initial dosage up to 2.0mg daily for patients in maintenance therapy with oral steroids. Maintenance: 0.25-1mg daily. Patients in maintenance therapy with oral steroids: See SPC.
Contraindications: Hypersensitivity to budesonide or any of the excipients.
Special precautions: Not indicated for the treatment of acute dyspnoea or status asthmaticus. Caution when switching from systemic treatment. Systemic effects of inhaled corticosteroids may occur, particularly at high doses, for prolonged periods. Discontinue immediately if paradoxical bronchospasm occurs. Monitor HPA axis function regularly in patients at risk of impaired adrenal function (previous prolonged systemic corticosteroid therapy, severe hepatic dysfunction). Advise patients to rinse out their mouth properly/brush their teeth after each administration to reduce risk of oral candidiasis and hoarseness. Treat acute respiratory tract bacterial infections with appropriate antibiotics. Caution: Active and quiescent pulmonary tuberculosis, fungal, viral or other infections of the airways (concomitant treatment required). Monitor the height of children receiving prolonged treatment. Pregnancy, lactation (if benefits outweigh risks).
Drug interactions: Can increase the efficacy of inhaled beta-2-sympathomimetics. Avoid ketoconazole,and other potent CYP3A4 inhibitors (erythromycin, clarithromycin, itraconazole, ketoconazole, ritonavir and saquinavir). Systemic or intranasal steroids (additive effect on adrenal function).
Adverse drug reactions: Oropharyngeal candidiasis, hoarseness, cough, oral mucosal irritation, difficulty in swallowing.
Full prescribing information and references available from Clonmel Healthcare Ltd. Telephone (052) 6177777. Fax: (052) 6177791. E-mail: firstname.lastname@example.org