Proxor® Prescribing Information
Prescribing Information for Proxor 100/6 micrograms and 200/6 micrograms per actuation pressurised inhalation solution.
Please refer to the Summary of Product Characteristics (SmPC) before prescribing Proxor.
Presentation: Each metered dose (ex-valve) contains 100 micrograms or 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate.
Indications: For use in adults only. Proxor 100/6 and 200/6: Regular treatment of asthma where use of a combination product is appropriate: Patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled rapid-acting beta2-agonist; Patients already adequately controlled on both inhaled corticosteroids and long-acting beta2– agonists. Proxor 100/6: Symptomatic treatment of severe COPD (FEV1< 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Dosage and administration: For use in adults only. Proxor is not intended for the initial management of asthma. Proxor 100/6: Asthma maintenance therapy: One or two inhalations twice daily. Maximum daily dose is 4 inhalations. Taken with a separate as needed rapid-acting bronchodilator. Asthma maintenance and reliever therapy: One inhalation twice daily. One additional inhalation when required, followed by one additional inhalation if symptoms persist. Maximum daily dose is 8 inhalations. Close monitoring for dose-related adverse effects is needed in patients who frequently take high numbers of Proxor as-needed inhalations. COPD: Two inhalations twice daily. Proxor 200/6: Asthma maintenance therapy: Two inhalations twice daily. Maximum daily dose is 4 inhalations. Taken with a separate as needed rapid-acting bronchodilator. Proxor should be titrated to the lowest dose at which effective control of symptoms is maintained. See SmPC for information on step down treatment.
Contraindications: Hypersensitivity to beclometasone dipropionate, formoterol fumarate dihydrate or any of the excipients.
Warnings and precautions: Caution in patients with cardiac arrhythmias, third-degree atrioventricular block, tachyarrhythmias, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease, acute myocardial infarction, ischaemic heart disease, congestive heart failure, occlusive vascular diseases, arteriosclerosis, arterial hypertension and aneurysm, and known or suspected prolongation of the QTc interval, either congenital or drug-induced (QTc > 0.44 seconds). Formoterol may induce prolongation of the QTc interval. Caution in thyrotoxicosis, diabetes mellitus, phaeochromocytoma and untreated hypokalaemia. Blood glucose should be closely monitored in patients with diabetes. Proxor should not be administered for at least 12 hours before the start of anaesthesia. Caution in patients with active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways. Proxor should not be stopped abruptly. Increasing use of rescue bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of asthma therapy. Sudden and progressive deterioration in control of asthma or COPD is potentially life-threatening and the patient should undergo an urgent medical assessment. Patients should not be initiated on Proxor during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Paradoxical bronchospasm may occur with an immediate increase in wheezing and rapidness of breath after dosing. This should be treated immediately with a fast-acting inhaled bronchodilator. Proxor should be discontinued immediately. Patients transferring from oral to inhaled corticosteroids or have received prolonged treatment may remain at risk of impaired adrenal reserve for a considerable time. Proxor 100/6 micrograms contains 7 mg of alcohol (ethanol) in each actuation which is equivalent to 0.19 mg/kg per dose of two actuations. Proxor 200/6 micrograms contains 9 mg of alcohol (ethanol) in each actuation which is equivalent to 0.25 mg/kg per dose of two actuations. Beta-blockers (including eye drops) should be avoided in asthmatic patients. Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines, monoamine oxidase inhibitors and tricyclic antidepressants can prolong the QTc-interval and increase the risk of ventricular arrhythmias. Concomitant treatment with monoamine oxidase inhibitors including agents with similar properties such as furazolidone and procarbazine may precipitate hypertensive reactions. Elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons. Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate a possible hypokalaemic effect of beta2-agonists. Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.
Pregnancy and lactation: Pregnancy – Proxor should only be used during pregnancy if the expected benefits outweigh the potential risks. Breast-feeding – Proxor should only be considered if the expected benefits outweigh the potential risks.
Undesirable effects: Serious common side effects: Pneumonia (in COPD patients). Other serious side effects: Oesophageal candidiasis, granulocytopenia, thrombocytopenia, adrenal suppression, hypokalaemia, glaucoma, cataract, atrial fibrillation, angina pectoris, asthmatic crisis, angioedema, growth retardation in children and adolescents, nephritis. Common side effects: Pharyngitis, oral candidiasis, headache.
For full list of side effects, consult SmPC.
Legal Category: POM
Pack size and price: 1 x Proxor 100/6 micrograms inhaler (£9.90); 1 x Proxor 200/6 micrograms inhaler (£9.90)
MA numbers: PL 06831/0391, PL 06831/0392
MA Holder: Genus Pharmaceuticals Ltd. t/a ‘STADA’ Linthwaite Huddersfield HD7 5QH, United Kingdom
Date of Preparation: December 2024
Unique ID number: UK-Prox-10(2)