Beclomethasone Dipropionate + Formoterol Fumarate

Beclomethasone Dipropionate + Formoterol Fumarate is used for: Treatment of asthma, where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate

Inhaler Adult >18 yr 1 or 2 inhalations twice daily. Max daily dose: 4 inhalations.

Before using the inhaler for the first time or if the inhaler has not been used for 14 days or more, one actuation should be released into the air in order to ensure that the inhaler is working properly. Whenever possible patients should stand or sit in an upright position when inhaling from their inhaler. The steps below should be followed: 1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt or any other foreign objects. 2. Breathe out as slowly and deeply as possible. 3. Hold the canister vertically with its body upwards and put the lips around the mouthpiece. Do not bite the mouthpiece. 4. At the same time, breathe in slowly and deeply through the mouth. After starting to breathe in press down on the top of the inhaler to release one puff. 5. Hold the breath for as long as possible and, finally, remove the inhaler from the mouth and breathe out slowly. Do not breath out into the inhaler. Should a further puff be needed, keep the inhaler in a vertical position for about half a minute and repeat steps 2 to 5. After use, close with protective cap.

Contraindicated in patients with hypersensitivity to any component of this product.

Cardiac arrhythmias especially 3rd degree AV block & tachyarrhythmias; idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease particularly acute MI, ischaemic heart disease, CHF, occlusive heart diseases particularly arteriosclerosis, arterial HTN & aneurysm. Known or suspected congenital or drug-induced prolongation of QTc interval. Thyrotoxicosis, DM, phaeochromocytoma & untreated hypokalaemia; active or quiescent pulmonary TB, fungal & viral infections in the airways. Monitor serum K levels in severe & unstable asthma. Monitor blood glucose levels regularly. Avoid abrupt discontinuation of treatment. Not for use in acute asthma. Prolonged & high-dose treatment. Pregnancy & lactation. Childn & adolescent <18 yr.

Use in Pregnancy: There are no relevant clinical data on the use of the drug in pregnant women. Animal studies using beclometasone dipropionate and formoterol combination showed evidence of toxicity to reproduction after high systemic exposure. Because of the tocolytic actions of beta2-sympathomimetic agents particular care should be exercised in the run up to delivery. Formoterol should not be recommended for use during pregnancy and particularly at the end of pregnancy or during labour unless there is no other (safer) established alternative. The drug should only be used during pregnancy if the expected benefits outweigh the potential risks. Use in Lactation: There are no relevant clinical data on the use of the drug in lactation in humans. Although no data from animal experiments are available, it is reasonable to assume that beclometasone dipropionate is secreted in milk, like other corticosteroids. While it is not known whether formoterol passes into human breast milk, it has been detected in the milk of lactating animals. Administration of the drug to women who are breast-feeding should only be considered if the expected benefits outweigh the potential risks.

Effect of formoterol may be reduced w/ β-blockers. β-adrenergic drugs may increase the effects of formoterol. Quinidine, disopyramide, procainamide, antihistamines, phenelzine & isocarboxazid, amitryptiline & imipramine, phenothiazines can cause some changes in the ECG, heart trace & may also increase the risk of disturbances of heart rhythm. Levodopa, L-thyroxine, medicines containing oxytocin & alcohol can lower heart’s tolerance to formoterol. MAOIs, including drugs w/ similar properties eg, furazolidone & procarbazine can cause a rise in BP. Digoxin can cause a fall in blood K level. Theophylline, aminophylline or steroids & diuretics may cause a fall in K level. Some anaesth can increase the risk of abnormal heart rhythms.

Side effects of Beclomethasone Dipropionate + Formoterol Fumarate : Common and uncommon adverse drug reactions were derived from clinical trial data. The incidence on placebo was not taken into account. Infections and Infestations: Common: Pharyngitis. Uncommon: Influenza, oral fungal infection, pharyngeal and oesophageal candidiasis, vaginal candidiasis, gastroenteritis, sinusitis. Blood and Lymphatic System Disorders: Uncommon: Granulocytopenia. Very Rare: Thrombocytopenia. Immune System Disorders: Uncommon: Allergic dermatitis. Very Rare: Hypersensitivity reactions, including erythema, lips, face, eye and pharyngeal oedema. Endocrine Disorders: Very Rare: Adrenal suppression. Metabolism and Nutrition Disorders: Uncommon: Hypokalaemia, hyperglycaemia. Psychiatric Disorders: Uncommon: Restlessness. Very Rare: Abnormal behaviour, sleep disorder, hallucination. Nervous System Disorders: Common: Headache. Uncommon: Tremor, dizziness. Eye Disorders: Very Rare: Glaucoma, cataract. Ear and Labyrinth Disorders: Uncommon: Otosalpingitis. Cardiac Disorders: Uncommon: Palpitations, prolonged ECG QT corrected interval, ECG change, tachycardia, tachyarrhythmia. Rare: Ventricular extrasystoles, angina pectoris. Very Rare: Atrial fibrillation. Vascular Disorders: Uncommon: Hyperaemia, flushing. Respiratory, Thoracic and Mediastinal Disorders: Common: Dysphonia. Uncommon: Rhinitis, cough, productive cough, throat irritation, asthmatic crisis. Rare: Paradoxical bronchospasm. Very Rare: Dyspnoea, exacerbation of asthma. Gastrointestinal Disorders: Uncommon: Diarrhoea, dry mouth, dyspepsia, dysphagia, burning sensation of the lips, nausea, dysgeusia. Skin and Subcutaneous Tissue Disorders: Uncommon: Pruritus, rash, hyperhidrosis. Rare: Urticaria, angioneurotic oedema. Musculoskeletal, Connective Tissue and Bone Disorders: Uncommon: Muscle spasms, myalgia. Very Rare: Growth retardation in children and adolescents. Renal and Urinary Disorders: Rare: Nephritis. General Disorders and Administration Site Conditions: Very Rare: Peripheral oedema. Investigations: Uncommon: Increased C-reactive protein, platelet count, free fatty acids, blood insulin, blood ketone body. Rare: Increased or decreased blood pressure. Very Rare: Decreased bone density. As with other inhalation therapy, paradoxical bronchospasm may occur Among the observed adverse reactions those typically associated with formoterol are: Hypokalaemia, headache, tremor, palpitations, cough, muscle spasms and prolongation of QTc interval. Adverse reactions typically associated with the administration of beclometasone dipropionate are: Oral fungal infections and candidiasis, dysphonia, throat irritation. Dysphonia and candidiasis may be relieved by gargling or rinsing the mouth with water or brushing the teeth after using Innovair. Symptomatic candidiasis can be treated with topical antifungal therapy while continuing the treatment with Innovair. Systemic effects of inhaled corticosteroids (eg, beclometasone dipropionate) may occur particularly when administered at high doses prescribed for prolonged periods, these may include adrenal suppression, decrease in bone mineral density, growth retardation in children and adolescents, cataract and glaucoma. Hypersensitivity reactions including rash, urticaria pruritus, erhythema and oedema of the eyes, face, lips and throat may also occur.

Beclomethasone dipropionate given by inhalation at recommended doses has a glucocorticoid antiinflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma with less adverse effects than when corticosteroids are administered systemically. Formoterol is a selective beta2-adrenergic agonist that produces relaxation of bronchial smooth muscle in patients with reversible airways obstruction. The bronchodilating effect sets in rapidly, within 1-3 minutes after inhalation, and has a duration of 12 hours after a single dose.