This is indicated in the regular treatment of asthma. They are also indicated in the symptomatic treatment of severe chronic obstructive pulmonary disease (COPD), with a history of repeated exacerbations despite regular therapy with long-acting bronchodilators.
Long-acting selective β2-adrenoceptor stimulants, Respiratory corticosteroids
Budesonide: It is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have a wide range of inhibitory activities against multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic and non-allergic mediated inflammation. These anti-inflammatory actions of corticosteroids may contribute to their efficacy in asthma.
Formoterol Fumarate Dihydrate: It is a long-acting, selective β2 - adrenergic agonist with a rapid onset of action. Inhaled Formoterol Fumarate Dihydrate BP acts locally in the lungs as a bronchodilator. The pharmacological effects of β2-adrenoceptor agonist drugs are attributable to the stimulation of intracellular adenyl cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic AMP. Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibit the release of mediators of immediate hypersensitivity from the cells, especially from mast cells.
Asthma Maintenance and reliever therapy: Adults and adolescents (12 years and older)- As both maintenance and reliever therapy: Adults and adolescents (12 years and older): The recommended maintenance dose is 1 puff twice daily or 2 puffs once daily. For some patients a maintenance dose of 2 puffs twice daily may be appropriate (for 160/4.5 mcg/inhalation only). Patients should take 1 additional puff as needed in response to symptoms. If symptoms persist after a few minutes, the additional puff should be taken. Not more than 6 puffs should be taken on any single occasion. Children: The usual maintenance dose is 1 -2 puffs once or twice daily. Patients should take 1 additional puff as needed in response to symptoms. If symptoms persist after a few minutes, the additional puff should be taken. Not more than 4 puffs should be taken on any single occasion. Convicap/cozycap: Maintenance dose: 100 Convicap twice daily. 200 Convicap twice daily. Reliever dose: 1 additional Convicap as needed in response to symptoms. If symptoms persist after a few minutes, an additional Convicap should be taken. Children-Maintenance dose: 100 Convicap: 1 -2 ConviCaps once daily. Reliever dose: 1 additional Convicap as needed in response to symptoms. If symptoms persist after a few minutes, an additional Convicap should be taken. COPD 200 Convicap: 2 Convicaps twice daily. 400 Convicap: 1 Convicap twice daily
Co-administration with strong cytochrome P450 3A4 inhibitors (e.g., ritonavir) should be avoided as they may cause increased systemic corticosteroid effects. Co-administration with Monoamine oxidase inhibitors and tricyclic antidepressants should be with extreme caution as they may potentiate effect of formoterol on vascular system. Beta-blockers should be use with caution as they may block bronchodilatory effects of beta-agonists and produce severe bronchospasm. Co-administration of Formocort with diuretics should be with caution, as they may cause electrocardiographic changes and/or hypokalemia associated with nonpotassium- sparing diuretics may worsen with concomitant beta-agonists.
Hypersensitivity to Budesonide, Formoterol or to Lactose. Treatment with Budesonide and Formoterol combination should not be initiated to treat a severe exacerbation or if patients have significantly worsening or acutely deteriorating asthma.
Budesonide: Hoarseness, and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported. Formoterol Fumarate Dihydrate: Tremor, palpitations, and headache have been reported. Cardiac arrhythmias, muscle cramps, and hypersensitivity reactions, including rash, oedema, and angio-oedema, may occur in some patients.
Administration of Budesonide & Formoterol Fumarate in pregnant women and lactating mother should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
An overdose of Formoterol would likely lead to effects that are typical for (32 adrenoceptor agonists: tremor, headache, palpitations. Symptoms reported from isolated cases are tachycardia, hyperglycaemia, hypokalaemia, prolonged QTc-interval, arrhythmia, nausea and vomiting. Supportive and symptomatic treatment may be indicated. A dose of 90 micrograms administered during three hours in patients with acute bronchial obstruction raised no safety concerns. Acute overdosage with Budesonide, even in excessive doses, is not expected to be a clinical problem. When used chronically in excessive doses, systemic glucocorticosteroid effects, such as hypercorticism and adrenal suppression, may appear.
Inhalation capsules must not be swallowed. Only to be used with inhalation device. Keep away from light and wet place. Store at or below 25°C temperature. Keep out of reach of children. Remove Inhalation capsule from the blister pack only immediately before use it in the inhalation device as Inhalation capsule exposed to moisture may not be pierced easily.
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