Formocort

Treatment of Asthma
: Budefort inhaler is indicated for the treatment of asthma in patients 12 years of age and older. This is not indicated for the relief of acute bronchospasm.
Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD)
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Treatment of Asthma
: Budefort inhaler is indicated for the treatment of asthma in patients 12 years of age and older. This is not indicated for the relief of acute bronchospasm.
Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD)
: Budefort inhalation capsule is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema. This inhalation capsule is the only approved dosage for the treatment of airflow obstruction in COPD.

As the combination inhaler contains Formoterol Fumarate and Budesonide, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds. Adverse events, which have been associated with Formoterol Fumarate Dihydrate and Budesonide, are given below:
Formoterol Fumarate
: Tremor, palpitations and headache are common adverse events. Cardiac arrhythmias, muscle cramps and hypersensitivity reactions, including rash, oedema and angiooedema are uncommon and rare.
Budesonide
: Hoarseness, candida infection in the oropharynx and throat irritation may occur in some patients. Cutaneous hypersensitivity reactions, respiratory tract infections, immunosuppression, growth effect in children, glaucoma & cataract have been reported.

Caution should be taken in patients with diabetes mellitus, thyrotoxicosis, untreated hypokalaemia, severe hypertension and severe cardiovascular disorders, such as ischaemic heart disease, tachycardia or severe heart failure, glaucoma and cataract, hypercorticism. Paradoxical bronchospasm may occur, with an immediate increase in wheezing and shortness of breath after dosing. If the patient experiences paradoxical bronchospasm the medication should be discontinued immediately.

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.