Budesonide + Formoterol Fumarate Dihydrate

Prescribing Information (Research Brand)

Indications

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.

Therapeutic Class

Long-acting selective β2-adrenoceptor stimulants, Respiratory corticosteroids

Pharmacology

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.

Dosage & Administration

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

Interaction

Concomitant treatment with Ritonavir, Itraconazole, Ketoconazole or other potent CYP3A4 inhibitors should be avoided.

Contraindications

Hypersensitivity to Budesonide, Formoterol or to Lactose.

Side Effects

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.

Pregnancy & Lactation

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

Precautions

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.

Use in Special Population

It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be re evaluated with the aim of reducing the dose of inhaled corticosteroid. The benefits of the corticosteroid therapy and the possible risks of growth suppression must be carefully weighed. In addition consideration should be given to referring the patient to a paediatric respiratory specialist.

Storage Conditions

Protect from light, store in cool & dry place. Do not store above 30° C. Keep out of the reach of children. Protect from freezing.

Available Brand Names