Generics: Budesonide + Formoterol fumarate dihydrate
Dosage Form: Inhalation capsule.
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.
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.
Inhaler (For Asthma)-
- 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.
Inhalation Capsule (For Asthma): There are two alternative dosage regimens for the treatment of asthma with Budesonide and Formoterol combination. Budesonide and Formoterol 100 & 200 Inhalation Capsule maintenance and reliever therapy.
Adults and adolescents (12 years and older):
- Maintenance dose: Budesonide and Formoterol 100 & 200 Inhalation Capsule twice daily
- Reliever dose: 1 additional Inhalation Capsule as needed in response to symptoms. If symptoms persist after a few minutes, an additional Inhalation Capsule should be taken. Not more than 6 Inhalation Capsule should be taken on any single occasion. A total daily dose of more than 8 Inhalation Capsule is not normally needed, however, a total daily dose of up to 12 Inhalation Capsule can be used temporarily.
- Children (4 years and older):
- Maintenance dose: Budesonide and Formoterol 100 Inhalation Capsule once daily.
- Reliever dose: 1 additional Inhalation Capsule as needed in response to symptoms. If symptoms persist after a few minutes, an additional Inhalation Capsule should be taken. Not more than 4 Inhalation Capsule should be taken on any single occasion. A total daily dose of more than 4 Inhalation Capsule is not normally needed, however, a total daily dose of up to 8 Inhalation Capsule could be used temporarily.
- Inhalation Capsule (For COPD): Adults (40 years and older)
- 200 Inhalation Capsule: 2 Inhalation Capsule twice daily. Maximum daily maintenance dose: 4 Inhalation Capsule
- 400 Inhalation Capsule: 1 Inhalation Capsule twice daily. Maximum daily maintenance dose: 2 Inhalation Capsule.
Route of administration: Intra nasal.
Concomitant treatment with Ritonavir, Itraconazole, Ketoconazole or other potent CYP3A4 inhibitors should be avoided.
Hypersensitivity to Budesonide, Formoterol or to Lactose.
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 & Warnings:
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.
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.
Long-acting selective β-adrenergic receptor stimulant, respiratory corticosteroid
Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.
Manufactured by: Square Pharmaceuticals Ltd.