What is it?
Budamate Transhaler is a combination of budesonide, a potent glucocorticoid and formoterol, a selective long-acting beta-2-agonist. Budesonide is a potent glucocorticoid that binds with high affinity to the glucocorticoid receptor. It has a high ratio of topical to systemic activity. Formoterol is a very potent long-acting beta-2-agonist with a high intrinsic activity and a rapid onset of action.
Indication
Budamate Transhaler is indicated in the regular treatment of asthma, where use of a combination (long acting beta-2-agonist and inhaled corticosteroid) has been found to be appropriate. Symptomatic treatment of severe chronic obstructive pulmonary disease (COPD) with a history of repeated exacerbations despite regular therapy with long acting bronchodilators.
Dosage & Administration
Dosage is individual and adjusted according to disease severity. When control has been achieved, the dose should be titrated to the lowest effective dose, which could include Budamate Transhaler given once daily.
Asthma
Adults (18 years and older):
Budamate – 100/ 200 Transhaler
1 – 2 inhalations twice daily
Maximum dose is 4 inhalations twice daily
Budamate – 400 Transhaler
1 inhalation twice daily
Maximum dose is 2 inhalations twice daily
Adolescents (12-17 years):
Budamate – 100/ 200 Transhaler
1 – 2 inhalations twice daily
Budamate – 400 Transhaler
1 inhalation twice daily
Children (6-11 years):
Budamate – 100 Transhaler
1 – 2 inhalations twice daily
Budamate – 200 Transhaler
1 inhalation twice daily
Chronic Obstructive pulmonary Disease (COPD)
Budamate- 200 Transhaler
2 inhalations twice daily
Budamate – 400 Transhaler
1 inhalation twice daily
Contradictions
Budamate Transhaler is contraindicated in patients with a history of hypersensitivity to any of the component of the drug product.
Warnings & Precautions
Patients should be made aware that Budamate Transhaler must be used daily for optimum benefit, even when asymptomatic.
Budamate Transhaler should not be used to treat acute asthma symptoms for which a fast and short-acting bronchodilator is required. Patients should be advised to have their relief medication available at all times.
Sudden and progressive deterioration in control of asthma is potentially life threatening and consideration should be given to the need for increased therapy with corticosteriod.
As with all inhaled medication containing corticosteroids, Budamate Transhaler should be administered with caution in patients with pulmonary tuberculosis.
Budamate Transhaler should be administered with caution in patients with severe cardiovascular disorders, including heart rhythm abnormalities, diabetes mellitus, untreated hypokalaemia or thyrotoxicosis.
Potentially serious hypokalaemia may result from systemic agonist therapy but following inhalation at therapeutic doses plasma levels of formoterol are very low.
Paradoxical bronchospasm may occur. In such case Budamate Transhaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Systemic effects are much less likely to occur with inhaled corticosteroids than with oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. It is important, therefore, that the dose is titrated to the lowest dose at which effective control is maintained.
Drug Interactions
Even though plasma levels of formoterol and budesonide are very low, potential interactions with other substrates or inhibitors of CYP3A4 cannot be excluded.
Both non-selective and selective beta-blockers should be avoided in patients with asthma, unless there are compelling reasons for their use.
Concomitant use of other beta-adrenergic containing drugs can have a potentially additive effect.
Pregnancy
Administration of Budamate Transhaler in pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Lactation
Use of Budamate Transhaler in women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
Side Effects
As Budamate Transhaler contains formoterol and budesonide, the type and severity of side effects associated with each of the compounds may be expected. There is no incidence of additional effects following concurrent administration of the two compounds.
Side effects associated with -
Formoterol:
Tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.
Cardiac arrhythmias muscle cramps and hypersensitivity reactions, including rash, oedema and angioedema may occur in some patients.
Budesonide:
Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported.
Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Budamate Transhaler.
Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst still continuing with Budamate Transhaler.
Overdose
The signs and symptoms of Budamate overdose are tremor, headache and tachycardia. The preferred antidotes are cardioselective beta-blocking agents, which should be used with caution in patients with a history of bronchospasm. If higher than recommended dosage is continued over prolonged periods, some degree of adrenal suppression may result. Monitoring of adrenal reserve may be necessary.
