Formoterol Fumarate Dihydrate BP and Budesonide BP
 
Composition : Budetrol 6/100 Mycap: Each Capsule Contains Formoterol Fumarate Dihydrate BP 6 mcg and Budesonide BP 100 mcg inhalation powder.
Budetrol 6/200 Mycap: Each Capsule Contains Formoterol Fumarate Dihydrate BP 6 mcg and Budesonide BP 200 mcg inhalation powder.
 
Indications : Asthma : Formoterol and Budesonide combination is indicated in the regular treatment of asthma where use of a combination (inhaled corticosteroid and long acting β2-agonist) is appropriate. This includes : patients who are not adequately controlled with inhaled corticosteroid therapy and as needed inhaled short-acting β2-adrenoceptor agonists.patients who are already adequately controlled on regular separate long-acting β2-agonist and inhaled corticosteroid therapies.
 
COPD : Formoterol and Budesonide combination is indicated in the regular treatment of adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) with frequent symptoms despite β2-agonist use and a history of exacerbations.
 
Dosage and administration : Asthma : Dosage is individual and should be adjusted according to disease severity. When control has been achieved, the dose should be titrated to the lowest effective dose. For Budetrol Mycap there are two treatment approaches: 1. Maintenance Therapy: Budetrol Mycap is taken as regular maintenance treatment with a separate rapid acting bronchodilator as rescue. 2. Single Maintenance And Reliever Therapy: Budetrol Mycap is taken as regular maintenance and as needed in response to symptoms. 1. Maintenance Therapy: Patients should be advised to have their separate rapid acting bronchodilator available for rescue use at all times. Adults (18 Years and Older): Budetrol 6/100 Mycap: 1-2 Mycap capsules, twice daily. Maximum dose is 4 Mycap capsules, twice daily. Budetrol 6/200 Mycap: 1-2 Mycap capsules, twice daily. Maximum dose is 4 Mycap capsules, twice daily. Adolescents (12-17 Years): Budetrol 6/100 Mycap: 1-2 Mycap capsules, twice daily. Budetrol 6/200 Mycap: 1-2 Mycap capsules, twice daily. Children (6-11 Years): Budetrol 6/100 Mycap: 2 Mycap capsules, twice daily. 2. Single Maintenance And Reliever Therapy (For Budetrol 6/100 and Budetrol 6/200): Patients take a daily maintenance dose of Budetrol Mycap and in combination take Budetrol Mycap as needed in response to symptoms. Patients should be advised to always have Budetrol Mycap cavailable for use. Adults (12 years and older): The recommended maintenance dose is 2 Budetrol Mycap per day, given either as one inhalation in the morning and evening or as 2 Budetrol Mycap in either the morning or evening. For some patients a maintenance dose of 2 Budetrol Mycap twice daily may be appropriate. Patients should take 1 additional Budetrol Mycap as needed in response to symptoms. If symptoms persist after a few minutes, an additional Budetrol Mycap should be taken. Not more than 6 Budetrol Mycap should be taken on any single occasion. A total daily dose of more than 8 Budetrol Mycap is not normally needed; however, a total daily dose of up to 12 Budetrol Mycap could be used for a limited period. Patients using more than 8 Budetrol Mycap daily should be strongly recommended to seek medical advice. COPD (Chronic Obstructive Pulmonary Disease): Budetrol 6/200 Mycap: 2 Mycap capsules, twice daily. Or, as directed by the registered physician. Rinsing the mouth after each inhalation is advised.
 
Use in Pregnancy and lactation : Pregnancy category C. There are no adequate and well controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk of fetus. Budesonide is excreted in human milk. It is not known whether formoterol is excreted in human milk. Caution should be exercised when formoterol is administered to a nursing woman.