Symbion Maxhaler
Generic Name: Inhalation Powder, Pre-dispensed
Dosage Form: Formoterol Fumarate Dihydrate and Budesonide
TG Name: Respiratory
1. What Symbion® F Maxhaler® is and what it is used for?
Symbion® F Maxhaler® is a Multi dose Dry Powder Inhaler, combination of Formoterol Fumarate Dihydrate BP and Budesonide BP. Formoterol Fumarate is a selective, long acting β2 agonist used in the treatment of asthma and other forms of diffuse airways obstruction. Budesonide is a corticosteroid with mainly glucocorticoid activity. Budesonide is stated to exert a topical effect on the lungs without systemic effects at usual dose.
Maxhaler® is a moulded plastic device containing a foil strip with 60 regularly placed blisters containing pre-dispensed inhalation powder. Symbion® is indicated in the regular treatment of asthma and COPD.
Mechanism of action
Budesonide: Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. 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 COPD and asthma.
Formoterol Fumarate: Formoterol Fumarate is a long-acting, selective beta2-adrenergic agonist with a rapid onset of action. Inhaled Formoterol Fumarate acts locally in the lungs as a bronchodilator.
2. How to take Symbion® Maxhaler®?
Asthma:
Adults and Adolescents (12 years and older):
As SMART Therapy:
Symbion® 6/100 Maxhaler®: One Inhalation twice daily as maintenance dose & upto 6 inhalation as reliever dose in response to symptom.
Symbion® 6/200 Maxhaler®: One Inhalation twice daily as maintenance dose & upto 6 inhalation as reliever dose in response to symptom.
As Maintenance Therapy:
Symbion® 12/400 Maxhaler®: One Inhalation twice daily as maintenance dose.
3. Possible side effects
The following side effects are generally observed:
Formoterol: Most common adverse events with Formoterol are tremor, palpitations, headache etc. Some uncommon and rare adverse events that occurred in the groups receiving Formoterol are cardiac arrhythmias, muscle cramps, and hypersensitivity reactions such as rash, edema and angio-oedema etc.
Budesonide: The incidence of common adverse events with Budesonide are oropharyngeal candidiasis, hoarseness or throat irritation, dysphonia, back pain, nausea, sinusitis, adrenal suppression, etc.
4. Use During Pregnancy and Lactation
There are no adequate data from use of Formoterol and Budesonide in pregnant women. Administration of Symbion® in pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
Budesonide is excreted in breast milk. However, at therapeutic doses no effects on the suckling child are anticipated. It is not known whether Formoterol passes into human breast milk.
5. Warnings & Precaution
Symbion® Maxhaler® 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 inhaler to be used for relief in an acute asthma attack available at all times.
6. How to store Symbion® Maxhaler?
Avoid storage in direct sunlight or heat. Do not store above 30° C. Store in a dry place. Keep away from children. Store your Maxhaler® in Carry-bag and always keep your information leaflet inside.
Special precautions for disposal and other handling of Symbion® Maxhaler®
Do not open until you ready to inhale it because after each opening of mouthpiece cover one dose is opened and your device will be clogged if it is not inhaled. If you accidentally open mouthpiece cover/ lever, make sure to gently shaking by holding mouthpiece downward to remove extra powder. The Maxhaler® releases a powder which is inhaled into the lungs. A dose indicator on the Maxhaler® indicates the number of doses left.
