Classes
DEA Class; Rx
Common Brand Names; Symbicort
- Respiratory Inhalant Combos
Description
Combination of an inhaled corticosteroid (ICS), budesonide, and a long-acting beta-2 agonist (LABA), formoterol; inhaled twice daily
Indicated for the maintenance treatment of asthma in adult and pediatric patients 6 years and older; clinical trials also support this combination for reliever therapy
Also used in adults for the maintenance treatment of COPD and to reduce exacerbations of COPD
Indications
Contraindications
Hypersensitivity
Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures
Adverse Effects
- Upper respiratory tract infection (URTI) (8-11%)
- Headache (7-11%)
- Nasopharyngitis (7-11%)
- Pharyngolaryngeal pain (6-9%)
- Stomach discomfort (1-7%)
- Sinusitis (5-6%)
- Oral candidiasis (1-6%)
- Bronchitis (5%)
- Viral URTI (4%)
- Backache (2-3%)
- Influenza (2-3%)
- Nasal congestion (2-3%)
- Vomiting (1- 3%)
Cardiovascular: Angina pectoris, tachycardia, atrial and ventricular tachyarrhythmias, atrial fibrillation, extrasystoles, palpitations, hypotension, hypertension
Warnings
Use of LABAs as monotherapy (without inhaled corticosteroids) for asthma is associated with an increased risk of asthma-related death
Data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patient
These findings are considered a class effect of LABA monotherapy
When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone
Do not initiate in patients experiencing rapidly deteriorating or potentially life-threatening asthma or COPD episodes; additionally, increased inhaled SABA use is marker of deteriorating asthma
Do not use for relief of acute symptoms (rescue therapy)
Maximum dosage must not be exceeded, because of increased risk of serious cardiovascular effects
Localized infections with Candida albicans in mouth and pharynx occur in some patients; to reduce risk, mouth must be rinsed after inhalation
Monitor COPD patients for signs and symptoms of pneumonia and lung infections
Risk of more serious or fatal course of chickenpox or measles exists in susceptible patients (eg, unvaccinated or immunologically unexposed individuals); care must be taken to avoid exposure
Pregnancy and Lactation
In women with poorly or moderately controlled asthma, there is increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in neonate
There are no available data on the breastfed child or on milk production; budesonide, like other inhaled corticosteroids, is present in human milk
Maximum Dosage
640 mcg of budesonide and 18 mcg of formoterol via oral inhalation/day. The maximum number of inhalations to be administered/day regardless of strength of Symbicort is 4.
640 mcg of budesonide and 18 mcg of formoterol via oral inhalation/day. The maximum number of inhalations to be administered/day regardless of strength of Symbicort is 4.
640 mcg of budesonide and 18 mcg of formoterol via oral inhalation/day. The maximum number of inhalations to be administered/day regardless of strength of Symbicort is 4.
12 years: 640 mcg of budesonide and 18 mcg of formoterol via oral inhalation/day. The maximum number of inhalations to be administered/day regardless of strength of Symbicort is 4.
6 to 11 years: 320 mcg of budesonide and 18 mcg of formoterol via oral inhalation/day. The maximum number of inhalations to be administered/day of Symbicort is 4.
1 to 5 years: Safety and efficacy have not been established.
How supplied
Budesonide/formoterol fumarate dihydrate
inhalation aerosol (Symbicort, generic)
- (80mcg/4.5mcg)/actuation
- (160mcg/4.5mcg)/actuation
