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(budesonide 80 mcg and formoterol fumarate dihydrate* 4.5 mcg) Inhalation Aerosol
SYMBICORT (budesonide and formoterol fumarate dihydrate) ® 160/4.5
(budesonide 160 mcg and formoterol fumarate dihydrate* 4.5 mcg) Inhalation Aerosol
WARNING: RISK OF ASTHMA RELATED DEATH
Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. Therefore, when treating patients with asthma, SYMBICORT (budesonide and formoterol fumarate dihydrate) should only be used for patients not adequately controlled on other asthma-controller medications (e.g., low-to-medium dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. Data from a large placebo-controlled U.S. study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting beta2-adrenergic agonist), one of the active ingredients in SYMBICORT [see WARNINGS AND PRECAUTIONS].
SYMBICORT (budesonide and formoterol fumarate dihydrate) 80/4.5 and SYMBICORT (budesonide and formoterol fumarate dihydrate) 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only.
Each SYMBICORT (budesonide and formoterol fumarate dihydrate) 80/4.5 and SYMBICORT (budesonide and formoterol fumarate dihydrate) 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing either 60 or 120 actuations [see Dosage Forms and Strengths and HOW SUPPLIED]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. SYMBICORT (budesonide and formoterol fumarate dihydrate) also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant.
SYMBICORT (budesonide and formoterol fumarate dihydrate) should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face.
One active component of SYMBICORT (budesonide and formoterol fumarate dihydrate) is budesonide, a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is:
Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103.
The other active component of SYMBICORT (budesonide and formoterol fumarate dihydrate) is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is:
Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group.
What are the possible side effects of budesonide and formoterol inhalation (Symbicort)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- worsening asthma symptoms;
- chest pain, fast or pounding heartbeats, tremors, nervousness;
- wheezing, throat irritation, choking, or other breathing problems after using this medication;
- signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding, unusual...
What are the precautions when taking budesonide and formoterol fumarate dihydrate (Symbicort)?
Before using this medication, tell your doctor or pharmacist if you are allergic to budesonide or formoterol; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/past infections (such as tuberculosis, herpes), high blood pressure, heart disease (such as chest pain, heart attack, irregular heartbeat), overactive thyroid (hyperthyroidism), seizures, bone loss (osteoporosis), eye problems (such as cataracts, glaucoma), diabetes, liver disease, swelling of an artery (aneurysm), a certain tumor of the adrenal gland (pheochromocytoma).
Last reviewed on RxList: 6/2/2009
This monograph has been modified to include the generic and brand name in many instances.
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