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ASTHMA RELATED DEATH
Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US 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 is considered a class effect of LABA, including arformoterol, the active ingredient in BROVANA Inhalation Solution [see WARNINGS AND PRECAUTIONS]. The safety and efficacy of BROVANA Inhalation Solution in patients with asthma have not been established. All LABA, including BROVANA Inhalation Solution, are contraindicated in patients with asthma without use of a long-term asthma control medication [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS].
BROVANA (arformoterol tartrate) Inhalation Solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol. Arformoterol is a selective beta2-adrenergic bronchodilator. The chemical name for arformoterol tartrate is formamide, N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-, (2R,3R)-2,3dihydroxybutanedioate (1:1 salt), and its established structural formula is as follows:
The molecular weight of arformoterol tartrate is 494.5 g/mol, and its empirical formula is C19H24N2O4•C4H6O6 (1:1 salt). It is a white to off-white solid that is slightly soluble in water.
Arformoterol tartrate is the United States Adopted Name (USAN) for (R,R)formoterol L-tartrate.
BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate.
BROVANA Inhalation Solution requires no dilution before administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend upon patient factors, the nebulizer used, and compressor performance. Using the PARI LC® PLUS nebulizer (with mouthpiece) connected to a PARI DURA NEB™3000 compressor under in vitro conditions, the mean delivered dose from the mouthpiece (% nominal) was approximately 4.1 mcg (27.6%) at a mean flow rate of 3.3 L/min. The mean nebulization time was 6 minutes or less. BROVANA Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via face mask or mouthpiece.
Patients should be carefully instructed on the correct use of this drug product (please refer to the accompanying Medication Guide).
What are the possible side effects of arformoterol inhalation (Brovana)?
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 a serious side effect such as:
- bronchospasm (wheezing, chest tightness, trouble breathing);
- chest pain, fast or pounding heart beats, restless feeling, tremor;
- feeling short of breath, even with mild exertion;
- swelling, rapid weight gain;
- white patches or sores inside your mouth or on your lips; or
- dry mouth, increased...
What are the precautions when taking arformoterol tartrate inhalation solution (Brovana)?
Before using arformoterol, tell your doctor or pharmacist if you are allergic to it; or to formoterol; or to sympathomimetic drugs (e.g., phenylephrine, pseudoephedrine); 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: heart problems (e.g., irregular heartbeat, angina), high blood pressure, overactive thyroid (hyperthyroidism), seizures, diabetes, liver problems, certain metabolic problem (ketoacidosis).
Arformoterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely...
Last reviewed on RxList: 8/26/2011
This monograph has been modified to include the generic and brand name in many instances.
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