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Details with Side Effects
Patients should be instructed to read the accompanying Medication Guide with each new prescription and refill. The complete text of the Medication Guide is reprinted at the end of this document. Patients should be given the following information:
Asthma-Related Deaths, Acute Exacerbations or Deteriorations
Patients should be informed that long-acting beta2-adrenergic agonists, such as BROVANA Inhalation Solution, increase risk of asthma-related death in patients with asthma.
BROVANA Inhalation Solution is not indicated to relieve acute respiratory symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting, beta2-agonist (the health-care provider should prescribe the patient with such medication and instruct the patient in how it should be used). Patients should be instructed to seek medical attention if their symptoms worsen despite recommended doses of BROVANA Inhalation Solution, if BROVANA Inhalation Solution treatment becomes less effective, or if they need more inhalations of a short-acting beta2-agonist than usual.
Patients should not stop using BROVANA Inhalation Solution unless told to do so by a healthcare provider because symptoms may get worse. Patients should not inhale more than one dose at any one time. The daily dosage of BROVANA Inhalation Solution should not exceed one unit-dose vial (15 mcg) by inhalation twice daily (30 mcg total daily dose). Excessive use of sympathomimetics may cause significant cardiovascular effects, and may be fatal.
Patients who have been taking inhaled, short-acting beta2-agonists (e.g., levalbuterol) on a regular basis should be instructed to discontinue the regular use of these products and use them only for the symptomatic relief of acute symptoms.
BROVANA Inhalation Solution should not be used in conjunction with other inhaled medications containing long-acting beta2-agonists. Patients should be warned not to stop or change the dose of other concomitant COPD therapy without medical advice, even if symptoms improve after initiating treatment with BROVANA Inhalation Solution.
Common Adverse Reactions with Beta2-agonists
Patients should be informed that treatment with beta2-agonists may lead to adverse reactions that include palpitations, chest pain, rapid heart rate, increased or decreased blood pressure, headache, tremor, nervousness, dry mouth, muscle cramps, nausea, dizziness, fatigue, malaise, low blood potassium, high blood sugar, high blood acid, or trouble sleeping [see ADVERSE REACTIONS].
Instructions for Administration
It is important that patients understand how to use BROVANA Inhalation Solution with a nebulizer appropriately and how it should be used in relation to other medications to treat COPD they are taking [see the accompanying Medication Guide]. Patients should be instructed not to mix other medications with BROVANA Inhalation Solution and not to inject or swallow BROVANA Inhalation Solution. Patients should throw the plastic dispensing vials away immediately after use. Due to their small size, the vials pose a danger of choking to young children.
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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