ay need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiographic changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression, although the clinical significance of these findings is unknown.
Therefore, BEVESPI AEROSPHERE should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
5.7. Coexisting Conditions
BEVESPI AEROSPHERE, like all medications containing sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis and in those who are unusually responsive to sympathomimetic amines. Doses of the related beta2-agonist albuterol, when administered intravenously, have been reported to aggravate pre-existing diabetes mellitus and ketoacidosis.
5.8. Hypokalemia and Hyperglycemia
Beta2-agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects [see CLINICAL PHARMACOLOGY (12.2)]. The decrease in serum potassium is usually transient, not requiring supplementation. Beta2-agonist medicines may produce transient hyperglycemia in some patients. In two clinical trials of 24-weeks and a 28-week safety extension study eva luating BEVESPI AEROSPHERE in subjects with COPD, there was no evidence of a treatment effect on serum glucose or potassium.
5.9. Worsening of Narrow-Angle Glaucoma
BEVESPI AEROSPHERE should be used with caution in patients with narrow-angle glaucoma. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately should any of these signs or symptoms develop.
5.10. Worsening of Urinary Retention
BEVESPI AEROSPHERE should be used with caution in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to consult a physician immediately should any of these signs or symptoms develop.
6 ADVERSE REACTIONS
LABAs, such as formoterol fumarate, one of the active ingredients in BEVESPI AEROSPHERE, increase the risk of asthma-related death. BEVESPI AEROSPHERE is not indicated for the treatment of asthma [see BOXED WARNING and WARNINGS AND PRECAUTIONS (5.1)].
The following adverse reactions are described in greater detail elsewhere in the labeling:
•
Paradoxical bronchospasm [see WARNINGS AND PRECAUTIONS (5.4)]
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Hypersensitivity reactions [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.5)]
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Cardiovascular effects [see WARNINGS AND PRECAUTIONS (5.6)]
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Worsening of narrow-angle glaucoma [see WARNINGS AND PRECAUTIONS (5.9)]
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Worsening of urinary retention [see WARNINGS AND PRECAUTIONS (5.10)]
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of an |
