men, giving special consideration to the possible need for anti-inflammatory treatment, e.g.,corticosteroids.
5.3 Use of Anti-Inflammatory Agents
The use of beta-adrenergic-agonist bronchodilators alone may not be adequate to control asthma in many patients. Earlyconsideration should be given to adding anti-inflammatory agents, e.g., corticosteroids, to the therapeutic regimen.
5.4 Cardiovascular Effects
ProAir Digihaler, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in somepatients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon afteradministration of ProAir Digihaler at recommended doses, if they occur, the drug may need to be discontinued. Inaddition, beta-agonists have been reported to produce ECG changes, such as flattening of the T-wave, prolongation of theQTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, ProAirDigihaler, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders,especially coronary insufficiency, cardiac arrhythmias, and hypertension.
5.5 Do Not Exceed Recommended Dose
Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma.
The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmaticcrisis and subsequent hypoxia is suspected.
5.6 Immediate Hypersensitivity Reactions
Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases ofurticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. ProAir Digihaler contains small amounts of lactose, which may contain trace levels of milk proteins. Hypersensitivity reactions including anaphylaxis,
angioedema, pruritus, and rash have been reported with the use of therapies containing lactose (lactose is an inactive
ingredient in ProAir Digihaler). The potential for hypersensitivity must be considered in the clinical eva luation of patients
who experience immediate hypersensitivity reactions while receiving ProAir Digihaler.
5.7 Coexisting Conditions
ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders,
especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders,
hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines.
Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be
expected to occur in some patients after use of any beta-adrenergic bronchodilator. Large doses of intravenous albuterol
have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.
5.8 Hypokalemia
As with other beta-agonists, ProAir Digihaler may produce significant hypokalemia in some patients, possibly through
intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient,
not requiring supplementation.
6 ADVERSE REACTIONS
Use of ProAir Digihaler may be associated with the following:
• Paradoxical bronchospasm [see Warnings and Precautions (5.1)]
• Cardiovascular Effe |
