Angioedema, including laryngeal edema, may occur at any time during treatment with ACE inhibitors,
including MAVIK. Patients should be so advised and told to report immediately any signs or symptoms suggesting
angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing) and to stop
taking the drug until they have consulted with their physician.
Patients should be cautioned that light-headedness can occur, especially during the first days of
MAVIK therapy, and should be reported to a physician. If actual syncope occurs, patients should be told to stop
taking the drug until they have consulted with their physician All patients should be cautioned that inadequate fluid
intake, excessive perspiration, diarrhea, or vomiting, resulting in reduced fluid volume, may precipitate an
excessive fall in blood pressure with the same consequences of light-headedness and possible syncope.
Patients planning to undergo any surgery and/or anesthesia should be told to inform their physician
that they are taking an ACE inhibitor that has a long duration of action.
Patients should be told not to use potassium supplements or salt substitutes containing potassium
without consulting their physician.
Patients should be told to report promptly any indication of infection (e.g., sore throat, fever)
which could be a sign of neutropenia.
Female patients of childbearing age should be told about the consequences of second- and
third-trimester exposure to ACE inhibitors, and they should also be told that these consequences do not appear to
have resulted from intrauterine ACE-inhibitor exposure that has been limited to the first trimester. These patients
should be asked to report pregnancies to their physicians as soon as possible. NOTE: As with many other drugs,
certain advice to patients being treated with MAVIK is warranted. This information is intended to aid in the safe and
effective use of this medication. It is not a disclosure of all possible adverse or intended effects.