"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
Patients should be instructed to take LEXXEL (enalapril maleate-felodipine) whole and not to divide, crush or chew the tablet.
All patients should be advised to consult their physician if they experience any of the following conditions:
Angioedema- Angioedema, including laryngeal edema, may occur at any time during treatment with angiotensin converting enzyme inhibitors, including enalapril. 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 take no more drug until they have consulted with the prescribing physician.
Hypotension- Patients should be cautioned to report light- headedness especially during the first few days of therapy. If actual syncope occurs, the patients should be told to discontinue LEXXEL (enalapril maleate-felodipine) until they have consulted with the prescribing physician. All patients should be cautioned that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume. Other causes of volume depletion, such as vomiting or diarrhea, may also lead to a fall in blood pressure; patients should be advised to consult with the physician.
Hyperkalemia- Patients should be told not to use salt substitutes containing potassium without consulting their physician.
Pregnancy- 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.
Gingival Hyperplasia- Patients should be told that mild gingival hyperplasia (gum swelling) has been reported. Good dental hygiene decreases its incidence and severity.
Note: As with many other drugs, certain advice to patients being treated with LEXXEL (enalapril maleate-felodipine) 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.
Last reviewed on RxList: 10/25/2007
This monograph has been modified to include the generic and brand name in many instances.
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