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| __NOTOC__
| | #REDIRECT [[Trandolapril#Warnings]] |
| {{Trandolapril}}
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| {{CMG}}; {{AE}} {{AM}}
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| ==Warnings==
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| ====Anaphylactoid and Possibly Related Reactions====
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| Presumably because [[angiotensin converting enzyme inhibitors]] affect the metabolism of [[eicosanoids]] and polypeptides, including endogenous [[bradykinin]], patients receiving ACE inhibitors, including MAVIK, may be subject to a variety of adverse reactions, some of them serious.
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| ====Anaphylactoid Reactions During Desensitization====
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| Two patients undergoing desensitizing treatment with [[hymenoptera venom]] while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. In the same patients, these reactions did not occur when ACE inhibitors were temporarily withheld, but they reappeared when the ACE inhibitors were inadvertently readministered.
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| ====Anaphylactoid Reactions During Membrane Exposure====
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| Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. Anaphylactoid reactions have also been reported in patients undergoing [[low-density lipoprotein]] apheresis with dextran sulfate absorption.
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| ====Head and Neck Angioedema====
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| In controlled trials ACE inhibitors (for which adequate data are available) cause a higher rate of [[angioedema]] in black than in non-black patients.
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| [[Angioedema]] of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with ACE inhibitors including MAVIK. Symptoms suggestive of [[angioedema]] or facial edema occurred in 0.13% of MAVIK-treated patients. Two of the four cases were life-threatening and resolved without treatment or with medication ([[corticosteroids]]). [[Angioedema]] associated with laryngeal edema can be fatal. If laryngeal [[stridor]] or angioedema of the face, tongue or glottis occurs, treatment with MAVIK should be discontinued immediately, the patient treated in accordance with accepted medical care and carefully observed until the swelling disappears. In instances where swelling is confined to the face and lips, the condition generally resolves without treatment; [[antihistamines]] may be useful in relieving symptoms. Where there is involvement of the tongue, glottis, or larynx, likely to cause airway obstruction, emergency therapy, including but not limited to subcutaneous [[epinephrine]] solution 1:1,000 (0.3 to 0.5 mL) should be promptly administered.
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| ====Intestinal Angioedema====
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| [[Intestinal angioedema]] has been reported in patients treated with ACE inhibitors. These patients presented with [[abdominal pain]] (with or without [[nausea]] or [[vomiting]]); in some cases there was no prior history of facial angioedema and [[C-1 esterase]] levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.
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| ====Hypotension====
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| MAVIK can cause symptomatic [[hypotension]]. Like other ACE inhibitors, MAVIK has only rarely been associated with symptomatic hypotension in uncomplicated hypertensive patients. Symptomatic hypotension is most likely to occur in patients who have been salt- or volume-depleted as a result of prolonged treatment with [[diuretics]], dietary salt restriction, [[dialysis]], [[diarrhea]], or [[vomiting]]. Volume and/or salt depletion should be corrected before initiating treatment with MAVIK. In controlled and uncontrolled studies, [[hypotension]] was reported as an adverse event in 0.6% of patients and led to discontinuations in 0.1% of patients.
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| In patients with concomitant [[congestive heart failure]], with or without associated [[renal insufficiency]], ACE inhibitor therapy may cause excessive [[hypotension]], which may be associated with [[oliguria]] or [[azotemia]], and rarely, with [[acute renal failure]] and death. In such patients, MAVIK therapy should be started at the recommended dose under close medical supervision. These patients should be followed closely during the first 2 weeks of treatment and, thereafter, whenever the dosage of MAVIK or diuretic is increased. Care in avoiding hypotension should also be taken in patients with [[ischemic heart disease]], [[aortic stenosis]], or [[cerebrovascular disease]].
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| If symptomatic hypotension occurs, the patient should be placed in the supine position and, if necessary, normal saline may be administered intravenously. A transient hypotensive response is not a contraindication to further doses; however, lower doses of MAVIK or reduced concomitant diuretic therapy should be considered.
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| ====Neutropenia/Agranulocytosis====
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| Another ACE inhibitor, [[captopril]], has been shown to cause [[agranulocytosis]] and bone marrow depression rarely in patients with uncomplicated hypertension, but more frequently in patients with renal impairment, especially if they also have a collagen-vascular disease such as [[systemic lupus erythematosus]] or [[scleroderma]]. Available data from clinical trials of trandolapril are insufficient to show that trandolapril does not cause [[agranulocytosis]] at similar rates. As with other ACE inhibitors, periodic monitoring of white blood cell counts in patients with collagen-vascular disease and/or renal disease should be considered.
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| ====Hepatic Failure====
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| ACE inhibitors rarely have been associated with a syndrome of [[cholestatic jaundice]], [[fulminant hepatic necrosis]], and death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop [[jaundice]] should discontinue the ACE inhibitor and receive appropriate medical follow-up.
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| ====Fetal Toxicity====
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| ====Pregnancy Category D====
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| Use of drugs that act on the [[renin-angiotensin system]] during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting [[oligohydramnios]] can be associated with [[fetal lung hypoplasia]] and skeletal deformations. Potential neonatal adverse effects include [[skull hypoplasia]], [[anuria]], [[hypotension]], [[renal failure]], and death. When pregnancy is detected, discontinue MAVIK as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.
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| In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If [[oligohydramnios]] is observed, discontinue MAVIK, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that [[oligohydramnios]] may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to MAVIK for [[hypotension]], [[oliguria]], and [[hyperkalemia]].
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| Doses of 0.8 mg/kg/day (9.4 mg/m2/day) in rabbits, 1000 mg/kg/day (7000 mg/m2/day) in rats, and 25 mg/kg/day (295 mg/m2/day) in cynomolgus monkeys did not produce teratogenic effects. These doses represent 10 and 3 times (rabbits), 1250 and 2564 times (rats), and 312 and 108 times (monkeys) the maximum projected human dose of 4 mg based on body-weight and body-surface-area, respectively assuming a 50 kg woman.
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| ====Precautions====
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| ====General====
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| ====Impaired Renal Function====
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| As a consequence of inhibiting the [[renin-angiotensin-aldosterone system]], changes in renal function may be anticipated in susceptible individuals. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors, including MAVIK (trandolapril), may be associated with [[oliguria]] and/or progressive [[azotemia]] and rarely with [[acute renal failure]] and/or death.
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| In hypertensive patients with unilateral or bilateral [[renal artery stenosis]], increases in [[blood urea nitrogen]] and [[serum creatinine]] have been observed in some patients following ACE inhibitor therapy. These increases were almost always reversible upon discontinuation of the ACE inhibitor and/or [[diuretic therapy]]. In such patients, renal function should be monitored during the first few weeks of therapy.
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| Some hypertensive patients with no apparent preexisting renal vascular disease have developed increases in [[blood urea]] and [[serum creatinine]], usually minor and transient, especially when ACE inhibitors have been given concomitantly with a diuretic. This is more likely to occur in patients with preexisting renal impairment. Dosage reduction and/or discontinuation of any diuretic and/or the ACE inhibitor may be required. Evaluation of hypertensive patients should always include assessment of renal function.
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| ====Hyperkalemia and Potassium-sparing Diuretics====
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| In clinical trials, [[hyperkalemia]] (serum potassium > 6.00 mEq/L) occurred in approximately 0.4% of hypertensive patients receiving MAVIK. In most cases, elevated serum potassium levels were isolated values, which resolved despite continued therapy. None of these patients were discontinued from the trials because of [[hyperkalemia]]. Risk factors for the development of hyperkalemia include [[renal insufficiency]], [[diabetes mellitus]], and the concomitant use of [[potassium-sparing diuretics]], potassium supplements, and/or potassium-containing salt substitutes, which should be used cautiously, if at all, with MAVIK.
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| ====Cough====
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| Presumably due to the inhibition of the degradation of endogenous [[bradykinin]], persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy. ACE inhibitor-induced cough should be considered in the differential diagnosis of [[cough]]. In controlled trials of trandolapril, cough was present in 2% of trandolapril patients and 0% of patients given placebo. There was no evidence of a relationship to dose.
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| ====Surgery/Anesthesia====
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| In patients undergoing major surgery or during anesthesia with agents that produce [[hypotension]], MAVIK will block [[angiotensin II]] formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = MAVIK (TRANDOLAPRIL) TABLET [ABBVIE INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5ad67ea2-409c-4f52-a9b8-38216209609a | publisher = | date = | accessdate = }}</ref>
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| ==References==
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| {{Reflist}}
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| {{FDA}}
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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