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| {{DrugProjectFormSinglePage
| | #REDIRECT [[Fosinopril]] |
| |authorTag={{AZ}}, {{AM}}
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| |genericName=Fosinopril
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| |aOrAn=an
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| |drugClass=Angiontensin converting enzyme inhibitor
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| |indication=[[hypertension]], [[heart failure]]
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| |hasBlackBoxWarning=Yes
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| |adverseReactions=[[hypotension]] (2.4% to 4.4%), [[hyperkalemia]] (2.6% ), [[dizziness]] (1.6% to 11.9% ), [[cough]] (2.2% to 9.7%).
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| |blackBoxWarningTitle=USE IN PREGNANCY
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| |blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, enalapril maleate should be discontinued as soon as possible.
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| |fdaLIADAdult======Hypertension=====
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| * Dosing Information
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| :* Initial dose (not receiving a diuretic): '''Fosinopril 10 mg PO qd''' should be used.
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| :* Maintenance dose: '''Fosinopril 20-40 mg PO qd on two divided doses, adjust dose based on response (MAX 40 mg/day)'''
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| =====Heart failure=====
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| * Dosing Information
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| :* Initial dose : '''Fosinopril''' 5 -10 mg PO qd or bid
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| :* Maintenance dose: '''Fosinopril 20-40 mg PO qd or Fosinopril 10—20 mg PO bid, in a divided doses (MAX 40 mg/day)'''
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| |warnings=====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 Fosinoprilat) may be subject to a variety of adverse reactions, some of them serious.
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| ====Head and Neck Angioedema====
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| * [[Angioedema]] of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with angiotensin converting enzyme inhibitors, including Fosinoprilat. This may occur at any time during treatment. In such cases Fosinoprilat should be promptly discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms has occurred. In instances where swelling has been confined to the face and lips the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms. Angioedema associated with [[laryngeal edema]] may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, e.g., subcutaneous epinephrine solution 1:1000 (0.3 mL to 0.5 mL) and/or measures necessary to ensure a patent airway, should be promptly provided (see ADVERSE REACTIONS).
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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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| ====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 were avoided when ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge.
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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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| ====Hypotension====
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| * Excessive hypotension is rare in uncomplicated hypertensive patients treated with Fosinoprilat alone. Patients with heart failure given Fosinoprilat commonly have some reduction in blood pressure, especially with the first dose, but discontinuation of therapy for continuing symptomatic hypotension usually is not necessary when dosing instructions are followed; caution should be observed when initiating therapy. Patients at risk for excessive hypotension, sometimes associated with [[oliguria]] and/or progressive [[azotemia]], and rarely with acute renal failure and/or death, include those with the following conditions or characteristics: [[heart failure]], [[hyponatremia]], high dose diuretic therapy, recent intensive diuresis or increase in diuretic dose, [[renal dialysis]], or severe volume and/or salt depletion of any etiology. It may be advisable to eliminate the diuretic (except in patients with heart failure), reduce the diuretic dose or increase salt intake cautiously before initiating therapy with Fosinoprilat in patients at risk for excessive hypotension who are able to tolerate such adjustments. In patients at risk for excessive [[hypotension]], therapy should be started under very close medical supervision and such patients should be followed closely for the first two weeks of treatment and whenever the dose of Fosinopril and/or diuretic is increased. Similar considerations may apply to patients with [[ischemic heart]] or [[cerebrovascular disease]], in whom an excessive fall in blood pressure could result in a [[myocardial infarction]] or [[cerebrovascular accident]].
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| * If excessive [[hypotension]] occurs, the patient should be placed in the supine position and, if necessary, receive an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further doses of Fosinoprilat, which usually can be given without difficulty once the blood pressure has stabilized. If symptomatic hypotension develops, a dose reduction or discontinuation of Fosinoprilat or concomitant [[diuretic]] may be necessary.
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| ====Neutropenia/Agranulocytosis====
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| * Another angiotensin converting enzyme inhibitor, captopril, has been shown to cause [[agranulocytosis]] and [[bone marrow depression]], rarely in uncomplicated patients but more frequently in patients with renal impairment especially if they also have a [[collagen vascular disease]]. Available data from clinical trials of Fosinopril are insufficient to show that Fosinopril does not cause agranulocytosis at similar rates. Marketing experience has revealed cases of [[neutropenia]] or [[agranulocytosis]] in which a causal relationship to Fosinopril cannot be excluded. Periodic monitoring of white blood cell counts in patients with collagen vascular disease and renal disease should be considered.
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| ====Hepatic Failure====
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| * Rarely, ACE inhibitors have been associated with a syndrome that starts with [[cholestatic jaundice]] and progresses to [[fulminant hepatic necrosis]], and (sometimes) death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop [[jaundice]] or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.
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| ====Fetal/Neonatal Morbidity and Mortality====
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| * ACE inhibitors can cause fetal and neonatal morbidity and death when administered to pregnant women. Several dozen cases have been reported in the world literature. When pregnancy is detected, ACE inhibitors should be discontinued as soon as possible.
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| * In a published restrospective epidemiological study, infants whose mothers had taken an ACE inhibitor during their first trimester of pregnancy appeared to have an increased risk of major [[congenital malformations]] compared with infants whose mothers had not undergone first trimester exposure to ACE inhibitor drugs. The number of cases of birth defects is small and the findings of this study have not yet been repeated.
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| * The use of ACE inhibitors during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal [[skull hypoplasia]], [[anuria]], reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; [[oligohydramnios]] in this setting has been associated with fetal limb contractures, craniofacial deformation, and [[hypoplastic lung development]]. [[Prematurity]], [[intrauterine growth retardation]], and [[patent ductus arteriosus]] have also been reported, although it is not clear whether these occurrences were due to the ACE-inhibitor exposure.
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| * These adverse effects do not appear to have resulted from intrauterine ACE-inhibitor exposure that has been limited to the first trimester. Mothers whose embryos and fetuses are exposed to ACE inhibitors only during the first trimester should be so informed. Nonetheless, when patients become pregnant, physicians should make every effort to discontinue the use of Fosinoprilat as soon as possible.
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| * Rarely (probably less often than once in every thousand pregnancies), no alternative to ACE inhibitors will be found. In these rare cases, the mothers should be apprised of the potential hazards to their fetuses, and serial ultrasound examinations should be performed to assess the intraamniotic environment.
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| * If [[oligohydramnios]] is observed, Fosinoprilat should be discontinued unless it is considered lifesaving for the mother. [[Contraction stress testing]] ([[CST]]), a [[non-stress test]] ([[NST]]), or [[biophysical profiling]] ([[BPP]]) may be appropriate, depending upon the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
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| * Infants with histories of in utero exposure to ACE inhibitors should be closely observed for hypotension, oliguria, and [[hyperkalemia]]. If [[oliguria]] occurs, attention should be directed toward support of blood pressure and renal perfusion. Exchange transfusion or [[dialysis]] may be required as means of reversing hypotension and/or substituting for disordered renal function. Fosinopril, which crosses the placenta, has been removed from [[neonatal circulation]] by [[peritoneal dialysis]] with some clinical benefit, and theoretically may be removed by [[exchange transfusion]], although there is no experience with the latter procedure.
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| * No teratogenic effects of Fosinopril were seen in studies of pregnant rats and rabbits. On a body surface area basis, the doses used were 57 times and 12 times, respectively, the maximum recommended human daily dose (MRHDD).
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