Fosinopril
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue fosinopril sodium tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS , Fetal Toxicity .
Dosing in kidney impairment
The appearance of hypotension, orthostasis, or azotemia easy in dose titration should not preclude further careful dose titration. Consideration should be given to reducing the dose of concomitant diuretic. For Hypertensive or Heart Failure Patients With Rena/Impairment : In patients with impaired renal function, the total body clearance of fosinoprilat is approximately 50% slower than in patients with normal renal function.
Since hepatobiliary elimination partially compensates for diminished renal elimination, the total body clearance of fosinoprilat does not differ appreciably with any degree of renal insufficiency (creatinine clearances <80 mL/min/1.73m 2 ), including end-stage renal failure (creatinine clearance <10 mL/min/1.73m 2 ). This relative constancy of body clearance of active fosinoprilat, resulting from the dual route of elimination, permits use of the usual dose in patients with any degree of renal impairment. (See WARNINGS, Anaphylactoid Reactions During Membrane Exposure and PRECAUTIONS , Hemodialysis ).
Drug interactions
Check fosinopril against a medication listLabel text (6 paragraphs)
Drug Interactions ). Cough : 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. Impaired Liver Function : Since fosinopril is primarily metabolized by hepatic and gut wall esterases to its active moiety, fosinoprilat, patients with impaired liver function could develop elevated plasma levels of unchanged fosinopril. In a study in patients with alcoholic or biliary cirrhosis. the extent of hydrolysis was unaffected, although the rate was slowed.
In these patients, the apparent total body clearance of fosinoprilat was decreased and the plasma AUC approximately doubled. Surgery/Anesthesia : In patients undergoing surgery or during anesthesia with agents that produce hypotension, fosinopril will block the angiotensin II formation that could otherwise occur secondary to compensatory renin release. Hypotension that occurs as a result of this mechanism can be corrected by volume expansion. Hemodialysis Recent clinical observations have shown an association of hypersensitivity-like (anaphylactoid) reactions during hemodialysis with high-flux dialysis membranes (e.g., AN69) in patients receiving ACE inhibitors as medication.
In these patients, consideration should be given to using a different type of dialysis membrane or a different class of medication (see WARNINGS, Anaphylactoid Reactions During Membrane Exposure ). Information for Patients Angioedema : Angioedema, including laryngeal edema, can occur with treatment with ACE inhibitors, especially following the first dose.
Patients should be advised to immediately report to their physician any signs or symptoms suggesting angioedema (e.g., swelling of face, eyes, lips, tongue, larynx, mucous membranes, and extremities; difficulty in swallowing or breathing; hoarseness) and to discontinue therapy (see WARNINGS, Anaphylactoid and Possible Related Reactions, Head and Neck Angioedema and Intestinal Angioedema ). Symptomatic Hypotension: Patients should be cautioned that lightheadedness can occur, especially during the first days of therapy, and it should be reported to a physician. Patients should be told that if syncope occurs, fosinopril sodium should be discontinued until the physician has been consulted.
All patients should be cautioned that inadequate fluid intake or excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope. Hyperkalemia : Patients should be told not to use potassium supplements or salt substitutes containing potassium without consulting the physician. Neutropenia : Patients should be told to promptly report any indication of infection (e.g., sore throat, fever), which could be a sign of neutropenia. Pregnancy : Female patients of childbearing age should be told about the consequences of exposure to fosinopril during pregnancy.
Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.
Supplement interactions
Dietary supplement interactions
2 noted- ACE inhibitors, such as benazepril (Lotensin), and angiotensin receptor blockers (ARBs) such as losartan (Cozaar), are used to treat hypertension and heart failure, slow progression of kidney disease in patients with chronic kidney disease and type 2 diabetes, and decrease morbidity and mortality after myocardial infarction. These medications reduce urinary potassium excretion, which can lead to hyperkalemia.
- Angiotensin-converting enzyme (ACE) inhibitors, such as benazepril (Lotensin), lisinopril (Prinivil and Zestril), and fosinopril (Monopril), are used primarily to treat high blood pressure. Taking potassium iodide with ACE inhibitors can increase the risk of hyperkalemia (elevated blood levels of potassium).
Contraindications
Fosinopril sodium is contraindicated in patients who are hypersensitive to this product or to any other angiotensin-converting enzyme inhibitor (e.g., a patient who has experienced angioedema with any other ACE inhibitor therapy).
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
DLikelihood score D: Possible rare cause of clinically apparent liver injury.
Fosinopril is an angiotensin-converting enzyme (ACE) inhibitor used in the therapy of hypertension and heart failure. Fosinopril is associated with a low rate of transient serum aminotransferase elevations during therapy and has been linked to rare instances of acute liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
Pregnancy : Female patients of childbearing age should be told about the consequences of exposure to fosinopril during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.
Lactation
Nursing Mothers Ingestion of 20 mg daily for three days resulted in detectable levels of fosinoprilat in breast milk. Fosinopril sodium should not be administered to nursing mothers.
Breastfeeding (LactMed)
Because no information is available on the use of fosinopril during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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