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Lotensin
Generic Name: Benazepril Hydrochloride
Drug Category: ACE Inhibitor
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 6 years old for a maximum duration of 2 years.
| Approved Uses |
|
Indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. When pregnancy is detected, discontinue Lotensin as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Lotensin is contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment. Avoid use of Lotensin in patients who are hemodynamically unstable after acute MI. Lotensin is not recommended in pediatric patients less than 6 years of age or in pediatric patients with GFR less than 30 mL/min/1.73m². Lotensin can also worsen renal function. Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with angiotensin-converting enzyme inhibitors. Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non blacks. Intestinal angioedema has occurred in patients treated with ACE inhibitors. ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. Intestinal angioedema has occurred in patients treated with ACE inhibitors. Lotensin can cause symptomatic hypotension, sometimes complicated by oliguria, progressive azotemia acute renal failure or death. Serum potassium should be monitored periodically in patients receiving Lotensin. Drugs that inhibit the renin-angiotensin system can cause 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. Lotensin is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Lotensin within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor. Patients receiving coadministration of ACE inhibitor and mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema. In patients undergoing major surgery or during anesthesia with agents that produce hypotension, Lotensin may block angiotensin II formation secondary to compensatory renin release. In general, avoid combined use of RAS inhibitors. Dual Blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypertension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including benazepril, may result in deterioration of renal function, including possible acute renal failure. Concomitant administration of Lotensin and antidiabetic medicines (insulins, oral hypoglycemic agents) may increase the risk of hypoglycemia. Do not co-administer aliskiren with angiotensin receptor blockers, ACE inhibitors, including Lotensin in patients with diabetes. Lithium toxicity has been reported in patients receiving lithium concomitantly with Lotensin. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. 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 Lotensin as soon as possible. Minimal amounts of unchanged benazepril and of benazeprilat are excreted into the breast milk of lactating women treated with benazepril. |
| Off-label Uses |
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• Use in patients under the age of 6. GoToSource • Total adult daily dosage greater than 80 mg with normal renal function. GoToSource • Cutaneous and lymphatic sarcoidosis. GoToSource • Advanced congestive heart failure. GoToSource • Diabetic nephropathy. GoToSource • Esophageal carcinoma. GoToSource • Atrial fibrillation. GoToSource |
| Adverse Events |
|
Liver injury. GoToSource Fetal injury and death. GoToSource Angioedema (swelling in deep layers of the skin). GoToSource Agranulocytosis (decreased number of granulocytes, a type of white blood cell) and neutropenia (low number of neutrophils, a type of white blood cell). GoToSource Hypotension (low blood pressure). GoToSource Subacute intestinal obstruction. GoToSource Hyperkalemia (high blood potassium level). GoToSource Pancreatitis (inflammation of pancreas). GoToSource Cough. GoToSource |
| Litigation |
|
Lawsuits filed for angioedema and birth defects. |
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