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Vaseretic
Generic Name: Enalapril Maleate/Hydrochlorothiazide
Drug Category: ACE Inhibitor/Diuretic
Litigation Alert Level: Medium
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 4 years.
| Approved Uses |
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Indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial treatment. In considering use of VASERETIC, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks. Do not co-administer aliskiren with VASERETIC in patients with diabetes. In using VASERETIC, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril does not have a similar risk. Excessive hypotension was rarely seen in uncomplicated hypertensive patients but is a possible consequence of enalapril use in severely salt/volume depleted persons such as those treated vigorously with diuretics or patients on dialysis. In patients with severe congestive heart failure, with or without associated renal insufficiency, excessive hypotension has been observed and may be associated with oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death. Because of the potential fall in blood pressure in these patients, therapy should be started under very close medical supervision. Thiazides should be used with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis, and (sometimes) death. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported. Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. As with all vasodilators, enalapril should be given with caution to patients with obstruction in the outflow tract of the left ventricle. All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance: hyponatremia, hypochloremic alkalosis, and hypokalemia. Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy. Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Thiazides have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia. Thiazides may decrease urinary calcium excretion. Thiazides may cause intermittent and slight elevation Hyperglycemia may occur with thiazide diuretics. Thus latent diabetes mellitus may become manifest Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy. Syncope has been reported in patients receiving VASERETIC. Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with angiotensin converting enzyme inhibitors, including enalapril. Intestinal angioedema has been reported in patients treated with ACE inhibitors. 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. Patients receiving co-administration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema. VASERETIC is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer VASERETIC within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor. Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy 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. Enalapril attenuates diuretic-induced potassium loss. Potassium-sparing diuretics (e.g., spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. Therefore, if concomitant use of these agents is indicated because of demonstrated hypokalemia they should be used with caution and with frequent monitoring of serum potassium. In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including enalapril, may result in deterioration of renal function, including possible acute renal failure. The antihypertensive effect of enalapril is augmented by antihypertensive agents that cause renin release (e.g., diuretics). Lithium generally should not be given with thiazides. Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. When pregnancy is detected, discontinue VASERETIC as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Enalapril, enalaprilat, and hydrochlorothiazide have been detected in human breast milk. |
| Off-label Uses |
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• Use in patients under the age of 18. GoToSource • Dosage greater than 20 mg of enalapril or 50 mg of hydrochlorothiazide per day. GoToSource • Preventing clinical proteinuria. GoToSource • Migraine prophylaxis. GoToSource • Raynaud’s phenomenon. GoToSource • Bartter syndrome. GoToSource • Adjunctive therapy to prevent chemotherapy-induced left ventricular systolic dysfunction in patients with hematological malignancies. GoToSource • Dementia and cognitive impairment. GoToSource |
| Adverse Events |
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Fetal death and injury. GoToSource Kidney injury. GoToSource Vasculitis. GoToSource Angioedema. GoToSource Reduction of zinc levels. GoToSource Cough, rhinopharyngeal inflammation, diurnal sleepiness and increased obstructive apnea-hypopnea episodes. GoToSource Pancreatitis. GoToSource Acute non-cardiogenic pulmonary edema. GoToSource Hypotension. GoToSource Hypokalaemia (low potassium), rash and transient taste loss. GoToSource Angioneurotic edema. GoToSource |
| Litigation |
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Lawsuits filed for birth defects. |
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