Renal Dose Adjustment (Based on CrCl)
Hepatic Dose Adjustment
- Hepatic impairment/progressive liver disease: Use with caution; dose adjustments not defined
See Supplemental Patient Information
- Rare occasions of excessive hypotension have occurred in patients with uncomplicated hypertension; salt/volume-depleted persons are more susceptible
- Perform proper titration of the individual components to reduce incidence of syncope
- Excessive hypotension with oliguria and/or progressive azotemia, and rare occasions of acute renal failure and/or death has occurred in patients with severe CHF, with or without associated renal insufficiency.
- Initiate therapy with very close medical supervision as potential for fall in blood pressure in such patients exists. Closely follow such patients for the first 2wks of treatment and whenever the dose of enalapril and/or diuretic is increased.
- Implicate similar considerations in patients with ischemic heart or cerebrovascular disease in whom an excessive fall in blood pressure results in a myocardial infarction or cerebrovascular accident. On occurrence of hypotension place the patient in the supine position and if essential provide an IV infusion of normal saline
- Anaphylactoid and possibly related reactions may occur in patients
- ACE-inhibitor component of this combination drug is associated with angioedema of the face, extremities, lips, tongue, glottis and/or larynx. Black patients are more prone to these events. Immediately discontinue this drug and institute appropriate therapy with monitoring until complete and sustained resolution of signs and symptoms
- ACE inhibitors are associated with intestinal angioedema. Patients having history of angioedema unrelated to ACE inhibitor therapy are at increased risk of angioedema
- Rare occasions of fatalities have occurred due to angioedema associated with laryngeal edema or tongue edema. Patients with involvement of the tongue, glottis or larynx having history of airway surgery are prone to experience airway obstruction. Provide SC epinephrine solution 1:1000 (0.3 mL-0.5 mL) and/or measures necessary to ensure a patent airway in cases where there is involvement of the tongue, glottis or larynx likely to cause airway obstruction
- Patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors are prone for occurrence of life-threatening anaphylactoid reactions
- Sudden and potentially life-threatening anaphylactoid reactions have occurred in some patients dialyzed with high-flux membranes and concomitantly treated with an ACE inhibitor
- Anaphylactoid reactions has developed in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption
- Patients with renal impairment with collagen vascular disease are more prone to agranulocytosis and bone marrow depression
- Cholestatic jaundice or hepatitis which progresses to fulminant hepatic necrosis and sometimes death have occurred. Discontinue the ACE inhibitor and conduct appropriate medical follow-up in patients who have developed jaundice or marked elevations of hepatic enzymes
- Precipitation of azotemia has occurred in patients with renal disease. Cumulative effects of the drug have occurred in patients with impaired renal function. Minor alterations of fluid and electrolyte balance is associated with precipitation of hepatic coma in patients with impaired hepatic function or progressive liver disease
- Hypersensitivity reactions have occurred in patients with or without a history of allergy or bronchial asthma
- Possibility of exacerbation or activation of systemic lupus erythematosus exists
- Avoid administration of lithium with thiazides
- Acute myopia and secondary angle-closure glaucoma may develop. Immediately discontinue this drug as a method of primary treatment, If untreated acute angle-closure glaucoma may lead to permanent vision loss. Consider prompt medical or surgical treatments if the intraocular pressure remains uncontrolled
- On detection of pregnancy immediately discontinue therapy with this combination drug. Injury and even death have occurred in developing fetus on using this drug in pregnancy during the second and third trimesters [US Black Box Warning]
- Fetal, neonatal morbidity and death have occurred on administration of this drug to pregnant women. Fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death have occurred
- Oligohydramnios associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development has occurred.
- Apprise mothers of the potential hazards to their fetuses, and perform serial ultrasound examinations to assess the intraamniotic environment. On observation of oligohydramnios discontinue therapy unless it is considered lifesaving for the mother. As appropriate perform contraction stress testing (CST), a nonstress test (NST), or biophysical profiling (BPP) depending upon the week of pregnancy. Oligohydramnios may not be observed until after the fetus has sustained irreversible injury
- At appropriate intervals periodically determine serum electrolytes to detect possible electrolyte imbalance. Observe patients receiving thiazide therapy for clinical signs of fluid or electrolyte imbalance. Determine serum and urine electrolyte when the patient is vomiting excessively or receiving parenteral fluids.
- Hypokalemia with brisk diuresis have occurred in presence of severe cirrhosis or after long term therapy. Cardiac arrhythmia has occurred in association with hypokalemia resulting in sensitization or exaggeration of the response of the heart to the toxic effects of digitalis. Chloride replacement may be essential for treatment of metabolic alkalosis.
- Dilutional hyponatremia has occurred in edematous patients in hot weather; Impose water restriction rather than administration of salt except in rare occasions when the hyponatremia is fatal.
- In actual salt depletion provide appropriate replacement therapy. Thiazide component is associated with hyperuricemia or precipitation of frank gout in certain patients
- ACE inhibitor component is associated with persistent nonproductive cough.
- Enalapril component is associated with blocking angiotensin II formation secondary to compensatory renin release in patients undergoing major surgery or during anesthesia with agents that produce hypotension
- Potential increase in serum creatinine and/or BUN especially with real artery stenosis. Monitoring recommended.
Cautions: Use cautiously in
Supplemental Patient Information
- Advise patients to immediately report any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing) and to withheld this drug until consultation with the prescribing physician
- Apprise female patients of childbearing that use of this combination drug during the second or third trimesters of pregnancy is associated with serious problems in the fetus and infant including low blood pressure, poor development of skull bones, kidney failure, and death
- Advise patients to inform their physician if they feel lightheaded or faintness; advise them to stop using this therapy and contact their prescribing doctor
- Advise patients to take adequate amount of fluids
Pregnancy Category:C (first trimester) and D (second and third trimesters)
Breastfeeding: Hydrochlorothiazide doses of 
50 mg/day are acceptable during lactation. Intense diuresis with higher doses may decrease breastmilk production. Prefer an alternative drug during breastfeeding as appropriate literature on the use of enalapril is unavailable. This information is (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 18 March 2011). This combination drug exhibits potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
US Trade Name(s)
US Availability
enalapril/hydrochlorothiazide (generic)
Vaseretic (enalapril/hydrochlorothiazide)
Canadian Trade Name(s)
Canadian Availability
enalapril/hydrochlorothiazide (generic)
Vaseretic (enalapril/hydrochlorothiazide)
UK Trade Name(s)
UK Availability
enalapril/hydrochlorothiazide (generic)
Innozide (enalapril/hydrochlorothiazide)
Australian Trade Name(s)
Australian Availability
enalapril/hydrochlorothiazide (generic)
Renitec plus (enalapril/hydrochlorothiazide)
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Vaseretic 5-12.5 MG TABS [Bottle] (BTA PHARMACEUTICALS)
30 mg = $41.99
90 mg = $125.97 - Vaseretic 10-25 MG TABS [Bottle] (VALEANT)
30 mg = $110.23
90 mg = $297.41
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
