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
- 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
- Patients may require long term observation even in those instances where swelling of only the tongue is involved without respiratory distress as treatment with antihistamines and corticosteroids may be insufficient
- 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
- ACE inhibitors are associated with intestinal angioedema. Patients having history of angioedema unrelated to ACE inhibitor therapy are at increased risk of angioedema
- Fatal anaphylactoid reactions during desensitization have occurred
- Avoid use in patients with severe renal dysfunction. Sudden and potentially life-threatening anaphylactoid reactions have occurred in some patients dialyzed with high-flux membranes and concomitantly treated with an ACE inhibitor. Immediately stop dialysis and aggressively initiate therapy for anaphylactoid reactions. Consider using a different type of dialysis membrane or a different class of antihypertensive agents in such patients
- Rare occasions of excessive hypotension has 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 lisinopril 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
- Patients with renal impairment with collagen vascular disease are more prone to agranulocytosis and bone marrow depression
- Periodically monitor WBC counts in patients with collagen vascular disease and renal disease
- Cholestatic jaundice or hepatitis which progresses to fulminant hepatic necrosis and sometimes death has occurred. Discontinue the ACE inhibitor and conduct appropriate medical follow-up in patients who have developed jaundice or marked elevations of hepatic enzymes
- On detection of pregnancy immediately discontinue therapy with this combination drug. Injury and even death has 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 has 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 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 fetal testing should be considered depending upon the week of pregnancy. Oligohydramnios may not be observed until after the fetus has sustained irreversible injury
- ACE inhibitor component of this combination drug is associated with hypotension, oliguria, and hyperkalemia; closely observe infants with histories of in utero exposure to ACE inhibitors. Provide support for blood pressure and renal perfusion on occurrence of oliguria. If required provide exchange transfusion or dialysis as means of reversing hypotension and/or substituting for impaired renal function
- Hydrochlorothiazide component is associated with fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions in adults
- Precipitation of azotemia has occurred in patients with renal disease. Cumulative effects of the drug has 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
- Anticipate changes in renal function in susceptible individuals. A patient whose renal function is depending on the activity of the renin-angiotensin-aldosterone system treatment with ACE inhibitors is associated with oliguria and/or progressive azotemia and rarely with acute renal failure or death. Increase in serum creatinine or BUN has occurred in hypertensive patients with unilateral or bilateral renal artery stenosis. Thiazide component is associated with precipitation of azotemia in patients with renal disease. Cumulative effects has developed in patients with impaired renal function; monitor renal function during the first few wks of therapy in such patients
- Occurrence of hyperkalemia exists; renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes are associated factors for occurrence of hyperkalemia. Frequently monitor serum potassium
- ACE inhibitor component is associated with persistent nonproductive cough. Lisinopril 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
- 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 has 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
Cautions: Use cautiously in
- Renal impairment
- Renal artery stenosis
- Hepatic impairment
- Progressive hepatic disease
- Diabetes mellitus
- Volume depletion
- Hyponatremia
- Severe CHF
- Collagen vascular disease
- Coronary artery disease
- Cerebrovascular disease
- Hypertrophic cardiomyopathy
- Post-sympathectomy
- History of gout
- Major surgery
- SLE
- Black patients
- Geriatrics
- History of asthma
- Dialysis with high-flux membranes
- LDL apheresis with dextran
- History of antigen desensitization
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 lisinopril is unavailable. This information is (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 23 February 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
hydrochlorothiazide/lisinopril (generic)
- TABS:
- 12.5 mg/10 mg
- 12.5 mg/20 mg
- 25 mg/20 mg
Prinzide (hydrochlorothiazide/lisinopril)
- TABS:
- 12.5 mg/10 mg
- 12.5 mg/20 mg
Zestoretic (hydrochlorothiazide/lisinopril)
- TABS:
- 12.5 mg/10 mg
- 12.5 mg/20 mg
- 25 mg/20 mg
Canadian Trade Name(s)
Canadian Availability
hydrochlorothiazide/lisinopril (generic)
- TABS:
- 12.5 mg/10 mg
- 12.5 mg/20 mg
- 25 mg/20 mg
Prinzide (hydrochlorothiazide/lisinopril)
- TABS:
- 12.5 mg/10 mg
- 12.5 mg/20 mg
Zestoretic (hydrochlorothiazide/lisinopril)
- TABS:
- 12.5 mg/10 mg
- 12.5 mg/20 mg
- 25 mg/20 mg
UK Trade Name(s)
- Carace 10 plus
- Carace 20 plus
- Zestoretic 10
- Zestoretic 20
UK Availability
Carace 10 plus (hydrochlorothiazide/lisinopril)
Carace 20 plus (hydrochlorothiazide/lisinopril)
Zestoretic 10 (hydrochlorothiazide/lisinopril)
Zestoretic 20 (hydrochlorothiazide/lisinopril)
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Zestoretic 20-12.5 MG TABS [Bottle] (ASTRAZENECA)
30 mg = $60.05
90 mg = $163.77 - Zestoretic 10-12.5 MG TABS [Bottle] (ASTRAZENECA)
30 mg = $56.78
90 mg = $147.4 - Zestoretic 20-25 MG TABS [Bottle] (ASTRAZENECA)
30 mg = $59.99
90 mg = $163.75 - Prinzide 10-12.5 MG TABS [Bottle] (MERCK SHARP & DOHME)
30 mg = $46.99
90 mg = $125.96
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.
