Dosing and uses of Zestoretic (lisinopril-hydrochlorothiazide)
Adult dosage forms and strengths
lisinopril/hydrochlorothiazide
tablet
- 10mg/12.5mg
- 20mg/12.5mg
- 20mg/25mg
Hypertension
10-80 mg lisinopril/6.25-50 mg hydrochlorothiazide PO qDay
Pediatric dosage forms and strengths
Safety and efficacy not established
Zestoretic (lisinopril-hydrochlorothiazide) adverse (side) effects
>10%
LisinopriL
- Dizziness (5-12%)
1-10%
LisinopriL
- Cough (4-9%)
- Headache (4-6%)
- Hyperkalemia (2-5%)
- Diarrhea (3-4%)
- Hypotension (1-4%)
- Chest pain (3%)
- Fatigue (3%)
- Nausea/vomiting (2%)
- Rash (1-2%)
- Psoriasis (frequency unknown)
Hydrochlorothiazide
- Hypotension
- Anorexia
- Epigastric distress
- Hypokalemia
- Phototoxicity
Warnings
Black box warnings
Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system, causing oligohydramnios, which may result in fetal injury and/or death
Contraindications
Hypersensitivity to ACE inhibitors, thiazides, or sulfonamides
ACE-inhibitor induced angioedema, hereditary or idiopathic angioedema
Anuria or renal stenosis
Do not coadminister with aliskiren in patients with diabetes mellitus or with renal impairment (ie, GFR <60 mL/min/1.73 m²)
Cautions
Begin combination therapy only after failed monotherapy
Severe renal impairment, hepatic impairment
Risk of hypotension, especially with CHF
Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with angiotensin-converting enzyme inhibitors
If laryngeal stridor or angioedema of the face, tongue, or glottis occurs discontinue therapy and institute appropriate therapy immediately
Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g. temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema Intestinal angioedema has been reported in patients treated with ACE inhibitors
Cholestatic jaundice may occur, which may progress to fulminant hepatic necrosis; discontinue is symptoms occur
Dry hacking nonproductive cough may occur within few months of treatment; consider other causes of cough prior to discontinuation
Hyperkalemia may occur with ACE inhibitors; risk factors include renal dysfunction, diabetes mellitus, and concomitant use of potassium sparing diuretics and potassium supplements; use cautiously if at all with these agents
Thiazide diuretics may cause hypokalemia, hypochloremic alkalosis, hypomagnesemia, and hyponatremia
Hydrochlorothiazide may precipitate gout in patients with familial predisposition to gout or chronic renal failure
Symptomatic hypotension with or without syncope can occur with ACE inhibitors; mostly observed in volume depleted patients, correct volume depletion prior to initiation; monitor closely when initiating and increasing dosing
Agranulocytosis, neutropenia, or leukopenia with myeloid hypoplasia reported with other ACE inhibitor; patients with renal impairment are at high risk; monitor CBC with differential in these patients
Photosensitization may occur
Hydrochlorothiazide may cause acute transient myopia and acute angle-closure glaucoma that may occur within hours of initiating therapy; discontinue therapy immediately in patients with acute decreases in visual acuity or ocular pain; additional treatment may be needed if uncontrolled intraocular pressure persists
Use caution in patients with severe aortic stenosis; may reduce coronary perfusion resulting in ischemia
Use hydrochlorothiazide with caution in patients with diabetes or at risk of diabetes; may see increase in glucose
Use caution in patients collagen vascular disease, especially in patients with concomitant renal impairment
Thiazide diuretics may decrease renal calcium excretion; consider avoiding use in patients with hypercalcemia
Increased cholesterol and triglyceride levels reported with thiazides; use caution in patients with moderate to high cholesterol concentrations
Pathologic changes in parathyroid glands with hypercalcemia and hypophosphatemia reported with prolonged use; discontinue prior to testing for parathyroid function
Dual blockade of the renin-angiotensin-aldosterone system (ie, ARB plus an ACE inhibitor or aliskiren) in patients with established atherosclerotic disease or heart failure or with diabetes with end organ damage is associated with a higher frequency of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure), as compared with the use of a single renin-angiotensin-aldosterone system agent; limit dual blockade to individually defined cases, with close monitoring of renal function
Neonates with history of in utero exposure: If oliguria or hypotension occurs, support of blood pressure and renal perfusion; exchange transfusions or dialysis may be required
Pregnancy and lactation
Pregnancy category: d
Lactation: Discontinue drug or do not nurse
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
