These highlights do not include all the information needed to use ZESTRIL safely and effectively. See full prescribing information for ZESTRIL
Zestril® (lisinopril) tablets, for oral use
Initial U.S. Approval: 1988
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
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When pregnancy is detected, discontinue Zestril as soon as possible. (5.1)
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Drugs that act directly on the rennin-angiotensin system can cause injury and death to the developing fetus. (5.1)
INDICATIONS AND USAGE
Zestril is an angiotensin converting enzyme (ACE) inhibitor indicated for:
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Treatment of hypertension in adults and pediatric patients 6 years of age and older ( 1.1)
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Adjunct therapy for heart failure ( 1.2)
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Treatment of Acute Myocardial Infarction ( 1.3 )
DOSAGE AND ADMINISTRATION
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Hypertension: Initial adult dose is 10 mg once daily. Titrate up to 40 mg daily based on blood pressure response. Initiate patients on diuretics at 5 mg once daily ( 2.1)
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Pediatric patients with glomerular filtration rate > 30 mL/min/1.73m 2: Initial dose in patients 6 years of age and older is 0.07 mg per kg (up to 5 mg total) once daily ( 2.1)
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Heart Failure: Initiate with 5 mg once daily. Increase dose as tolerated to 40 mg daily ( 2.2)
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Acute Myocardial Infarction (MI): Give 5 mg within 24 hours of MI. followed by 5 mg after 24 hours, then 10 mg once daily ( 2.3)
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Renal Impairment: For patients with creatinine clearance ≥ 10 mL/min and ≤ 30 mL/min, halve usual initial dose. For patients with creatinine clearance < 10 mL/min or on hemodialysis, the recommended initial dose is 2.5 mg ( 2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg (3)
CONTRAINDICATIONS
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Angioedema or a history of hereditary or idiopathic angioedema ( 4)
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Hypersensitivity ( 4)
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Co-administration of aliskiren with Zestril in patients with diabetes (4, 7.4)
WARNINGS AND PRECAUTIONS
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Angioedema: Discontinue Zestril, provide appropriate therapy and monitor until resolved (5.2)
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Renal impairment: Monitor renal function periodically (5.3)
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Hypotension: Patients with other heart or renal diseases have increased risk, monitor blood pressure after initiation (5.4)
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Hyperkalemia: Monitor serum potassium periodically (5.5)
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Cholestatic jaundice and hepatic failure: Monitor for jaundice or signs of liver failure (5.6)
ADVERSE REACTIONS
Common adverse reactions (events 2% greater than placebo) by use:
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Hypertension: headache, dizziness and cough (6.1)
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Heart Failure: hypotension and chest pain (6.1)
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Acute Myocardial Infarction: hypotension (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca Pharmaceuticals LP at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Diuretics: Excessive drop in blood pressure (7.1)
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NSAIDS: Increased risk of renal impairment and loss of antihypertensive efficacy (7.3)
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Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia (7.4)
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Lithium: Symptoms of lithium toxicity (7.5)
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Gold: Nitritoid reactions have been reported (7.6)
USE IN SPECIFIC POPULATIONS
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Pregnancy: Discontinue drug if pregnancy is detected ( 5.1, 8.1)
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Pediatrics: Safety and effectiveness have not been established in patients < 6 years of age or with glomerular filtration rate < 30 mL/min/1.73m 2 ( 8.4)
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Race: Less antihypertensive effect in blacks than non blacks ( 8.6)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 6/2014
