ZESTRIL

and 10 CLINICAL PHARMACOLOGY). • Acute Myocardial Infarction: in the treatment of hemodynamically stable patients as early as within 24 hours following acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, ASA and beta blocker(s).

Therapy with ZESTRIL should be reassessed after 6 weeks. If there is no evidence of symptomatic or asymptomatic left ventricular dysfunction, treatment with ZESTRIL can be stopped. ZESTRIL should not be used if systolic blood pressure is <100 mmHg, if clinically relevant renal failure is present, or if there is a history of bilateral stenosis of the renal arteries (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Hypotension Following Acute Myocardial Infarction and Renal, Renal Impairment).

73 m2 has been established. 3 Pediatrics). 3 Pediatrics). 4 Geriatrics). Pharmacokinetic studies indicate that maximum blood levels and area under the plasma concentration time curve (AUC) are doubled in older patients (See 4. DOSAGE AND ADMINISTRATION).

CONTRAINDICATIONS ZESTRIL (lisinopril tablets USP) is contraindicated in patients who: • are hypersensitive to the drug or to any ingredient in the formulation. For a complete listing, see

2 Breast-feeding); • are taking sacubitril/valsartan due to an increased risk of angioedema. ZESTRIL must not be initiated until at least 36 hours have elapsed following discontinuation of salcubitril/valsartan therapy. If treatment with ZESTRIL is stopped, sacubitril/valsartan therapy must not be initiated until 36 hours after the last dose of ZESTRIL.

73m2). SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions When used in pregnancy, ACE inhibitors can cause injury or even death of the developing fetus. 1 Pregnant Women). 1 Dosing Considerations • Dosage must be individualized and should be adjusted according to blood pressure response.

2 Recommended Dose and Dosage Adjustment Essential Hypertension In patients with essential hypertension, not on diuretic therapy, the usual recommended starting dose is 10 mg once a day. The usual dosage range is 10 to 40 mg per day, administered in a single daily dose.

The antihypertensive effect may diminish toward the end of the dosing interval regardless of the administered dose, but most commonly with a dose of 10 mg daily. This can be evaluated by measuring blood pressure just prior to dosing to determine whether satisfactory control is being maintained for 24 hours.

If it is not, an increase in dose should be considered. The maximum dose used in long-term controlled clinical trials was 80 mg/day. If blood pressure is not controlled with ZESTRIL alone, a low dose of diuretic may be added. 5 mg has been shown to provide an additive effect.

After the addition of diuretic, it may be possible to reduce the dose of ZESTRIL. Diuretic Treated Patients In hypertensive patients who are currently being treated with a diuretic, symptomatic hypotension may occur occasionally following the initial dose of ZESTRIL.

The diuretic should be discontinued, if possible, for 2-3 days before beginning therapy with ZESTRIL to reduce the likelihood of hypotension (see 7 WARNINGS AND PRECAUTIONS). The dosage of ZESTRIL should be adjusted according to blood pressure response.

11/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................

2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................

4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................

4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 8 5 OVERDOSAGE..............................................................................................................

8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 8 7 WARNINGS AND PRECAUTIONS .................................................................................. 14 8 ADVERSE REACTIONS ................................................................................................

18 9 DRUG INTERACTIONS ................................................................................................ 24 10 CLINICAL PHARMACOLOGY .......................................................................................

27 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 28 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 28 PART II: SCIENTIFIC INFORMATION .......................................................................................

11/2023 7 WARNINGS AND PRECAUTIONS 11/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................

2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................

4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................

4