Lisinopril (Page 7 of 8)

Pediatric Patients

In a clinical study involving 115 hypertensive pediatric patients 6 to 16 years of age, patients who weighed < 50 kg received either 0.625 mg, 2.5 mg or 20 mg of lisinopril tablets once daily and patients who weighed ≥ 50 kg received either 1.25 mg, 5 mg, or 40 mg of lisinopril tablets once daily. At the end of 2 weeks, lisinopril tablets lowered trough blood pressure in a dose-dependent manner with antihypertensive efficacy demonstrated at doses > 1.25 mg (0.02 mg per kg). This effect was confirmed in a randomized withdrawal phase, where the diastolic pressure rose by about 9 mmHg more in patients randomized to placebo than compared to patients who remained on the middle and high doses of lisinopril. The dose-dependent antihypertensive effect of lisinopril tablets was consistent across several demographic subgroups: age, Tanner stage, gender, and race. In this study, lisinopril was generally well-tolerated.

In the above pediatric studies, lisinopril was given either as tablets or in a suspension for those children and infants who were unable to swallow tablets or who required a lower dose than is available in tablet form [see Dosage and Administration (2.1)] .

14.2 Heart Failure

In two placebo controlled, 12-week clinical studies compared the addition of lisinopril tablets up to 20 mg daily to digitalis and diuretics alone. The combination of lisinopril tablets, digitalis and diuretics reduced the following signs and symptoms of heart failure: edema, rales, paroxysmal nocturnal dyspnea and jugular venous distention. In one of the studies, the combination of lisinopril tablets, digitalis and diuretics reduced orthopnea, presence of third heart sound and the number of patients classified as NYHA Class III and IV; and improved exercise tolerance. A large (over 3000 patients) survival study, the ATLAS Trial, comparing 2.5 mg and 35 mg of lisinopril in patients with systolic heart failure, showed that the higher dose of lisinopril had outcomes at least as favorable as the lower dose.

During baseline-controlled clinical trials, in patients with systolic heart failure receiving digitalis and diuretics, single doses of lisinopril tablets resulted in decreases in pulmonary capillary wedge pressure, systemic vascular resistance and blood pressure accompanied by an increase in cardiac output and no change in heart rate.

14.3 Acute Myocardial Infarction

The Gruppo Italiano per lo Studio della Sopravvienza nell’Infarto Miocardico (GISSI-3) study was a multicenter, controlled, randomized, unblinded clinical trial conducted in 19,394 patients with acute myocardial infarction (MI) admitted to a coronary care unit. It was designed to examine the effects of short-term (6 week) treatment with lisinopril, nitrates, their combination, or no therapy on short-term (6 week) mortality and on long-term death and markedly impaired cardiac function. Hemodynamically-stable patients presenting within 24 hours of the onset of symptoms were randomized, in a 2 x 2 factorial design, to 6 weeks of either 1) lisinopril tablets alone (n = 4841), 2) nitrates alone (n = 4869), 3) lisinopril tablets plus nitrates (n = 4841), or 4) open control (n = 4843). All patients received routine therapies, including thrombolytics (72%), aspirin (84%), and a beta blocker (31%), as appropriate, normally utilized in acute myocardial infarction (MI) patients.

The protocol excluded patients with hypotension (systolic blood pressure ≤ 100 mmHg), severe heart failure, cardiogenic shock, and renal dysfunction (serum creatinine > 2 mg per dL and/or proteinuria > 500 mg per 24 h). Patients randomized to lisinopril tablets received 5 mg within 24 hours of the onset of symptoms, 5 mg after 24 hours, and then 10 mg daily thereafter. Patients with systolic blood pressure less than 120 mmHg at baseline received 2.5 mg of lisinopril tablets. If hypotension occurred, the lisinopril tablets dose was reduced or if severe hypotension occurred lisinopril tablets were stopped [see Dosage and Administration (2.3)] .

The primary outcomes of the trial were the overall mortality at 6 weeks and a combined end point at 6 months after the myocardial infarction, consisting of the number of patients who died, had late (day 4) clinical congestive heart failure, or had extensive left ventricular damage defined as ejection fraction ≤ 35% or an akinetic-dyskinetic [A-D] score ≥ 45%. Patients receiving lisinopril tablets (n = 9646), alone or with nitrates, had an 11% lower risk of death (p = 0.04) compared to patients who did not receive lisinopril tablets (n = 9672) (6.4% vs. 7.2%, respectively) at 6 weeks. Although patients randomized to receive lisinopril tablets for up to 6 weeks also fared numerically better on the combined end point at 6 months, the open nature of the assessment of heart failure, substantial loss to follow-up echocardiography, and substantial excess use of lisinopril tablets between 6 weeks and 6 months in the group randomized to 6 weeks of lisinopril, preclude any conclusion about this end point.

Patients with acute myocardial infarction, treated with lisinopril tablets, had a higher (9.0% versus 3.7%) incidence of persistent hypotension (systolic blood pressure < 90 mmHg for more than 1 hour) and renal dysfunction (2.4% versus 1.1%) in-hospital and at 6 weeks (increasing creatinine concentration to over 3 mg per dL or a doubling or more of the baseline serum creatinine concentration) [see Adverse Reactions (6.1)] .

16 HOW SUPPLIED/STORAGE AND HANDLING

Lisinopril Tablets, USP are available containing 5 mg, 10 mg, 20 mg or 40 mg of lisinopril, USP.

The 5 mg tablet is a peach, round, scored tablet debossed with M over L23 on one side of the tablet and scored on the other side. They are available as follows:

NDC 51079-981-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).
NDC 51079-981-56 – Unit dose punch cards of 300 (10 punch cards of 30 tablets each).

The 10 mg tablet is a white, round, unscored tablet debossed with L over 24 on one side of the tablet and M on the other side. They are available as follows:

NDC 51079-982-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).
NDC 51079-982-56 – Unit dose punch cards of 300 (10 punch cards of 30 tablets each).

The 20 mg tablet is a yellow, round, unscored tablet debossed with L over 25 on one side of the tablet and M on the other side. They are available as follows:

NDC 51079-983-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).
NDC 51079-983-56 – Unit dose punch cards of 300 (10 punch cards of 30 tablets each).

The 40 mg tablet is a green, round, unscored tablet debossed with L over 26 on one side of the tablet and M on the other side. They are available as follows:

NDC 51079-984-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from moisture, freezing and excessive heat.

17 PATIENT COUNSELING INFORMATION

NOTE: This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

Pregnancy: Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to notify their healthcare provider with a known or suspected pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

Angioedema: Angioedema, including laryngeal edema may occur at any time during treatment with angiotensin converting enzyme inhibitors, including lisinopril tablets. Tell patients to report immediately any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing) and to take no more drug until they have consulted with the prescribing physician.

Lactation: Advise women not to breastfeed during treatment with lisinopril tablets [see Use in Specific Populations (8.2)].

Symptomatic Hypotension: Tell patients to report light-headedness especially during the first few days of therapy. If actual syncope occurs, tell the patient to discontinue the drug until they have consulted with the prescribing physician.

Tell patients that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume. Other causes of volume depletion such as vomiting or diarrhea may also lead to a fall in blood pressure; advise patients accordingly.

Hyperkalemia: Tell patients not to use salt substitutes containing potassium without consulting their physician.

Hypoglycemia: Tell diabetic patients treated with oral antidiabetic agents or insulin starting an ACE inhibitor to monitor for hypoglycemia closely, especially during the first month of combined use [see Drug Interactions (7.2)] .

Leukopenia/Neutropenia: Tell patients to report promptly any indication of infection (e.g., sore throat, fever), which may be a sign of leukopenia/neutropenia.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Laboratories Limited
Hyderabad – 500 034, India
Code No.: MH/DRUGS/AD/089

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

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