MILTON LISINOPRIL TAB 10 MG AND 5 MG BY 28’S
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LISINOPRIL is an angiotensin converting enzyme (ACE) inhibitor FOR :
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INDICATIONS AND USAGE
LISINOPRIL is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of
age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal
cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in
controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.
Control of high blood pressure should be part of comprehensive cardiovascular risk management,
including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower bloodpressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
LISINOPRIL may be administered alone or with other antihypertensive agents
PRINIVIL is indicated to reduce signs and symptoms of heart failure in patients who are not responding adequately to diuretics and digitalis
Acute Myocardial Infarction
LISINOPRIL is indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard
recommended treatments such as thrombolytics, aspirin and beta-blockers
DOSAGE AND ADMINISTRATION
Initial therapy in adults: The recommended initial dose is 10 mg once a day. Adjust dosage according to blood pressure response. The usual dosage range is 20 to 40 mg per day administered in a single daily dose. Doses up to 80 mg have been used but do not appear to give a greater effect.
Use with Diuretics in Adults
If blood pressure is not controlled with LISINOPRIL alone, a low dose of a diuretic may be added (e.g.,
hydrochlorothiazide 12.5 mg).
The recommended starting dose in adult patients with hypertension taking diuretics is 5 mg once per day
For pediatric patients with glomerular filtration rate >30 mL/min/1.73
the recommended starting dose is 0.07 mg/kg once daily (up to 5 mg total). Dosage should be adjusted according to blood pressure response up to a maximum of 0.61 mg/kg (up to 40 mg) once daily. Doses above 0.61 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients [see Clinical Pharmacology (12.3)].
LISINOPRIL is not recommended in pediatric patients <6 years or in pediatric patients with glomerular filtration rate <30 mL/min/1.73
The recommended starting dose for LISINOPRIL, when used with diuretics and (usually) digitalis as
adjunctive therapy is 5 mg once daily. The recommended starting dose in these patients with
hyponatremia (serum sodium <130 mEq/L) is 2.5 mg once daily. Increase as tolerated to a maximum of 40 mg once daily.
Diuretic dose may need to be adjusted to help minimize hypovolemia, which may contribute to hypotension . The appearance of hypotension after the initial dose of PRINIVIL does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.
Acute Myocardial Infarction
In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial
infarction, give LISINOPRIL 5 mg orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10
mg once daily. Dosing should continue for at least 6 weeks.
Initiate therapy with 2.5 mg in patients with a low systolic blood pressure (100-120 mmHg) during the first
3 days after the infarct [see Warnings and Precautions (5.4)]. If hypotension occurs (systolic blood
pressure ≤100 mmHg) consider doses of 2.5 or 5 mg. If prolonged hypotension occurs (systolic blood
pressure <90 mmHg for more than 1 hour) discontinue PRINIVIL.
2.4 Dose in Patients with Renal Impairment
No dose adjustment of PRINIVIL is required in patients with creatinine clearance >30 mL/min. In patients with creatinine clearance 10-30 mL/min, reduce the initial dose of PRINIVIL to half of the usual recommended dose (i.e., hypertension, 5 mg; heart failure or acute MI, 2.5 mg). For patients on hemodialysis or creatinine clearance <10 mL/min, the recommended initial dose is 2.5 mg once daily
DOSAGE FORMS AND STRENGTHS
Tablets lisinopril, 5 mg, are white, oval-shaped compressed tablets
Tablets lisinopril, 10 mg, are light yellow, oval-shaped compressed tablets
Lisinopril is contraindicated in patients with:
a history of angioedema or hypersensitivity related to previous treatment with an angiotensin
converting enzyme inhibitor
hereditary or idiopathic angioedema.
Mechanism of Action
Lisinopril inhibits angiotensin converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II.
Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. The beneficial effects of
Lisinopril in hypertension and heart failure appear to result primarily from suppression of the reninangiotensin-aldosterone system. Inhibition of ACE results in decreased plasma angiotensin II which leads 11
To decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in a small increase of serum potassium. In hypertensive patients with normal renal function treated with Lisinopril alone for up to 24 weeks, the mean increase in serum potassium was approximately 0.1 mEq/L; however, approximately 15% of patients had increases greater than 0.5 mEq/L and approximately 6% had a decrease greater than 0.5 mEq/L. In the same study, patients treated with LISINOPRIL and hydrochlorothiazide for up to 24 weeks had a mean decrease in serum potassium of 0.1 mEq/L; approximately 4% of patients had increases greater than 0.5 mEq/L and approximately 12% had a decrease greater than 0.5 mEq/L [see Warnings and Precautions (5.5)]. Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity.
ACE is identical to kininase, an enzyme that degrades bradykinin. Whether increased levels of bradykinin, a potent vasodepressor peptide, play a role in the therapeutic effects of PRINIVIL remains to be elucidated.
While the mechanism through which LISINOPRIL lowers blood pressure is believed to be primarily
suppression of the renin-angiotensin-aldosterone system, PRINIVIL is antihypertensive even in patients with low-renin hypertension. Although PRINIVIL was antihypertensive in all races studied, Black hypertensive patients (usually a low-renin hypertensive population) had a smaller average response to monotherapy than non-Black patients.
Concomitant administration of LISINOPRIL and hydrochlorothiazide further reduced blood pressure in Black and non-Black patients and any racial difference in blood pressure response was no longer evident.
HOW SUPPLIED/STORAGE AND HANDLING
LISINOPRIL is supplied as oval-shaped
5 mg White
10 mg Light yellow
Store at controlled room temperature, 15-30°C (59-86°F), and protect from moisture.
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