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PRINIVIL

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Overview

What is PRINIVIL?

PRINIVIL contains lisinopril, a synthetic peptide derivative, and an oral, long-acting angiotensin converting enzyme inhibitor. Lisinopril is chemically described as ()-1-[ -(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is CHNO∙2HO and its structural formula is:

Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol.

PRINIVIL is supplied as 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient, lisinopril, each tablet contains the following inactive ingredients: calcium phosphate, mannitol, magnesium stearate, and starch. The 10 mg and 20 mg tablets also contain iron oxide.



What does PRINIVIL look like?



What are the available doses of PRINIVIL?

Tablets PRINIVIL, 5 mg, are white, oval-shaped compressed tablets with code MSD 19 on one side and scored on the other side.

Tablets PRINIVIL, 10 mg, are light yellow, oval-shaped compressed tablets with code MSD 106 on one side and scored on the other side.

Tablets PRINIVIL, 20 mg, are peach, oval-shaped compressed tablets with code MSD 207 on one side and scored on the other side.

What should I talk to my health care provider before I take PRINIVIL?

How should I use PRINIVIL?

PRINIVIL 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 blood pressure 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.

PRINIVIL may be administered alone or with other antihypertensive agents .

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.


What interacts with PRINIVIL?

Sorry No Records found


What are the warnings of PRINIVIL?

Sorry No Records found


What are the precautions of PRINIVIL?

Sorry No Records found


What are the side effects of PRINIVIL?

Sorry No records found


What should I look out for while using PRINIVIL?

PRINIVIL is contraindicated in patients with:

Do not coadminister aliskiren with PRINIVIL in patients with diabetes .

PRINIVIL is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer PRINIVIL within 36 hours of switching to or from sacubitril/valsartan, a product containing a neprilysin inhibitor .

When pregnancy is detected, discontinue PRINIVIL as soon as possible

[see ]

.

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.


What might happen if I take too much PRINIVIL?

Following a single oral dose of 20 g/kg, no lethality occurred in rats and death occurred in one of 20 mice receiving the same dose. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution.

Lisinopril can be removed by hemodialysis .


How should I store and handle PRINIVIL?

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].PRINIVIL is supplied as oval-shaped, compressed tablets scored on one side.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

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 renin-angiotensin-aldosterone system. Inhibition of ACE results in decreased plasma angiotensin II which leads 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 PRINIVIL 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 PRINIVIL 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 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 PRINIVIL 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 PRINIVIL and hydrochlorothiazide further reduced blood pressure in Black and non-Black patients and any racial difference in blood pressure response was no longer evident.

Non-Clinical Toxicology
PRINIVIL is contraindicated in patients with:

Do not coadminister aliskiren with PRINIVIL in patients with diabetes .

PRINIVIL is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer PRINIVIL within 36 hours of switching to or from sacubitril/valsartan, a product containing a neprilysin inhibitor .

When pregnancy is detected, discontinue PRINIVIL as soon as possible

[see ]

.

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.

Butalbital and acetaminophen may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.

Angioedema: Discontinue PRINIVIL ()

Renal impairment: Monitor renal function periodically ()

Hypotension: Monitor blood pressure after initiation ()

Hyperkalemia: Monitor serum potassium periodically ()

Cholestatic jaundice and hepatic failure: Discontinue PRINIVIL ()

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

Tips

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Interactions

Interactions

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