"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
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 nonfatal 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 [see Clinical Studies].
Acute Myocardial Infarction
PRINIVIL 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 [see Clinical Studies].
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 PRINIVIL 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 [see DRUG INTERACTIONS].
Pediatric Patients 6 Years of Age and Older with Hypertension
For pediatric patients with glomerular filtration rate > 30 mL/min/1.73m², 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].
The recommended starting dose for PRINIVIL, 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 [see WARNINGS AND PRECAUTIONS, and DRUG INTERACTIONS]. 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 PRINIVIL 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]. 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.
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 [see Use in Specific Populations and CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
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.
Storage And Handling
PRINIVIL is supplied as oval-shaped, compressed tablets scored on one side.
|Color||Printing||Unit of use Bottle/90|
|5 mg||White||MSD 19||NDC 0006-001954|
|10 mg||Light yellow||MSD 106||NDC 0006-010654|
|20 mg||Peach||MSD 207||NDC 0006-020754|
Store at controlled room temperature, 15-30°C (59-86°F), and protect from moisture.
Dispense in a tight container, if product package is subdivided.
Distributed by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Revised: July 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/26/2015
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