Epaned

EPANED- enalapril maleate solution
Silvergate Pharmaceuticals, Inc.

WARNING: FETAL TOXICITY

When pregnancy is detected, discontinue EPANED® as soon as possible. [See Warnings and Precautions (5.1)]
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. [See Warnings and Precautions (5.1)]

1 INDICATIONS AND USAGE

1.1 Hypertension

EPANED is indicated for the treatment of hypertension, to lower blood pressure in adults and children older than one month [see Pediatric Use (8.4) and Clinical Studies (14)].

Lowering blood pressure reduces 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 including this drug.

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 one 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.

EPANED is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of EPANED and thiazides are approximately additive.

1.2 Heart Failure

EPANED is indicated for the treatment of symptomatic heart failure, usually in combination with diuretics and digitalis. In these patients, EPANED increases survival and decreases the frequency of hospitalization.

1.3 Asymptomatic Left Ventricular Dysfunction

In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), EPANED decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure.

2 DOSAGE AND ADMINISTRATION

2.1 Hypertension

Adults: The recommended initial dose in adults is 5 mg taken orally once a day. Titrate upward to maximum of 40 mg daily as needed to help achieve blood pressure goals. The dose may be divided and administered twice daily if the antihypertensive effect diminishes at the end of the dosing interval.

Use with diuretics: If additional blood pressure reduction is needed, EPANED may be administered with a low dose of diuretic. The recommended initial dose in patients taking diuretics is 2.5 mg daily.

Dosage Adjustment for Renal Impairment: See table below. The dosage may be titrated upward as needed to a maximum of 40 mg daily.

*
[See Warnings and Precautions (5.2)].
Should be taken after hemodialysis on dialysis days [see Clinical Pharmacology (12.3)]. Calculated using ideal body weight.

Renal Status

Creatinine-ClearancemL/min

Initial Dosemg/day

Normal or Mild Impairment of Renal Function

>30 mL/min

5 mg

Moderate to Severe Impairment

≤30 mL/min

2.5 mg

Dialysis Patients *

2.5 mg

Children greater than 1 month of age: The usual recommended starting dose is 0.08 mg/kg (up to 5 mg) once daily. Adjust dose based on blood pressure response. Doses above 0.58 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients [see Clinical Pharmacology (12.3)].

EPANED is not recommended in neonates (i.e., infants 1 month of age or less), preterm infants who have not reached a corrected post-conceptual age of 44 weeks, and in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m2.

2.2 Heart Failure

The recommended initial dose is 2.5 mg twice a day titrated up to a maximum of 20 mg twice a day, as tolerated. Doses are usually given in combination with diuretics and digitalis.

In patients with hyponatremia (serum sodium less than 130 mEq/L) or serum creatinine greater than 1.6 mg/dL, the recommended initial dose is 2.5 mg once daily.

Diuretic dose may need to be adjusted to minimize hypovolemia and hypotension. The appearance of hypotension after the initial dose of EPANED does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

2.3 Asymptomatic Left Ventricular Dysfunction

The recommended initial dose is 2.5 mg twice a day titrated up to a maximum of 10 mg twice a day, as tolerated. Diuretic dose may need to be adjusted [see Dosage and Administration (2.1)].

3 DOSAGE FORMS AND STRENGTHS

EPANED is a ready-to-use oral solution that contains 1 mg/mL of enalapril maleate. It is a clear, colorless solution with a mixed berry flavor packaged in a 150 mL white, round, high-density polyethylene bottle with a white, polypropylene, child-resistant cap and tamper-evident seal. Each bottle contains 150 mL.

4 CONTRAINDICATIONS

EPANED is contraindicated in patients with:

a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme (ACE) inhibitor [see Warnings and Precautions (5.2)].
hereditary or idiopathic angioedema [see Warnings and Precautions (5.2)].

Do not co-administer aliskiren with EPANED in patients with diabetes [see Drug Interactions (7.2)].

EPANED is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer EPANED within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions (5.2)].

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