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Uses
EPANED is indicated for the treatment of hypertension, to lower blood pressure in adults and children older than one month.
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.
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.
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.
History
There is currently no drug history available for this drug.
Other Information
EPANED (Enalapril Maleate) Powder for Oral Solution is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5•C4H4O4, and its structural formula is:
Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.52. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol.
Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor.
EPANED Powder for Oral Solution is a kit consisting of 1 bottle containing a dry powder blend of enalapril maleate, USP, mannitol, and colloidal silicon dioxide and 1 bottle of Ora-Sweet SF diluent for reconstitution resulting in a 1 mg/mL EPANED oral solution. The Ora-Sweet SF diluent contains: purified water, glycerin, sorbitol, sodium saccharin, xanthan gum, and flavoring. Buffered with citric acid and sodium citrate. Preserved with methylparaben (0.03%), propylparaben (0.008%), and potassium sorbate (0.1%).
Sources
Epaned Manufacturers
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Silvergate Pharmaceuticals, Inc.
![Epaned (Enalapril Maleate) Kit [Silvergate Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Epaned | Silvergate Pharmaceuticals, Inc.
2.1 HypertensionAdults: The recommended initial dose in adults is 5 mg 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)]. † Dosage on nondialysis days should be adjusted depending on the blood pressure response.Renal Status
Creatinine-Clearance
mL/minInitial Dose
mg/dayNormal 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 on dialysis days†
Children >1 month: The usual recommended starting dose is 0.08 mg/kg (up to 5 mg) once daily. Dosage should be adjusted according to 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 and in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m2, as no data are available.
2.2 Heart FailureGenerally, 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 DysfunctionThe 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)].
2.4 Preparation of EPANED (for 150 mL, 1 mg/mL enalapril solution)EPANED Powder for Oral Solution is a kit containing 1 bottle of enalapril powder and 1 bottle of Ora-Sweet SF diluent to be added to the enalapril powder prior to dispensing to the patient.
Firmly tap the EPANED Powder for Oral Solution bottle on a hard surface 5 times. Add approximately one-half (75 mL) of the Ora-Sweet SF diluent to the 150 mL EPANED Powder for Oral Solution bottle. Replace the child-resistant cap. Shake well for 30 seconds. Reopen. Add the remainder of the Ora-Sweet SF diluent to the EPANED Powder for Oral Solution bottle, replace the child-resistant cap and shake well for an additional 30 seconds. Calculate 60 days from the date of reconstitution. Write this date as the discard date on the front of the label. Affix a “Do Not Use After” or a “Discard After” label with the calculated date added to the reconstituted EPANED bottle.
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