Prescription Drug Information: Enalapril Maleate (Page 4 of 4)

OVERDOSAGE

Limited data are available in regard to overdosage in humans.

Single oral doses of enalapril above 1,000 mg/kg and ≥ 1,775 mg/kg were associated with lethality in mice and rats, respectively.

The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution.

Enalaprilat may be removed from general circulation by hemodialysis and has been removed from neonatal circulation by peritoneal dialysis (see WARNINGS , Anaphylactoid Reactions during Membrane Exposure).

DOSAGE AND ADMINISTRATION

Hypertension

In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of Enalapril Maleate Tablets. The diuretic should, if possible, be discontinued for two to three days before beginning therapy with Enalapril Maleate Tablets to reduce the likelihood of hypotension (see WARNINGS, Hypotension). If the patient’s blood pressure is not controlled with Enalapril Maleate Tablets alone, diuretic therapy may be resumed.

If the diuretic cannot be discontinued an initial dose of 2.5 mg should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS, Hypotension and PRECAUTIONS, Drug Interactions).

The recommended initial dose in patients not on diuretics is 5 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 10 to 40 mg per day administered in a single dose or two divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, an increase in dosage or twice daily administration should be considered. If blood pressure is not controlled with Enalapril Maleate Tablets alone, a diuretic may be added. Concomitant administration of Enalapril Maleate Tablets with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics may lead to increases of serum potassium (see PRECAUTIONS).

Dosage Adjustment in Hypertensive Patients with Renal Impairment

The usual dose of enalapril is recommended for patients with a creatinine clearance more than 30 mL/min (serum creatinine of up to approximately 3 mg/dL). For patients with creatinine clearance less than or equal to 30 mL/min (serum creatinine more than or equal to 3 mg/dL), the first dose is 2.5 mg once daily. The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily.

Renal Status Creatinine Clearance mL/min Initial Dose mg/day

Normal Renal Function

>80 mL/min

5 mg

Mild Impairment

≤ 80 >30 mL/min

5 mg

Moderate to SevereImpairment

≤30 mL/min

2.5 mg

Dialysis Patients*

-

2.5 mg ondialysis days

* See WARNINGS, Anaphylactoid Reactions during Membrane Exposure.

Dosage on nondialysis days should be adjusted depending on the blood pressure response.

Heart Failure

Enalapril Maleate Tablets is indicated for the treatment of symptomatic heart failure, usually in combination with diuretics and digitalis. In the placebo-controlled studies that demonstrated improved survival, patients were titrated as tolerated up to 40 mg, administered in two divided doses.

The recommended initial dose is 2.5 mg. The recommended dosing range is 2.5 to 20 mg given twice a day. Doses should be titrated upward, as tolerated, over a period of a few days or weeks. The maximum daily dose administered in clinical trials was 40 mg in divided doses.

After the initial dose of Enalapril Maleate Tablets, the patient should be observed under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS and PRECAUTIONS , Drug Interactions). If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of Enalapril Maleate Tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

Asymptomatic Left Ventricular Dysfunction

In the trial that demonstrated efficacy, patients were started on 2.5 mg twice daily and were titrated as tolerated to the targeted daily dose of 20 mg (in divided doses).

After the initial dose of Enalapril Maleate Tablets, the patient should be observed under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS and PRECAUTIONS, Drug Interactions). If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of Enalapril Maleate Tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

Dosage Adjustment in Patients with Heart Failure and Renal Impairment or Hyponatremia

In patients with heart failure who have hyponatremia (serum sodium less than 130 mEq/L) or with serum creatinine greater than 1.6 mg/dL, therapy should be initiated at 2.5 mg daily under close medical supervision (see DOSAGE AND ADMINISTRATION, Heart Failure , WARNINGS and PRECAUTIONS, Drug Interactions). The dose may be increased to 2.5 mg b.i.d., then 5 mg b.i.d. and higher as needed, usually at intervals of four days or more if at the time of dosage adjustment there is not excessive hypotension or significant deterioration of renal function. The maximum daily dose is 40 mg.

Pediatric Hypertensive Patients

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, Clinical Pharmacology in Pediatric Patients).

Enalapril Maleate Tablets is not recommended in neonates and in pediatric patients with glomerular filtration rate less than 30 mL/min/1.73 m2 , as no data are available.

Preparation of Suspension (for 200 mL of a 1.0 mg/mL suspension)

Add 50 mL of sodium citrate and citric acid oral solution, USP to a polyethylene terephthalate (PET) bottle containing ten 20 mg tablets of Enalapril Maleate Tablets and shake for at least 2 minutes. Let concentrate stand for 60 minutes. Following the 60-minute hold time, shake the concentrate for an additional minute. Add 150 mL of Ora-Sweet SF to the concentrate in the PET bottle and shake the suspension to disperse the ingredients. The suspension should be refrigerated at 2° to 8°C (36° to 46°F) and can be stored for up to 30 days. Shake the suspension before each use.

How Supplied

Tablets are: Peach, rounded triangle shaped tablet imprinted with “VASO 20” on one side and scored on the other.

Enalapril maleate tablets

NDC Number

Strength

Quantity

68788-7309-3

68788-7309-6

68788-7309-9

20 mg

Bottles of 30

Bottles of 60

Bottles of 90

PRINCIPAL DISPLAY PANEL – 20 mg

Enalapril Maleate Tablets  USP 20mg
(click image for full-size original)

NDC 68788-7309

Rx only

Enalapril Maleate Tablets

20 mg

Oceanside Pharmaceuticals

Repackaged By: Preferred Pharmaceuticals Inc.

ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-7309(NDC:68682-713)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Enalapril Maleate (Enalaprilat Anhydrous) Enalapril Maleate 20 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM
magnesium stearate
sodium stearate
sodium bicarbonate
starch, corn
ferric oxide red
ferric oxide yellow
Product Characteristics
Color PINK (Pink Peach color) Score 2 pieces
Shape TRIANGLE (rounded triangle) Size 8mm
Flavor Imprint Code VASO;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7309-3 30 TABLET in 1 BOTTLE None
2 NDC:68788-7309-6 60 TABLET in 1 BOTTLE None
3 NDC:68788-7309-9 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA018998 01/04/2019
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-7309)

Revised: 05/2020 Preferred Pharmaceuticals Inc.

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