Enalapril Maleate (Page 5 of 5)

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.

Image
(click image for full-size original)

Heart Failure

Enalapril maleate tablets are 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 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

Enalapril maleate tablets USP, 2.5 mg are available as yellow, oval, convex tablets debossed “704” on one side and bisect on the other side.

They are supplied as follows:

NDC 69043-035-01 bottles of 100 (with desiccant)

NDC 69043-035-99 bottles of 1000 (with desiccant)

Enalapril maleate tablets USP, 5 mg are available as white, oval, convex tablets debossed “705” on one side and bisect on the other side.

They are supplied as follows:

NDC 69043-032-01 bottles of 100 (with desiccant)

NDC 69043-032-99 bottles of 1000 (with desiccant)

Enalapril maleate tablets USP, 10 mg are available as salmon, oval, convex tablets debossed “706” on one side and plain on the other side.

They are supplied as follows:

NDC 69043-033-01 bottles of 100 (with desiccant)

NDC 69043-033-99 bottles of 1000 (with desiccant)

Enalapril maleate tablets USP, 20 mg are available as peach, oval, convex tablets debossed “707” on one side and plain on the other side.

They are supplied as follows:

NDC 69043-034-01 bottles of 100 (with desiccant)

NDC 69043-034-99 bottles of 1000 (with desiccant)

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep container tightly closed. Protect from moisture.

Dispense in a tight container as per USP, if product package is subdivided.

All brand names listed are the registered trademarks of their respective owners and are not the trademarks of Chronus Pharma LLC.

Manufactured for:

Cronus Pharma LLC

2 Tower Center Boulevard,

Suite 1101A, East Brunswick,

NJ, 08816 USA

Image

51UCP0000009US02

Revised: 01/2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69043-035 -01

Enalapril Maleate Tablets, USP

2.5 mg

100 Tablets

Rx only

2.5 mg
(click image for full-size original)

NDC 69043-032 -01

Enalapril Maleate Tablets, USP

5 mg

100 Tablets

Rx only

5 mg
(click image for full-size original)

NDC 69043-033 -01

Enalapril Maleate Tablets, USP

10 mg

100 Tablets

Rx only

10 mg
(click image for full-size original)

NDC 69043-034 -01

Enalapril Maleate Tablets, USP

20 mg

100 Tablets

Rx only

20 mg
(click image for full-size original)
ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69043-035
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENALAPRIL MALEATE (ENALAPRILAT ANHYDROUS) ENALAPRIL MALEATE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
SODIUM BICARBONATE
MAGNESIUM STEARATE
WATER
FD&C YELLOW NO. 6
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL (convex) Size 9mm
Flavor Imprint Code 704
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69043-035-01 100 TABLET in 1 BOTTLE None
2 NDC:69043-035-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075479 05/12/2021
ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69043-032
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENALAPRIL MALEATE (ENALAPRILAT ANHYDROUS) ENALAPRIL MALEATE 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
SODIUM BICARBONATE
MAGNESIUM STEARATE
WATER
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (convex) Size 11mm
Flavor Imprint Code 705
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69043-032-01 100 TABLET in 1 BOTTLE None
2 NDC:69043-032-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075479 05/12/2021
ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69043-033
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENALAPRIL MALEATE (ENALAPRILAT ANHYDROUS) ENALAPRIL MALEATE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
SODIUM BICARBONATE
FD&C RED NO. 40
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
WATER
MAGNESIUM STEARATE
Product Characteristics
Color PINK (salmon) Score no score
Shape OVAL (convex) Size 10mm
Flavor Imprint Code 706
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69043-033-01 100 TABLET in 1 BOTTLE None
2 NDC:69043-033-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075479 05/12/2021
ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69043-034
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 MONOHYDRATE
STARCH, CORN
SODIUM BICARBONATE
FD&C YELLOW NO. 6
WATER
MAGNESIUM STEARATE
Product Characteristics
Color PINK (peach) Score no score
Shape OVAL (convex) Size 10mm
Flavor Imprint Code 707
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69043-034-01 100 TABLET in 1 BOTTLE None
2 NDC:69043-034-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075479 05/12/2021
Labeler — Cronus Pharma LLC (079421067)
Registrant — Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. (189630168)
Establishment
Name Address ID/FEI Operations
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. 189630168 ANALYSIS (69043-032), ANALYSIS (69043-033), ANALYSIS (69043-034), ANALYSIS (69043-035), LABEL (69043-032), LABEL (69043-033), LABEL (69043-034), LABEL (69043-035), MANUFACTURE (69043-032), MANUFACTURE (69043-033), MANUFACTURE (69043-034), MANUFACTURE (69043-035), PACK (69043-032), PACK (69043-033), PACK (69043-034), PACK (69043-035)

Revised: 05/2021 Cronus Pharma LLC

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.