ENALAPRIL MALEATE (Page 7 of 7)

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 m 2 , 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 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 o C (36° to 46 o F) and can be stored for up to 30 days. Shake the suspension before each use.

HOW SUPPLIED

Product: 50090-0689

NDC: 50090-0689-0 30 TABLET in a BOTTLE

NDC: 50090-0689-1 100 TABLET in a BOTTLE

Product: 50090-0690

NDC: 50090-0690-0 30 TABLET in a BOTTLE

NDC: 50090-0690-1 100 TABLET in a BOTTLE

NDC: 50090-0690-2 60 TABLET in a BOTTLE

NDC: 50090-0690-4 90 TABLET in a BOTTLE

Product: 50090-0692

NDC: 50090-0692-0 30 TABLET in a BOTTLE

NDC: 50090-0692-1 60 TABLET in a BOTTLE

NDC: 50090-0692-3 90 TABLET in a BOTTLE

ENALAPRIL MALEATE

Label ImageLabel Image

ENALAPRIL MALEATE

Label ImageLabel Image

ENALAPRIL MALEATE

Label ImageLabel Image
ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0689(NDC:64679-924)
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
ANHYDROUS LACTOSE
HYPROMELLOSE 2910 (6 MPA.S)
STARCH, CORN
STEARIC ACID
TALC
Product Characteristics
Color white (White) Score 2 pieces
Shape ROUND (round flat-faced beveled edged) Size 8mm
Flavor Imprint Code W;924
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-0689-1 100 TABLET in 1 BOTTLE None
2 NDC:50090-0689-0 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 12/11/2009
ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0690(NDC:64679-925)
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
ANHYDROUS LACTOSE
FERRIC OXIDE RED
HYPROMELLOSE 2910 (6 MPA.S)
STARCH, CORN
STEARIC ACID
TALC
Product Characteristics
Color ORANGE (Light Salmon) Score no score
Shape ROUND (round flat-faced beveled edged) Size 8mm
Flavor Imprint Code W;925
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-0690-1 100 TABLET in 1 BOTTLE None
2 NDC:50090-0690-2 60 TABLET in 1 BOTTLE None
3 NDC:50090-0690-4 90 TABLET in 1 BOTTLE None
4 NDC:50090-0690-0 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 12/11/2009
ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0692(NDC:64679-926)
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
ANHYDROUS LACTOSE
BROWN IRON OXIDE
HYPROMELLOSE 2910 (6 MPA.S)
STARCH, CORN
STEARIC ACID
TALC
Product Characteristics
Color BROWN (Light Beige) Score no score
Shape ROUND (round flat-faced beveled edged) Size 8mm
Flavor Imprint Code W;926
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-0692-1 60 TABLET in 1 BOTTLE None
2 NDC:50090-0692-3 90 TABLET in 1 BOTTLE None
3 NDC:50090-0692-0 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 12/11/2009
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-0689), REPACK (50090-0689), RELABEL (50090-0690), REPACK (50090-0690), RELABEL (50090-0692), REPACK (50090-0692)

Revised: 06/2022 A-S Medication Solutions

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.