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°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, 20 mg are peach colored, round, biconvex, slightly speckled tablets. One side scored and engraved with “T” above the score and with “20” under the score. The other side plain. They are supplied as follows:

  • NDC 51655-341-26 unit of use bottles of 90
    (with desiccant)

Storage

Store at 20° to 25°C (68° to 77°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.

Manufactured by:
Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761

Distributed by:
Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

Revised: January, 2019
89639-0119-11

Principal Display Panel

NDC; 51655-341-26

Label
(click image for full-size original)
ENALAPRIL MALEATE
enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-341(NDC:51672-4040)
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
MAGNESIUM STEARATE
SODIUM BICARBONATE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color orange (peach colored, slightly speckled) Score 2 pieces
Shape ROUND (biconvex) Size 8mm
Flavor Imprint Code T;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-341-26 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075657 05/28/2020
Labeler — Northwind Pharmaceuticals (036986393)
Registrant — Northwind Pharmaceuticals (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals 036986393 repack (51655-341)

Revised: 12/2021 Northwind Pharmaceuticals

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