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 Error! Hyperlink reference not valid..

Enalapril maleate tablets are 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 10 Tablets are:

Red, rounded triangle shaped scored tablet debossed with “S 7” on one side and scored on the other side.

Supplied:

In Bottles of 30 NDC 68788-8385-3

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Container Label-10 mg

Rx only

NDC 68788-8385

Enalapril Maleate Tablets, USP

Each tablet contains: 10 mg of Enalapril Maleate, USP.

Usual Dosage: See package insert for dosage information.

This package is child-resistant. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.

WARNING: Keep out of the reach of children.

Pharmacist: Dispense in tight container as per USP.

Protect from moisture. Bottle contains desiccant.

Manufactured by:

Zhejiang Huahai Pharmaceutical Co., Ltd.

Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:

Solco Healthcare US, LLC

Somerset, NJ 08873, USA

Rev.: 03/2022

203410-01

Repackaged By: Preferred Pharmaceuticals Inc.

ENALAPRIL MALEATE enalapril maleate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-8385(NDC:43547-547) 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 FERRIC OXIDE RED LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM BICARBONATE STARCH, CORN

Product Characteristics Color RED Score 2 pieces Shape TRIANGLE (rounded triangle) Size 9mm Flavor Imprint Code S;7 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68788-8385-3 30 TABLET in 1 BOTTLE None 2 NDC:68788-8385-6 60 TABLET in 1 BOTTLE None 3 NDC:68788-8385-9 90 TABLET in 1 BOTTLE None 4 NDC:68788-8385-1 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213273 03/01/2023

Labeler — Preferred Pharmaceuicals Inc. (791119022)

Registrant — Preferred Pharmaceuicals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Operations
Preferred Pharmaceuicals Inc.		791119022	REPACK (68788-8385)

Revised: 03/2023 Preferred Pharmaceuicals Inc.