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.
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.
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.
Enalapril Maleate 10 Tablets are:
Red, rounded triangle shaped scored tablet debossed with “S 7” on one side and scored on the other side.
- In Bottles of 30 NDC 68788-8385-3
Container Label-10 mg
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.
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang 317024, China
Solco Healthcare US, LLC
Somerset, NJ 08873, USA
Repackaged By: Preferred Pharmaceuticals Inc.
| ENALAPRIL MALEATE |
enalapril maleate tablet
|Labeler — Preferred Pharmaceuicals Inc. (791119022)|
|Registrant — Preferred Pharmaceuicals Inc. (791119022)|
|Preferred Pharmaceuicals Inc.||791119022||REPACK (68788-8385)|
Revised: 03/2023 Preferred Pharmaceuicals Inc.
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