Prescription Drug Information: Enalapril Maleate (Page 4 of 4)

Clinical Laboratory Test Findings

Serum Electrolytes: Hyperkalemia (see PRECAUTIONS), hyponatremia.

Creatinine, Blood Urea Nitrogen: In controlled clinical trials minor increases in blood urea nitrogen and serum creatinine, reversible upon discontinuation of therapy, were observed in about 0.2 percent of patients with essential hypertension treated with enalapril maleate alone. Increases are more likely to occur in patients receiving concomitant diuretics or in patients with renal artery stenosis. (See PRECAUTIONS.) In patients with heart failure who were also receiving diuretics with or without digitalis, increases in blood urea nitrogen or serum creatinine, usually reversible upon discontinuation of enalapril maleate and/or other concomitant diuretic therapy, were observed in about 11 percent of patients. Increases in blood urea nitrogen or creatinine were a cause for discontinuation in 1.2 percent of patients.

Hematology: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.3 g percent and 1.0 vol percent, respectively) occur frequently in either hypertension or congestive heart failure patients treated with enalapril maleate but are rarely of clinical importance unless another cause of anemia coexists. In clinical trials, less than 0.1 percent of patients discontinued therapy due to anemia. Hemolytic anemia, including cases of hemolysis in patients with G-6-PD deficiency, has been reported; a causal relationship to enalapril cannot be excluded.

Liver Function Tests: Elevations of liver enzymes and/or serum bilirubin have occurred (see WARNINGS, Hepatic Failure).

OVERDOSAGE

Limited data are available in regard to overdosage in humans. Single oral doses of enalapril above 1,000 mg/kg and Greater than or equal to 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.) 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 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 potassiumsparing 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 Greater 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 Greater 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.

Tabel-3
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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 1.6mg/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 Bicitra®** 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 SFTM*** to the concentrate in the PET bottle and shake the suspension to disperse the ingredients.

The suspension should be refrigerated at 2-8°C (36-46°F) and can be stored for up to 30 days. Shake the suspension before each use.

HOW SUPLLIED

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Storage

Store below 30°C (86°F) and avoid transient temperatures above 50°C (122°F). Keep container tightly closed. Protect from moisture.

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

** Registered trademark of Alza Corporation.

*** Trademark of Paddock Laboratories, Inc.

Manufactured by:

Wockhardt Limited,

Mumbai, India.

Distributed By:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippainy, NJ 07054

USA

Rev.080610

Repackaged by:

Med-Health Pharma, LLC

North Las Vegas, NV 89032

MHP LB-60011 rev00

PRINCIPAL DISPLAY PANEL

Label
(click image for full-size original)

ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51138-033(NDC:64679-923)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Enalapril Maleate (Enalapril) Enalapril Maleate 2.5 mg
Product Characteristics
Color white (White) Score score with uneven pieces
Shape ROUND (Round flat-faced beveled edged) Size 6mm
Flavor Imprint Code W;923
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51138-033-30 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 01/01/2011
ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51138-034(NDC:64679-924)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Enalapril Maleate (Enalapril) Enalapril Maleate 5 mg
Product Characteristics
Color white (White) Score score with uneven 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:51138-034-30 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 01/01/2011
ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51138-035(NDC:64679-925)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Enalapril Maleate (Enalapril) Enalapril Maleate 10 mg
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:51138-035-30 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 01/01/2011
ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51138-036(NDC:64679-926)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Enalapril Maleate (Enalapril) Enalapril Maleate 20 mg
Product Characteristics
Color brown (light beige) Score no score
Shape ROUND (round flat-faced beve;ed edged) Size 8mm
Flavor Imprint Code W;926
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51138-036-30 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 01/01/2011
Labeler — Med Health Pharma, LLC (962603812)

Revised: 01/2011 Med Health Pharma, LLC

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