Enalapril Maleate (Page 8 of 8)

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 2 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 1.6 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 4 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 tablets are not recommended in neonates and in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m 2 , as no data are available.

Preparation of Suspension (for 200 mL of a 1 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 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 are available containing 2.5 mg, 5 mg, 10 mg or 20 mg of enalapril maleate, USP.

The 2.5 mg tablets are white, round tablets debossed with M over E15 on one side and scored on the other side. They are available as follows:

NDC 51079-950-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).

The 5 mg tablets are white, round tablets debossed with M over E16 on one side and scored on the other side. They are available as follows:

NDC 51079-951-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).

The 10 mg tablets are light blue, round, unscored tablets debossed with M over E17 on one side and blank on the other side. They are available as follows:

NDC 51079-952-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).

The 20 mg tablets are medium blue, round, unscored tablets debossed with M over E18 on one side and blank on the other side. They are available as follows:

NDC 51079-953-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from moisture.

The brands listed are trademarks of their respective owners.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-12191 R2
2/16

PRINCIPAL DISPLAY PANEL — 2.5 mg

NDC 51079-950-20

Enalapril
Maleate
Tablets, USP
2.5 mg

100 Tablets (10 x 10)

Each tablet contains:
Enalapril maleate, USP . . . . 2.5 mg

Usual Dosage: See accompanying
prescribing information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from moisture.

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-7557 R3

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Enalapril Maleate 2.5 mg Tablets Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 mg

NDC 51079-951-20

Enalapril
Maleate
Tablets, USP
5 mg

100 Tablets (10 x 10)

Each tablet contains:
Enalapril maleate, USP . . . . 5 mg

Usual Dosage: See accompanying
prescribing information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from moisture.

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-7558 R4

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Enalapril Maleate 5 mg Tablets Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg

NDC 51079-952-20

Enalapril
Maleate
Tablets, USP
10 mg

100 Tablets (10 x 10)

Each tablet contains:
Enalapril maleate, USP . . . . 10 mg

Usual Dosage: See accompanying
prescribing information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from moisture.

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-7559 R5

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Enalapril Maleate 10 mg Tablets Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg

NDC 51079-953-20

Enalapril
Maleate
Tablets, USP
20 mg

100 Tablets (10 x 10)

Each tablet contains:
Enalapril maleate, USP . . . . 20 mg

Usual Dosage: See accompanying
prescribing information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from moisture.

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-7560 R3

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Enalapril Maleate 20 mg Tablets Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)
ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-950(NDC:0378-1051)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENALAPRIL MALEATE (ENALAPRILAT ANHYDROUS) ENALAPRIL MALEATE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
MALEIC ACID
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM LAURYL SULFATE
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code M;E15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-950-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-950-01)
1 NDC:51079-950-01 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (51079-950-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075480 11/15/2000 11/30/2018
ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-951(NDC:0378-1052)
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
SILICON DIOXIDE
MAGNESIUM STEARATE
MALEIC ACID
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM LAURYL SULFATE
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code M;E16
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-951-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-951-01)
1 NDC:51079-951-01 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (51079-951-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075480 11/15/2000 04/30/2019
ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-952(NDC:0378-1053)
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
SILICON DIOXIDE
MAGNESIUM STEARATE
MALEIC ACID
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
Product Characteristics
Color blue (light blue) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code M;E17
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-952-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-952-01)
1 NDC:51079-952-01 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (51079-952-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075480 11/15/2000 01/31/2019
ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-953(NDC:0378-1054)
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
SILICON DIOXIDE
MAGNESIUM STEARATE
MALEIC ACID
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
Product Characteristics
Color blue (medium blue) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code M;E18
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-953-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-953-01)
1 NDC:51079-953-01 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (51079-953-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075480 11/15/2000 11/30/2018
Labeler — Mylan Institutional Inc. (039615992)

Revised: 12/2018 Mylan Institutional Inc.

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