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 <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 BicitraÒ** 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 2-8o C (36-46o F) and can be stored for up to 30 days. Shake the suspension before each use.

HOW SUPPLIED

Enalapril Maleate Tablets, USP
NDC number Strength Description Quantity
NDC 64679-923-01 2.5 mg White, round flat-faced beveled 90’s bottle
NDC 64679-923-02 edged, compressed tablets with W 100’s bottle
NDC 64679-923-03 923 on one side and breakline 1000’s bottle
NDC 64679-923-07 on the other side. Unit Dose Cartonof 100
NDC 64679-924-01 5 mg White, round flat-faced beveled 90’s bottle
NDC 64679-924-02 edged, compressed tablets with W 100’s bottle
NDC 64679-924-03 924 on one side and breakline 1000’s bottle
NDC 64679-924-07 on the other side. Unit Dose Carton of 100
NDC 64679-925-01 10 mg Light Salmon, round flat-faced 90’s bottle
NDC 64679-925-02 beveled edged, compressed tablets 100’s bottle
NDC 64679-925-03 with W 925 on one side, plain on the 1000’s bottle
NDC 64679-925-07 other side. Unit Dose Carton of 100
NDC 64679-926-01 20 mg Light Beige, round flat-faced 90’s bottle
NDC 64679-926-02 beveled edged, compressed tablets 100’s bottle
NDC 64679-926-03 with W 926 on one side, plain on the 1000’s bottle
NDC 64679-926-07 other side. Unit Dose Carton of 100

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

H-14/2, M.I.D.C. Area, Waluj,

Aurangabad, Maharashtra,

India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Rev.080515

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Enalapril Maleate

GENERIC: Enalapril Maleate

DOSAGE: Tablets

ADMINSTRATION: Oral

NDC: 64679-923-02

STRENGTH: 2.5 mg

COLOR: White

SHAPE: Round (flat-faced beveled edged)

SCORE: Score

SIZE: 6 mm

IMPRINT: W923

QTY: 100 Tablets

Label-2.5 mg-100T
(click image for full-size original)

DRUG: Enalapril Maleate

GENERIC: Enalapril Maleate

DOSAGE: Tablets

ADMINSTRATION: Oral

NDC: 64679-924-02

STRENGTH: 5 mg

COLOR: White

SHAPE: Round (flat-faced beveled edged)

SCORE: Score

SIZE: 8 mm

IMPRINT: W924

QTY: 100 Tablets

Label-5 mg-100T
(click image for full-size original)

DRUG: Enalapril Maleate

GENERIC: Enalapril Maleate

DOSAGE: Tablets

ADMINSTRATION: Oral

NDC: 64679-925-03

STRENGTH: 10 mg

COLOR: Orange

SHAPE: Round (flat-faced beveled edged)

SCORE: No Score

SIZE: 8 mm

IMPRINT: W925

QTY: 1000 Tablets

Label-10 mg-1000T
(click image for full-size original)

DRUG: Enalapril Maleate

GENERIC: Enalapril Maleate

DOSAGE: Tablets

ADMINSTRATION: Oral

NDC: 64679-926-03

STRENGTH: 20 mg

COLOR: Brown (Light Beige)

SHAPE: Round (flat-faced beveled edged)

SCORE: No Score

SIZE: 8 mm

IMPRINT: W926

QTY: 1000 Tablets

Label-20 mg-1000T
(click image for full-size original)
ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55648-923
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
HYPROMELLOSE 2910 (6 MPA.S)
STARCH, CORN
STEARIC ACID
TALC
Product Characteristics
Color WHITE (White) Score 2 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:55648-923-07 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (55648-923-07)
2 NDC:55648-923-01 90 TABLET in 1 BOTTLE None
3 NDC:55648-923-02 100 TABLET in 1 BOTTLE None
4 NDC:55648-923-03 1000 TABLET in 1 BOTTLE None
5 NDC:55648-923-09 40000 TABLET in 1 DRUM None
6 NDC:55648-923-10 8000 TABLET in 1 DRUM None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 12/11/2009
ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55648-924
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
HYPROMELLOSE 2910 (6 MPA.S)
STARCH, CORN
STEARIC ACID
TALC
Product Characteristics
Color WHITE (White) Score 2 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:55648-924-07 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (55648-924-07)
2 NDC:55648-924-01 90 TABLET in 1 BOTTLE None
3 NDC:55648-924-02 100 TABLET in 1 BOTTLE None
4 NDC:55648-924-03 1000 TABLET in 1 BOTTLE None
5 NDC:55648-924-09 40000 TABLET in 1 DRUM None
6 NDC:55648-924-10 8000 TABLET in 1 DRUM None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 12/11/2009
ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55648-925
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
FERRIC OXIDE RED
HYPROMELLOSE 2910 (6 MPA.S)
STARCH, CORN
STEARIC ACID
TALC
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:55648-925-07 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (55648-925-07)
2 NDC:55648-925-01 90 TABLET in 1 BOTTLE None
3 NDC:55648-925-02 100 TABLET in 1 BOTTLE None
4 NDC:55648-925-03 1000 TABLET in 1 BOTTLE None
5 NDC:55648-925-09 40000 TABLET in 1 DRUM None
6 NDC:55648-925-10 8000 TABLET in 1 DRUM None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 12/11/2009
ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55648-926
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
BROWN IRON OXIDE
HYPROMELLOSE 2910 (6 MPA.S)
STARCH, CORN
STEARIC ACID
TALC
Product Characteristics
Color BROWN (Light Beige) Score no score
Shape ROUND (round flat-faced beveled edged) Size 8mm
Flavor Imprint Code W;926
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55648-926-07 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (55648-926-07)
2 NDC:55648-926-01 90 TABLET in 1 BOTTLE None
3 NDC:55648-926-02 100 TABLET in 1 BOTTLE None
4 NDC:55648-926-03 1000 TABLET in 1 BOTTLE None
5 NDC:55648-926-09 40000 TABLET in 1 DRUM None
6 NDC:55648-926-10 8000 TABLET in 1 DRUM None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 12/11/2009
Labeler — Wockhardt Limited (650069115)
Registrant — Wockhardt Limited (650069115)
Establishment
Name Address ID/FEI Operations
Wockhardt Limited 916489953 analysis (55648-923), analysis (55648-924), analysis (55648-925), analysis (55648-926), manufacture (55648-923), manufacture (55648-924), manufacture (55648-925), manufacture (55648-926), label (55648-923), label (55648-924), label (55648-925), label (55648-926), pack (55648-923), pack (55648-924), pack (55648-925), pack (55648-926)
Establishment
Name Address ID/FEI Operations
Wockhardt Limited 676257570 analysis (55648-923), analysis (55648-924), analysis (55648-925), analysis (55648-926), manufacture (55648-923), manufacture (55648-924), manufacture (55648-925), manufacture (55648-926), label (55648-923), label (55648-924), label (55648-925), label (55648-926), pack (55648-923), pack (55648-924), pack (55648-925), pack (55648-926)

Revised: 05/2015 Wockhardt Limited

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