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.
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** Registered trademark of Alza Corporation
*** Trademark of Paddock Laboratories, Inc.
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
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
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
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
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
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ENALAPRIL MALEATE enalapril maleate tablet | |||||||||||||||||||||||||||||||||||||
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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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