Lisinopril (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Lisinopril Tablets, USP, for oral administration, are available as

5 mg

Pink, oval, biconvex, uncoated tablets debossed “E 54” on one side and bisected on the other side and supplied as:

NDC 0185-5400-01 bottles of 100

NDC 0185-5400-10 bottles of 1000

NDC 69189-5400-1 single dose pack with 1 tablet as repackaged by Avera McKennan Hospital

Storage

Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.

17 PATIENT COUNSELING INFORMATION

NOTE

This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

Pregnancy

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to notify their healthcare provider with a known or suspected pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

Angioedema

Angioedema, including laryngeal edema may occur at any time during treatment with angiotensin converting enzyme inhibitors, including lisinopril. Tell patients to report immediately any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing) and to take no more drug until they have consulted with the prescribing physician.

Lactation

Advise women not to breastfeed during treatment with lisinopril [see Use in Specific Populations (8.2)].

Symptomatic Hypotension

Tell patients to report light-headedness especially during the first few days of therapy. If actual syncope occurs, tell the patient to discontinue the drug until they have consulted with the prescribing physician.

Tell patients that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume. Other causes of volume depletion such as vomiting or diarrhea may also lead to a fall in blood pressure; advise patients accordingly.

Hyperkalemia

Tell patients not to use salt substitutes containing potassium without consulting their physician.

Hypoglycemia

Tell diabetic patients treated with oral antidiabetic agents or insulin starting an ACE inhibitor to monitor for hypoglycaemia closely, especially during the first month of combined use [see Drug Interactions (7.2)].

Leukopenia/Neutropenia

Tell patients to report promptly any indication of infection (e.g., sore throat, fever), which may be a sign of leukopenia/neutropenia.

Sandoz Inc.

Princeton, NJ 08540

46158592

Rev. May 2016

MF0025REV05/16

Package/Label Display Panel

Lisinopril 5 mg tablet
(click image for full-size original)

LISINOPRIL
lisinopril tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-5400(NDC:0185-5400)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISINOPRIL (LISINOPRIL ANHYDROUS) LISINOPRIL 5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
MAGNESIUM STEARATE
MANNITOL
FERRIC OXIDE RED
STARCH, CORN
Product Characteristics
Color PINK Score 2 pieces
Shape OVAL Size 8mm
Flavor Imprint Code E54
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69189-5400-1 1 TABLET in 1 DOSE PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075994 04/15/2016
Labeler — Avera McKennan Hospital (068647668)
Establishment
Name Address ID/FEI Operations
Avera McKennan Hospital 068647668 relabel (69189-5400), repack (69189-5400)

Revised: 03/2017 Avera McKennan Hospital

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