Lisinopril (Page 6 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Lisinopril tablet USP is available as uncoated biconvex tablets in blistercards of below mentioned package size

Strength Color Shape Scored Side 1 / Side 2 NDC
2.5 mg White to off-white Round No LUPIN/2.5 Blistercards of 30: 0615-8252-39Blistercards of 15: 0615-8252-05
5 mg Pink Round Yes 5/Breakline Blistercards of 30: 0615-8253-39Blistercards of 15: 0615-8253-05Unit-Dose Boxes of 30: 0615-8253-30
10 mg Pink Round No LUPIN/10

Blistercards of 30: 0615-8254-39 Blistercards of 15: 0615-8254-05Unit-Dose Boxes of 30: 0615-8254-30

20 mg Pink Round No LUPIN/20 Blistercards of 30: 0615-8255-39Blistercards of 15: 0615-8255-05Unit-Dose Boxes of 30: 0615-8255-30
30 mg Red Round No LUPIN/30
40 mg Yellow Round No LUPIN/40

Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP]. 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.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States.

MADE IN INDIA

Revised: October 2017 ID#: 253314

PRINCIPAL DISPLAY PANEL — 2.5 MG

PRINCIPAL DISPLAY PANEL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 MG BINGO CARD

PRINCIPAL DISPLAY PANEL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 MG UNIT-DOSE

Principal Display Panel Lisinopril 5 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 MG BINGO CARD

PRINCIPAL DISPLAY PANEL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 MG UNIT-DOSE

PRINCIPAL DISPLAY PANEL
(click image for full-size original)

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