Lisinopril (Page 6 of 6)

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: Tell female patients of childbearing age about the consequences of exposure to lisinopril during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible.

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.

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

OS7708

Rev. 01/15

MF0025REV01/15

MG #16344

Package/Label Display Panel – 5 mg

Blenheim Pharmacal, Inc.

NDC 10544-903-90

Lisinopril Tablets USP

5 mg

Rx only

90 Tablets

Package/Label Display Panel – 10 mg

Blenheim Pharmacal, Inc.

NDC 10544-905-00

Lisinopril Tablets USP

10 mg

Rx only

100 Tablets

Package/Label Display Panel – 20 mg

Blenheim Pharmacal, Inc.

NDC 10544-904-00

Lisinopril Tablets USP

20 mg

Rx only

100 Tablets

11 DESCRIPTION

Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C ₂₁ H ₃₁ N ₃ O ₅ • 2H ₂ O and its structural formula is:

Lisinopril USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol.

Lisinopril tablets USP, for oral administration, is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40

mg tablets.

Inactive Ingredients:

2.5 mg tablets – dibasic calcium phosphate, magnesium stearate, mannitol, corn starch.

5 mg, 10 mg and 30 mg tablets – dibasic calcium phosphate, magnesium stearate, mannitol, red iron oxide, corn starch.

20 mg tablets – dibasic calcium phosphate, magnesium stearate, mannitol, red iron oxide, corn starch, yellow iron oxide.

40 mg tablets – dibasic calcium phosphate, magnesium stearate, mannitol, corn starch, yellow iron oxide.

LISINOPRIL lisinopril tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-903(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:10544-903-90 90 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075994 02/19/2015

LISINOPRIL lisinopril tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-905(NDC:0185-0101) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LISINOPRIL (LISINOPRIL ANHYDROUS) LISINOPRIL 10 mg

Inactive Ingredients Ingredient Name Strength CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FERRIC OXIDE RED MAGNESIUM STEARATE MANNITOL STARCH, CORN

Product Characteristics Color pink Score no score Shape OVAL Size 10mm Flavor Imprint Code E101 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:10544-905-00 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075994 02/19/2015

LISINOPRIL lisinopril tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-904(NDC:0185-0102) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LISINOPRIL (LISINOPRIL ANHYDROUS) LISINOPRIL 20 mg

Inactive Ingredients Ingredient Name Strength CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS MAGNESIUM STEARATE MANNITOL FERRIC OXIDE RED STARCH, CORN FERRIC OXIDE YELLOW

Product Characteristics Color orange (Peach) Score no score Shape OVAL Size 10mm Flavor Imprint Code E102 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:10544-904-00 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075994 02/19/2015

Labeler — Blenheim Pharmacal, Inc. (171434587)

Registrant — Blenheim Pharmacal, Inc. (171434587)

Establishment
Name	Address	ID/FEI	Operations
Blenheim Pharmacal, Inc.		171434587	repack (10544-903), repack (10544-904), repack (10544-905)

Revised: 04/2015 Blenheim Pharmacal, Inc.