DESCRIPTION
id: 905981b3-e216-4d51-b79b-6fdcf2ac3976
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
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 C21H31N3O5·2H2O and its structural formula is:
Lisinopril 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 are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration.
Inactive Ingredients:
2.5 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, starch.
5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, red iron oxide, starch.
40 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, starch, yellow iron oxide.
CONTRAINDICATIONS
id: 0dc71021-b29d-415f-8878-dd0122ff8691
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Lisinopril tablets are contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema.
ADVERSE REACTIONS
id: f76f70b3-52de-40ae-baf0-e3596759c4f8
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Lisinopril has been found to be generally well tolerated in controlled clinical trials involving 1969 patients with hypertension or heart failure. For the most part, adverse experiences were mild and transient.
OVERDOSAGE
id: 4da29415-c95f-428b-af1e-69b9db58fb06
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Following a single oral dose of 20 g/kg no lethality occurred in rats, and death occurred in one of 20 mice receiving the same dose. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution.
Lisinopril can be removed by hemodialysis. (See
WARNINGS, Anaphylactoid Reactions During Membrane Exposure
).
HOW SUPPLIED
id: e3bfc6bc-4ab1-4879-a220-6de22958b99e
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Lisinopril Tablets, USP are available as:
2.5 mg tablet is a white to off-white, round, biconvex uncoated tablet with ‘LUPIN” debossed on one side and “2.5” on other side. They are available as follows:
Bottles of 100 NDC 68180-512-01
Bottles of 500 NDC 68180-512-02
Bottles of 1000 NDC 68180-512-03
5 mg tablet is a pink coloured, round, biconvex uncoated tablet with “5” debossed on one side and breakline on other side. They are available as follows:
Bottles of 100 NDC 68180-513-01
Bottles of 500 NDC 68180-513-02
Bottles of 1000 NDC 68180-513-03
Bottles of 5000 NDC 68180-513-05
10 mg tablet is a pink coloured, round, biconvex uncoated tablet with “LUPIN” debossed on one side and “10” on other side. They are available as follows:
Bottles of 100 NDC 68180-514-01
Bottles of 500 NDC 68180-514-02
Bottles of 1000 NDC 68180-514-03
Bottles of 5000 NDC 68180-514-05
20 mg tablet is a pink coloured, round, biconvex uncoated tablet with “LUPIN” debossed on one side and “20” on other side. They are available as follows:
Bottles of 100 NDC 68180-515-01
Bottles of 500 NDC 68180-515-02
Bottles of 1000 NDC 68180-515-03
Bottles of 5000 NDC 68180-515-05
30 mg tablet is a red coloured, round, biconvex uncoated tablet with “LUPIN” debossed on one side and “30” on other side. They are available as follows:
Bottles of 100 NDC 68180-516-01
Bottles of 500 NDC 68180-516-02
Bottles of 1000 NDC 68180-516-03
40 mg tablet is a yellow coloured, round, biconvex uncoated tablet with “LUPIN” debossed on one side and “40” on other side. They are available as follows:
Bottles of 100 NDC 68180-517-01
Bottles of 500 NDC 68180-517-02
Bottles of 1000 NDC 68180-517-03
Bottles of 2000 NDC 68180-517-04
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.
Manufactured for:
Lupin Pharmaceuticals, Inc.
Baltimore, Maryland 21202
United States.
Manufactured by:
Lupin Limited
Goa 403 722
INDIA.
Revised: June 2010
ID#: 221990
Image of Label
id: 9e3df516-9456-462d-a677-9cb0761a7c36
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
