DESCRIPTION
id: feb11076-b73c-43fc-9561-55db4df2f817
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 USP is 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 – calcium phosphate, magnesium stearate, mannitol, corn starch.
5 mg, 10 mg and 30 mg tablets – calcium phosphate, magnesium stearate, mannitol, red iron oxide, corn starch.
20 mg tablets – calcium phosphate, magnesium stearate, mannitol, red iron oxide, corn starch, yellow iron oxide.
40 mg tablets – calcium phosphate, magnesium stearate, mannitol, corn starch, yellow iron oxide.
CONTRAINDICATIONS
id: 6b866a9b-5af8-4e97-a8f3-231f95bf3430
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Lisinopril is 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.
Do not co-administer aliskiren with Lisinopril in patients with diabetes (see PRECAUTIONS,
Drug Interactions
).
ADVERSE REACTIONS
id: 16620def-2fca-4ce6-a330-f02dd359d5e4
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Lisinopril has been found to be generally well tolerated in controlled clinical trials involving 1,969 patients with hypertension or heart failure. For the most part, adverse experiences were mild and transient.
OVERDOSAGE
id: 86b45af6-a10d-417c-8bb4-41a556c84b9b
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: 61651599-611c-4c95-a32d-9a2a4ac2ca3b
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Lisinopril Tablets USP, for oral administration, are available as:
2.5 mg: White, oval, biconvex, uncoated tablets debossed “E 25” on one side and plain on the other side and supplied as:
NDC 0615-7774-39 Blistercards of 30
NDC 0615-7774-30 Unit-Dose Boxes of 30
5 mg: Pink, oval, biconvex, uncoated tablets debossed “E 54” on one side and bisected on the other side and supplied as:
NDC 0615-7775-39 Blistercards of 30
NDC 0615-7775-31 Blistercards of 31
NDC 0615-7775-05 Blistercards of 15
NDC 0615-7775-30 Unit-Dose Boxes of 30
10 mg: Pink, oval, biconvex, uncoated tablets debossed “E 101” on one side and plain on the other side and supplied as:
NDC 0615-7776-39 Blistercards of 30
NDC 0615-7776-31 Blistercards of 31
NDC 0615-7776-05 Blistercards of 15
NDC 0615-7776-30 Unit-Dose Boxes of 30
20 mg: Peach, oval, biconvex, uncoated tablets debossed “E 102” on one side and plain on the other side and supplied as:
NDC 0615-7777-39 Blistercards of 30
NDC 0615-7777-31 Blistercards of 31
NDC 0615-7777-05 Blistercards of 15
NDC 0615-7777-30 Unit-Dose Boxes of 30
30 mg: Red, oval, biconvex, uncoated tablets debossed “E 103” on one side and plain on the other side.
40 mg: Yellow, oval, biconvex, uncoated tablets debossed “E 104” on one side and plain on the other side and supplied as:
NDC 0615-7779-39 Blistercards of 30
NDC 0615-7779-05 Blistercards of 15
NDC 0615-7779-30 Unit-Dose Boxes of 30
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.
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Sandoz Inc.
Princeton, NJ 08540
OS7708
Rev. 01/14
MF0025REV01/14
PRINCIPAL DISPLAY PANEL – 2.5 mg
id: 6457407e-6c32-4201-b378-1a97ec32819b
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
PRINCIPAL DISPLAY PANEL – 5 mg
id: 4e29f61b-4a49-4eeb-963c-ade188bd348f
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Lisinopril Tablets USP 5 mg
PRINCIPAL DISPLAY PANEL – 10 mg
id: d7d2a2ce-22b3-44e5-a797-a3ce6a9bdcb8
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
PRINCIPAL DISPLAY PANEL – 20 mg
id: 00b4caa6-b7a8-4ea8-928f-e899014ccb80
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
PRINCIPAL DISPLAY PANEL – 40 mg
id: 4a7fb820-9811-45b5-8e2d-143b6b77bc5e
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
