Lisinopril

DESCRIPTION

id: 8e1efa5b-d61c-4f37-a345-3f67c04d3ff9
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Lisinopril, USP is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, USP, a synthetic peptide derivative, is chemically described as (S)-1-[N²-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its molecular formula is C₂₁H₃₁N₃O₅·2H₂O and its structural formula is: Lisinopril, USP is a white crystalline powder, with a molecular weight of 441.52. It is soluble in water; sparingly soluble in methanol; practically insoluble in alcohol, in acetone, in acetonitrile and in chloroform. Lisinopril, 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, 5, 10, 20 and 30 mg tablets–dibasic calcium phosphate (anhydrous), ferric oxide (red), magnesium stearate, mannitol, pregelatinized starch, and corn starch. 40 mg tablets-dibasic calcium phosphate (anhydrous), ferric oxide (yellow), magnesium stearate, mannitol, pregelatinized starch, and corn starch.

CONTRAINDICATIONS

id: 29c6872c-52e8-4945-bf23-be94f0c3bf22
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.

ADVERSE REACTIONS

id: 2a06bcb7-9dfc-4e24-90b6-1b08a3efd6d3
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: cd1e489b-90ea-45f5-8a36-3a7aa1f9f349
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: 98206181-1a10-44ec-803e-ae1a5a3fa15b
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Lisinopril Tablets, USP 10 mg, light pink colored, round, flat faced, beveled edge tablets, debossed with “RX 533” on one side and plain on the other side. They are supplied as follows: NDC 67046-426-30 Blister of 30 Lisinopril Tablets, USP 20 mg, light rust colored, round, flat faced, beveled edge tablets, debossed with “RX 534” on one side and plain on the other side. They are supplied as follows: NDC 67046-428-30 Blister of 30 Storage Store at 20 – 25° C (68 – 77° F) [See USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container. ¹AN69^® is a registered trademark of Hospal Ltd. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ohm Laboratories Inc. North Brunswick, NJ 08902 USA August 2009 Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA Original–10/2009–NJW Updated–02/2010–NJW

Lisinopril Tablets, USP 10 mg

id: 89190eeb-ea77-4854-b70a-a3c8a944eb17
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Lisinopril Tablets, USP 20 mg

id: c1fc0ffb-7b07-4fdf-8ed5-8387e1f4f054
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4