USE IN PREGNANCY
displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1
When used in pregnancy, during the second and third trimesters, ACE inhibitors can cause
injury and even death to the developing fetus. When pregnancy is detected, lisinopril should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.
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-[ N
C21H31N3O5 •2H2O M.W. 441.53
Lisinopril is a white to off-white, crystalline powder. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol.
Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg or 40 mg tablets for oral administration. In addition to the active ingredient lisinopril, each tablet contains the following inactive ingredients: corn starch, dibasic calcium phosphate, magnesium stearate, mannitol, and talc.
2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L- proline dihydrate. It has the following structural formula:
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.
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.
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
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Lisinopril Tablets USP, 2.5 mg are available as white, round, flat-faced, beveled-edged, unscored tablets debossed
on one side and “3757” on the other side containing 2.5 mg lisinoprils.
Lisinopril Tablets USP, 5 mg are available as white, square-shaped tablets, debossed
with a bisect on one side and “3758” on the other side containing 5 mg lisinopril.
Lisinopril Tablets USP, 10 mg are available as white, arc triangle shaped, unscored tablets debossed
on one side and “3759” on the other side containing 10 mg lisinopril.
Lisinopril Tablets USP, 20 mg are available as white, pentagonal-shaped, unscored tablets debossed
on one side and “3760” on the other side containing 20 mg lisinopril.
Lisinopril Tablets USP, 30 mg are available as white, oval-shaped, unscored tablets debossed
on one side and “3762” on the other side containing 30 mg lisinopril, packaged in bottles of 100 and 500 tablets and unit-dose boxes of 100 tablets.
Lisinopril Tablets USP, 40 mg are available as white, round, flat-faced, beveled-edged, unscored tablets debossed
on one side and “3761” on the other side containing 40 mg lisinopril.
They are supplied by State of Florida DOH Central Pharmacy as follows:
PHARMACIST: Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).
PROTECT FROM MOISTURE, FREEZING AND EXCESSIVE HEAT
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Manufactured In India By:
EMCURE PHARMACEUTICALS LTD.
Hinjwadi, Pune, India
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. D 3/2010
This Product was Repackaged By:
State of Florida DOH Central Pharmacy
Source Prod. Code
||30 Tablets in a Blister Pack
104-2 Hamilton Park Drive
Tallahassee, FL 32304
PRINCIPAL DISPLAY PANEL
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4