USE IN PREGNANCY
id: 65d4e231-8103-4f16-e053-2991aa0a3ad2
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 Tablets should be discontinued as soon as possible. See
WARNINGS, Fetal/Neonatal Morbidity and Mortality.
DESCRIPTION
id: 65d4e231-8106-4f16-e053-2991aa0a3ad2
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
2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C
21H
31N
3O
5•2H
2O 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 are as follows:
2.5 mg: Corn Starch, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Magnesium Stearate, Mannitol, and Sodium Starch Glycolate.
5 mg, 10 mg, 20 mg and 30 mg: Corn Starch, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Magnesium Stearate, Mannitol, Red Iron Oxide, and Sodium Starch Glycolate.
40 mg: Corn Starch, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Magnesium Stearate, Mannitol, Sodium Starch Glycolate, and Yellow Iron Oxide.
CONTRAINDICATIONS
id: 65d4e231-8109-4f16-e053-2991aa0a3ad2
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: 65d4e231-810c-4f16-e053-2991aa0a3ad2
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Lisinopril Tablets have 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: 65d4e231-810d-4f16-e053-2991aa0a3ad2
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: 65d4f363-590d-40be-e053-2991aa0a0239
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Lisinopril Tablets USP 10 mg: Pink, Round Tablet; Embossed “WW” on one side and “267” on the other side.
NDC 60760-267-30 BOTTLES OF 30
60760-267-90 BOTTLES OF 90
Lisinopril Tablets USP 20 mg: Red, Round, Unscored Tablet; Debossed “WW 268”
NDC 60760-128-30 BOTTLES OF 30
60760-128-90 BOTTLES OF 90
Lisinopril Tablets USP 40 mg: Golden Yellow, Round, Unscored Tablet; Debossed “WW 270”
NDC 60760-270-30 BOTTLES OF 30
60760-270-90 BOTTLES OF 90
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat.
Manufactured by:
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724
Revised December 2009
PRINCIPAL DISPLAY PANEL
id: 65d4e231-8110-4f16-e053-2991aa0a3ad2
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
PRINCIPAL DISPLAY PANEL
id: 65d4e231-8111-4f16-e053-2991aa0a3ad2
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
PRINCIPAL DISPLAY PANEL
id: 65d4e231-8112-4f16-e053-2991aa0a3ad2
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
