LISINOPRIL tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

LISINOPRIL (UNII: E7199S1YWR) (LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD)

제공처:

Med-Health Pharma, LLC

INN (국제 이름):

LISINOPRIL

구성:

LISINOPRIL 2.5 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Lisinopril Tablets are indicated for the treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents. Lisinopril Tablets are indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis. Lisinopril Tablets are indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers. In using Lisinopril Tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that Lisinopril Tablets do not have a similar risk.(See WARNINGS .) In considering the use of Lisinopril Tablets, it

제품 요약:

Lisinopril Tablets USP 2.5 mg: White, Oblong Tablet; Debossed “WW 65” Bottles of 30 tablets Lisinopril Tablets USP 5 mg: Red, Oblong, Bisected Tablet; Embossed “WW 66” Bottles of 30 tablets Lisinopril Tablets USP 10 mg: Pink, Round Tablet; Embossed “WW” on one side and “267” on the other side. Bottles of 30 tablets Lisinopril Tablets USP 20 mg: Red, Round, Unscored Tablet; Debossed “WW 268” Bottles of 30 tablets Lisinopril Tablets USP 30 mg: Red, Round, Unscored Tablet; Debossed “WW 280” Bottles of 30 tablets Lisinopril Tablets USP 40 mg: Golden Yellow, Round, Unscored Tablet; Debossed “WW 270” Bottles of 30 tablets 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 Repackaged By: Med-Health Pharma, LLC North Las Vegas, NV 89032 SP-60017 Rev01

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

LISINOPRIL- LISINOPRIL TABLET
MED-HEALTH PHARMA, LLC
----------
LISINOPRIL TABLETS, USP
Rev. 12/09
RX ONLY
USE IN PREGNANCY
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
Lisinopril is an oral long-acting angiotensin converting enzyme
inhibitor. Lisinopril, a synthetic peptide
derivative, is chemically described as (S)-1-[_N _
-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline
dihydrate. Its empirical formula is C
H N O •2H O 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.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Lisinopril inhibits angiotensin-converting enzyme (ACE) in human
subjects and animals. ACE is a
peptidyl dipeptidase that catalyzes the conversion of angiotensin I to
the vasoconstrictor substance,
angiotensin II. Angiotensin II also stimulates aldosterone secretion
by the adrenal cortex. The beneficial
effects of lisinopril in hypertension and heart failure appear to
result primarily from suppression of the
renin-angiotensin-aldosterone system. Inhibition of ACE results in
decreased plasma angiotensin