LISINOPRIL tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Liberty Pharmaceuticals, Inc.

INN (International ime):

LISINOPRIL

Sastav:

LISINOPRIL 5 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Lisinopril tablet is indicated for the treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents. Lisinopril tablet is indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis. Lisinopril tablet is 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 tablet, 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 tablet does not have a similar risk (See WARNINGS). In considering the use of Lisinopril tablet, it should

Proizvod sažetak:

5 mg Tablets, white to off-white, round biconvex uncoated tablets debossed with W/928 on one side and breakline on other side. (NDC 00440-7674-90) Bottles of 90 tablets.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

LISINOPRIL- LISINOPRIL TABLET
LIBERTY PHARMACEUTICALS, INC.
----------
LISINOPRIL TABLETS USP
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 tablet
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 tablet 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, 5 mg, 10 mg tablets - dibasic calcium phosphate dihydrate,
povidone, pregelatinized starch,
mannitol, colloidal silicon dioxide, corn starch, magnesium stearate.
20 mg, 30 mg, 40 mg tablets - dibasic calcium phosphate dihydrate,
povidone, pregelatinized starch,
mannitol, colloidal silicon dioxide, corn starch, magnesium stearate,
ferric oxide yellow (for 20 mg),
ferric oxide red (for 30 mg) and ferric oxide brown (for 40 mg).
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
reninangiotensin-aldosterone system. Inhibition of ACE results in
decreased plasma angiotensin II
which leads to decreased vasopressor activity and to