LISINOPRIL tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

LISINOPRIL (UNII: E7199S1YWR) (LISINOPRIL - UNII:E7199S1YWR)

Tersedia dari:

RedPharm Drug Inc.

INN (Nama Internasional):

LISINOPRIL

Komposisi:

LISINOPRIL 20 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

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 67296-0542-1 Bottles 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. 1 AN69® 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

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

LISINOPRIL - LISINOPRIL TABLET
REDPHARM DRUG INC.
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LINSOPRIL TABLETS
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 should be
discontinued as soon as possible. See WARNINGS, FETAL/NEONATAL
MORBIDITY AND MORTALITY.
DESCRIPTION
Lisinopril, USP is an oral long-acting angiotensin converting enzyme
inhibitor. Lisinopril, USP, a
synthetic peptide derivative, is chemically described as (S)-1-[N
-(1-carboxy-3-phenylpropyl)-L-
lysyl]-L-proline dihydrate. Its molecular formula is C
H N O ·2H O 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.
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
rennin-angiotensin-aldosterone system. Inhibition of ACE results in
decreased plasma angiotensin II
which leads to decreased vasopressor activity and to decreased
aldosterone secretion. The latter
decrease may result in a small increase of serum potassi