TRANDOLAPRIL tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

TRANDOLAPRIL (UNII: 1T0N3G9CRC) (TRANDOLAPRILAT - UNII:RR6866VL0O)

Доступна з:

Carilion Materials Management

ІПН (Міжнародна Ім'я):

TRANDOLAPRIL

Склад:

TRANDOLAPRIL 1 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Trandolapril tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. Trandolapril tablets USP are indicated in stable patients who have evidence of left-ventricular systolic dysfunction (identified by wall motion abnormalities) or who are symptomatic from congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of trandolapril to Caucasian patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risk of heart failure-related hospitalization (see CLINICAL PHARMACOLOGY -Heart Failure or Left-Ventricular Dysfunction Post Myocardial Infarction for details of the survival trial). Trandolapril tablets are contraindicated in patients who are hypersensitive to this product, in patients with hereditary/idiopathic angioedema and in patients with a history of angioedema related to previous treatment with an A

Огляд продуктів:

Product: 68151-0757 NDC: 68151-0757-0 1 TABLET in a PACKAGE

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

TRANDOLAPRIL- TRANDOLAPRIL TABLET
CARILION MATERIALS MANAGEMENT
----------
TRANDOLAPRIL TABLETS
RX ONLY
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE TRANDOLAPRIL TABLETS AS SOON
AS POSSIBLE.
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE
DEVELOPING FETUS _(SEE WARNINGS:FETAL TOXICITY)_ .
DESCRIPTION
Trandolapril is the ethyl ester prodrug of a nonsulfhydryl angiotensin
converting enzyme (ACE)
inhibitor, trandolaprilat. Trandolapril is chemically described as
(2S,3aR,7aS)-1-[(S)-N-[(S)-1-Carboxy-
3-phenylpropyl] alanyl] hexahydro-2-indolinecarboxylic acid, 1-ethyl
ester. Its empirical formula is
C
H N O and its structural formula is
IMAG E
M.W.=430.54
Melting Point=125°C
Trandolapril is a white or almost white powder that is soluble (>100
mg/mL) in chloroform,
dichloromethane, and methanol. Trandolapril tablets USP contain 1 mg,
2 mg, or 4 mg of trandolapril for
oral administration. Each tablet also contains croscarmellose sodium,
hypromellose, lactose
monohydrate, povidone, starch (corn starch), sodium stearyl fumarate,
red iron oxide or yellow iron
oxide.
CLINICAL PHARMACOLOGY
24
34
2
5
MECHANISM OF ACTION
Trandolapril is deesterified to the diacid metabolite, trandolaprilat,
which is approximately eight times
more active as an inhibitor of ACE activity. ACE is a peptidyl
dipeptidase that catalyzes the conversion
of angiotensin I to the vasoconstrictor, angiotensin II. Angiotensin
II is a potent peripheral
vasoconstrictor that also stimulates secretion of aldosterone by the
adrenal cortex and provides
negative feedback for renin secretion. The effect of trandolapril in
hypertension appears to result
primarily from the inhibition of circulating and tissue ACE activity
thereby reducing angiotensin II
formation, decreasing vasoconstriction, decreasing aldosterone
secretion, and increasing plasma renin.
Decreased aldosterone secretion leads to diuresis, natriuresis, and a
small increase of serum potassium.
In controlled clinical trials, treatment with tr