TRANDOLAPRIL tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Physicians Total Care, Inc.

ІПН (Міжнародна Ім'я):

TRANDOLAPRIL

Склад:

TRANDOLAPRIL 4 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Hypertension: Trandolapril tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. In considering the use of trandolapril tablets, it should be noted that in controlled trials ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients. (See Warnings: Angioedema .) When using trandolapril 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. Available data are insufficient to show that trandolapril tablets do not have a similar risk. (See WARNINGS .) Trandolapril 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 ACE inhibitor.

Огляд продуктів:

Trandolapril tablets 4 mg are rose colored, oval shaped compressed tablets debossed “cor 163” on one side and other side is plain. They are supplied as follows: Bottles of 90   (NDC 54868-6061-1) Bottles of 100 (NDC 54868-6061-0) Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in well-closed container with safety closure as defined in the USP. Keep this and all drugs out of the reach of children. Manufactured by: Corepharma LLC Middlesex, NJ 08846 for: Sandoz Inc Princeton ,NJ 08540 MF# 572-01 Rev.08-2007 Repackaging and Relabeling by: Physicians Total Care, Inc. Tulsa, OK      74146

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

TRANDOLAPRIL - TRANDOLAPRIL TABLET
PHYSICIANS TOTAL CARE, INC.
----------
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, TRANDOLAPRIL
SHOULD BE DISCONTINUED AS SOON AS POSSIBLE. SEE WARNINGS, FETAL
NEONATAL MORBIDITY AND
MORTALITY
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 molecular formula is
C
H N O and its structural formula is
M.W.=430.54
Melting Point=125°C
Trandolapril is a colorless, crystalline substance that is soluble
(>100 mg/mL) in chloroform,
dichloromethane, and methanol. Trandolapril tablets contain 1 mg, 2 mg
or 4 mg of trandolapril for oral
administration. Each tablet also contains the inactive ingredients:
corn starch, croscarmellose sodium,
hypromellose, lactose monohydrate, povidone, sodium stearyl fumarate.
In addition, trandolapril tablets
1 mg and 4 mg contain red 30 iron oxide and trandolapril tablets 2 mg
contain yellow 10 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 le