TRANDOLAPRIL tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Aurobindo Pharma Limited

INN (Rahvusvaheline Nimetus):

TRANDOLAPRIL

Koostis:

TRANDOLAPRIL 1 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Hypertension Trandolapril tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction 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 ACE inhibitor. Do not co-administer aliskiren with trandolapril in patients with diabetes (see PRECAUTIONS, Drug Interactions ). Trandolapril tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer trandolapril tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS ).  

Toote kokkuvõte:

Trandolapril tablets USP are supplied as follows: Trandolapril Tablets USP 1 mg are salmon colored, round, biconvex, uncoated tablets debossed with ‘E’ on upper side of the bisector line on one side and ‘35’ on the other side.                      Bottles of 100               NDC 65862-164-01                      Bottles of 1,000             NDC 65862-164-99 Trandolapril Tablets USP 2 mg are yellow colored, round, biconvex, uncoated tablets debossed with ‘E’ on one side and ‘36’ on the other side.                      Bottles of 100               NDC 65862-165-01                      Bottles of 1,000             NDC 65862-165-99 Trandolapril Tablets USP 4 mg are rose colored, round, biconvex, uncoated tablets debossed with ‘E’ on one side and ‘37’ on the other side.                      Bottles of 100               NDC 65862-166-01                      Bottles of 1,000             NDC 65862-166-99 Dispense in well-closed container with safety closure. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad–500 032, India Revised: 02/2022  

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

TRANDOLAPRIL - TRANDOLAPRIL TABLET
AUROBINDO PHARMA LIMITED
----------
TRANDOLAPRIL TABLETS USP
RX ONLY
WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue trandolapril 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 molecular formula is C
H
N O and its structural formula is
M.W. = 430.54
Melting Point = 125°C
Trandolapril USP 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 USP for oral administration. Each tablet
also contains lactose
monohydrate, corn starch, croscarmellose sodium, hypromellose,
povidone, and
sodium stearyl fumarate. In addition 1 mg and 4 mg tablet also
contains ferric oxide red
and 2 mg tablet contains ferric oxide yellow.
24
34
2
5
CLINICAL PHARMACOLOGY
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 se