TRANDOLAPRIL- trandolapril tablets tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Epic Pharma, LLC

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 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

পণ্য সারাংশ:

Trandolapril Tablets USP, 1 mg are pink, round biconvex beveled edge tablets, debossed “Є52” on one side and bisected on the other side; available in bottles of 100 and 1000. Trandolapril Tablets USP, 2 mg are pink, round biconvex beveled edge tablets, debossed “Є53” on one side and plain on the other side; available in bottles of 100 and 1000. Trandolapril Tablets USP, 4 mg are pink, round biconvex beveled edge tablets, debossed “Є54” on one side and plain on the other side; available in bottles of 100 and 1000. Store at 20°-25°C (68°-77°F) see USP Controlled Room Temperature. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure as required. Manufactured by Epic Pharma, LLC Laurelton, NY 11413 Rev. 11-2017-00 MF052REV11/17 OE1420

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

TRANDOLAPRIL- TRANDOLAPRIL TABLETS TABLET
EPIC PHARMA, LLC
----------
TRANDOLAPRIL TABLETS USP
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 empirical
formula is C
H
N
O
and its structural formula is:
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 contain 1 mg, 2
mg, or 4 mg of trandolapril USP for
oral administration. Each tablet also contains corn starch,
croscarmellose sodium, hypromellose, ferric
oxide red, lactose monohydrate, povidone and sodium stearyl fumarate.
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
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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 potassiu