Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
TRANDOLAPRIL (UNII: 1T0N3G9CRC) (TRANDOLAPRILAT - UNII:RR6866VL0O)
Rising Pharma Holdings, Inc.
TRANDOLAPRIL
TRANDOLAPRIL 1 mg
ORAL
PRESCRIPTION DRUG
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 ).
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 57237-089-01 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 57237-090-01 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 57237-091-01 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: Rising Health, LLC Saddle Brook, NJ 07663 Made in India Code: TS/DRUGS/19/1993 Revised: 01/2018
Abbreviated New Drug Application
TRANDOLAPRIL - TRANDOLAPRIL TABLET RISING PHARMA HOLDINGS, INC. ---------- 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 24 34 2 5 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. 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 o Baca dokumen lengkapnya