PERINDOPRIL ERBUMINE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

PERINDOPRIL ERBUMINE (UNII: 1964X464OJ) (PERINDOPRIL - UNII:Y5GMK36KGY)

Verfügbar ab:

Lupin Pharmaceuticals, Inc

INN (Internationale Bezeichnung):

PERINDOPRIL ERBUMINE

Zusammensetzung:

PERINDOPRIL ERBUMINE 2 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Stable Coronary Artery Disease Perindopril erbumine tablets are indicated in patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or non-fatal myocardial infarction. Perindopril erbumine tablets can be used with conventional treatment for management of coronary artery disease, such as antiplatelet, antihypertensive or lipid-lowering therapy. Hypertension Perindopril erbumine tablets are indicated for the treatment of patients with essential hypertension. Perindopril erbumine tablets may be used alone or given with other classes of antihypertensives, especially thiazide diuretics. When using perindopril erbumine 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 determine whether perindopril erbumine tablets has a similar potential. (See WARNINGS .) In considering use of

Produktbesonderheiten:

Perindopril Erbumine Tablets are supplied as below: White to off-white, round, biconvex tablets, debossed with ‘L’ and ‘U’ on either side of the breakline on one side and ‘C11’ on the other side. Bottles of 100                              NDC 68180-235-01 White to off-white, capsule-shaped, biconvex tablets, debossed with ‘L’ and ‘U’ on either side of the breakline on one side and ‘C12’ on the other side. Bottles of 100                              NDC 68180-236-01 White to off-white, round, biconvex tablets, debossed with ‘L’ and ‘U’ on either side of the breakline on one side and ‘C13’ on the other side. Bottles of 100                               NDC 68180-237-01 Storage Conditions: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Keep out of the reach of children. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Goa - 403 722 INDIA Revision Date: January 2010                                                            Item Code: 21207

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

PERINDOPRIL ERBUMINE- PERINDOPRIL ERBUMINE TABLET
LUPIN PHARMACEUTICALS, INC
----------
PERINDOPRIL ERBUMINE TABLETS
2 MG, 4 MG AND 8 MG
RX ONLY
USE IN PREGNANCY
When used in pregnancy, ACE inhibitors can cause injury and even death
to the developing fetus.
When pregnancy is detected, perindopril erbumine tablets should be
discontinued as soon as
possible. See WARNINGS: FETAL/NEONATAL MORBIDITY AND MORTALITY.
DESCRIPTION
Perindopril erbumine tablets are the tert-butylamine salt of
perindopril, the ethyl ester of a non-
sulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Perindopril
erbumine is chemically
described as
(2S,3αS,7αS)-1-[(S)-N-[(S)-1-Carboxy-butyl]alanyl]hexahydro-2-indolinecarboxylic
acid,
1-ethyl ester, compound with tert-butylamine (1:1). Its molecular
formula is C
H N O C H N. Its
structural formula is:
Perindopril erbumine is a white, crystalline powder with a molecular
weight of 368.47 (free acid) or
441.61 (salt form). It is freely soluble in water (60% w/w), alcohol
and chloroform.
Perindopril is the free acid form of perindopril erbumine, is a
pro-drug and metabolized _in vivo _by
hydrolysis of the ester group to form perindoprilat, the biologically
active metabolite.
Perindopril erbumine tablets are available in 2 mg, 4 mg and 8 mg
strengths for oral administration. In
addition to perindopril erbumine, each tablet contains the following
inactive ingredients: hydrophobic
colloidal silica, lactose monohydrate, magnesium stearate and
microcrystalline cellulose.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
Perindopril erbumine tablets are a pro-drug for perindoprilat, which
inhibits ACE in human subjects and
animals. The mechanism through which perindoprilat lowers blood
pressure is believed to be primarily
inhibition of ACE activity. ACE is a peptidyl dipeptidase that
catalyzes conversion of the inactive
decapeptide, angiotensin I, to the vasoconstrictor, angiotensin II.
Angiotensin II is a potent peripheral
vasoconstrictor, which stimulates aldosterone secretion by the adrenal
cortex, an