PREXUM Film-coated tablet Ref.[50301] Active ingredients: Perindopril

Source: Pharmaceutical Benefits Scheme (AU)  Revision Year: 2022  Publisher: Servier Laboratories (Aust.) Pty. Ltd., www.servier.com.au, Level 4, Building 9, 588A Swan Street, Burnley, 3121, Victoria

Product name and form

PREXUM Perindopril arginine.

Pharmaceutical Form

PREXUM 2.5 is a white, round, convex, film-coated tablet.

PREXUM 5 is a light-green, rod-shaped, film-coated tablet engraved with a “Servier” logo on one face and scored on both edges.

PREXUM 10 is a green, round, biconvex film-coated tablet with a “Servier” logo on one face and a “heart” logo on the other face.

Qualitative and quantitative composition

Each PREXUM 2.5 tablet contains 2.5 mg of perindopril arginine. Each PREXUM 5 tablet contains 5 mg of perindopril arginine. Each PREXUM 10 tablet contains 10 mg of perindopril arginine.

Excipient with known effect: contains sugars as lactose

For the full list of excipients, see section 6.1 – List of excipients.

The active component of PREXUM is perindopril arginine which has the chemical name, L-arginine(2S,3aS,7aS)1[(2S)2[[(1S)1(ethoxycarbonyl)butyl]amino] propanoyl]octahydro-1H-indole-2-carboxylate. Perindopril is a dipeptide monoacid monoester with a perhydroindole group and no sulfydryl radical. Perindopril arginine is a white powder, readily soluble in purified water, slightly soluble in 95% ethanol and practically insoluble in chloroform. Perindopril has five asymmetric centres and is synthesised stereoselectively so that it is a single enantiomer (all S stereochemistry).

Chemical structure

CAS number: 612548-45-5

Active Ingredient Description
Perindopril

Perindopril is an inhibitor of the enzyme that converts angiotensin I into angiotensin II (Angiotensin Converting Enzyme ACE). The converting enzyme, or kinase, is an exopeptidase that allows conversion of angiotensin I into the vasoconstrictor angiotensin II as well as causing the degradation of the vasodilator bradykinin into an inactive heptapeptide. Inhibition of ACE results in a reduction of angiotensin II in the plasma, which leads to increased plasma renin activity (by inhibition of the negative feedback of renin release) and reduced secretion of aldosterone. Since ACE inactivates bradykinin, inhibition of ACE also results in an increased activity of circulating and local kallikrein-kinin systems (and thus also activation of the prostaglandin system).

List of Excipients

PREXUM 2.5, PREXUM 5 & PREXUM 10:

Hydrophobic colloidal silica anhydrous
Lactose monohydrate
Macrogol 6000
Magnesium stearate
Maltodextrin
Sodium starch glycollate (type A)
Glycerol
Hypromellose
Titanium dioxide

PREXUM 5 only:

Premix for light-green colour coating [copper chlorophyllin (E141ii)]

PREXUM 10 only:

Premix for green colour coating [copper chlorophyllin (E141ii)]

Pack sizes and marketing

Thirty (30) tablets supplied in a white HDPE bottle equipped with a white induction-sealed child resistant-closure and desiccant sachets. PREXUM 5 only, is also supplied in a 10-tablet bottle.

Marketing authorization holder

Servier Laboratories (Aust.) Pty. Ltd., www.servier.com.au, Level 4, Building 9, 588A Swan Street, Burnley, 3121, Victoria

Marketing authorization dates and numbers

12 February 2013

Drugs

Drug Countries
PREXUM Australia, South Africa

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