COVERAM Tablet Ref.[50881] Active ingredients: Amlodipine 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

COVERAM (Perindopril arginine / Amlodipine besilate) Tablets.

Pharmaceutical Form

COVERAM 5/5 is a white, rod-shaped tablet engraved with 5/5 on one face and the Servier company logo on the other face.

COVERAM 5/10 is a white, square-shaped tablet engraved with 5/10 on one face and the Servier company logo on the other face.

COVERAM 10/5 is a white, triangular-shaped tablet engraved with 10/5 on one face and the Servier company logo on the other face.

COVERAM 10/10 is a white, round tablet engraved with 10/10 on one face and the Servier company logo on the other face.

Qualitative and quantitative composition

The active components of COVERAM are perindopril arginine and amlodipine besilate.

Each COVERAM 5/5 tablet contains 5 mg of perindopril arginine and 5 mg of amlodipine (as besilate).

Each COVERAM 5/10 tablet contains 5 mg of perindopril arginine and 10 mg of amlodipine (as besilate).

Each COVERAM 10/5 tablet contains 10 mg of perindopril arginine and 5 mg of amlodipine (as besilate).

Each COVERAM 10/10 tablet contains 10 mg of perindopril arginine and 10 mg of amlodipine (as besilate).

Excipient with known effect: contains sugars as lactose

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

Amlodipine doses are given as active base

Perindopril arginine

Perindopril arginine has the chemical name, L-arginine (2S,3aS,7aS)1[(2S)2[[(1S)1 (ethoxycarbonyl)butyl]amino] propanoyl]octahydro-1H-indole-2-carboxylate. It 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. The drug is synthesised stereoselectively so that it is a single enantiomer (all S stereochemistry).

Chemical structure:

CAS number: 612548-45-5

Amlodipine besilate

Amlodipine besilate is a dihydropyridine derivative, and has the following chemical name: 3-Ethyl 5-methyl (4RS)2[(2-aminoethoxy)methyl]4(2-chorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate. Amlodipine besilate is chiral and present as a racemate. It is a white crystalline powder and is slightly soluble in water and sparingly soluble in ethanol.

Chemical structure:

CAS number: 111470-99-6

Active Ingredient Description
Amlodipine

Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle.

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

Lactose monohydrate
Microcrystalline cellulose
Colloidal anhydrous silica
Magnesium stearate

Pack sizes and marketing

Thirty (30) tablets supplied in a white HDPE bottle equipped with a white induction-sealed child resistantclosure and desiccant sachets. COVERAM 5/5 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

11 January, 2010

Drugs

Drug Countries
COVERAM Australia, Cyprus, Ecuador, Estonia, Finland, France, Malta, Netherlands, Singapore, Tunisia, Turkey, South Africa

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