BIPRETERAX Film-coated tablet Ref.[50602] Active ingredients: Indapamide Perindopril

Source: Web Search  Revision Year: 2005 

Product name and form

Bipreterax 10mg/2.5mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White, round film-coated tablet, with a diameter of 8 mm and a curvature radius of 11 mm.

Qualitative and quantitative composition

One film-coated tablet contains 6.79 mg perindopril equivalent to 10 mg perindopril arginine and 2.5 mg indapamide.

Excipient with known effect: lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Indapamide

Indapamide is a sulfonamide derivative with an indole ring, pharmacologically related to thiazide diuretics, which acts by inhibiting the reabsorption of sodium in the cortical dilution segment. It increases the urinary excretion of sodium and chlorides and, to a lesser extent, the excretion of potassium and magnesium, thereby increasing urine output and having an antihypertensive action.

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

Core:

Lactose monohydrate
Magnesium stearate (E470B)
Maltodextrin
Silica colloidal anhydrous (E551)
Sodium starch glycolate (type A)

Film-coating:

Glycerol (E422)
Hypromellose (E464)
Macrogol 6000
Magnesium stearate (E470B)
Titanium dioxide (E171)

Pack sizes and marketing

14, 20, 28, 30 or 50 tablets in polypropylene tablet container equipped with a low density polyethylene flow reducer and a low density polyethylene stopper containing a white desiccant gel.

Pack sizes:

1 × 14, 1 × 20, 1 × 28, 1 × 30 or 1 × 50 tablets
2 × 28, 2 × 30 or 2 × 50 tablets
3 × 30 tablets
10 × 50 tablets

Not all pack sizes may be marketed.

Drugs

Drug Countries
BIPRETERAX Germany, Spain, France, Tunisia, South Africa

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