Source: Pharmaceutical Benefits Scheme (AU) Revision Year: 2021 Publisher: Organon Pharma Pty Ltd, Building A, 26 Talavera Road, Macquarie Park NSW 2113
Enalapril maleate.
| Pharmaceutical Form |
|---|
|
RENITEC M (enalapril maleate) 5mg, white, barrel-shaped biconvex compressed tablet, scored on one side and engraved ‘RENITEC’ on the other. RENITEC (enalapril maleate) 10mg, rust-red, barrel-shaped biconvex compressed tablet, scored on one side and engraved ‘RENITEC’ on the other. RENITEC 20 (enalapril maleate) 20mg, peach barrel-shaped biconvex compressed tablet engraved ‘MSD714’ on one side. |
Enalapril maleate is a white to off-white crystalline powder. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol and dimethylformamide.
RENITEC tablets contain 5 mg, 10 mg or 20 mg enalapril maleate.
List of excipients with known effect: sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.
| Active Ingredient | Description | |
|---|---|---|
| Enalapril |
Enalapril is hydrolysed via hepatic CES 1 to the active metabolite enalaprilat, which acts as an ACE inhibitor. ACE is a peptidyl dipeptidase which catalyses the conversion of angiotensin I to the vasoconstrictor substance angiotensin II and hence inhibition of ACE results in decreased plasma angiotensin II. This also leads to increased plasma renin activity and decreased aldosterone secretion. The mechanism of action of enalapril is therefore primarily via the suppression of the RAAS. However, ACE is identical to kininase II, and so enalapril may also exert its effects by blocking the degradation of bradykinin, a potent vasodepressor peptide. |
| List of Excipients |
|---|
|
Sodium bicarbonate |
Supplied in blister packs of 30 tablets.
Organon Pharma Pty Ltd, Building A, 26 Talavera Road, Macquarie Park NSW 2113
Date of first approval: 10 May 1996
| Drug | Countries | |
|---|---|---|
| RENITEC | Austria, Australia, Brazil, Ecuador, Estonia, Spain, Finland, France, Netherlands, New Zealand, Romania, South Africa |
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