Enalapril Actavis

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Enalapril maleate 10mg

Available from:

Actavis New Zealand Limited

INN (International Name):

Enalapril maleate 10 mg

Dosage:

10 mg

Pharmaceutical form:

Tablet

Composition:

Active: Enalapril maleate 10mg Excipient: Iron oxide red Iron oxide yellow Lactose monohydrate Magnesium stearate Maize starch Pregelatinised maize starch Sodium bicarbonate

Units in package:

Blister pack, Aluminium/aluminium 30 tablets, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Neuland Laboratories Limited

Product summary:

Package - Contents - Shelf Life: Blister pack, Aluminium/aluminium - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, Aluminium/aluminium - 90 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE 33-40cc, PP cap / induction sealed - 90 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE 35ml, PP cap 28mm induction sealed - 90 tablets - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2009-05-11

Summary of Product characteristics

ARROW - ENALAPRIL 
_ENALAPRIL MALEATE TABLETS 5MG, 10MG & 20MG _
PRESENTATION 
5 mg tablet:  White to off-white barrel-shaped tablet with “EL” scoreline “5” on  

one side and “>” on reverse side. 
10 mg tablet: Salmon coloured, barrel-shaped tablet with “EL 10” on one side  

and “>” on reverse side. 
20 mg tablet: Peach coloured, barrel-shaped tablet with “EL 20” on one side  

and “>” on reverse side. 
USES 
_ACTIONS _
Angiotensin converting enzyme (ACE) is a peptidyl dipeptidase which catalyses the 
conversion of angiotensin I to the pressor substance angiotensin II.  After absorption, 
enalapril is hydrolysed to enalaprilat, which inhibits ACE.  Inhibition of ACE results in 
decreased plasma angiotensin II, which leads to increased plasma renin activity (due 
to removal of negative feedback of renin release), and decreased aldosterone 
secretion. 
ACE is identical to kininase II.  Therefore enalapril may also block the degradation of 
bradykinin, a potent vasodepressor peptide.  However, the role that this plays in the 
therapeutic effects of enalapril remains to be elucidated. 
While the mechanism through which enalapril lowers blood pressure is believed to 
be primarily suppression of the renin-angiotensin-aldosterone system, which plays a 
major role in the regulation of blood pressure, enalapril is anti-hypertensive even in 
patients with low-renin hypertension. 
The onset of action of oral enalapril is gradual and smooth; it begins within one hour 
and its effects usually continue for 24 hours.  Consequently, enalapril may be 
administered on a once-daily basis, with the advantages this brings in convenience 
and compliance. 
The Studies of (patients with) Left Ventricular Dysfunction (SOLVD) was a 
m