m-Enalapril

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Enalapril maleate 20mg;  

Available from:

Multichem NZ Limited

INN (International Name):

Enalapril maleate 20 mg

Dosage:

20 mg

Pharmaceutical form:

Tablet

Composition:

Active: Enalapril maleate 20mg   Excipient: Ferrous oxide Hypromellose Lactose Maize starch Purified talc Stearic acid

Units in package:

Bottle, plastic, HDPE with silica gel canister, 90 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Neuland Laboratories Limited

Therapeutic indications:

All grades of essential hypertension.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with silica gel canister - 90 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2001-02-07

Summary of Product characteristics

M-ENALAPRIL

ENALAPRIL MALEATE 
5 MG, 10 MG, AND 20 MG TABLETS USP 
PRESENTATION 
5 mg tablet: A white, round, flat-faced with bevelled edge tablet.
The tablet is debossed W 
over 924 on one side with a break line on the other. Each tablet
contains 5 mg of enalapril 
maleate. 
10 mg tablet: A light salmon coloured, round, flat-faced with
bevelled edge tablet. The tablet is 
debossed W over 925 on one side and plain on the other side. Each
tablet contains 10 mg of 
enalapril maleate. 
20 mg tablet: A light beige coloured, round, flat-faced with
bevelled edge tablet. The tablet is 
debossed W over 926 on one side and plain on the other side. Each
tablet contains 20 mg of 
enalapril maleate.  
THERAPEUTIC CLASS 
m-Enalapril (enalapril maleate) is the maleate salt of enalapril, a
derivative of two amino 
acids, L-alanine and L-prolin. Following oral administration,
enalapril is rapidly absorbed and 
then hydrolysed to enalaprilat, which is a highly specific, long
acting, non-sulphydryl 
angiotensin converting enzyme inhibitor. 
INDICATIONS 
Treatment of: 
  All grades of essential hypertension  
  Renovascular hypertension  
  All degrees of heart failure 
In patients with symptomatic heart failure, m-Enalapril is also
indicated to:  
  Improve survival  
  Retard the progression of heart failure  
  Reduce hospitalisation for heart failure  
  Prevention of symptomatic heart failure 
In asymptomatic patients with left ventricular dysfunction,
m-Enalapril is indicated to:  
  Retard the development of symptomatic heart failure  
  Reduce hospitalisation for heart failure  
  Prevention of coronary ischaemic events in patients with
left ventricular dysfunction  

m-Enalapril is indicated to: 
  Reduce the incidence of myocardial infarction  
  Reduce hospitalisation for unstable angina pectoris  

DOSAGE AND ADMINISTRATION 
Since absorption of enalapril maleate tablets is not affec