ENALAPRIL MALEATE

BNF Classification:
2.5.5.1 Antigotensin-coverting enzyme inhibitors
Medicinal Product names available:
Enalapril
Maleate
(Non-p)

Innovace

Dosage form

Innozide

tablets

Enalapril Maleate strength (mg)

2.5 / 5 / 10/
20

2.5 / 5 / 10/
20

20

Hydrochlorothiazide strength (mg)

12.5

Package size

28

28

28

Principal therapeutic uses:

All medicinal products stated above are indicated for the treatment of hypertension.
Innozide, whose containing hydrochlorothiazide, are indicated for patients whose
blood pressure cannot be controlled by ENALAPRIL MALEATE alone or
hydrochlorothiazide alone.
Mechanism of action:
After absorption, enalapril is hydrolysed to enalaprilat which inhibits angiotension
converting enzyme (ACE). This results in the decrease in plasma angiotensin II (lead
to increased plasma rennin activity) and the decrease in aldosterone secretion.
Formulations available:
Tablets only
Dosages for adult:
For Enalapril Maleate (Non-p) and Innovace:
Initial dose ranges from 5 to maximum 20 mg daily, depending on the degree of
hypertension and specific condition of the patient:
mile hypertension:
5 10 mg daily
with strongly activated rennin-angiotensin-aldosterone system:*
5mg or lower daily

previously treated with high dose diuretics:**

5mg or lower daily
Maintenance dose is usually 20mg daily and at most not exceeding 40mg daily.
For Innozide:
Usual dosage is one tablet per day, at maximum two tablets per day. **

Excessive blood pressure fall after the initial dose is expected

**

Discontinuation of diuretic therapy for 2-3days prior to the initial dose is recommended

Important adverse drug reactions:

Contra-indications:
Hypersensitivity to ACE inhibitors / excipients and enalapril
History of angioedema associated with previous ACE inhibitor therapy
Hereditary / idiopathic angioedema
Pregnancy
Patients with Anuria (Innozide only)
Hypersensitivity to other sulphonamide-derived drugs (Innozide only)
Patients with stenosis of the renal arteries (Innozide only)
Precautions:
Renal impairment:
initial dosage adjusted according to the patients condition
Significant interactions:
Potassium-sparing diuretics, diuretics, antihypertensive agents, lithium, narcotics,
NSAIDs, sympathomimetics, antidiabetics, alcohol, -blockers,
Side effects:
General side effects of ACE inhibitors
Palpitation, arrhythmias, angina, chest pain, Raynauds syndrome, syncope,
cerebrovascular accident, myocardial infarction
Abdominal pain, dry mouth, peptic ulcer, anorexia, ileus, stomatitis, glossitis,
hepatic failure
Dermatological side effects including Stevens_Johnson syndrome, toxic
epidermal necrolysis, exfoliative dermatitis and pemphigus
Gastro-intestinal angioedema, confusion, depression, nervousness, asthenia,
drowsiness, insomnia, dream abnormalities, vertigo, blurred vision, tinnitus,
flushing, impotence, gynaecomastia, alopecia, dyspnoea, ashma, pulmonary
infiltrates, muscle cramps and hyponatraemia
Legal status
All medicinal products of enalapril maleate are prescription-only medicine (POM).

My reflection on this exercise:

Critical skills for this exercise are to filter and to reorganize data that you found in
BNF and EMC. One interesting thing that I found is that the price for proprietary
products is three to four times of the non-p one, which is pharmacologically identical
to the p products. One of my friend who is now working in hospital pharmacy told me
that it is basically a marking strategy. There is a patent period once a new drug is first
released into the market. Once expired, non-p products are then available at a much
lower price. Not many of the public know that, though.