Saturday, September 14, 2013


EZAPRIL Co Enalapril Maleate Hydrochiorothiazide
COMPOSTION: Each tablet contains:
Enalapril maleate 20 mg 
Hydrochiorothiazide 12.5mg
PROPERTIES: Enalapril Maleate, one component of EZAPRIL-CO, is a new oral cardiovascular drug which facilitates the treatment of patients with hypertension and chronic congestive cardiac insufficiency. Enalapril Maleate is the first non suiphidrylic inhibitor of angiotensine conversion enzyme (ACE), with long lasting action, highly specific.
It is a drug which specifically inhibits enzymatic formation of angiotensine II, the most pontent known endogenous pressor substance.
Angiotensine II, displays its potent pressor effects by constricting resistant vessels and by expanding hematic volume through its action on aldosterone synthesis and release.
Hydrochlorothiazide, the second component of EZAPRIL-CO is a thiazide diuretic that helps reduce the amount of salt and water in the body by acting on the kidneys to increase the flow of urine, this also helps to lower blood pressure.
INDICATIONS: All degrees of essential or renovascular hypertension in patients who have been stabilized on the individual components in the same proportions.
Congestive cardiac failure.
Ascertained individual hypersensitivity to any of the ingredients.
Allergy to suiphonamide derived drugs.
Urine retention.
In case of ascertained or supposed pregnancy.
WARMNGS AND PRECAUTIONS: Thiazide diuretics may provoke hyperglycaemia and glycosuria in diabetic and other susceptible patients. It is advisable to carry out urine and or blood sugar testing while taking this medicine. Thiazide diuretics may cause hyperuricaemia and precipitate attacks of gout in some patients.
Administration of thiazide diuretics may be associated with electrolyte imbalances including hypochloraemia alkalosis, hyponatraemia, and hypokalaemia.
Hypokalaemia intensifies the effect of digitalis on cardiac muscle and administration of digitalis or its glycosides may have to be temporarily suspended.
Hyponatraemia may occur in patients with severe congestive heart failure who are very oedematous. particularly with large doses in conjunction with restricted salt in the diet.
A periodic observation of hemochrome in subjects suffering from
renal insufficiency or collagene diseases is advised. It is not known whether Enalapnl Maleate is detectable in maternal
milk. Since many drugs are secreted with human milk and since Enalapril Maleste is detectable in milk of laboratory animals, it is advisable to be careful when administering EZAPRIL-CO to women who are giving suck.
EFFECTS ON DRIVING ABILITY AND USE OF MACHINERY EZAPRIL-CO does not interfere with driving ability nor the ability to use machinery. However, dizziness or lightheadedness might occur especially after the first dose of this medicine. In this case, reaction to the medicine should be recognized before driving or using machines.
Agents influencing the sympathetic activity (such as ganglioplegics or adrenergic blockers) must be used with csution. Beta-blocking drags and methyldopa enhance the antihypertensive effect of the medicine.
Since no tests are available on it, the association with calcium antagonists is not advisable.
The contemporary therapy with lithium salts may cause an increase of the serum concentration of lithium.
Use of Cholestyramine or Colestipol with thiazide diuretics may prevent the diuretic part of EZAPRIL-CO from working properly, the diuretic should be taken at least 1 hour before or 4 hours after Cholestyramine or Colestipol.
Contemporary therapy with Digitalis glycosides may cause symptoms of digitalis toxicity if potassium levels in the body are decreased.
SIDE-EFFECTS: This medicine is generally well tolerated. Most of the side-effects have been mild and transitory and do not require the suspension of the therapy.
Individual cases of angioneurotic oedema with face, tongue and glottis swelling with severe respiratory difficulties occurred. In such cases the medicine must be discontinued and proper medical measures must be taken immediately.
Dizziness or lightheadedness and symptoms of too much potassium loss may be more likely to occur in the elderly, who may be more sensitive to the effects of this medicine.
DOSAGE OUTLINE: The usual dose: 1-2 tablets once a day or as prescribed.
Pediatric use : Has not been studied in children.
STORAGE: The drug should be stored in its original pack in a cool dry place.
Keep out of children’s reach.
PACKAGING: Blisters of 10 scored tablets.
Manufactured by Multi-Apex Pharma-Badr City Cairo