EZAPRIL Tablet COMPOSITION :
Each tablet contains:
Enalapril maleate 20 mg
hydrochlorothiazide 12.5 mg
EZAPRIL Tablet 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 sulphidrylic inhibitor of angiotensine conversion enzyme (ACE), with long lasting action, highly specific.
– It is a dnug which specifically inhibits enzymatic formation of angiotensine II, the most pontent known endogenous pressor substance.
– Angiotensine It, 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.
EZAPRIL Tablet INDICATIONS :
– All degrees of essential or renovascular hypertension in patients who have been stabilized on the individual components in thesame proportions.
– Congestive cardiac failure.
EZAPRIL Tablet CONTRAINDICATIONS:
– Ascertained individual hypersensitivity to any of the ingredients.
– Urine retention.
– Allergy to sulphonamide – derived dnugs.
– In case of ascertained or supposed pregnancy.
EZAPRIL Tablet WARNINGS 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.
– Aperiodic observation of hemochrome in subjects suffering from renal insufficiency or collagene diseases is advised.
– It is not known whether Enalapril Maleate is detectable in maternal milk, Since many drugs are secreted with human milk and since enalapril Maleate is detectable in milk of laboratory animals it is advisable to be careful when administering ezapril co to women who are giving suck.
EZAPRIL Tablet Pregnancy :
When used in pregnancy, ACE inhibitors can cause injury and even death to the developing fetus.
EZAPRIL Tablet EFFECTS ON DRIVING ABIL TTY 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 . .ln this case, reaction to the medicine should be recognized before driving or using machines.
EZAPRIL Tablet DRUG INTERACTION :
– Agents influencing the sympathetic activity (such as ganglioplegics or adrenergic blockers) must be used with caution,
– Beta-blocking drugs and methyldopa.
– 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 senum 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 glycoside. may cause symptoms of digitalis toxicity if potassium levels in the body are decreased.
EZAPRIL Tablet 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 toomuch potassium loss may be more likely to occur in the elderly, who may be more sensitive to the effects of this medicine.
EZAPRIL Tablet DOSAGE OUTLINE :
The usual dose: .1-2 tablets once a day or as prescribed,
Pediatric use: Ha; notbeen studied in children.
EZAPRIL Tablet STORAGE :
The drug should be stored in its origin’al pack in a cool dry place
EZAPRIL Tablet PACKAGING :
Blisters of 10 scored tablets,
Keep All Medicine Out of Reach of Children
Manufactured by :
Multi-Apex for Pharmaceutical Industries 0 S.A.E. – Badr City – Egypt.