Medicinal Products

ENALAPRIL / HYDROCHLOR MERCK 20 mg / 12.5 mg

Generic drug of CO Renitec
Therapeutic class: Cardiology and angiology
Active ingredients: Enalapril, Hydrochlorothiazide
laboratory: Generic Merck

Tablet breackable
Box of 28
All forms

Indication

Treatment of arterial hypertension in case of therapeutic failure of monotherapy with a converting enzyme inhibitor.

Dosage ENALAPRIL / HYDROCHLOR MERCK 20 mg / 12.5 mg scored tablet Box of 28

Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.
- Normal renal function: the usual dosage is 1 tablet in one daily dose.
- Renal failure :
. creatinine clearance between 30 and 80 ml / min : the usual dosage is 1/2 tablet daily.
In these patients, normal medical practice includes a periodic control of potassium and creatinine, for example every two months in times of therapeutic stability.
. creatinine clearance less than 30 ml / min or serum creatinine greater than 250 μmol / L : contraindication.
- Elderly: it is recommended to initiate the treatment at the dosage of a half-tablet, in case there is a physiological decline in renal function (see section warnings and precautions for use / precautions of employment).

Against indications

CONTRAINDICATED:
Due to the presence of lactose, this drug is contraindicated in cases of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
RELATED TO ENALAPRIL :
This medicine MUST NEVER BE USED in case of:
hypersensitivity to enalapril,
- history of angioedema (Quincke's edema) related to the use of a conversion enzyme inhibitor and / or hereditary or idiopathic angioedema,
- during the 2nd and 3rd trimesters of pregnancy: administration during the 2nd and 3rd trimesters, and especially if it continues until delivery, exposes to a risk of renal damage which may lead to: a decrease in fetal renal function with possibly oligoamnios; renal insufficiency neonatal, with hypotension and hyperkalemia, or even anuria (reversible or not); some rare cases of cranial vault abnormalities have been reported with the use of angiotensin converting enzyme inhibitors throughout pregnancy. As a result, in the 2nd and 3rd trimesters, the prescription of enalapril is contraindicated.
RELATED TO HYDROCHLOROTHIAZIDE :
This medicine MUST NEVER BE USED in case of:
- hypersensitivity to sulphonamides,
- severe renal insufficiency (creatinine clearance less than 30 ml / min),
- hepatic encephalopathy,
- during breastfeeding: Thiazides are excreted in a small quantity in breast milk and can cause a decrease or even a suppression of the milk secretion, undesirable effects, especially biological (potassium), due to the fact that they belong to the sulphonamides. risk of allergy and nuclear jaundice. As a result, the use of this medication is not recommended during the breastfeeding period.
NOT RECOMMENDED :
Use in children is not recommended.
RELATED TO ENALAPRIL :
This medicine IS GENERALLY NOT RECOMMENDED in case of:
- bilateral stenosis of the renal artery or functionally unique kidney,
- hyperkalemia,
- during the first trimester of pregnancy and in the woman who is breastfeeding:
. Pregnancy: studies in animals have not shown teratogenic effect but fetotoxicity on several species. In clinic: there is no epidemiological study available; isolated observations of pregnancies exposed in the first trimester are a priori reassuring in terms of malformation; some rare cases of cranial vault abnormalities have been reported with the use of angiotensin converting enzyme inhibitors throughout pregnancy. As a result, the malformation risk, if any, is likely to be low. The fortuitous finding of a pregnancy during treatment does not justify an interruption of it. Nevertheless, the cranial vault will be monitored by ultrasound. On the other hand, the discovery of a pregnancy under a conversion enzyme inhibitor makes it necessary to modify the treatment and this, during the entire pregnancy,
. Breastfeeding: Minimal amounts of enalapril and its active metabolite have been found in breast milk. As a result, the use of this drug is not recommended during the breastfeeding period,
- combination with hyperkalemic diuretics (amiloride, potassium canrenoate, spironolactone, triamterene), potassium salts, lithium and estramustine (see section on interactions).
RELATED TO HYDROCHLOROTHIAZIDE :
This medicine IS GENERALLY NOT RECOMMENDED in the following situations:
- in case of bilateral stenosis of the renal artery or functionally unique kidney,
- in case of hyperkalemia,
- Pregnancy (1st trimester): As a general rule, thiazide and related diuretics should be avoided in pregnant women and should never be prescribed during physiological hypostases (and therefore not requiring treatment) of pregnancy. Diuretics can, in fact, lead to fetal-placental ischemia, with a risk of fetal hypotrophy. In rare cases, severe neonatal thrombocytopenia has been reported. Diuretics remain nevertheless an essential element of the treatment of oedemas of cardiac, hepatic and renal origin occurring in the pregnant woman,
- in combination with lithium and sultopride (see section interactions).

Adverse effects Enalapril / Hydrochlor Merck

CLINICAL PLAN :
- Linked to enalapril :
. headache, asthenia, dizziness, syncope;
. hypotension, orthostatic or not (see section cautionary statements and precautions for use);
. rash, rash, photosensitization, severe bull rash (erythema multiforme, Stevens-Johnson syndrome, a well-documented case of toxic epidermal necrolysis), exfoliative dermatitis, pemphigus, urticaria, alopecia, pruritus;
. nausea, diarrhea, constipation, abdominal pain, vomiting, anorexia, cholestatic or cytolytic hepatitis, liver failure, pancreatitis, jaundice;
. muscle cramps, dysgeusia;
. depression, confusion, nervousness, bronchospasm, dyspnea;
. dry cough has been reported with the use of angiotensin converting enzyme inhibitors. It is characterized by its persistence as well as its disappearance at the end of treatment. The iatrogenic etiology should be considered in the presence of this symptom;
. exceptionally: angio-edema (Quincke's edema) (see section on warnings and precautions for use);
. very rarely: impotence, flushing, tinnitus, glossitis, blurred vision;
. other symptoms that may be associated: fever, serous inflammation, vasculitis, myalgia, arthralgia, antinuclear antibodies, elevated sedimentation rate, eosinophilia, leukocytosis.
- Hydrochlorothiazide-related :
. in case of hepatic insufficiency, possibility of occurrence of hepatic encephalopathy (see sections contraindications and warnings and precautions for use);
. possibility of worsening of pre-existing disseminated acute lupus erythematosus, necrotizing vasculitis, exceptional Lyell syndrome;
. nausea, constipation, dizziness, asthenia, paresthesia, headache, rarely seen and usually giving way to a reduction in dosage;
. exceptionally: pancreatitis, visual disturbances at the beginning of treatment.
AT THE BIOLOGICAL PLAN:
- Linked to enalapril :
. moderate increase in urea and plasma creatinine, reversible upon discontinuation of treatment. This increase is more frequently encountered in cases of stenosis of the renal arteries, arterial hypertension treated with diuretics, renal failure.
In case of glomerular nephropathy, the administration of an inhibitor of the conversion enzyme may give rise to proteinuria;
. hyperkalemia, usually transient;
. increased liver enzymes and / or bilirubin;
. neutropenia and agranulocytosis, when high doses are administered in areas of renal failure and collagenosis (SLE, scleroderma) (see section on warnings and precautions for use / warnings);
. anemia has been reported with angiotensin-converting enzyme inhibitors on specific sites (kidney transplant, hemodialysis - see section on warnings and precautions for use / precautions for use).
- Hydrochlorothiazide-related :
. potassium depletion with hypokalemia, especially in the case of intensive diuresis, and particularly severe in certain at-risk populations (see section on warnings and precautions for use);
. hyponatremia with hypovolemia leading to dehydration and orthostatic hypotension or even confusional syndrome.
The concomitant loss of chlorine ions may secondarily lead to a compensatory metabolic alkalosis: the incidence and magnitude of this effect are low;
. Elevation of serum uric acid and blood glucose levels during treatment: the use of these diuretics will be carefully discussed in gouty and diabetic subjects;
. an increase in plasma lipids in high doses;
. haematological disorders, much rarer, thrombocytopenia, leukopenia, agranulocytosis, bone marrow aplasia, haemolytic anemia;
. an exceptional hypercalcemia.

Popular Posts

Category Medicinal Products, Next Article