Medicinal Products

ENALAPRIL EG 5 mg

Generic drug from Renitec
Therapeutic class: Cardiology and angiology
active ingredients: Enalapril
laboratory: EG Labo

Tablet breackable
Box of 28
All forms

Indication

- Hypertension.
- Heart failure.
Enalapril treatment versus placebo:
a) in patients with symptomatic heart failure:
. delay the progression of heart failure,
. decreases the number of hospitalizations for heart failure,
. increases survival.
b) in asymptomatic patients with demonstrated left ventricular dysfunction:
. delays the development of symptomatic heart failure,
. decreases the number of hospitalizations for heart failure.

Dosage ENALAPRIL EG 5 mg scored tablet Box of 28

- Enalapril, in the form of scored tablets, can be taken before, during or after meals, the intake of food does not alter its bioavailability.
- Enalapril is given in one or two daily doses.
ARTERIAL HYPERTENSION :
- In the absence of prior hydrosodeal depletion or renal insufficiency (in common practice): the effective dose is 20 mg once daily.
Depending on the response to the treatment, the dosage should be adjusted, within 3-4 weeks, up to 40 mg / day once.
- In arterial hypertension previously treated with a diuretic:
. stop the diuretic 3 days ago to reintroduce it later if necessary,
. either give initial doses of 5 mg or less, and adjust for the blood pressure response.
It is also recommended to dose plasma creatinine and serum potassium before treatment and within 15 days of starting therapy.
- In the elderly, possibly initiate treatment with a lower dosage adapted to the renal function of the patient, appreciated before the start of treatment, in the case where the creatinine clearance is less than 80 ml / min (see table below).
The value of creatinine clearance (CrCl) calculated from serum creatinine and adjusted for age, weight, and sex, as per the Cockroft * formula, for example, correctly reflects the state of renal function in this patient. type of patient:
* Clcr = [(140 - age ) x weight ] / [0.814 x creatinine level ].
with age expressed in years,
the weight in kg,
creatinine in micromol / L.
This formula is valid for male subjects, and must be corrected for women by multiplying the result by 0.85.
- In renovascular hypertension, it is recommended to start the treatment at the dosage of 5 mg per day, or less, to adjust thereafter to the patient's blood pressure response (see precautions for use). Most patients respond to a dosage of 10 to 20 mg per day in one or two doses.
Serum creatinine and serum potassium will be monitored for the presence of possible renal impairment (see precautions for use).
- In case of renal insufficiency, the dosage of enalapril is adjusted to the degree of this insufficiency:
Creatinine clearance: Initial dosage .
. <Clr <80 ml / min : 5-10 mg / day.
. <Clcr <30 ml / min : 2.5-5 mg / day.
The diuretics to be associated in this case are the so-called loop diuretics.
In these patients, normal medical practice includes a periodic control of potassium and creatinine, for example every two months in times of therapeutic stability (see precautions for use).
- In hypertensive hemodialysis:
Enalapril is dialysable (see warnings). The clearance of dialysis is 62 ml / min.
The dosage is 2.5 mg on the day of dialysis.
On days when patients are not dialysed, the dosage should be adjusted according to the results obtained on the blood pressure.
CARDIAC INSUFFICIENCY :
- The initial dose should be low, especially in case of:
. normal or low blood pressure initially,
. renal failure,
. hyponatremia, iatrogenic (diuretic) or not.
- Enalapril can be used in combination with diuretic therapy with, if necessary, digitalis treatment.
- It is recommended to start treatment with 2.5 mg under blood pressure monitoring and gradually increase it (within 2 to 4 weeks) to the usual 20 mg daily maintenance dose divided into 1 or 2 taken.
- The dose chosen should not lower the systolic blood pressure in orthostatism below 90 mmHg.
- Symptomatic hypotension may occur in patients with heart failure treated with high doses of diuretics: the initial dose should in this case be reduced by half (see precautions for use).
- The dosage of creatinine and serum potassium should be done at each dose increase, then every 3-6 months depending on the stage of heart failure, to control the tolerance to treatment.

Against indications

CONTRAINDICATED:
- This medicine should never be used in case of:
. hypersensitivity to enalapril,
. history of angioedema (angioedema) associated with the use of a conversion enzyme inhibitor and / or hereditary or idiopathic angioedema,
. in the 2nd and 3rd trimesters of pregnancy: administration during the 2nd and 3rd trimester, and especially if it continues until delivery, exposes to a risk of renal damage which may lead to: a decrease in function fetal kidney with possibly oligo-amnion, neonatal renal insufficiency, hypotension and hyperkalemia, or even anuria (reversible or not), a few rare cases of cranial vault abnormalities have been reported with the use of inhibitors of the enzyme conversion throughout pregnancy. Consequently: in the 2nd and 3rd trimesters, the prescription of enalapril is contraindicated.
- Due to the presence of lactose, this drug is contraindicated in case of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
NOT RECOMMENDED :
This medicine is generally not recommended in case:
- 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 the clinic: there is no epidemiological study available, isolated observations of pregnancies exposed in the first trimester are a priori reassuring in terms of malformation. 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 inhibitor of the conversion enzyme imposes to modify the treatment and this, during all the pregnancy.
. Breastfeeding: Minimal amounts of enalapril and its active metabolite have been found in breast milk. As a result, administration of this drug is not recommended for women who are breastfeeding.
- combinations with alone or associated hyperkalemic diuretics (amiloride, potassium canrenoate, spironolactone, triamterene) with the exception of the case of treatment of heart failure (treated with the IEC combination at low doses + diuretic hypokalaemic at low doses), potassium salts, lithium and estramustine.

Adverse effects Enalapril EG

- Clinically:
. headache, asthenia, dizziness, syncope,
. hypotension, orthostatic or not (see precautions for use),
. skin rash, rash, photosensitization, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, 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 must be considered in the presence of this symptom,
. exceptionally: angioedema (angioedema) (see warnings),
. very rarely: impotence, flushing, tinnitus, glossitis, blurred vision,
. also association of symptoms including fever, serous inflammation, vasculitis, myalgia, arthralgia, antinuclear antibodies, elevated sedimentation rate, eosinophilia, hyperleucocytosis.
- Biologically:
. Moderate increase in urea and plasma creatinine, reversible upon discontinuation of treatment. This increase is more frequently seen in patients with renal artery stenosis, diuretic-treated arterial hypertension, and renal failure.
In case of glomerular nephropathy, administration of a conversion enzyme inhibitor may cause proteinuria.
. Hyperkalemia, usually transient.
. Increased liver enzymes and / or bilirubin.
. Neutropenia and agranulocytosis, when administered at high doses in areas of renal failure and collagenosis (SLE, scleroderma) (see warnings).
. Anemia has been reported with angiotensin-converting enzyme inhibitors on particular sites (kidney transplant, hemodialysis - see precautions for use).

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