Medicinal Products

ENALAPRIL EG 20 mg

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

Tablet breackable
Box of 30
All forms

Indication

· Hypertension

· Heart failure
Treatment with enalapril versus placebo a) in patients with symptomatic heart failure:

o delays the progression of heart failure,

o decreases the number of hospitalizations for heart failure,

o increases survival.

b) in asymptomatic patients with demonstrated left ventricular dysfunction:

o delays the development of symptomatic heart failure,

o Decrease the number of hospitalizations for heart failure.

Dosage ENALAPRIL EG 20 mg scored tablet Box of 30

Enalapril, in the form of scored tablets, may be taken before, during or after meals, as food does not alter its bioavailability.

Enalapril is given once or twice daily.

ARTERIAL HYPERTENSION

In the absence of prior hydrosodium depletion or renal failure (in common practice):

The effective dosage 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 dose adapted to the renal function of the patient, appreciated before the start of treatment, if the clearance of creatinine is less than 80 ml / min (see table below).

The value of creatinine clearance (Cl cr ) calculated from serum creatinine and adjusted for age, weight, and sex, as per the Cockcroft * formula, for example, correctly reflects the state of renal function in this type of patient.

* Cl cr = (140 - age) x weight / 0.814 x serum creatinine

With the 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 a dosage of 5 mg per day, or less, to adjust it to the patient's blood pressure response (see Warnings and precautions for use section). 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 Warnings and Precautions for Use section).

· In renal impairment, the dosage of enalapril is adjusted to the degree of this deficiency.

Creatinine clearance (ml / min)

Initial dosage (mg / day)

30 <Cl cr <80

5-10

10 <Clcr <30

2, 5 - 5

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 during periods of therapeutic stability (see section Warnings and precautions for use Precautions).

In hypertensive hemodialysis

Enalapril is dialysable (see Warnings and Precautions section of the Special 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.

HEART FAILURE

The initial dose should be low, especially in case of:

· Normal or low blood pressure at baseline,

· 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 initiate treatment with 2.5 mg under blood pressure monitoring and increase gradually (within 2 to 4 weeks) to the usual 20 mg daily maintenance dose divided into 1 or 2 sockets.

The dose chosen should not lower systolic blood pressure to orthostatism below 90 mmHg.

Symptomatic hypotension may occur in patients with heart failure treated with high doses of diuretics: in this case, the initial dose should be reduced by half (see Warnings and Precautions for Use Precautions).

Assays of creatinine and serum potassium should be done at each dose increase, then every 3 to 6 months depending on the stage of heart failure, in order to control the tolerance to treatment.

Against indications

This medicine should never be used in case of:

Hypersensitivity to enalapril or any of the excipients,

· History of angioedema (angioedema) associated with the use of an angiotensin converting enzyme inhibitor and / or hereditary or idiopathic angioedema,

· 2nd and 3rd trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and lactation ).

This medicine is generally not recommended in case of:

· Combinations with potassium diuretics, potassium salts, lithium and estramustine (see section 4.5, Interactions with other medicinal products and other forms of interaction )

Bilateral stenosis of the renal artery or functionally unique kidney,

· Hyperkalemia,

Adverse effects Enalapril EG

Clinically

· Headache, asthenia, dizziness, syncope,

Hypotension, orthostatic or not (see Warnings and Precautions for Use Precautions),

· 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 should be considered in the presence of this symptom.

· Exceptionally: angioedema (Quincke's edema) (see Warnings and Precautions section Special 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, leukocytosis;

Biologically

· Moderate increase in plasma urea and 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 and Precautions for Special Warnings section).

· Anemia has been reported with angiotensin-converting enzyme inhibitors on specific sites (kidney transplant, hemodialysis) - see Warnings and Precautions for Use section Precautions for use.

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