Generic drug from Renitec
Therapeutic class: Cardiology and angiology
active ingredients: Enalapril
Box of 84
· 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:
· Delay the development of symptomatic heart failure,
· Decreases the number of hospitalizations for heart failure.
Dosage ENALAPRIL ACTAVIS 5 mg scored tablet Box of 84
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.
· In the absence of prior water-soluble depletion or renal insufficiency (in routine 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, 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, in the case where the creatinine clearance 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.
* Clcr = (140-age) x weight
0.814 x serum creatinine
· The age expressed in years,
· The weight in kg,
· Serum 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 that treatment be initiated at a dose of 5 mg per day, or less, and subsequently adjusted 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 to detect the onset of possible renal impairment (see Precautions).
· In renal impairment, the dosage of enalapril is adjusted to the degree of this deficiency.
Clearance of creatinine
(Ml / min.)
(Mg / day)
30 <Cl cr <80
10 <Cl cr <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 Precautions).
· 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.
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: the initial dose should in this case be reduced by half (see Precautions for use).
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.
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,
· During the first trimester of pregnancy and in breastfeeding women (see section Pregnancy and breastfeeding ).
Adverse effects Enalapril Actavis
· Headache, asthenia, dizziness, syncope,
Hypotension, orthostatic or not (see 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),
· 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.
· 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.
o Increased liver enzymes and / or bilirubin.
o Neutropenia and agranulocytosis, when given at high doses in areas of renal failure and collagenosis (SLE, scleroderma) (see Warnings).
o Anemia has been reported with angiotensin-converting enzyme inhibitors on specific sites (kidney transplant, hemodialysis) (see Precautions).