Энам®

General characteristics. Structure:

Enam of 2.5 mg
1 tablet without cover contains: active ingredient - enalapril a maleate of 2.5 mg; excipients - lactose anhydrous, maleic acid, zinc stearate.
Enam of 5 mg
1 tablet without cover contains: active ingredient - enalapril a maleate of 5 mg; excipients - lactose anhydrous, maleic acid, zinc stearate.
Enam of 10 mg
1 tablet without cover contains: active ingredient - enalapril a maleate of 10 mg; excipients - lactose anhydrous, zinc stearate.
Enam of 20 mg
1 tablet without cover contains: active ingredient - enalapril a maleate of 20 mg, excipients - lactose anhydrous, zinc stearate.

Pharmacological properties:

Pharmacodynamics. Enalapril - anti-hypertensive drug which mechanism of action is connected with oppression of activity of the angiotensin-converting enzyme leading to reduction of formation of angiotensin - II. Enalapril belongs to "pro-drugs": after its hydrolysis in an organism the active metabolite enalaprilat which is APF inhibitor is formed. Hypotensive action of Enam is caused by generally following mechanisms:

Braking of transformation of angiotensin-1 into angiotensin-II
Reduction of secretion of Aldosteronum, vasopressin
Reduction of an inactivation of vazodilatator of bradikinin and atrial natriuretic factor
Braking of activity of sympathoadrenal system
Suppression of a hypertrophy of smooth muscles of arteries, a hyperplasia and proliferation of smooth muscle cells that promotes decrease in peripheric resistance

Pharmacokinetics. After intake about 60% of enalapril are soaked up and the peak of concentration in plasma is reached by the end of the first hour. Absorption does not depend on meal. Drug is metabolized by the most part in a liver, forming an active metabolite enalaprilat which maximum concentration in plasma is reached 3-4 hours later after reception. Stable level of drug in blood is established after 3-4 receptions. Drug is removed by kidneys. The elimination half-life makes about 11 hours. The period of elimination of active metabolites makes about 30-35 hours.

Indications to use:

Arterial hypertension in the form of monotherapy and in a combination with drugs of other groups.
Chronic heart failure.
Prevention of coronary ischemia of a myocardium at patients dysfunction of a left ventricle.
Complex therapy of a myocardial infarction
Diabetic nephropathy.

Route of administration and doses:

Enam appoint inside irrespective of meal time.
Arterial hypertension:
For the patients who are not receiving diuretics the initial dose of 10-20 mg a day is recommended. Further the dose gradually raises depending on the response to the carried-out therapy. Usually the dose from 10 to 40 mg (the maximum daily dose) in days in one or two receptions is required.
Renovascular hypertensia:
Therapy begin 2.5 - 5 mg with a dose, then the dose gradually raises depending on reaction of the patient to the carried-out therapy.
Cordial insufficiency / asymptomatic dysfunction of a left ventricle
The initial dose of Enam at patients with the heart failure (HF) makes 2.5 mg. In case of good tolerance the dose should be raised gradually to the usual supporting daily dose 10-20 mg in 2 receptions under control of the ABP and function of kidneys.
Complex therapy of a myocardial infarction: from 7-14 in the afternoon after a heart attack in a dose of 2.5-20 mg a day depending on the ABP figures.
Nephropathy, diabetes mellitus
With a normal pressure an initial dose of 2.5 - 5 mg/days, with the increased arterial pressure selection of a dose is carried out as well as at arterial hypertension.

Features of use:

Prior to the beginning of and during use of an enam control of arterial pressure and functions of kidneys in connection with a possibility of development of "effect of the first dose" is necessary especially at a concomitant use of diuretics. Development of hypotension occurs among the patients with uncomplicated hypertensia receiving enalapril as monotherapy seldom. To risk group of development of arterial hypotension which can be associated with an oliguria and/or the accruing azotemia it is rare with an acute renal failure, the following categories of patients belong: patients with chronic heart failure, a hyponatremia, the patients accepting high doses of diuretics or increasing a dose of the accepted diuretics, the patients who are on dialysis, patients with disturbance of electrolytic balance of various etiology. At the beginning of a course of treatment of these groups of patients observance of precautionary measures is necessary. Development of arterial hypotension is not a reason for full drug withdrawal, but demands observance of measures of prevention (control of electrolytes, the ABP, function of kidneys, dose adjustment of Enam and the drugs accepted with it)
Enam's reception along with diuretics:
If the condition of the patient allows, it is desirable in 1-2 days prior to reception of an enam to reduce a dose of the accepted diuretics or completely to cancel them. At impossibility of it the initial daily dose of Enam does not exceed 5 mg. Further the dose can be increased taking into account a condition of the patient. Within the first two weeks of treatment, and every time when the dose of enalapril or diuretic is adjusted, patients have to be under constant medical observation. Therapy and control of patients with coronary heart disease and cerebrovascular diseases (at these patients hypotension can provoke a myocardial infarction or acute cerebrovascular pathology) is similarly exercised.
Heart failure: Enam's use at this group of patients it is desirable to begin with the minimum doses (2.5 mg 1-2 times a day), to make increase in a dose under careful control of the ABP and function of kidneys.
Renal failure: since Enam is brought from an organism preferential by kidneys, at a renal failure it is necessary to reduce a drug dose depending on clearance of creatinine. At clearance of creatinine from 80 to 30 ml/min. the daily dose is equal to 5-10 mg, at clearance of creatinine from 30 to 10 ml/min. 2.5-5 mg of Enam a day are accepted. At the expressed renal failures (the clearance of creatinine <10 ml/min.) enalapril is not recommended to be used. Further change of a dose is made under careful control of the ABP and function of kidneys.
Hemodialysis: an initial dose and a dose in days of dialysis of 2.5 mg/days, it is desirable to make Enam's reception upon termination of dialysis session. It is necessary to remember risk of development of anaphylactic reactions up to shock within dialysis at use of certain membranes.

Neutropenia / Agranulocytosis
Due to higher risk of emergence of disturbances of a hemopoiesis at patients with system collagenoses, vasculites and pathology of kidneys, periodic hematologic control of the patients of this group accepting Enam is necessary.

Anaphylactoid reactions
At emergence of this side effect it is necessary to cancel drug and to take necessary measures; if hypostasis is limited to area of the person and lips, then process is usually allowed without additional treatment.

Use for patients with an abnormal liver function.
As enalapril is metabolized in a liver, at patients with disturbances of functions of a liver time of effect of drug can increase.
At emergence at accepting APF inhibitors (including Enam) patients of jaundice, it is necessary to stop reception of APF inhibitors and to resort to the corresponding treatment

Instructions for participants of the road and transport movement
As a result of treatment by enalapril development of individual reactions which can break ability of the patient to active participation in the road and transport movement that should be meant also at service of cars and during the work with the devices requiring special attention is possible. These phenomena amplify at increase in a dose and at alcohol intake.

Side effects:

From TsNS: headache, dizziness, increased fatigue.
From a respiratory organs: dry cough, an asthma can meet.
From digestive organs: nausea, diarrhea, a lock, abdominal pains, are seldom observed: disturbance of flavoring feelings (metal smack in a mouth, taste loss), pancreatitis, hepatitis, a liver failure are possible. Sometimes connect a syndrome of damage of a liver which begins with cholestatic jaundice and progresses in the acute gepatonekroz sometimes leading to death with reception of APF inhibitors.
From cardiovascular system: arterial hypotension, faints, are possible disturbances of a rhythm, stenocardia
Allergic reactions: skin rashes, itch, Quincke's disease of various localization.
Influence on indicators of laboratory analyses: proteinuria, hyperpotassemia, increase in bilirubin and activity of hepatic transaminases, leukopenia, neutropenia anemia, thrombocytopenia.
Very seldom when using in high doses - sleeplessness, the increased nervous irritability, a depression, disturbance of balance, paresthesia, a sonitus, a hair loss, decrease in a potentiality.
At emergence of any side effects surely consult to the attending physician.

Interaction with other medicines:

Simultaneous use with hypotensive drugs of other groups (in - blockers, blockers of calcium channels, diuretics, metildopy, α-adrenoblokatoramiya др), and also nitrates strengthens hypotensive effect of drug.
At a concomitant use with diuretics development of the expressed hypotension at the beginning of therapy is possible.
Co-administration of analgetics or febrifugal drugs from the NPVP group and enalapril can reduce hypotensive effect of the last.
If kaliysberegayushchy diuretics and drugs of potassium (are shown at a hypopotassemia), it is necessary to be careful and to constantly control potassium concentration in plasma since enalapril reduces removal of potassium from an organism. It is desirable to avoid appointment potassium - the containing drugs and kaliysberegayushchy diuretics to the patients with a renal failure receiving enalapril in connection with a possibility of increase in content of potassium in blood.
At reception with lithium salts - lithium removal delay (control of concentration of lithium in a blood plasma is shown). Cases of lithium intoxication at a concomitant use of lithium with the drugs (including enalapril) strengthening sodium removal were described.
When sharing with Allopyrinolum, novokainamidy, glucocorticosteroids, cytostatics the risk of emergence of disturbances from a blood count (a lekopeniya, a neutropenia) increases.
Due to Enam's influence on digestion of glucose in fabrics, when sharing Enam with peroral glucose-lowering drugs or drugs of insulin dose adjustment of glucose-lowering drugs can be required
Cimetidinum extends Enam's action.
Use of an enam together with anesthetics can strengthen hypotensive action.
Meal does not influence enalapril absorption. During treatment enamy alcohol intake since alcohol strengthens hypotensive effect of drug is forbidden.

Use at pregnant women and the feeding women.
Efficiency and safety of enalapril at pregnant women is not studied, thus, it is not recommended to use enalapril at this group of patients. Enam is allocated with maternal milk therefore during feeding by a breast it is not used.

Contraindications:

Hypersensitivity to enalapril and other components of drug, existence in the anamnesis of the Quincke's disease connected with treatment by APF inhibitors, pregnancy, a lactation, children's age, the expressed liver pathology, a liver failure, a bilateral renal artery stenosis, or a stenosis of an artery of the only kidney, primary hyper aldosteronism, arterial hypotension, the expressed aortal or mitral stenosis.

Overdose:

The most frequent symptom of overdose is hypotension.
Treatment: It is necessary to lay the patient, having raised legs. In mild cases. water saline solutions are inside appointed. In hard cases in the conditions of a hospital hold the events directed to stabilization of the ABP: injection of aqueous salt solutions, plasma substitutes. Use of a hemodialysis is possible.

Storage conditions:

To store in the dry place at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 2 years.

Issue conditions:

According to the recipe

Packaging:

2 strips, on 10 tablets in everyone, are packed into a cardboard box with the application instruction.