Universal reference book for medicines
Product name: RENIPRIL В® (RENIPRIL)

Active substance: enalapril

Type: ACE inhibitor

Manufacturer: ФАРМСТАНСТАНАР-ЛЕКСРЕДСТВА (Russia)
Composition, form of production and packaging
Tablets of
white color, round, flat-cylindrical, with a risk and a facet.

1 tab.

enalapril maleate 10 mg

- "- 20 mg

20 pcs.
- packings of cellular contour (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

The description of the drug was approved by the manufacturer for the 2006 print edition.

PHARMACHOLOGIC EFFECT

Antihypertensive drug, ACE inhibitor.
The mechanism of action of enalapril is associated with the inhibition of ACE activity, which reduces the formation of angiotensin II, which contributes to the narrowing of blood vessels, and simultaneously activates the formation of kinins and prostacyclin, which have a vasodilating action. Enalapril belongs to prodrugs, after its hydrolysis, enalaprilate is formed in the body, which also inhibits this enzyme. Enalapril also has some diuretic effect associated with moderate inhibition of aldosterone synthesis. Along with a decrease in blood pressure, the drug reduces pre- and postnagruzku on the myocardium in heart failure, improves blood circulation in the small circle and the function of breathing, reduces resistance in the vessels of the kidneys, which contributes to the normalization of blood circulation in them.
PHARMACOKINETICS

After ingestion, absorption is 60%.
Eating does not affect absorption. In the liver is metabolized with the formation of active metabolite enalaprilata. Binding to plasma proteins for enalaprilat is 50-60%. C max enalapril is achieved after 1 h, enalaprilata - after 3-4 hours. Enalaprilat poorly penetrates the BBB, in a small amount - through the placental barrier and is released in small amounts with breast milk. It is excreted by the kidneys (up to 60%, 20% in the form of enalapril and 40% in the form of enalaprilate) and through the intestine (33%, 6% in the form of enalapril and 27% in the form of enalaprilate).
INDICATIONS

- various forms of arterial hypertension (including renovascular);

- chronic heart failure (as part of combination therapy).

DOSING MODE

Renipril is administered orally regardless of food intake.

In the treatment of essential hypertension, the initial dose of Renipril is 10-20 mg / day.
In the future, the dose is selected individually.
With moderate arterial hypertension, a dose of 10 mg / day is sufficient.
The maximum daily dose is 80 mg.
With Renovascular hypertension, Renipril is prescribed in smaller doses.
The initial dose is usually 5 mg / day, then the dose is selected individually. The maximum dose is 20 mg / day.
With heart failure, Renipril is prescribed starting at 2.5 mg, then the dose is gradually increased to 10-20 mg (1-2 times / day).

The duration of treatment depends on the effectiveness of therapy.

In all cases with too pronounced decrease in blood pressure, the dose of the drug is gradually reduced.

The drug is used both with monotherapy, and in combination with other antihypertensive drugs.

In patients with impaired renal function , the single dose should be reduced or the intervals between doses should be increased.

SIDE EFFECT

From the central nervous system and peripheral nervous system: 2-3% - headache, dizziness, fatigue;
rarely (when used in high doses) - insomnia, nervousness, depression, imbalance, paresthesia, tinnitus.
From the cardiovascular system: less than 2% - arterial hypotension, syncope;
rarely - arrhythmias, angina.
On the part of the digestive system: less than 2% - nausea, diarrhea;
in some cases - pancreatitis, liver failure, dyspepsia.
Allergic reactions: less than 2% - skin rashes;
in some cases - angioedema (face, larynx).
From the respiratory system: dry cough, shortness of breath.

On the part of laboratory indicators: less than 2% - proteinuria, hyperkalemia, increased activity of hepatic transaminases, increased bilirubin concentration in the blood, neutropenia.

Other: rarely (when used in high doses) - glossitis, hair loss, hot flashes, impotence;
in patients with autoimmune diseases - agranulocytosis.
Renipril is generally well tolerated and in most cases does not cause adverse reactions requiring the drug to be withdrawn.

CONTRAINDICATIONS

- angioedema, associated with the use of ACE inhibitors (in the anamnesis);

- progressive azotemia in bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney;

- childhood;

- Pregnancy;

- lactation (breastfeeding);

- Hypersensitivity to enalapril and other components of the drug;

- Hypersensitivity to other ACE inhibitors.

PREGNANCY AND LACTATION

Renipril is contraindicated in pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

In patients with impaired renal function , the single dose should be reduced or the intervals between doses should be increased.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With extreme caution, the drug should be used in patients with impaired liver function.

APPLICATION FOR CHILDREN

The drug is contraindicated in childhood.

SPECIAL INSTRUCTIONS

With extreme caution, the drug should be used in patients with autoimmune diseases, impaired liver or kidney function, loss of fluid and salts, concurrent with immunosuppressants and diuretics.
In the case of previous treatment with diuretics, in particular in chronic heart failure, RENIPRIL increases the risk of developing arterial hypotension, so before starting treatment with Renipril it is necessary to compensate for the loss of fluid and salts.
In the process of long-term therapy, control of the picture of peripheral blood is shown.

Before the study of the function of parathyroid glands, Renipril should be discontinued.

OVERDOSE

Symptoms: arterial hypotension.

Treatment: Place the patient in a position with raised legs.
In mild cases, administer saline solution. In more severe cases in hospital conditions, measures aimed at stabilizing blood pressure are performed: intravenous injection of physiological solution or plasma substitutes. It is possible to use hemodialysis.
DRUG INTERACTION

With simultaneous administration of Renipril and NSAIDs, a decrease in the effectiveness of Renipril is possible;
with potassium-sparing diuretics (spironolactone, triamterene, amiloride) - it is possible to develop hyperkalemia; with lithium salts - slowing of lithium removal (control of lithium concentration in blood plasma is shown).
With simultaneous use with analgesics-antipyretics, a decrease in the effectiveness of Renipril is possible.

Renipril weakens the effect of drugs containing theophylline.

Cimetidine extends the action of Renipril.

Simultaneous application of Renipril with diuretics, beta-adrenoblockers, methyldopa, nitrates, calcium channel blockers, hydralazine, prazosin intensifies the hypotensive effect.

Ethanol enhances the antihypertensive effect of the drug.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of the reach of children, dry, protected from light.
Shelf life - 3 years.
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