Enap-N, tablets 25 mg+10 mg 20 pcs

Pharmgroup:

Hypertensive combination drug (ACE inhibitor+diuretic).

Pharm Action:

Enap-H is a combination drug whose action is due to the properties of its constituent components. It has an antihypertensive effect.

– Enalapril inhibits ACE, which promotes transformation of angiotensin I into angiotensin II, reduces the concentration of aldosterone in blood, increases renin release by juxtaglomerular cells in the walls of arterioles of renal tubules, improves functioning of kallikrein-kinin system, stimulates release of prostaglandins and endothelial relaxing factor (NO), inhibits sympathetic nervous system.

Taken together, these effects eliminate spasm and dilate peripheral arteries, reduce RPS, systolic and diastolic BP, post- and preload on the myocardium. It dilates arteries to a greater extent than veins, and there is no reflex increase in HR. Hypotensive effect is more pronounced at high plasma renin concentration than at normal or reduced concentration. Reduction of BP within therapeutic limits has no effect on cerebral blood flow. Improves blood supply to ischemic myocardium. Increases renal blood flow without changing glomerular filtration rate. In patients with initially decreased glomerular filtration, its rate usually increases.

The maximum effect of enalapril develops after 6-8 hours and lasts up to 24 hours.

Hydrochlorothiazide is a medium-acting thiazide diuretic. It reduces the reabsorption of sodium ions at the level of the cortical segment of the loop of Genle without affecting its section in the medullary layer of the kidney. It blocks carboanhydrase in the proximal part of the convoluted tubules, increases renal excretion of potassium ions, hydrocarbonates and phosphates.

It has practically no effect on the acid-base state. Increases the excretion of magnesium ions. Delays calcium ions in the body. Diuretic effect develops after 1-2 hours, reaches a maximum after 4 hours, lasts for 10-12 hours. The action decreases with decreasing glomerular filtration rate and stops when its value is less than 30 ml/min. It decreases BP by decreasing the BCC and changing the reactivity of the vascular wall.

The use of combination of enalapril and hydrochlorothiazide causes more significant decrease of BP in comparison with monotherapy of each of agents separately and allows to maintain hypotensive effect of Enap®-N at least for 24 hours.

Indications

arterial hypertension
chronic heart failure.

Pharmacological effect

Pharmaceutical group:

antihypertensive combination drug (ACE inhibitor + diuretic).

Pharmaceutical action:

Enap-N is a combination drug, the effect of which is determined by the properties of the components included in its composition. Has an antihypertensive effect.

– Enalapril inhibits ACE, which promotes the conversion of angiotensin I to angiotensin II, reduces the concentration of aldosterone in the blood, increases the release of renin by juxtaglomerular cells in the walls of the arterioles of the renal glomeruli, improves the functioning of the kallikrein-kinin system, stimulates the release of prostaglandins and endothelial relaxing factor (NO), inhibits the sympathetic nervous system system.

Together, these effects eliminate spasm and dilate peripheral arteries, reduce peripheral vascular resistance, systolic and diastolic blood pressure, post- and preload on the myocardium. It dilates arteries to a greater extent than veins, but there is no reflex increase in heart rate. The hypotensive effect is more pronounced at high plasma renin concentrations than at normal or reduced levels. Reducing blood pressure within therapeutic limits does not affect cerebral circulation. Improves blood supply to ischemic myocardium. Increases renal blood flow, while the glomerular filtration rate does not change. In patients with initially reduced glomerular filtration rate, its rate usually increases.

The maximum effect of enalapril develops after 6-8 hours and lasts up to 24 hours.

– Hydrochlorothiazide is a thiazide diuretic of moderate potency. Reduces the reabsorption of sodium ions at the level of the cortical segment of the loop of Henle, without affecting its section passing through the medulla of the kidney. Blocks carbonic anhydrase in the proximal convoluted tubule, enhances the excretion of potassium ions, bicarbonates and phosphates by the kidneys.

Has virtually no effect on the acid-base state. Increases the excretion of magnesium ions. Retains calcium ions in the body. The diuretic effect develops after 1-2 hours, reaches a maximum after 4 hours, and lasts 10-12 hours. The effect decreases as the glomerular filtration rate decreases and stops when it is less than 30 ml/min. Reduces blood pressure by reducing blood volume and changing the reactivity of the vascular wall.

The use of a combination of enalapril and hydrochlorothiazide leads to a more pronounced decrease in blood pressure compared to monotherapy with each drug separately and allows the hypotensive effect of Enap®-N to be maintained for at least 24 hours.

Special instructions

During treatment with Enap-H, regular monitoring of liver and kidney function, as well as blood patterns, is necessary.

2-3 days before starting treatment with Enap-H, diuretic therapy should be stopped. The simultaneous use of Enap-H with lithium and potassium preparations is not recommended.

It is possible to combine the drug Enap-H with beta blockers.

Active ingredient

Hydrochlorothiazide, Enalapril

Composition

1 tab.:

– enalapril maleate 10 mg

– hydrochlorothiazide 25 mg

Excipients:

sodium bicarbonate,

quinoline yellow dye (E104),

lactose monohydrate,

calcium hydrogen phosphate anhydrous,

corn starch,

talc,

magnesium stearate.

Contraindications

severe renal dysfunction
hypersensitivity to the drug Enap-H.

Side Effects

nausea, vomiting, abdominal discomfort
dizziness when suddenly rising from a lying position, headache, dizziness
dry cough
allergic reactions.

Interaction

The use of potassium supplements, potassium-sparing agents or preparations containing potassium, salt substitutes, especially in patients with renal failure, can lead to a significant increase in serum potassium levels.

Potassium loss while taking thiazide diuretics is usually reduced by enalapril. Serum potassium levels usually remain within normal limits.

When used simultaneously with lithium preparations, the excretion of lithium slows down (increased cardiotoxic and neurotoxic effects of lithium).
Thiazide diuretics may enhance the effect of tubocurarine chloride.

Concomitant use of thiazide diuretics, opioid analgesics or phenothiazine derivatives may lead to orthostatic hypotension.

The combined use of beta-blockers, alpha-blockers, ganglion-blocking agents, methyldopa or slow calcium channel blockers with enalapril can further reduce blood pressure.

Concomitant use of allopurinol, cytostatics and immunosuppressants with ACE inhibitors may increase the risk of developing leukopenia.

Concomitant use of thiazide diuretics with corticosteroids and calcitonin can lead to the development of hypokalemia.

Concomitant use of cyclosporine with ACE inhibitors may increase the risk of developing hyperkalemia.

Concomitant use of NSAIDs (including selective COX-2 inhibitors) may weaken the antihypertensive effect of ACE inhibitors. NSAIDs and ACE inhibitors have an additive effect on increasing serum potassium, which may lead to a deterioration of renal function, especially in patients with impaired renal function. This effect is reversible. NSAIDs may reduce the diuretic and antihypertensive effects of diuretics.

Antacids may reduce the bioavailability of ACE inhibitors.
Sympathomimetics may reduce the antihypertensive effect of ACE inhibitors.

Thiazide diuretics may reduce the effect of adrenergic agonists (epinephrine).
Ethanol enhances the hypotensive effect of ACE inhibitors and thiazide diuretics, which can cause orthostatic hypotension.
Epidemiological studies suggest that the simultaneous use of ACE inhibitors and hypoglycemic agents may lead to hypoglycemia.

More often, hypoglycemia develops in the first weeks of therapy in patients with impaired renal function. Long-term and controlled clinical studies of enalapril do not confirm these data and do not limit the use of enalapril in patients with diabetes mellitus. However, such patients should be under regular medical supervision. The use of oral hypoglycemic agents and insulin with thiazide diuretics may require adjustment of their doses.

A single dose of cholestyramine or colestipol reduces the absorption of hydrochlorothiazide in the gastrointestinal tract by 85% and 43%, respectively.
With the simultaneous use of ACE inhibitors and gold preparations (sodium aurothiomalate) intravenously, a symptom complex has been described, including facial flushing, nausea, vomiting and arterial hypotension.

Overdose

Symptoms: increased diuresis, marked decrease in blood pressure with bradycardia or other heart rhythm disturbances, convulsions, disturbances of consciousness (including coma), acute renal failure, disturbances in blood pressure and water-electrolyte balance.

Treatment: the patient is transferred to a horizontal position with raised legs. In mild cases, gastric lavage and ingestion of activated charcoal are indicated; in more serious cases, measures aimed at stabilizing blood pressure are indicated – intravenous administration of plasma expanders, infusion of 0.9% sodium chloride solution.

The patient must monitor the level of blood pressure, heart rate, respiratory rate, serum concentration of urea, creatinine, electrolytes and diuresis, if necessary, intravenous administration of angiotensin II, hemodialysis (enalaprilat excretion rate – 62 ml/min).

Storage conditions

Store in a place protected from moisture at a temperature not exceeding 25°C.

Manufacturer

KRKA-RUS, Russia