Enap-H tabs 10mg/25mg #20

Enap-H user manual

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Composition

In the drug Enap H contains two active components: enalapril maleate and hydrochlorothiazide.
The tablets also contain a number of additional components: sodium bicarbonate, lactose monohydrate, quinoline dye, talc, calcium hydrogosphate anhydrous, corn starch, magnesium stearate.

Form of issue

At present, several manufacturers of Enap H. tablets are produced by several manufacturers. The tablets are flat, round in shape, yellow in color, the edge is oblique, on the one side of the risk. In the blister - 10 tablets, in a cardboard bundle - two blisters. Depending on the manufacturer, the bundle can have more blisters - 3, 6, 9.

pharmachologic effect

Enap H is a combination of two active ingredients, enalapril maleate and hydrochlorothiazide (10 mg + 25 mg). Its effect is determined by those components that make up the means. Tablets produce an antihypertensive effect.
The substance enalapril inhibits ACE that promotes the conversion of angiotensin I into angiotensin II, reduces the concentration in the blood of aldosterone, stimulates the release of prostaglandins and endothelial relaxing factor. Under the influence of this substance, the sympathetic nervous system is depressed.
Producing the described effects, the substance contributes to the elimination of spasms and the widening of the peripheral arteries, lowers blood pressure, OPSS, as well as post and preload on the myocardium. Enalapril extends the arteries to a greater extent, but there is no reflex increase in heart rate. With decreasing pressure within the therapeutic limits, there is no effect on blood circulation in the brain. At the same time, the blood supply of the ischemic myocardium improves. The kidney blood flow is activated, but there is no change in glomerular filtration, and its speed, as a rule, increases.
The substance hydrochlorothiazide is a thiazide diuretic with an average force of exposure. Under its influence, the reabsorption of sodium ions at the level of the cortical segment of the Henle loop decreases, and there is no effect on its site, which passes in the medulla of the kidney.
Hydrochlorothiazide activates the process of excretion of phosphates, potassium ions and hydrocarbonates by the kidneys, provides blockage of carbonic anhydrase in the proximal part of the convoluted tubules. Almost no effect on the acid-base state. Hydrochlorothiazide increases the excretion of magnesium ions, while contributing to the retention of calcium ions in the body. There is a decrease in blood pressure due to a change in the reactivity of the vessel wall,
With the combined use of enalapril and hydrochlorothiazide, a more pronounced decrease in blood pressure is observed compared to treatment with each substance separately.
As a consequence, the hypotensive effect of the Enap-H drug persists for at least 24 hours.

Pharmacokinetics and pharmacodynamics

After the tablets have been taken orally, the substance enalapril is absorbed by 60%, its absorption is not affected by the intake of food. Metabolism of the substance occurs in the liver, while the active metabolite enalaprilat is produced, showing a greater effect as an ACE inhibitor, compared with enalapril. The period of the greatest concentration in enalapril is 1 h, enalaprilate is 3-4 h.
In the body, the metabolite overcomes the histohematological barriers, except for the BBB, binds to plasma proteins by 50-60%. After taking the greatest effect after 6-8 hours, it persists up to 24 hours.
Metabolite enalaprilat in the body is subject to further metabolism. The elimination half-life is 11 hours. Basically, the excretion occurs through the kidneys (about 60%), another part through the intestine (33%). The substance is removed from the body during hemodialysis.
Hydrochlorothiazide is mainly absorbed in the small intestine (in the proximal part), as well as in the duodenum. Absorption is 70%, when taken with food increases by 10%. The maximum concentration in the blood is observed after 1.5-5 hours. The level of bioavailability is 70%. With blood proteins, hydrochlorothiazide binds to 40%.
The substance penetrates the placenta and into the breast milk, it gradually accumulates in the amniotic fluid. Metabolism in the liver does not occur.
At 95% is excreted in the urine, the substance has a two-phase clearance profile. In the initial phase, the elimination half-life is 2 hours, in the final phase approximately 10 hours.
With the simultaneous use of the described substances, there is no effect on the pharmacokinetics of each.

Indications for use

Use Enap H is suitable for arterial hypertension.

Contraindications

Tablets are contraindicated for use in such conditions and diseases:
    severe renal dysfunction;
    anuria;
    angioedema (presence in the anamnesis, provided that this condition was associated with the administration of ACE inhibitors);
    angioedema edema idiopathic or associated with heredity;
    renal artery stenosis bilateral or single kidney;
    pregnancy and natural feeding;
    deficiency of lactase, lactose intolerance, glucose / galactose malabsorption;
    age to 18 years;
    a high level of sensitivity to the components of this remedy.
There are also conditions in which it is necessary to apply with care Enap H. This is a pronounced stenosis of the aortic aorta, hypertrophic subaortal stenosis, cerebrovascular diseases, ischemic heart disease, too strong a decrease in pressure and stroke, myocardial infarction (as a consequence), heart failure in chronic form, atherosclerosis pronounced, autoimmune connective tissue diseases in severe form, diabetes mellitus, disorders of bone marrow hematopoiesis, patient's condition after kidney transplantation, hypercalcemia a condition with a decrease in BCC, liver and kidney disease. Caution Enap H is prescribed for elderly patients.

Side effects

In the process of treatment of Enap H, such negative effects can appear:
    hemopoiesis: neutropenia, thrombocytopenia, lowering of hemoglobin and hematocrit, leukopenia;
    metabolism: gout;
    cardiovascular system: hypotension, lowering blood pressure, fainting, severe palpitation, a feeling of chest pain, tachycardia;
    nervous system: weakness, dizziness, asthenia, headache, drowsiness or insomnia, high excitability, sensation of noise in the ears;
    respiratory system: cough, shortness of breath;
    allergy: Stevens-Johnson syndrome, angioedema;
    digestive system: nausea, dyspepsia, diarrhea, vomiting, constipation, flatulence, abdominal pain, dry mouth, cholestatic jaundice;
    skin reactions: itching, rash, severe sweating, alopecia, skin necrosis;
    genitourinary system: disruption of kidney function, renal failure in acute form, decreased libido, impotence;
    musculoskeletal system: muscle spasms, arthralgia;
    laboratory parameters: hyperuricemia, hyperglycemia, hyperkalemia, hypokalemia, hyponatremia, increased urea and serum creatinine, increased activity of bilirubin and hepatic transaminases;
    other manifestations: fever, arthralgia, myalgia, vasculitis, increased ESR, rash on the skin, leukocytosis and eosinophilia.

Instructions for use Enap H (Method and dosage)

As the official instruction on the use of Enap H informs, Enap H should be taken regularly, whenever possible, doing this at one time every day. You do not need to chew the pills. As a rule, Enap H is prescribed one tablet a day. If necessary, increase the dose to two tablets daily.
People who have been treated with diuretics for a long time are advised to either completely discontinue such medications or reduce the dose three days before the Enap H tablets are taken to prevent symptomatic hypotension. Before starting treatment, the patient needs to conduct a study of kidney function.
The specialist individually sets the duration of treatment. If during the therapy there is no expected effect, the doctor either changes the treatment, or appoints a second drug.

Overdose

In case of taking high doses of Enap H, a person can sharply and strongly decrease pressure, bradycardia develop, also intensified diuresis develops, consciousness is disturbed, water-electrolyte balance, renal failure.
Assisting the patient, it is necessary to give his body a horizontal position, raise his legs. If the condition is not heavy, the patient is washed with a stomach, activated charcoal is given. If the condition is more serious, measures are taken to stabilize blood pressure. Introduced intravenously, plasma substitutes, 0.9% sodium chloride solution. It is important to carefully monitor blood pressure, respiratory rate and heart rate, as well as laboratory indicators. You may need hemodialysis, angiotensin II infusion.

Interaction

In the case of simultaneous intake of drugs, which contain potassium, the content of this element in blood serum can significantly increase. When taken simultaneously with lithium preparations, the process of removing lithium from the body slows down.
The use of thiazide diuretics can lead to an increase in the effect of tubocurarine chloride.
Simultaneous treatment with thiazide diuretics, phenothiazine derivatives or opioid analgesics may lead to orthostatic hypotension.
When using enalapril with beta-blockers, alpha-blockers, methyldopa, slow calcium channel blockers or ganglion blocking agents, blood pressure can be further reduced.
When taking thiazide diuretics with calcitonin, GCS increases the likelihood of hypokalemia.
In the case of treatment with ACE inhibitors and cytostatics, Allopurinol, immunosuppressants, there is also a risk of developing leukopenia.
The antihypertensive effects of ACE inhibitors may be weakened when taking NSAIDs. With this combination, renal function may be impaired, which is especially likely in people with kidney disease. NSAIDs also reduce the effect of diuretics.
Admission of ACE inhibitors and cyclosporine leads to an increased risk of hyperkalemia.
Simultaneous use of sympathomimetics may lead to a decrease in the antihypertensive effect of ACE inhibitors.
The bioavailability of ACE inhibitors decreases when antacids are taken.
The hypotensive effect of Enap H is enhanced when taking ethanol, with such a combination orthostatic hypotension is possible.
With simultaneous use of thiazide diuretics reduce the effect of adrenomimetics (epinephrine).
There is evidence that hypoglycemia may develop simultaneously with the administration of ACE inhibitors and hypoglycemic drugs. Therefore, people with diabetes are important to regularly visit a doctor, undergo research and adjust the dosage of medications.
The absorption of hydrochlorothiazide decreases with a single application of colestyramine or colestipol.
There is evidence that with the use of ACE inhibitors and gold preparations, skin redness, vomiting, and arterial hypotension may develop.

Terms of sale

To buy Enap H the prescription is not needed.

Storage conditions

The drug should be protected from children, stored at a temperature of up to 30 ° C.
Shelf life - 5 years.

special instructions

Immediately after the first use of tablets by patients who are diagnosed with hyponatremia, severe renal failure, left ventricular dysfunction, severe heart failure, hypotension may develop. Its occurrence after the first dose of the drug does not require the withdrawal of treatment.
During the treatment, serum concentrations of electrolytes should be monitored, especially for people with prolonged vomiting or diarrhea.
In people who practice taking these pills, it is important to determine in a timely manner the symptoms of water-electrolyte balance disorders (thirst, drowsiness, dry mouth, convulsions, tachycardia, etc.)
Carefully apply the drug in liver diseases, since hydrochlorothiazide can provoke a hepatic coma even in the case of the least violations of water-electrolyte balance.
If jaundice develops and the activity of liver transaminases increases, the treatment should be immediately stopped, and the patient should be monitored.
If the patient develops a pronounced hypercalcemia, this condition may indicate a latent hyperparathyroidism. It is necessary to cancel thiazide diuretics before examining the functions of parathyroid glands.
During the treatment of thiazide diuretics, the concentration of cholesterol and triglycerides in serum can increase.
During treatment with thiazide diuretics, the course of gout, hyperuricemia, can become worse.
In this enalapril activates the excretion of uric acid through the kidneys, which leads to counteract the hyperuricemic effect of hydrochlorothiazide.
If angioedema develops in the face, Enap H should be abolished and angioedurotic drugs should be prescribed.
Before performing surgical operations, including dental surgery, an anesthesiologist should be warned that the patient is taking ACE inhibitors
During the treatment, the drug may be coughing - prolonged and dry. Cough disappears after the patient stops taking drugs.
Since with the Enap H treatment, pressure can drop drastically, dizziness and weakness develop, it is necessary to carefully manage the transport and engage in other activities that require concentration of attention. Especially cautious patients should be at the beginning of treatment.

Children

Drugs are not prescribed for children under 18 years of age.

With alcohol

Do not combine Enap H and alcohol, since alcohol activates the hypotensive effect of tablets.

In pregnancy and lactation

Contraindicated use of the drug during pregnancy, as well as during natural feeding. There may be a negative effect on the fetus and on the newborn.

Reviews about Enap H

Those reviews on Enap H 10 mg + 25 mg, which occur on the network, indicate that the drug in most cases effectively and stably reduces the pressure. As side effects, cough is most often manifested.