Hydrochlorothiazide, Enalapril

Brand Krka dd Novo mesto AO

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Available since: 2019-09-19

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Clinical Pharmacology

Combined drug, the action of which is due to the properties of the components included in its composition.

Enalapril is an ACE inhibitor, is a prodrug: as a result of its hydrolysis, enalaprilat is formed, which inhibits ACE.

Hydrochlorothiazide - thiazide diuretic. Acts at the level of the distal renal tubules, increasing the excretion of sodium ions and chlorine.

At the beginning of hydrochlorothiazide treatment, the volume of fluid in the vessels decreases as a result of an increase in the excretion of sodium and fluid, which leads to a decrease in blood pressure and a decrease in cardiac output.

Due to hyponatremia and reduction of body fluids, the renin-angiotensin-aldosterone system is activated. A reactive increase in the concentration of angiotensin II partially limits blood pressure reduction. With continued therapy, the hypotensive effect of hydrochlorothiazide is based on a decrease in the total peripheral vascular resistance. The activation of the renin-angiotensin-aldosterone system results in metabolic effects on the electrolyte balance of the blood, uric acid, glucose and lipids, which partially neutralizes the effectiveness of antihypertensive treatment.

Despite an effective reduction in blood pressure, thiazide diuretics do not reduce structural changes in the heart and blood vessels. Enalapril enhances the antihypertensive effect: inhibits the renin-angiotensin-aldosterone system, i.e. angiotensin II production and its effects. Additionally reduces the production of aldosterone and enhances the effect of bradykinin and the release of prostaglandins. Since it often has its own diuretic effect, which may enhance the action of hydrochlorothiazide.

Enalapril reduces the pre- and afterload, which unloads the left ventricle, reduces the regression of hypertrophy and the growth of collagen, prevents damage to myocardial cells. As a result, the heart rhythm slows down and reduces the load on the heart (with chronic heart failure), improves coronary blood flow and decreases oxygen consumption by cardiomyocytes. Thus, the sensitivity of the heart to ischemia decreases, and the number of dangerous ventricular arrhythmias also decreases. It has a beneficial effect on cerebral blood flow in patients with arterial hypertension and chronic cardiovascular diseases. It prevents the development of glomerulosclerosis, supports and improves kidney function, and slows down the course of chronic kidney disease, even in those patients who have not yet developed arterial hypertension.

It is known that the antihypertensive effect of ACE inhibitors is higher in patients with hyponatremia, hypovolemia and elevated serum renin levels, whereas the effect of hydrochlorothiazide does not depend on serum renin level. Therefore, the simultaneous appointment of enalapril and hydrochlorothiazide has an additional antihypertensive effect. In addition, enalapril prevents or reduces the metabolic effects of diuretic therapy and has a beneficial effect on structural changes in the heart and blood vessels.

The simultaneous appointment of an ACE inhibitor and hydrochlorothiazide is used when each drug alone is not sufficiently effective or monotherapy is performed using maximum doses of the drug, which increases the incidence of adverse effects. This combination allows you to get a better therapeutic effect with lower doses of enalapril and hydrochlorothiazide and reduce the development of undesirable effects.

The antihypertensive effect of the combination usually persists for 24 hours.

Indications

Arterial hypertension (for patients who are recommended combination therapy).

Composition

Active ingredients:

Enalapril maleate 10 mg.

Hydrochlorothiazide 12.5 mg.

Excipients:

Sodium bicarbonate, lactose monohydrate, calcium hydrogen phosphate (anhydrous), corn starch, talc, magnesium stearate.

Hydrochlorothiazide, Enalapril is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Enap-nl	Krka dd Novo mesto AO	Slovenia	pills
Enap-N	Krka dd Novo mesto AO	Slovenia	pills
Co-Renitec	Merck Sharp & Dohme	USA	pills
ENALAPRIL NL	Ozon	Russia	pills
Berlipril	Berlin-Chemie/Menarini	Germany	pills
Renipril GT	Pharmstandard	Russia	pills

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Dosage and Administration

Treatment of hypertension should not begin with a combination of drugs. Initially, adequate doses of the individual components should be determined. The dose should always be selected individually for each patient.

Take the drug regularly at the same time (preferably in the morning). The pills are swallowed whole during or after a meal, washed down with a small amount of liquid.

The usual dose is 1 tab. / Day.

In case of skipping the next dose of the drug, it should be taken as soon as possible, if a sufficiently large amount of time is left before the next dose. If there are a few hours left before taking the next dose, you should wait and take it only. Do not double the dose.

If a satisfactory therapeutic effect is not achieved, it is recommended to add another drug or change therapy.

In patients on diuretic therapy, it is recommended to cancel treatment or reduce the dose of diuretics at least 3 days before the start of treatment with Enapom-NL to prevent the development of symptomatic hypotension. Renal function should be examined before starting treatment.

The duration of treatment is not limited.

Use in violation of kidney function:

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Adverse reactions

Since the cardiovascular system:

Palpitations, various cardiac arrhythmias, marked reduction in blood pressure, orthostatic hypotension, cardiac arrest, myocardial infarction, cerebrovascular stroke, angina pectoris, Raynaud's syndrome, necrotizing angiitis.

From the digestive system:

Dry mouth, glossitis, stomatitis, inflammation of the salivary glands, Anorexia, nausea, vomiting, diarrhea, constipation, flatulence, epigastric pain, intestinal colic, ileus, pancreatitis, liver failure, hepatitis, jaundice, melena.

On the part of the respiratory system:

Rhinitis, sinusitis, pharyngitis, hoarseness, bronchospasm, asthma, pneumonia, pulmonary infiltrates, eosinophilic pneumonia, pulmonary embolism, pulmonary infarction, non-productive dry cough, respiratory distress syndrome, including pneumonitis and pulmonary edema.

From the side of the central nervous system and peripheral nervous system:

Depression, ataxia, drowsiness, Insomnia, anxiety, nervousness, peripheral neuropathy (Paresthesia, dysesthesia).

From the urinary system:

Oliguria, renal failure, impaired renal function, interstitial nephritis.

From the reproductive system:

Gynecomastia, reduced potency.

From the senses:

Visual impairment, taste disturbance, impaired sense of smell, tinnitus, conjunctivitis, dry conjunctiva, lacrimation.

From the hemopoietic system:

Leukocytosis, eosinophilia, neutropenia, leukopenia, agranulocytosis, anemia, hypoglobinemia, pancytopenia.

Metabolism:

Hypokalemia, hyperkalemia, hypomagnesemia, hypercalcemia, hyponatremia, hypochloremic alkalosis, hyperglycemia, glycosuria, hyperuricemia, hypercholesterolemia, hypertriglyceridemia, increased activity of hepatic enzymes, hyperbilirubinemia.

Dermatological reactions:

Sweating, rash, shingles, alopecia.

Allergic reactions:

Urticaria, pruritus, skin rash, exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme, Stephen-Johnson syndrome, photosensitivity, hypersensitivity reactions (angioedema, thrombocytopenic purpura), anaphylactic reactions.

Other:

Weakness, fever, lupus-like syndrome described in the literature (fever, myalgia and arthralgia, serositis, vasculitis, skin rash, increased ESR, leukocytosis, eosinophilia, positive test for antinuclear antibodies).

Contraindications

Carefully:

Bilateral renal artery stenosis.
Stenosis of the artery of the only kidney.
Renal dysfunction (CC 30-75 ml / min).
Pronounced stenosis of the mouth of the aorta.
Idiopathic hypertrophic subaortic stenosis.
CHD.
Cerebrovascular diseases (including with cerebrovascular insufficiency).
Chronic heart failure.
Severe autoimmune systemic diseases of the connective tissue (including SLE, scleroderma).
Inhibition of bone marrow hematopoiesis.
Diabetes.
Hyperkalemia.
Condition after kidney transplantation.
Severe abnormal liver and / or kidney function.
States accompanied by a decrease in the BCC:
As a result of diuretic therapy.
When limiting the consumption of salt.
Diarrhea.
Vomiting.
Gout.
Elderly patients.

Drug interactions

The simultaneous use of Enapa-NL with other antihypertensive drugs, barbiturates, tricyclic antidepressants, phenothiazine and narcotic drugs, as well as with ethanol, enhances the antihypertensive effect of Enap-NL.

Analgesics and NSAIDs, a large amount of salt in the diet, the simultaneous reception of Kolestiramin or Colestipol reduce the effect of Enap-NL.

If possible, the simultaneous use of Enapa-NL and lithium preparations should be avoided, since lithium intoxication may develop as a result of reduced lithium excretion. It is necessary to control the concentration of lithium in the blood serum; its dose is adjusted accordingly.

The simultaneous use of Enapa-NL and NSAIDs, analgesics (due to inhibition of prostaglandin synthesis) may reduce the effectiveness of enalapril and increase the risk of deterioration of renal function and / or heart failure. In some patients with simultaneous treatment, the anti-hypertensive effect of enalapril may also be reduced, so patients should be carefully monitored.

The simultaneous use of Enapa-NL with potassium-sparing diuretics (including spironolactone, amiloride, triamterene) or the addition of potassium can lead to hyperkalemia.

The simultaneous use of Enapa-NL with allopurinol, cytotoxic drugs, immunosuppressants, or systemic corticosteroids can cause leukopenia, anemia, or pancytopenia, therefore, periodic hemogram monitoring is required.

It was reported about acute renal failure in 2 patients after kidney transplantation, while receiving enalapril and cyclosporine. It is assumed that acute renal failure was the result of a decrease in renal blood flow caused by cyclosporine and a decrease in glomerular filtration caused by enalapril. Therefore, caution is necessary while using enalapril and cyclosporine.

The simultaneous use of Enapa-NL with sulfonamides and oral hypoglycemic agents from the sulfonylurea group can cause hypersensitivity reactions (cross-sensitivity is possible).

Care must be taken with the simultaneous use of Enapa-NL with cardiac glycosides. Possible hydrochlorothiazidine-induced hypovolemia, hypokalemia and hypomagnesemia can increase the toxicity of glycosides.

The simultaneous use of Enapa-NL with GCS increases the risk of hypokalemia.

With simultaneous use of Enapa-NL and theophylline, enalapril can reduce T 1/2 of theophylline.

With the simultaneous use of Enapa-NL and cimetidine, T 1/2 enalapril may increase.

The risk of hypotension increases during general anesthesia or the use of non-depolarizing muscle relaxants (for example, tubocurarine).

Pregnancy and Lactation

The drug is contraindicated in pregnancy. When pregnancy occurs, the drug should be immediately discontinued.

If necessary, the use of the drug during lactation should decide on the termination of breastfeeding.

Special instructions

A significant increase in serum calcium levels may be a sign of latent hyperparathyroidism.

In some patients, hyperuricemia or worsening of the course of gout may occur as a result of hydrochlorothiazide. If a rise in serum uric acid concentration is noted, treatment should be discontinued.It can be resumed after normalization of laboratory parameters and in the future, be carried out under their control.

Caution in the use of the drug is necessary in all patients receiving treatment with oral hypoglycemic agents or insulin, since hydrochlorothiazide may weaken, and enalapril enhance their effect. Patients with diabetes mellitus should be observed more frequently; some dose change of hypoglycemic agents may be required.

In the event of angioedema of the face or neck, it is usually sufficient to discontinue the therapy and prescribe an antihistamine to the patient. In more severe cases (swelling of the tongue, pharynx, and larynx), angioedema is treated with epinephrine, the airway is maintained by intubation or laryngotomy.

The antihypertensive effect of Enapa-NL may increase after sympathectomy.

Due to the increased risk of anaphylactic reactions, Enap-NL should not be given to patients on hemodialysis using polyacrylonitrile membranes that are subjected to apheresis with dextran sulfate and immediately before the desensitization procedure to wasp or bee venom.

During treatment with Enap-NL, hypersensitivity reactions may be observed in patients without prior allergies or bronchial asthma.

Reported deterioration in the course of SLE during therapy with ACE inhibitors.

Caution is also needed in patients taking sulfonamides or oral hypoglycemic agents from the sulfonylurea group due to possible cross-sensitivity.

During treatment, periodic monitoring of white blood cell count is required, especially in patients with connective tissue or kidney disease.

In patients who received during general anesthesia or after extensive surgical operations drugs that cause arterial hypotension, enalapril can block the formation of angiotensin II, secondary to compensatory release of renin. If the doctor suggests this mechanism of arterial hypotension, treatment can be carried out by increasing the BCC.

During treatment, periodic monitoring of the serum concentration of electrolytes, glucose, urea, creatinine and liver enzyme activity, as well as urine protein, is necessary. Treatment with Enapom-NL should be discontinued before conducting research on the function of the parathyroid glands.

Influence on ability to drive motor transport and control mechanisms

Enap-NL does not affect driving or working with mechanisms, however, in some patients (mainly at the beginning of treatment) arterial hypotension and dizziness may occur, which can reduce the ability to drive and work with mechanisms. Therefore, at the beginning of treatment, it is recommended to avoid driving, working with mechanisms and doing other work that requires concentration, until the answer to treatment is established.

Overdosage

When a patient takes too many pills at once, you should immediately call a doctor.

Symptoms: increased diuresis, marked reduction in blood pressure with bradycardia or other heart rhythm disturbances, convulsions, Paresis, paralytic ileus, impairment of consciousness (including Coma), renal failure, impaired CShR, electrolyte imbalance.

Treatment: the patient is transferred to a horizontal position with a low head. In mild cases, gastric lavage and ingestion of saline is indicated. In more serious cases, measures aimed at stabilizing blood pressure are shown: iv injection of saline, plasma substitutes. It is necessary to control the level of blood pressure, heart rate, respiratory rate, serum concentration of urea, creatinine, electrolytes and patient's diuresis.If necessary, in / in the introduction of angiotensin II, hemodialysis (the rate of removal of enalaprilat - 62 ml / min).