Enalapril-FPO, 20mg pills 20pcs

Composition

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of 1 tab. contains:

hydrochlorothiazide 12.5 mg,

enalapril maleate 20 mg

Auxiliary substances:

lactose monohydrate 18.5 mg,

potato starch 10 mg,

microcrystalline cellulose 31 mg,

povidone 2 mg,

sodium bicarbonate 2 mg,

sodium carboxymethyl starch (sodium starch glycolate) 2 mg,

talcum powder 1 mg,

magnesium stearate 1 mg

Pharmacological action

Antihypertensive combination agent (ACE blocker+diuretic)

Indications

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

Contraindications

— hypersensitivity to drug or a derivative of sulfonamide;

— anuria;

— severe renal dysfunction (CC<30 ml/min);

— a history of angioedema associated with the use of earlier ACE inhibitors, and derivatives of sulfonamide;

— hereditary or idiopathic angioedema;

— lactose intolerance, lactase deficiency or malabsorption of glucose/galactose;

— pregnancy;

— lactation (breastfeeding);

— children and adolescence to 18 years (efficacy and safety not established).

With caution the drug should be used under the following conditions: bilateral renal artery stenosis, stenosis of the artery to a solitary kidney;

pronounced aortic and mitral stenosis, or hypertrophic obstructive cardiomyopathy;

ischemic heart disease and cerebrovascular disease (including cerebrovascular insufficiency), because of an excessive decrease in blood pressure can lead to myocardial infarction and stroke;

congestive heart failure; severe atherosclerosis;

severe autoimmune systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma);

oppression of bone marrow hematopoiesis;

diabetes mellitus, because thiazide diuretics can reduce glucose tolerance;

hyperkalemia; condition after kidney transplantation, disorders of liver function and/or kidney (KK 30-75 ml/min);

state, accompanied by a decrease in BCC (the result of diuretic therapy, while limiting the intake of salt, diarrhoea or vomiting);

primary aldosteronism;

older age.

Side effects

WHO classification of side effects: very common (>1/10), common (>>1/100 and >><1/10), uncommon (>1/1000 and <1/10), uncommon (><1/100), rare (>1/10 000 and <1/100), rare (><1/1000), very rare (

From the hematopoietic system:  infrequently-anemia; rarely-neutropenia, decreased hemoglobin and hematocrit, thrombocytopenia, leukopenia, agranulocytosis, bone marrow suppression, bone marrow suppression, pancytopenia, leukopenia, lymphadenopathy, autoimmune diseases.

From the endocrine system:  frequency unknown – syndrome of impaired ADH secretion.

Nervous system disorders:  often – headache, depression, fainting; infrequently-confusion, drowsiness, insomnia, nervousness, paresthesia, dizziness; rarely-sleep disorders, paresis (due to hypokalemia).

From the side of the visual organ:  very often – visual disturbances; frequency unknown-xanthopsy.

From the cardiovascular system:  often – marked decrease in blood pressure (including orthostatic hypotension), chest pain, rhythm disturbances, tachycardia, angina pectoris; infrequently-myocardial infarction or stroke, palpitation sensation; rarely-Raynaud’s syndrome; frequency unknown-necrotic angiitis (vasculitis, cutaneous vasculitis).

Respiratory system disorders:  very common-cough; often-shortness of breath; infrequently rhinorrhea, sore throat, hoarseness, bronchospasm; rarely pulmonary infiltrates, rhinitis, allergic alveolitis/eosinophilic pneumonia, respiratory distress syndrome (including pneumonitis and pulmonary edema).

From the digestive system:  very often – nausea; often – diarrhea, abdominal pain, taste disorders; infrequently – intestinal obstruction, pancreatitis, vomiting, dyspepsia, constipation, anorexia, stomach irritation, dry oral mucosa, peptic ulcer; rarely – stomatitis, aphthous ulcers, glossitis, liver failure, hepatitis (hepatocellular or hemolytic), cholestasis, fulminant necrosis of the liver; very rarely – intestinal angioedema.

Skin and subcutaneous tissue disorders:  often – skin rash, angioedema of the face, limbs, lips, tongue, glottis, larynx; infrequently-increased sweating, pruritus, urticaria, alopecia; rarely-erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma, lupus-like skin reactions, exacerbation of systemic lupus erythematosus.

Musculoskeletal disorders:  often-muscle cramps; infrequently-arthralgia.

From the urinary system:  infrequently-impaired renal function, acute renal failure, proteinuria; rarely-oliguria, interstitial nephritis.

From the side of the reproductive system:  infrequently-decreased potency; rarely-gynecomastia.

Other services:  very often – asthenia; often-fatigue; infrequently-muscle cramps, tinnitus, general malaise, fever; frequency unknown (for hydrochlorothiazide) – fever, weakness.

Laboratory tests:  often – hyperkalemia, hypercreatininemia; infrequently-hyperuricemia, hyponatremia; rarely-increased activity of hepatic transaminases, hyperbilirubinemia.

When using ACE inhibitors, a symptom complex has been described that includes fever, serositis, vasculitis, myalgia, myositis, arthralgia, arthritis, a positive antinuclear antibody test, increased ESR, eosinophilia, leukocytosis, exanthema, photosensitivity reactions or other dermatological disorders.

When taking ACE inhibitors and intravenous use of sodium aurothiomalate at the same time, a symptom complex has been described, including hyperemia of the facial skin, nausea, vomiting and hypotension.

Interaction

The use of potassium supplements, potassium-sparing agents or preparations containing potassium, salt substitutes, especially in patients with renal insufficiency, can lead to a significant increase in the content of potassium in the blood serum. Potassium loss in patients taking thiazide diuretics is usually reduced by enalapril. The level of potassium in the blood serum usually remains within the normal range.

When used concomitantly with lithium preparations, lithium excretion slows down (increasing the cardiotoxic and neurotoxic effects of lithium).

Thiazide diuretics may increase the effect of tubocurarin chloride.

Concomitant use of thiazide diuretics, opioid analgesics, or phenothiazine derivatives may result in orthostatic hypotension.

Concomitant use of other antihypertensive agents, including beta-blockers, alpha-blockers, ganglion-blocking agents, methyldopa or slow calcium channel blockers with enalapril may further reduce blood pressure.

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

Concomitant use of thiazide diuretics with corticosteroids, calcitonin may lead to the development of hypokalemia.

Concomitant use of cyclosporine with ACE inhibitors may increase the risk of hyperkalemia. Concomitant use of hydrochlorothiazide and cyclosporine may increase the risk of hyperuricemia and complicate the course of gout.

Concomitant use of NSAIDs (including selective COX-2 inhibitors) may weaken the antihypertensive effect of ACE inhibitors or angiotensin II receptor antagonists. NSAIDs and ACE inhibitors have an additive effect on increasing serum potassium, which can lead to 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 adrenomimetics (epinephrine).

Ethanol increases 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 trials 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 hypoglycemic agents for oral use and insulin with thiazide diuretics may require dose adjustment.

A single dose of colestyramine or colestipol reduces the absorption of hydrochlorothiazide in the gastrointestinal tract by 85% and 43%, respectively.

With simultaneous use of ACE inhibitors and gold preparations (sodium aurothiomalate) iv, a symptom complex is described, including hyperemia of the facial skin, nausea, vomiting and hypotension.

Concomitant use of ACE inhibitors and thiazide diuretics with trimethoprim increases the risk of hyperkalemia.

Concomitant use of ACE inhibitors and lovastatin increased the risk of hyperkalemia.

When used concomitantly with ACE inhibitors, they may increase the hypotensive effect of tricyclic antidepressants, neuroleptics, and anesthetics.

Enalapril can be used simultaneously with acetylsalicylic acid (in doses up to 300 mg / day), thrombolytics, beta-blockers and nitrates.

It may be necessary to adjust the dosage of medications used for gout (probenecid, sulfinpyrazone and allopurinol), since hydrochlorothiazide can increase the concentration of uric acid; co-use of thiazide diuretics can lead to an increase in the frequency of hypersensitivity reactions to allopurinol.

Holinoblokatorov (atropine, biperidene) they can increase the bioavailability of thiazide diuretics, reducing motility and the rate of gastrointestinal emptying.

Thiazide diuretics slow down the elimination of cytotoxic drugs by the kidneys (for example, cyclophosphamide, methotrexate) and thereby enhance their myelosuppressive effect.

It is possible to develop hemolytic anemia with the combined use of hydrochlorothiazide and methyldopa.

Hypokalemia or hypomagnesemia caused by the use of thiazide diuretics may contribute to the development of rhythm disorders when taking cardiac glycosides.

In the case of hypovolemia caused by taking thiazide diuretics, the risk of acute renal failure increases with the introduction of iodine-containing contrast agents in high doses.

Simultaneous intravenous use of amphotericin B, as well as the use of corticosteroids, corticotropin or laxatives and hydrochlorothiazide, may increase the violation of the water-electrolyte balance, especially hypokalemia.

Concomitant use with carbamazepine may lead to symptomatic hyponatremia.

It is necessary to use hydrochlorothiazide with caution with drugs that can cause ventricular tachycardia of the “pirouette” type, for example, some antiarrhythmic drugs, neuroleptics.

Concomitant use of thiazide diuretics with drugs containing calcium salts may develop hypercalcemia.

How to take, course of use and dosage

Assign inside, during or after a meal, tablets are taken without chewing, washed down with a small amount of liquid.

Initially, adequate doses of individual components should be determined. The dose should always be selected individually for each patient. The recommended dose is 1 tablet/day. Patients should get into the habit of taking the drug regularly, at the same time, preferably in the morning.

In patients undergoing diuretic therapy, it is recommended to discontinue treatment or reduce the dose of diuretics at least 3 days before starting treatment with the drug to prevent the development of symptomatic hypotension.

Renal function should be evaluated before starting treatment.

The duration of treatment is determined by the doctor.

If you miss the next dose of the drug, it should be taken as soon as possible, if there is enough time left before taking the next dose. If there are several hours left before taking the next dose, you should wait and take only this dose. Never double the dose.

In patients with renal insufficiency with creatinine clearance 30-75 ml / min, the drug should be used only after preliminary titration of enalapril and hydrochlorothiazide doses separately, according to the doses in the combined preparation Enalapril N.

In the absence of a therapeutic effect, it is recommended to add another drug or change the therapy.

The duration of treatment is not limited.

Overdose

Symptoms: increased diuresis, a marked decrease in blood pressure with bradycardia or other cardiac arrhythmias, convulsions, impaired consciousness (including coma), acute renal failure, impaired ESR and water-electrolyte balance of the blood.

Treatment: the patient is moved to a horizontal position with raised legs.

In mild cases, gastric lavage and ingestion of activated carbon are indicated, in more serious cases-measures aimed at stabilizing blood pressure – intravenous use of plasma substitutes, infusion of 0.9% sodium chloride solution. The patient should be monitored for blood pressure, heart rate, respiratory rate, serum concentration of urea, creatinine, electrolytes and diuresis, if necessary – intravenous use of angiotensin II, hemodialysis (the rate of elimination of enalaprilat-62 ml / min).

Special instructions

Hypotension with all clinical consequences may occur after the first use of Enalapril-H tablets in patients with severe CHF and hyponatremia, severe renal insufficiency or left ventricular dysfunction, and especially in patients with hypovolemia as a result of diuretic therapy, a salt-free diet, diarrhea, vomiting or hemodialysis.

In case of hypotension, the patient should be placed on his back with a low headboard and, if necessary, adjust the volume of BCC by infusion of 0.9% sodium chloride solution. Hypotension that occurs after the first dose is not a contraindication for further treatment.

Caution should be exercised in patients with CHD, severe cerebrovascular diseases, aortic stenosis or idiopathic hypertrophic obstructive subaortic stenosis that interferes with the outflow of blood from the left ventricle, severe atherosclerosis, in elderly patients as a result of the risk of hypotension and impaired blood supply to the heart, brain and kidneys.

It is necessary to regularly monitor the serum concentration of electrolytes during treatment to identify possible imbalances and timely take the necessary measures. Determination of serum electrolyte concentrations is mandatory for patients with prolonged diarrhea and vomiting.

In patients taking Enalapril H, it is necessary to detect signs of impaired water-electrolyte balance, such as dryness of the oral mucosa, thirst, weakness, drowsiness, increased excitability, myalgia and convulsions (mainly of the calf muscles), decreased blood pressure, tachycardia, oliguria and gastrointestinal disorders (nausea, vomiting).

Enalapril H in patients with renal insufficiency (creatinine clearance 30-75 ml / min) should be used only after preliminary titration of enalapril and hydrochlorothiazide doses separately, according to the doses in the combined Enalapril H preparation.

Enalapril H should be used with caution in patients with hepatic insufficiency or progressive liver disease, since hydrochlorothiazide can cause hepatic coma even with minimal disturbances in the water-electrolyte balance. Several cases of acute hepatic insufficiency with cholestatic jaundice, fulminant liver necrosis, and death (rare) have been reported during treatment with ACE inhibitors. If jaundice occurs and hepatic transaminase activity increases, treatment with Enalapril H should be discontinued immediately and patients should be monitored.

Caution should be exercised in all patients treated with hypoglycemic agents for oral use or insulin, as hydrochlorothiazide may weaken, and enalapril may increase their effect.

Thiazide diuretics can reduce the excretion of calcium by the kidneys and cause a slight and transient increase in serum calcium.

Severe hypercalcemia may be a sign of latent hyperparathyroidism. Thiazide diuretics should be discontinued prior to parathyroid function testing.

During treatment with thiazide diuretics, serum cholesterol and triglyceride concentrations may increase.

Thiazide diuretic therapy may worsen hyperuricemia and/or exacerbate the course of gout in some patients. However, enalapril increases the excretion of uric acid by the kidneys, thereby counteracting the hyperuricemic effect of hydrochlorothiazide.

If angioedema of the face occurs, it is usually sufficient to cancel therapy and prescribe antihistamines to the patient.

Angioedema of the tongue, pharynx, or larynx can be fatal. In case of angioedema of the tongue, pharynx or larynx, which can lead to airway obstruction, it is necessary to immediately introduce epinephrine (0.3-0.5 ml of epinephrine (epinephrine) subcutaneous solution in a ratio of 1:1000) and maintain airway patency (intubation or tracheostomy).

Among black patients receiving ACE inhibitor therapy, the incidence of angioedema is higher than among patients of other races.

Patients with a history of angioedema that is not associated with ACE inhibitors have an increased risk of developing angioedema when taking any ACE inhibitor.

Hypersensitivity reactions may occur in patients taking thiazide diuretics, both in the presence and in the absence of a history of allergic reactions. Worsening of the course of systemic lupus erythematosus has been reported.

Due to the increased risk of anaphylactic reactions, Enalapril H should not be prescribed to patients undergoing hemodialysis using high-flow polyacrylonitrile membranes (AN 69®), undergoing LDL apheresis using dextran sulfate and immediately before the procedure of desensitization with an allergen from hymenopteran venom.

Before surgery (including dentistry), it is necessary to warn the anesthesiologist about the use of ACE inhibitors. During surgery or general anesthesia using agents that cause hypotension, ACE inhibitors can block the formation of angiotensin II in response to the compensatory release of renin.If a marked decrease in blood pressure occurs due to such a mechanism, it can be corrected by increasing the BCC.

Coughing has been reported with ACE inhibitors. The cough is dry and prolonged, which disappears after discontinuation of ACE inhibitors. In the differential diagnosis of cough, it is necessary to take into account the cough caused by the use of ACE inhibitors.

The drug may cause a positive result in anti-doping tests.

Influence on the ability to drive motor vehicles and manage mechanisms

At the beginning of treatment with Enalapril H, a marked decrease in blood pressure, dizziness and drowsiness may occur, which may reduce the ability to drive vehicles, to engage in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions. Therefore, at the beginning of treatment, it is not recommended to drive vehicles and engage in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Tablets are round, biconvex, white or almost white in color.

Active ingredient

Enalapril

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Heart Failure, Hypertension