Enap-NL 20 pills 12.5mg+20mg, 20pcs

Composition

1 tablet contains:

Active ingredients:

Enalapril maleate 20 mg.

Hydrochlorothiazide 12.5 mg.

Auxiliary substances:

sodium bicarbonate,

lactose monohydrate,

calcium hydrophosphate (anhydrous),

corn starch,

talc,

magnesium stearate.

Pharmacological action

A combined drug, the action of which is determined by the properties of the components that make up its composition.

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

Hydrochlorothiazide is a thiazide diuretic. It acts at the level of the distal renal tubules, increasing the excretion of sodium and chlorine ions.

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

Due to hyponatremia and decreased body fluids, the renin-angiotensin-aldosterone system is activated. A reactive increase in the concentration of angiotensin II partially limits the decrease in blood pressure. With continued therapy, the hypotensive effect of hydrochlorothiazide is based on a decrease in total peripheral vascular resistance.

Activation of the renin-angiotensin-aldosterone system results in metabolic effects on blood electrolyte balance, uric acid, glucose, and lipids, which partially neutralizes the effectiveness of antihypertensive treatment.

Indications

• Arterial hypertension.
• chronic heart failure.

Use during pregnancy and lactation

Enap-HL is contraindicated during pregnancy, breast-feeding and under the age of 14 years.

Contraindications

• Hypersensitivity to the components of the drug.
• Hypersensitivity to sulfonamides.
• Anuria.
• Severe renal dysfunction.
• Hereditary or idiopathic angioedema.
• Angioedema associated with the use of ACE inhibitors.
• Primary hyperaldosteronism.
• Addison’s disease.
• Porphyria.
• Children and adolescents under 18 years of age.

With caution:

• Bilateral renal artery stenosis.
• Stenosis of the artery of a single kidney.
• Impaired renal function.
• Severe aortic stenosis.
• Idiopathic hypertrophic subaortic stenosis.
• IHD.
• Cerebrovascular diseases.
• Chronic heart failure.
• Severe autoimmune systemic connective tissue diseases.
• Inhibition of bone marrow hematopoiesis.
• Diabetes mellitus.
• Hyperkalemia.
• Condition after kidney transplantation.
• Severe hepatic and/or renal impairment.
• Conditions accompanied by a decrease in BCC:
• As a result of diuretic therapy.
• When limiting the consumption of table salt.
• Diarrhea.
• Vomiting.
• Gout.
• Elderly patients.

Side effects

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

From the cardiovascular system:

Palpitations, various cardiac arrhythmias, marked decrease 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, salivary gland inflammation, Anorexia, nausea, vomiting, diarrhea, constipation, flatulence, epigastric pain, intestinal colic, ileus, pancreatitis, liver failure, hepatitis, jaundice, melena.

Respiratory system disorders:

Rhinitis, sinusitis, pharyngitis, hoarseness, bronchospasm, asthma, pneumonia, pulmonary infiltrates, eosinophilic pneumonia, pulmonary embolism, lung infarction, unproductive ” dry ” cough, respiratory distress syndrome, including pneumonitis and pulmonary edema.

From the central nervous system and peripheral nervous system:

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

From the urinary system:

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

From the side of the reproductive system:

Gynecomastia, decreased potency.

From the side of the senses:

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

From the hematopoietic system:

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

From the side of metabolism:

Hypokalemia, hyperkalemia, hypomagnesemia, hypercalcemia, hyponatremia, hypochloremic alkalosis, hyperglycemia, glucosuria, hyperuricemia, hypercholesterolemia, hypertriglyceridemia, increased activity of liver enzymes, hyperbillirubinemia.

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 services:

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

Interaction

Concomitant use of Enap-NL with other antihypertensive agents, 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, and simultaneous use of colestyramine or colestipol reduce the effect of Enap-NL.

If possible, the simultaneous use of Enap-NL and lithium preparations should be avoided, since lithium intoxication may develop due to a decrease in lithium excretion. It is necessary to monitor the concentration of lithium in the blood serum ; its dose is adjusted accordingly.

Concomitant use of Enapril with NSAIDs, analgesics (due to inhibition of prostaglandin synthesis) may reduce the effectiveness of enalapril and increase the risk of worsening renal function and/or heart failure. In some patients, concomitant treatment may also reduce the antihypertensive effect of enalapril, so patients should be carefully monitored.

Concomitant use of Enap-NL with potassium-sparing diuretics (including spironolactone, amiloride, triamterene ) or potassium supplementation may lead to hyperkalemia.

Concomitant use of Enap-NL with allopurinol, cytostatics, immunosuppressants, or systemic corticosteroids may cause leukopenia, anemia, or pancytopenia, so periodic monitoring of the hemogram is required.

Acute renal failure has been reported in 2 post-renal transplant patients treated concomitantly with enalapril and cyclosporine. Acute renal failure is thought to be the result of decreased renal blood flow caused by cyclosporine and decreased glomerular filtration caused by enalapril. Therefore, caution should be exercised when using enalapril and cyclosporine at the same time.

Concomitant use of Enap-NL with sulfonamides and oral hypoglycemic agents from the sulfonylurea group may cause hypersensitivity reactions (cross-hypersensitivity is possible).

Caution should be exercised when Enap-NL is co-administered with cardiac glycosides. Possible hydrochlorothiazide-induced hypovolemia, hypokalemia, and hypomagnesemia may increase the toxicity of glycosides.

Concomitant use of Enap-NL with corticosteroids increases the risk of hypokalemia.

When Enap-NL and theophylline are co-administered, enalapril may reduce the T 1/2 of theophylline.

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

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

How to take it, course of use and dosage

Treatment of hypertension should not be initiated with a combination of medications. Initially, adequate doses of 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). Tablets are swallowed whole during or after a meal, washed down with a small amount of liquid.

The usual dose is one to two tablets per day.

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

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

In patients receiving diuretic therapy, it is recommended to cancel treatment or reduce the dose of diuretics at least 3 days before the start of treatment with Enap-NL 20 to prevent the development of symptomatic hypotension. Renal function should be evaluated before starting treatment.

The duration of treatment is not limited.

Use in patients with impaired renal function:

Patients with creatinine clearance greater than 0.5 ml / s or serum creatinine less than 265 mmol / L (3 mg/dl) may be prescribed the usual dose of Enap-NL 20.

Overdose

If the patient takes too many pills at a time, you should immediately call a doctor.

Symptoms: increased diuresis, marked decrease in blood pressure with bradycardia or other cardiac arrhythmias, convulsions, Paresis, paralytic ileus, impaired consciousness (including Coma), renal failure, impaired ESR, impaired blood electrolyte balance.

Treatment: the patient is placed in a horizontal position with a low headboard. In mild cases, gastric lavage and oral saline solution are indicated. In more serious cases, measures aimed at stabilizing blood pressure are indicated: intravenous use of saline solution, plasma substitutes.

It is necessary to monitor the patient’s blood pressure, heart rate, respiratory rate, serum urea, creatinine, electrolytes and diuresis. If necessary, intravenous use of angiotensin II, hemodialysis (enalaprilat elimination rate-62 ml / min).

Special instructions

Influence on the ability to drive motor vehicles and manage mechanisms:

Enap-NL does not affect driving or working with mechanisms, but some patients (mainly at the beginning of treatment) may experience hypotension and dizziness, contributing to a decrease in the ability to drive and work with mechanisms.

Therefore, at the beginning of treatment, it is recommended to avoid driving a car, working with mechanisms and performing other work that requires concentration of attention, until the response to treatment is established.

Form of production

Pills.

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

5 years

Active ingredient

Hydrochlorothiazide, Enalapril

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension, Heart Failure