Enap-NL, tablets 12.5mg+10 mg 20 pcs

A combination drug, the action of which is due to the properties of its constituent components.

Enalapril is an ACE inhibitor and is a prodrug: its hydrolysis produces enalaprilate, 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.

In 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 BP and a decrease in cardiac output.

As a consequence of hyponatremia and decreased body fluid, the renin-angiotensin-aldosterone system is activated. Reactive increase of angiotensin II concentration partially limits BP reduction. With continued therapy, the hypotensive effect of hydrochlorothiazide is based on a decrease

Total peripheral vascular resistance .

The result of activation of renin-angiotensin-aldosterone system is metabolic effects on electrolyte balance of blood, uric acid, glucose and lipids, which partially neutralizes the effectiveness of antihypertensive treatment.

Indications

Active ingredient

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,

talk,

magnesium stearate.

How to take, the dosage

The treatment of arterial hypertension should not begin with a combination of medications. Initially, adequate doses of the individual components should be determined. The dose should always be chosen individually for each patient.

The drug should be taken regularly at the same time (preferably in the morning). The tablets should be swallowed whole with a small amount of fluid during or after a meal.

The usual dose is one to two tablets a day.

If another dose of the drug is missed, it should be taken as soon as possible if there is plenty of time left before the next dose. If several hours are left before the next dose, just wait and take the next dose. Do not double the dose.

If satisfactory therapy is not achieved, it is recommended that another medication be added or therapy changed.

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

The duration of treatment is not limited.

Use in impaired renal function:

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

Interaction

The concomitant use of Enap-NL with other antihypertensives, barbiturates, tricyclic antidepressants, phenothiazine and narcotic drugs, as well as with ethanol, increases the antihypertensive effect of Enap-NL.

Analgesics and NSAIDs, large amounts of salt in the diet, concomitant administration of colestyramine or colestipol reduce the effect of Enapa-NL.

If possible, concomitant use of Enap-NL and lithium preparations should be avoided because lithium intoxication may develop due to decreased lithium excretion. Serum lithium concentrations should be monitored; its dose should be adjusted accordingly.

The concomitant use of Enap-NL with NSAIDs, analgesics (due to inhibition of prostaglandin synthesis) may decrease enalapril efficacy and increase the risk of worsening of renal function and/or heart failure course. The antihypertensive effect of enalapril may also decrease in some patients with concomitant treatment, so patients should be closely monitored.

The concomitant use of Enapa NL with potassium-saving diuretics (including spironolactone, amiloride, triamterene) or potassium supplementation may lead to hyperkalemia.

The concomitant use of Enapa NL with allopurinol, cytostatics, immunosuppressants, or systemic GCS may cause leukopenia, anemia, or pancytopenia, so periodic hemogram monitoring is necessary.

An acute renal failure has been reported in 2 patients after renal transplantation who received enalapril and cyclosporine concomitantly. 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 is required when using enalapril and cyclosporine concomitantly.

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

Cautious use of Enapa NL concomitantly with cardiac glycosides is necessary. Possible hydrochlorothiazidine-induced hypovolemia, hypokalemia and hypomagnesemia may increase the toxicity of glycosides.

The concomitant use of Enap-NL with GCS increases the risk of hypokalemia.

In concomitant use of Enapa NL and theophylline, enalapril may decrease T 1/2 of theophylline.

Concomitant use of Enapa NL and cimetidine may increase T 1/2 of enalapril.

The risk of arterial hypotension is increased during general anesthesia or the use of nondepolarizing myorelaxants (e.g., tubocurarine).

Special Instructions

Impact on driving and operating machinery:

Enap-NL has no effect on driving or operating machinery, but some patients (predominantly at the start of treatment) may experience arterial hypotension and Dizziness, contributing to impaired ability to drive and operate machinery.

Therefore, at the start of treatment, it is recommended to avoid driving, operating machinery, and performing other work requiring concentration until a response to treatment has been established.

Contraindications

With caution:

Side effects

Cardiovascular disorders:

Heart palpitations, various heart rhythm abnormalities, marked BP decrease, Orthostatic hypotension, cardiac arrest, myocardial infarction, cerebrovascular stroke, angina pectoris, Raynaud’s syndrome, necrotizing angiitis.

Digestive system disorders:

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

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.

The CNS and peripheral nervous system:

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

The urinary system:

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

Reproductive system disorders:

Gynecomastia, decreased potency.

Sensory system disorders:

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

The hematopoietic system:

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

Metabolism disorders:

Hypokalemia, hyperkalemia, hypomagnesemia, hypercalcemia, hyponatremic alkalosis, hyperglycemia, glucosuria, hyperuricemia, hypercholesterolemia, hypertriglyceridemia, increased liver enzyme activity, hyperbilirubinemia.

Dermatological reactions:

Sweating, rash, shingles, alopecia.

Allergic reactions:

Hives, 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 (increased body temperature, Myalgia and arthralgia, serositis, vasculitis, skin rash, increased CRP , leukocytosis, eosinophilia, positive antinuclear antibody test).

Overdose

If a patient takes too many pills at one time, call a doctor immediately.

Symptoms: increased diuresis, marked BP decrease with bradycardia or other heart rhythm disturbances, seizures, Paresis, paralytic ileus, impaired consciousness (including Coma), renal failure, impaired acid and blood electrolyte balance.

Treatment: patient should be placed in horizontal position with low head rest. In mild cases gastric lavage and oral administration of saline solution are indicated. In more serious cases measures aimed at blood pressure stabilization are indicated: intravenous infusion of physiological solution and plasma substitutes. BP, HR, respiratory rate, serum concentrations of urea, creatinine, electrolytes and urine output should be monitored. If necessary, IV administration of angiotensin II, hemodialysis (elimination rate of enalaprilat is 62 ml/min).

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