Properties
- Form
- tableti
- Dosage mg
- 10მგ+25
- Pack
- 20
What is it?
Composition ENAP-H 1 tablet contains 10 mg enalapril maleate and 25 mg hydrochlorothiazide. Excipients: lactose. Pharmacological properties ENAP-H is a combined preparation containing active substances: enalapril maleate and hydrochlorothiazide. The preparation has an antihypertensive effect. Indications for use The preparation is used in the treatment of all stages of arterial hypertension when the use of combined preparations is necessary. Contraindications The preparation cannot be prescribed in cases of hypersensitivity to the preparation, its components, sulfonamides, history of angioneurotic edema, severe renal impairment (creatinine clearance <0.5 ml/sec, plasma creatinine concentration >265 mmol/l (3 mg/100 ml), post-renal transplant status, primary hyperaldosteronism, porphyria, pregnancy and lactation, childhood. Pregnancy and lactation The preparation is contraindicated during pregnancy (especially in the second and third trimesters) and lactation. Precautions Caution is necessary in patients with impaired renal function (creatinine clearance 0.5-1.3 ml/sec). ENAP-H should be avoided in cases of bilateral renal artery stenosis with preserved function of one kidney. Therefore, in case of suspected renovascular hypertension or its latent form, treatment should be supervised by an experienced specialist. When taking allopurinol (or in combination with allopurinol), cytostatics, immunosuppressants, or systemic corticosteroids, regular blood count monitoring is necessary due to the risk of developing leukopenia, anemia, or pancytopenia. Caution is necessary in all cases where antidiabetic treatment is carried out. Enalapril can enhance their effect. Therefore, in diabetes mellitus, dose adjustment of the antidiabetic drug and frequent glucose monitoring are necessary. In severe heart failure and hyponatremia, severe renal failure, left ventricular hypertrophy or dysfunction, especially against the background of hypovolemia caused by diuretics, salt-free diet, diarrhea, vomiting, or hemodialysis, arterial hypotension may develop after taking one tablet of ENAP-H. In case of arterial hypotension, the patient should assume a horizontal position, elevate the legs, and if necessary, plasma volume correction with 0.9% sodium chloride solution is required. In case of angioneurotic edema in the neck and face area, as well as the tongue, pharynx, and larynx, it is usually sufficient to discontinue ENAP-H and prescribe antihistamines. In severe cases, adrenaline administration and ensuring airway patency (intubation or laryngotomy) are necessary. Particular caution is required in aortic stenosis or subaortic muscular stenosis and generalized atherosclerosis. The antihypertensive effect of ENAP-H may be enhanced during sympathectomy. Due to the increased risk of anaphylactic effect, ENAP-H is not recommended for patients undergoing hemodialysis with polyacrylonitrile membranes, immediately before desensitization to wasp or bee venom. Particular caution is also required when used concurrently with sulfonamides and sulfonylurea antidiabetic drugs. During treatment, periodic monitoring of electrolytes, urea, creatinine, and liver transaminases in the blood, and protein in the urine is necessary. Treatment with the preparation should be temporarily discontinued before examination of parathyroid gland function. Dosage and administration The dose of the preparation and the duration of treatment are determined by the doctor. The usual dose of the preparation is one to two tablets per day. Dose adjustment is necessary based on the patient's individual response. Treatment of arterial hypertension should never be initiated with a fixed combination. Before starting therapy with a fixed combination, the appropriate dose of each active component must be determined. For most patients, even 50 mg of hydrochlorothiazide per day is sufficient, so it is not recommended to prescribe more than 2 tablets of ENAP-H per day. If the desired therapeutic effect is not achieved, the daily dose should be increased. If the patient is already taking diuretics, it is recommended to reduce the dose 2-3 days prior or discontinue diuretics before starting treatment with ENAP-H to avoid sudden drops in blood pressure. Renal function should be monitored before starting treatment. The duration of treatment is not specified. Interaction with other drugs It is necessary to inform the doctor about all medications the patient is taking, regardless of whether they are prescribed by a doctor. Food intake does not affect the absorption of ENAP-H. Concomitant administration of other antihypertensive agents, tricyclic antidepressants, phenothiazines, and alcohol enhances the antihypertensive effect of ENAP-H. Analgesics and non-steroidal anti-inflammatory drugs, excessive salt intake, and concomitant administration of cholestyramine or colestipol reduce the effect of ENAP-H. Concomitant administration of lithium preparations and ENAP-H can lead to lithium intoxication, as they reduce lithium clearance. Concomitant use of potassium-sparing diuretics (spironolactone, amiloride, triamterene) or additional potassium intake can lead to hyperkalemia. The use of allopurinol, cytostatics, immunosuppressants, or systemic corticosteroids can cause leukopenia, anemia, or pancytopenia; cyclosporine intake can cause renal failure. Taking sulfonamides or sulfonylurea antidiabetic drugs can cause allergic reactions (cross-allergy is possible). Caution is necessary with concomitant use of glycoside preparations, as their toxic effect may be accompanied by hypovolemia, hypokalemia, and hypomagnesemia. Concomitant use of corticosteroids increases the risk of hypokalemia. The risk of developing arterial hypotension increases with concomitant administration of general anesthesia or non-depolarizing muscle relaxants (e.g., tubocurarine). Side effects The patient must report any undesirable (side) effects to the doctor, especially if the side effects are indicated in the instructions. Side effects are mild and transient and therefore do not require discontinuation of the preparation. The most common are dizziness, headache, fatigue, nausea, muscle cramps, rarely arterial hypotension, orthostatic hypotension, dry cough, vomiting, diarrhea, skin rash, angioneurotic edema, anemia, thrombocytopenia, leukopenia, agranulocytosis, increased serum urea, creatinine, or transaminases. Overdose The most common sign of overdose is arterial hypotension. In case of arterial hypotension caused by an overdose of the preparation, assuming a horizontal position with elevated legs is usually sufficient, but in more severe cases, infusion of 0.9% sodium chloride solution is necessary. Relatively frequent symptoms of overdose include: increased diuresis, pronounced arterial hypotension with bradycardia or other heart rhythm disturbances, seizures, paresis, paralytic ileus, impaired consciousness (including coma), renal failure, decreased electrolyte levels, acid-base imbalance. After oral administration of a large number of tablets, gastric lavage, intake of activated charcoal, and laxatives are recommended. Monitoring of blood pressure, pulse, respiratory function, urea concentration, creatinine, and electrolyte levels, as well as diuresis, is necessary. In case of arterial hypotension, administration of 0.9% sodium chloride solution is necessary. Hemodialysis may also be performed. Dosage form ENAP-H 20 tablets. Storage conditions Store in a dry place, at a temperature not exceeding 25°C, out of reach of children. Expiration date is indicated on the packaging. The preparation is not recommended for use after the expiration date indicated on the packaging. Dispensing conditions Available by prescription only. Manufacturer KRKA, d.d., Slovenia