Description
Description
Enalapril Round, biconvex white tablets with a risk on one side. Indapamide Round, biconvex film-coated tablets in white.
Packing
30 pcs.
Contraindications
Enixix contains lactose monohydrate. The drug should not be used in patients with lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
enalapril
Hypersensitivity to enalapril and other ACE inhibitors, a history of angioedema associated with treatment with ACE inhibitors, hereditary or idiopathic angioedema, simultaneous use with aliskiren and / or aliskiren-containing drugs in patients with diabetes mellitus and / or moderate or severe impaired renal function (glomerular filtration rate (GFR) less than 60 ml / min / 1.73 m2), pregnancy, breast-feeding, age up to 18 years (efficacy and safety not established).
Use with caution in case of primary hyperaldosteronism, bilateral renal artery stenosis, conditions accompanied by a decrease in circulating blood volume (BCC) (including vomiting, diarrhea), single kidney artery stenosis, hyperkalemia, condition after kidney transplantation, aortic stenosis, mitral (with impaired hemodynamic parameters), hypertrophic obstructive cardiomyopathy, renovascular hypertension, systemic diseases of the connective tissue (systemic lupus erythematosus, scleroderma, etc.), coronary heart disease, cerebrovascular disease, diabetes mellitus, renal failure (proteinuria more than 1 g / day), liver failure, a history of allergic or angioedema in patients, in patients that adhere to a diet with a restriction of sodium chloride or are on hemodialysis while taking it with immunosuppressants, saluretics, potassium-sparing diuretics, drugs to Leah, potassium-containing salt substitutes and lithium drugs during apheresis procedures low density lipoprotein (LDL apheresis) using dextran sulfate, during desensitization by venom of hymenopteran insects in patients of the Negroid race in patients after major surgical interventions or during general anesthesia in patients undergoing dialysis using high-flow membranes (such as AN 69 ®) in elderly patients (over 65 years old).
Indapamide
Hypersensitivity to the drug, other sulfonamide derivatives or other components of the drug, anuria, refractory hypokalemia, severe liver failure (including encephalopathy) and / or severe renal failure (creatinine clearance less than 30 ml / min), pregnancy , the period of breastfeeding, age up to 18 years (effectiveness and safety have not been established).
With caution is prescribed for diabetes mellitus in the stage of decompensation, hyperuricemia (especially accompanied by gout and urate nephrolithiasis), impaired liver and kidney function, impaired water-electrolyte balance, hyperparathyroidism in debilitated patients or in patients receiving combination therapy with other antiarrhythmic drugs, while taking drugs that extend the QT interval.
Use during pregnancy and lactation
The drug is contraindicated in pregnancy and lactation. If necessary, use the drug Enzix during lactation, breastfeeding should be discontinued.
It is recommended to carefully monitor newborns and infants who have been exposed to intrauterine exposure to ACE inhibitors to timely detect a pronounced decrease in blood pressure, oliguria, hyperkalemia and neurological disorders, the development of which is possible due to a decrease in renal and cerebral blood flow with a decrease in blood pressure caused by ACE inhibitors. In oliguria, it is necessary to maintain blood pressure and renal perfusion by introducing appropriate fluids and vasoconstrictors.
Special instructions
Enalapril
Patients need medical supervision within 2 hours after taking the initial dose of the drug and an additional 1 hour before stabilization of blood pressure.
In patients with a decrease in BCC (as a result of diuretic therapy, while restricting salt intake, hemodialysis, diarrhea, vomiting) with enalapril (like other ACE inhibitors), even at the initial dose, the risk of a sudden and pronounced decrease in blood pressure is increased.
Transient arterial hypertension is not a contraindication to continue treatment with the drug after stabilization of blood pressure. In the case of a repeated marked decrease in blood pressure, the dose should be reduced or the drug should be discontinued.
The use of high-strength dialysis membranes increases the risk of anaphylactic reactions. On dialysis free days the dosage regimen should be adjusted depending on the level of blood pressure.
The condition of patients with severe heart failure, coronary heart disease and with vascular diseases of the brain should be carefully monitored. In such patients, a sharp decrease in blood pressure can lead to myocardial infarction, stroke, or impaired renal function.
Sudden withdrawal of the drug does not lead to a sharp increase in blood pressure.
Enalapril should be discontinued before examining parathyroid function.
In case of side effects or Quincke’s edema, the drug should be discontinued and appropriate treatment prescribed.
Before surgery (including dentistry), the patient should warn the surgeon / anesthetist about the use of ACE inhibitors.
Before and during treatment with ACE inhibitors, periodic monitoring of blood pressure and blood counts (hemoglobin, potassium, creatinine, urea, hepatic transaminase activity), protein in the urine.
Indapamide
When prescribing indapamide, patients taking cardiac glycosides, laxatives, against the background of hyperaldosteronism, as well as elderly patients, are regularly monitored for potassium and creatinine.
While taking indapamide, the concentration of potassium, sodium, magnesium in the blood plasma, pH, the concentration of glucose, uric acid and residual nitrogen should be systematically monitored. The most careful control is indicated for cirrhosis (especially with edema or ascites – the risk of developing metabolic alkalosis, which increases the manifestations of hepatic encephalopathy), coronary heart disease, heart failure, as well as in elderly patients. An increased risk group also includes patients with an increased QT interval on the ECG (congenital or developing against the background of any pathological process). The first determination of the concentration of potassium in the blood should be carried out during the first week of treatment.
Hypercalcemia with indapamide may be due to previously undiagnosed hyperparathyroidism.
In patients with diabetes, it is extremely important to control the level of glucose in the blood, especially in the presence of hypokalemia.
Significant dehydration can lead to the development of acute renal failure (decreased glomerular filtration). Patients need to compensate for water loss and carefully monitor renal function at the beginning of treatment.
Indapamide can give a positive result when conducting a doping control.
Patients with arterial hypertension and hyponatremia (due to taking diuretics) need to stop taking diuretics 3 days before taking ACE inhibitors (if necessary, diuretics can be resumed somewhat later), or in such cases, initial low doses of ACE inhibitors are prescribed.
When prescribing indapamide, it should be borne in mind that sulfonamide derivatives can exacerbate SLE.
Pediatric use
The efficacy and safety of enalapril and indapamide in children and adolescents under the age of 18 have not been established.
Influence on the ability to drive vehicles and operate mechanisms
At the beginning of treatment, until the end of the dose selection period, the patient should refrain from driving vehicles and engaging in potentially dangerous activities, requiring increased concentration of attention and speed of psychomotor reactions, because dizziness is possible, especially after taking the initial dose of the drug.
The use of the drug Enzix, which includes Enalapril and Indapamide, is contraindicated in pregnancy and lactation. If necessary, use the drug Enzix (tablets set: Enalapril and Indapamide), breastfeeding should be discontinued.
Composition of
1 tablet of enalapril contains: active ingredient – enalapril maleate – 10,000 mg
excipients: lactose monohydrate – 125,000 mg, magnesium carbonate – 84,600 mg, gelatin – 9,200 mg, 9,200 mg per gallon.
1 tablet of indapamide contains: active ingredient – indapamide 2.5000 mg excipients: lactose monohydrate – 76.9600 mg, povidone-K30 – 2.8200 mg, crospovidone – 0.8800 mg, magnesium stearate – 0.8800 mg, sodium lauryl sulfate – 0.4400 mg, talc – 3.5200 mg
shell composition: hypromellose – 1.7222 mg, macrogol 6000 – 0.3445 mg, talc – 1.9030 mg, titanium dioxide E 171 – 0.4303 mg.
Dosage and administration
ENZIX: 1 tablet Enalapril (10 mg) and 1 tablet film-coated Indapamide (2.5 mg) are taken orally, in the morning at the same time. Depending on the dynamics of blood pressure indicators, the dose of enalapril can be increased to twice a day.
The maximum daily dose of enalapril is 40 mg, indapamide – 2.5 mg.
In chronic renal failure, accumulation of enalapril occurs with a decrease in filtration of less than 10 ml / min. With creatinine clearance of 80-30 ml / min. the dose of enalapril should be 5-10 mg / day.
Side effects of
Enalapril
From the central nervous system and peripheral nervous system: headache, dizziness, weakness, insomnia, anxiety, confusion, fatigue, drowsiness (2-3%) in some cases when used in high doses – nervousness, depression paresthesia.
From the respiratory system: unproductive dry cough, interstitial pneumonitis, bronchospasm / bronchial asthma, shortness of breath, rhinorrhea, pharyngitis.
From the sensory organs: disturbances of the vestibular apparatus, impaired hearing and vision, tinnitus.
From the digestive system: dry mouth, anorexia, dyspeptic symptoms (nausea, diarrhea or constipation, vomiting, abdominal pain), intestinal obstruction, pancreatitis, impaired liver and bile secretion, hepatitis (hepatocellular or cholestatic), jaundice, increased activity hepatic transaminases, hyperbilirubinemia.
From the cardiovascular system: excessive decrease in blood pressure, orthostatic collapse rarely – chest pain, angina pectoris, myocardial infarction (usually associated with a pronounced decrease in blood pressure), arrhythmias (atrial brady or tachycardia, atrial fibrillation), palpitations, pulmonary embolism , pain in the heart, fainting.
From the side of metabolism: hyperkalemia, hyponatremia, hypoglycemia (in patients with diabetes mellitus).
From the hemopoietic system: rarely – a decrease in hematocrit and hemoglobin concentration, thrombocytopenia, neutropenia, agranulocytosis (in patients with autoimmune diseases), eosinophilia, increased ESR.
From the urinary system: impaired renal function, proteinuria, hypercreatininemia, increased urea.
From the reproductive system: decreased libido, hot flashes, decreased potency.
Dermatological reactions: alopecia, photosensitivity.
Allergic reactions: skin rash, angioedema of the face, limbs, lips, tongue, glottis and / or larynx, dysphonia, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, pemphigus, pruritus, urticaria, serositis myositis, arthralgia, arthritis, stomatitis, glossitis is very rare – intestinal angioedema.
Indapamide
From the central nervous system and peripheral nervous system: asthenia, nervousness, headache, dizziness, drowsiness, vertigo, insomnia, depression, paresthesia rarely – fatigue, general weakness, malaise, muscle spasm, tension, irritability, anxiety.
From the digestive system: nausea, anorexia, dry mouth, gastralgia, vomiting, diarrhea or constipation, a feeling of discomfort in the abdomen, pancreatitis are possible.
On the part of the sensory organs: conjunctivitis, visual impairment.
From the respiratory system: cough, pharyngitis, sinusitis, rhinorrhea rarely – rhinitis.
From the cardiovascular system: orthostatic hypotension, characteristic for hypokalemia changes on the ECG, arrhythmias, palpitations.
From the urinary system: increased incidence of infections, nocturia, polyuria, increased urea nitrogen in blood plasma, hypercreatininemia.
From the side of metabolism: hypokalemia, hyponatremia, hypochloremic alkalosis, hypercalcemia, glucosuria, sweating, weight loss.
From the reproductive system: decreased potency, decreased libido.
Allergic reactions: skin rash, urticaria, pruritus, hemorrhagic vasculitis.
Other: flu-like syndrome, chest pain, back pain, infection, exacerbation of SLE.
Drug Interactions
Enalapril
The simultaneous use of enalapril and indapamide increases the antihypertensive effect of enalapril.
With the simultaneous use of enalapril with NSAIDs, including selective COX-2 inhibitors, antipyretic analgesics may decrease the hypotensive effect of enalapril.
In some cases, in patients with impaired renal function, receiving NSAIDs, including selective COX-2 inhibitors, the use of ACE inhibitors can lead to further deterioration of renal function. These changes are reversible.
The antihypertensive effect of enalapril is enhanced by diuretics, beta-blockers, methyldopa, nitrates, dihydropyridine slow calcium channel blockers, hydralazine, prazosin.
The use of enalapril together with potassium-sparing diuretics (spironolactone, triamteren, amiloride), as well as potassium-containing drugs increases the risk of hyperkalemia.
Enalapril attenuates the effects of theophylline-containing drugs.
Immunosuppressants, allopurinol, cytostatics enhance the hematotoxicity of enalapril. Bone marrow suppression drugs increase the risk of neutropenia and / or agranulocytosis.
Enalapril helps to slow down the excretion of lithium (with the simultaneous use of enalapril with lithium salts, a control of the concentration of lithium in the blood plasma is indicated).
The combined use of ACE inhibitors and hypoglycemic agents (insulin, oral hypoglycemic drugs) can enhance the hypoglycemic effect of the latter with a risk of hypoglycemia. This is most common during the first 3 weeks of co-administration, as well as in patients with renal failure. In patients with diabetes receiving hypoglycemic drugs for oral administration and insulin, it is necessary to control the level of glucose in the blood, especially during the first month of co-administration with ACE inhibitors.
The symptom complex, including facial redness, nausea, vomiting, and arterial hypotension, has been described in rare cases when gold preparations for parenteral administration (sodium aurothiomalate) and ACE inhibitors (enalapril) are used together.
Ethanol enhances the hypotensive effect of enalapril.
Indapamide
With the simultaneous use of indapamide with saluretics, cardiac glycosides, gluco- and mineralocorticoids, tetracosactide, amphotericin B (intravenously), laxatives, the risk of hypokalemia increases.
With the simultaneous use of indapamide with cardiac glycosides, the likelihood of developing glycoside intoxication with calcium preparations – hypercalcemia with metformin – increases, lactic acidosis may worsen.
Indapamide slows down the excretion of lithium and thereby increase its concentration in blood plasma.
Astemizole, erythromycin (intravenously), pentamidine, suloprid, terfenadine, vincamine, class IA antiarrhythmic drugs (quinidine, disopyramide) and class III (amiodarone, bretilium, sotalol) when taken against idapamide can lead to the development of pirouette-type arrhythmia.
NSAIDs, corticosteroids, tetracosactides, sympathomimetics reduce the hypotensive effect of indapamide baclofen – enhances.
The combination of indapamide with potassium-sparing diuretics may be effective in some categories of patients, however, the possibility of developing hypo- or hyperkalemia, especially in patients with diabetes mellitus and with renal failure, is not completely ruled out.
ACE inhibitors with simultaneous use with indapamide increase the risk of developing arterial hypotension and / or acute renal failure (especially with existing renal artery stenosis).
Indapamide increases the risk of developing impaired renal function while using high-dose iodine-containing contrast agents (dehydration). Before using iodine-containing contrast agents in patients taking indapamide, it is necessary to restore fluid loss.
Tricyclic antidepressants and antipsychotics increase the hypotensive effect of indapamide and increase the risk of orthostatic hypotension.
With the simultaneous use of indapamide with cyclosporine, the risk of developing hypercreatininemia increases.
Indapamide reduces the effect of indirect anticoagulants (coumarin or indandion derivatives) due to an increase in the concentration of coagulation factors as a result of a decrease in BCC and an increase in their production by the liver (dose adjustment may be required).
Indapamide enhances the action of non-depolarizing muscle relaxants.
Overdose
Enalapril
Symptoms: marked decrease in blood pressure up to the development of collapse, myocardial infarction, acute cerebral circulation or thromboembolic complications, convulsions, stupor.
Treatment: the patient is transferred to a horizontal position with a low head. In mild cases, gastric lavage and intake of saline laxatives are indicated. In more severe cases, activities aimed at stabilizing blood pressure: intravenous administration of saline, plasma substitutes, angiotensin II, hemodialysis.
Indapamide
Symptoms: nausea, vomiting, weakness, gastrointestinal dysfunction, water-electrolyte disorders in some cases – excessive decrease in blood pressure, dizziness, drowsiness, confusion, respiratory depression. Patients with cirrhosis may develop liver coma.
Treatment: gastric lavage and / or administration of activated charcoal, correction of water-electrolyte balance, symptomatic therapy. There is no specific antidote.
Storage conditions
Store in a dry place, at a temperature of 15 to 25 ° C.
Keep out of the reach and sight of children.
Shelf life
3 years. Do not use after the expiration date printed on the package.
Active ingredient
Indapamide, Enalapril
Terms and conditions
By prescription
dosage form
tablets
Hemofarm LLC, Serbia
