Enaghexal compositum

Enaghexal compositum is a complex agent from the category of ACE inhibitors.

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Indications Enahexal compositum

It is used for therapy with different types of hypertension having different degrees of severity.

Release form

Release of the medication is realized in tablets, which are packed into 10 pieces in blister plates. The pack contains 3 such plates.

Pharmacodynamics

Combined antihypertensive drug, which contains enalapril, which is an ACE inhibitor, as well as hydrochlorothiazide, which is a thiazide type diuretic.

Enalapril suppresses the formation of angiotensin 2, and also eliminates its vasoconstrictor effect. In addition, it weakens the overall resistance of peripheral vessels, reduces the severity of postload, blood pressure, as well as pressure in the right atrium and a small circle of blood flow. Together with this, enalapril reduces the vascular resistance of the kidneys, as a result of which the kidney circulation improves.

Hydrochlorothiazide has natriuretic and diuretic effects, and besides it enhances the antihypertensive properties of enalapril.

Reduction of blood pressure values is noted after about 1 hour after drug use, and this effect lasts about 24 hours (on average).

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Pharmacokinetics

Enalapril.

After consuming the tablet, about 50-70% of the substance enalapril maleate is absorbed.

Serum Cmax values are recorded after 1 hour. After absorption, the substance is hydrolyzed, transforming into enalaprilate, which is an even stronger ACE inhibitor than enalapril. Peak values of enalaprilat within the blood plasma are noted after 3-4 hours after the drug was consumed.

Approximately 50-60% of enalaprilat is subjected to protein synthesis within the plasma.

About 94% of the enalapril maleate portion is excreted in urine and feces in the form of enalapril with enalaprilate. The main element of urine is the substance enalaprilat, which is approximately 94% of the dosage. The half-life of the drug is 35 hours.

Excretion decreases in people with impaired renal activity - in accordance with the degree of severity of failure. Dialysis of the enalaprilat component occurs with the development of a rate of 62 ml / hr.

Hydrochlorothiazide.

The degree of absorption of hydrochlorothiazide is 65-75%. In people with heart failure, which is stagnant, the absorption of the substance is reduced. Peak plasma parameters of hydrochlorothiazide are in the range of 70-490 ng / ml, and they require 1.5-4 hours for oral use of 12.5 mg, and 25 hours for oral administration of 25 mg of the substance.

The protein synthesis of the element within the plasma is approximately 40-68%.

The excretion of hydrochlorothiazide is practically complete -> 95% is excreted through the kidneys in the unmodified state. The half-life is within 6-15 hours.

Hydrochlorothiazide penetrates the placenta, but does not pass through the BBB. If the kidneys are deficient, the rate of excretion may decrease, and the half-life may be longer.

Dosing and administration

The medication is taken orally by selecting the dosing regimen separately for each patient, given its condition and the severity of the AH. Therapy begins with the use of small portions of medicine, gradually increasing them.

The appointment of a fixed combination of Enahexal Compositum is allowed only in cases where previous adjustments of the portion (titration) or individual combinations (enalapril or hydrochlorothiazide) failed. People with appropriate clinical indications should take into account the possibility of a direct transition from monotherapy to the use of a fixed combination of drugs.

Dosage regimens for the preparation 10/25.

The size of the initial daily portion in people who are prescribed complex treatment: taking the 1st tablet in the form of 10/25 mg, once a day.

The average dosage for the day is 1-2 such tablets, which are used once or twice a day.

With maintenance treatment, the medication is also used for once-daily administration.

For a day, a maximum of 40 mg enalapril and 0.1 g hydrochlorothiazide are allowed, which is 4 tablets of therapeutic substance. Use this portion should be for 1 or 2 reception.

Ways of using a dose of medicine 20 / 12,5.

First, to persons to whom co-therapy was prescribed, one should take 0.5 tablets of 20 / 12.5 mg dosage a day.

The size of the average serving per day is a one-time intake of the 1st tablet 20 / 12.5 mg.

With maintenance treatment, once a day you need to take 0.5 tablets with a dosage of 20 / 12.5 mg.

During the day, you can consume a maximum of 2 tablets 20 / 12.5 mg of Enahexal Compositum - either a single dose, or divide the dose into 2 applications.

Medication is consumed without reference to the reception of food, washing down the pill with plenty of plain water.

Use Enahexal compositum during pregnancy

Use Enaghexal compositum during pregnancy or lactation can not.

Contraindications

Among the contraindications:

• presence of strong sensitivity to enalapril or other ACE inhibitors;
• the presence of edema of Quincke in the anamnesis;
• violation of renal activity in severe degree (QC level below 30 ml / minute) or conduct of dialysis sessions;
• clinically significant deviations in electrolyte indices (development of hypercalcemia or hypokalemia and hyponatremia);
• arterial stenosis in the kidney region (2-sided or 1-sided (if the patient has only 1 kidney));
• patients who have recently had a kidney transplant;
• mitral or aortic stenosis, having hemodynamic significance;
• Obstructive type of cardiomyopathy of hypertrophic type;
• disorders of hepatic function in severe degree (coma or hepatic coma);
• diabetes mellitus or gout in a difficult stage.

Side effects Enahexal compositum

The use of medication can lead to the development of some side effects:

• systemic signs: dizziness, sensation of weakness, as well as pain in the abdomen or sternum;
• disorders related to the work of CAS: tachycardia, orthostatic collapse or palpitations;
• disorders of digestive activity: bloating, dry mouth mucosa, pancreatitis, constipation, cholestatic jaundice or vomiting;
• lesions affecting the NA: a feeling of drowsiness or nervousness, a state of arousal, insomnia and paresthesia;
• symptoms associated with the epidermis: erythema multiforme, pruritus, and in addition Stevens-Johnson syndrome and exfoliation-like dermatitis, including hair loss and TEN;
• problems with kidney function: failure of renal function or tubulointerstitial nephritis;
• signs of allergy: urticaria, Quincke edema, anaphylactoid manifestations, as well as RDS;
• disorders of the hematopoietic function: agranulocytosis, thrombocyto- or leukopenia, and in addition aplastic or hemolytic form of anemia;
• violations of the visual organs: xantopsy or transient visual turbidity;
• other symptoms: pain in the back, muscle weakness or cramps, dyspnoea, ear noise, arthralgia, profuse sweating and weakening of libido.

Long-term use of drugs can lead to the emergence of hyponatremia or -kalemia.

Overdose

In view of the severity of poisoning, such symptoms may appear: salt balance disorder, paresis, lowering of blood pressure, suppression of consciousness (up to the coma), arrhythmia, cardiovascular shock, and besides convulsions, bradycardia, ileus paralytic form, Quincke edema and insufficiency renal function.

When intoxication, it is necessary to carry out procedures that help to remove the drug from the body (gastric lavage and use of activated charcoal for half an hour from the moment of taking drugs), and in addition to monitor the work of life-critical systems in the hospital.

At a severe degree of poisoning at the hospital, procedures are performed that allow stabilizing the values of blood pressure: intravenous injection of NaCl solution with plasma substitutes; as well as hemodialysis and angiotensin 2 injections, if necessary.

With the development of Quinck edema or other anaphylactic signs, desensitizing treatment is prescribed, during which antihistamines (such as loratadine with suprastin) and SCS (including dexamethasone with prednisolone) are used, and measures are also taken to ensure the patency of the respiratory ducts.

Along with this, it is necessary to regularly monitor the values of acid-base, water and salt balances, and in addition glucose and compounds excreted in urine. When hypokalemia appears, you need to replenish the potassium reserves.

Interactions with other drugs

The combination with antihypertensive medications (among other such diuretic drugs and drugs that block the activity of β-receptors), vasodilators, nitrates, phenothiazines, as well as barbiturates, tricyclics and alcoholic beverages, causes potentiation of the hypotensive properties of the drug.

Anti-inflammatory and analgesic drugs (among them indomethacin and aspirin) can reduce the antihypertensive effect of Enahexal Compositum. In people with hypovolemia, this combination can lead to the appearance of a deficiency of renal function in an acute form.

The use of large portions of salicylates with the drug leads to the potentiation of their toxic properties against the CNS (this is affected by the activity of hydrochlorothiazide).

Diuretics, potassium, and potassium-sparing agents (for example, amiloride with spinolrolactone and triamterene), and in addition, other medicines that increase the potassium level (among them heparin) lead to a strong increase in potassium values under the influence of enalapril.

Combination of drugs with diuretics (such as furosemide), carbenoxolone, GCS, as well as salicylates, ACTH, amphotericin B and penicillin G, or the abuse of laxative medicines leads to an increase in the lack of magnesium or potassium by hydrochlorothiazide.

The combination with lithium causes an increase in serum lithium values (you need to constantly monitor this indicator), which can potentiate its neurotoxic and cardiotoxic effect.

The substances of the digitalis glycosides can increase the severity and side effects of digitalis in people with hypomagnesemia or -calemia.

Catecholamines (such as epinephrine) lower the therapeutic effect of hydrochlorothiazide.

Narcotic drugs, hypnotics and anesthetics significantly increase the blood pressure values (therefore, before anesthesia is administered, the anesthesiologist should be informed of the treatment with Enaghexal Compositum).

Immunosuppressants, procainamide, as well as allopurinol with systemic SCS and drugs suppressing bone marrow activity, reduce the number of leukocytes inside the blood and cause leukopenia.

The use of cytostatics (including cyclophosphamide and methotrexate with fluorouracil) leads to the potentiation of toxic effects on the bone marrow (in particular granulocytopenia) - arises from the action of hydrochlorothiazide.

Combination with ingested hypoglycemic drugs (among such biguanides or sulfonylureas), as well as insulin leads to a weakening of hypoglycemic effects.

Admission together with colestipol or cholestyramine reduces the degree of absorption of hydrochlorothiazide.

Kurarepodobnye muscle relaxants, as well as non-polarizing agents that block the neuromuscular transmission, increase the duration and potentiate a relaxing effect on the muscles under the action of hydrochlorothiazide (anesthesiologist must first inform about the use of the drug).

The combination with methyldopa sometimes causes hemolysis - in connection with the formation of antibodies against the substance hydrochlorothiazide.

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Storage conditions

Enaghexal Composite should be kept in a dark and dry place, inaccessible to infiltration of small children. The temperature does not exceed 25 ° C.

Shelf life

Enaghexal Compositum is allowed to be used within 36 months from the date of release of the drug.

Application for children

It is forbidden to prescribe a medication in pediatrics.

Analogues

The analogues of the drug are Berlipril plus, Enap H, Enaloside 25, Enafril with Enzyx, and also Enap HL, Enapril H, Enap 20 HL with Enzyx Duo and Ena Sandoz with Enzyx Duo Forte.