Co-renitec, 20 mg+12, 5 mg tablets 28 pcs

• Co-renitec – hypotensive, diuretic.

• Inhibits ACE, reduces reabsorption of ions and water in the convoluted tubules.

• Reduces the content of sodium ions in the vascular wall, reduces arterial vascular tone, BP, and PPS, increases diuresis. The hypotensive effect lasts for 24 hours.

Indications

Arterial hypertension; chronic heart failure.

Active ingredient

Composition

The active ingredients:

Enalapril maleate 20 mg;

Hydrochlorothiazide 12.5 mg

BAuxiliary substances:

Sodium bicarbonate;

Lactose aqueous;

Corn starch;

Pregelatinized corn starch;

Iron oxide yellow dye;

Magnesium stearate.

How to take, the dosage

Ingestion.

Hypertension: The initial dose is 1 tablet once daily. If necessary, the dose may be increased to 2 tablets once a day.

Pre-treatment with diuretics: At the beginning of CO-renitec therapy symptomatic hypotension may occur, which is more often in patients with electrolyte-water balance disorders due to previous diuretic therapy. Taking diuretics should be discontinued 2-3 days before starting therapy with KO-RENITEK.

Hepatic impairment: Thiazides may not be sufficiently effective diuretics in patients with impaired renal function, and are ineffective when creatinine clearance decreases to 30 ml/min or less (i.e. in moderate or severe renal impairment). In patients with creatinine clearance of more than 30 but less than 80 ml/min, CO-renitec should be used only after prior selection of the doses of each component. In mild renal failure, the recommended starting dose of enalapril when administered in monotherapy is 5 to 10 mg.

Interaction

Other hypotensive agents: Prescribing enalapril in combination with other hypotensive agents may result in a summation of effects.

Serum potassium: Potassium loss with thiazide diuretics is generally reduced by enalapril. Serum potassium concentrations usually remain within normal limits. Use of potassium supplements, potassium-saving agents, or potassium-containing salts, especially in patients with renal insufficiency, may lead to a significant increase in serum potassium.

Lithium drugs: Diuretics and ACE inhibitors decrease renal excretion of lithium and increase the risk of lithium intoxication. Before using lithium preparations, you should read the instructions for use for this medication.

Non-steroidal anti-inflammatory drugs (NSAIDs): Non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors, may decrease the effect of diuretics and other antihypertensive medications. Therefore, the hypotensive effect of ACE inhibitors may be reduced when concomitant administration of NSAIDs, including COX-2 inhibitors. In some patients with impaired renal function taking NSAIDs, including selective cyclooxygenase-2 inhibitors, concomitant administration of ACE inhibitors may lead to further deterioration of renal function. These changes are generally reversible.

Nondepolarizing myorelaxants: Thiazide diuretics may increase the effect of tubocurarine.

Other drugs: Hypotensive effects are reduced by estrogens, ethanol . Immunosuppressants, allopurinol, cytostatics increase the risk of hematotoxicity.

Special Instructions

Arterial hypotension and electrolyte balance disorders: As with any hypotensive therapy, some patients may develop symptomatic hypotension. Patients should be examined for clinical signs of electrolyte-water imbalance, i.e., hypovolemia, hyponatremic alkalosis, hypomagnesemia, or hypokalemia, which may result from diarrhea or vomiting. Periodic determination of serum electrolytes should be performed at regular intervals in such patients. Patients with coronary heart disease or cerebrovascular diseases should be treated with special caution since an excessive decrease of BP may lead to myocardial infarction or stroke. If arterial hypotension occurs, the patient should be laid down and, if necessary, 0.9% sodium chloride solution should be administered. Transient arterial hypotension, when the drug is prescribed, is not a contraindication for its further use. After normalization of blood pressure and replenishment of circulating blood volume, therapy may be resumed in lower doses, or each of the components of the drug may be used separately.

Aortic stenosis/hypertrophic cardiomyopathy: As with all drugs with a vasodilator effect, ACE inhibitors should be used with caution in patients with left ventricular outflow tract obstruction.

Relary impairment: Thiazide diuretics may not be sufficiently effective in patients with impaired renal function and are ineffective when creatinine clearance is 30 mL/min or less (i.e. in moderate to severe renal impairment). The drug should not be administered to patients with renal insufficiency (creatinine clearance less than 80 ml/min) until the selection of individual components of the drug shows that the required doses are present in this dosage form. In some patients without any signs of renal disease before treatment, treatment with enalapril in combination with a diuretic has usually resulted in a slight and transient increase in blood urea and serum creatinine levels. In such cases, treatment with the drug should be discontinued. Thereafter, therapy may be resumed in lower doses, or each of the drug components may be administered separately. In some patients with bilateral renal artery stenosis or stenosis of the artery of the only kidney, an increase in blood urea and serum creatinine was observed during treatment with ACE inhibitors. These changes were reversible, as a rule, the indicators returned to normal after discontinuation of treatment.

Hepatic diseases Thiazide diuretics should be used with caution in patients with impaired liver function or advanced liver disease, because even small changes in electrolyte-water balance can lead to hepatic coma.

Surgery/general anesthesia: During major surgery or general anesthesia with hypotensive agents, enalaprilat blocks angiotensin II formation caused by compensatory renin release. If a marked decrease in BP develops, explained by a similar mechanism, it can be corrected by increasing the volume of circulating blood.

Metabolic and endocrine effects: Thiazide diuretics may cause impaired glucose tolerance . Doses of hypoglycemic agents, including insulin, may need to be adjusted. Thiazide diuretics may decrease urinary calcium excretion and cause a slight and transient increase in serum calcium concentration. Severe hypercalcemia may be a sign of occult hyperparathyroidism. Thiazide diuretics should be discontinued before a parathyroid function study. Elevated cholesterol and triglyceride levels may also be associated with thiazide diuretic therapy, but no or only minor effects have been observed with the 12.5 mg dose of hydrochlorothiazide contained in the KO-RENITEK tablet. Therapy with thiazide diuretics may lead to hyperuricemia and/or gout in some patients. However, enalapril may increase uric acid content in the urine and thus weaken the hyperuricemic effect of hydrochlorothiazide.

Allergic reactions/Angioneurotic edema: Rare cases of angioedema of the face, extremities, lips, tongue, vocal cleft and/or larynx have been described during treatment with ACE inhibitors, including enalapril. These phenomena may occur during any phase of therapy. In such cases, enalapril should be discontinued immediately and the patient should be closely monitored for control and correction of clinical symptoms. Even in cases where only tongue edema without respiratory edema is observed, patients may require long-term monitoring, since therapy with antihistamines and corticosteroids may not be sufficient. Rarely, death has been reported following angioedema associated with laryngeal or tongue edema. Edema of the tongue, vocal cleft or larynx may result in airway obstruction, particularly in patients who have undergone surgical procedures on the respiratory tract. In cases where swelling is localized in the region of the tongue, glottis or pharynx, which may lead to airway obstruction, 0.3-0.5 ml 0.1% epinephrine (adrenaline) solution should be injected subcutaneously immediately and the airway quickly cleared. Angioneurotic edema has been observed more frequently in black patients taking ACE inhibitors than in other patients. Patients with a history of angioedema not associated with ACE inhibitors may be at greater risk of angioedema with ACE inhibitor therapy (see also CONTRAINDICATIONS). In patients receiving thiazides, allergic reactions may occur regardless of a history of allergic conditions and bronchial asthma. Relapses or worsening of the severity of systemic lupus erythematosus have been reported in patients receiving thiazides.

Anaphylactoid reactions during hyposensitization with Hymenoptera venom allergen: In rare cases, patients receiving ACE inhibitors have developed life-threatening anaphylactoid reactions during hyposensitization with Hymenoptera venom allergen. Such reactions can be avoided by temporarily discontinuing the ACE inhibitor prior to hyposensitization.

Patients on hemodialysis: Administration of KO-RENITEK is not indicated in patients with renal failure who are on hemodialysis. Anaphylactoid reactions have been observed in patients on dialysis using high-flow membranes (such as AN 69s) simultaneously treated with ACE inhibitors. In these patients, a different type of dialysis membrane or other classes of hypotensive agents should be used.

Cough: There have been cases of cough on therapy with ACE inhibitors. As a rule, cough is dry, persistent and disappears after termination of therapy. Cough associated with ACE inhibitor use should be considered as part of the differential diagnosis of cough.

Use in elderly patients: In clinical trials, the efficacy and tolerability of enalapril and hydrochlorothiazide, when prescribed together, were similar in older and younger patients with arterial hypertension .

Pediatric use: The safety and efficacy of the drug in children have not been established. Therefore, the use of KO-RENITEK in pediatrics is not recommended.

Contraindications

Hypersensitivity (including to other ACE inhibitors and sulfonamide derivatives), anuria, childhood.

Side effects

In clinical trials, side effects were usually mild, transient, and in most cases did not require treatment interruption.

Cardiovascular side effects: 1-2% – orthostatic effects, including arterial hypotension; rarely – fainting, arterial hypotension regardless of body position, palpitations, tachycardia, chest pain.

CNS and peripheral nervous system disorders:often, dizziness, increased fatigue (usually resolved with dose reduction and rarely required drug withdrawal); 1-2%, asthenia, headaches; rarely, insomnia, somnolence, systemic dizziness, paresthesias, increased excitability.

In the respiratory system: 1-2% – cough; rarely – shortness of breath.

The digestive system: 1-2% – nausea; rarely – pancreatitis, diarrhea, vomiting, dyspepsia, abdominal pain, flatulence, constipation, dry mouth.

Muscular system disorders: 1-2% – muscle cramps; rarely – arthralgia.

Allergic reactions: rarely – angioedema of the face, extremities, lips, tongue, vocal cleft and/or larynx. There have been rare reports of the development of angioedema of the bowel in connection with the administration of ACE inhibitors, including enalapril.

Dermatological reactions: rarely – Stevens-Johnson syndrome, hyperhidrosis, skin rash, itching.

Since the urinary system: rarely – renal dysfunction, renal failure.

From the sexual system: 1-2% – impotence; rarely – decreased libido.

On the side of laboratory parameters: Possible hyperglycemia, hyperuricemia, hypo- or hyperkalemia, increased blood concentrations of urea, serum creatinine, increased liver enzyme activity and/or increased serum bilirubin (these parameters usually normalized after discontinuation of Co-renitec therapy); in some cases – decrease in hemoglobin and hematocrit.

Others: frequently – tinnitus, gout. A symptom complex has been described, with possible manifestations including fever, serositis, vasculitis, myalgia, myositis, arthralgia/arthritis, positive antinuclear antibody test, accelerated COE, eosinophilia and leukocytosis; photosensitization may develop.

Overdose

Symptoms:

Similarities