CO-PERINEVA PILLS 0.625 MG + 2 MG

Packaging

30 pieces

Mechanism of action

Co-Perineva is a combination antihypertensive drug containing an ACE inhibitor - Perindopril and thiazide-like diuretic - Indapamide. The drug has antihypertensive, diuretic and vasodilating action. Co-Perineva has a pronounced dose-dependent antihypertensive effect, independent of the age and body position of the patient and not accompanied by reflex tachycardia. It does not affect lipid metabolism (total cholesterol, LDL, VLDL, HDL, triglycerides and carbohydrates), incl. in patients with diabetes. Reduces the risk of hypokalemia caused by diuretic monotherapy. The antihypertensive effect persists for 24 hours. A steady decrease in blood pressure is achieved within 1 month against the background of the use of the drug Co-Perineva without an increase in heart rate. Termination of treatment does not lead to the development of withdrawal syndrome.

Indications and usage

Arterial hypertension.

Contraindications

• history of angioedema (hereditary, idiopathic or angioedema due to the use of ACE inhibitors);
• severe renal failure (CC less than 30 ml / min);
• azotemia;
• anuria;
• bilateral renal artery stenosis, single kidney artery stenosis;
• chronic heart failure in the stage of decompensation;
• refractory hyperkalemia;
• hereditary galactosemia, lactase deficiency, glucose-galactose malabsorption;
• age up to 18 years (efficacy and safety not established);
• severe liver failure (including with encephalopathy);
• pregnancy;
• lactation period;
• hypersensitivity to the components of Co-Perineva.

Pregnancy and Breastfeeding

Use of the drug Ko-Perinev during pregnancy is contraindicated. Taking the drug during pregnancy can cause placental ischemia with the risk of slowing the development of the fetus.The use of the drug Ko-Perinev during lactation is not recommended (indapamide is excreted in breast milk). If necessary, the use of the drug Ko-Perinev during lactation breastfeeding should be discontinued.

Dosage and administration

Assign inside 1 time / day, preferably in the morning before breakfast, drinking plenty of fluids. Doses are given for the ratio of perindopril / indapamide. The initial dose of the drug Ko-Perinev - 2 mg / 625 mg (1 tab.) 1 time / day. If after 1 month of taking the drug it is not possible to achieve adequate blood pressure control, then the dose of the drug should be increased to 4 mg / 1.25 mg (1 tab.) 1 time / day. For elderly patients, the initial dose of Ko-Perinev is 2 mg / 625 mg (1 tab.) 1 time / day. Patients with renal insufficiency (CC 60 ml / min or more) do not require dose adjustment. For patients with CC 30-60 ml / min, the maximum dose of Ko-Perinev is 2 mg / 625 mg (1 tab.) 1 time / day. When QA is less than 30 ml / min, the drug Ko-Perinev is contraindicated. Patients with moderate hepatic impairment do not require dose adjustment.

Adverse reactions

Classification of the incidence of side effects: very often -> 1/10; often from> 1/100 to 1/1000 to 1 / 10,000 to

From the hematopoietic system and lymphatic system: very rarely - hemorrhagic vasculitis, hemolytic anemia; with prolonged use in high doses - thrombocytopenia, leukopenia / neutropenia, agranulocytosis, aplastic anemia, which was recorded while taking ACE inhibitors (patients on hemodialysis or peritoneal dialysis).

From the central and peripheral nervous system: often - paresthesias, headache, dizziness, vertigo, asthenia; infrequently - mood lability, sleep disturbances, increased sweating; very rarely - confusion.

Special senses: often - visual disturbances, tinnitus.

Cardiovascular: often - pronounced decrease in blood pressure, orthostatic hypotension; very rarely - arrhythmias, incl. and bradycardia, ventricular tachycardia, atrial flutter, angina pectoris, myocardial infarction or stroke, possibly secondary, due to severe arterial hypotension in high-risk patients.

Respiratory: often - dry, irritating, persistent nature of cough, passing after drug withdrawal, shortness of breath; infrequently - bronchospasm; very rarely - eosinophilic pneumonia, rhinitis.

Gastrointestinal: often - constipation, dryness of the oral mucosa, loss of appetite, nausea, epigastric pain, abdominal pain, change in taste, vomiting, dyspepsia, diarrhea; very rarely - pancreatitis, jaundice (cytolytic or cholestatic); frequency not established: in the case of liver failure, there is a likelihood of developing hepatic encephalopathy; intestinal edema.

From the skin and subcutaneous fat: often - pruritus, maculopapular rash; infrequently - angioedema of the face, oral mucosa, tongue, uvula and / or larynx, urticaria; reactions of individual hypersensitivity, mainly dermatological, in patients with burdened allergological anamnesis; purpura; possible exacerbation of the course of SLE; very rarely - erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome; isolated cases of photosensitivity reaction.

Musculoskeletal system: often - muscle cramps.

Urogenital: infrequently - renal failure; very rarely, acute renal failure.

On the part of the reproductive system and the mammary glands: infrequently - impotence.

Laboratory values: hypokalemia; hyponatremia with hypovolemia leading to reduced BCC and orthostatic hypotension; increasing the concentration of uric acid and glucose in the serum; a slight increase in plasma creatinine and urea concentrations, reversible after cessation of therapy, which often develops on the background of renal artery stenosis or arterial stenosis of a single kidney, on the background of arterial hypertension therapy with diuretics, in renal failure; a transient increase in sodium in the blood plasma; hypochloraemia; proteinuria; rarely - hypercalcemia.

Drug Interactions

Simultaneous use is not recommended.

Lithium preparations. With the simultaneous use of lithium preparations and ACE inhibitors, there have been cases of a reversible increase in the concentration of lithium in the blood serum. Simultaneous administration of thiazide diuretics may contribute to an increase in the concentration of lithium and the risk of its toxic action in the presence of an ACE inhibitor.

Potassium-sparing diuretics (such as spironolactone, eplerenone, triamterene, amiloride),preparations of potassium or potassium containing substitutes for edible salt, as well as other drugs that increase the content of potassium in the blood plasma (for example, heparin).

Simultaneous use requiring special care

Baclofen - potentiation of the hypotensive effect. Control of blood pressure, kidney function and, if necessary, dose adjustment of antihypertensive drugs.

NSAIDs. The combination of ACE inhibitors with NSAIDs (non-selective COX inhibitors from the group of NSAIDs, for example, acetic salicylic acid in doses that have anti-inflammatory effect; COX-2 inhibitors) - reduces the hypotensive effect of ACE inhibitors; increases the risk of impaired renal function, up to the development of acute renal failure; increases the content of potassium in the blood serum in patients with already existing renal dysfunction.

This combination is recommended to be used with caution, especially in elderly patients. Patients should receive a sufficient amount of fluid, as well as monitor kidney function before and after the start of treatment with Ko-Perinev.

Simultaneous use requiring caution

Tricyclic antidepressants, antipsychotics (neuroleptics). Enhance the hypotensive effect and increase the risk of orthostatic hypotension (additive effect).

GKS, tetracosactide. Reduction of the hypotensive effect (fluid retention).

Other antihypertensive drugs: may increase the hypotensive effect of the drug Ko-Perinev®.

Perindopril

Simultaneous use is not recommended.

Potassium-sparing diuretics (spironolactone, triamteren, amiloride, eplerenone) andpotassium preparations: when combined with their use of ACE inhibitors, it is possible to increase the content of potassium in the blood serum up to a lethal outcome. If the combined use of an ACE inhibitor and the above drugs (in the case of confirmed hypokalemia) is necessary, care should be taken to regularly monitor the potassium content in the blood plasma and ECG parameters.

Simultaneous use requiring special care

Oral hypoglycemic agents (sulfonylurea derivatives) andinsulin: the use of ACE inhibitors may enhance the hypoglycemic effect of hypoglycemic agents for oral administration and insulin in patients with diabetes mellitus; when used together, it is possible to increase glucose tolerance, which may require correction of doses of hypoglycemic agents for oral administration and insulin.

Simultaneous use requiring caution

Allopurinol, cytostatic immunosuppressants, GKS (with systemic use) and procainamide: The simultaneous use of these drugs with ACE inhibitors may increase the risk of leukopenia.

General anesthesia products: ACE inhibitors can enhance the hypotensive effect of certain agents for general anesthesia.

Diuretics (thiazide and loop): the use of diuretics in high doses can lead to hypovolemia (due to a decrease in BCC), and the addition to perindopril to therapy can lead to a pronounced decrease in blood pressure.

Gold preparations: when prescribing ACE inhibitors, incl. perindopril, patients receiving gold medication (sodium aurothiomalate) IV were found to have nitrate-like reactions (nausea, vomiting, marked reduction in blood pressure, flushing of the skin of the face).

Indapamide

Simultaneous use requiring special care

Drugs that cause arrhythmia type "pirouette": Because of the risk of hypokalemia, indapamide should be used with caution in conjunction with drugs that cause arrhythmia of the "pirouette" type, such as: antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide, Amiodarone, dofetilide, ibutilide, bretilium, sotalol); some neuroleptics: chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazin; benzamides vincamine at / in the application, methadone, astemizol, terfenadine. It is necessary to control the concentration of potassium in order to avoid hypokalemia, during the development of which it is necessary to correct it, to monitor the QT interval on the ECG.

Drugs that can cause hypokalemia: Amphotericin B with IV injection, gluco- and mineralocorticoid (for systemic use), laxatives that stimulate intestinal motility (laxatives that do not stimulate intestinal motility should be used), tetracosactids increase the risk of hypokalemia (additive effect). It is necessary to control the concentration of potassium in the blood plasma, if necessary, its correction. Special attention should be paid to patients who are simultaneously receiving cardiac glycosides.

Cardiac glycosides: hypokalemia enhances the toxic effect of cardiac glycosides. With simultaneous use of indapamide and cardiac glycosides should be monitored for the content of potassium in the blood plasma, ECG indicators and, if necessary, adjust the dose of cardiac glycosides.

Simultaneous use requiring caution

Metformin: while taking diuretics can develop renal failure. With simultaneous use with Metformin increases the risk of lactic acidosis. Metformin should not be used if the concentration of creatinine in the blood plasma exceeds 15 mg / l (135 μmol / l) in men and 12 mg / l (110 μmol / l) in women.

Iodine-containing contrast agents: reduced bcc with diuretic intake, increased risk of acute renal failure, especially with high doses of iodine-containing contrast media. Before using iodine-containing contrast agents, it is necessary to compensate for the BCC.

Calcium preparations: with simultaneous use may develop hypercalcemia due to a decrease in Calcium excretion by the kidneys.

Cyclosporine: increases the risk of developing impaired renal function (hypercreatininemia).

Symptoms: pronounced decrease in blood pressure, nausea, vomiting, muscle cramps, dizziness, drowsiness, confusion, oliguria up to anuria (due to a decrease in the BCC); possible violations of water and electrolyte balance (low sodium and potassium in the blood plasma).
Treatment: gastric lavage and / or the appointment of Activated carbon, the restoration of water and electrolyte balance in the hospital. With a pronounced decrease in blood pressure, it is necessary to transfer the patient to a supine position with their legs elevated; then it is necessary to carry out measures aimed at increasing the bcc (introduction of a 0.9% solution of sodium chloride in / in). Perindoprilat, the active metabolite of perindopril, can be eliminated from the body through dialysis.

At a temperature not higher than 30 ° C.