indapamide, Perindopril | Co-Perineva tablets 1.25 + 4 mg, 90 pcs

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BID466304
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Latin name

Co-Perineva
Latin name

Co-Perineva

Release form

Tablets.

Packing

90 pcs.

Indications

Arterial hypertension.

Contraindications

history of angioedema (hereditary, idiopathic or angioneurotic edema due to ACE inhibitors)

severe renal failure (CC less than 30 ml / min)

azotemia

anuria

bilateral renal artery stenosis, single-artery stenosis

chronic heart disease hepatic insufficiency at stage lactase deficiency, glucose-galactose malabsorption

age up to 18 years (efficacy and safety have not been established)

severe liver failure (i.e. including encephalopathy)

pregnancy

lactation period

hypersensitivity to the components of Ko-Perinev.

Use during pregnancy and lactation

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

Composition

1 tablet contains: perindopril erbumin K prefabricated granules 75.03 mg, which corresponds to the content of perindopril erbumin 4 mg., indapamide 1.25 mg.

excipients: calcium chloride hexahydrate, lactose monohydrate, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate.

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 Co-Perinev is 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 should be increased to 4 mg / 1.25 mg (1 tab.) 1 time / day. For elderly patients, the initial dose of Co-Perinev is 2 mg / 625 mg (1 tab.) 1 time / day. Patients with renal failure (CC 60 ml / min or more) dose adjustment is not required. For patients with CC 30-60 ml / min, the maximum dose of Co-Perinev is 2 mg / 625 mg (1 tab.) 1 time / day. With CC less than 30 ml / min, the drug Co-Perineva is contraindicated. Patients with moderate hepatic impairment do not require dose adjustment.

Side effects

Classification of the incidence of side effects: very often -> 1/10 often - from> 1/100 to1 / 1000 to1 / 10000 to

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

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

From the sensory organs: often - visual impairment, tinnitus.

From the cardiovascular system: often - a marked decrease in blood pressure, orthostatic hypotension is very rare - 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.

From the respiratory system: often - a dry, irritating, persistent cough that goes away after discontinuation of the drug, shortness of breath infrequently - bronchospasm is very rare - eosinophilic pneumonia, rhinitis.

From the digestive system: often - constipation, dry mucous membrane of the oral cavity, decreased appetite, nausea, epigastric pain, abdominal pain, taste change, vomiting, dyspepsia, diarrhea is very rare - pancreatitis, jaundice (cytolytic or cholestatic) frequency is not found: in case of liver failure, there is a possibility of developing hepatic encephalopathy, intestinal edema.

From the skin and subcutaneous fat: often - itching, maculopapular eruptions infrequently - angioedema of the face, oral mucosa, tongue, tongue of the upper palate and / or larynx, urticaria of an individual hypersensitivity reaction, mainly dermatological, in in patients with an aggravated allergic history of purpura, a possible exacerbation of SLE is very rare - erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, isolated cases otochuvstvitelnosti.

From the musculoskeletal system: often - muscle cramps.

From the urinary system: infrequently - renal failure very rarely - acute renal failure.

From the reproductive system and mammary glands: infrequently - impotence.

Laboratory indicators: hypokalemia, hyponatremia with hypovolemia, leading to a decrease in BCC and orthostatic hypotension, an increase in the concentration of uric acid and glucose in the blood serum, a slight increase in the concentration of creatinine and urea in the blood plasma, reversible after discontinuation of therapy, which often develops against renal artery stenosis or stenosis arteries of a single kidney, against the background of therapy with hypertension with diuretics, in renal failure a transient increase in sodium in plasma and proteinuria hypochloremia rarely - hypercalcemia.

Drug Interaction

Concomitant use not recommended

Lithium preparations. With the concomitant use of lithium and ACE inhibitors, cases of reversible increases in serum lithium concentrations have been reported. Concomitant use of thiazide diuretics may increase the concentration of lithium and the risk of its toxic effect against the backdrop of ACE inhibitor.

Potassium-sparing diuretics (such as spironolactone, eplerenone, triamterene, amiloride), potassium supplements or potassium-containing dietary supplements, and other drugs that increase potassium in blood plasma (eg heparin).

Concurrent use requiring extreme caution

Baclofen is a potentiating antihypertensive effect. Control of blood pressure, kidney function and, if necessary, dose adjustment of antihypertensive agents are necessary.

NSAIDs. The combination of ACE inhibitors with NSAIDs (non-selective COX inhibitors from the NSAIDs group, such as acetylsalicylic acid at doses that have anti-inflammatory effects of COX-2 inhibitors) - reduces the hypotensive effect of ACE inhibitors increases the risk of impaired development of function. blood in patients with pre-existing renal dysfunction.

This combination is recommended for use with caution, especially in elderly patients. Patients should receive sufficient fluid and monitor renal function before and after initiation of treatment with Ko-Perinev.

Concurrent use with caution

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

ACS, tetracosactide. Reduction of antihypertensive effect (fluid retention).

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

Perindopril

Concomitant use is not recommended

Potassium-sparing diuretics (spironolactone, triamterene, amiloride, eplerenone) and potassium preparations: when co-administered with ACE inhibitors, it is possible to increase the content of potassium in syrup. If co-administration of an ACE inhibitor and the above drugs is required (in the case of confirmed hypokalemia), caution should be exercised and regular monitoring of potassium in the blood plasma and ECG parameters should be performed.

Concurrent Application, requiring extreme caution

Hypoglycemic agents for ingestion (sulfonylureas derivatives) and insulin: use of ACE inhibitors may enhance the hypoglycemic effect of hypoglycemic agents for intake and insulin in patients with diabetes mellitus, which may increase hypoglycemic agents for ingestion and insulin.

Concomitant use with caution

Allopurinol, cytostatic immunosuppressants, ACS (with systemic use) and procainamide: concomitant administration of these drugs with ACE inhibitors may increase the risk of leukopenia.

General anesthesia agents: ACE inhibitors may enhance the hypotensive effect of some general anesthesia agents.

Diuretics (Thiazide and Loop): The use of high-dose diuretics can lead to hypovolemia (by reducing BCC), and the addition of perindopril therapy to a marked decrease in blood pressure.

Gold preparations: when appointing ACE inhibitors, incl. perindopril, patients receiving the drug gold (sodium aurothiomalate) in / in, were noted nitratopodobny reactions (nausea, vomiting, marked decrease in blood pressure, facial skin hyperemia).

Indapamide

Concurrent use requiring extreme caution

Drugs causing pirouette arrhythmia: due to the risk of hypokalemia, indapamide should be used with caution in conjunction with drugs that cause pyruvic acid such as: , disopyramide, amiodarone, dofetilide, ibutilide, bretilium, sotalol) some neuroleptics: chlorpromazine, ciamemazine, levomepromazine, thioridazine, trifluoperazine benzamides (amisulfrid, sulfride, sultopride, tiapride), butyrophenones (droperidol, haloperidol), pimozide, other substances, such as cytoprol / in use, halofantrine, misolastin, moxifloxacin, pentamidine, sparfloxacin, vincamine in / in use, methadone, astemizole, terfenadine. It is necessary to control the concentration of potassium in order to avoid hypokalemia, in the development of which it is necessary to carry out its correction, to control the QT interval on the ECG.

Medicines capable of causing hypokalemia: amphotericin B when administered / in administration, gluco- and mineralocorticoids (for systemic use), laxatives that stimulate bowel motility (laxatives should be used, not stimulating intestinal motility), tetracosactide - increase the risk of hypokalemia (additive effect). It is necessary to control the concentration of potassium in the blood plasma, if necessary, its correction. Particular attention should be paid to patients receiving concomitant cardiac glycosides.

Cardiac glycosides: hypokalemia increases the toxicity of cardiac glycosides. With the concomitant use of indapamide and cardiac glycosides, potassium content in the blood plasma, ECG parameters should be monitored and, if necessary, the dose of cardiac glycosides adjusted.

Concomitant use with caution

Metformin: Renal failure may develop against diuretics. Co-administration with metformin increases the risk of lactic acidosis. Metformin should not be used, if the plasma creatinine concentration exceeds 15 mg / l (135 μmol / l) in men and 12 mg / l (110 μmol / l) in women.

Iodine Contrasts: Reduced BCCs against diuretics, increased risk of acute renal failure, especially with high doses of iodine contrast agents. BCS must be offset before the use of iodine-containing contrast agents.

Calcium preparations: the development of hypercalcemia due to the reduction of calcium excretion by the kidneys may be possible with the simultaneous use.

Cyclosporine: Increases the risk of kidney dysfunction (hypercreatinemia).

overdose

Symptoms: marked decrease in blood pressure, nausea, vomiting, muscle cramps, dizziness, drowsiness, confusion, oliguria up to anuria (due to decrease in BCC).

Treatment: gastric lavage and / or administration of activated charcoal, restoration of hydro-electrolyte balance in hospital. With a marked decrease in blood pressure, it is necessary to move the patient to a supine position with his legs raised up, then follow the measures, aimed at increasing BCC (introduction of 0.9% sodium chloride solution in / in). Perindoprilat, the active metabolite of perindopril, can be eliminated through dialysis.

Storage conditions

At a temperature not exceeding 30 РC.

Expiration

2 years.



pharmacy terms for

dosage form

drug venal form

tablets

KRKA d.d. Novo mesto AO, Slovenia

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