Roxatenz-inda pills 1.25mg+4mg+10mg, 30pcs

Composition

1 film-coated tablet,1.25 mg + 4 mg + 10 mg contains:

Core

Active ingredients:

Indapamide 1,250 mg

Perindopril erbumin 4,000 mg

Rosuvastatin Calcium 10,395 mg, equivalent to rosuvastatin 10,000 mg

Auxiliary substances: microcrystalline cellulose, type 200, low humidity, microcrystalline cellulose, type 112, crospovidone, type A, colloidal silicon dioxide, magnesium stearate

Film shell:

Film-forming mixture 1: polyvinyl alcohol, macrogol-3350, titanium dioxide (E 171), talc, iron oxide dye red (E 172), iron oxide dye black (E 172), iron oxide dye yellow (E 172)

1 film-coated tablet,1.25 mg + 4 mg + 20 mg contains:

Core

Active ingredients:

Indapamide 1,250 mg

Perindopril erbumin 4,000 mg

Rosuvastatin Calcium 20,790 mg, equivalent to rosuvastatin 20,000 mg

Auxiliary substances: microcrystalline cellulose, type 200, low humidity, microcrystalline cellulose, type 112, crospovidone, type A, colloidal silicon dioxide, magnesium stearate

Film shell:

Film-forming mixture 2: polyvinyl alcohol, macrogol-3350, titanium dioxide (E 171), talc, iron oxide dye red (E 172), iron oxide dye yellow (E 172), iron oxide dye black (E 172)

1 film-coated tablet,2.5 mg + 8 mg + 10 mg contains:

Core

Active ingredients:

Indapamide 2,500 mg

Perindopril erbumin 8,000 mg

Rosuvastatin Calcium 10,395 mg, equivalent to rosuvastatin 10,000 mg

Auxiliary substances: microcrystalline cellulose, type 200, low humidity, microcrystalline cellulose, type 112, crospovidone, type A, colloidal silicon dioxide, magnesium stearate

Film shell:

Film-forming mixture 3: polyvinyl alcohol, macrogol-3350, titanium dioxide (E 171), talc, iron oxide red dye (E 172)

1 film-coated tablet,2.5 mg + 8 mg + 20 mg contains:

Core

Active ingredients:

Indapamide 2,500 mg

Perindopril erbumin 8,000 mg

Rosuvastatin Calcium 20,790 mg, equivalent to rosuvastatin 20,000 mg

Auxiliary substances: microcrystalline cellulose, type 200, low humidity, microcrystalline cellulose, type 112, crospovidone, type A, colloidal silicon dioxide, magnesium stearate

Film shell:

Film-forming mixture 4: polyvinyl alcohol, macrogol-3350, titanium dioxide (E 171), talc, iron oxide yellow dye (E 172), iron oxide red dye (E 172), iron oxide black dye (E 172)

Pharmacological action

combined drug (diuretic + angiotensin converting enzyme inhibitor + HMG-CoA reductase inhibitor)

Indications

Roxatenz-inda is indicated as a replacement therapy in adult patients whose condition is adequately controlled by taking indapamide, perindopril and rosuvastatin at the same doses as in Roxatenz-inda, in the treatment of arterial hypertension and concomitant dyslipidemia: primary hypercholesterolemia (type IIa according to the Fredrickson classification, including familial heterozygous hypercholesterolemia), mixed hypercholesterolemia (type IIb according to the classification Fredrickson’s disease) or familial homozygous hypercholesterolemia.

Use during pregnancy and lactation

Application of the drugRoxatenz-inda is contraindicated during pregnancy and lactation.

Pregnancy

The use of ACE inhibitors is not recommended during the first trimester of pregnancy. The use of ACE inhibitors is contraindicated during the second and third trimesters of pregnancy.

No controlled clinical studies have been conducted on the use of ACE inhibitors in pregnant women. Limited data indicate that taking ACE inhibitors in the first trimester did not lead to fetal malformations associated with fetotoxicity, but the fetotoxic effect of ACE inhibitors cannot be completely excluded.

When planning pregnancy or when it occurs while taking the drug, you should immediately stop taking the drug and prescribe an alternative antihypertensive therapy that has an established safety profile for use during pregnancy.

It is known that the use of ACE inhibitors in the second and third trimesters of pregnancy can lead to impaired fetal development (decreased renal function, oligohydramnios, slowing of ossification of the skull bones) and the development of complications in the newborn (renal failure, hypotension, hyperkalemia).

If a woman has taken an ACE inhibitor in the second and third trimesters of pregnancy, an ultrasound examination of the fetal kidneys and skull is recommended.

Newborns whose mothers have been treated with ACE inhibitors may experience hypotension, so newborns should be closely monitored (see the sections “Contraindications” and “Special instructions”).

Long-term use of thiazide diuretics in the third trimester of pregnancy can cause hypovolemia in the mother and a decrease in uteroplacental blood flow, which leads to fetoplacental ischemia and fetal development delay. In rare cases, hypoglycemia and thrombocytopenia were observed in newborns while taking diuretics.

Women of reproductive age should use adequate methods of contraception.

Since cholesterol and substances synthesized from cholesterol are important for fetal development, the potential risk of HMG-CoA reductase inhibition for the fetus exceeds the benefit of using the drug during pregnancy for the mother. Limited data on reproductive toxicity have been obtained in animal studies.

If pregnancy occurs during therapy, the use of the drug should be stopped immediately.

Breast-feeding period

Application of the drugRoxatenz-inda is contraindicated during breastfeeding.

Due to the lack of information on the use of perindopril during breastfeeding, its use is not recommended, the use of alternative drugs with an established safety profile is preferable, especially when feeding newborns or premature babies.

Indapamide is excreted in breast milk. Taking thiazide diuretics causes a decrease in the amount of breast milk or suppression of lactation. A newborn may develop hypersensitivity to sulfonamide derivatives, hypokalemia, and “nuclear” jaundice.

Rosuvastatin is excreted in the milk of rats. There are no data on the excretion of rosuvastatin in human breast milk.

Contraindications

·  Hypersensitivity to indapamide and other sulfonamide derivatives, perindopril and other ACE inhibitors, rosuvastatin or any other component of the drug.

· A history of angioedema (angioedema) associated with ACE inhibitors (see section “Special instructions”).

* Hereditary / idiopathic angioedema.

·  Severe renal insufficiency (creatinine clearance less than 30 ml / min).

·  Severe hepatic insufficiency (including hepatic encephalopathy).

* Liver diseases in the active phase (including a persistent increase in the activity of” hepatic “transaminases and an increase in the activity of” hepatic ” transaminases in blood serum by more than 3 times compared to the upper limit of normal).

* Myopathy.

* Patients predisposed to the development of myotoxic complications.

* Hypokalemia.

* Concomitant use with drugs that may cause polymorphic ventricular arrhythmia of the “pirouette” type (see the section “Interaction with other drugs”).

* Concomitant use of cyclosporine.

* Concomitant use with aliskiren or drugs containing aliskiren in patients with diabetes mellitus and / or moderate to severe renal impairment (glomerular filtration rate (GFR) less than 60 ml/min/1.73 m2 of body surface area).

* Concomitant use with angiotensin II receptor antagonists in patients with diabetic nephropathy.

* Concomitant use with neutral endopeptidase inhibitors (for example, with drugs containing sacubitril) due to a high risk of angioedema (see the section “Interaction with other drugs”).

* Extracorporeal treatments using certain membranes with negatively charged surfaces.

* Severe bilateral renal artery stenosis or renal artery stenosis of the only functioning kidney.

·  Use in women of childbearing age who do not use adequate methods of contraception.

* Pregnancy, breast-feeding period.

·  Age up to 18 years (efficacy and safety have not been established).

· Due to the lack of sufficient clinical experience, it should not be used in patients undergoing hemodialysis, as well as in patients with untreated heart failure in the decompensation stage.

How to take it, course of use and dosage

Inside,1 tablet 1 time a day, preferably in the morning, before meals.

A combination drug with fixed doses is not suitable for initial therapy.

When switching to treatment with Roxatenz-inda, it is necessary to achieve adequate control of the patient’s condition while taking constant doses of monopreparations. The dose of Roxatenz-inda should be determined by the doses of monopreparations included in the fixed combination at the time of transition.

If you need to change the dose of one of the active ingredients in a fixed combination drug (for example, due to a newly diagnosed disease, a change in the patient’s condition, or a drug interaction), individual selection of doses of individual components is necessary.

Elderly patients

In elderly patients, the standard indicator of creatinine concentration in blood plasma should be adjusted for age, weight and gender.

Before starting the drug, it is necessary to assess the functional activity of the kidneys and the degree of blood pressure reduction.

Impaired renal function

In patients with severe renal insufficiency (CC

In patients with CC

No dose adjustment is required in patients with creatinine clearance of 60 ml / min. During therapy, it is necessary to regularly monitor the concentration of creatinine and potassium in the blood serum.

Impaired liver function

Roxatenz-inda is contraindicated in patients with severe hepatic insufficiency and patients with active liver diseases (see the section “Contraindications”).

In moderate hepatic insufficiency, no dose adjustment is required.

No increase in systemic exposure to rosuvastatin was observed in patients with hepatic insufficiency of 7 points or lower on the Child-Pugh scale. However, in patients with hepatic insufficiency of 8-9 points on the Child-Pugh scale, an increase in systemic exposure was noted (see the section ” Pharmacological properties. Pharmacokinetics”). In such patients, renal function should be evaluated (see section “Special instructions”).

There is no experience of using rosuvastatin in patients with hepatic insufficiency above 9 points on the Child-Pugh scale.

Ethnic groups

In patients of the Mongolian race, an increase in systemic exposure to rosuvastatin was noted (see the sections “Contraindications”, “Special instructions”, ” Pharmacological properties. Pharmacokinetics”).

Genetic polymorphism

Certain types of genetic polymorphisms may lead to increased exposure to rosuvastatin (see section ” Pharmacological properties. Pharmacokinetics”). Lower daily doses of rosuvastatin are recommended for patients with these types of polymorphism.

Concomitant therapy

Rosuvastatin binds to various transport proteins (in particular, OATP1 In 1 and BCRP). Concomitant use of rosuvastatin with certain medications (such as cyclosporine, certain human immunodeficiency virus (HIV) protease inhibitors, including the combination of ritonavir with atazanavir, lopinavir, and / or tipranavir) that increase the concentration of rosuvastatin in blood plasma due to interaction with transport proteins may increase the risk of developing myopathy (including rhabdomyolysis). In such cases, the possibility of alternative therapy or temporary discontinuation of rosuvastatin should be evaluated. If it is necessary to use the above drugs, the benefit-risk ratio of concomitant therapy with rosuvastatin should be evaluated and the possibility of dose adjustment should be considered (see the sections “Interaction with other drugs”, “Special instructions”).

Children

The safety and efficacy of Roxatenz-inda in children and adolescents under 18 years of age have not been established. The use of Roxatenz-inda is contraindicated in patients under 18 years of age.

Overdose

Symptoms

The most likely symptom of overdose is a marked decrease in blood pressure, sometimes combined with nausea, vomiting, convulsions, dizziness, drowsiness, confusion, and oliguria, which can progress to anuria (as a result of hypovolemia). Electrolyte disturbances (hyponatremia, hypokalemia) may also occur.

Treatment

There is no special treatment for overdose. In case of overdose, the patient is indicated for symptomatic treatment and substitution therapy, if necessary. Emergency measures are aimed at removing the drug from the gastrointestinal tract: gastric lavage and / or taking activated carbon, followed by restoring the water-electrolyte balance. With a marked decrease in blood pressure, the patient should be placed with an elevated position of the lower extremities, if necessary, correction of hypovolemia (for example, an intravenous infusion of 0.9% sodium chloride solution). Monitoring of liver function and serum CPK activity is necessary.

Perindoprilat, the active metabolite of perindopril, is removed by hemodialysis.

The effectiveness of hemodialysis for rosuvastatin is unlikely.

Description

Tablets 1.25 mg + 4 mg + 10 mg:

Round, slightly biconvex tablets, film-coated in reddish-brown color, with the inscription PIR1 on one side and a chamfer.

Tablets 1.25 mg + 4 mg + 20 mg:

Round, slightly biconvex tablets, coated with a film coating of pink with a grayish tinge, with an engraving PIR2 on one side and a chamfer.

2.5 mg + 8 mg + 10 mg tablets:

Round, slightly biconvex tablets, film-coated in light pink color, with the inscription PIR3 on one side and a chamfer.

2.5 mg + 8 mg + 20 mg tablets:

Round, slightly biconvex tablets, film-coated in a pale pinkish-brown color, with the inscription PIR4 on one side and a chamfer.

Special instructions

Systemic connective tissue diseases (including systemic lupus erythematosus (SLE), scleroderma), therapy with immunosuppressants (risk of neutropenia, agranulocytosis), oppression of bone marrow hematopoiesis, decreased volume of circulating blood (BCC) (diuretics, diet with restriction of salt, vomiting, diarrhea), ischemic heart disease, cerebrovascular disease, impaired liver and kidney failure, renovascular hypertension, diabetes, CHF (IV functional class NYHA classification), hyperuricemia (especially accompanied by a gout and urate nephrolithiasis), the labile blood pressure, use in elderly patients, blacks, athletes (possible positive reaction in doping control), the hemodialysis using a high-flow polyacrylonitrile membranes (e. g., AN69®), before the procedure LDL apheresis, the simultaneous holding of desensitizing therapy allergens (e. g. Hymenoptera venom), condition after kidney transplantation, stenosis of aortic and/or mitral valve disease, hypertrophic obstructive cardiomyopathy (HACMP), bilateral renal artery stenosis, stenosis of the artery to a solitary kidney, the simultaneous use with lithium preparations, gold, nonsteroidal anti-inflammatory drugs (NSAIDs), with baclofen, corticosteroids, drugs that can cause polymorphic ventricular tachycardia type “pirouette”, there is a risk of myopathy/rhabdomyolysis renal failure, hypothyroidism, hereditary muscle disease in history (including family) and previous history of muscular toxicity with the use of other inhibitors of HMG-COA reductase inhibitors or fibrates; excessive alcohol use, a condition in which increased plasma concentrations of rosuvastatin, race (Mongoloid race – the Japanese and Chinese), the simultaneous use of fibrates, diseases of liver disease, sepsis, hypotension, extensive surgical intervention trauma, severe metabolic, endocrine, or electrolyte disorders or uncontrolled seizures, concurrent use with ezetimiba.

The safety and efficacy of Roxatenz-inda in children and adolescents under 18 years of age have not been established. The use of Roxatenz-inda is contraindicated in patients under 18 years of age.

Elderly patients

In elderly patients, the standard indicator of creatinine concentration in blood plasma should be adjusted for age, weight and gender.

Before starting the drug, it is necessary to assess the functional activity of the kidneys and the degree of blood pressure reduction.

Impaired renal function

In patients with severe renal insufficiency (CC

In patients with CC

No dose adjustment is required in patients with creatinine clearance of 60 ml / min. During therapy, it is necessary to regularly monitor the concentration of creatinine and potassium in the blood serum.

Impaired liver function

Roxatenz-inda is contraindicated in patients with severe hepatic insufficiency and patients with active liver diseases (see the section “Contraindications”).

In moderate hepatic insufficiency, no dose adjustment is required.

No increase in systemic exposure to rosuvastatin was observed in patients with hepatic insufficiency of 7 points or lower on the Child-Pugh scale. However, in patients with hepatic insufficiency of 8-9 points on the Child-Pugh scale, an increase in systemic exposure was noted (see the section ” Pharmacological properties.Pharmacokinetics”). In such patients, renal function should be evaluated (see section “Special instructions”).

There is no experience of using rosuvastatin in patients with hepatic insufficiency above 9 points on the Child-Pugh scale.

The drug does not affect the ability to drive vehicles and work with mechanisms, but some patients may develop different individual reactions in response to a decrease in blood pressure, especially at the beginning of therapy or when other antihypertensive agents are added to the therapy.

Studies on the effect of rosuvastatin on the ability to drive vehicles and work with mechanisms have not been conducted. However, given the pharmacodynamic properties, it is unlikely that rosuvastatin can affect these abilities. When driving vehicles or working with mechanisms, the possibility of dizziness during treatment should be taken into account.

As a result, the ability to drive vehicles or other mechanisms may be reduced.

Form of production

Film-coated tablets,1.25 mg + 4 mg + 10 mg,1.25 mg + 4 mg + 20 mg,2.5 mg + 8 mg + 10 mg,2.5 mg + 8 mg + 20 mg.

10 tablets in a blister of combined OPA/Al/PVC material and aluminum foil.

3,6 or 9 blisters together with the instructions for use are placed in a cardboard pack.

Storage conditions

At a temperature not exceeding 25 ° C, in the original packaging (blister).

Keep out of reach of children.

Shelf

life is 3 years.

Do not use the drug after the expiration date.

Active ingredient

Indapamide, Perindopril, Rosuvastatin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets