Universal reference book for medicines
Product name: TEVASTOR ® (TEVASTOR)

Active substance: rosuvastatin

Type: Lipid-lowering drug

Manufacturer: Teva Pharmaceutical Industries (Israel)
Composition, form of production and packaging
The tablets covered with a film membrane
from light yellow or light orange (possible grayish shade) to orange color, round, biconcave, with engraving "N" on one side and "5" - on the other;
on the cross section - the core is white or almost white.
1 tab.

rosuvastatin calcium 5.21 mg,

which corresponds to the content of rosuvastatin 5 mg

[PRING] microcrystalline cellulose - 47.82 mg, crospovidone - 30 mg, lactose - 54.97 mg, povidone K30 - 8.5 mg, sodium stearyl fumarate - 3.5 mg.

The composition of the shell: opedrai II 85F23426 orange (partially hydrolyzed polyvinyl alcohol 1.8 mg, titanium dioxide (E171) 1.025 mg, macrogol 3350 0.909 mg, talc 0.666 mg, ferric iron oxide yellow (E172) 0.075 mg, iron oxide dye black (E172) - 0.003 mg, dye sunset yellow sunset (E110) - 0.022 mg).

10 pieces.
- blisters of PVC / PVA / aluminum foil (3) - packs of cardboard.
10 pieces.
- blisters of PVC / PVA / aluminum foil (9) - packs of cardboard.
Tablets covered with a film membrane from light pink to pink, round, biconvex, with an engraved "N" on one side and "10" on the other;
on the cross section - the core is white or almost white.
1 tab.

rosuvastatin calcium 10.42 mg,

which corresponds to the content of rosuvastatin 10 mg

[PRING] microcrystalline cellulose - 45.22 mg, crospovidone - 30 mg, lactose - 52.36 mg, povidone K30 - 8.5 mg, sodium stearyl fumarate - 3.5 mg.

The composition of the shell: opedrai II 85F24155 pink (partially hydrolyzed polyvinyl alcohol 1.8 mg, titanium dioxide (E171) -1.105 mg, macrogol 3350-0.909 mg, talc 0.666 mg, iron oxide yellow oxide (E172) 0.009 mg, iron oxide dye red (E172) - 0.005 mg, dye azorubin aluminum varnish (E122) 0.005 mg, indigocarmine aluminum varnish (E132) 0.001 mg).

10 pieces.
- blisters of PVC / PVA / aluminum foil (3) - packs of cardboard.
10 pieces.
- blisters of PVC / PVA / aluminum foil (9) - packs of cardboard.
The tablets covered with a film cover from light pink to pink color, round, biconcave, with engraving "N" on one side and "20" - on another;
on the cross section - the core is white or almost white.
1 tab.

rosuvastatin calcium 20.83 mg,

which corresponds to the content of rosuvastatin 20 mg

[PRING] microcrystalline cellulose - 90.45 mg, crospovidone - 60 mg, lactose - 104.72 mg, povidone K30 - 17 mg, sodium stearyl fumarate - 7 mg.

The composition of the shell: opadrai II 85F24155 pink (partially hydrolyzed polyvinyl alcohol 3.6 mg, titanium dioxide (E171) 2.21 mg macrogol 3350 1.818 mg talc 1.332 mg iron oxide yellow oxide (E172) 0.018 mg iron oxide dye red (E172) 0.01 mg, azorubin dye aluminum lacquer (E122) 0.009 mg, indigocarmine aluminum lacquer (E132) 0.003 mg).

10 pieces.
- blisters of PVC / PVA / aluminum foil (3) - packs of cardboard.
10 pieces.
- blisters of PVC / PVA / aluminum foil (9) - packs of cardboard.
The tablets covered with a film membrane from light pink to pink, oval, with an engraving "N" on one side and "40" on the other;
on the cross section - the core is white or almost white.
1 tab.

rosuvastatin calcium 41.67 mg,

which corresponds to the content of rosuvastatin 40 mg

[PRING] microcrystalline cellulose - 80.03 mg, crospovidone - 60 mg, lactose - 94.3 mg, povidone K30 - 17 mg, sodium stearyl fumarate - 7 mg.

The composition of the shell: opadrai II 85F24155 pink (partially hydrolyzed polyvinyl alcohol 3.6 mg, titanium dioxide (E171) 2.21 mg macrogol 3350 1.818 mg talc 1.332 mg iron oxide yellow oxide (E172) 0.018 mg iron oxide dye red (E172) 0.01 mg, azorubin dye aluminum lacquer (E122) 0.009 mg, indigocarmine aluminum lacquer (E132) 0.003 mg).

10 pieces.
- blisters of PVC / PVA / aluminum foil (3) - packs of cardboard.
10 pieces.
- blisters of PVC / PVA / aluminum foil (9) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

A hypolipidemic drug, a selective competitive inhibitor of HMG-CoA reductase, an enzyme that converts 3-hydroxy-3-methylglutarylcoenzyme A into mevalonate, a cholesterol precursor (Xc).
The main target of rosuvastatin is the liver, where the synthesis of cholesterol and catabolism of LDL is carried out. Rosuvastatin increases the number of "liver" LDL receptors on the cell surface, increasing the uptake and catabolism of LDL, which in turn leads to inhibition of VLDL synthesis, thereby reducing the total number of LDL and VLDL. Rosuvastatin reduces the elevated concentration of LDL-C, total cholesterol, TG, increases the concentration of X-HDL, and also reduces the concentrations of apolipoprotein B (ApoV), Xc-non-HDL, Xc-VLDL, TG-VLDL and increases the concentration of apolipoprotein A-1 (ApoA- 1), reduces the ratio of Xc-LDL / Xc-HDL cholesterol, total Xc / Xc-HDL and Xc-non-HDL / Xc-HDL and the ApoB / ApoA-1 ratio.
Therapeutic effect appears within 1 week after the beginning of rosuvastanin therapy, after 2 weeks of treatment it reaches 90% of the maximum possible effect.
The maximum therapeutic effect is usually achieved by week 4 and is maintained with regular admission.
PHARMACOKINETICS

Suction

C max rosuvastatin in blood plasma is reached approximately 5 hours after ingestion.
Absolute bioavailability is approximately 20%
Distribution

Binding to plasma proteins (predominantly with albumin) is approximately 90%.
Rosuvastatin accumulates mainly in the liver - the main organ of synthesis of Xc and clearance of Xc-LDL. V d - about 134 liters.
Metabolism

Biotransformed to a small extent (about 10%), being a non-core substrate for metabolism by enzymes of the cytochrome P450 system.
The main isoenzyme involved in the metabolism of rosuvastatin is CYP2C9. Isozymes CYP2C19, CYP3A4 and CYP2D6 are less involved in metabolism. The main revealed metabolites of rosuvastatin are N-dysmethyl and lactone metabolites. N-dimethyl is about 50% less active than rosuvastatin, lactone metabolites are pharmacologically inactive. More than 90% of the pharmacological activity of inhibiting the circulating HMG-CoA reductase is provided by rosuvastatin, the rest - by its metabolites.
Excretion

T 1/2 - about 19 hours. T 1/2 does not change with increasing dose of the drug.
About 90% of the dose of rosuvastatin is excreted unchanged with feces. The remainder is excreted in the urine. The average value of plasma clearance is approximately 50 l / h (coefficient of variation - 21.7%). As in the case of other HMG-CoA-redukase inhibitors, the membrane anion carrier Xc is involved in the "hepatic" capture of rosuvastatin, which plays an important role in the hepatic elimination of rosuvastatin.
Pharmacokinetics in special clinical cases

Sex and age do not have a clinically significant effect on the pharmacokinetics of rosuvastatin.

In patients with mild and moderate renal failure, the plasma concentration of rosuvastatin or N-dimethyl does not change significantly.
In patients with severe renal failure (CC <30 ml / min), the concentration of rosuvastatin in blood plasma is 3 times higher, and the concentration of N-dimethyl is 9 times higher than in healthy volunteers.
The concentration of rosuvastatin in blood plasma in patients on hemodialysis was approximately 50% higher than in healthy volunteers.

Patients with different stages of hepatic insufficiency (score 7 and lower on the Child-Pugh scale) showed no increase in T 1/2 of rosuvastatin.
In 2 patients with scores of 8 and 9 on the Child-Pugh scale, an increase in T 1/2 was observed at least 2-fold. The experience with rosuvastatin in patients with a score above 9 on the Child-Pugh scale is not available.
Comparative studies of the pharmacokinetics of rosuvastatin in Japanese and Chinese patients living in Asia showed approximately a twofold increase in the mean AUC values, compared to those of Europeans living in Europe and Asia.
The influence of genetic factors and environmental factors on the differences in pharmacokinetic parameters was not revealed. Pharmacokinetic analysis among different ethnic groups of patients did not reveal clinically significant differences among Europeans, Hispanics, blacks or blacks.
INDICATIONS

- Primary hypercholesterolemia or mixed hypercholesterolemia (type IIb by Fredrickson) - as a supplement to the diet, when the diet and other non-medicamentous treatments (for example, physical exercises, weight loss) are insufficient;

- family homozygous hypercholesterolemia - as a supplement to the diet and other lipid-lowering therapy, or in cases when such therapy is not effective enough;

- hypertriglyceridemia (type IV according to Fredrickson) as a supplement to the diet;

- to slow the progression of atherosclerosis as a supplement to the diet in patients who are shown therapy to reduce the concentration of total Xc and Xc-LDL;

- primary prevention of major cardiovascular complications (stroke, heart attack, arterial revascularization) in adults without clinical signs of IHD, but with an increased risk of its development (age over 50 for men and over 60 for women, increased concentration of C-reactive protein (at least 2 mg / L) in the presence of at least one of additional risk factors, such as hypertension, low concentration of HDL cholesterol, smoking, family history of early onset of coronary artery disease).

DOSING MODE

The drug is taken orally at any time of the day, regardless of food intake.
The tablet should be swallowed whole, washed down with water, not chewing or grinding. If you need to take the drug at a dose of 5 mg, you should divide the tablet 10 mg in half.
Before beginning therapy with Tevastor ®, the patient should begin to follow the standard lipid-lowering diet and continue to observe it during treatment.

The dose of the drug should be selected individually, depending on the indications and therapeutic response, taking into account the current recommendations on target levels of lipids.

The recommended initial dose of Tevastor ® for patients who start taking the drug, or for patients transferred from other HMG-CoA reductase inhibitors, is 5 or 10 mg 1 time / day.
When choosing the initial dose should be guided by the content of cholesterol in the patient and take into account the risk of cardiovascular complications, as well as the potential risk of side effects. If necessary, after 4 weeks, the dose may be increased.
Patients with severe hypercholesterolemia and a high risk of cardiovascular complications (especially patients with familial hypercholesterolemia) who did not achieve the desired result when taking a dose of 20 mg during a 4-week therapy, with an increase in the dose of the drug to 40 mg should be administered the doctor's control in connection with a possible increase in the risk of side effects.
It is recommended especially careful monitoring of patients receiving the drug in a dose of 40 mg. After 2-4 weeks of therapy and / or an increase in the dose of Tevastor ® , control of lipid metabolism parameters is necessary.
In elderly patients (over 65 years) it is recommended to start treatment with a dose of 5 mg.

Patients with renal insufficiency of mild or moderate severity do not need a dose adjustment.
Contraindicated the use of the drug Tevastor in any doses for severe renal insufficiency (CC less than 30 ml / min). Contraindicated the use of the drug Tevastor in a dose of 40 mg in patients with moderate renal dysfunction (CC less than 60 ml / min) . Patients with moderate impairment of renal function are recommended an initial dose of 5 mg.
For Asian patients, the recommended initial dose is 5 mg.
Contraindicated the use of Tevastor ® in a dose of 40 mg in patients of the Asian race.
Contraindicated the appointment of Tevastor ® in a dose of 40 mg to patients with factors that may indicate a predisposition to the development of myopathy.
When prescribing the drug at doses of 10 mg and 20 mg, an initial dose for patients in this group of 5 mg is recommended.
In carriers of the genotypes SLCO1B1 (OATP1B1) c.521CC and ABCG2 (BCRP) c.421AA, the increase in the exposure (AUC) to rosuvastatin was noted in comparison with the carriers of the genotypes SLCO1B1 c.521TT and ABCG2c.421CC.
For patients carrying genotypes p.521CC or c.421AA, the recommended maximum daily dose of Tevastor ® is 20 mg 1 time / day (see the sections "Pharmacokinetics", "Special instructions" and "Drug interactions").
With the simultaneous use of the drug Tevastor with cyclosporine and HIV protease inhibitors (including combination of ritonavir with atazanavir, lopinavir), the risk of myopathy (including rhabdomyolysis) increases, therefore, alternative therapy or temporary discontinuation of Tevastor ® should be considered.
If simultaneous application of these drugs is unavoidable, the benefit / risk ratio of concomitant therapy with Tevastor ® should be assessed and the possibility of reducing its dose should be considered.
SIDE EFFECT

Side effects observed with the use of the drug Tevastor ® , usually expressed slightly and pass independently.
As with other inhibitors of HMG-CoA reductase, the incidence of side effects is mainly dose-dependent.
Determination of the frequency of side effects: often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10 000, <1/1000);
very rarely (<1/10 000), unknown frequency (can not be calculated from available data).
From the immune system: rarely - reactions of hypersensitivity, including angioedema.

On the part of the endocrine system: often - type 2 diabetes.

From the side of the central nervous system: often - headache, dizziness.

From the digestive system: often - constipation, nausea, abdominal pain;
rarely - pancreatitis.
From the skin: rarely - skin itching, rash, urticaria.

From the osteomuscular system : often - myalgia;
rarely - myopathy (including myositis), rhabdomyolysis. When using Tevastor ® in all doses, especially at doses exceeding 20 mg - myalgia, myopathy (including myositis); in rare cases - rhabdomyolysis with or without acute renal failure. A dose-dependent increase in the activity of CK is observed in a small number of patients taking rosuvastatin. In most cases, the increase in activity of CKK was insignificant, asymptomatic and temporary. In case of increased activity of CKK (more than 5 times compared with VGN), therapy with rosuvastatin should be stopped.
From the side of the urinary system: in patients receiving Tevastor ® , proteinuria can be detected.
Changes in the amount of protein in the urine (from absence or trace amounts to ++ or more) are observed in less than 1% of patients receiving the drug at a dose of 10-20 mg, and about 3% of patients receiving the drug at a dose of 40 mg. In most cases, proteinuria decreases or disappears during therapy and does not indicate the onset or progression of an existing kidney disease.
On the part of the liver: a dose-dependent increase in hepatic transaminase activity in a small number of patients.
In most cases, it is insignificant, asymptomatic and temporary.
On the part of laboratory indicators: an increase in the concentration of glucose, bilirubin, GGT activity, alkaline phosphatase, thyroid dysfunction.

Other: often - asthenic syndrome.

Postmarketing application

From the side of blood and lymphatic system: unspecified frequency - thrombocytopenia.

On the part of the digestive system: rarely - increased activity of hepatic transaminases;
very rarely - jaundice, hepatitis; unspecified frequency - diarrhea.
From the musculoskeletal system: very rarely - arthralgia;
Unspecified frequency - immuno-mediated necrotizing myopathy.
From the side of the central nervous system: very rarely - polyneuropathy, memory loss.

On the part of the respiratory system: unspecified frequency - cough, shortness of breath.

From the side of the urinary system: very rarely - hematuria.

On the part of the skin and subcutaneous fat: an unspecified frequency - Stevens-Johnson syndrome.

On the part of the reproductive system: unspecified frequency - gynecomastia.

Other: unspecified frequency - peripheral edema.

Some statins reported the following side effects: depression, sleep disorders (including insomnia, nightmarish dreams), sexual dysfunction.
Single cases, interstitial lung disease, have been reported, especially with prolonged use of drugs.
CONTRAINDICATIONS

For tablets 5, 10 and 20 mg

- liver disease in the active phase, including a persistent increase in hepatic transaminase activity or any increase in hepatic transaminase activity (more than 3-fold compared with IGN);

- severe violations of the liver (more than 9 points on the scale Child-Pugh) (no experience of use);

- severe renal dysfunction (CC less than 30 ml / min);

- myopathy;

- simultaneous administration of cyclosporine;

- Pregnancy;

- the period of breastfeeding;

- lack of reliable methods of contraception;

- lactose intolerance, lactase deficiency or glucose-galactose malabsorption (the preparation contains lactose);

- age under 18 years (insufficient data on efficiency and safety);

- Hypersensitivity to the components of the drug.

For tablets 40 mg

- liver disease in the active phase, including a persistent increase in hepatic transaminase activity and any increase in hepatic transaminase activity (more than 3-fold compared with IGN);

- simultaneous reception of fibrates;
severe violations of the liver (more than 9 points on the scale Child-Pugh) (no experience of use);
- patients with risk factors for myopathy / rhabdomyolysis: renal impairment (creatinine clearance less than 60 mL / min), hypothyroidism, personal or family analysis of muscle diseases miotoksichnost in patients receiving other HMG-Co-A reductase inhibitors or fibrates history; excessive alcohol consumption; conditions that may lead to increased plasma concentrations of rosuvastatin;
- concomitant use of cyclosporine;
- Pregnancy;

- the period of breastfeeding;

- the lack of reliable methods of contraception;
- lactose intolerance, lactase deficiency or glucose-galactose malabsorption (formulation contains lactose);
- up to age 18 years (insufficient efficacy and safety data);
- Use in patients of Asian race;
- Hypersensitivity to the components of the drug.

Carefully

For tablets of 5, 10 and 20 mg: the presence of risk factors for myopathy and / or rhabdomyolysis - renal failure, hypothyroidism, personal or family analysis of hereditary muscular disease and the previous history of muscle toxicity with other inhibitors of HMG-Co-A reductase inhibitors or fibrates; excessive alcohol consumption, age greater than 65 years, the state in which the observed increase in plasma concentrations of rosuvastatin; race (Asian race), the simultaneous application with fibrates, history of liver disease, septicemia, hypotension, extensive surgery, trauma, severe metabolic, endocrine, or electrolyte disorders, or uncontrolled seizures.
To 40 mg tablets:renal failure (creatinine clearance of more than 60 ml / min), age 65 years, a history of liver disease, septicemia, hypotension, extensive surgery, trauma, severe metabolic, endocrine, or electrolyte disorders, or uncontrolled seizures.
PREGNANCY AND LACTATION

Tevastor ® is contraindicated in pregnancy and during breastfeeding. In the diagnosis of pregnancy during therapy the drug should be discontinued immediately.
Women of childbearing age should use reliable methods of contraception. Since cholesterol and products of its biosynthesis are important for the development of the fetus, the potential risk of inhibition of HMG-CoA reductase inhibitors outweigh the benefits of the drug.
The allocation of data rosuvastatin into breast milk is not available, so if you need the drug Tevastor ® breastfeeding lactation should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER

Patients with renal insufficiency mild or moderate dose adjustment is required. Tevastor not use this drug at any dose with severe renal impairment (creatinine clearance less than 30 mL / min). Tevastor not use this drug in the dose of 40 mg in patients with moderate renal impairment (creatinine clearance less than 60 mL / min) . Patients with moderate renal impairment recommended initial dose of 5 mg.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindications: liver disease in its active phase, including the persistent elevation of liver transaminases or any increase in liver transaminases (more than 3 times compared to the ULN); severe liver function abnormalities (more than 9 points on a scale Child-Pugh) (no experience with).
APPLICATION FOR CHILDREN

Contraindicated in children and adolescents under 18 years.

APPLICATION IN ELDERLY PATIENTS

Elderly patients (over 65) is recommended to begin treatment with a dose of 5 mg.
SPECIAL INSTRUCTIONS

Proteinuria, mostly renal origin, discovered as a result of testing, observed in patients taking rosuvastatin at a dose of 40 mg and higher, and in most cases is transient.This proteinuria is not a symptom of acute or progressive renal disease. Total cases of serious renal complications seen with the application of rosuvastatin 40mg. In applying the drug Tevastor ® 40 mg is recommended to monitor renal function.
Effects on skeletal muscles (myalgia, myopathy and rhabdomyolysis rarely) observed in patients taking the drug Tevastor ®In particular, in a dose of 20 mg. Very rare cases of rhabdomyolysis have been registered in the application of ezetimibe with inhibitors of HMG-CoA reductase. The probability of rhabdomyolysis, as the application of rosuvastatin and other inhibitors of HMG-CoA reductase at a dose higher than 40 mg.
Determining the activity of CK should not be carried out after intense exercise or when there are other possible reasons for the increase CPK due to the potential distortion of the results. If the initial activity greatly increased CPK (5 times above ULN), after 5-7 days should conduct measurement again. Should not begin therapy if retest confirms the initial CK activity (5 times above ULN).
Patients should be warned of the need to inform the doctor immediately when new, had previously not seen symptoms of unexplained muscle pain, weakness or cramps, especially combined with fever and malaise. Therapy should be discontinued if CK activity is 5 times higher than the ULN or when there are severe symptoms of muscle, causing constant discomfort. With the disappearance of symptoms and normalization of activity of CK, should consider the repeated use of rosuvastatin with minimum dose and close monitoring. Routine monitoring of CPK activity in the absence of symptoms impractical.
It is recommended that liver function diagnosis before and 3 months after initiation of therapy.
Impact on the ability to drive vehicles and manage mechanisms

Research aimed at studying the effect of the drug Tevastor ® on ability to road management and work with the technique was carried out. In applying the drug Tevastor ® caution due to the fact that the possible development of vertigo.
OVERDOSE

At simultaneous reception of several daily doses of rosuvastatin pharmacokinetic parameters are not changed.
Treatment: overdose if necessary symptomatic therapy, requires the monitoring of liver function, and CPK.
There is no specific antidote. Hemodialysis is not effective.
DRUG INTERACTION

With simultaneous use of rosuvastatin and cyclosporine rosuvastatin AUC was on average 7-fold higher than the value which was seen in healthy volunteers, the plasma concentration of cyclosporin is not changed.
Starting therapy rosuvastatin or increasing doses in patients receiving both vitamin K antagonists (e.g. warfarin), may lead to an increase in international normalized ratio (MHO). Cancel rosuvastatin or reducing the dose may reduce the MHO (in such cases MHO monitoring).
The simultaneous use of rosuvastatin in a dose of 10 mg of ezetimibe and 10 mg was accompanied by an increase in AUC of rosuvastatin in patients with hypercholesterolemia. We can not exclude an increased risk of side effects due to the pharmacodynamic interaction between rosuvastatin and ezetimibe.
The simultaneous use of rosuvastatin and gemfibrozil leads to an increase in 2 times C maxin plasma and AUC of rosuvastatin. According to special studies relevant pharmacokinetic interaction with fenofibrate is not marked, but it is possible pharmacodynamic interactions. Gemofibrozil, fenofibrate, other fibrates and lipid-lowering doses of nicotinic acid, increase the risk of myopathy, when applied simultaneously with inhibitors of HMG-CoA reductase inhibitors (probably due to the fact that inhibitors of HMG-CoA can cause myopathy and when used as monotherapy) .
Although the exact mechanism of the interaction with protease inhibitors rosuvastatin unknown, their simultaneous use can cause a persistent strengthening action rosuvastatin. The pharmacokinetic studies in healthy volunteers, the combined use of 20 mg of rosuvastatin, and combinations of protease inhibitors (400 mg lopinavir / ritonavir 100 mg) produced approximately 2- and 5-fold increase in AUC and C max , respectively. Therefore, in patients with HIV therapy simultaneous use of rosuvastatin and protease inhibitors is not recommended.
The simultaneous use of rosuvastatin and antacid suspensions containing aluminum or magnesium hydroxide, results in decreased plasma rosuvastatin concentrations by approximately 50%. This effect is less pronounced, if antacids applied 2 hours after receiving rosuvastatin. The clinical significance of this interaction has not been studied.
The simultaneous use of rosuvastatin and erythromycin decreases the AUC of rosuvastatin is 20% and C max of rosuvastatin 30%, probably due to the increased motility of intestines caused by reception of erythromycin.
The simultaneous use of oral contraceptives and rosuvastatin increases the AUC of ethinyl estradiol and norgestrel AUC by 26% and 34% respectively. This increase in plasma concentrations should be considered when selecting the dose of oral contraceptives during treatment with rosuvastatin.
Based on studies of the interaction with digoxin rosuvastatin clinically significant interactions not revealed.
The results of studies in vivo and in vitro have shown that rosuvastatin is neither an inhibitor or inducer of P450 isoenzyme cytochrome. Furthermore, rosuvastatin is poor substrate for these isoenzymes. There were no clinically significant interaction between rosuvastatin and fluconazole (an inhibitor of CYP2C9 and CYP3A4), and ketoconazole (CYP2A6 inhibitor and a CYP3A4). Thus it is not expected interaction associated with the cytochrome P450 system.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TSTR-RU-00011-DOK-PHARM-14082016
TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 2 years.
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