Rosuvastatin (Tablets) Instructions for Use

Instructions
Dosage forms

ATC Code

C10AA07 (Rosuvastatin)

Active Substance

Rosuvastatin

Clinical-Pharmacological Group

Hypolipidemic agent

Pharmacotherapeutic Group

Hypolipidemic agent – HMG-CoA reductase inhibitor

Pharmacological Action

Hypolipidemic drug, a selective competitive inhibitor of the enzyme HMG-CoA reductase, which converts 3-hydroxy-3-methylglutaryl-CoA into mevalonate, a precursor of cholesterol. The main target of action of rosuvastatin is the liver, where the synthesis of cholesterol and the catabolism of low-density lipoproteins (LDL) take place. Rosuvastatin increases the number of LDL receptors on the surface of liver cells, increasing the uptake and catabolism of LDL, which in turn leads to inhibition of the synthesis of very low-density lipoproteins (VLDL), thereby reducing the total amount of LDL and VLDL.

Rosuvastatin reduces elevated concentrations of LDL cholesterol (LDL-C), total cholesterol (TC), triglycerides (TG), increases the concentration of high-density lipoprotein cholesterol (HDL-C), and also reduces the concentrations of apolipoprotein B (Apo-B), VLDL cholesterol, VLDL triglycerides and increases the concentration of apolipoprotein A-I (ApoA-I). As a result of the action of rosuvastatin, a decrease in the atherogenic coefficient (index) is observed, which characterizes an improvement in the lipid profile in patients with hypercholesterolemia.

Atherogenic index = (TC – HDL-C)/HDL-C.

The therapeutic effect develops within one week after the start of treatment with rosuvastatin. The maximum therapeutic effect is usually achieved by the 4th week of therapy and is maintained with regular use of the drug.

It is effective in adult patients with hypercholesterolemia, with or without hypertriglyceridemia, including patients with diabetes mellitus and familial hypercholesterolemia.

An additive effect is noted in combination with fenofibrate (in relation to TG concentration) and with nicotinic acid in lipid-lowering doses (in relation to HDL-C concentration), however, the very possibility of such combinations should be decided by the attending physician, taking into account possible risks (see also the section “Special Instructions”).

Pharmacokinetics

Absorption and Distribution

The maximum plasma concentration (C_max) of rosuvastatin is reached approximately 5 hours after oral administration. The absolute bioavailability is approximately 20%.

Rosuvastatin is metabolized mainly by the liver, which is the main site of cholesterol synthesis and LDL-C metabolism. The volume of distribution (V_d) of rosuvastatin is approximately 134 L. Approximately 90% of rosuvastatin is bound to plasma proteins, mainly albumin.

Metabolism

It undergoes limited metabolism (about 10%). Rosuvastatin is a non-preferential substrate for metabolism by cytochrome P450 isoenzymes. The main isoenzyme involved in the metabolism of rosuvastatin is the CYP2C9 isoenzyme. The CYP2C19, CYP3A4 and CYP2D6 isoenzymes are involved in the metabolism to a lesser extent.

The main identified metabolites of rosuvastatin are N-desmethylrosuvastatin and lactone metabolites. N-desmethylrosuvastatin is approximately 50% less active than the original rosuvastatin; lactone metabolites are pharmacologically inactive. More than 90% of the pharmacological activity for inhibiting circulating HMG-CoA reductase is provided by rosuvastatin, the rest by its metabolites.

Excretion

About 90% of the rosuvastatin dose is excreted unchanged through the intestine (including absorbed and unabsorbed rosuvastatin). The remainder is excreted by the kidneys. The plasma elimination half-life (T_1/2) is approximately 19 hours. The T_1/2 does not change with an increase in the drug dose. The geometric mean plasma clearance is approximately 50 L/h (coefficient of variation 21.7%). As with other HMG-CoA reductase inhibitors, the membrane cholesterol transporter is involved in the “hepatic” uptake of rosuvastatin, playing an important role in the hepatic elimination of rosuvastatin.

Linearity

The systemic exposure of rosuvastatin increases proportionally to the dose. Pharmacokinetic parameters do not change with daily administration.

Special Patient Populations

Age and Sex

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

Ethnic Groups

Pharmacokinetic studies have shown an approximately two-fold increase in the median AUC (area under the concentration-time curve) and C_max (maximum plasma concentration) of rosuvastatin in Mongoloid patients (Japanese, Chinese, Filipinos, Vietnamese, and Koreans) compared with Caucasians; in Indian patients, an increase in median AUC and C_max of 1.3 times was shown. Pharmacokinetic analysis did not reveal clinically significant differences in the pharmacokinetics of rosuvastatin between Caucasians and Blacks.

Renal Impairment

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

Hepatic Impairment

In patients with various stages of hepatic impairment, no increase in the T_1/2 of rosuvastatin was detected in patients with 7 points or less on the Child-Pugh scale. In two patients with 8 and 9 points on the Child-Pugh scale, an increase in T_1/2 of at least 2 times was noted. There is no experience with the use of rosuvastatin in patients with more than 9 points on the Child-Pugh scale.

Genetic Polymorphism

HMG-CoA reductase inhibitors, including Rosuvastatin, bind to the transport proteins OATP1B1 (organic anion transporting polypeptide involved in the uptake of statins by hepatocytes) and BCRP (efflux transporter). Carriers of the SLCO1B1 (OATP1B1) c.521CC and ABCG2 (BCRP) c.421AA genotypes showed an increase in exposure (AUC) to rosuvastatin by 1.6 and 2.4 times, respectively, compared with carriers of the SLCO1B1 c.521TT and ABCG2 c.421CC genotypes.

Indications

Primary hypercholesterolemia according to the Fredrickson classification (type IIa, including familial heterozygous hypercholesterolemia) or mixed hypercholesterolemia (type IIb) as an adjunct to diet, when diet and other non-drug treatments (e.g., exercise, weight loss) are insufficient;
Familial homozygous hypercholesterolemia as an adjunct to diet and other lipid-lowering therapy (e.g., LDL apheresis), or in cases where such therapy is not sufficiently effective;
Hypertriglyceridemia (type IV according to the Fredrickson classification) as an adjunct to diet;
To slow the progression of atherosclerosis as an adjunct to diet in patients who are indicated for therapy to reduce total cholesterol and LDL-C concentrations;
Primary prevention of major cardiovascular complications (stroke, myocardial infarction, arterial revascularization) in adult patients without clinical signs of coronary artery disease (CAD), but with an increased risk of its development (age over 50 years for men and over 60 years for women), increased concentration of C-reactive protein (≥ 2 mg/l) in the presence of at least one additional risk factor, such as arterial hypertension, low HDL-C concentration, smoking, family history of early-onset CAD.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
E78.0	Pure hypercholesterolemia
E78.1	Pure hyperglyceridemia
E78.2	Mixed hyperlipidemia
I21	Acute myocardial infarction
I63	Cerebral infarction
I70	Atherosclerosis

ICD-11 code	Indication
5C80.00	Primary hypercholesterolemia
5C80.1	Hypertriglyceridemia
5C80.2	Mixed hyperlipidemia
8B11	Cerebral ischemic stroke
BA41.Z	Acute myocardial infarction, unspecified
BD40.Z	Atherosclerosis of peripheral arteries, unspecified
EB90.21	Tuberous xanthoma
EB90.22	Eruptive xanthoma

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

Orally, do not chew or crush the tablet, swallow it whole with water. The drug can be taken at any time of the day, regardless of meals.

Before starting therapy with Rosuvastatin, the patient should begin to follow a standard hypocholesterolemic diet and continue to follow it during treatment. The dose of the drug should be selected individually depending on the goals of therapy and the therapeutic response to treatment, taking into account current recommendations for target lipid concentrations.

The recommended initial dose for patients starting the drug or for patients transferred from taking other HMG-CoA reductase inhibitors should be 5 mg or 10 mg of Rosuvastatin once a day. When choosing the initial dose, one should be guided by the individual cholesterol content and take into account the possible risk of cardiovascular complications, and it is also necessary to assess the potential risk of developing side effects. If necessary, the dose can be increased to a higher one after 4 weeks (see the “Pharmacodynamics” section).

Due to the possible development of side effects when taking a dose of 40 mg, compared with lower doses of the drug (see the “Adverse Reactions” section), increasing the dose to 40 mg, after additional intake of a dose above the recommended initial dose for 4 weeks of therapy, can only be carried out in patients with severe hypercholesterolemia and a high risk of cardiovascular complications (especially in patients with familial hypercholesterolemia), in whom the desired result of therapy was not achieved when taking a dose of 20 mg, and who will be under the supervision of a specialist (see the “Special Instructions” section). Especially careful monitoring of patients receiving the drug at a dose of 40 mg is recommended.

Prescribing a dose of 40 mg is not recommended for patients who have not previously consulted a doctor.

After 2-4 weeks of therapy and/or when increasing the dose of Rosuvastatin, it is necessary to monitor lipid metabolism parameters (if necessary, dose adjustment is required). The use of the drug at a dose higher than 40 mg is not justified due to the increase in side effects and in most cases is not recommended.

Elderly patients

No dose adjustment is required.

Patients with renal impairment

In patients with mild or moderate renal impairment, no dose adjustment is required. In patients with severe renal impairment (creatinine clearance less than 30 ml/min), the use of Rosuvastatin is contraindicated. The use of the drug at a dose of 40 mg is contraindicated in patients with moderate renal impairment (creatinine clearance 30-60 ml/min) (see sections “Special Instructions”, “Pharmacodynamics”). For patients with moderate renal impairment, the recommended initial dose of the drug is 5 mg.

Patients with hepatic impairment

Rosuvastatin is contraindicated in patients with active liver disease (see section “Contraindications”).

Special populations. Ethnic groups

When studying the pharmacokinetic parameters of rosuvastatin in patients belonging to different ethnic groups, an increase in the systemic concentration of rosuvastatin was noted among Japanese and Chinese (see the “Special Instructions” section). This fact should be taken into account when prescribing Rosuvastatin to these groups of patients. When prescribing doses of 10 mg and 20 mg, the recommended initial dose for Mongoloid patients is 5 mg. Prescribing the drug at a dose of 40 mg is contraindicated in Mongoloid patients (see section “Contraindications”).

Genetic polymorphism

Carriers of the SLCO1B1 (OATP1B1) c.521CC and ABCG2 (BCRP) c.421AA genotypes showed an increase in exposure (AUC) to rosuvastatin compared with carriers of the SLCO1B1 c.521TT and ABCG2 c.421CC genotypes. For patients who are carriers of the c.521CC or c.421AA genotypes, the recommended maximum dose of Rosuvastatin is 20 mg once a day (see sections “Pharmacokinetics”, “Special Instructions” and “Interaction with other medicinal products and other forms of interaction”).

Patients predisposed to myopathy

Prescribing the drug at a dose of 40 mg is contraindicated in patients with factors that may indicate a predisposition to the development of myopathy (see section “Contraindications”). When prescribing doses of 10 mg and 20 mg, the recommended initial dose for this group of patients is 5 mg (see section “Contraindications”).

Concomitant therapy

Rosuvastatin binds to various transport proteins (in particular, OATP1B1 and BCRP). When Rosuvastatin is used concomitantly with drugs (such as cyclosporine, some HIV protease inhibitors, including the combination of ritonavir with atazanavir, lopinavir and/or tipranavir) that increase the plasma concentration of rosuvastatin due to interaction with transport proteins, the risk of myopathy (including rhabdomyolysis) may increase (see sections “Special Instructions” and “Interaction with other medicinal products and other forms of interaction”). In such cases, the possibility of prescribing alternative therapy or temporarily discontinuing Rosuvastatin should be assessed. If the use of the above drugs is necessary, the benefit-risk ratio of concomitant therapy with Rosuvastatin should be assessed and the possibility of reducing its dose should be considered (see section “Interaction with other medicinal products and other forms of interaction”).

Adverse Reactions

Side effects observed when taking Rosuvastatin are usually mild and go away on their own. As with the use of other HMG-CoA reductase inhibitors, the frequency of side effects is mainly dose-dependent.

The frequency of adverse effects is presented in accordance with the World Health Organization classification: common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10000, <1/1000); very rare (<1/10000), frequency not specified (cannot be calculated from the available data).

Immune system rare – hypersensitivity reactions, including angioedema.

Endocrine system: common – type 2 diabetes mellitus.

Nervous system disorders common – headache, dizziness.

Gastrointestinal tract: common – constipation, nausea, abdominal pain; rare – pancreatitis.

Skin and subcutaneous tissue: uncommon – skin itching, rash, urticaria.

Musculoskeletal system: common – myalgia; rare – myopathy (including myositis), rhabdomyolysis.

General disorders: common – asthenic syndrome.

Urinary system

Proteinuria may be detected in patients receiving Rosuvastatin. Changes in the amount of protein in the urine (from absent or trace amounts to ++ or more) are observed in less than 1% of patients receiving 10-20 mg of the drug, and in approximately 3% of patients receiving 40 mg of the drug. A slight change in the amount of protein in the urine was noted when taking a dose of 20 mg. In most cases, proteinuria decreases or disappears during therapy and does not mean the occurrence of acute or progression of existing kidney disease.

Musculoskeletal system

When using Rosuvastatin at all doses and, especially when taking doses of the drug exceeding 20 mg, the following effects on the musculoskeletal system have been reported: myalgia, myopathy (including myositis), in rare cases – rhabdomyolysis with or without acute renal failure.

A dose-dependent increase in creatine phosphokinase (CPK) activity is observed in a small number of patients taking Rosuvastatin. In most cases, it was minor, asymptomatic and temporary. If CPK activity increases (more than 5 times the upper limit of normal), therapy should be suspended (see section “Special Instructions”).

Liver

When using rosuvastatin, a dose-dependent increase in the activity of “hepatic” transaminases is observed in a small number of patients. In most cases, it is minor, asymptomatic and temporary.

Laboratory parameters

When using Rosuvastatin, the following changes in laboratory parameters were also observed: increased concentration of glucose, bilirubin, activity of gamma-glutamyl transpeptidase, alkaline phosphatase, thyroid dysfunction.

Post-marketing experience

The following side effects have been reported in the post-marketing use of Rosuvastatin

Blood and lymphatic system disorders: frequency not specified – thrombocytopenia.

Gastrointestinal tract: very rare – jaundice, hepatitis; rare – increased activity of “hepatic” transaminases; frequency not specified – diarrhea.

Musculoskeletal system very rare – arthralgia; frequency not specified – immune-mediated necrotizing myopathy.

Nervous system disorders: very rare – memory loss or impairment; frequency not specified – peripheral neuropathy.

Respiratory system disorders: frequency not specified – cough, shortness of breath.

Urinary system: very rare – hematuria.

Skin and subcutaneous tissue disorders: frequency not specified – Stevens-Johnson syndrome.

Reproductive system and breast disorders: frequency not specified – gynecomastia.

General disorders: frequency not specified – peripheral edema.

The following side effects have been reported with the use of some statins: depression, sleep disorders, including insomnia and “nightmare” dreams, sexual dysfunction, hyperglycemia, increased concentration of glycosylated hemoglobin. Isolated cases of interstitial lung disease have been reported, especially with long-term use of drugs (see section “Special Instructions”).

Contraindications

For the drug in a daily dose of 5 mg, 10 mg and 20 mg

Hypersensitivity to rosuvastatin or any of the components of the drug;
Lactose intolerance, lactase deficiency, or glucose-galactose malabsorption (the drug contains lactose);
Children under 18 years of age;
Active liver disease, including persistent elevation of serum transaminase activity and any elevation of serum transaminase activity (more than 3 times the upper limit of normal);
Severe renal impairment (creatinine clearance less than 30 ml/min);
Myopathy and predisposition to the development of myotoxic complications;
Concomitant use of cyclosporine;
For women: pregnancy, breastfeeding period, lack of adequate contraceptive methods.

For the drug at a daily dose of 40 mg

Hypersensitivity to rosuvastatin or any of the components of the drug;
Lactose intolerance, lactase deficiency, or glucose-galactose malabsorption (the drug contains lactose);
Children under 18 years of age;
Concomitant use of cyclosporine;
For women: pregnancy, breastfeeding period, lack of adequate contraceptive methods;
Active liver disease, including persistent elevation of serum transaminase activity and any elevation of serum transaminase activity (more than 3 times the upper limit of normal) in patients with risk factors for myopathy/rhabdomyolysis, namely
Moderate renal impairment (creatinine clearance less than 60 ml/min);
Hypothyroidism;
Personal or family history of muscle diseases;
History of myotoxicity while taking other HMG-CoA reductase inhibitors or fibrates;
Excessive alcohol consumption;
Conditions that may lead to an increase in the plasma concentration of rosuvastatin;
Concomitant use of fibrates;
Use in patients of Mongoloid race.

With caution

For the drug at a daily dose of 5 mg, 10 mg and 20 mg

Presence of risk factors for the development of myopathy/rhabdomyolysis – renal failure, hypothyroidism, personal or family history of hereditary muscle diseases and previous history of muscle toxicity when using other HMG-CoA reductase inhibitors (statins) or fibrates; excessive alcohol consumption; age over 65 years; conditions in which an increase in the plasma concentration of rosuvastatin has been noted; racial affiliation (Mongoloid race); concomitant administration with fibrates (see section “Pharmacokinetics”); history of liver disease; sepsis; arterial hypotension; major surgical interventions, trauma, severe metabolic, endocrine or water-electrolyte disturbances or uncontrolled seizures.

For the drug at a daily dose of 40 mg

Mild renal impairment (creatinine clearance greater than 60 ml/min); age over 65 years; history of liver disease; sepsis; arterial hypotension; major surgical interventions, trauma, severe metabolic, endocrine or water-electrolyte disturbances or uncontrolled seizures.

Patients with hepatic impairment

There are no data or experience with the use of the drug in patients with more than 9 points on the Child-Pugh scale (see sections “Pharmacodynamics” and “Special Instructions”).

Use in Pregnancy and Lactation

Rosuvastatin is contraindicated during pregnancy and breastfeeding.

Women of reproductive age should use adequate contraceptive methods.

Since cholesterol and other products of cholesterol biosynthesis are important for fetal development, the potential risk of HMG-CoA reductase inhibition outweighs the benefit of using the drug in pregnant women.

If pregnancy is diagnosed during therapy, the drug should be discontinued immediately.

There are no data regarding the excretion of rosuvastatin in breast milk, therefore, during breastfeeding, the drug should be discontinued (see section “Contraindications”).

Use in Hepatic Impairment

The use of the drug at a daily dose of 5 mg, 10 mg, 20 mg and 40 mg is contraindicated in patients with active liver disease, including persistent elevation of serum transaminase activity and any elevation of serum transaminase activity (more than 3 times the upper limit of normal).

Use the drug at a daily dose of 5 mg, 10 mg, 20 mg and 40 mg with caution in patients with a history of liver disease.

Use in Renal Impairment

The use of the drug at a daily dose of 5 mg, 10 mg and 20 mg is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 ml/min).

The use of the drug at a daily dose of 40 mg is contraindicated in patients with moderate renal impairment (creatinine clearance less than 60 ml/min).

Use the drug at a daily dose of 5 mg, 10 mg and 20 mg with caution in patients with renal failure.

Use the drug at a daily dose of 40 mg with caution in patients with mild renal impairment (creatinine clearance greater than 60 ml/min).

An initial dose of 5 mg is recommended for patients with moderate renal impairment.

Pediatric Use

The use of the drug in children and adolescents under 18 years of age is contraindicated.

Geriatric Use

No dose adjustment is required for elderly patients.

Special Precautions

Renal effects

Tubular proteinuria, which was transient in most cases, was observed in patients receiving high doses of Rosuvastatin (mainly 40 mg). Such proteinuria did not indicate acute kidney injury or progression of kidney disease. In patients taking the drug at a dose of 40 mg, it is recommended to monitor renal function parameters during treatment.

Musculoskeletal system

When using Rosuvastatin at all doses, and especially when taking doses of the drug exceeding 20 mg, the following effects on the musculoskeletal system have been reported: myalgia, myopathy, and in rare cases, rhabdomyolysis.

Determination of creatine phosphokinase activity

Determination of CPK activity should not be performed after intense physical exertion or in the presence of other possible causes of increased CPK activity, as this may lead to misinterpretation of the results. If the baseline CPK activity is significantly elevated (5 times above the upper limit of normal), a repeat measurement should be performed after 5-7 days. Therapy should not be initiated if the repeat test confirms the baseline CPK activity (more than 5 times the upper limit of normal).

Before starting therapy

When prescribing Rosuvastatin, as well as when prescribing other HMG-CoA reductase inhibitors, caution should be exercised in patients with existing risk factors for myopathy/rhabdomyolysis (see section “With caution”), the risk-benefit ratio of therapy should be considered and clinical monitoring should be carried out.

During therapy

The patient should be informed of the need to immediately inform the doctor of any cases of unexpected muscle pain, muscle weakness or cramps, especially in combination with malaise and fever. In such patients, CPK activity should be determined. Therapy should be discontinued if CPK activity is significantly increased (more than 5 times the upper limit of normal) or if muscle symptoms are severe and cause daily discomfort (even if CPK activity is increased by no more than 5 times the upper limit of normal). If symptoms disappear and CPK activity returns to normal, the question of re-prescribing Rosuvastatin or other HMG-CoA reductase inhibitors at lower doses with careful monitoring of the patient should be considered. Routine monitoring of CPK activity in the absence of symptoms is not advisable.

Very rare cases of immune-mediated necrotizing myopathy with clinical manifestations of persistent proximal muscle weakness and increased serum CPK activity during treatment or after discontinuation of statins, including rosuvastatin, have been noted. Additional investigations of the muscular and nervous systems, serological tests, and therapy with immunosuppressive agents may be required.

No signs of increased effects on skeletal muscles were observed when taking Rosuvastatin and concomitant therapy. However, an increase in the number of cases of myositis and myopathy has been reported in patients taking other HMG-CoA reductase inhibitors in combination with fibrinic acid derivatives, including gemfibrozil, cyclosporine, nicotinic acid in lipid-lowering doses (more than 1 g/day), azole antifungals, HIV protease inhibitors and macrolide antibiotics. Gemfibrozil increases the risk of myopathy when co-administered with some HMG-CoA reductase inhibitors. Therefore, the concomitant use of Rosuvastatin and gemfibrozil is not recommended. The risk-benefit ratio should be carefully weighed when co-administering Rosuvastatin and fibrates or lipid-lowering doses of nicotinic acid. The use of Rosuvastatin at a dose of 40 mg concomitantly with fibrates is contraindicated (see sections “Interaction with other medicinal products and other forms of interaction”, “Contraindications”).

Lipid metabolism parameters should be monitored 2-4 weeks after the start of treatment and/or when increasing the dose of Rosuvastatin (dose adjustment may be required if necessary).

Liver

It is recommended to determine liver function parameters before starting therapy and 3 months after starting therapy. Rosuvastatin should be discontinued or the dose reduced if the activity of “liver” transaminases in the blood serum is 3 times the upper limit of normal.

In patients with hypercholesterolemia due to hypothyroidism or nephrotic syndrome, therapy for the underlying diseases should be carried out before starting treatment with Rosuvastatin.

Special populations. Ethnic groups

Pharmacokinetic studies among Chinese and Japanese patients have shown an increase in the systemic concentration of rosuvastatin compared with the rates obtained among Caucasian patients (see sections “Dosage and Administration” and “Pharmacokinetics”).

HIV protease inhibitors

Concomitant use of the drug with HIV protease inhibitors is not recommended (see section “Interaction with other medicinal products and other forms of interaction”).

Lactose

The drug should not be used in patients with lactase deficiency, lactose intolerance and glucose-galactose malabsorption.

Interstitial lung disease

Isolated cases of interstitial lung disease have been reported with the use of some statins, especially over a long period. Manifestations of the disease may include shortness of breath, non-productive cough and deterioration in general health (weakness, weight loss and fever). If interstitial lung disease is suspected, statin therapy should be discontinued.

Type 2 diabetes

In patients with glucose concentrations from 5.6 to 6.9 mmol/L, therapy with Rosuvastatin was associated with an increased risk of developing type 2 diabetes.

Effect on ability to drive and use machines

No studies have been conducted on the effect of Rosuvastatin on the ability to drive vehicles and use mechanisms. Caution should be exercised when driving vehicles or performing work that requires increased concentration and speed of psychomotor reactions (dizziness and weakness may occur during therapy).

Overdose

When taking several daily doses simultaneously, the pharmacokinetic parameters of rosuvastatin do not change.

Symptoms No symptoms specific to rosuvastatin are observed. They represent effects that are enhanced and similar to those described in the “Adverse Reactions” section.

Treatment There is no specific treatment for rosuvastatin overdose or a specific antidote. Timely gastric lavage and symptomatic treatment are recommended; monitoring of liver function and CPK activity is necessary, as well as measures aimed at maintaining the functions of vital organs and systems; hemodialysis is ineffective.

Drug Interactions

Effect of other drugs on Rosuvastatin

Transporter protein inhibitors: Rosuvastatin binds to some transporter proteins, in particular OATP1B1 and BCRP. Concomitant use of drugs that are inhibitors of these transporter proteins may be accompanied by an increase in the plasma concentration of rosuvastatin and an increased risk of myopathy (see Table 1 and sections “Dosage and Administration” and “Special Instructions”).

Cyclosporine: When rosuvastatin and cyclosporine were used concomitantly, the AUC of rosuvastatin was on average 7 times higher than the value observed in healthy volunteers (see Table 1). It does not affect the plasma concentration of cyclosporine. Rosuvastatin is contraindicated in patients taking cyclosporine (see section “Contraindications”).

Human Immunodeficiency Virus (HIV) protease inhibitors: Although the exact mechanism of interaction is unknown, co-administration of HIV protease inhibitors may lead to a significant increase in exposure to rosuvastatin (see Table 1). A pharmacokinetic study of the simultaneous use of 20 mg rosuvastatin with a combined preparation containing two HIV protease inhibitors (400 mg lopinavir/100 mg ritonavir) in healthy volunteers resulted in approximately a two-fold and five-fold increase in AUC_(0-24) and C_max of rosuvastatin, respectively. Therefore, the simultaneous use of rosuvastatin and HIV protease inhibitors is not recommended (see sections “Dosage and Administration”, “Special Instructions”, Table 1).

Gemfibrozil and other lipid-lowering agents: Concomitant use of rosuvastatin and gemfibrozil leads to a 2-fold increase in the maximum plasma concentration of rosuvastatin and the AUC of rosuvastatin (see section “Special Instructions”). Based on specific interaction data, no pharmacokinetically significant interaction with fenofibrate is expected; a pharmacodynamic interaction is possible.

Gemfibrozil, fenofibrate, other fibrates and lipid-lowering doses of nicotinic acid (more than 1 g/day) increased the risk of myopathy when used concomitantly with HMG-CoA reductase inhibitors, possibly because they can cause myopathy when used as monotherapy (see section “Special Instructions”). When the drug is taken concomitantly with gemfibrozil, fibrates, nicotinic acid in lipid-lowering doses (more than 1 g/day), an initial dose of 5 mg is recommended for patients; the use of a 40 mg dose is contraindicated when co-administered with fibrates (see sections “Contraindications”, “Dosage and Administration”, “Special Instructions”).

Ezetimibe Concomitant use of Rosuvastatin at a dose of 10 mg and ezetimibe at a dose of 10 mg was accompanied by an increase in the AUC of rosuvastatin in patients with hypercholesterolemia (see Table 1). An increased risk of adverse effects due to pharmacodynamic interaction between Rosuvastatin and ezetimibe cannot be excluded.

Antacids: Concomitant use of rosuvastatin and antacid suspensions containing magnesium and aluminum hydroxide leads to a decrease in the plasma concentration of rosuvastatin by approximately 50%. This effect is less pronounced if antacids are taken 2 hours after taking rosuvastatin. The clinical significance of this interaction has not been studied.

Erythromycin: Concomitant use of rosuvastatin and erythromycin leads to a 20% decrease in the AUC of rosuvastatin and a 30% decrease in the C_max of rosuvastatin. This interaction may occur as a result of increased intestinal motility caused by taking erythromycin.

Cytochrome P450 isoenzymes: Results of in vivo and in vitro studies have shown that Rosuvastatin is neither an inhibitor nor an inducer of cytochrome P450 isoenzymes. In addition, Rosuvastatin is a weak substrate for these isoenzymes. Therefore, no interaction of rosuvastatin with other drugs at the level of metabolism involving cytochrome P450 is expected. No clinically significant interaction of rosuvastatin with fluconazole (an inhibitor of CYP2C9 and CYP3A4 isoenzymes) and ketoconazole (an inhibitor of CYP2A6 and CYP3A4 isoenzymes) was noted.

Fusidic acid: No studies on the interaction of rosuvastatin and fusidic acid have been conducted; as with the use of other statins, post-marketing reports of cases of rhabdomyolysis with the simultaneous use of rosuvastatin and fusidic acid have been received; patients should be monitored and, if necessary, temporary discontinuation of rosuvastatin may be considered.

Interaction with drugs that requires adjustment of the rosuvastatin dose (see Table 1)

The dose of Rosuvastatin should be adjusted if it is necessary to use it concomitantly with drugs that increase exposure to rosuvastatin. The instructions for use of these drugs should be read before prescribing them simultaneously with Rosuvastatin. If an increase in exposure of 2 times or more is expected, the initial dose of Rosuvastatin should be 5 mg once a day. The maximum daily dose of Rosuvastatin should also be adjusted so that the expected exposure to rosuvastatin does not exceed that for a 40 mg dose taken without the concomitant use of drugs that interact with rosuvastatin. For example, the maximum daily dose of Rosuvastatin when used concomitantly with gemfibrozil is 20 mg (increase in exposure by 1.9 times), with ritonavir/atazanavir – 10 mg (increase in exposure by 3.1 times).

Table 1. Effect of concomitant therapy on exposure to rosuvastatin (AUC, data are presented in descending order) – results of published clinical studies

Concomitant therapy regimen	Rosuvastatin regimen	Change in rosuvastatin AUC
Cyclosporine 75-200 mg Twice a day, 6 months	10 mg once a day, 10 days	Increase by 7.1 times
Atazanavir 300 mg/ritonavir 100 mg Once a day, 8 days	10 mg single dose	Increase by 3.1 times
Simeprevir 152 mg Once a day, 7 days	10 mg single dose	Increase by 2.8 times
Lopinavir 400 mg/ritonavir 100 mg Twice a day, 17 days	20 mg once a day, 7 days	Increase by 2.1 times
Clopidogrel 300 mg (loading dose), Then 75 mg after 24 h	20 mg single dose	Increase by 2 times
Gemfibrozil 600 mg Twice a day, 7 days	80 mg single dose	Increase by 1.9 times
Eltrombopag 75 mg Once a day, 10 days	10 mg single dose	Increase by 1.6 times
Darunavir 600 mg/ritonavir 100 mg Twice a day, 7 days	10 mg once a day, 7 days	1.5-fold increase
Tipranavir 500 mg/ritonavir 200 mg Twice daily, 11 days	10 mg single dose	1.4-fold increase
Dronedarone 400 mg Twice daily	No data	1.4-fold increase
Itraconazole 200 mg once daily, 5 days	10 mg or 80 mg single dose	1.4-fold increase
Ezetimibe 10 mg once daily, 14 days	10 mg once daily, 14 days	1.2-fold increase
Fosamprenavir 700 mg/ritonavir 100 mg Twice daily, 8 days	10 mg single dose	No change
Aleglitazar 0.3 mg, 7 days	40 mg, 7 days	No change
Silymarin 140 mg Three times daily, 5 days	10 mg single dose	No change
Fenofibrate 67 mg Three times daily, 7 days	10 mg, 7 days	No change
Rifampin 450 mg once daily, 7 days	20 mg single dose	No change
Ketoconazole 200 mg Twice daily, 7 days	80 mg single dose	No change
Fluconazole 200 mg once daily, 11 days	80 mg single dose	No change
Erythromycin 500 mg Four times daily, 7 days	80 mg single dose	28% decrease
Baicalin 50 mg Three times daily, 14 days	20 mg single dose	47% decrease

Effect of Rosuvastatin on Other Drugs

Vitamin K antagonists: initiation of rosuvastatin therapy or an increase in its dose in patients concurrently receiving vitamin K antagonists (e.g., warfarin) may lead to an increase in the International Normalized Ratio (INR). Discontinuation of rosuvastatin or a decrease in its dose may lead to a decrease in the INR. In such cases, monitoring of the INR is recommended.

Oral contraceptives/Hormone replacement therapy: concomitant use of rosuvastatin and oral contraceptives increases the AUC of ethinyl estradiol and the AUC of norgestrel by 26% and 34%, respectively. This increase in plasma concentration should be considered when selecting the dose of oral contraceptives. Pharmacokinetic data on the concomitant use of Rosuvastatin and hormone replacement therapy are not available; therefore, a similar effect cannot be ruled out with this combination. However, this combination has been widely used in clinical trials and was well tolerated by patients.

Other drugs: no clinically significant interaction between rosuvastatin and digoxin is expected.

Storage Conditions

Store the drug in a light-protected place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Rosuvastatin [TAD PHARMA GmbH (Germany)]
Film-coated tablets, 10 mg: 10, 14, 20, 28, 30, 56, 60, 84, or 90 pcs.

Marketing Authorization Holder

TAD PHARMA GmbH (Germany)

Manufactured By

Krka-Rus, LLC (Russia)

Krka d.d., Novo mesto (Slovenia)

Dosage Form

Rosuvastatin

Film-coated tablets, 10 mg: 10, 14, 20, 28, 30, 56, 60, 84, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, round, biconvex, with a bevel and the engraving “10” on one side; the fracture shows a white rough mass with a white film coating.

	1 tab.
Rosuvastatin calcium	10.42 mg,
Equivalent to rosuvastatin content	10 mg

Excipients: microcrystalline cellulose type 102, lactose, crospovidone, colloidal anhydrous silicon dioxide, magnesium stearate.

Film coating composition: copolymer of butyl methacrylate, dimethylaminoethyl methacrylate, and methyl methacrylate (1:2:1), macrogol 6000, titanium dioxide (E171), lactose monohydrate.

10 pcs. – blisters (1) made of combined material – cardboard packs.
10 pcs. – blisters (2) made of combined material – cardboard packs.
10 pcs. – blisters (3) made of combined material – cardboard packs.
10 pcs. – blisters (6) made of combined material – cardboard packs.
10 pcs. – blisters (9) made of combined material – cardboard packs.
14 pcs. – blisters (1) made of combined material – cardboard packs.
14 pcs. – blisters (2) made of combined material – cardboard packs.
14 pcs. – blisters (4) made of combined material – cardboard packs.
14 pcs. – blisters (6) made of combined material – cardboard packs.

Rosuvastatin [TAD PHARMA GmbH (Germany)]
Film-coated tablets, 20 mg: 10, 14, 20, 28, 30, 56, 60, 84, or 90 pcs.

Marketing Authorization Holder

TAD PHARMA GmbH (Germany)

Manufactured By

Krka-Rus, LLC (Russia)

Krka d.d., Novo mesto (Slovenia)

Dosage Form

Rosuvastatin

Film-coated tablets, 20 mg: 10, 14, 20, 28, 30, 56, 60, 84, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, round, biconvex, with a bevel; the fracture shows a white rough mass with a white film coating.

	1 tab.
Rosuvastatin calcium	20.83 mg,
Equivalent to rosuvastatin content	20 mg

Excipients: microcrystalline cellulose type 102, lactose, crospovidone, colloidal anhydrous silicon dioxide, magnesium stearate.

Film coating composition: copolymer of butyl methacrylate, dimethylaminoethyl methacrylate, and methyl methacrylate (1:2:1), macrogol 6000, titanium dioxide (E171), lactose monohydrate.

Rosuvastatin [TAD PHARMA GmbH (Germany)]
Film-coated tablets, 40 mg: 10, 14, 20, 28, 30, 56, 60, 84 or 90 pcs.

Marketing Authorization Holder

TAD PHARMA GmbH (Germany)

Manufactured By

Krka-Rus, LLC (Russia)

Krka d.d., Novo mesto (Slovenia)

Dosage Form

Rosuvastatin

Film-coated tablets, 40 mg: 10, 14, 20, 28, 30, 56, 60, 84 or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, oblong with rounded ends, biconvex; the fracture shows a white rough mass with a white film coating.

	1 tab.
Rosuvastatin calcium	41.66 mg,
Equivalent to rosuvastatin content	40 mg

Excipients: microcrystalline cellulose type 102, lactose, crospovidone, colloidal anhydrous silicon dioxide, magnesium stearate.

Film coating composition: copolymer of butyl methacrylate, dimethylaminoethyl methacrylate, and methyl methacrylate (1:2:1), macrogol 6000, titanium dioxide (E171), lactose monohydrate.

Rosuvastatin [TAD PHARMA GmbH (Germany)]
Film-coated tablets, 5 mg: 10, 14, 20, 28, 30, 56, 60, 84 or 90 pcs.

Marketing Authorization Holder

TAD PHARMA GmbH (Germany)

Manufactured By

Krka-Rus, LLC (Russia)

Krka d.d., Novo mesto (Slovenia)

Dosage Form

Rosuvastatin

Film-coated tablets, 5 mg: 10, 14, 20, 28, 30, 56, 60, 84 or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, round, biconvex, with a bevel and the engraving “5” on one side; the fracture shows a white rough mass with a white film coating.

	1 tab.
Rosuvastatin calcium	5.21 mg,
Equivalent to rosuvastatin content	5 mg

Excipients: microcrystalline cellulose type 102, lactose, crospovidone, colloidal anhydrous silicon dioxide, magnesium stearate.

Film coating composition: copolymer of butyl methacrylate, dimethylaminoethyl methacrylate, and methyl methacrylate (1:2:1), macrogol 6000, titanium dioxide (E171), lactose monohydrate.

Rosuvastatin [Alsi Pharma, JSC (Russia)]
Film-coated tablets, 5 mg: 30 or 60 pcs.
Film-coated tablets, 10 mg: 30 or 60 pcs.
Film-coated tablets, 20 mg: 30 or 60 pcs.

Marketing Authorization Holder

Alsi Pharma, JSC (Russia)

Dosage Forms

	Rosuvastatin	Film-coated tablets, 5 mg: 30 or 60 pcs.
		Film-coated tablets, 10 mg: 30 or 60 pcs.
		Film-coated tablets, 20 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from light pink to pink, round, biconvex; the cross-section shows an inner layer of white or almost white color.

	1 tab.
Rosuvastatin calcium	5.21 mg,
Equivalent to rosuvastatin content	5 mg

Excipients: microcrystalline cellulose – 49.19 mg, pregelatinized starch – 24.00 mg, colloidal silicon dioxide (aerosil) – 0.80 mg, magnesium stearate – 0.80 mg.

Coating composition: pink opadry – 3.20 mg (lactose monohydrate – 1.28 mg, hypromellose – 0.90 mg, titanium dioxide – 0.75 mg, triacetin – 0.25 mg, carmine red dye – 0.02 mg).

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.

Film-coated tablets from light pink to pink, round, biconvex; the cross-section shows an inner layer of white or almost white color.

	1 tab.
Rosuvastatin calcium	10.42 mg,
Equivalent to rosuvastatin content	10 mg

Excipients: microcrystalline cellulose – 93.38 mg, pregelatinized starch – 48.00 mg, colloidal silicon dioxide (aerosil) – 1.60 mg, magnesium stearate – 1.60 mg.

Coating composition: pink opadry – 6.40 mg (lactose monohydrate – 2.56 mg, hypromellose – 1.80 mg, titanium dioxide – 1.50 mg, triacetin – 0.50 mg, carmine red dye – 0.04 mg).

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.

Film-coated tablets from light pink to pink, round, biconvex; the cross-section shows an inner layer of white or almost white color.

	1 tab.
Rosuvastatin calcium	20.84 mg,
Equivalent to rosuvastatin content	20 mg

Excipients: microcrystalline cellulose – 196.76 mg, pregelatinized starch – 96.00 mg, colloidal silicon dioxide (aerosil) – 3.20 mg, magnesium stearate – 3.20 mg.

Coating composition: pink opadry – 12.80 mg (lactose monohydrate – 5.12 mg, hypromellose – 3.60 mg, titanium dioxide – 3.00 mg, triacetin – 1.00 mg, carmine red dye – 0.08 mg).

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.

Rosuvastatin [Atoll LLC (Russia)]
Film-coated tablets, 5 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 60, 70, 90, 100, 120, 140, 150 or 300 pcs.
Film-coated tablets, 10 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 60, 70, 90, 100, 120, 140, 150 or 300 pcs.
Film-coated tablets, 20 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 60, 70, 90, 100, 120, 140, 150 or 300 pcs.
Film-coated tablets, 40 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 60, 70, 90, 100, 120, 140, 150 or 300 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Forms

	Rosuvastatin	Film-coated tablets, 5 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 60, 70, 90, 100, 120, 140, 150 or 300 pcs.
		Film-coated tablets, 10 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 60, 70, 90, 100, 120, 140, 150 or 300 pcs.
		Film-coated tablets, 20 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 60, 70, 90, 100, 120, 140, 150 or 300 pcs.
		Film-coated tablets, 40 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 60, 70, 90, 100, 120, 140, 150 or 300 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Rosuvastatin calcium	5.21 mg
Equivalent to rosuvastatin content	5.21 mg

Excipients: lactose monohydrate (milk sugar) – 70.329 mg, microcrystalline cellulose – 12.307 mg, croscarmellose sodium – 4.577 mg, povidone (polyvidone K25) – 2.637 mg, colloidal silicon dioxide – 0.97 mg, magnesium stearate – 0.97 mg.

Coating composition: hypromellose – 1.65 mg, macrogol 4000 – 0.45 mg, titanium dioxide – 0.9 mg.

7 pcs. – contour cell blisters (1) – cardboard packs.
7 pcs. – contour cell blisters (2) – cardboard packs.
7 pcs. – contour cell blisters (3) – cardboard packs.
7 pcs. – contour cell blisters (4) – cardboard packs.
7 pcs. – contour cell blisters (5) – cardboard packs.
7 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
14 pcs. – contour cell blisters (1) – cardboard packs.
14 pcs. – contour cell blisters (2) – cardboard packs.
14 pcs. – contour cell blisters (3) – cardboard packs.
14 pcs. – contour cell blisters (4) – cardboard packs.
14 pcs. – contour cell blisters (5) – cardboard packs.
14 pcs. – contour cell blisters (10) – cardboard packs.
30 pcs. – contour cell blisters (1) – cardboard packs.
30 pcs. – contour cell blisters (2) – cardboard packs.
30 pcs. – contour cell blisters (3) – cardboard packs.
30 pcs. – contour cell blisters (4) – cardboard packs.
30 pcs. – contour cell blisters (5) – cardboard packs.
30 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
14 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
20 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
28 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
40 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
50 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
100 pcs. – polyethylene terephthalate jars (1) – cardboard packs.

Film-coated tablets white or almost white, round, biconvex, with a score on one side.

	1 tab.
Rosuvastatin calcium	10.42 mg
Equivalent to rosuvastatin content	10 mg

Excipients: lactose monohydrate (milk sugar) – 140.658 mg, microcrystalline cellulose – 24.614 mg, croscarmellose sodium – 9.154 mg, povidone (povidone K25) – 5.274 mg, colloidal silicon dioxide – 1.94 mg, magnesium stearate – 1.94 mg.

Shell composition hypromellose – 3.3 mg, macrogol 4000 – 0.9 mg, titanium dioxide – 1.8 mg.

7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (5) – cardboard packs.
7 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
14 pcs. – contour cell packs (1) – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (3) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.
14 pcs. – contour cell packs (5) – cardboard packs.
14 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – contour cell packs (4) – cardboard packs.
30 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
14 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
20 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
28 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
40 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
50 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
100 pcs. – polyethylene terephthalate jars (1) – cardboard packs.

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Rosuvastatin calcium	20.83 mg
Equivalent to rosuvastatin content	20 mg

Excipients: lactose monohydrate (milk sugar) – 132.329 mg, microcrystalline cellulose – 23.157 mg, croscarmellose sodium – 8.842 mg, povidone (povidone K25) – 4.962 mg, colloidal silicon dioxide – 1.94 mg, magnesium stearate – 1.94 mg.

Shell composition hypromellose – 3.3 mg, macrogol 4000 – 0.9 mg, titanium dioxide – 1.8 mg.

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Rosuvastatin calcium	41.66 mg
Equivalent to rosuvastatin content	40 mg

Excipients: lactose monohydrate (milk sugar) – 264.658 mg, microcrystalline cellulose – 46.314 mg, croscarmellose sodium – 17.684 mg, povidone (povidone K25) – 9.924 mg, colloidal silicon dioxide – 3.88 mg, magnesium stearate – 3.88 mg.

Shell composition hypromellose – 6.6 mg, macrogol 4000 – 1.8 mg, titanium dioxide – 3.6 mg.

Film-coated tablets pink in color, round, biconvex; the core is white in cross-section.

	1 tab.
Rosuvastatin calcium	20.8 mg,
Equivalent to Rosuvastatin content	20 mg

Excipients: lactose monohydrate (milk sugar), calcium hydrogen phosphate dihydrate, povidone (low molecular weight medical polyvinylpyrrolidone 12600±2700, Plasdone K-17), croscarmellose sodium (primellose), sodium stearyl fumarate, colloidal silicon dioxide (aerosil), microcrystalline cellulose (type 102).

Shell composition film coating Opadry 85F240195 pink, containing polyvinyl alcohol, titanium dioxide, macrogol, talc, carmine, iron oxide yellow dye.

7 pcs. – contour cell packs – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (5) – cardboard packs.
7 pcs. – contour cell packs (6) – cardboard packs.
7 pcs. – contour cell packs (7) – cardboard packs.
7 pcs. – contour cell packs (8) – cardboard packs.
7 pcs. – contour cell packs (9) – cardboard packs.
7 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – contour cell packs – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
14 pcs. – contour cell packs – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (3) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.
14 pcs. – contour cell packs (5) – cardboard packs.
14 pcs. – contour cell packs (6) – cardboard packs.
14 pcs. – contour cell packs (7) – cardboard packs.
14 pcs. – contour cell packs (8) – cardboard packs.
14 pcs. – contour cell packs (9) – cardboard packs.
14 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – jars – cardboard packs.
20 pcs. – jars – cardboard packs.
30 pcs. – jars – cardboard packs.
40 pcs. – jars – cardboard packs.
50 pcs. – jars – cardboard packs.
60 pcs. – jars – cardboard packs.
70 pcs. – jars – cardboard packs.
80 pcs. – jars – cardboard packs.
90 pcs. – jars – cardboard packs.
100 pcs. – jars – cardboard packs.

Film-coated tablets pink in color, round, biconvex; the core is white in cross-section.

	1 tab.
Rosuvastatin calcium	41.6 mg,
Equivalent to Rosuvastatin content	40 mg

Shell composition film coating Opadry 85F240195 pink, containing polyvinyl alcohol, titanium dioxide, macrogol, talc, carmine, iron oxide yellow dye.

Film-coated tablets white, round, biconvex, without a score; on the cross-section, the tablet is white or almost white.

	1 tab.
Rosuvastatin calcium	15.63 mg,
Equivalent to rosuvastatin content	15 mg

Excipients : lactose monohydrate, microcrystalline cellulose (type 102), povidone K-25 (polyvinylpyrrolidone K-25), croscarmellose sodium, magnesium stearate, colloidal silicon dioxide.

Film coating composition: hypromellose, macrogol 400, dimethicone 100, titanium dioxide.

Film-coated tablets from pinkish to light pink, round, biconvex, with a score; on the cross-section, two layers are visible, the inner layer is white or almost white.

	1 tab.
Rosuvastatin calcium	20.84 mg,
Equivalent to rosuvastatin content	20 mg

Excipients : lactose monohydrate, microcrystalline cellulose (type 102), povidone K-25 (polyvinylpyrrolidone K-25), croscarmellose sodium, magnesium stearate, colloidal silicon dioxide.

Film coating composition: hypromellose, macrogol 400, dimethicone 100, titanium dioxide, iron oxide yellow, iron oxide red.

Film-coated tablets white, round, biconvex, with a score; on the cross-section, the tablet is white or almost white.

	1 tab.
Rosuvastatin calcium	31.26 mg,
Equivalent to rosuvastatin content	30 mg

Excipients : lactose monohydrate, microcrystalline cellulose (type 102), povidone K-25 (polyvinylpyrrolidone K-25), croscarmellose sodium, magnesium stearate, colloidal silicon dioxide.

Film coating composition: hypromellose, macrogol 400, dimethicone 100, titanium dioxide.

Film-coated tablets from pinkish to light pink, round, biconvex, with a score; on the cross-section, two layers are visible, the inner layer is white or almost white.

	1 tab.
Rosuvastatin calcium	41.68 mg,
Equivalent to rosuvastatin content	40 mg

Excipients : lactose monohydrate, microcrystalline cellulose (type 102), povidone K-25 (polyvinylpyrrolidone K-25), croscarmellose sodium, magnesium stearate, colloidal silicon dioxide.

Film coating composition: hypromellose, macrogol 400, dimethicone 100, titanium dioxide, iron oxide yellow, iron oxide red.

Rosuvastatin [Citypharm LLC (Russia)]
Film-coated tablets, 5 mg: 7, 10, 14, 20, 21, 25, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 90 or 100 pcs.
Film-coated tablets, 10 mg: 7, 10, 14, 20, 21, 25, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 90 or 100 pcs.
Film-coated tablets, 20 mg: 7, 10, 14, 20, 21, 25, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 90 or 100 pcs.
Film-coated tablets, 40 mg: 7, 10, 14, 20, 21, 25, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 90 or 100 pcs.

Marketing Authorization Holder

Citypharm LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Forms

	Rosuvastatin	Film-coated tablets, 5 mg: 7, 10, 14, 20, 21, 25, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 90 or 100 pcs.
		Film-coated tablets, 10 mg: 7, 10, 14, 20, 21, 25, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 90 or 100 pcs.
		Film-coated tablets, 20 mg: 7, 10, 14, 20, 21, 25, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 90 or 100 pcs.
		Film-coated tablets, 40 mg: 7, 10, 14, 20, 21, 25, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 90 or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pink, round, biconvex; on the cross-section, the core is white or almost white.

	1 tab.
Rosuvastatin calcium	5.2 mg,
In terms of Rosuvastatin	5 mg

Excipients : lactose monohydrate (milk sugar), calcium hydrogen phosphate dihydrate, povidone (low molecular weight medical polyvinylpyrrolidone 12600±2700, Plasdone K-17), croscarmellose sodium (primellose), sodium stearyl fumarate, colloidal silicon dioxide (aerosil), microcrystalline cellulose.

Film coating composition: ready film coating Opadry^® 13A540003 pink: hypromellose, talc, titanium dioxide (E171), polysorbate 80, aluminum lake based on dye carmoisine (E122).

7 pcs. – contour cell packaging (1) – cardboard packs.
7 pcs. – contour cell packaging (2) – cardboard packs.
7 pcs. – contour cell packaging (3) – cardboard packs.
7 pcs. – contour cell packaging (4) – cardboard packs.
7 pcs. – contour cell packaging (5) – cardboard packs.
7 pcs. – contour cell packaging (6) – cardboard packs.
7 pcs. – contour cell packaging (7) – cardboard packs.
7 pcs. – contour cell packaging (8) – cardboard packs.
7 pcs. – contour cell packaging (9) – cardboard packs.
7 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (7) – cardboard packs.
10 pcs. – contour cell packaging (8) – cardboard packs.
10 pcs. – contour cell packaging (9) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
20 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
25 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
50 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
100 pcs. – polyethylene terephthalate jars (1) – cardboard packs.

Film-coated tablets pink, round, biconvex; on the cross-section, the core is white or almost white.

	1 tab.
Rosuvastatin calcium	10.4 mg,
In terms of Rosuvastatin	10 mg

Excipients : lactose monohydrate (milk sugar), calcium hydrogen phosphate dihydrate, povidone (low molecular weight medical polyvinylpyrrolidone 12600±2700, Plasdone K-17), croscarmellose sodium (primellose), sodium stearyl fumarate, colloidal silicon dioxide (aerosil), microcrystalline cellulose.

Film coating composition: ready film coating Opadry^® 13A540003 pink: hypromellose, talc, titanium dioxide (E171), polysorbate 80, aluminum lake based on dye carmoisine (E122).

Film-coated tablets pink, round, biconvex; on the cross-section, the core is white or almost white.

	1 tab.
Rosuvastatin calcium	20.8 mg,
In terms of Rosuvastatin	20 mg

Excipients : lactose monohydrate (milk sugar), calcium hydrogen phosphate dihydrate, povidone (low molecular weight medical polyvinylpyrrolidone 12600±2700, Plasdone K-17), croscarmellose sodium (primellose), sodium stearyl fumarate, colloidal silicon dioxide (aerosil), microcrystalline cellulose.

Film coating composition: ready film coating Opadry^® 13A540003 pink: hypromellose, talc, titanium dioxide (E171), polysorbate 80, aluminum lake based on dye carmoisine (E122).

Film-coated tablets pink, round, biconvex; on the cross-section, the core is white or almost white.

	1 tab.
Rosuvastatin calcium	41.6 mg,
In terms of Rosuvastatin	40 mg

Excipients : lactose monohydrate (milk sugar), calcium hydrogen phosphate dihydrate, povidone (low molecular weight medical polyvinylpyrrolidone 12600±2700, Plasdone K-17), croscarmellose sodium (primellose), sodium stearyl fumarate, colloidal silicon dioxide (aerosil), microcrystalline cellulose.

Film coating composition: ready film coating Opadry^® 13A540003 pink: hypromellose, talc, titanium dioxide (E171), polysorbate 80, aluminum lake based on dye carmoisine (E122).

Rosuvastatin [Tatkhimpharmpreparaty, JSC (Russia)]
Film-coated tablets, 5 mg: 28, 30, 56, 60, 90 or 98 pcs.
Film-coated tablets, 10 mg: 28, 30, 56, 60, 90, 98, or 126 pcs.
Film-coated tablets, 20 mg: 28, 30, 56, 60, 90, 98, or 126 pcs.
Film-coated tablets, 40 mg: 28, 30, 56, 60, 90, or 98 pcs.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Forms

	Rosuvastatin	Film-coated tablets, 5 mg: 28, 30, 56, 60, 90 or 98 pcs.
		Film-coated tablets, 10 mg: 28, 30, 56, 60, 90, 98, or 126 pcs.
		Film-coated tablets, 20 mg: 28, 30, 56, 60, 90, 98, or 126 pcs.
		Film-coated tablets, 40 mg: 28, 30, 56, 60, 90, or 98 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, round, biconvex; the cross-section shows two layers: a core of white or white with a light brown or yellowish tint, and a white coating; slight roughness is allowed.

	1 tab.
Rosuvastatin calcium	5.2 mg,
Equivalent to rosuvastatin content	5 mg

Excipients: mannitol, microcrystalline cellulose 102, talc, crospovidone, magnesium stearate.

Film coating composition Opadry II White (32K280000) [hypromellose, lactose monohydrate, titanium dioxide, triacetin].

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
14 pcs. – contour cell blisters (2) – cardboard packs.
14 pcs. – contour cell blisters (4) – cardboard packs.
14 pcs. – contour cell blisters (7) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.
15 pcs. – contour cell blisters (6) – cardboard packs.

Film-coated tablets from pink to dark pink, round, biconvex; the cross-section shows two layers: a core of white or white with a light brown or yellowish tint, and a coating from pink to dark pink; slight roughness is allowed.

	1 tab.
Rosuvastatin calcium	10.4 mg,
Equivalent to rosuvastatin content	10 mg

Excipients: mannitol, microcrystalline cellulose 102, talc, crospovidone, magnesium stearate.

Film coating composition Opadry II pink (32K240021) [hypromellose, lactose monohydrate, titanium dioxide, triacetin, iron oxide red dye].

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
14 pcs. – contour cell blisters (2) – cardboard packs.
14 pcs. – contour cell blisters (4) – cardboard packs.
14 pcs. – contour cell blisters (7) – cardboard packs.
14 pcs. – contour cell blisters (9) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.
15 pcs. – contour cell blisters (6) – cardboard packs.

	1 tab.
Rosuvastatin calcium	20.8 mg,
Equivalent to rosuvastatin content	20 mg

Excipients: mannitol, microcrystalline cellulose 102, talc, crospovidone, magnesium stearate.

Film coating composition Opadry II pink (32K24002) [hypromellose, lactose monohydrate, titanium dioxide, triacetin, iron oxide red dye].

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
14 pcs. – contour cell blisters (2) – cardboard packs.
14 pcs. – contour cell blisters (4) – cardboard packs.
14 pcs. – contour cell blisters (7) – cardboard packs.
14 pcs. – contour cell blisters (9) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.
15 pcs. – contour cell blisters (6) – cardboard packs.

	1 tab.
Rosuvastatin calcium	41.6 mg,
Equivalent to rosuvastatin content	40 mg

Excipients: mannitol, microcrystalline cellulose 102, talc, crospovidone, magnesium stearate.

Film coating composition Opadry II pink (32K240021) [hypromellose, lactose monohydrate, titanium dioxide, triacetin, iron oxide red dye].

Rosuvastatin [Pharmstandard-Tomskkhimpharm OJSC (Russia)]
Film-coated tablets, 10 mg: 10, 20, 30, 60, or 90 pcs.
Film-coated tablets, 20 mg: 10, 20, 30, 60, or 90 pcs.

Marketing Authorization Holder

Pharmstandard-Tomskkhimpharm OJSC (Russia)

Manufactured By

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Forms

	Rosuvastatin	Film-coated tablets, 10 mg: 10, 20, 30, 60, or 90 pcs.
		Film-coated tablets, 20 mg: 10, 20, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from light pink to pink, round, biconvex; the cut surface is from white to cream-colored.

	1 tab.
Rosuvastatin calcium	10.4 mg,
Equivalent to rosuvastatin content	10 mg

Excipients: lactose monohydrate (milk sugar), microcrystalline cellulose, calcium hydrogen phosphate (E341), crospovidone, magnesium stearate.

Coating composition lactose monohydrate (milk sugar), hypromellose (hydroxypropyl methylcellulose), titanium dioxide (E171), triacetin (glyceryl triacetate), iron oxide red dye (E172).

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.

Film-coated tablets from light pink to pink, round, biconvex; the cut surface is from white to cream-colored.

	1 tab.
Rosuvastatin calcium	20.8 mg,
Equivalent to rosuvastatin content	20 mg

Excipients: lactose monohydrate (milk sugar), microcrystalline cellulose, calcium hydrogen phosphate (E341), crospovidone, magnesium stearate.

Coating composition lactose monohydrate (milk sugar), hypromellose (hydroxypropyl methylcellulose), titanium dioxide (E171), triacetin (glyceryl triacetate), iron oxide red dye (E172).

Medixlife (Author)

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