Rosuvastatin (Tablets) Instructions for Use

Instructions
Dosage forms

ATC Code

C10AA07 (Rosuvastatin)

Active Substance

Rosuvastatin (Rec.INN WHO registered)

Clinical-Pharmacological Group

Hypolipidemic agent

Pharmacotherapeutic Group

Hypolipidemic agents; HMG-CoA reductase inhibitors

Pharmacological Action

Hypolipidemic agent from the group of statins, an inhibitor of HMG-CoA reductase. Through the principle of competitive antagonism, the statin molecule binds to the part of the coenzyme A receptor where this enzyme attaches. Another part of the statin molecule inhibits the process of converting hydroxymethylglutarate to mevalonate, an intermediate product in the synthesis of the cholesterol molecule. Inhibition of HMG-CoA reductase activity leads to a series of sequential reactions, resulting in a decrease in intracellular cholesterol content and a compensatory increase in LDL receptor activity and, accordingly, an acceleration of LDL cholesterol (C) catabolism.

The hypolipidemic effect of statins is associated with a decrease in total C levels due to LDL-C. The reduction in LDL levels is dose-dependent and is not linear but exponential in nature.

Statins do not affect the activity of lipoprotein and hepatic lipases, and do not have a significant effect on the synthesis and catabolism of free fatty acids; therefore, their effect on TG levels is secondary and mediated through their main effects of reducing LDL-C levels. The moderate reduction in TG levels during statin treatment is apparently associated with the expression of remnant (apo E) receptors on the surface of hepatocytes, which are involved in the catabolism of IDL, which contain approximately 30% TG.

In addition to the hypolipidemic effect, statins have a positive effect on endothelial dysfunction (a preclinical sign of early atherosclerosis), on the vascular wall, the state of the atheroma, improve the rheological properties of blood, and have antioxidant and antiproliferative properties.

The therapeutic effect appears within 1 week after the start of therapy and after 2 weeks of treatment is 90% of the maximum possible effect, which is usually achieved by the 4th week and thereafter remains constant.

Pharmacokinetics

After oral administration, the C_max of rosuvastatin in blood plasma is reached in approximately 5 hours. Bioavailability is approximately 20%.

Rosuvastatin accumulates in the liver. V_d is approximately 134 L. Binding to plasma proteins (mainly albumin) is approximately 90%.

It is biotransformed to a small extent (about 10%), being a non-profile substrate for the cytochrome P450 system isoenzymes. The main isoenzyme involved in the metabolism of rosuvastatin is CYP2C9. Isoenzymes CYP2C19, CYP3A4, and CYP2D6 are involved in the metabolism to a lesser extent.

The main identified metabolites of rosuvastatin are N-desmethyl and lactone metabolites. N-desmethyl is approximately 50% less active than rosuvastatin; lactone metabolites are pharmacologically inactive.

About 90% of the rosuvastatin dose is excreted unchanged in the feces. The remainder is excreted in the urine. Plasma T_1/2 is approximately 19 hours. T_1/2 does not change with increasing dose. The mean plasma clearance value 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 process of rosuvastatin, playing an important role in the hepatic elimination of rosuvastatin.

The systemic exposure of rosuvastatin increases proportionally with the dose.

In patients with severe renal failure (CrCl<30 ml/min), the plasma concentration of rosuvastatin is 3 times higher, and the concentration of N-desmethyl 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.

In patients with hepatic insufficiency of severity 8 and 9 on the Child-Pugh scale, an increase in T_1/2 of at least 2 times was noted.

Indications

Hypercholesterolemia (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 cholesterol-lowering therapy or in cases where such therapy is not suitable for the patient.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
E78.0	Pure hypercholesterolemia
E78.2	Mixed hyperlipidemia

ICD-11 code	Indication
5C80.00	Primary hypercholesterolemia
5C80.2	Mixed hyperlipidemia
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

Take orally. The recommended initial dose is 10 mg once a day. If necessary, the dose can be increased to 20 mg after 4 weeks. Increasing the dose to 40 mg is possible only in patients with severe hypercholesterolemia and a high risk of cardiovascular complications (especially in patients with familial hypercholesterolemia) with insufficient effectiveness at a dose of 20 mg and under medical supervision.

Adverse Reactions

Nervous system disorders frequent – headache, dizziness, asthenic syndrome; possible – anxiety, depression, insomnia, neuralgia, paresthesia.

Digestive system disorders: frequent – constipation, nausea, abdominal pain; possible – reversible transient dose-dependent increase in liver transaminase activity, dyspepsia (including diarrhea, flatulence, vomiting), gastritis, gastroenteritis.

Respiratory system disorders: frequent – pharyngitis; possible – rhinitis, sinusitis, bronchial asthma, bronchitis, cough, dyspnea, pneumonia.

Cardiovascular system disorders possible – angina pectoris, increased blood pressure, palpitations, vasodilation.

Musculoskeletal system disorders frequent – myalgia; possible – arthralgia, arthritis, muscle hypertonia, back pain, pathological limb fracture (without injury); rare – myopathy, rhabdomyolysis (concurrently with impaired renal function, while taking rosuvastatin at a dose of 40 mg); frequency unknown – occurrence or exacerbation of myasthenia.

Urinary system disorders tubular proteinuria (in less than 1% of cases – for doses of 10 and 20 mg, 3% of cases – for a dose of 40 mg); possible – peripheral edema (hands, feet, ankles, legs), lower abdominal pain, urinary tract infections.

Eye disorders frequency unknown – ocular myasthenia.

Allergic reactions possible – skin rash, skin itching; rare – angioedema.

Laboratory parameters transient dose-dependent increase in CPK activity (if CPK activity increases more than 5 times compared to ULN, therapy should be temporarily discontinued).

Other frequent – asthenic syndrome; possible – accidental injury, anemia, chest pain, diabetes mellitus, ecchymosis, flu-like syndrome, periodontal abscess.

Contraindications

Active liver disease (including persistent elevation of liver transaminases or any elevation of transaminases more than 3 times the ULN), severe renal impairment (CrCl<30 ml/min), myopathy, concurrent use of cyclosporine, pregnancy, lactation (breastfeeding), women of reproductive age not using adequate contraception, children and adolescents under 18 years of age, hypersensitivity to rosuvastatin.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Do not use in women of reproductive age who are not using reliable methods of contraception.

Use in Hepatic Impairment

Contraindicated in active liver diseases (including persistent elevation of liver transaminases or any elevation of transaminases more than 3 times the ULN).

Use in Renal Impairment

Contraindicated in severe renal impairment (CrCl<30 ml/min).

Pediatric Use

Contraindicated in children and adolescents under 18 years of age (since efficacy and safety have not been established).

Special Precautions

Use with caution in the presence of risk factors for the development of rhabdomyolysis (including renal failure, hypothyroidism, personal or family history of hereditary muscle diseases and previous history of muscle toxicity when using other HMG-CoA reductase inhibitors or fibrates), in chronic alcoholism, in patients over 65 years of age, with a history of liver disease, sepsis, arterial hypotension, during major surgical interventions, trauma, severe metabolic, endocrine or electrolyte disturbances, with uncontrolled epilepsy, in persons of Asian origin (Chinese, Japanese).

Therapy should be discontinued if the CPK level is significantly increased (more than 5 times the ULN) or if muscle symptoms are severe and cause daily discomfort (even if the CPK level is 5 times less than the ULN).

When using rosuvastatin at a dose of 40 mg, it is recommended to monitor renal function parameters.

In most cases, proteinuria decreases or disappears during therapy and does not indicate the occurrence of acute or progression of existing kidney disease.

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, azole antifungals, protease inhibitors and macrolide antibiotics. Gemfibrozil increases the risk of myopathy when co-administered with some HMG-CoA reductase inhibitors. Thus, simultaneous administration of rosuvastatin and gemfibrozil is not recommended. The risk-benefit ratio should be carefully weighed when using rosuvastatin concomitantly with fibrates or niacin.

It is recommended to determine liver function parameters before starting therapy and 3 months after starting therapy. The use of rosuvastatin should be discontinued or the dose reduced if the level of transaminase activity in the blood serum is 3 times the ULN.

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

Effect on the ability to drive vehicles and operate machinery

When engaging in potentially hazardous activities, patients should take into account that dizziness may occur during therapy.

Drug Interactions

With simultaneous use of rosuvastatin and cyclosporine, the AUC of rosuvastatin was on average 7 times higher than the value observed in healthy volunteers, while the plasma concentration of cyclosporine did not change.

Initiation of rosuvastatin therapy or an increase in the dose of the drug in patients simultaneously receiving vitamin K antagonists (e.g., warfarin) may lead to an increase in prothrombin time and INR, and discontinuation of rosuvastatin or a dose reduction may lead to a decrease in INR (in such cases, monitoring of INR is recommended).

Concomitant use of rosuvastatin and gemfibrozil leads to a 2-fold increase in C_max in blood plasma and the AUC of rosuvastatin.

Simultaneous use of rosuvastatin and antacids containing aluminum and magnesium 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 (clinical significance is unknown).

Simultaneous use of rosuvastatin and erythromycin leads to a decrease in the AUC of rosuvastatin by 20% and C_max of rosuvastatin by 30% (probably as a result of increased intestinal motility caused by taking erythromycin).

Simultaneous use of rosuvastatin and oral contraceptives increases the AUC of ethinyl estradiol and the AUC of norgestrel by 26% and 34%, respectively. Such interaction cannot be excluded with simultaneous use of rosuvastatin and hormone replacement therapy.

Gemfibrozil, other fibrates and hypolipidemic doses of nicotinic acid (≥1 g/day) increased the risk of myopathy when used simultaneously with other HMG-CoA reductase inhibitors, possibly because they can cause myopathy when used as monotherapy.

Concomitant use of rosuvastatin and itraconazole (a CYP3A4 inhibitor) increases the AUC of rosuvastatin by 28% (clinically insignificant).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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-Vertex [Vertex, JSC (Russia)]
Film-coated tablets, 5 mg: 28, 30, 56, 60, 84, or 90 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Rosuvastatin-Vertex

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

Dosage Form, Packaging, and Composition

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

	1 tab.
Rosuvastatin (as rosuvastatin calcium)	5 mg

Excipients: lactose monohydrate – 54.9 mg, microcrystalline cellulose – 18 mg, calcium hydrogen phosphate dihydrate – 6.5 mg, crospovidone – 4.5 mg, magnesium stearate – 0.9 mg.

Film coating composition: [hypromellose – 1.62 mg, talc – 0.54 mg, titanium dioxide – 0.2862 mg, macrogol 4000 (polyethylene glycol 4000) – 0.243 mg, iron oxide red (iron oxide) – 0.0108 mg] or [dry mixture for film coating, containing hypromellose (60%), talc (20%), titanium dioxide (10.6%), macrogol 4000 (polyethylene glycol 4000) (9%), iron oxide red (iron oxide) (0.4%) – 2.7 mg].

10 pcs. – blister packs (3) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.
14 pcs. – blister packs (4) – cardboard packs.
14 pcs. – blister packs (6) – cardboard packs.
15 pcs. – blister packs (2) – cardboard packs.
15 pcs. – blister packs (4) – cardboard packs.
15 pcs. – blister packs (6) – cardboard packs.
30 pcs. – blister packs (1) – cardboard packs.
30 pcs. – blister packs (3) – cardboard packs.
30 pcs. – high-density polyethylene jars (1) – cardboard packs.

Rosuvastatin-Vertex [Vertex, JSC (Russia)]
Film-coated tablets, 10 mg: 28, 30, 56, 60, 84, or 90 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Rosuvastatin-Vertex

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

Dosage Form, Packaging, and Composition

Film-coated tablets pink, oblong, biconvex, with a score on each side; the core is white or almost white in cross-section.

	1 tab.
Rosuvastatin (as rosuvastatin calcium)	10 mg

Excipients: lactose monohydrate – 109.8 mg, microcrystalline cellulose – 36 mg, calcium hydrogen phosphate dihydrate – 13 mg, crospovidone – 9 mg, magnesium stearate – 1.8 mg.

Film coating composition [hypromellose – 3.24 mg, talc – 1.08 mg, titanium dioxide – 0.5724 mg, macrogol 4000 (polyethylene glycol 4000) – 0.486 mg, iron oxide red (iron oxide) – 0.0216 mg] or [dry mixture for film coating, containing hypromellose (60%), talc (20%), titanium dioxide (10.6%), macrogol 4000 (polyethylene glycol 4000) (9%), iron oxide red (iron oxide) (0.4%) – 5.4 mg].

10 pcs. – blister packs (3) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.
14 pcs. – blister packs (4) – cardboard packs.
14 pcs. – blister packs (6) – cardboard packs.
15 pcs. – blister packs (2) – cardboard packs.
15 pcs. – blister packs (4) – cardboard packs.
15 pcs. – blister packs (6) – cardboard packs.
30 pcs. – high-density polyethylene jars (1) – cardboard packs.

Rosuvastatin-Vertex [Vertex, JSC (Russia)]
Film-coated tablets, 20 mg: 28, 30, 56, 60, 84, or 90 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Rosuvastatin-Vertex

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

Dosage Form, Packaging, and Composition

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

	1 tab.
Rosuvastatin (as rosuvastatin calcium)	20 mg

Excipients: lactose monohydrate – 219.6 mg, microcrystalline cellulose 102 – 72 mg, calcium hydrogen phosphate dihydrate – 26 mg, crospovidone – 18 mg, magnesium stearate – 3.6 mg.

Film coating composition[hypromellose – 6.48 mg, talc – 2.16 mg, titanium dioxide – 1.1448 mg, macrogol 4000 (polyethylene glycol 4000) – 0.9720 mg, iron oxide red (iron oxide) – 0.0432 mg]or[dry mix for film coating containing hypromellose (60%), talc (20%), titanium dioxide (10.6%), macrogol 4000 (polyethylene glycol 4000) (9%), iron oxide red (iron oxide) (0.4%) – 10.8 mg].

10 pcs. – contour cell packs (3) – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.
14 pcs. – contour cell packs (6) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.
15 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – high-density polyethylene jars (1) – cardboard packs.

Rosuvastatin-Vertex [Vertex, JSC (Russia)]
Film-coated tablets, 40 mg: 28, 30, 60, or 90 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Rosuvastatin-Vertex

Film-coated tablets, 40 mg: 28, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pink, oblong, biconvex, with a score on each side; the core on the cross-section is white or almost white.

	1 tab.
Rosuvastatin (as rosuvastatin calcium)	40 mg

Excipients: lactose monohydrate – 439.2 mg, microcrystalline cellulose 102 – 144 mg, calcium hydrogen phosphate dihydrate – 52 mg, crospovidone – 36 mg, magnesium stearate – 7.2 mg.

Film coating composition[hypromellose – 12.96 mg, talc – 4.32 mg, titanium dioxide – 2.2896 mg, macrogol 4000 (polyethylene glycol 4000) – 1.944 mg, iron oxide red (iron oxide) – 0.0864 mg]or[dry mix for film coating containing hypromellose (60%), talc (20%), titanium dioxide (10.6%), macrogol 4000 (polyethylene glycol 4000) (9%), iron oxide red (iron oxide) (0.4%) – 21.6 mg].

6 pcs. – contour cell packs (5) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.
14 pcs. – contour cell packs (6) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.
15 pcs. – contour cell packs (6) – cardboard packs.

Rosuvastatin Avexima [Avexima JSC (Russia)]
Film-coated tablets 10 mg: 10, 20, 30 or 60 pcs.
Film-coated tablets 20 mg: 10, 20, 30 or 60 pcs.
Film-coated tablets 40 mg: 10, 20, 30, or 60 pcs.

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Forms

	Rosuvastatin Avexima	Film-coated tablets 10 mg: 10, 20, 30 or 60 pcs.
		Film-coated tablets 20 mg: 10, 20, 30 or 60 pcs.
		Film-coated tablets 40 mg: 10, 20, 30, or 60 pcs.

Dosage Form, Packaging, and Composition

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

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

Excipients: microcrystalline cellulose 102, lactose monohydrate, calcium hydrogen phosphate dihydrate, crospovidone, magnesium stearate.

Film coating composition: lactose monohydrate, hypromellose, triacetin, titanium dioxide, iron oxide red dye.

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 (6) – cardboard packs.
30 pcs. – polyethylene jars (1) – cardboard packs.

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

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

Excipients: microcrystalline cellulose 102, lactose monohydrate, calcium hydrogen phosphate dihydrate, crospovidone, magnesium stearate.

Film coating composition: lactose monohydrate, hypromellose, triacetin, titanium dioxide, iron oxide red dye.

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

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

Excipients: microcrystalline cellulose 102, lactose monohydrate, calcium hydrogen phosphate dihydrate, crospovidone, magnesium stearate.

Film coating composition: lactose monohydrate, hypromellose, triacetin, titanium dioxide, iron oxide red dye.

Rosuvastatin Avva [Avva Rus, JSC (Russia)]
Film-coated tablets 5 mg
Film-coated tablets 10 mg
Film-coated tablets, 20 mg

Marketing Authorization Holder

Avva Rus, JSC (Russia)

Dosage Forms

	Rosuvastatin Avva	Film-coated tablets 5 mg
		Film-coated tablets 10 mg
		Film-coated tablets, 20 mg

Dosage Form, Packaging, and Composition

Film-coated tablets

	1 tab.
Rosuvastatin (as rosuvastatin calcium)	5 mg

10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – By prescription
10 pcs. – contour cell packs (9 pcs.) – cardboard packs (90 pcs.) – By prescription
15 pcs. – contour cell packs (2 pcs.) – cardboard packs (30 pcs.) – By prescription
15 pcs. – contour cell packs (6 pcs.) – cardboard packs (90 pcs.) – By prescription
30 pcs. – jars – cardboard packs (30 pcs.) – By prescription
60 pcs. – jars – cardboard packs (60 pcs.) – By prescription
90 pcs. – jars – cardboard packs (90 pcs.) – By prescription

Film-coated tablets

	1 tab.
Rosuvastatin (as rosuvastatin calcium)	10 mg

10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – By prescription
10 pcs. – contour cell packs (6 pcs.) – cardboard packs (60 pcs.) – By prescription
10 pcs. – contour cell packs (9 pcs.) – cardboard packs (90 pcs.) – By prescription
15 pcs. – contour cell packs (2 pcs.) – cardboard packs (30 pcs.) – By prescription
15 pcs. – contour cell packs (4 pcs.) – cardboard packs (60 pcs.) – By prescription
15 pcs. – contour cell packs (6 pcs.) – cardboard packs (90 pcs.) – By prescription
30 pcs. – jars – cardboard packs (30 pcs.) – By prescription
60 pcs. – jars – cardboard packs (60 pcs.) – By prescription
90 pcs. – jars – cardboard packs (90 pcs.) – By prescription

Film-coated tablets

	1 tab.
Rosuvastatin (as rosuvastatin calcium)	20 mg

Rosuvastatin Canon [Canonpharma Production, CJS (Russia)]
Film-coated tablets, 10 mg: 7, 10, 14, 20, 28, 30, 56, or 60 pcs.
Film-coated tablets, 20 mg: 7, 10, 14, 20, 28, 30, 56, or 60 pcs.
Film-coated tablets, 40 mg: 7, 10, 14, 20, 28, 30, 56, or 60 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Forms

	Rosuvastatin Canon	Film-coated tablets, 10 mg: 7, 10, 14, 20, 28, 30, 56, or 60 pcs.
		Film-coated tablets, 20 mg: 7, 10, 14, 20, 28, 30, 56, or 60 pcs.
		Film-coated tablets, 40 mg: 7, 10, 14, 20, 28, 30, 56, or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets red, round, biconvex, with a score; on the cross-section – the core is almost white.

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

Excipients: calcium hydrogen phosphate dihydrate – 44.2 mg, corn starch pregelatinized – 41.8 mg, magnesium stearate – 1 mg, povidone – 7 mg, microcrystalline cellulose – 35.6 mg.

Film coating composition Selecote AQ-01032 red – 4 mg (hypromellose (hydroxypropyl methylcellulose) – 1.6 mg, macrogol-400 (polyethylene glycol 400) – 0.4 mg, macrogol-6000 (polyethylene glycol 6000) – 0.4 mg, titanium dioxide – 1.2 mg, aluminum lake based on Ponceau 4R dye – 0.4 mg).

7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (8) – 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 (6) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.

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

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

Excipients: calcium hydrogen phosphate dihydrate – 66.3 mg, corn starch pregelatinized – 57.5 mg, magnesium stearate – 1.5 mg, povidone – 10.5 mg, microcrystalline cellulose – 53.4 mg.

Film coating composition Selecote AQ-01032 red – 6 mg (hypromellose (hydroxypropyl methylcellulose) – 2.4 mg, macrogol-400 (polyethylene glycol 400) – 0.6 mg, macrogol-6000 (polyethylene glycol 6000) – 0.6 mg, titanium dioxide – 1.8 mg, aluminum lake based on Ponceau 4R dye – 0.6 mg).

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

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

Excipients: calcium hydrogen phosphate dihydrate – 101 mg, corn starch pregelatinized – 80.3 mg, magnesium stearate – 2.5 mg, povidone – 13.4 mg, microcrystalline cellulose – 81.2 mg.

Film coating composition Selecote AQ-01032 red – 10 mg (hypromellose (hydroxypropyl methylcellulose) – 4 mg, macrogol-400 (polyethylene glycol 400) – 1 mg, macrogol-6000 (polyethylene glycol 6000) – 1 mg, titanium dioxide – 3 mg, aluminum lake based on Ponceau 4R dye – 1 mg).

Rosuvastatin Medisorb [Medisorb, JSC (Russia)]
Film-coated tablets, 5 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, 56, 60, 80, 84, or 112 pcs.

Marketing Authorization Holder

Medisorb, JSC (Russia)

Dosage Form

Rosuvastatin Medisorb

Film-coated tablets, 5 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, 56, 60, 80, 84, or 112 pcs.

Dosage Form, Packaging, and Composition

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

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

Excipients: lactose monohydrate (milk sugar), microcrystalline cellulose type 102, calcium phosphate, croscarmellose sodium, calcium stearate.

Coating composition OPADRY^® II (85F18422) (polyvinyl alcohol, titanium dioxide, macrogol, talc).

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 (6) – cardboard packs.
7 pcs. – contour cell packs (8) – 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 (6) – cardboard packs.
10 pcs. – contour cell packs (8) – 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 (6) – cardboard packs.
14 pcs. – contour cell packs (8) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
56 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
112 pcs. – polymer jars (1) – cardboard packs.

Rosuvastatin Medisorb [Medisorb, JSC (Russia)]
Film-coated tablets, 10 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, 56, 60, 80, 84, or 112 pcs.

Marketing Authorization Holder

Medisorb, JSC (Russia)

Dosage Form

Rosuvastatin Medisorb

Film-coated tablets, 10 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, 56, 60, 80, 84, or 112 pcs.

Dosage Form, Packaging, and Composition

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

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

Excipients: lactose monohydrate (milk sugar), microcrystalline cellulose type 102, calcium phosphate, croscarmellose sodium, calcium stearate.

Shell composition OPADRY^® II (85F18422) (polyvinyl alcohol, titanium dioxide, macrogol, talc).

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 (6) – cardboard packs.
7 pcs. – contour cell blisters (8) – 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 (6) – cardboard packs.
10 pcs. – contour cell blisters (8) – 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 (6) – cardboard packs.
14 pcs. – contour cell blisters (8) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
56 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
112 pcs. – polymer jars (1) – cardboard packs.

Rosuvastatin Medisorb [Medisorb, JSC (Russia)]
Film-coated tablets, 20 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, 56, 60, 80, 84, or 112 pcs.

Marketing Authorization Holder

Medisorb, JSC (Russia)

Dosage Form

Rosuvastatin Medisorb

Film-coated tablets, 20 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, 56, 60, 80, 84, or 112 pcs.

Dosage Form, Packaging, and Composition

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

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

Excipients: lactose monohydrate (milk sugar), microcrystalline cellulose type 102, calcium phosphate, croscarmellose sodium, calcium stearate.

Shell composition OPADRY^® II (85F18422) (polyvinyl alcohol, titanium dioxide, macrogol, talc).

Rosuvastatin PhT [Pharmtekhnologiya LLC (Republic of Belarus)]
Film-coated tablets, 5 mg: 30 pcs.
Film-coated tablets, 10 mg: 30 pcs.
Film-coated tablets, 20 mg: 30 pcs.

Marketing Authorization Holder

Pharmtekhnologiya LLC (Republic of Belarus)

Dosage Forms

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

Dosage Form, Packaging, and Composition

Film-coated tablets pink, round, biconvex.

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

Excipients: microcrystalline cellulose, crospovidone, povidone, magnesium stearate, lactose monohydrate.

Film coating composition lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide red (E172).

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

Film-coated tablets pink, round, biconvex, with a score on one side.

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

Excipients: microcrystalline cellulose, crospovidone, povidone, magnesium stearate, lactose monohydrate.

Film coating composition lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide red (E172).

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

Film-coated tablets pink, round, biconvex.

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

Excipients: microcrystalline cellulose, crospovidone, povidone, magnesium stearate, lactose monohydrate.

Film coating composition lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide red color (E172).

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

Rosuvastatin Renewal [Obnovlenie Pfc, JSC (Russia)]
Film-coated tablets, 5 mg: 30, 60, or 90 pcs.
Film-coated tablets, 10 mg: 30, 60, or 90 pcs.
Film-coated tablets, 20 mg: 30, 60 or 90 pcs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Forms

	Rosuvastatin Renewal	Film-coated tablets, 5 mg: 30, 60, or 90 pcs.
		Film-coated tablets, 10 mg: 30, 60, or 90 pcs.
		Film-coated tablets, 20 mg: 30, 60 or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from light pink to pink, round, biconvex; surface roughness is allowed; the core on the cross-section is white or almost white.

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

Excipients: lactose monohydrate, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, crospovidone, magnesium stearate.

Shell composition: hypromellose, talc, titanium dioxide, macrogol 4000, iron oxide red color (E172).

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; surface roughness is allowed; the core on the cross-section is white or almost white.

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

Excipients: lactose monohydrate, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, crospovidone, magnesium stearate.

Shell composition: hypromellose, talc, titanium dioxide, macrogol 4000, iron oxide red color (E172).

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; surface roughness is allowed; the core on the cross-section is white or almost white.

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

Excipients: lactose monohydrate, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, crospovidone, magnesium stearate.

Shell composition: hypromellose, talc, titanium dioxide, macrogol 4000, iron oxide red color (E172).

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

Rosuvastatin Velpharm [Velpharm, LLC (Russia)]
Film-coated tablets 5 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 84, 90, 98, 100, 112, 126, or 140 pcs.
Film-coated tablets 10 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 84, 90, 98, 100, 112, 126, or 140 pcs.
Film-coated tablets 20 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 84, 90, 98, 100, 112, 126, or 140 pcs.
Film-coated tablets 40 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 84, 90, 98, 100, 112, 126 or 140 pcs.

Marketing Authorization Holder

Velpharm, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

Velpharm-M, LLC (Russia)

Dosage Forms

	Rosuvastatin Velpharm	Film-coated tablets 5 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 84, 90, 98, 100, 112, 126, or 140 pcs.
		Film-coated tablets 10 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 84, 90, 98, 100, 112, 126, or 140 pcs.
		Film-coated tablets 20 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 84, 90, 98, 100, 112, 126, or 140 pcs.
		Film-coated tablets 40 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 84, 90, 98, 100, 112, 126 or 140 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Rosuvastatin calcium	5.2 mg,
Equivalent to rosuvastatin content	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 PH102.
Shell composition dry mix for film coating containing polyvinyl alcohol, titanium dioxide, macrogol, talc, carmine, iron oxide yellow color.

7 pcs. – contour cell blister (from 1 to 10) – cardboard packs.
10 pcs. – contour cell blister (from 1 to 10) – cardboard packs.
14 pcs. – contour cell blister (from 1 to 10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
70 pcs. – polymer jars (1) – cardboard packs.
80 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

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

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

7 pcs. – contour cell blisters (from 1 to 10) – cardboard packs.
10 pcs. – contour cell blisters (from 1 to 10) – cardboard packs.
14 pcs. – contour cell blisters (from 1 to 10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
70 pcs. – polymer jars (1) – cardboard packs.
80 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

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

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

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

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

Rosuvastatin- Vial [Vial, LLC (Russia)]
Film-coated tablets, 20 mg: 30, 40, 60 pcs.

Marketing Authorization Holder

Vial, LLC (Russia)

Manufactured By

Protech Biosystems, Pvt. Ltd. (India)

Dosage Form

Rosuvastatin-Vial

Film-coated tablets, 20 mg: 30, 40, 60 pcs.

Dosage Form, Packaging, and Composition

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

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

Excipients: corn starch – 115.5 mg, microcrystalline cellulose – 55 mg, lactose monohydrate – 90 mg, sodium carboxymethyl starch – 7.5 mg, magnesium stearate – 6 mg, talc – 4.25 mg, croscarmellose sodium – 4 mg, colloidal silicon dioxide – 3 mg, methylparaben – 0.35 mg, propylparaben – 0.07 mg.

Excipients (shell): hypromellose, 15 cP – 5.004 mg, titanium dioxide – 1.603 mg, dibutyl sebacate – 1.395 mg, talc – 1.466 mg, hypromellose, 5 cP – 0.999 mg, colloidal silicon dioxide – 0.603 mg.

10 pcs. – PVC/aluminum foil blisters (3) – cardboard packs.
40 pcs. – polyethylene containers (1) – cardboard packs.
50 pcs. – polyethylene containers (1) – cardboard packs.

Rosuvastatin- Vial [Vial, LLC (Russia)]
Film-coated tablets, 10 mg: 30, 40, 60 pcs.

Marketing Authorization Holder

Vial, LLC (Russia)

Manufactured By

Protech Biosystems, Pvt. Ltd. (India)

Dosage Form

Rosuvastatin-Vial

Film-coated tablets, 10 mg: 30, 40, 60 pcs.

Dosage Form, Packaging, and Composition

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

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

Excipients: corn starch – 73.25 mg, microcrystalline cellulose – 30 mg, lactose monohydrate – 52.5 mg, sodium carboxymethyl starch – 3.75 mg, magnesium stearate – 3 mg, talc – 2.125 mg, croscarmellose sodium – 2 mg, colloidal silicon dioxide – 1.5 mg, methylparaben – 0.175 mg, propylparaben – 0.035 mg.

Excipients (shell): hypromellose, 15 cP – 2.919 mg, titanium dioxide – 0.852 mg, dibutyl sebacate – 0.814 mg, talc – 0.768 mg, hypromellose, 5 cP – 0.582 mg, colloidal silicon dioxide – 0.352 mg.

10 pcs. – PVC/aluminum foil blisters (3) – cardboard packs.
40 pcs. – polyethylene containers (1) – cardboard packs.
50 pcs. – polyethylene containers (1) – cardboard packs.

Rosuvastatin-Akrikhin [Polpharma Pharmaceutical Works, Sa (Poland)]
Film-coated tablets, 5 mg: 30 pcs.
Film-coated tablets, 10 mg: 30 pcs.
Film-coated tablets, 20 mg: 30 pcs.
Film-coated tablets, 40 mg: 30 pcs.

Marketing Authorization Holder

Polpharma Pharmaceutical Works, Sa (Poland)

Manufactured By

Pharmaceutical Works “Polpharma”, SA (Poland)

Labeled By

Pharmaceutical Works “POLPHARMA”, SA (Poland)

AKRIKHIN Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Forms

	Rosuvastatin-Akrikhin	Film-coated tablets, 5 mg: 30 pcs.
		Film-coated tablets, 10 mg: 30 pcs.
		Film-coated tablets, 20 mg: 30 pcs.
		Film-coated tablets, 40 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; engraved with “5” on one side; the core on the cross-section is white or almost white.

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

Excipients: lactose monohydrate type 1, lactose monohydrate type 2, microcrystalline cellulose, sodium citrate, crospovidone type B, colloidal anhydrous silicon dioxide, magnesium stearate.

Film coating composition Opadry II White 33G28523 (hypromellose, lactose monohydrate, macrogol 3350, triacetin, titanium dioxide (E171)).

10 pcs. – blisters (3) – cardboard packs.

Film-coated tablets white or almost white, round, biconvex; engraved with “10” on one side; the core on the cross-section is white or almost white.

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

Excipients: lactose monohydrate type 1, lactose monohydrate type 2, microcrystalline cellulose, sodium citrate, crospovidone type B, colloidal anhydrous silicon dioxide, magnesium stearate.

Film coating composition Opadry II White 33G28523 (hypromellose, lactose monohydrate, macrogol 3350, triacetin, titanium dioxide (E171)).

10 pcs. – blisters (3) – cardboard packs.

Film-coated tablets white or almost white, round, biconvex; engraved with “20” on one side; the core on the cross-section is white or almost white.

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

Excipients: lactose monohydrate type 1, lactose monohydrate type 2, microcrystalline cellulose, sodium citrate, crospovidone type B, colloidal anhydrous silicon dioxide, magnesium stearate.

Film coating composition Opadry II White 33G28523 (hypromellose, lactose monohydrate, macrogol 3350, triacetin, titanium dioxide (E171)).

10 pcs. – blisters (3) – cardboard packs.

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

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

Excipients: lactose monohydrate type 1, lactose monohydrate type 2, microcrystalline cellulose, sodium citrate, crospovidone type B, colloidal anhydrous silicon dioxide, magnesium stearate.

Film coating composition Opadry II White 33G28523 (hypromellose, lactose monohydrate, macrogol 3350, triacetin, titanium dioxide (E171)).

10 pcs. – blisters (3) – cardboard packs.

Rosuvastatin-Alium [Aliym, JSC (Russia)]
Film-coated tablets, 5 mg: from 7 to 180 pcs.
Film-coated tablets, 10 mg: from 7 to 180 pcs.
Film-coated tablets, 20 mg: from 7 to 180 pcs.
Film-coated tablets, 40 mg: from 7 to 180 pcs.

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Forms

	Rosuvastatin-Alium	Film-coated tablets, 5 mg: from 7 to 180 pcs.
		Film-coated tablets, 10 mg: from 7 to 180 pcs.
		Film-coated tablets, 20 mg: from 7 to 180 pcs.
		Film-coated tablets, 40 mg: from 7 to 180 pcs.

Dosage Form, Packaging, and Composition

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

	1 tab.
Rosuvastatin calcium	5.315 mg,
Equivalent to rosuvastatin content	5 mg

Excipients: calcium hydrogen phosphate dihydrate – 16.3 mg, hypromellose (hydroxypropyl cellulose) – 2.385 mg, crospovidone – 3.5 mg, lactose monohydrate – 59 mg, microcrystalline cellulose – 12.5 mg, magnesium stearate – 1 mg.

Shell composition ready-made mixture for pink film coating [polyvinyl alcohol – 1.2 mg, macrogol – 0.606 mg, talc – 0.444 mg, titanium dioxide – 0.702 mg, aluminum lake based on brilliant red dye – 0.017 mg, aluminum lake based on azorubine dye – 0.014 mg, aluminum lake based on sunset yellow dye – 0.017 mg].

From 7 to 30 pcs. – contour cell blisters (from 1 to 6 pcs.) – cardboard packs.

Film-coated tablets pink, biconvex, oblong with rounded ends, with a score; the core on the cross-section is white or almost white.

	1 tab.
Rosuvastatin calcium	10.63 mg,
Equivalent to rosuvastatin content	10 mg

Excipients: calcium hydrogen phosphate dihydrate – 14 mg, hypromellose (hydroxypropyl cellulose) – 2.2 mg, crospovidone – 3.5 mg, lactose monohydrate – 56.17 mg, microcrystalline cellulose – 12.5 mg, magnesium stearate – 1 mg.

From 7 to 30 pcs. – contour cell blisters (from 1 to 6 pcs.) – cardboard packs.

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

	1 tab.
Rosuvastatin calcium	21.26 mg,
Equivalent to rosuvastatin content	20 mg

Excipients: calcium hydrogen phosphate dihydrate – 28 mg, hypromellose (hydroxypropyl cellulose) – 4.4 mg, crospovidone – 7 mg, lactose monohydrate – 112.34 mg, microcrystalline cellulose – 25 mg, magnesium stearate – 2 mg.

Shell composition ready-made mixture for pink film coating [polyvinyl alcohol – 2.4 mg, macrogol – 1.212 mg, talc – 0.888 mg, titanium dioxide – 1.404 mg, aluminum lake based on brilliant red dye – 0.034 mg, aluminum lake based on azorubine dye – 0.028 mg, aluminum lake based on sunset yellow dye – 0.034 mg].

From 7 to 30 pcs. – contour cell blisters (from 1 to 6 pcs.) – cardboard packs.

Film-coated tablets pink, biconvex, oblong with rounded ends, with a score; the core on the cross-section is white or almost white.

	1 tab.
Rosuvastatin calcium	42.52 mg,
Equivalent to rosuvastatin content	40 mg

Excipients: calcium hydrogen phosphate dihydrate – 56 mg, hypromellose (hydroxypropyl cellulose) – 8.8 mg, crospovidone – 14 mg, lactose monohydrate – 224.68 mg, microcrystalline cellulose – 50 mg, magnesium stearate – 4 mg.

Shell composition ready-made mixture for pink film coating [polyvinyl alcohol – 4.8 mg, macrogol – 2.424 mg, talc – 1.776 mg, titanium dioxide – 2.808 mg, aluminum lake based on brilliant red dye – 0.068 mg, aluminum lake based on azorubine dye – 0.056 mg, aluminum lake based on sunset yellow dye – 0.068 mg].

From 7 to 30 pcs. – contour cell blisters (from 1 to 6 pcs.) – cardboard packs.

Rosuvastatin-LekT [Patent-Pharm, JSC (Russia)]
Film-coated tablets, 10 mg: 10, 30 or 90 pcs.
Film-coated tablets, 20 mg: 10, 30 or 90 pcs.
Film-coated tablets, 40 mg: 10, 30 or 90 pcs.

Marketing Authorization Holder

Patent-Pharm, JSC (Russia)

Manufactured By

Tyumen Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Forms

	Rosuvastatin-LekT	Film-coated tablets, 10 mg: 10, 30 or 90 pcs.
		Film-coated tablets, 20 mg: 10, 30 or 90 pcs.
		Film-coated tablets, 40 mg: 10, 30 or 90 pcs.

Dosage Form, Packaging, and Composition

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

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

Excipients: anhydrous lactose – 76.1 mg, microcrystalline cellulose MCC 102 – 58.6 mg, croscarmellose sodium – 3.5 mg, calcium stearate – 0.7 mg, colloidal silicon dioxide – 0.7 mg.

Film coating composition: OPADRY II white 85F48105 (polyvinyl alcohol, macrogol-3350, talc, titanium dioxide) – 0.7 mg.

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

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

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

Excipients: anhydrous lactose – 152.2 mg, microcrystalline cellulose MCC 102 – 117.2 mg, croscarmellose sodium – 7 mg, calcium stearate – 1.4 mg, colloidal silicon dioxide – 1.4 mg.

Film coating composition: OPADRY II white 85F48105 (polyvinyl alcohol, macrogol-3350, talc, titanium dioxide) – 10 mg.

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

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

	1 tab.
Rosuvastatin calcium	41.16 mg,
Equivalent to rosuvastatin content	40 mg

Excipients: anhydrous lactose – 304.4 mg, microcrystalline cellulose MCC 102 – 234.4 mg, croscarmellose sodium – 14 mg, calcium stearate – 2.8 mg, colloidal silicon dioxide – 2.8 mg.

Film coating composition: OPADRY II white 85F48105 (polyvinyl alcohol, macrogol-3350, talc, titanium dioxide) – 20 mg.

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

Rosuvastatin-Xantis [Xantis Pharma, Limited (Cyprus)]
Film-coated tablets, 5 mg: 30, 60, or 90 pcs.
Film-coated tablets, 10 mg: 30, 60, or 90 pcs.
Film-coated tablets, 20 mg: 30, 60 or 90 pcs.

Marketing Authorization Holder

Xantis Pharma, Limited (Cyprus)

Manufactured By

Alsi Pharma, JSC (Russia)

Dosage Forms

	Rosuvastatin-Xantis	Film-coated tablets, 5 mg: 30, 60, or 90 pcs.
		Film-coated tablets, 10 mg: 30, 60, or 90 pcs.
		Film-coated tablets, 20 mg: 30, 60 or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from light pink to pink, round, biconvex; on the cross-section – the inner layer is white or almost white.

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

Excipients: microcrystalline cellulose (type 102) – 49.19 mg, pregelatinized starch – 24 mg, colloidal silicon dioxide (aerosil) – 0.8 mg, magnesium stearate – 0.8 mg.

Shell composition Opadry II pink (85F240181) – 3.2 mg (polyvinyl alcohol – 1.28 mg, titanium dioxide – 0.78 mg, macrogol (polyethylene glycol) – 0.65 mg, talc – 0.47 mg, dye carmine red (E120) – 0.02 mg).

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; on the cross-section – the inner layer is white or almost white.

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

Excipients: microcrystalline cellulose (type 102) – 98.37 mg, pregelatinized starch – 48 mg, colloidal silicon dioxide (aerosil) – 1.6 mg, magnesium stearate – 1.6 mg.

Coating composition Opadry II pink (85F240181) – 6.4 mg (polyvinyl alcohol – 2.56 mg, titanium dioxide – 1.56 mg, macrogol (polyethylene glycol) – 1.3 mg, talc – 0.94 mg, dye carmine red (E120) – 0.04 mg).

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

Film-coated tablets from light pink to pink in color, round, biconvex; on the cross-section – the inner layer is white or almost white.

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

Excipients : microcrystalline cellulose (type 102) – 196.76 mg, pregelatinized starch – 96 mg, colloidal silicon dioxide (aerosil) – 3.2 mg, magnesium stearate – 3.2 mg.

Coating composition Opadry II pink (85F240181) – 12.8 mg (polyvinyl alcohol – 5.12 mg, titanium dioxide – 3.12 mg, macrogol (polyethylene glycol) – 2.6 mg, talc – 1.88 mg, dye carmine red (E120) – 0.08 mg).

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

Medixlife (Author)

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