Rosuvastatin, 10 mg 90 pcs

Special Instructions

Influence on renal function

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

Motor system disorders

The following musculoskeletal effects have been reported with rosuvastatin at all doses and particularly with doses above 20 mg: Myalgia, myopathy, rhabdomyolysis (in rare cases).

Creatine phosphokinase (CPK)

The determination of CPK activity should not be performed after intense physical activity or in the presence of other possible causes of increased CPK activity, which may lead to misinterpretation of the results. If the baseline CPK activity is significantly elevated (5 times higher than VGN), a repeat measurement should be performed after 5-7 days. The therapy should not be started if the repeat test confirms the initial CPK activity (higher by more than 5 times compared to IGN).

Before initiating therapy

Before using rosuvastatin, as well as before using other HMG-CoA reductase inhibitors, the risk-benefit ratio of therapy in patients with existing risk factors for myopathy/rhabdomyolysis should be considered (see section “Caution.

Cautions should be taken and these patients should be closely monitored by a physician.

At the time of treatment

The patient should be informed to inform the physician immediately if new, previously unreported symptoms of unexplained muscle pain, muscle weakness or seizures occur, especially if combined 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-fold compared to IGN) or if muscle symptoms and daily discomfort are acute (even if CPK activity is 5-fold lower than IGN). If symptoms disappear and CPK activity returns to normal, re-administration of rosuvastatin or other HMG-CoA reductase inhibitors at lower doses with close patient monitoring should be considered.

Routine monitoring of CPK activity in the absence of the symptoms described above is not advisable.

There have been very rare cases of immune-mediated necrotizing myopathy with clinical manifestations as persistent proximal muscle weakness and elevated plasma CPK activity during therapy or upon discontinuation of statins, including rosuvastatin. Additional muscular and nervous system studies, serologic studies, and therapy with immunosuppressive agents may be required.

There have been no indications of increased skeletal muscle effects with rosuvastatin and concomitant therapy. However, an increase in myositis and myopathy has been reported in patients taking other HMG-CoA reductase inhibitors in combination with fibrin acid derivatives, including gemfibrozil, cyclosporine, nicotinic acid, azole antifungals, protease inhibitors and macrolide antibiotics. Gemfibrozil increases the risk of myopathy when concomitantly prescribed with some HMG-CoA reductase inhibitors. Thus, concomitant administration of rosuvastatin and gemfibrozil is not recommended.

The risk/benefit ratio of co-administration of rosuvastatin and fibrates or lipid-lowering doses of nicotinic acid should be carefully weighed. Rosuvastatin at a dose of 40 mg in combination with fibrates is contraindicated (see sections “Contraindications” and “Interactions with other medicinal products”).

Two to four weeks after the start of treatment and/or when increasing the dose of Rosuvastatin-Teva it is necessary to monitor lipid metabolism parameters; if necessary, the dose of the drug is adjusted.

Influence on liver function

The determination of liver function parameters before the start of therapy and 3 months after the start of therapy is recommended. Rosuvastatin should be discontinued or the dose should be reduced if plasma hepatic transaminase activity is 3 times greater than BHF.

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

There are no data or experience with rosuvastatin in patients with severe hepatic impairment (above 9 points on the Child-Pugh score).

Special populations. Ethnic groups

In pharmacokinetic studies in Chinese and Japanese patients, increased systemic concentrations of rosuvastatin have been observed compared to those obtained in European patients (see sections “Pharmacokinetics” and “Administration and Doses”).

HIV protease inhibitors

The co-administration of rosuvastatin with HIV protease inhibitors is not recommended (see section “Interaction with other medicinal products”).

Interstitial lung disease

Single cases of interstitial lung disease have been reported with some statins, especially for long periods of time. Manifestations of the disease may include dyspnea, non-productive cough, and deterioration in general well-being (weakness, weight loss, and fever). If interstitial lung disease is suspected, statin therapy should be discontinued.

Type 2 diabetes mellitus

In patients with glucose concentrations between 5.6 and 6.9 mmol/L, rosuvastatin therapy has been associated with an increased risk of developing type 2 diabetes mellitus.

Influence on ability to drive vehicles and mechanisms

There have been no studies on the effect of the drug Rosuvastatin-Teva on the ability to drive vehicles and mechanisms. When using Rosuvastatin-Teva, caution should be exercised when driving vehicles or working that requires high concentration and quick psychomotor reactions.

Synopsis

Tablets 5 mg. Circular biconvex film-coated tablets, light yellow or light orange (grayish tint possible) to orange in color, engraved “N” on one side and “5” on the other.

Tablets 10 mg. Circular biconvex film-coated tablets, light pink to pink in color, engraved “N” on one side and “10” on the other.

Tablets 20 mg. Circular biconvex film-coated tablets, light pink to pink in color, engraved “N” on one side and “20” on the other.

Tablets 40 mg. Oval film-coated tablets, light pink to pink in color, engraved “N” on one side and “40” on the other.

Contraindications

For doses of the drug of 5 mg, 10 mg, 20 mg:

• hypersensitivity to rosuvastatin and/or any of the excipients in the drug;
• active liver disease, including a persistent increase in hepatic transaminase activity and any increase in plasma hepatic transaminase activity (more than 3 times the upper limit of normal (ULN));
• severe renal failure (CKR less than 30 ml/min);
• myopathy;
• current use of cyclosporine;
• in women: pregnancy, breastfeeding period, lack of adequate contraceptive methods in women with preserved reproductive function;
• age less than 18 years old (due to lack of data on efficacy and safety in children and adolescents less than 18 years old);
• lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome (the drug contains lactose).

For the drug dosage of 40 mg:

• hypersensitivity to rosuvastatin and/or any of the excipients in the drug;
• active-phase liver disease, including persistent elevation of “hepatic” transaminase activity and any increase in plasma “hepatic” transaminase activity (more than 3 times that of IHN);
• Patients with risk factors for myopathy/rhabdomyolysis, viz:
• moderate renal insufficiency (CK less than 60 mL/min);
• hypothyroidism;
• myotoxicity with a history of taking other HMG-CoA reductase inhibitors or fibrates;
excessive alcohol consumption;
• conditions that may lead to increased plasma concentrations of rosuvastatin;
• concomitant use of fibrates;
• Patients of Asian race;
• concomitant use of cyclosporine;
• in women: pregnancy, breastfeeding period, lack of adequate contraceptive methods in women with preserved reproductive function;
• age less than 18 years old (due to lack of data on efficacy and safety in children and adolescents less than 18 years old);
• lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome (the drug contains lactose).

Cautions

For drug doses of 5 mg, 10 mg, 20 mg:

The presence of risk factors for myopathy and/or rhabdomyolysis – renal failure, hypothyroidism, personal or family history of hereditary muscle disease and prior history of muscle toxicity with other HMG-CoA reductase inhibitor or fibrate medications; excessive alcohol intake, age over 65 years conditions with increased plasma concentrations of rosuvastatin; race (Asian race), concomitant use with fibrates, history of liver disease, sepsis, arterial hypotension, major surgery, trauma, severe metabolic, endocrine or electrolyte disorders or uncontrolled seizures.

For a dosage of 40 mg:

Mild renal impairment (CK greater than 60 mL/min), age over 65 years, history of liver disease, sepsis, arterial hypotension, extensive surgery, trauma, severe metabolic, endocrine, or electrolyte abnormalities, or uncontrolled seizures.

Side effects

NRs observed when taking Rosuvastatin-Teva are usually mild and go away on their own. As with other HMG-CoA reductase inhibitors, the incidence of HF is mostly dose-dependent.

The incidence of side effects is given according to the following classification: Very common (>1/10); common (>1/100, <1/10); infrequent (>1/1000, <1/100); rare (>1/10,000, <1/1000); very rare (<1/10,000); frequency unknown (cannot be determined from available data).

Immune system disorders: Rarely, hypersensitivity reactions, including angioedema.

Endocrine system disorders:often – diabetes mellitus type 2.

Nervous system disorders:often – headache, dizziness; frequency unknown – peripheral neuropathy.

Gastrointestinal tract disorders:often – constipation, nausea, abdominal pain; rarely – pancreatitis.

Hepatic and biliary tract disorders: when using rosuvastatin there is a dose-dependent increase in the activity of “hepatic” transaminases in a small number of patients. In most cases it is mild, asymptomatic and temporary.

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

Muscular and connective tissue disorders:often – myalgia; rarely – myopathy (including myositis), rhabdomyolysis, lupus-like syndrome, muscle rupture.

When using Rosuvastatin-Teva at all doses, and especially when taking doses of the drug greater than 20 mg, the following musculoskeletal effects 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 was observed in a small number of patients taking rosuvastatin. In most cases it was insignificant, asymptomatic and temporary. In the case of an increase in CPK activity (more than 5-fold that of IGN), therapy should be suspended.

Kidney and urinary tract disorders: Proteinuria may be detected in patients receiving Rosuvastatin-Teva. Changes in the amount of protein in the urine (from no or trace amounts to ++ or more) are observed in less than 1% of patients receiving the drug at a dose of 10-20 mg, and in approximately 3% of patients receiving the drug at a dose of 40 mg. Little change in urine protein has been observed with the 20 mg dose. In most cases, proteinuria decreases or disappears during therapy and does not indicate the occurrence of acute or progression of existing renal disease.

General disorders and disorders at the site of administration:Asthenic syndrome is common.

Laboratory and instrumental data:the following changes in laboratory parameters have also been observed when using rosuvastatin: increased glucose concentration, increased bilirubin concentration, increased gammaglutamyltransferase activity, increased alkaline phosphatase activity, thyroid function disorders.

Post-marketing use

The following HPs have been reported in the post-marketing use of rosuvastatin:

Disorders of the blood and lymphatic system: frequency unknown- thrombocytopenia.

Mental disorders:frequency unknown – depression, sleep disorders, including insomnia and “nightmares” dreams.

Nervous system disorders:very rare – loss or impairment of memory; frequency unknown – peripheral neuropathy.

Disorders of the respiratory system, chest and mediastinum: frequency unknown – cough, dyspnea, interstitial lung disease (especially with long-term use).

Gastrointestinal disorders:very rare – jaundice, hepatitis; frequency unknown – diarrhea.

Liver and biliary tract disorders: frequently – increased activity of “hepatic” transaminases.

Dermatological and subcutaneous tissue disorders:frequency unknown – Stevens-Johnson syndrome.

Muscular and connective tissue disorders:very rare – arthralgia; frequency unknown – immune-mediated necrotizing myopathy.

Kidney and urinary tract disorders:very rare – hematuria.

Renital and mammary gland disorders: frequency unknown – sexual dysfunction, gynecomastia.

General disorders and disorders at the site of administration:frequency unknown – peripheral edema.

The following HRs have been reported with some statins: depression, sleep disturbances including insomnia and “nightmares” dreams, sexual dysfunction, hyperglycemia, increased concentration of glycosylated hemoglobin. Single cases of interstitial lung disease have been reported, especially with long-term drug use.

Overdose

Pharmacokinetic parameters of rosuvastatin do not change with simultaneous administration of several daily doses.
There is no specific antidote. If necessary, symptomatic therapy is administered, hepatic function and CPK activity should be monitored. Hemodialysis is not effective.

Pregnancy use

Rosuvastatin-Teva is contraindicated in pregnancy and during breastfeeding. If pregnancy is diagnosed during therapy, the drug should be stopped immediately.
Women of reproductive age should use reliable contraceptive methods. Since cholesterol and its biosynthesis products are important for fetal development, the potential risk of HMG-CoA reductase inhibition exceeds the benefit of the drug.
There are no data on penetration of rosuvastatin into breast milk, therefore if the drug Rosuvastatin-Teva should be used during lactation, breastfeeding should be stopped.

Similarities

Mertenil, Crestor, Rosulip, Rosucard, Rosart, Rosuvastatin, Rosistarque, Roxera, Suvardio, Rosuvastatin NW, Cardiolip