Compound
1 tablet of the drug contains 10.40 mg or 20.80 mg of the active ingredient rosuvastatin and excipients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, calcium hydrogen phosphate dihydrate.
Each tablet is film coated. Film shell composition: selecoate AQ-01032 red, titanium dioxide, hypromellose, macrogol-400, macrogol-6000.
Depending on the dosage (10 mg, 20 mg, 40 mg), the composition of the tablet changes.
Instructions for use of Rosuvastatin
The dosage is selected by the attending physician depending on the severity of the lipid profile disorder and the presence of cardiovascular risk.
The starting dose is 10 mg per day. If necessary, it is possible to increase the amount of the drug taken to 20 or 40 milligrams, but not earlier than after the start of treatment.
Increasing the daily dosage is possible only under the strict supervision of a specialist.
The drug should be taken whole, without chewing and with a sufficient amount of water. It is advisable to take the medication before meals.
Contraindications
This medicine is contraindicated in people with hypersensitivity to the components of the drug.
Also, the following diseases are contraindications to taking the original drug:
- myopathy;
- all liver-related diseases;
- renal failure.
during pregnancy and breastfeeding .
People with:
- sepsis;
- during surgical interventions;
- for endocrine disorders;
- for injuries.
Representatives of the Asian race also need to be careful when using Rosuvastatin.
This medicine is not recommended for people under 18 and over 65 years of age.
Analogues of the drug
The drug has a fairly large number of analogues. Their cost can be both higher and lower and varies from 100 to 1000 rubles.
The most well-known analogues of Rosuvastatin include: Pravastatin, Lipitor, Simvastol, Lovastatin, Rozulip, Simvastatin, Atoris, Roxera, Crestor and a number of other drugs.
It is not recommended to change one medicine to another without the consent of a specialist. If necessary, the doctor himself will adjust the treatment, change the dosage and prescribe another drug.
Side effects
This drug has a wide range of side effects:
Musculoskeletal system:
- arthritis;
- myopathy;
- backache.
Nervous system:
- dizziness;
- headache;
- neuralgia;
- state of anxiety, depression;
- insomnia.
Respiratory system:
- cough;
- asthma;
- pneumonia;
- bronchitis;
- pharyngitis;
- rhinitis.
Urinary system:
- infections;
- pain in the lower abdomen.
Gastrointestinal tract:
- diarrhea;
- vomit;
- nausea;
- constipation;
- gastritis.
Heart rate:
- cardiopalmus;
- angina pectoris.
Rosuvastatin analogues
Level 4 ATX code matches:
Akorta
Atomax
Lipitor
Pravastatin
Simvastol
Owencore
Simgal
Tulip
Lovastatin
Liptonorm
Rozulip
Zokor
Rosart
Tevastor
Atorvastatin
Liprimar
Simvastatin
Atoris
Basilip
Rosecard
Analogues of this drug are the following drugs:
- Crestor
- Kleval
- Rosart
- Rosicore
- Roseystar
- Roxera
- Tevastor
However, you should choose one or another analogue only in consultation with a doctor.
Rosuvastatin price
On average, the price of this drug ranges from 200 to 600 rubles.
- Online pharmacies in RussiaRussia
- Online pharmacies in UkraineUkraine
ZdravCity
- Rosuvastatin-Canon tablets p.p.o.
10 mg 28 pcs. Canonpharma Production JSC 323 rub. order - Rosuvastatin-SZ tab. p/o captivity. 5mg 30pcsNAO Northern Star
RUB 224 order
- Rosuvastatin-SZ tab. p/o captivity. 0.01g 30pcsNAO Northern Star
RUB 279 order
- Rosuvastatin tablets p.p.o 20 mg 30 pcs Izvarino Pharma LLC
RUR 954 order
- Rosuvastatin tablets p.p.o. 10 mg 30 pcs. Ozone LLC
RUB 365 order
Pharmacy Dialogue
- Rosuvastatin Canon tablets 10 mg No. 28Canonpharma Production
RUB 302 order
- Rosuvastatin-Teva tablets 20 mg No. 30Teva LLC
RUB 774 order
- Rosuvastatin-Teva tablets 10 mg No. 90 Teva LLC
RUB 1,316 order
- Rosuvastatin-Teva tablets 10 mg No. 30Teva LLC
RUR 565 order
- Rosuvastatin-SZ tablets 5 mg No. 90 North Star NAO
RUR 574 order
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Pharmacy24
- Rosuvastatin Sandoz 5 mg No. 28 tablets Lek pharmaceutical company d.d., Slovenia
96 UAH. order - Rosuvastatin Sandoz 10 mg No. 28 tablets Lek pharmaceutical company d.d., Slovenia
130 UAH order
- Rosuvastatin Teva 10 mg No. 30 tablets TEVA Pharmaceutical Industries Ltd., Israel
101 UAH order
- Rosuvastatin Teva 5 mg No. 30 tablets TEVA Pharmaceutical Industries Ltd., Israel
73 UAH order
- Rosuvastatin IC 5 mg No. 30 tablets INTERCHEM Partnership with additional coverage, Ukraine
67 UAH order
Rosuvastatin-Xantis tab 10 mg 90 pcs
The effect of the use of other drugs on rosuvastatin. Transport protein inhibitors: Rosuvastatin is a substrate for some transport proteins, in particular OATP1B1 and BCRP. The simultaneous use of drugs that are inhibitors of these transport proteins may be accompanied by an increase in the concentration of rosuvastatin in the blood plasma and an increased risk of developing myopathy.
Cyclosporine: With simultaneous use of rosuvastatin and cyclosporine, the AUC of rosuvastatin is on average 7 times higher than the value observed in healthy volunteers. Concomitant use with rosuvastatin does not affect the concentration of cyclosporine in the blood plasma. The use of rosuvastatin is contraindicated in patients taking cyclosporine (see section "Contraindications").
HIV protease inhibitors: Concomitant use of HIV protease inhibitors may significantly increase the exposure of rosuvastatin. The simultaneous use of 20 mg of rosuvastatin and a combination of two HIV protease inhibitors (400 mg of lopinavir/100 mg of ritonavir) is accompanied by an increase in the equilibrium AUC (0-24 hours) and Cmax of rosuvastatin by 2 and 5 times, respectively. Therefore, simultaneous use of rosuvastatin and HIV protease inhibitors is not recommended.
Gemfibrozil and other lipid-lowering drugs: The simultaneous use of rosuvastatin and gemfibrozil leads to a 2-fold increase in the Cmax and AUC of rosuvastatin in blood plasma (see section “Special Instructions”). Based on specific interaction data, a pharmacokinetically significant interaction with fenofibrate is not expected, but 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 due to the fact that they can cause myopathy when used in monotherapy (see . section "Special instructions"). The simultaneous use of fibrates and rosuvastatin in a daily dose of 30 mg is contraindicated. In such patients, therapy should begin with a dose of 5 mg/day (see sections “Contraindications”, “Dosage and Administration”, “Special Instructions”).
Ezetimibe: Concomitant use of rosuvastatin 10 mg and ezetimibe 10 mg was associated with an increase in rosuvastatin AUC in patients with hypercholesterolemia. A pharmacodynamic interaction between rosuvastatin and ezetimibe, manifested by an increased risk of adverse reactions, cannot be excluded.
Antacids: The simultaneous use of rosuvastatin and antacids containing aluminum and/or magnesium hydroxide leads to a decrease in the plasma concentration of rosuvastatin by approximately 50%. This effect is less pronounced if antacids are used 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 decrease in AUC(0-t) of rosuvastatin by 20% and its Cmax by 30%. This interaction may occur as a result of increased intestinal motility caused by the use of erythromycin.
Isoenzymes of the cytochrome P450 system: The results of studies conducted in vivo and in vitro showed that rosuvastatin is neither an inhibitor nor an inducer of isoenzymes of the cytochrome P450 system. In addition, rosuvastatin is a weak substrate for this isoenzyme system. Therefore, interaction of rosuvastatin with other drugs at the metabolic level involving isoenzymes of the cytochrome P450 system is not expected. No clinically significant interaction was observed between rosuvastatin and fluconazole (an inhibitor of CYP2C9 and CYP3A4 isoenzymes) and ketoconazole (an inhibitor of CYP2A6 and CYP3A4 isoenzymes).
Interactions with drugs that require dose adjustment of rosuvastatin.
The dose of Roxera® should be adjusted if it is necessary to use it simultaneously with drugs that increase the exposure of rosuvastatin. If exposure is expected to increase by 2 times or more, the initial dose of Roxera® should be 5 mg 1 time per day. The maximum daily dose of Roxera® should also be adjusted so that the expected exposure to rosuvastatin does not exceed that for a dose of 40 mg taken without the simultaneous administration of drugs that interact with rosuvastatin. For example, the maximum daily dose of Roxera® when used simultaneously with gemfibrozil is 20 mg (increased exposure by 1.9 times), with ritonavir/atazanavir - 10 mg (increased exposure by 3.1 times).
Effect of concomitant therapy on rosuvastatin exposure (AUC, data in descending order) - results of published clinical studies:
Concomitant therapy regimen/rosuvastatin regimen/Change in rosuvastatin AUC: Cyclosporine 75-200 mg 2 times a day, 6 months/rosuvastatin 10 mg 1 time a day, 10 days/7.1-fold increase; Regorafenib 160 mg once daily, 14 days/rosuvastatin 5 mg once/3.8-fold increase; Atazanavir 300 mg/ritonavir 100 mg once a day, 8 days/rosuvastatin 10 mg once/3.1-fold increase; Simeprevir 150 mg once a day, 7 days/rosuvastatin 10 mg once/2.8-fold increase; Velpatasvir 100 mg once a day/rosuvastatin 10 mg once/2.7-fold increase; Ombitasvir 25 mg/paritaprevir 150 mg/ritonavir 100 mg once daily/dasabuvir 400 mg twice daily, 14 days/rosuvastatin 5 mg once/2.6-fold increase; Grazoprevir 200 mg/elbasvir 50 mg once a day, 11 days/rosuvastatin 10 mg once/2.3-fold increase; Glecaprevir 400 mg/pibrentasvir 120 mg once daily, 7 days/rosuvastatin 5 mg once daily, 7 days/2.2-fold increase; Lopinavir 400 mg/ritonavir 100 mg 2 times a day, 17 days/rosuvastatin 20 mg 1 time a day, 7 days/2.1-fold increase; Clopidogrel 300 mg (loading dose), then 75 mg after 24 hours/rosuvastatin 20 mg once/2-fold increase; Gemfibrozil 600 mg 2 times a day, 7 days/rosuvastatin 80 mg once/1.9-fold increase; Eltrombopag 75 mg once a day, 5 days/rosuvastatin 10 mg once/1.6-fold increase; Darunavir 600 mg/ritonavir 100 mg 2 times a day, 7 days/rosuvastatin 10 mg 1 time a day, 7 days/Increase by 1.5 times; Tipranavir 500 mg/ritonavir 200 mg 2 times a day, 11 days/rosuvastatin 10 mg once/Increase by 1.4 times; Dronedarone 400 mg 2 times a day/No data/Increase by 1.4 times; Itraconazole 200 mg once a day, 5 days/rosuvastatin 10 mg once/**Increase by 1.4 times; Ezetimibe 10 mg once daily, 14 days/rosuvastatin 10 mg once daily, 14 days/**Increase by 1.2 times; Fosamprenavir 700 mg/ritonavir 100 mg 2 times a day, 8 days/rosuvastatin 10 mg once/No changes; Aleglitazar 0.3 mg, 7 days/rosuvastatin 40 mg, 7 days/No change; Silymarin 140 mg 3 times a day, 5 days/rosuvastatin 10 mg once/No change; Fenofibrate 67 mg 3 times a day, 7 days/rosuvastatin 10 mg, 7 days/No change; Rifampicin 450 mg once a day, 7 days/rosuvastatin 20 mg once/No change; Ketoconazole 200 mg 2 times a day, 7 days/rosuvastatin 80 mg once/No changes; Fluconazole 200 mg once a day, 11 days/rosuvastatin 80 mg once/No change; Erythromycin 500 mg 4 times a day, 7 days/rosuvastatin 80 mg once/20% reduction; Baicalin 50 mg 3 times a day, 14 days/rosuvastatin 20 mg once/47% reduction.
The effect of rosuvastatin on other drugs.
Vitamin K antagonists: As with other HMG-CoA reductase inhibitors, initiating or increasing the dose of rosuvastatin in patients taking concomitant vitamin K antagonists (eg, warfarin) may result in an increase in the international normalized ratio (INR). Discontinuation of rosuvastatin or reduction in its dose may lead to a decrease in MHO. In such cases, MHO monitoring is recommended.
Oral contraceptives/hormone replacement therapy (HRT): Concomitant use of rosuvastatin and oral contraceptives increased the AUC of ethinyl estradiol and norgestrel by 26% and 34%, respectively. This increase in plasma concentration should be taken into account when selecting the dose of hormonal contraceptives. There are no pharmacokinetic data on the simultaneous use of rosuvastatin and HRT; therefore, a similar effect cannot be excluded when using this combination. However, this combination was widely used during clinical trials and was well tolerated by patients.
Other medicinal products No clinically significant interaction between rosuvastatin and digoxin is expected.
Fusidic acid The risk of developing myopathy, including rhabdomyolysis, may be increased when systemic fusidic acid is used concomitantly with statins. The mechanism of this interaction (pharmacodynamic or pharmacokinetic, or both) is not yet known. There have been reports of rhabdomyolysis (including death in some cases) in patients receiving concomitant statins and fusidic acid. If it is necessary to use systemic fusidic acid, rosuvastatin therapy should be discontinued for the entire period of use of fusidic acid.
