What is Rosutec 10 mg?
Rosutec 10 mg (Rosutec 10 mg) belongs to a a group of drugs called HMG CoA reductase inhibitors, or "statins." Rosutec 10 mg reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).
Rosutec 10 mg is used in adults and children who are at least 8 years old to lower cholesterol and triglycerides (types of fat) in the blood and to slow the build-up of plaque (fatty deposits) in your blood vessels.
Rosutec 10 mg is also used to lower the risk of stroke, heart attack, and other heart complications in certain people with diabetes, coronary heart disease, or other risk factors.
Rosutec 10 mg is also used to treat hereditary forms of high cholesterol, including the heterozygous type (inherited from one parent) and the homozygous type (inherited from both parents). For the heterozygous type, Rosutec 10 mg can be used in children who are at least 8 years old. For the homozygous type, Rosutec 10 mg can be used in children as young as 7 years old.
Rosutec 10 mg indications
Rosutec 10 mg should be used as an adjunct to diet when the response to diet and exercise is inadequate.
Prevention of Cardiovascular Events: In adult patients with an increased risk of atherosclerotic cardiovascular disease based on the presence of cardiovascular disease risk markers such as an elevated hsCRP level, age, hypertension, low HDL-C, smoking or a family history of premature coronary heart disease, Rosutec 10 mg is indicated to reduce total mortality and the risk of major cardiovascular events (cardiovascular death, stroke, MI, unstable angina, or arterial revascularization).
In Adult Patients with Hypercholesterolaemia: Rosutec 10 mg is indicated to: Reduce elevated LDL-C, Total Cholesterol, triglycerides and to increase HDL-cholesterol in patients with primary hypercholesterolaemia (heterozygous familial and non familial) and mixed dyslipidaemia (Fredrickson Types IIa and IIb). Rosutec 10 mg also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios and increases ApoA-I in these populations.
Treat patients with primary dysbetalipoproteinaemia (Fredrickson Type III hyper lipoproteinaemia).
Treat isolated hypertriglyceridaemia (Fredrickson Type IV hyperlipidaemia).
Reduce Total Cholesterol and LDL-C in patients with homozygous familial hypercholesterolaemia, as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or alone if such treatments are unavailable.
Slow or delay the progression of atherosclerosis.
Children and Adolescents 6 to 17 Years of Age: Rosutec 10 mg is indicated to reduce the Total Cholesterol, LDL-C and Apo B in patients with heterozygous familial hypercholesterolaemia (HeFH).
How should I use Rosutec 10 mg?
Use Rosutec 10 mg as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Rosutec 10 mg. Talk to your pharmacist if you have questions about this information.
- Take Rosutec 10 mg by mouth with or without food.
- Swallow the tablets whole.
- If you also take an antacid that has aluminum or magnesium in it, take it at least 2 hours after taking Rosutec 10 mg. Check with your doctor if you have any questions.
- Taking Rosutec 10 mg at the same time each day will help you remember to take it.
- Continue to take Rosutec 10 mg even if you feel well. Do not miss any doses.
- If you miss a dose of Rosutec 10 mg, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once or within 12 hours of each other.
Ask your health care provider any questions you may have about how to use Rosutec 10 mg.
Uses of Rosutec 10 mg in details
- Rosutec 10 mg is used for the treatment of high cholesterol, high LDL, high triglycerides and low HDL in addition to diet, when response to non-medicine options (diet, exercise and weight loss) is not adequate.
- It is also used to lower the risk of stroke, heart attack, or other heart complications in people who are at high risk of heart diseases, as an adjuvant to correction of the risk factors.
Rosutec 10 mg description
Rosutec 10 mg also contains the following inactive ingredients: Tribasic calcium phosphate, microcrystalline cellulose (PH 102), butylated hydroxy toluene, povidone K-30, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Instacoat universal white IH, purified water; color: Titanium dioxide.
Rosutec 10 mg is a synthetic lipid-lowering agent for oral administration. The chemical name for Rosutec 10 mg calcium is bis[(E)-7-[4(4-fluorophenyl)-6-isopropyl 2[methyl (methylsulfonyl) amino] pyrimidin-5-yl](3R,5S)3,5-dihydroxyhept-6-enoic acid] calcium salt. The empirical formula is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14.
Rosutec 10 mg dosage
General Dosing Information: The dose range for Rosutec 10 mg is 5-40 mg orally once daily.
Rosutec 10 mg can be administered as a single dose at any time of the day, with or without food. When initiating Rosutec 10 mg therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate Rosutec 10 mg starting dose should first be utilized, and only then titrated according to the patient's response and individualized goal of therapy.
The 40 mg dose of Rosutec 10 mg should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose.
Hyperlipidemia, Mixed Dyslipidemia, Hypertriglyceridemia, Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia) and Slowing of the Progression of Atherosclerosis: The recommended starting dose of Rosutec 10 mg is 10 mg dose once daily. For patients with marked hyperlipidemia (LDL-C >190 mg/dL) and aggressive lipid targets, a 20 mg starting dose may be considered.
After initiation or upon titration of Rosutec 10 mg, lipid levels should be analyzed within 2-4 weeks and the dosage adjusted accordingly.
Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10-17 years): The usual dose range of Rosutec 10 mg is 5-20 mg/day; the maximum recommended dose is 20 mg/day (doses >20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of ≥4 weeks.
Homozygous Familial Hypercholesterolemia: The recommended starting dose of Rosutec 10 mg is 20 mg once daily. Response to therapy should be estimated from pre-aphereses LDL-C levels.
Dosage in Asian Patients: Initiation of Rosutec 10 mg therapy with 5 mg once daily should be considered for Asian patients.
Use with Cyclosporine or Lopinavir/Ritonavir: In patients taking cyclosporine, the dose of Rosutec 10 mg should be limited to 5 mg once daily. In patients taking a combination of lopinavir and ritonavir, the dose of Rosutec 10 mg should be limited to 10 mg once daily.
Concomitant Lipid-Lowering Therapy: The risk of skeletal muscle effects may be enhanced when Rosutec 10 mg is used in combination with niacin or fenofibrate; a reduction in Rosutec 10 mg is used in combination with gemfibrozil, the dose of Rosutec 10 mg should be limited to 10 mg daily.
Dosage in Patients with Severe Renal Impairment: For patients with severe renal impairment (CrCl <30 mL/min/1.73 m2) not on hemodialysis, dosing of Rosutec 10 mg should be started at 5 mg once daily and should not exceed 10 mg once daily.
Rosutec 10 mg interactions
See also:
What other drugs will affect Rosutec 10 mg?
Effect of Co-Administered Medicinal Products on Rosutec 10 mg: In vitro and in vivo data indicate that Rosutec 10 mg has no clinically significant cytochrome P450 interactions (as a substrate, inhibitor or inducer). Rosutec 10 mg is a substrate for certain transporter proteins including the hepatic uptake transporter OATP1B1 and efflux transporter BCRP. Concomitant administration of Rosutec 10 mg with medicinal products that are inhibitors of these transporter proteins may result in increased Rosutec 10 mg plasma concentrations and an increased risk of myopathy.
Interactions Requiring Rosutec 10 mg Dose Adjustments : When it is necessary to co-administer Rosutec 10 mg with other medicinal products known to increase exposure to Rosutec 10 mg, doses of Rosutec 10 mg should be adjusted. It is recommended that prescribers consult the relevant product information when considering administration of such products together with Rosutec 10 mg. Start with a 5 mg once daily dose of Rosutec 10 mg if the expected increase in exposure (AUC) is approximately 2-fold or higher. The maximum daily dose of Rosutec 10 mg should be adjusted so that the expected Rosutec 10 mg exposure would not likely exceed that of a 40 mg daily dose of Rosutec 10 mg taken without interacting medicinal products, for example a 5 mg dose of Rosutec 10 mg with ciclosporin (7.1-fold increase in exposure), a 10 mg dose of Rosutec 10 mg with ritonavir/atazanavir combination (3.1-fold increase) and a 20 mg dose of Rosutec 10 mg with gemfibrozil (1.9-fold increase).
Other Interacting Medicinal Products: Antacid: The simultaneous dosing of Rosutec 10 mg with an antacid suspension containing aluminum and magnesium hydroxide resulted in a decrease in Rosutec 10 mg plasma concentration of approximately 50%. This effect was mitigated when the antacid was dosed 2 hours after Rosutec 10 mg. The clinical relevance of this interaction has not been studied.
Fusidic Acid: Interaction studies with Rosutec 10 mg and fusidic acid have not been conducted. As with other statins, muscle related events, including rhabdomyolysis, have been reported in post-marketing experience with Rosutec 10 mg and fusidic acid given concurrently. Patients should be closely monitored and temporary suspension of Rosutec 10 mg treatment may be appropriate.
Effect of Rosutec 10 mg on Co-Administered Medicinal Products: Warfarin: The pharmacokinetics of warfarin are not significantly affected following co-administration with Rosutec 10 mg. However, as with other HMG-CoA reductase inhibitors, co-administration of Rosutec 10 mg and warfarin may result in a rise in INR compared to warfarin alone. In patients taking vitamin K antagonists monitoring of INR is recommended both at initiation or cessation of therapy with Rosutec 10 mg or following dose adjustment.
Fenofibrates/Fibric Acid Derivatives: Although no pharmacokinetic interaction between Rosutec 10 mg and fenofibrate was observed; a pharmacodynamic interaction may occur. Gemfibrozil, fenofibrate and other fibric acids, including nicotinic acid, may increase the risk of myopathy when given concomitantly with HMG-CoA reductase inhibitors.
Cyclosporin: Co-administration of Rosutec 10 mg with cyclosporin resulted in no significant changes in cyclosporin plasma concentration.
Other Medications: There were no clinically significant interactions with an oral contraceptive, digoxin, ezetimibe, or fenofibrate.
In clinical studies Rosutec 10 mg was co-administered with antihypertensive agents, antidiabetic agents and hormone replacement therapy. These studies did not produce any evidence of clinically significant adverse interactions.
Rosutec 10 mg side effects
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What are the possible side effects of Rosutec 10 mg?
Rosutec 10 mg is generally well tolerated. The adverse events seen with Rosutec 10 mg are generally mild and transient. In controlled clinical trials less than 4% of Rosutec 10 mg treated patients were withdrawn due to adverse events. This withdrawal rate was comparable to that reported in patients receiving placebo.
Common (≥1/100, <1/10): Headache, myalgia, asthenia, constipation, dizziness, nausea, abdominal pain, diabetes mellitus*.
Uncommon (≥1/1000, <1/100): Pruritus, rash and urticaria.
Rare (≥1/10,000, <1/1000): Myopathy (including myositis), hypersensitivity reactions (including angioedema), rhabdomyolysis, pancreatitis.
*Observed in the JUPITER study (reported overall frequency 2.8% in Rosutec 10 mg and 2.3% in placebo) primarily in patients already at high risk for developing diabetes.
As with other HMG CoA reductase inhibitors, the incidence of adverse drug reactions tends to increase with increasing dose.
Skeletal Muscle Effects: Rare cases of rhabdomyolysis, which were occasionally associated with impairment of renal function, have been reported with Rosutec 10 mg and with other marketed statins.
Laboratory Effects: As with other HMG-CoA reductase inhibitors, a dose-related increase in liver transaminases and CK has been observed in a small number of patients taking Rosutec 10 mg. Increases in HbA1c have also been observed in patients treated with Rosutec 10 mg. Abnormal urinalysis testing (dipstick-positive proteinuria) has been seen in a small number of patients taking Rosutec 10 mg and other HMG-CoA reductase inhibitors. The protein detected was mostly tubular in origin. In most cases, proteinuria decreases or disappears spontaneously on continued therapy, and is not predictive of acute or progressive renal disease.
Other Effects: In a long-term controlled clinical trial Rosutec 10 mg was shown to have no harmful effects on the ocular lens.
In Rosutec 10 mg treated patients, there was no impairment of adrenocortical function.
Post Marketing Experience: In addition to the previously mentioned effects, the following adverse events have been reported during post marketing experience of Rosutec 10 mg: Haematological Disorders: Frequency Unknown: Thrombocytopenia.
Hepatobiliary Disorders: Very Rare: Jaundice, hepatitis. Rare: Increased hepatic transaminases.
Musculoskeletal Disorder: Frequency Unknown: Immune-mediated necrotising myopathy. Very Rare: Arthralgia.
As with other HMG-CoA reductase inhibitors, the reporting rate for rhabdomyolysis in post-marketing use is higher at the highest marketed dose.
Nervous System Disorder: Very Rare: Memory loss. Frequency Unknown: Peripheral neuropathy.
Psychiatric Disorders: Frequency Unknown: Depression, sleep disorders (including insomnia and nightmares).
Reproductive System and Breast Disorders: Frequency Unknown: Gynaecomastia.
Children and Adolescents 6 to 17 Years of Age: The safety profile of Rosutec 10 mg is similar in children or adolescent patients and adults although CK elevations >10 x ULN and muscle symptoms following exercise or increased physical activity, which resolved with continued treatment, were observed more frequently in clinical trial of children and adolescents. However, the same special warnings and special precautions for use in adults also apply to children and adolescents.
Rosutec 10 mg contraindications
See also:
What is the most important information I should know about Rosutec 10 mg?
Hypersensitivity to Rosutec 10 mg or to any of the excipients of Rosutec 10 mg Sandoz.
Hepatic impairment; severe renal impairment; repeated or unexplained muscle aches or pain (myopathy); ciclosporin (eg, used after organ transplants).
In addition, the 40 mg dose of Rosutec 10 mg Sandoz is contraindicated in: Repeated or unexplained muscle aches or pains (myopathy), a personal or family history of muscle problems or a previous history of muscle problems when taking other cholesterol-lowering drugs; moderate renal impairment; thyroid gland disorders; regular consumption of large amounts of alcohol; if taking fibrates to lower cholesterol; Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
Use in pregnancy & lactation: Rosutec 10 mg Sandoz should not be taken by pregnant and breastfeeding women. If the patient become pregnant while taking Rosutec 10 mg Sandoz, stop taking it immediately and inform the physician. Women should avoid becoming pregnant while taking Rosutec 10 mg Sandoz by using suitable contraception.
Active ingredient matches for Rosutec 10 mg:
Rosuvastatin in Hungary.
List of Rosutec 10 mg substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Rosutec 40 mg (Hungary) | |
| ROSUTERO | |
| ROSUTERO 10 MG TABLET 1 strip / 10 tablets each (Hetero Drugs Ltd) | $ 0.57 |
| ROSUTERO 5 MG TABLET 1 strip / 10 tablets each (Hetero Drugs Ltd) | $ 0.30 |
| Rosutero 10mg Tablet (Hetero Drugs Ltd) | $ 0.06 |
| Rosutero 5mg Tablet (Hetero Drugs Ltd) | $ 0.03 |
| Rosuterol (South Korea) | |
| ROSUTIME | |
| ROSUTIME 10 MG TABLET 1 strip / 10 tablets each (TTK Healthcare Ltd) | $ 1.20 |
| ROSUTIME 20 MG TABLET 1 strip / 10 tablets each (TTK Healthcare Ltd) | $ 2.29 |
| Rosutime 10mg Tablet (TTK Healthcare Ltd) | $ 0.12 |
| Rosutime 20mg Tablet (TTK Healthcare Ltd) | $ 0.23 |
| Rosutin (Bangladesh) | |
| ROSUTIN 10MG TABLET | |
| ROSUTIN 10MG TABLET 1 strip / 10 tablets each (Aventure Pharma) | $ 1.20 |
| ROSUTOP (India) | |
| ROSUTOP tab 10 mg x 10's (Innovative) | $ 1.19 |
| ROSUTOP tab 20 mg x 10's (Innovative) | $ 2.28 |
| ROSUTOR | |
| ROSUTOR 10MG TABLET 1 strip / 10 tablets each (Ajanta Pharma Ltd) | $ 1.16 |
| Rosutor 10mg Tablet (Ajanta Pharma Ltd) | $ 0.12 |
| Rosutropic (Paraguay) | |
| Rosutrox (Poland) | |
| Rosuva (Bangladesh, Ireland) | |
| Rosuva 10 | |
| Rosuva 20 | |
| Rosuvacard (Latvia, Lithuania) | |
| ROSUVAKARE (India) | |
| 5 mg x 100's (Nitro Cadineur) | $ 8.22 |
| 10 mg x 100's (Nitro Cadineur) | $ 13.92 |
| Rosuvakare 5mg TAB / 100 (Nitro Cadineur) | $ 8.22 |
| Rosuvakare 10mg TAB / 100 (Nitro Cadineur) | $ 13.92 |
| ROSUVAKARE tab 5 mg x 10's (Nitro Cadineur) | $ 0.82 |
| ROSUVAKARE tab 10 mg x 10's (Nitro Cadineur) | $ 1.39 |
| Rosuvakare 5mg TAB / 100 (Nitro Cadineur) | $ 8.22 |
| Rosuvakare 10mg TAB / 100 (Nitro Cadineur) | $ 13.92 |
| Rosuval (Greece) | |
| Rosuvanor (Bulgaria) | |
| Rosuvas (India, Peru) | |
| 5 mg x 10's (Ranbaxy) | $ 0.82 |
| 10 mg x 10's (Ranbaxy) | $ 1.39 |
| 20 mg x 10's (Ranbaxy) | $ 3.20 |
| 40 mg x 10's (Ranbaxy) | |
| Rosuvas 5mg FC-TAB / 10 (Ranbaxy) | $ 0.82 |
| Rosuvas 10mg FC-TAB / 10 (Ranbaxy) | $ 1.39 |
| Rosuvas 20mg FC-TAB / 10 (Ranbaxy) | $ 3.20 |
| Tablets, Film-Coated; Oral; Rosuvastatin Calcium 5 mg (Ranbaxy) | |
| Tablets, Film-Coated; Oral; Rosuvastatin Calcium 10 mg (Ranbaxy) | |
| Tablets, Film-Coated; Oral; Rosuvastatin Calcium 20 mg (Ranbaxy) | |
See 1847 substitutes for Rosutec 10 mg | |
References
- DailyMed. "ROSUVASTATIN CALCIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "Rosuvastatin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "Rosuvastatin". http://www.drugbank.ca/drugs/DB01098 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Rosutec 10 mg are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Rosutec 10 mg. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
