Rosetor (Rosetor) belongs to a a group of drugs called HMG CoA reductase inhibitors, or "statins." Rosetor 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).
Rosetor 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.
Rosetor 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.
Rosetor 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, Rosetor can be used in children who are at least 8 years old. For the homozygous type, Rosetor can be used in children as young as 7 years old.
Rosetor indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Rosetor 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, Rosetor 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: Rosetor 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). Rosetor 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: Rosetor is indicated to reduce the Total Cholesterol, LDL-C and Apo B in patients with heterozygous familial hypercholesterolaemia (HeFH).
How should I use Rosetor?
Use Rosetor as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Rosetor. Talk to your pharmacist if you have questions about this information.
Take Rosetor 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 Rosetor. Check with your doctor if you have any questions.
Taking Rosetor at the same time each day will help you remember to take it.
Continue to take Rosetor even if you feel well. Do not miss any doses.
If you miss a dose of Rosetor, 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 Rosetor.
Uses of Rosetor in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Rosetor 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.
Rosetor description
Rosetor 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.
Rosetor is a synthetic lipid-lowering agent for oral administration. The chemical name for Rosetor 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.
Rosetor dosage
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General Dosing Information: The dose range for Rosetor is 5-40 mg orally once daily.
Rosetor can be administered as a single dose at any time of the day, with or without food. When initiating Rosetor therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate Rosetor 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 Rosetor 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 Rosetor 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 Rosetor, 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 Rosetor 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 Rosetor is 20 mg once daily. Response to therapy should be estimated from pre-aphereses LDL-C levels.
Dosage in Asian Patients: Initiation of Rosetor 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 Rosetor should be limited to 5 mg once daily. In patients taking a combination of lopinavir and ritonavir, the dose of Rosetor should be limited to 10 mg once daily.
Concomitant Lipid-Lowering Therapy:The risk of skeletal muscle effects may be enhanced when Rosetor is used in combination with niacin or fenofibrate; a reduction in Rosetor is used in combination with gemfibrozil, the dose of Rosetor 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 Rosetor should be started at 5 mg once daily and should not exceed 10 mg once daily.
Effect of Co-Administered Medicinal Products on Rosetor: In vitro and in vivo data indicate that Rosetor has no clinically significant cytochrome P450 interactions (as a substrate, inhibitor or inducer). Rosetor is a substrate for certain transporter proteins including the hepatic uptake transporter OATP1B1 and efflux transporter BCRP. Concomitant administration of Rosetor with medicinal products that are inhibitors of these transporter proteins may result in increased Rosetor plasma concentrations and an increased risk of myopathy.
Interactions Requiring Rosetor Dose Adjustments : When it is necessary to co-administer Rosetor with other medicinal products known to increase exposure to Rosetor, doses of Rosetor should be adjusted. It is recommended that prescribers consult the relevant product information when considering administration of such products together with Rosetor. Start with a 5 mg once daily dose of Rosetor if the expected increase in exposure (AUC) is approximately 2-fold or higher. The maximum daily dose of Rosetor should be adjusted so that the expected Rosetor exposure would not likely exceed that of a 40 mg daily dose of Rosetor taken without interacting medicinal products, for example a 5 mg dose of Rosetor with ciclosporin (7.1-fold increase in exposure), a 10 mg dose of Rosetor with ritonavir/atazanavir combination (3.1-fold increase) and a 20 mg dose of Rosetor with gemfibrozil (1.9-fold increase).
Other Interacting Medicinal Products: Antacid: The simultaneous dosing of Rosetor with an antacid suspension containing aluminum and magnesium hydroxide resulted in a decrease in Rosetor plasma concentration of approximately 50%. This effect was mitigated when the antacid was dosed 2 hours after Rosetor. The clinical relevance of this interaction has not been studied.
Fusidic Acid: Interaction studies with Rosetor and fusidic acid have not been conducted. As with other statins, muscle related events, including rhabdomyolysis, have been reported in post-marketing experience with Rosetor and fusidic acid given concurrently. Patients should be closely monitored and temporary suspension of Rosetor treatment may be appropriate.
Effect of Rosetor on Co-Administered Medicinal Products: Warfarin: The pharmacokinetics of warfarin are not significantly affected following co-administration with Rosetor. However, as with other HMG-CoA reductase inhibitors, co-administration of Rosetor 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 Rosetor or following dose adjustment.
Fenofibrates/Fibric Acid Derivatives: Although no pharmacokinetic interaction between Rosetor 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 Rosetor 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 Rosetor was co-administered with antihypertensive agents, antidiabetic agents and hormone replacement therapy. These studies did not produce any evidence of clinically significant adverse interactions.
Rosetor is generally well tolerated. The adverse events seen with Rosetor are generally mild and transient. In controlled clinical trials less than 4% of Rosetor treated patients were withdrawn due to adverse events. This withdrawal rate was comparable to that reported in patients receiving placebo.
*Observed in the JUPITER study (reported overall frequency 2.8% in Rosetor 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 Rosetor 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 Rosetor. Increases in HbA1c have also been observed in patients treated with Rosetor. Abnormal urinalysis testing (dipstick-positive proteinuria) has been seen in a small number of patients taking Rosetor 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 Rosetor was shown to have no harmful effects on the ocular lens.
In Rosetor 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 Rosetor: 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 Rosetor 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.
Patients with known hypersensitivity to any component of Rosetor. Hypersensitivity reactions including rash, pruritus, urticaria and angioedema have been reported with Rosetor.
Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels.
Use in pregnancy: Pregnancy Category: X.
Rosetor is contraindicated in women who are or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy and cholesterol products are essential for fetal development. Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hyperlipidemia therapy.
There are no adequate and well-controlled studies of Rosetor in pregnany women. There have been rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors.
Rosetor may cause fetal harm when administered to a pregnant woman. If the patient becomes pregnant while taking Rosetor, the patient should be apprised of the potential risks to the fetus and the lack of known clinical benefit with continued use during pregnancy.
Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, Rosetor may cause fetal harm when administered to pregnant women. Additionally, there is no apparent benefit to therapy during pregnancy and safety in pregnant women has not been established. If the patient becomes pregnant while taking Rosetor, the patient should be apprised of the potential hazard to the fetus and the lack of known clinical benefit with continued use during pregnancy.
Use in lactation: It is not known whether Rosetor is excreted in human milk, but a small amount of another drug in this class does pass into breast milk.
Because another drug in this class passes into human milk and because HMG-CoA reductase inhibitors have a potential to cause serious adverse reactions in nursing infants, women who require Rosetor treatment should be advised not to nurse their infants.
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).
The results of a survey conducted on ndrugs.com for Rosetor 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 Rosetor. 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
Consumer reported useful
No survey data has been collected yet
1 consumer reported price estimates
Was the price you paid to purchase the drug reasonable? Did you feel it was expensive? The below mentioned numbers have been reported by ndrugs.com website users about whether the Rosetor drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
Users
%
Expensive
1
100.0%
Consumer reported time for results
No survey data has been collected yet
3 consumers reported age
Users
%
46-60
2
66.7%
> 60
1
33.3%
Consumer reviews
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