What is Rostar?
Rostar (Rostar) belongs to a a group of drugs called HMG CoA reductase inhibitors, or "statins." Rostar 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).
Rostar 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.
Rostar 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.
Rostar 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, Rostar can be used in children who are at least 8 years old. For the homozygous type, Rostar can be used in children as young as 7 years old.
Rostar indications
Rostar 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, Rostar 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: Rostar 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). Rostar 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: Rostar is indicated to reduce the Total Cholesterol, LDL-C and Apo B in patients with heterozygous familial hypercholesterolaemia (HeFH).
How should I use Rostar?
Use Rostar as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Rostar. Talk to your pharmacist if you have questions about this information.
- Take Rostar 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 Rostar. Check with your doctor if you have any questions.
- Taking Rostar at the same time each day will help you remember to take it.
- Continue to take Rostar even if you feel well. Do not miss any doses.
- If you miss a dose of Rostar, 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 Rostar.
Uses of Rostar in details
- Rostar 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.
Rostar description
Rostar 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.
Rostar is a synthetic lipid-lowering agent for oral administration. The chemical name for Rostar 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.
Rostar dosage
General Dosing Information: The dose range for Rostar is 5-40 mg orally once daily.
Rostar can be administered as a single dose at any time of the day, with or without food. When initiating Rostar therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate Rostar 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 Rostar 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 Rostar 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 Rostar, 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 Rostar 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 Rostar is 20 mg once daily. Response to therapy should be estimated from pre-aphereses LDL-C levels.
Dosage in Asian Patients: Initiation of Rostar 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 Rostar should be limited to 5 mg once daily. In patients taking a combination of lopinavir and ritonavir, the dose of Rostar should be limited to 10 mg once daily.
Concomitant Lipid-Lowering Therapy: The risk of skeletal muscle effects may be enhanced when Rostar is used in combination with niacin or fenofibrate; a reduction in Rostar is used in combination with gemfibrozil, the dose of Rostar 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 Rostar should be started at 5 mg once daily and should not exceed 10 mg once daily.
Rostar interactions
See also:
What other drugs will affect Rostar?
Effect of Co-Administered Medicinal Products on Rostar: In vitro and in vivo data indicate that Rostar has no clinically significant cytochrome P450 interactions (as a substrate, inhibitor or inducer). Rostar is a substrate for certain transporter proteins including the hepatic uptake transporter OATP1B1 and efflux transporter BCRP. Concomitant administration of Rostar with medicinal products that are inhibitors of these transporter proteins may result in increased Rostar plasma concentrations and an increased risk of myopathy.
Interactions Requiring Rostar Dose Adjustments : When it is necessary to co-administer Rostar with other medicinal products known to increase exposure to Rostar, doses of Rostar should be adjusted. It is recommended that prescribers consult the relevant product information when considering administration of such products together with Rostar. Start with a 5 mg once daily dose of Rostar if the expected increase in exposure (AUC) is approximately 2-fold or higher. The maximum daily dose of Rostar should be adjusted so that the expected Rostar exposure would not likely exceed that of a 40 mg daily dose of Rostar taken without interacting medicinal products, for example a 5 mg dose of Rostar with ciclosporin (7.1-fold increase in exposure), a 10 mg dose of Rostar with ritonavir/atazanavir combination (3.1-fold increase) and a 20 mg dose of Rostar with gemfibrozil (1.9-fold increase).
Other Interacting Medicinal Products: Antacid: The simultaneous dosing of Rostar with an antacid suspension containing aluminum and magnesium hydroxide resulted in a decrease in Rostar plasma concentration of approximately 50%. This effect was mitigated when the antacid was dosed 2 hours after Rostar. The clinical relevance of this interaction has not been studied.
Fusidic Acid: Interaction studies with Rostar and fusidic acid have not been conducted. As with other statins, muscle related events, including rhabdomyolysis, have been reported in post-marketing experience with Rostar and fusidic acid given concurrently. Patients should be closely monitored and temporary suspension of Rostar treatment may be appropriate.
Effect of Rostar on Co-Administered Medicinal Products: Warfarin: The pharmacokinetics of warfarin are not significantly affected following co-administration with Rostar. However, as with other HMG-CoA reductase inhibitors, co-administration of Rostar 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 Rostar or following dose adjustment.
Fenofibrates/Fibric Acid Derivatives: Although no pharmacokinetic interaction between Rostar 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 Rostar 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 Rostar was co-administered with antihypertensive agents, antidiabetic agents and hormone replacement therapy. These studies did not produce any evidence of clinically significant adverse interactions.
Rostar side effects
See also:
What are the possible side effects of Rostar?
Rostar is generally well tolerated. The adverse events seen with Rostar are generally mild and transient. In controlled clinical trials less than 4% of Rostar 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 Rostar 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 Rostar 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 Rostar. Increases in HbA1c have also been observed in patients treated with Rostar. Abnormal urinalysis testing (dipstick-positive proteinuria) has been seen in a small number of patients taking Rostar 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 Rostar was shown to have no harmful effects on the ocular lens.
In Rostar 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 Rostar: 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 Rostar 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.
Rostar contraindications
See also:
What is the most important information I should know about Rostar?
Hypersensitivity to Rostar or to any of the excipients of Rostar 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 Rostar 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: Rostar Sandoz should not be taken by pregnant and breastfeeding women. If the patient become pregnant while taking Rostar Sandoz, stop taking it immediately and inform the physician. Women should avoid becoming pregnant while taking Rostar Sandoz by using suitable contraception.
Active ingredient matches for Rostar:
Rosuvastatin in India.
| Unit description / dosage (Manufacturer) | Price, USD |
| Rostar 5mg TAB / 10 | $ 0.54 |
| Rostar 10mg TAB / 10 | $ 1.11 |
| 5 mg x 10's | $ 0.54 |
| 10 mg x 10's | $ 1.11 |
| 20 mg x 10's | $ 1.45 |
| Rostar 20mg TAB / 10 | $ 1.45 |
| ROSTAR 10MG TABLET 1 strip / 10 tablets each (Unichem Laboratories Ltd) | $ 1.45 |
| ROSTAR 20MG TABLET 1 strip / 10 tablets each (Unichem Laboratories Ltd) | $ 1.96 |
| ROSTAR 40MG TABLET 1 strip / 10 tablets each (Unichem Laboratories Ltd) | $ 2.89 |
| ROSTAR 5MG TABLET 1 strip / 10 tablets each (Unichem Laboratories Ltd) | $ 0.76 |
| ROSTAR tab 5 mg x 10's (Unichem) | $ 0.54 |
| ROSTAR tab 10 mg x 10's (Unichem) | $ 1.14 |
| ROSTAR tab 20 mg x 10's (Unichem) | $ 1.45 |
| Rostar 10mg Tablet (Unichem Laboratories Ltd) | $ 0.16 |
| Rostar 20mg Tablet (Unichem Laboratories Ltd) | $ 0.22 |
| Rostar 40mg Tablet (Unichem Laboratories Ltd) | $ 0.29 |
| Rostar 5mg Tablet (Unichem Laboratories Ltd) | $ 0.08 |
List of Rostar substitutes (brand and generic names): | |
| Rostan (Argentina) | |
| Rostan 20 mg | |
| Rostat (Romania) | |
| Rostatin (Bangladesh) | |
| Rostatin FC tab 10 mg 1 x 10's (Maple Pharma) | |
| Rostatin FC tab 40 mg 1 x 10's (Maple Pharma) | |
| Rostatin FC tab 5 mg 1 x 10's (Maple Pharma) | |
| Rostazen (South Korea) | |
| Rostor (Vietnam) | |
| Rostor 10/20 (Vietnam) | |
| Rostor 10/20 10 mg x 2 Blister x 14 Tablet | |
| Rostor 10/20 20 mg x 2 Blister x 14 Tablet | |
| Rosu Hdl | |
| Rosu Hdl 40mg Tablet (Morepen Laboratories Ltd) | $ 0.51 |
| Rosu Hdl 5mg Tablet (Morepen Laboratories Ltd) | $ 0.08 |
| ROSUAST | |
| ROSUAST 10MG TABLET 1 strip / 10 tablets each (Astorion Pharmaceuticals Pvt Ltd) | $ 0.87 |
| Rosuben (Greece) | |
| ROSUBID | |
| ROSUBID 10MG TABLET 1 strip / 10 tablets each (Jarun Pharmaceuticals) | $ 0.79 |
| ROSUCAD (India) | |
| ROSUCAD tab 5 mg x 10's (Cadell) | $ 0.47 |
| ROSUCAD tab 10 mg x 10's (Cadell) | $ 0.84 |
| Rosucard (Bulgaria, Croatia (Hrvatska), Estonia) | |
| ROSUCARD -10 TABLET 1 strip / 10 tablets each (Tycoon Pharmaceuticals Pvt Ltd) | $ 1.20 |
| ROSUCARD -20 TABLET 1 strip / 10 tablets each (Tycoon Pharmaceuticals Pvt Ltd) | $ 2.41 |
| ROSUCARD -5 TABLET 1 strip / 10 tablets each (Tycoon Pharmaceuticals Pvt Ltd) | $ 0.66 |
| Rosucard 10mg Tablet (Tycoon Pharmaceuticals Pvt Ltd) | $ 0.13 |
| Rosucard 20mg Tablet (Tycoon Pharmaceuticals Pvt Ltd) | $ 0.24 |
| Rosucard 5mg Tablet (Tycoon Pharmaceuticals Pvt Ltd) | $ 0.07 |
| Rosucard Sanofi (Singapore) | |
| Rosucard Sanofi FC tab 10 mg 30's (sanofi-aventis) | |
| Rosucard Sanofi FC tab 20 mg 30's (sanofi-aventis) | |
| Rosucard Sanofi FC tab 40 mg 30's (sanofi-aventis) | |
| ROSUCHEK | |
| ROSUCHEK 10 MG TABLET 1 strip / 10 tablets each (Indoco Remedies Ltd) | $ 1.01 |
| ROSUCHEK 5 MG TABLET 1 strip / 10 tablets each (Indoco Remedies Ltd) | $ 0.57 |
| Rosuchek 10mg Tablet (Indoco Remedies Ltd) | $ 0.11 |
| Rosuchek 5mg Tablet (Indoco Remedies Ltd) | $ 0.06 |
| Rosuchen (Estonia, Latvia, Lithuania, Romania) | |
| ROSUCHOL | |
| ROSUCHOL 10MG TABLET 1 strip / 10 tablets each (Ajanta Pharma Ltd) | $ 3.23 |
| ROSUCHOL 5MG TABLET 1 strip / 10 tablets each (Ajanta Pharma Ltd) | $ 1.94 |
| Rosuchol 5mg Tablet (Ajanta Pharma Ltd) | $ 0.19 |
| ROSUCIA | |
| ROSUCIA 10 MG TABLET 1 strip / 10 tablets each (Precia Pharma) | $ 1.19 |
| ROSUCIA 20 MG TABLET 1 strip / 10 tablets each (Precia Pharma) | $ 2.40 |
| ROSUCIA 40 MG TABLET 1 strip / 10 tablets each (Precia Pharma) | $ 4.47 |
| ROSUCIA 5 MG TABLET 1 strip / 10 tablets each (Precia Pharma) | $ 0.68 |
| Rosucia 10mg Tablet (Precia Pharma) | $ 0.12 |
| Rosucia 20mg Tablet (Precia Pharma) | $ 0.24 |
| Rosucia 40mg Tablet (Precia Pharma) | $ 0.45 |
| Rosucia 5mg Tablet (Precia Pharma) | $ 0.07 |
| Rosucia Gold Tablet (Precia Pharma) | $ 0.12 |
See 1831 substitutes for Rostar | |
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 Rostar 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 Rostar. 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 yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
No survey data has been collected yetConsumer reported age
No survey data has been collected yetConsumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
