Rostor 10/20 Uses

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• Rostor 10/20 indications
• Uses of Rostor 10/20 in details
• Rostor 10/20 description
• Rostor 10/20 dosage
• Rostor 10/20 interactions
• Rostor 10/20 side effects
• Rostor 10/20 contraindications

What is Rostor 10/20?

Rostor 10/20 (Rostor 10/20) belongs to a a group of drugs called HMG CoA reductase inhibitors, or "statins." Rostor 10/20 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).

Rostor 10/20 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.

Rostor 10/20 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.

Rostor 10/20 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, Rostor 10/20 can be used in children who are at least 8 years old. For the homozygous type, Rostor 10/20 can be used in children as young as 7 years old.

Rostor 10/20 indications

Rostor 10/20 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, Rostor 10/20 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: Rostor 10/20 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). Rostor 10/20 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: Rostor 10/20 is indicated to reduce the Total Cholesterol, LDL-C and Apo B in patients with heterozygous familial hypercholesterolaemia (HeFH).

How should I use Rostor 10/20?

Use Rostor 10/20 as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Rostor 10/20. Talk to your pharmacist if you have questions about this information.
• Take Rostor 10/20 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 Rostor 10/20. Check with your doctor if you have any questions.
• Taking Rostor 10/20 at the same time each day will help you remember to take it.
• Continue to take Rostor 10/20 even if you feel well. Do not miss any doses.
• If you miss a dose of Rostor 10/20, 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 Rostor 10/20.

Uses of Rostor 10/20 in details

• Rostor 10/20 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.

Rostor 10/20 description

Rostor 10/20 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.

Rostor 10/20 is a synthetic lipid-lowering agent for oral administration. The chemical name for Rostor 10/20 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.

Rostor 10/20 dosage

General Dosing Information: The dose range for Rostor 10/20 is 5-40 mg orally once daily.

Rostor 10/20 can be administered as a single dose at any time of the day, with or without food. When initiating Rostor 10/20 therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate Rostor 10/20 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 Rostor 10/20 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 Rostor 10/20 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 Rostor 10/20, 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 Rostor 10/20 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 Rostor 10/20 is 20 mg once daily. Response to therapy should be estimated from pre-aphereses LDL-C levels.

Dosage in Asian Patients: Initiation of Rostor 10/20 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 Rostor 10/20 should be limited to 5 mg once daily. In patients taking a combination of lopinavir and ritonavir, the dose of Rostor 10/20 should be limited to 10 mg once daily.

Concomitant Lipid-Lowering Therapy: The risk of skeletal muscle effects may be enhanced when Rostor 10/20 is used in combination with niacin or fenofibrate; a reduction in Rostor 10/20 is used in combination with gemfibrozil, the dose of Rostor 10/20 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 Rostor 10/20 should be started at 5 mg once daily and should not exceed 10 mg once daily.

Rostor 10/20 interactions

See also:
What other drugs will affect Rostor 10/20?

Effect of Co-Administered Medicinal Products on Rostor 10/20: In vitro and in vivo data indicate that Rostor 10/20 has no clinically significant cytochrome P450 interactions (as a substrate, inhibitor or inducer). Rostor 10/20 is a substrate for certain transporter proteins including the hepatic uptake transporter OATP1B1 and efflux transporter BCRP. Concomitant administration of Rostor 10/20 with medicinal products that are inhibitors of these transporter proteins may result in increased Rostor 10/20 plasma concentrations and an increased risk of myopathy.

Interactions Requiring Rostor 10/20 Dose Adjustments : When it is necessary to co-administer Rostor 10/20 with other medicinal products known to increase exposure to Rostor 10/20, doses of Rostor 10/20 should be adjusted. It is recommended that prescribers consult the relevant product information when considering administration of such products together with Rostor 10/20. Start with a 5 mg once daily dose of Rostor 10/20 if the expected increase in exposure (AUC) is approximately 2-fold or higher. The maximum daily dose of Rostor 10/20 should be adjusted so that the expected Rostor 10/20 exposure would not likely exceed that of a 40 mg daily dose of Rostor 10/20 taken without interacting medicinal products, for example a 5 mg dose of Rostor 10/20 with ciclosporin (7.1-fold increase in exposure), a 10 mg dose of Rostor 10/20 with ritonavir/atazanavir combination (3.1-fold increase) and a 20 mg dose of Rostor 10/20 with gemfibrozil (1.9-fold increase).

Other Interacting Medicinal Products: Antacid: The simultaneous dosing of Rostor 10/20 with an antacid suspension containing aluminum and magnesium hydroxide resulted in a decrease in Rostor 10/20 plasma concentration of approximately 50%. This effect was mitigated when the antacid was dosed 2 hours after Rostor 10/20. The clinical relevance of this interaction has not been studied.

Fusidic Acid: Interaction studies with Rostor 10/20 and fusidic acid have not been conducted. As with other statins, muscle related events, including rhabdomyolysis, have been reported in post-marketing experience with Rostor 10/20 and fusidic acid given concurrently. Patients should be closely monitored and temporary suspension of Rostor 10/20 treatment may be appropriate.

Effect of Rostor 10/20 on Co-Administered Medicinal Products: Warfarin: The pharmacokinetics of warfarin are not significantly affected following co-administration with Rostor 10/20. However, as with other HMG-CoA reductase inhibitors, co-administration of Rostor 10/20 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 Rostor 10/20 or following dose adjustment.

Fenofibrates/Fibric Acid Derivatives: Although no pharmacokinetic interaction between Rostor 10/20 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 Rostor 10/20 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 Rostor 10/20 was co-administered with antihypertensive agents, antidiabetic agents and hormone replacement therapy. These studies did not produce any evidence of clinically significant adverse interactions.

Rostor 10/20 side effects

See also:
What are the possible side effects of Rostor 10/20?

Rostor 10/20 is generally well tolerated. The adverse events seen with Rostor 10/20 are generally mild and transient. In controlled clinical trials less than 4% of Rostor 10/20 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 Rostor 10/20 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 Rostor 10/20 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 Rostor 10/20. Increases in HbA1c have also been observed in patients treated with Rostor 10/20. Abnormal urinalysis testing (dipstick-positive proteinuria) has been seen in a small number of patients taking Rostor 10/20 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 Rostor 10/20 was shown to have no harmful effects on the ocular lens.

In Rostor 10/20 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 Rostor 10/20: 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 Rostor 10/20 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.

Rostor 10/20 contraindications

See also:
What is the most important information I should know about Rostor 10/20?

Hypersensitivity to Rostor 10/20 or to any of the excipients of Rostor 10/20 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 Rostor 10/20 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: Rostor 10/20 Sandoz should not be taken by pregnant and breastfeeding women. If the patient become pregnant while taking Rostor 10/20 Sandoz, stop taking it immediately and inform the physician. Women should avoid becoming pregnant while taking Rostor 10/20 Sandoz by using suitable contraception.

Active ingredient matches for Rostor 10/20:

Rosuvastatin in Vietnam.

References

1. 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).
2. PubChem. "Rosuvastatin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "Rosuvastatin". http://www.drugbank.ca/drugs/DB01098 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology