• Dosage of Rosugraf in details
• Rosugraf interactions
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Dosage of Rosugraf in details

Rosugraf Dosage

Generic name: Rosugraf CALCIUM 5mg

Dosage form: tablet, film coated

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

General Dosing Information

The dose range for Rosugraf in adults is 5 to 40 mg orally once daily. The usual starting dose is 10 to 20 mg once daily. The usual starting dose in adult patients with homozygous familial hypercholesterolemia is 20 mg once daily.

The maximum Rosugraf dose of 40 mg should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose.

Rosugraf can be administered as a single dose at any time of day, with or without food. The tablet should be swallowed whole.

When initiating Rosugraf therapy or switching from another HMG‑CoA reductase inhibitor therapy, the appropriate Rosugraf starting dose should first be utilized, and only then titrated according to the patient’s response and individualized goal of therapy.

After initiation or upon titration of Rosugraf, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

​2.2 Pediatric Dosing

​In heterozygous familial hypercholesterolemia, the recommended dose range is 5 to 10 mg orally once daily in patients 8 to less than 10 years of age, and 5 to 20 mg orally once daily in patients 10 to 17 years of age.

​In homozygous familial hypercholesterolemia, the recommended dose is 20 mg orally once daily in patients 7 to 17 years of age.

Dosing in Asian Patients

In Asian patients, consider initiation of Rosugraf therapy with 5 mg once daily due to increased Rosugraf plasma concentrations. The increased systemic exposure should be taken into consideration when treating Asian patients not adequately controlled at doses up to 20 mg/day.

Use with Concomitant Therapy

Patients taking cyclosporine

The dose of Rosugraf should not exceed 5 mg once daily.

Patients taking gemfibrozil

Avoid concomitant use of Rosugraf with gemfibrozil. If concomitant use cannot be avoided, initiate Rosugraf at 5 mg once daily. The dose of Rosugraf should not exceed 10 mg once daily.

Patients taking atazanavir and ritonavir, lopinavir and ritonavir, or simeprevir

Initiate Rosugraf therapy with 5 mg once daily. The dose of Rosugraf should not exceed 10 mg once daily.

Dosing in Patients with Severe Renal Impairment

For patients with severe renal impairment (CLcr <30 mL/min/1.73 m2) not on hemodialysis, dosing of Rosugraf should be started at 5 mg once daily and not exceed 10 mg once daily.

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What other drugs will affect Rosugraf?

Using certain other drugs together with Rosugraf can increase your risk of serious muscle problems. It is very important to tell your doctor about all medicines you use, and those you start or stop using during your treatment with Rosugraf, especially:

• colchicine;

• cyclosporine;

• another "statin" medicine - atorvastatin, lovastatin, simvastatin, Lipitor, Pravachol, Zocor, Vytorin, and others;

• antifungal medicine - fluconazole, itraconazole, ketoconazole;

• antiviral medicine to treat HIV or hepatitis C - atazanavir, fosamprenavir, lopinavir, ritonavir, simeprevir, tipranavir, and others;

• a blood thinner - warfarin, Coumadin, Jantoven;

• other cholesterol medications - fenofibrate, gemfibrozil; or

• medicines that contain niacin or nicotinic acid - vitamin B3, Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others.

This list is not complete. Other drugs may interact with Rosugraf, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Rosugraf interactions

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

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

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

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

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

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

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. FDA/SPL Indexing Data. "413KH5ZJ73: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
3. MeSH. "Hydroxymethylglutaryl-CoA Reductase Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

Reviews

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Information checked by Dr. Sachin Kumar, MD Pharmacology