• Dosage of Rosuast in details
• Rosuast interactions
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Dosage of Rosuast in details

Rosuast Dosage

Generic name: Rosuast 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 Rosuast 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 Rosuast dose of 40 mg should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose.

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

When initiating Rosuast therapy or switching from another HMG‑CoA reductase inhibitor therapy, the appropriate Rosuast 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 Rosuast, 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 Rosuast therapy with 5 mg once daily due to increased Rosuast 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 Rosuast should not exceed 5 mg once daily.

Patients taking gemfibrozil

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

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

Initiate Rosuast therapy with 5 mg once daily. The dose of Rosuast 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 Rosuast should be started at 5 mg once daily and not exceed 10 mg once daily.

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What other drugs will affect Rosuast?

Using certain other drugs together with Rosuast 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 Rosuast, 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 Rosuast, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Rosuast interactions

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

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

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

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

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

Fenofibrates/Fibric Acid Derivatives: Although no pharmacokinetic interaction between Rosuast 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 Rosuast 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 Rosuast 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