Rosuvastatin Calcium (rosuvastatin calcium)

Dosage of rosuvastatin calcium is expressed in terms of rosuvastatin.

The dosage range of rosuvastatin in adults is 5-40 mg once daily.

Table. Dosage Modification for Concomitant Therapy

Concomitant Drug Rosuvastatin Dosage Modifications Antiviral Medications: Simeprevir Initiate at 5 mg once daily; do not Elbasvir/Grazoprevir exceed 10 mg once daily Sofosbuvir/Velpatasvir Glecaprevir/Pibrentasvir Atazanavir/Ritonavir Lopinavir/Ritonavir Capmatinib Do not exceed 10 mg once daily Cyclosporine Do not exceed 5 mg once daily Darolutamide Do not exceed 5 mg once daily Enasidenib Do not exceed 10 mg once daily Febuxostat Do not exceed 20 mg once daily Fostamatinib Do not exceed 20 mg once daily Gemfibrozil Avoid concomitant use. If used concomitantly, initiate at 5 mg once daily and do not exceed 10 mg once daily Regorafenib Do not exceed 10 mg once daily Tafamadis Avoid concomitant use. If used concomitantly, initiate at 5 mg once daily and do not exceed 20 mg once daily Teriflunomide Do not exceed 10 mg once daily

Rosuvastatin is administered orally as a single dose at any time of day, with or without food. Rosuvastatin tablets should be swallowed whole.

If a dose of rosuvastatin is missed, resume treatment with the next dose; patients should not take an extra dose.

Store tablets at 20-25degreesC; excursions permitted to 15-30degreesC. Protect from moisture.

No dosing information is available for this tab.

No dosing information is available for this tab.

Rosuvastatin is minimally (approximately 10%) metabolized by cytochrome P-450 (CYP) isoenzyme 2C9. Clearance of rosuvastatin is not dependent on metabolism by CYP3A4 to a clinically important extent. Rosuvastatin is also a substrate for the organic anion transport protein (OATP) 1B1 and the breast cancer resistance protein (BCRP).

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Acute liver failure or decompensated cirrhosis.

*Known hypersensitivity to rosuvastatin or any component of the formulation. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects reported in at least 2% of patients receiving rosuvastatin include headache, nausea, myalgia, asthenia, and constipation.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy of rosuvastatin have not been established in pediatric patients younger than 8 years of age with heterozygous familial hypercholesterolemia (HeFH), younger than 7 years of age with HoFH, or in pediatric patients with other types of hyperlipidemia (other than HeFH and HoFH).

Safety and effectiveness of rosuvastatin have been established in pediatric patients 8 years of age and older with HeFH. Use of rosuvastatin in the pediatric population is based on a 12-week controlled trial with a 40-week open-label extension period in 176 pediatric patients 10 years of age and older with HeFH and a 2-year open-label, uncontrolled trial in 175 pediatric patients 8 years of age and older with HeFH. The observed reductions in LDL-cholesterol concentrations from baseline were consistent across age groups. In a population pharmacokinetic analysis of the 2 pediatric studies in patients with HeFH, rosuvastatin exposure appeared similar to or less than that observed in adults.

Safety and effectiveness of rosuvastatin have been established in pediatric patients 7 years of age and older with HoFH. Use of rosuvastatin in the pediatric population is based on a randomized, placebo-controlled, cross-over study in 14 pediatric patients 7 years of age and older with HoFH. Substantial reductions in LDL-cholesterol (22.3%), total cholesterol (20.1%), non-HDL-cholesterol (22.9%), and apo B (17.1%) were observed with rosuvastatin compared with placebo in these patients.

In studies evaluating rosuvastatin in the pediatric population, there were no detectable adverse effects on growth, weight, body mass index (BMI), or sexual maturation.

All statins were previously contraindicated in pregnant women because the fetal risk with these drugs was thought to outweigh any possible benefit. This determination was based on several factors including safety signals from animal data. In addition, congenital anomalies including severe CNS defects and unilateral limb deficiencies were reported in a case series of pregnant women who were exposed to a lipophilic statin (rosuvastatin is a hydrophilic statin) during the first trimester. Because statins decrease synthesis of cholesterol and possibly other products of the cholesterol biosynthetic pathway, there is also a concern that these drugs can potentially cause fetal harm. More recent data from case series and observational cohort studies have not shown evidence of an increased risk of major birth defects with statin use during pregnancy, and this was observed after controlling for potential confounders such as maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use. The overall evidence from animal studies suggests limited potential for statins to cause malformations or other adverse fetal effects. While an increased risk of miscarriage has been reported in pregnant women exposed to statins, it is not clear whether this effect is related to the drugs or to other confounding factors. FDA conducted a comprehensive review of all available clinical and nonclinical data related to statin use in pregnant women and concluded that the totality of evidence suggests that there is limited potential for statins to cause malformations and other adverse embryofetal effects. Because statins may prevent serious or potentially fatal cardiovascular events in certain high-risk patients who are pregnant, FDA has requested that the contraindication in pregnant women be removed from the prescribing information for all statins. While FDA still advises that most pregnant patients discontinue statins because of the possibility of fetal harm, there may be some patients (e.g., those with homozygous familial hypercholesterolemia (HoFH) or established cardiovascular disease) in whom continued therapy may be beneficial; therefore, decisions should be individualized based on the patient's risks versus benefits. Patients who become pregnant or suspect that they are pregnant while receiving a statin should notify their clinician who can advise them on the appropriate course of action.

Limited data indicate that rosuvastatin is distributed into human milk; however, the effects of the drug on breast-fed infants or milk production are not known. Because of the potential for serious adverse reactions from rosuvastatin in nursing infants, the drug is not recommended in nursing women. Women who require rosuvastatin therapy should not breast-feed their infants. Many patients can stop statin therapy temporarily until breast-feeding is complete; patients who require ongoing statin treatment should not breast-feed and should use alternatives such as infant formula.

Although there are no specific dosage recommendations for geriatric patients, caution is recommended when rosuvastatin is used. Dose selection in geriatric patients (>=65 years of age) should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy.

Of the total number of patients receiving rosuvastatin in clinical studies, 31% were 65 years of age or older, and 6.8% were 75 years of age or older. Although no overall differences in efficacy or safety were observed between geriatric and younger patients, and other clinical experience has not revealed age-related differences in response, the possibility that some geriatric patients may exhibit increased sensitivity to the drug cannot be ruled out. Advanced age (>=65 years) is a risk factor for rosuvastatin-associated myopathy and rhabdomyolysis. There are no differences in plasma concentrations of rosuvastatin between geriatric (65 years of age or older) and younger patients.

Because patients older than 75 years of age may have a higher risk of adverse effects and lower adherence to therapy, the expected benefits versus adverse effects should be considered before initiating statin therapy in this population.

Monitor geriatric patients for development of myopathy.