Rosuvastatin Calcium Ru10 16252 0616 30 Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
What should I know before taking it?
Rosuvastatin tablets is contraindicated in the following conditions: • Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including rash, pruritus,urticaria, and angioedema have been reported with rosuvastatin tablets [ see Adverse Reactions (6.1) ]. • Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels [ see Warnings and Precautions (5.2) ]. • Pregnancy [see Use in Specific Populations (8.1, 8.3)] • Lactation. Limited data indicate that rosuvastatin tablets is present in human milk. Because statins have the potential for serious adverse reactions in nursing infants, women who.
What important warnings are listed?
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (≥65), hypothyroidism, renal impairment, and combination use with cyclosporine, darolutamide, regorafenib, certain anti-viral medicines or their combinations. Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness and discontinue rosuvastatin tablets if signs or symptoms appear. ( 5.1, 7.4, 7.5, 7.7, 7.8) Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Perform liver.
How is this medication usually taken?
5 mg: Yellow color,circular,biconvex,film coated tablets debossed with “R” on one side and “5” on the other side. 10 mg: Pink color,circular,biconvex,film coated tablets debossed with “R” on one side and “10” on the other side. 20 mg: Pink color,circular,biconvex,film coated tablets debossed with “R” on one side and “20” on the other side. 40 mg: Pink color,oval shape,biconvex,film coated tablets debossed with “R” on one side and “40” on the other side.
What side effects are listed?
The following serious adverse reactions are discussed in greater detail in other sections of the label: • Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis) [ see Warnings and Precautions ( 5.1)] • Liver enzyme abnormalities [ see Warnings and Precautions ( 5.2)]
What interactions are listed?
Combination of sofosbuvir/velpatasvir/voxilaprevir or ledipasvir/sofosbuvir: Combination increases rosuvastatin exposure. Use with rosuvastatin tablets is not recommended. ( 2.4, 5.1, 7.3, 12.3) Cyclosporine and darolutamide: Combination increases rosuvastatin tablets exposure. Limit rosuvastatin tablets dose to 5 mg once daily. ( 2.4, 5.1, 7.1, 7.4 , 12.3) Gemfibrozil: Combination should be avoided. If used together, limit rosuvastatin tablets dose to 10 mg once daily. (2.4, 5.1, 7.2) Atazanavir/ritonavir, lopinavir/ritonavir, simeprevir or combination of dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir and glecaprevir/pibrentasvir: Combination.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c2d9a04e-8c72-d487-e053-2a95a90a0fcd
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.