Rosuvastatin is a hmg-coa reductase inhibitor sold in the U.S. under 3 brand and generic names, for coronary artery disease, hypercholesterolemia and hyperlipoproteinemias. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Rosuvastatin Calcium (application ANDA205587). Other rosuvastatin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Rosuvastatin calcium tablets can be taken with or without food, at any time of day. (2.1) • Dose range: 5 to 40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg. (2.1) • Adult HoFH : Starting dose 20 mg/day. Error! Hyperlink reference not valid. 2.1 General Dosing Information The dose range for rosuvastatin calcium tablets 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 rosuvastatin calcium tablets dose of 40 mg should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose [see Warnings and Precautions (5.1) ]. Rosuvastatin calcium tablets can be administered as a single dose at any time of day, with or without food. The tablet should be swallowed whole. When initiating rosuvastatin calcium tablets therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate rosuvastatin calcium tablets 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 rosuvastatin calcium tablets, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly. Pediatric…
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) ] Most frequent adverse reactions (rate ≥2%) are headache, myalgia, abdominal pain, asthenia, and nausea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. In the rosuvastatin controlled clinical trials database (placebo or active-controlled) of 5394 patients with a mean treatment duration of 15 weeks, 1.4% of patients discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were: • myalgia • abdominal pain • nausea The most commonly reported adverse reactions (incidence ≥ 2%) in the rosuvastatin controlled clinical trial database of 5394 patients were: • headache • myalgia • abdominal pain • asthenia • nausea Adverse…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
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| 1 | 56/100 | Prescription | Tablet | Generic | $1 | View → | |
| 2 | Not yet rated | Prescription | Tablet | Generic | $1 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 1182 | 40 mg | pink | oval | — |
| R5 | 5 mg | pink | round | — |
| R10 | 10 mg | pink | round | — |
| R20 | 20 mg | pink | round | — |
| R40 | 40 mg | pink | oval | — |
| 79 | 5 mg | yellow |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
The elimination half-life of rosuvastatin is about 19 hours. Blood levels run roughly 2-fold higher in people of Asian descent, which can raise exposure without changing the ~19-hour half-life. The parent drug drives over 90% of the active effect; its main breakdown product (N-desmethyl rosuvastatin) is weaker and does not extend how long the drug lasts.
CRESTOR- rosuvastatin calcium tablet, film coated (DailyMed) ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Rosuvastatin calcium tablets are 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 [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 is present in human milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require rosuvastatin treatment should not breastfeed their infants [see Use in Specific Populations (8.2) ]. • Known hypersensitivity to product components (4) • Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels (4) • Pregnancy (4, 8.1 , 8.3 ) • Lactation ( 4 , 8.2 )
Cyclosporine: Combination increases rosuvastatin exposure. Limit rosuvastatin dose to 5 mg once daily. ( 2.4 , 5.1 , 7.1 , 12.3) • Gemfibrozil: Combination should be avoided. If used together, limit rosuvastatin dose to 10 mg once daily. ( 2.4 , 5.1 , 7.2 ) • Atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir: Combination increases rosuvastatin exposure. Limit rosuvastatin dose to 10 mg once daily. ( 2.4 , 5.1 , 7.3 , 12.3) • Coumarin anticoagulants: Combination prolongs INR. Achieve stable INR prior to starting rosuvastatin calcium tablets. Monitor INR frequently until stable upon initiation or alteration of rosuvastatin therapy. (5.3 , 7.4) • Concomitant lipid-lowering therapies: Use with fibrates or lipid-modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with rosuvastatin. (5.1 , 7.5 , 7.6 ) 7.1 Cyclosporine Cyclosporine increased rosuvastatin exposure (AUC) 7-fold. Therefore, in patients taking cyclosporine, the dose of rosuvastatin should not exceed 5 mg once daily [see Dosage and Administration (2.4) , Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ]. 7.2 Gemfibrozil Gemfibrozil significantly increased rosuvastatin exposure. Due to an observed increased risk of myopathy/rhabdomyolysis, combination therapy with rosuvastatin and gemfibrozil should…
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| 3 | Not yet rated | Prescription | Capsule | Generic | $1 | View → |
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| 1180 | 10 mg | pink | round | — |
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| 1181 | 20 mg | pink | round | — |
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| R5 | 5 mg | pink | round | — |
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| R10 | 10 mg | pink | round | — |
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| R20 | 20 mg | pink | round | — |
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| R40 | 40 mg | pink | oval | — |
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