Directory of Drugs: Crestor(Rosuvastatin Calcium) facts and information

What Is Crestor?

Crestor is a medicine that lowers "bad" cholesterol and triglycerides and raises "good" cholesterol in the blood. Crestor is part of a treatment program that should also include a low-fat diet and exercise.

Who Should Not Take Crestor?

Do not take Crestor if you:

Have liver problems or have persistently high liver enzymes
Are pregnant or planning to become pregnant. Crestor may harm your unborn baby. If you get pregnant, stop Crestor and call your healthcare professional right away.
Are breast-feeding. It is not known if Crestor can pass into your milk, and if it can harm your baby. You should choose to either take Crestor or breastfeed, but not both.
Are allergic to Crestor or any of its ingredients

Crestor has not been studied in children.

What Are The Risks?

Crestor may cause rare, but serious, side effects including:

Muscle damage. Crestor can cause serious muscle damage that can lead to kidney damage. The risk of muscle damage may be increased by taking certain drugs. Crestor should be used with caution if you have kidney problems, advanced age, and hypothyroidism because you are at a greater risk of muscle damage. Tell your healthcare professional if you develop unexplained muscle pain, tenderness, or weakness while on Crestor, particularly if accompanied by malaise or fever.

Liver damage. Crestor can cause liver damage like other lipid lowering medicines. This risk may be increased when Crestor is used with certain medicines. Your healthcare professional may do blood tests to check your liver before you start taking Crestor, and while you take it. Crestor should be used with caution if you have a history of liver disease or drink substantial amounts of alcohol.
Other side effects include muscle pain, constipation, weakness, abdominal pain, and nausea

What Should I Tell My Healthcare Professional?

Before starting Crestor, tell your healthcare professional about all your medical conditions, including if you:

Are pregnant or planning to become pregnant
Are breast-feeding
Have liver problems
Have kidney problems
Drink alcohol

Are There Any Interactions With Drugs Or Foods?

Tell your healthcare professional about all the medicines you take, including prescription and over the counter drugs, and supplements. Crestor and certain medicines may interact with each other causing serious side effects. Crestor and other medicines may affect each other, causing serious side effects. Especially tell your healthcare professional if you take:

Cyclosporine (Gengraf, Neoral, Sandimmune)
Warfarin (Coumadin)
Gemfibrozil (Lopid)
Drugs that may decrease the levels or activity of your body’s own steroid hormones. These drugs include ketoconazole (Nizoral), spironolactone (Aldactone), and cimetidine (Tagamet)
Aluminum and magnesium hydroxide combination antacids (for example, Maalox)

How do I take Crestor?

You should be placed on a standard lipid-lowering diet and an exercise routine before receiving Crestor and should continue these during treatment. Crestor can be taken as a single dose at any time of day, with or without food.
The dose range for Crestor is 5 to 40 mg once daily. You should start on the lowest possible dose, and never start with 40 mg. After starting or changing your dose of Crestor, your lipid levels should be checked within 2 to 4 weeks and your dose adjusted as needed.
FDA ALERT [03/2005]: Rhabdomyolysis (serious muscle damage) has been reported in patients taking Crestor as well as other statin drugs. To date, it does not appear that the risk is greater with Crestor than with other marketed statins. However, the labeling for Crestor is being revised to highlight important information on the safe use of Crestor to reduce the risk for serious muscle toxicity (myopathy/rhabdomyolysis), especially at the highest approved dose of 40 mg. The labeling will also be revised to reflect the results of a large pharmacokinetic study involving a diverse population of Asian patients compared with a Caucasian control group that found drug levels to be elevated approximately 2-fold. Kidney failure of various types has also been reported in patients treated with Crestor as well as other statins. Patients who are candidates for statin therapy (e.g., patients with diabetes, hypertension, atherosclerosis, and/or heart failure) may also be at higher risk for kidney failure even when they are not taking statins. At this time, the FDA cannot conclude that recommended doses of Crestor can cause or exacerbate renal failure, but is continuing to carefully evaluate the data.

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.

Recommendations

Crestor should be used only at doses recommended in the label. Initiation of Crestor therapy with 5 mg daily should be considered in Asian patients.

Data Summary

Crestor, like all statins, has been associated with a low incidence of rhabdomyolysis. The data available to date from controlled trials as well as postmarketing safety information indicate that the risk of serious muscle damage is similar with Crestor compared to other marketed statins. As with all statins, some individuals taking Crestor will experience muscle side effects, most commonly mild aches and very rarely severe muscle damage. Like all drugs in this class, risks of muscle injury can be minimized by adhering to labeled warnings and precautions, carefully following dosing instructions, and instructing patients to be aware of and to report possible side effects to their healthcare professionals. Finally, like all statins, Crestor should be prescribed at the lowest dose that achieves the goals of therapy (e.g., target LDL-C level).

Various forms of kidney failure have been reported in patients taking Crestor, as well as with other statins. Renal failure due to other factors is known to occur at a higher rate in patients who are candidates for statin therapy (e.g., patients with diabetes, hypertension, atherosclerosis, heart failure). No consistent pattern of clinical presentation or of renal injury (i.e., pathology) is evident among the cases of renal failure reported to date that clearly indicate causation by Crestor or other statins.

Mild, transient proteinuria (non-glomerular in origin), with and without microscopic hematuria, occurred with Crestor, as it has with other statins, in preapproval trials. The frequency of occurrence of proteinuria appeared dose-related. In clinical trials with doses from 5 to 40 mg daily, this effect was not associated with renal impairment or renal failure. Nevertheless, dose reduction in addition to other investigations as to the cause should nevertheless be considered if a patient develops unexplained persistent proteinuria.

Ongoing controlled clinical trials of Crestor and other statins, epidemiologic studies of the safety and side effects of Crestor, and ongoing pharmacovigilance by FDA will continue to provide information on the balance of risks and benefits of Crestor and other members of this important class of drugs. This information will be made available and, as appropriate, applied to drug labeling in a timely fashion.

Date created: March 2, 2005



What Is Crestor? Crestor is a medicine that lowers "bad" cholesterol and triglycerides and raises "good" cholesterol in the blood. Crestor is part of a treatment program that should also include a low-fat diet and exercise. Who Should Not Take Crestor? Do not take Crestor if you: Have liver problems or have persistently high liver enzymes Are pregnant or planning to become pregnant. Crestor may harm your unborn baby. If you get pregnant, stop Crestor and call your healthcare professional right away. Are breast-feeding. It is not known if Crestor can pass into your milk, and if it can harm your baby. You should choose to either take Crestor or breastfeed, but not both. Are allergic to Crestor or any of its ingredients Crestor has not been studied in children. What Are The Risks? Crestor may cause rare, but serious, side effects including: *Muscle damage. Crestor can cause serious muscle damage that can lead to kidney damage. The risk of muscle damage may be increased by taking certain drugs. Crestor should be used with caution if you have kidney problems, advanced age, and hypothyroidism because you are at a greater risk of muscle damage. Tell your healthcare professional if you develop unexplained muscle pain, tenderness, or weakness while on Crestor, particularly if accompanied by malaise or fever. Liver damage. Crestor can cause liver damage like other lipid lowering medicines. This risk may be increased when Crestor is used with certain medicines. Your healthcare professional may do blood tests to check your liver before you start taking Crestor, and while you take it. Crestor should be used with caution if you have a history of liver disease or drink substantial amounts of alcohol. Other side effects* include muscle pain, constipation, weakness, abdominal pain, and nausea What Should I Tell My Healthcare Professional? Before starting Crestor, tell your healthcare professional about all your medical conditions, including if you: Are pregnant or planning to become pregnant Are breast-feeding Have liver problems Have kidney problems Drink alcohol Are There Any Interactions With Drugs Or Foods? Tell your healthcare professional about all the medicines you take, including prescription and over the counter drugs, and supplements. Crestor and certain medicines may interact with each other causing serious side effects. Crestor and other medicines may affect each other, causing serious side effects. Especially tell your healthcare professional if you take: Cyclosporine (Gengraf, Neoral, Sandimmune) Warfarin (Coumadin) Gemfibrozil (Lopid) Drugs that may decrease the levels or activity of your body’s own steroid hormones. These drugs include ketoconazole (Nizoral), spironolactone (Aldactone), and cimetidine (Tagamet) Aluminum and magnesium hydroxide combination antacids (for example, Maalox) How do I take Crestor? You should be placed on a standard lipid-lowering diet and an exercise routine before receiving Crestor and should continue these during treatment. Crestor can be taken as a single dose at any time of day, with or without food. The dose range for Crestor is 5 to 40 mg once daily. You should start on the lowest possible dose, and never start with 40 mg. After starting or changing your dose of Crestor, your lipid levels should be checked within 2 to 4 weeks and your dose adjusted as needed. FDA ALERT [03/2005]: Rhabdomyolysis (serious muscle damage) has been reported in patients taking Crestor as well as other statin drugs. To date, it does not appear that the risk is greater with Crestor than with other marketed statins. However, the labeling for Crestor is being revised to highlight important information on the safe use of Crestor to reduce the risk for serious muscle toxicity (myopathy/rhabdomyolysis), especially at the highest approved dose of 40 mg. The labeling will also be revised to reflect the results of a large pharmacokinetic study involving a diverse population of Asian patients compared with a Caucasian control group that found drug levels to be elevated approximately 2-fold. Kidney failure of various types has also been reported in patients treated with Crestor as well as other statins. Patients who are candidates for statin therapy (e.g., patients with diabetes, hypertension, atherosclerosis, and/or heart failure) may also be at higher risk for kidney failure even when they are not taking statins. At this time, the FDA cannot conclude that recommended doses of Crestor can cause or exacerbate renal failure, but is continuing to carefully evaluate the data. This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available. Recommendations Crestor should be used only at doses recommended in the label. Initiation of Crestor therapy with 5 mg daily should be considered in Asian patients. Data Summary Crestor, like all statins, has been associated with a low incidence of rhabdomyolysis. The data available to date from controlled trials as well as postmarketing safety information indicate that the risk of serious muscle damage is similar with Crestor compared to other marketed statins. As with all statins, some individuals taking Crestor will experience muscle side effects, most commonly mild aches and very rarely severe muscle damage. Like all drugs in this class, risks of muscle injury can be minimized by adhering to labeled warnings and precautions, carefully following dosing instructions, and instructing patients to be aware of and to report possible side effects to their healthcare professionals. Finally, like all statins, Crestor should be prescribed at the lowest dose that achieves the goals of therapy (e.g., target LDL-C level). Various forms of kidney failure have been reported in patients taking Crestor, as well as with other statins. Renal failure due to other factors is known to occur at a higher rate in patients who are candidates for statin therapy (e.g., patients with diabetes, hypertension, atherosclerosis, heart failure). No consistent pattern of clinical presentation or of renal injury (i.e., pathology) is evident among the cases of renal failure reported to date that clearly indicate causation by Crestor or other statins. Mild, transient proteinuria (non-glomerular in origin), with and without microscopic hematuria, occurred with Crestor, as it has with other statins, in preapproval trials. The frequency of occurrence of proteinuria appeared dose-related. In clinical trials with doses from 5 to 40 mg daily, this effect was not associated with renal impairment or renal failure. Nevertheless, dose reduction in addition to other investigations as to the cause should nevertheless be considered if a patient develops unexplained persistent proteinuria. Ongoing controlled clinical trials of Crestor and other statins, epidemiologic studies of the safety and side effects of Crestor, and ongoing pharmacovigilance by FDA will continue to provide information on the balance of risks and benefits of Crestor and other members of this important class of drugs. This information will be made available and, as appropriate, applied to drug labeling in a timely fashion. Date created: March 2, 2005