Rosuvastatin

Rosuvastatin (Crestor) is a prescription medicine used to treat high cholesterol and to reduce the risk of major cardiovascular events such as heart attack and stroke.

Rosuvastatin belongs to a class of medicines called statins. It works by blocking HMG-CoA reductase, the rate-limiting enzyme the liver uses to make cholesterol. With cholesterol synthesis reduced, the liver increases its LDL receptors and clears more LDL, or "bad" cholesterol, from the blood. LDL and total cholesterol levels fall, with the maximum reduction usually reached by four weeks.

Rosuvastatin comes as a tablet. It was first approved by the US Food and Drug Administration (FDA) on August 12, 2003, under the brand name Crestor. Many generic versions of rosuvastatin tablets have since been approved.

Rosuvastatin is used:

• to reduce the risk of major adverse cardiovascular (CV) events, such as death from cardiovascular disease, heart attack, stroke, or the need for procedures to improve blood flow to the heart called arterial revascularization, in adults at increased risk for these events.
• along with diet and exercise to lower the level of low-density lipoprotein (LDL-C) cholesterol or "bad" cholesterol: in adults with primary hypercholesterolemia. and slow the buildup of fatty deposits (plaque) in the walls of blood vessels in adults. in adults and children 8 years of age and older with high blood cholesterol due to heterozygous familial hypercholesterolemia (HeFH) (an inherited condition that causes high levels of LDL-C). in adults and children 7 years of age and older with homozygous familial hypercholesterolemia (HoFH) (an inherited condition that causes high levels of LDL-C).
• along with diet for the treatment of adults with: primary dysbetalipoproteinemia (an inherited condition that causes high levels of cholesterol and fat). hypertriglyceridemia.

It is not known if rosuvastatin is safe and effective in children younger than 8 years of age with HeFH, children younger than 7 years of age with HoFH, or in children with other types of hypercholesterolemia (other than HeFH or HoFH).

• Take rosuvastatin exactly as your doctor tells you to.
• Take rosuvastatin by mouth once daily. Swallow the tablet whole.
• Rosuvastatin can be taken at any time of day, with or without food.
• Do not change your dose or stop this medicine without talking to your doctor, even if you are feeling well.
• Your doctor may do blood tests to check your cholesterol levels before and during your treatment with rosuvastatin. Your doctor may change your dose if needed.
• Your doctor may start you on a cholesterol-lowering diet before giving you rosuvastatin. Stay on this diet when you take this medicine.
• If you take an antacid that contains a combination of aluminum and magnesium hydroxide, take rosuvastatin at least 2 hours before you take the antacid.

Do not take rosuvastatin if you:

• are allergic to rosuvastatin or any of the ingredients in your rosuvastatin tablets. See below for a complete list of ingredients.
• have liver problems.

Rosuvastatin pregnancy and breastfeeding warnings (more detail)

Before taking rosuvastatin, tell your healthcare provider about all of your medical conditions, including if you:

• have unexplained muscle aches or weakness
• have or have had kidney problems
• have or have had liver problems
• drink more than 2 glasses of alcohol daily
• have thyroid problems
• are of Asian descent

Also tell your healthcare provider if you are 65 years of age or older.

Common side effects

The most common side effects may include headache, nausea, muscle aches and pains, weakness, and constipation.

Serious side effects

Rosuvastatin may cause serious side effects, including:

• Muscle pain, tenderness and weakness (myopathy). Muscle problems, including muscle breakdown, can be serious in some people and rarely cause kidney damage that can lead to death. Tell your doctor right away if: you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual, while you take this medicine. you have muscle problems that do not go away even after your doctor has told you to stop taking this medicine. Your doctor may do further tests to diagnose the cause of your muscle problems. Your chances of getting muscle problems are higher if you: are taking certain other medicines while you take rosuvastatin are 65 years of age or older are of Asian descent have thyroid problems (hypothyroidism) that are not controlled have kidney problems are taking higher doses of this medicine
• Liver problems. Your doctor may do blood tests to check your liver before you start taking this medicine and if you have symptoms of liver problems while you are taking it. Call your doctor right away if you have any of the following symptoms of liver problems: feel unusually tired or weak loss of appetite upper belly pain dark urine yellowing of your skin or the whites of your eyes
• Protein and blood in the urine. Rosuvastatin may cause you to have protein and blood in your urine. If you develop protein or blood in your urine, your doctor may decrease your dose.
• Increase in blood sugar (glucose) levels. Rosuvastatin may cause an increase in your blood sugar levels.

Additional side effects that have been reported with rosuvastatin include abdominal pain, dizziness, memory loss and confusion.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Dose range: 5 mg to 40 mg once daily. The dose depends on the reason you are taking it, your LDL cholesterol level, and your individual risk of cardiovascular events.
• People of Asian descent: the recommended starting dose is 5 mg once daily.
• Severe kidney impairment (not on hemodialysis): the recommended starting dose is 5 mg once daily, and the dose should not exceed 10 mg once daily.
• Children with homozygous familial hypercholesterolemia: 20 mg once daily for those 7 years of age and older.
• Children with heterozygous familial hypercholesterolemia: 5 mg to 10 mg once daily for those 8 years to less than 10 years of age, and 5 mg to 20 mg once daily for those 10 years of age and older.
• Some medicines require a lower rosuvastatin dose, and a few should not be taken with rosuvastatin at all. See the detailed dosage information for the full list.

If you miss a dose of rosuvastatin, take your next dose at your normal scheduled time. Do not take an extra dose.

In case of an overdose, get medical help or contact a live Poison Center expert right away at 1-800-222-1222. Advice is also available online at poisonhelp.org.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Also tell the doctor who prescribes rosuvastatin if another doctor increases the dose of another medicine you are taking. Rosuvastatin may affect the way other medicines work, and other medicines may affect how rosuvastatin works. Especially tell your doctor if you take:

• coumarin anticoagulants (medicines that prevent blood clots, such as warfarin)
• antacids (medicines you take for heartburn that contain aluminum and magnesium hydroxide)

Taking rosuvastatin with certain medicines may increase the risk of muscle problems. Especially tell your doctor if you take:

• cyclosporine (a medicine for your immune system)
• teriflunomide (a medicine used to treat relapsing remitting multiple sclerosis)
• enasidenib (a medicine used to treat acute myeloid leukemia)
• capmatinib (a medicine for the treatment of non-small cell lung cancer)
• fostamatinib (a medicine used to treat low platelet counts)
• febuxostat (a medicine used to treat and prevent high blood levels of uric acid)
• gemfibrozil (a fibric acid medicine for lowering cholesterol)
• tafamidis [used to treat cardiomyopathy (enlarged and thickened heart muscle)]
• anti-viral medicines including certain HIV or hepatitis C virus drugs such as: lopinavir, ritonavir, fosamprenavir, tipranavir, atazanavir, simeprevir combination of sofosbuvir/velpatasvir/voxilaprevir dasabuvir/ombitasvir/paritaprevir/ritonavir elbasvir/grazoprevir sofosbuvir/velpatasvir glecaprevir/pibrentasvir and all other combinations with ledipasvir including ledipasvir/sofosbuvir
• darolutamide (a medicine for the treatment of prostate cancer)
• regorafenib (a medicine used to treat cancer of the colon and rectum)
• fibric acid derivatives (such as fenofibrate)
• ticagrelor (helps reduce the chance of blood clot formation that can block a blood vessel)
• niacin or nicotinic acid
• colchicine (a medicine used to treat gout)
• belumosudil (used to treat chronic graft-versus-host disease)
• momelotinib (used to treat myelofibrosis, a rare form of blood cancer)
• vadadustat (medicine used to treat anemia caused by chronic kidney disease (CKD) in adults on dialysis for at least 3 months)

Ask your doctor or pharmacist for a list of these medicines if you are not sure. Know all of the medicines you take. Keep a list of them to show your doctor and pharmacist when you get new medicine.

Tell your doctor if you are pregnant or think you may be pregnant, or are planning to become pregnant. Rosuvastatin may harm your unborn baby. If you become pregnant while taking rosuvastatin, call your doctor right away to discuss your treatment.

Tell your doctor if you are breastfeeding or plan to breastfeed. Medicines like rosuvastatin can pass into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take this medicine. Do not breastfeed while taking rosuvastatin.

• Store rosuvastatin at room temperature, between 68°F and 77°F (20°C and 25°C).
• Store in a dry place.
• Safely throw away medicine that is out of date or no longer needed.
• Keep this and all medicines out of the reach of children.

Active ingredient: rosuvastatin calcium

Inactive ingredients:

Crestor tablets: microcrystalline cellulose NF, lactose monohydrate NF, tribasic calcium phosphate NF, crospovidone NF, magnesium stearate NF, hypromellose NF, triacetin NF, titanium dioxide USP, yellow ferric oxide, and red ferric oxide NF.

Generic versions of rosuvastatin tablets may contain different inactive ingredients from those listed above. Check the product label for your particular formulation for a complete list of ingredients.

The Crestor brand of rosuvastatin tablets is distributed by AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, under license from Shionogi & Co., LTD., Osaka, Japan.

Generic versions are also manufactured by several other companies.

Ezallor Sprinkle (rosuvastatin) has been discontinued and is no longer available.