Rosuvastatin

Rosuvastatin is used together with diet, weight-loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease. Rosuvastatin is also used to decrease the amount of cholesterol such as low-density lipoprotein (LDL) cholesterol ('bad cholesterol') and triglycerides in the blood and to increase the amount of high-density lipoprotein (HDL) cholesterol ('good cholesterol') in the blood. Rosuvastatin may also be used together with diet to decrease the amount of cholesterol and other fatty substances in the blood in adults and children and teenagers 8 to 17 years of age who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). Rosuvastatin is used together with diet, and alone or in combination with other medications, to decrease the amount of cholesterol and other fatty substances in the blood in adults and children and teenagers 7 to 17 years of age who have familial homozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). Rosuvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

Accumulation of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats with rosuvastatin has been shown to prevent heart disease, angina (chest pain), strokes, and heart attacks.

Rosuvastatin comes as a tablet (Crestor) and a capsule (Ezallor) to take by mouth. It is usually taken once a day with or without food. Take rosuvastatin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rosuvastatin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of rosuvastatin and gradually increase your dose, not more than once every 2 to 4 weeks.

Swallow the tablets (Crestor) whole; do not split, chew, or crush them.

Swallow the capsules (Ezallor) whole; do not chew or crush them. If you cannot swallow the capsule, open the capsule and carefully sprinkle the contents onto 1 teaspoonful of applesauce or chocolate or vanilla pudding. Stir the mixture for 10–15 seconds and swallow the entire mixture within 60 minutes of mixing, without chewing. Do not save the mixture for later use.

If you have a nasogastric (NG) tube, your doctor or pharmacist will explain how to prepare rosuvastatin capsules (Ezallor) to give through an NG tube.

Continue to take rosuvastatin even if you feel well. Do not stop taking rosuvastatin without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking rosuvastatin,

• tell your doctor and pharmacist if you are allergic to rosuvastatin, any other medications, or any of the ingredients in rosuvastatin tablets or capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking aluminum and magnesium hydroxide antacids (Mylanta, Maalox), take them at least 2 hours after rosuvastatin.
• tell your doctor if you have or ever had liver disease. Your doctor will order laboratory tests to see how well your liver is working even if you do not think you have liver disease. Your doctor will probably tell you not to take rosuvastatin if you have liver disease or if the tests show that you may be developing liver disease.
• tell your doctor if you are Asian, if you drink more than 2 alcoholic beverages daily, if you are 65 years of age or older, or if you have or have ever had seizures, muscle aches or weakness, low blood pressure, impaired fasting glucose (pre-diabetes) or diabetes, or kidney or thyroid disease.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking rosuvastatin, call your doctor immediately.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking rosuvastatin.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking rosuvastatin. If you are hospitalized due to serious injury or infection, tell the doctor who treats you that you are taking rosuvastatin.
• ask your doctor about the safe use of alcoholic beverages while you are taking rosuvastatin. Alcohol can increase the risk of serious side effects.

Eat a low-fat, low-cholesterol diet. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. You can also visit the National Cholesterol Education Program (NCEP) website for additional dietary information at https://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Rosuvastatin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• stomach pain
• dizziness
• difficulty falling asleep or staying asleep
• depression
• joint pain
• headache
• memory loss or forgetfulness
• confusion

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately or get emergency medical help:

• muscle pain, tenderness, or weakness (or if these symptoms continue after stopping rosuvastatin)
• lack of energy
• fever
• dark, reddish urine or decreased amount of urine
• yellowing of the skin or eyes
• dark colored urine
• pain in the upper right part of the abdomen
• nausea
• extreme tiredness
• unusual bleeding or bruising
• loss of appetite
• flu-like symptoms
• rash
• hives
• itching
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness

Rosuvastatin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order lab tests during your treatment, especially if you develop symptoms of liver damage.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking rosuvastatin.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Crestor^®
• Ezallor^® Sprinkle