Brand Name: Crestor
Generic Name: Rosuvastatin
Drug Class: Lipid-Lowering Agents, Statins; HMG-CoA Reductase Inhibitors
What Is Rosuvastatin and How Does It Work?
Rosuvastatin is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. It belongs to a group of drugs known as "statins." It works by reducing the amount of cholesterol made by the liver. Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol decreases the risk of heart disease and helps to prevent strokes and heart attacks.
In addition to eating a proper diet (such as a low cholesterol/low-fat diet), other lifestyle changes that may help rosuvastatin work better include exercising, losing weight if overweight, and stopping smoking. Talk with your doctor for more details.
Rosuvastatin is available under the following different brand names: Crestor.
Dosages of Rosuvastatin
Adult and Pediatric Dosage Forms and Strengths
- 5 mg
- 10 mg
- 20 mg
- 40 mg
Dosage Considerations – Should be Given as Follows:
- Hypertriglyceridemia, hyperlipidemia, mixed dyslipidemia, slowing progression of atherosclerosis, primary dysbetalipoproteinemia
- 10-20 mg orally once/day initially; may titrate; not to exceed 40 mg/day
- Dosage range: 5-40 mg/day
- Homozygous familial hypercholesterolemia: Initiate with 20 mg orally once/day; may titrate; not to exceed 40 mg/day
Indicated to reduce total-C, LDL-C, and ApoB levels in children and adolescents aged 8-17 years if after an adequate trial of diet therapy the following findings are present: LDL-C greater than 190 mg/dL, or greater than 160 mg/dL along with a positive family history of premature cardiovascular disease (CVD) or 2 cardiovascular disease or more risk factors
- Children under 8 years: Safety and efficacy not established
- Children 8 to under 10 years: 5-10 mg orally once/day
- Children 10-17 years: 5-20 mg orally once/day; may adjust dose at intervals of at least 4 weeks; not to exceed 20 mg/day
Homozygous Familial Hypercholesterolemia (HoFH)
Indicated to reduce LDL-C, Total-C, nonHDL-C and ApoB in children and adolescents aged 7 to 17 years with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis)
- Children under 7 years: Safety and efficacy not established
- Children 7-17 years: 20 mg orally once/day
Primary prevention of cardiovascular disease in individuals with no clinically evident heart disease but who are at risk because of combined effect of risk factors listed below
- Approval based on JUPITER trial (Justification for the Use of statins in Prevention: an Intervention Trial Evaluation Rosuvastatin)
- Initial: 10-20 mg orally once/day
- Dosage range 5-40 mg/day
- Cardiovascular disease
- Risk factors
- Patients of Asian descent: Initiate with 5 mg/day
- Coadministration with other lipid-lowering therapy: Consider dose reduction if combined with niacin or fenofibrate, because of increased risk for skeletal muscle effects
- Coadministration with cyclosporine: Not to exceed 5 mg/day
- Coadministration with gemfibrozil: Avoid if possible; if used together, do not exceed 10 mg/day
- Coadministration with ritonavir, lopinavir/ritonavir, or atazanavir/ritonavir: Not to exceed 10 mg/day
- Overdose management
- Severe (CrCl less than 30 mL/min/1.73m²) and not on hemodialysis: Decrease starting dose to 5 mg orally once/day; not to exceed 10 mg orally once/day
- CrCl greater than 30mL/min/1.73m²: Dose adjustment not necessary
- Active liver disease: Use is contraindicated
- Chronic alcoholic liver disease is known to increase rosuvastatin exposure; caution advised
What Are Side Effects Associated with Using Rosuvastatin?
Common side effects of rosuvastatin include:
- Muscle pain
- Joint pain
- Diabetes mellitus, new onset
- Sore throat
- Weakness/lack of energy
- Creatine phosphokinase (CPK) increased
- Abdominal pain
- Alanine transaminase (ALT) increased
- Flulike illness
- Urinary tract infection (UTI)
- Hypersensitivity reactions (including rash, itching, hives, and swelling)
Less common side effects of rosuvastatin include:
Postmarketing side effects of rosuvastatin reported include:
- Joint pain
- Numbness/tingling/pain in extremities
- Depression and sleep disorders (including insomnia and nightmares)
- Fatal and nonfatal hepatic failure, hepatitis, jaundice
- Low blood platelet count (thrombocytopenia)
- Breast tissue enlargement in males
This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What Other Drugs Interact with Rosuvastatin?
If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.
Severe interactions of rosuvastatin include:
- red yeast rice
Serious interactions of rosuvastatin include:
- fenofibrate micronized
- fenofibric acid
- ombitasvir/paritaprevir/ritonavir and dasabuvir
Rosuvastatin has moderate interactions with at least 46 different drugs.
Mild interactions of rosuvastatin include:
- coenzyme Q10
- erythromycin base
- erythromycin ethylsuccinate
- erythromycin lactobionate
- erythromycin stearate
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.
What Are Warnings and Precautions for Rosuvastatin?
This medication contains rosuvastatin. Do not take Crestor if you are allergic to rosuvastatin or any ingredients contained in this drug.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
Effects of Drug Abuse
- See "What Are Side Effects Associated with Using Rosuvastatin?"
- See "What Are Side Effects Associated with Using Rosuvastatin?"
- Non-serious and reversible cognitive side effects may occur.
- Increased blood sugar and glycosylated hemoglobin (HbA1c) levels reported with statin intake; in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus.
- Chronic liver disease.
- Measure liver enzymes before initiating and if signs or symptoms of liver injury occur.
- Consider lower initial dose (5 mg once/day) in patients with risk of myopathy.
- Increased risk of rhabdomyolysis, especially at highest approved dose of 40 mg/day; reserve highest dose only for patients who fail to achieve desired cholesterol level at 20 mg/day.
- Use 5 mg/day starting dose in people of Asian ancestry, who may build up higher drug levels and be at higher risk of myopathy.
- Rare reports of immune-mediated necrotizing myopathy (IMNM), characterized by increased serum creatine kinase that persists despite discontinuing statin.
- Discontinue if creatine kinase (CK) levels are markedly elevated.
Pregnancy and Lactation
- Rosuvastatin is contraindicated for use during pregnancy. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol (e.g., cell membranes), rosuvastatin may cause fetal harm when administered to pregnant women.
- Rosuvastatin is contraindicated for use while breastfeeding. 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.