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Why it's used

Rosuvastatin is a prescription medicine that is used to decrease the amount of bad cholesterol (low-density lipoprotein (LDL)) and triglycerides in the blood. This medicine works by slowing down the synthesis of cholesterol in the body. This medicine helps by decreasing the amount of cholesterol that may build up on the walls of the arteries. Rosuvastatin is also used to raise the amounts of good cholesterol (high-density lipoprotein (HDL)) in the blood, to decrease the amount of cholesterol, fats, and other fatty substances in the blood in children with age of 10 to 17 years who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body), to treat a genetic condition characterized by increased levels of low-density lipoprotein cholesterol in adults (Homozygous Familial Hypercholesterolemia), to decrease the progression of the condition of the build-up of fats, fatty substances, and cholesterol in the arteries of the heart (atherosclerosis), and to reduce the risk of stroke, heart attack, and surgical procedures to restore necessary blood flow to the heart muscles.
HMG-CoA Reductase Inhibitor
Rosuvastatin belongs to the HMG-CoA Reductase Inhibitor class of medicines. HMG-CoA Reductase Inhibitors are a class of lipid-lowering medications, effective at lowering high cholesterol levels. These medicines also reduce the risk of having a heart attack or stroke or developing angina.

How to use

Follow directions on the product label, information guide, and provided by your doctor before using Rosuvastatin. Eat this medicine as per your doctor's instructions.
Rosuvastatin is eaten with or without food.
The typical adult dose of Rosuvastatin is 5 to 40 mg once daily. The typical dose for children is 5 to 20 mg/day. The maximum dose for adults of Rosuvastatin is 40 mg/day per day.
You should continue to use this medicine as directed by the doctor even if you feel well.
Tell your doctor if your condition does not improve. Talk to your doctor if muscle problems (muscular pain, muscle weakness and muscle breakdown). If you have any kidney disease, In patients with the severe condition of abnormal functioning of the kidneys, the dose of Rosuvastatin should be started at 5 mg once daily. This dosing limit should not be exceeded more than 10 mg once daily in such patients. If you have issues with the health of your liver, Rosuvastatin should be used under necessary precautions in patients with active liver disease. Consult with your doctor before stopping the use of Rosuvastatin.
To see the impact of Rosuvastatin on the body, your doctor may recommend a lower initial dose. Please follow your doctor's instructions carefully. Older patients may see an increase in the risk of side-effects. Hence, a lower dose may be recommended.
If you are giving Rosuvastatin to a child, be sure to use a product that is meant for use in children. Before giving this medicine, use the child's weight or age to find the right dose from the leaflet or product package. You can also read the dosage section of this page to know the correct dose for your child. Else, consult with your doctor and follow their recommendation.
Avoid drinking alcohol with Rosuvastatin.
Your doctor may require that certain tests be performed before using Rosuvastatin. The doctor may ask you to have Liver Panel test. Liver enzyme tests are being used to detect increased levels of liver enzymes in the blood such as AST (SGOT), or ALT (SGPT) before starting the therapy with Rosuvastatin. Your doctor may request Cholesterol test. The high levels of cholesterol in the blood is determined before starting the treatment with Rosuvastatin.
Medicines may be given for uses other than those listed in the medicine guide. Do not use Rosuvastatin for symptoms for which it was not prescribed. Do not give Rosuvastatin to others who may have similar symptoms as you. Self-medication can cause harm.
Store Rosuvastatin 20-25ºC (68-77ºF), and away from moisture. Keep this medicine away from children and pets.

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How to take Rosuvastatin

Your dose may depend on several personal factors. You should consult with your doctor to find out the dose that is best for you. The dose of Rosuvastatin depends on the following factors:
  • patient's age
  • patient's health
  • the health of the patient's liver
  • the health of the patient's kidneys
  • medicines recommended by your doctor
  • any other medicines in use
  • herbal supplements consumed
  • response to treatment

Rosuvastatin Dosage

Dosage for a genetic condition characterized by increased levels of low-density lipoprotein cholesterol (Homozygous Familial Hypercholesterolemia)

Adult
  • Recommended: 5-40 mg once a day
  • Initial: 20 mg once a day
  • Maximum: 40 mg
Children (7 to 17 years)
  • Recommended: 20 mg once a day
  • Initial: 5 to 10 mg once daily depending upon the patient's weight, age, and previous statin therapy
  • Maximum: 20 mg once daily

Dosage for a genetic disorder that causes extremely high levels of cholesterol, which can further result in heart diseases, heart attack, or damage to the brain (heterozygous familial hypercholesterolemia)

Children (8 to less than 10 years)
  • Recommended: 5 to 10 mg once a day
  • Initial: 5 mg/day
  • Maximum: 10 mg
Children (10 to 17 years)
  • Recommended: 5 to 20 mg once a day
  • Maximum: 20 mg

Minimum Age

6 years

Maximum Age

75 years and above

Dosage calculation for children

To calculate the dosage for children please use the weight based dose calculator to calculate the appropriate dosage as per the weight of your child.

Forms

Tablet
Strength: 5 mg, 10 mg, 20 mg and 40 mg

Special Instructions

Patients taking cyclosporine in combination with Rosuvastatin
The dose of Rosuvastatin should not be increased by more than 5 mg once a day.
Use of Rosuvastatin in patients taking gemfibrozil
The use of Rosuvastatin with gemfibrozil should be avoided. If this combination cannot be avoided, the dose of Rosuvastatin can be initiated at 5 mg once daily. The dose of Rosuvastatin should not exceed 10 mg once a day.
Patients taking Rosuvastatin along with atazanavir and ritonavir, lopinavir and ritonavir, or simeprevir
The dose with Rosuvastatin should be initiated at 5 mg once a day. The dose of Rosuvastatin should not exceed 10 mg once a day.
Asian patients
In Asian patients, the dose of Rosuvastatin should be initiated with 5 mg once a day due to increased levels of Rosuvastatin in the blood.
Patients with severe abnormal functioning of the kidney
In patients with severe abnormal functioning of the kidney, but not on hemodialysis, the dosing with Rosuvastatin should be initiated at 5 mg once a day and should not exceed 10 mg once daily.

Missed Dose

The missed dose should be taken as soon as you remember it. However, if it is less than 12 hours before the next dose is scheduled, the missed dose should be skipped, and the regular dosing schedule should be continued. A double dose should not be taken to make up for a missed dose.

Overdose

What to do if you overdose on Rosuvastatin?
In case of overdose, there is no specific treatment. Supportive care and the treatment according to the symptoms should be provided. Hemodialysis does not significantly increase the excretion of Rosuvastatin.
If you think you have overdosed on Rosuvastatin, call a poison control center immediately. You can look up the poison control center information from the Poison Center Finder at TabletWise.com.

Precautions while using Rosuvastatin

Before you use Rosuvastatin, discuss with your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information.
Before you use Rosuvastatin, tell your doctor of your medical and health history including the following: liver disease, heart disease, muscle disorders, or high blood pressure. Before having surgery during the use of Rosuvastatin, discuss with your doctor and dentist about the medicinal products you use including prescription/non-prescription/herbal medicines.
The use of this medicine may change alkaline phosphatase levels. The levels of alkaline phosphatase have been found to be increased during treatment with Rosuvastatin.
The use of this medicine may change glucose. Glucose levels have been found to be increased during Rosuvastatin treatment.
The use of Rosuvastatin may change transaminase levels. The levels of liver enzymes are found to increase during therapy with Rosuvastatin.
The use of this medicine may change creatine phosphokinase levels. The levels of creatine phosphokinase have been found to be increased during treatment with Rosuvastatin.
The use of Rosuvastatin may change glutamyl transpeptidase levels. The levels of glutamyl transpeptidase are found to increase during therapy with Rosuvastatin.
Rosuvastatin can make you feel sleepy. Be careful when using any machinery, driving a vehicle, or doing any other activity that needs you to be fully alert. The consumption of alcohol with Rosuvastatin can worsen the sleepiness.
Pregnant/breastfeeding women should not use this medicine. Rosuvastatin is not for use by women. The safety data in such women has not been confirmed, and there is no benefit to treatment with Rosuvastatin during pregnancy. Therefore, the use of Rosuvastatin in pregnant women is not recommended as it may cause harm to the unborn baby. Women who are breastfeeding a baby should not use this medicine. Studies indicate that Rosuvastatin may be present in human milk which may cause severe side effects in nursing infants. Therefore, women who require Rosuvastatin therapy should not breastfeed their infants. If a patient becomes pregnant while using this medicine, treatment should be stopped immediately.
Avoid consuming alcohol together with Rosuvastatin.
Rosuvastatin may cause increased incidence of side-effects in older patients. Elderly patients may see an increased risk of muscle disease (myopathy).

Rosuvastatin Side-effects

The following side-effects may commonly occur when using Rosuvastatin. If any of these side-effects worsen or last for a long time, you should consult with your doctor:
The following side-effects may commonly occur in older patients on the use of Rosuvastatin. Discuss with your doctor if any of these side-effects last for a long time or are severe:
Rarely, the use of Rosuvastatin may cause the following side-effects:
The following severe side-effects may also occur when using Rosuvastatin:
  • nervous system disorders
    Symptoms: weakness, numbness, and pain from nerve damage (peripheral neuropathy) damage to the peripheral nerves (polyneuropathy)
  • psychiatric disorders
    Symptoms: depression
  • endocrine disorders
    Symptoms: high blood sugar levels
  • immune system disorders
    Symptoms: severe allergic reactions
  • blood and lymphatic system disorders
    Symptoms: abnormally low level of thrombocytes
  • respiratory, thoracic and mediastinal disorders
  • stomach and intestinal disorders
    Symptoms: inflammation of the pancreas (pancreatitis), diarrhea constipation
  • kidney, urinary and liver disorders
    Symptoms: the presence of blood in the urine (haematuria), yellowing of the skin (jaundice), inflammation of the liver (hepatitis) increased liver enzymes (transaminases)
  • skin and subcutaneous tissue disorders
    Symptoms: severe skin reactions (Stevens-Johnson syndrome)
  • musculoskeletal and connective tissue disorders
    Symptoms: tendon disorders including tendon rupture, muscle weakness (immune-mediated necrotizing myopathy) breakdown of damaged skeletal muscle
Your doctor has prescribed this Rosuvastatin because they have judged that the benefits outweigh the risks posed by side-effects. Many people using this medicine do not have serious side-effects. This is not a complete list of possible side-effects for Rosuvastatin.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Warnings

Skeletal muscle abnormalities

The patients with age more than 65 years, abnormal functioning of the kidneys and inadequately treated thyroid diseases are at an increased risk. The risk of muscle disorders during treatment with Rosuvastatin may get increased with combined use of some other lipid-lowering therapies (niacin or fibrates), cyclosporine, gemfibrozil, ritonavir/atazanavir, simeprevir, or lopinavir/ritonavir. Cases of a muscle disorder, including a breakdown of damaged skeletal muscle (rhabdomyolysis), have been reported with HMG-CoA reductase inhibitors, including Rosuvastatin, taken with colchicine. Discontinue the therapy with Rosuvastatin during increased levels of creatine kinase or if the condition of muscle diseases is being diagnosed or suspected.

Liver enzyme abnormalities

Patients who consume large quantities of alcohol, have a history of long-term liver diseases and have active liver disease are at an increased risk while using this medicine. Increase in the blood levels of liver enzymes such as AST (SGOT) or ALT (SGPT) (blood transaminases) has been reported with the use of HMG-CoA reductase inhibitors, including Rosuvastatin. In most cases, the increase was temporary and improved on continued therapy or after a short delay in treatment. It is advised to perform liver enzyme tests before starting the treatment with Rosuvastatin and if symptoms or signs of liver injury occur. Take necessary precautions while using Rosuvastatin in patients who consume large quantities of alcohol or have a history of long-term liver diseases. Patients who have active liver disease should not use Rosuvastatin. There have been some reports of fatal and non-fatal liver failure in patients taking statins, including Rosuvastatin. If severe liver injury with clinical symptoms or increased bilirubin or yellow discoloration of the skin occurs during treatment with Rosuvastatin, immediately discontinue treatment.

The combined use of coumarin anticoagulants with Rosuvastatin

Patients who are on anticoagulant therapy are at an increased risk while using this medicine. Rosuvastatin when used in combination with coumarin anticoagulants, may raise the effects of coumarin-type anticoagulants in increasing the time taken by blood to clot (prothrombin time)/INR. In patients taking coumarin anticoagulants and Rosuvastatin together, the international normalized ratio (INR) should be determined before starting the treatment with Rosuvastatin.

Patients with presence of proteins and blood in the urine

During the clinical trial program of Rosuvastatin, the presence of proteins and blood in the urine were observed in patients using 40 mg of Rosuvastatin. A dose reduction should be considered for patients on Rosuvastatin treatment with unexplained persistent proteins and blood in the urine during a regular urine test.

Endocrine Effects

Increase in fasting blood glucose and hemoglobin levels have been observed with the use of HMG-CoA reductase inhibitors, including Rosuvastatin. Caution should be used if Rosuvastatin is taken in combination with drugs which may reduce the levels of endogenous steroid hormones such as spironolactone, ketoconazole, and cimetidine.

Interstitial lung diseases

The patients with long-term therapy of some statins including Rosuvastatin are at an increased risk. Such patients may develop an increased risk of symptoms such as difficulty in breathing, non-productive cough and worsening of general health conditions (fatigue, weight loss, and fever). Discontinue the use of statin therapy if a patient may develop the condition of interstitial lung disease.

Patients with lactose intolerance

It is advised not to take this medicine by patients with the Lapp lactase deficiency, rare family history problems of galactose intolerance or incomplete absorption of glucose-galactose.

Patients using protease inhibitors

Patients using protease inhibitors may lead to increased exposure of Rosuvastatin in the body. The combined use with specific protease inhibitors should not be recommended unless the dose of Rosuvastatin is adjusted.

Diabetes Mellitus

Patients with fasting glucose ranging from 5.6 to 6.9 mmol/l, body mass index more than 30 kg/m2, increased levels of triglycerides and high blood pressure are at an increased risk. Such patients may develop increased levels of glucose in the blood. Proper monitoring of both clinical and biochemical parameters is required in patients who are at risk.

Interactions with Rosuvastatin

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.
Rosuvastatin interacts with protease inhibitors, which are used for the treatment of HIV/AIDS and hepatitis C. The use of Rosuvastatin along with specific protease inhibitors has different effects on its absorption rate. Simeprevir, which is a hepatitis C virus protease inhibitor, or atazanavir/ritonavir and lopinavir/ritonavir combinations, which are HIV-1 protease inhibitors, increase the absorption of Rosuvastatin and its level in blood up to threefold. When Rosuvastatin is given in combination with protease inhibitors, the dose of Rosuvastatin should not exceed 10 mg once a day. The combinations of fosamprenavir/ritonavir or tipranavir/ritonavir, which are HIV-1 protease inhibitors, produce little or no change in the absorption of Rosuvastatin. Caution should be used when Rosuvastatin is given in combination with protease inhibitors.
There may be an interaction of Rosuvastatin with gemfibrozil, which is used to lower the level of lipids. The absorption of gemfibrozil is significantly increased by Rosuvastatin. Also, the use of these drugs together resulted in a 2-fold increase in Rosuvastatin levels in the blood. Due to an increased risk of muscle disease (myopathy) and breakdown of damaged muscles (rhabdomyolysis), the combination treatment with Rosuvastatin and gemfibrozil should be avoided. If both the drugs are used together, the dose of Rosuvastatin should not exceed 10 mg once a day.
Rosuvastatin may interact with cyclosporine, which is used as an immunosuppressant. The use of Rosuvastatin and cyclosporine in combination increased the amount of Rosuvastatin in blood by 7-fold. The use of Rosuvastatin is not recommended in patients who are also on treatment with cyclosporin. If this treatment is necessary, the dose of Rosuvastatin should not be exceeded by 5 mg once a day.
Your doctor's guidelines may need to be followed while taking this medicine along with niacin, which is a vitamin and also used along with other lipid lowering drugs. The risk of skeletal muscle effects may be increased when Rosuvastatin is used in combination with lipid-modifying doses of 1 g/day of niacin. Take necessary precautions while using niacin with Rosuvastatin.
Special instructions need to be followed while taking this medicine along with coumarin anticoagulants, which are used to prevent clotting of blood. Rosuvastatin significantly increases INR which is how long blood takes to clot in patients who are on coumarin anticoagulants treatment. Caution should be used when coumarin anticoagulants are given in combination with Rosuvastatin. In such patients, INR should be determined before beginning Rosuvastatin therapy and frequently during early treatment to ensure that no significant change of INR takes place.
Your doctor's guidelines may need to be followed while taking this medicine along with erythromycin, which is used for the treatment of bacterial infections. The use of Rosuvastatin and erythromycin together has resulted in a decrease in the levels of Rosuvastatin in the blood. This interaction may be caused by an increase in the abnormal contractions of the intestine.
Special instructions need to be followed while taking this medicine along with antacids, which are used to treat acidity. The treatment with Rosuvastatin and an antacid suspension containing aluminum and magnesium hydroxide has resulted in a decrease in the levels of Rosuvastatin in the blood. This effect was decreased when the antacid was given after 2 hours of Rosuvastatin.
Rosuvastatin interacts with ezetimibe, which is used to lower the levels of cholesterol in the blood. The use of 10 mg of Rosuvastatin with 10 mg of ezetimibe resulted in an increase in the blood level of Rosuvastatin in patients with high cholesterol levels.
There may be an interaction of Rosuvastatin with colchicine, which is used for the treatment of gout. The combined use of Rosuvastatin with colchicine may lead to an emergence of muscle diseases (myopathy), including the breakdown of damaged skeletal muscles (rhabdomyolysis). Necessary precautions are to be made when Rosuvastatin is prescribed with colchicine.
Rosuvastatin may interact with fenofibrate, which is used to reduce the levels of cholesterol in the blood. When Rosuvastatin is given in combination with fenofibrate, no clinically significant increase in the level of rosuvastatin or fenofibrate in the blood was seen. The risk of muscle disease (myopathy) during treatment with HMG-CoA reductase inhibitors is increased with simultaneous use of fenofibrate. Caution should be exercised when fenofibrate is prescribed with Rosuvastatin.
Rosuvastatin interacts with fusidic acid, which is an antibiotic used in the treatment of inflammation of the skin, hair follicles, and infections of the skin. The risk of muscle diseases (myopathy), including the breakdown of damaged skeletal muscles (rhabdomyolysis) may be increased when Rosuvastatin is given together with systemic fusidic acid. If the treatment with systemic fusidic acid is necessary, therapy with Rosuvastatin should be discontinued as long as treatment with fusidic acid is required.
There may be an interaction of Rosuvastatin with oral contraceptives, which are used as birth control measures and hormone replacement therapy (HRT), is a form of hormone therapy used to treat symptoms related to menopause in women. The use of Rosuvastatin with oral contraceptives has resulted in an increased level of ethinyl estradiol and norgestrel in the blood. These increased levels of drugs in the blood should be considered while selecting the doses of oral contraceptive.
Rosuvastatin may interact with vitamin K antagonists, which are used for clotting of blood. Patients using vitamin K antagonists with Rosuvastatin are at risk of an increase in International Normalised Ratio, which is the time that blood takes to clot. Discontinuation of such treatment or decrease in dosage of Rosuvastatin may result in a reduction in INR. In such cases, proper monitoring of INR is advisable.
This page does not contain all the possible interactions of Rosuvastatin. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.

Traveling With Medication

  • Ensure that you carry enough doses of each of your prescription medicines to last the entire trip. The best place to store your medicines is in the carry on baggage. However, while flying, if carrying liquid medicines, make sure you do not go over the limits imposed for carry-on liquids.
  • While traveling overseas, make sure that you can carry each of your prescription medicines legally to your destination country. One way to ensure this is by checking with your destination country's embassy or website.
  • Make sure that you carry each of your medicines in their original packaging, which should typically include your name and address, and the details of the prescribing doctor.
  • If your travel involves crossing time zones, and you are required to take your medicine as per a fixed schedule, make sure that you adjust for the change in time.

Expired Medication

Taking a single dose of expired Rosuvastatin is unlikely to cause a side-effect. However, please discuss with your doctor or pharmacist, if you feel unwell or sick. An expired medicine may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use an expired drug. You are much safer by always keeping a fresh supply of unexpired medicines.

Safe Disposal of Medication

  • If there are disposal instructions on the package, please follow the instructions.
  • If there are medicine take-back programs in your country, you should contact the respective authority to arrange for the disposal of the medicine. For example, in the USA, the Drug Enforcement Administration regularly hosts National Prescription Drug Take-Back events.
  • If there are no take-back programs, mix the medicine with dirt and place them in a sealed plastic bag. Throw the plastic bag in your household trash. Separately, remove all personal information including the prescription label from the medicine packaging and then dispose off the container.
  • If specifically indicated on the medicine package that it needs to be flushed down the toilet when no longer needed, perform the required step.
This page provides information for Rosuvastatin .
Hyperlipidaemia
High Triglycerides
High Cholesterol
Atherosclerosis

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