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How does this medication work? What will it do for me?
Rosuvastatin belongs to the group of medications known as HMG CoA reductase inhibitors ("statins"). It is used, along with a healthy diet and exercise program, to improve cholesterol levels by lowering bad cholesterol and raising good cholesterol. It is also used to treat people who have certain inherited cholesterol disorders.
Rosuvastatin works by blocking the enzyme that helps make cholesterol in the body. People with high blood cholesterol levels have a higher risk of heart diseases such as heart attacks. When cholesterol levels are lowered with a combination of medication, diet, and exercise, the risk of heart disease is lowered, too. It takes 2 to 4 weeks to see the maximum effect of this medication on cholesterol levels in blood tests.
It can also be used to reduce the risk of heart attacks, stroke, and angioplasty for people who have at least 2 risk factors for cardiovascular disease.
Your doctor may have suggested this medication for conditions other than the ones listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each yellow, round, biconvex, coated tablet engraved with "ROS" over "5" on one side and nothing on the other side contains rosuvastatin calcium equivalent to 5 mg rosuvastatin. Nonmedicinal ingredients: colloidal silicone dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.
Each pink, round, biconvex, coated tablet engraved with "ROS" over "10" on one side and nothing on the other side contains rosuvastatin calcium equivalent to 10 mg rosuvastatin. Nonmedicinal ingredients: colloidal silicone dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.
Each pink, round, biconvex, coated tablet engraved with "ROS" over "20" on one side and nothing on the other side contains rosuvastatin calcium equivalent to 20 mg rosuvastatin. Nonmedicinal ingredients: colloidal silicone dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.
Each pink, oval, biconvex, coated tablet engraved with "ROS"on one side and "40" on the other side contains rosuvastatin calcium equivalent to 40 mg rosuvastatin. Nonmedicinal ingredients: colloidal silicone dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.
How should I use this medication?
Before starting rosuvastatin, you should be following a cholesterol-lowering diet. If appropriate, a program of weight control and physical exercise should also be implemented.
The recommended dose of rosuvastatin ranges between 5 mg and 40 mg once daily. For most people, the usual recommended starting dose of rosuvastatin is 10 mg once daily. It may be taken in the morning or in the evening, with or without food. If necessary, the dose may be increased to a maximum of 40 mg daily. People who require the maximum dose of 40 mg per day should consult a specialist.
For people with severely reduced liver function, the maximum daily dose is 20 mg.
For people with severely reduced kidney function, the maximum daily dose is 10 mg.
A starting dose of 5 mg daily is recommended for people of Asian descent (Chinese, Filipino, Japanese, Korean, Vietnamese, or Asian-Indian origin) and those who have severe kidney problems. This low dose should also be considered for people who do not need aggressive cholesterol-lowering effects and for people who may be at a greater risk of experiencing muscle-related problems.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is very important to take this medication exactly as prescribed by the doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and carry on with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Rosuvastatin should not be taken by anyone who:
- is allergic to rosuvastatin or to any of the ingredients of the medication
- is pregnant
- is breast-feeding
- is taking cyclosporine
- has active liver disease or has unexplained increases in certain liver function tests
The 40 mg strength of rosuvastatin should not be taken by anyone who:
- is of Asian descent (Chinese, Filipino, Japanese, Korean, Vietnamese, or Asian-Indian origin)
- is taking niacin or a fibrate (e.g., gemfibrozil, fenofibrate)
- has alcoholism or consumes large quantities of alcohol
- has an inherited muscle disorder or a family history of these disorders
- has had muscle damage with another statin medication (e.g., lovastatin, pravastatin, simvastatin)
- has hypothyroidism
- has other medical conditions or is taking other medications that would increase blood levels of rosuvastatin (check with your doctor or pharmacist to see if this applies to you)
- has severely reduced liver or kidney function
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- stomach pain
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- symptoms of liver damage (such as yellow skin or eyes, abdominal pain, dark urine, clay-coloured stools, loss of appetite, nausea and vomiting, or itching)
- symptoms of muscle damage (unexplained muscle pain, tenderness or weakness, or brown or discoloured urine - especially if you also have a fever or a general feeling of being unwell)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- severe skin rash, including skin blistering and peeling (possibly with headache, fever, coughing, or aching before the rash begins)
- symptoms of a serious allergic reaction (such as swelling of the face or throat, hives, or difficulty breathing)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
January 24, 2013
Health Canada has issued new restrictions concerning the use of rosuvastatin. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Alcohol: People who drink large quantities of alcohol should be closely monitored by their doctor while they are taking this medication.
Kidney problems: People with decreased kidney function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: Your doctor will perform regular tests to check your liver function. This medication should not be used by people with active liver disease or by people whose liver function tests are higher than normal. People with a history of liver disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Muscle damage: In rare cases, serious muscle damage been associated with the use of statin medications, especially at higher doses. Before taking this medication, tell your doctor or pharmacist if you:
- are of Asian ancestry (Chinese, Filipino, Japanese, Korean, Vietnamese, or Asian-Indian origin)
- are over the age of 70
- are taking other cholesterol-lowering medication such as fibrates (e.g., gemfibrozil, fenofibrate) or niacin
- are taking other medications (as drug interactions are possible), including prescription, non-prescription, and natural health products
- do excessive physical exercise
- have diabetes
- have a family history of muscular disorders
- have had any past problems with muscles (pain, tenderness) after taking a statin
- have kidney or liver problems
- have thyroid problems
- have undergone surgery or other tissue injury
- regularly drink 3 or more alcoholic drinks daily
Report any unexplained muscle pain, tenderness, weakness, cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.
Pregnancy: This medication should not be taken during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if rosuvastatin passes into breast milk. If you are a breast-feeding mother and are taking this medication, if may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: There is limited experience with the use of this medication by children. Its safety and effectiveness have not been established for this age group. If rosuvastatin is to be used by a child, the treatment should be supervised by a specialist.
Seniors: If you are older than 70 years of age, your doctor will likely monitor you closely for muscle-related side effects.
What other drugs could interact with this medication?
There may be an interaction between rosuvastatin and any of the following:
- antacids (if taken within 2 hours of taking rosuvastatin)
- anticoagulants (e.g., warfarin)
- antifungal agents (e.g.,, itraconazole, ketoconazole)
- birth control pills
- lopinavir - ritonavir
- macrolide antibiotics (e.g., erythromycin, clarithromycin)
- niacin (nicotinic acid)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material © 1996-2014 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.
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