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In this drug factsheet:
- How does this medication work? What will it do for me?
- How should I use this medication?
- What form(s) does this medication come in?
- Who should NOT take this medication?
- What side effects are possible with this medication?
- Are there any other precautions or warnings for this medication?
- What other drugs could interact with this medication?
DIN (Drug Identification Number)
|02378523||PMS-ROSUVASTATIN 5MG TABLET|
|02378531||PMS-ROSUVASTATIN 10MG TABLET|
|02378558||PMS-ROSUVASTATIN 20MG TABLET|
|02378566||PMS-ROSUVASTATIN 40MG TABLET|
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. 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.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. 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.
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. 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 children 10 to 17 years of age,who have inherited cholesterol disorders, the recommended starting dose is 5 mg taken once daily. Your doctor may increase this dose to a maximum of 10 mg daily, depending on the effectiveness of the medication and how well it is tolerated.
For people with severely reduced liver function, the maximum daily dose is 20 mg.
For people with severely reduced kidney function, the starting dose should be 5 mg daily and 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.
Rosuvastatin may be taken in the morning or in the evening, with or without food.It is very important that this medication be taken exactly as prescribed by your 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.
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.
Do not take rosuvastatin if you:
- are allergic to rosuvastatin or any ingredients of the medication
- are pregnant
- are breast-feeding
- are taking cyclosporine
- have active liver disease or have unexplained increases in certain liver function tests
Do not take the 40 mg strength of rosuvastatin if you:
- are of Asian descent (Chinese, Filipino, Japanese, Korean, Vietnamese, or Asian-Indian origin)
- are taking niacin or a fibrate (e.g., gemfibrozil, fenofibrate)
- have alcoholism or consume large quantities of alcohol
- have an inherited muscle disorder or a family history of these disorders
- have had muscle damage with another statin medication (e.g., lovastatin, pravastatin, simvastatin)
- have hypothyroidism (an underactive thyroid gland)
- have other medical conditions or are taking other medications that would increase blood levels of rosuvastatin (check with your doctor or pharmacist to see if this applies to you)
- have severely reduced liver or kidney function
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.
- difficulty sleeping
- sexual difficulties
- 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 check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- breast enlargement
- poor memory
- signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
- skin rash
- 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.
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. The combination of alcohol and rosuvastatin increases the risk of developing liver problems.
Diabetes: Rosuvastatin, like other medications in this family, may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Hypersensitivity syndrome: A severe allergic reaction called hypersensitivity syndrome has occurred for some people with the use of "statin" cholesterol medication. Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.
Kidney function: If you have decreased kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. Do not use this medication if you have active liver disease or have liver function tests are higher than normal. If you have reduced liver function or a history of liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Rosuvastatin may cause decreased liver function. Consuming alcohol can increase the risk of developing liver problems. Your doctor will perform regular blood tests to check your liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
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. Women should not breast-feed while taking this medication.Children: There is limited experience with the use of this medication by children. Rosuvastatin may be used by children between 10 and 17 years of age who have certain inherited cholesterol disorders. Girls should be at least 1 year past their first menstrual period. It should be used in addition to diet, when diet alone has not provided a satisfactory reduction in cholesterol levels. The safety and effectiveness of this medication has not been established for children less than 10 years of age. 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.
There may be an interaction between rosuvastatin and any of the following:
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.
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