September 1, 2014
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Drug Factsheets

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RAN-Rosuvastatin

(rosuvastatin)

DIN (Drug Identification Number)

02382644 RAN-ROSUVASTATIN 5MG TABLET
02382652 RAN-ROSUVASTATIN 10MG TABLET
02382660 RAN-ROSUVASTATIN 20MG TABLET
02382679 RAN-ROSUVASTATIN 40MG TABLET

How does RAN-Rosuvastatin 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. 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.

How should I use RAN-Rosuvastatin?

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.





What form(s) does RAN-Rosuvastatin come in?

5 mg
Each light yellow to yellow colored, round, film-coated tablet with "RT 1" debossed on one side and plain on other side, contains rosuvastatin 5 mg as rosuvastatin calcium. Nonmedicinal ingredients: crospovidone, hypromellose, iron oxide yellow, iron oxide red, lactose monohydrate, polyethylene glycol 400, magnesium stearate, microcrystalline cellulose, sodium citrate, and titanium dioxide.

10 mg
Each light pink to pink colored, round, film-coated tablet with "RT 2" debossed on one side and plain on other side, contains rosuvastatin 10 mg as rosuvastatin calcium. Nonmedicinal ingredients: crospovidone, hypromellose, iron oxide yellow, iron oxide red, lactose monohydrate, polyethylene glycol 400, magnesium stearate, microcrystalline cellulose, sodium citrate, and titanium dioxide.

20 mg
Each light pink to pink colored, round, film-coated tablet with "RT 3" debossed on one side and plain on other side, contains rosuvastatin 20 mg as rosuvastatin calcium. Nonmedicinal ingredients: crospovidone, hypromellose, iron oxide yellow, iron oxide red, lactose monohydrate, polyethylene glycol 400, magnesium stearate, microcrystalline cellulose, sodium citrate, and titanium dioxide.

40 mg
Each light pink to pink colored, oval, film-coated tablet with "RT 4" debossed on one side and plain on other side, contains rosuvastatin 40 mg as rosuvastatin calcium. Nonmedicinal ingredients: crospovidone, hypromellose, iron oxide yellow, iron oxide red, lactose monohydrate, polyethylene glycol 400, magnesium stearate, microcrystalline cellulose, sodium citrate, and titanium dioxide.

Who should NOT take RAN-Rosuvastatin?

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

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