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 Rosuvastatin 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 Rosuvastatin 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.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause constipation - to prevent this, drink plenty of water or juice, and eat more dietary fibre; it may cause stomach ache; it may cause muscle pain; it may cause nausea or, rarely, vomiting. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

5 mg
Each yellow, round, biconvex, film-coated tablet engraved "APO" on one side and "ROS" over "5" on the other side, contains rosuvastatin calcium equivalent to 5 mg of rosuvastatin. Nonmedicinal ingredients: lactose monohydrate NF, microcrystalline cellulose NF, crospovidone NF, magnesium stearate NF, colloidal silicon dioxide NF, hydroxypropyl cellulose USP, hydroxypropyl cellulose NF, polyethylene glycol NF, titanium dioxide USP, and yellow ferric oxide NF.

10 mg
Each pink, round, biconvex, film-coated tablet engraved "APO" on one side and "ROS" over "10" on the other side, contains rosuvastatin calcium equivalent to 10 mg of rosuvastatin. Nonmedicinal ingredients: lactose monohydrate NF, microcrystalline cellulose NF, crospovidone NF, magnesium stearate NF, colloidal silicon dioxide NF, hydroxypropyl cellulose USP, hydroxypropyl cellulose NF, polyethylene glycol NF, titanium dioxide USP, and red ferric oxide NF.

20 mg
Each pink, round, biconvex, film-coated tablet engraved "APO" on one side and "ROS" over "20" on the other side, contains rosuvastatin calcium equivalent to 20 mg of rosuvastatin. Nonmedicinal ingredients: lactose monohydrate NF, microcrystalline cellulose NF, crospovidone NF, magnesium stearate NF, colloidal silicon dioxide NF, hydroxypropyl cellulose USP, hydroxypropyl cellulose NF, polyethylene glycol NF, titanium dioxide USP, and red ferric oxide NF.

40 mg
Each pink, oval, biconvex, film-coated tablet engraved "APO" on one side and "ROS40" on the other side, contains rosuvastatin calcium equivalent to 40 mg of rosuvastatin. Nonmedicinal ingredients: lactose monohydrate NF, microcrystalline cellulose NF, crospovidone NF, magnesium stearate NF, colloidal silicon dioxide NF, hydroxypropyl cellulose USP, hydroxypropyl cellulose NF, polyethylene glycol NF, titanium dioxide USP, and red ferric oxide NF.

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

There may be an interaction between rosuvastatin and any of the following:

• Amiodarone
• antacids (if taken within 2 hours of taking rosuvastatin)
• Bezafibrate
• calcium carbonate
• Clopidogrel
• colchicines
• cyclosporine
• daptomycin
• Dronedarone
• Eltrombopag
• Eslicarbazepine
• fenofibrate
• gemfibrozil
• Hepatitis C antivirals (e.g., daclatasvir, dasabuvir, ledipasvir, ombitasvir, paritaprevir, simeprevir, sofosbuvir)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• itraconazole
• niacin (nicotinic acid)
• niacinamide
• Pazopanib
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole, Pantoprazole)
• Repaglinide
• other "statin" anti-cholesterol medications (e.g., Atorvastatin, lovastatin, simvastatin)
• Teriflunomide
• trabectedin
• Warfarin

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 Rosuvastatin. 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.

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 Rosuvastatin.

Alcohol: People who drink large quantities of alcohol should be closely monitored by their doctor while they are taking Rosuvastatin. 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 Rosuvastatin.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Rosuvastatin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Rosuvastatin, and whether any special monitoring is needed.

Hypersensitivity syndrome: A Anaphylaxis (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 Rosuvastatin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Rosuvastatin, and whether any special monitoring is needed.

Liver function: Rosuvastatin may cause decreased liver function, including liver failure. 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.

Do not use Rosuvastatin if you have active liver disease or have liver function tests that are higher than normal. If you have reduced liver function or a history of liver disease, discuss with your doctor how Rosuvastatin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Rosuvastatin, and whether any special monitoring is needed.

Muscle damage: In rare cases, serious muscle damage has been associated with the use of "statin" medications, especially at higher doses. Before taking Rosuvastatin, 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: Rosuvastatin should not be taken during pregnancy. If you become pregnant while taking Rosuvastatin, 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 Rosuvastatin, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: There is limited experience with the use of Rosuvastatin 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 Rosuvastatin 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 65 years of age, your doctor will likely monitor you closely for muscle-related side effects.

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up. This medication may be taken with or without food. Avoid excessive alcohol consumption during treatment. To ensure effectiveness, avoid taking an antacid containing aluminum or magnesium within 2 hours (before or after) of this medication.