Pronunciation:

roe-SOO-va-sta-tin

Brand Names:

• Crestor

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antihyperlipidemic

Pharmacologic—

HMG-COA Reductase Inhibitor

Uses of This Medicine:

Rosuvastatin is used to lower cholesterol and triglycerides (fats) in the blood. This medicine may help prevent or slow down medical problems, like atherosclerosis (hardening of the arteries), that are caused by fats clogging the blood vessels .

Rosuvastatin belongs to a group of medicines called HMG-CoA reductase inhibitors or "statins." It works by blocking an enzyme that is needed by the body to make cholesterol, so this reduces the amount of cholesterol in the blood .

Rosuvastatin is available only with your doctor's prescription .

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of rosuvastatin in the pediatric population. Safety and efficacy have not been established .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of rosuvastatin in the elderly. However, elderly patients are more likely to have age-related heart problems, which may require caution in patients receiving rosuvastatin .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cyclosporine
• Gemfibrozil
• Lopinavir
• Niacin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of, or
• Kidney disease or
• Liver disease, or history of, or
• Thyroid disease, underactive—May cause side effects to become worse .

• Blood in the urine or
• Protein in the urine—May make these conditions worse .

• Chinese or Japanese ancestry—May increase the amount of rosuvastatin in the body .

• Convulsions (seizures), uncontrolled, or
• Electrolyte deficiency or disorder or
• Infection, severe or
• Low blood pressure or
• Major surgery, recent or
• Major trauma, recent or
• Metabolic enzyme deficiency or disorder—Patients with these conditions may be at risk for muscle problems .

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more or less of it, and do not use it more often or for a longer time than your doctor ordered. Also, this medicine works best if there is a constant amount in the blood. To help keep this amount constant, do not miss any doses and take the medicine at the same time each day .

Remember that this medicine will not cure your cholesterol problem, but it does help control it. You must continue to take it as directed if you expect to keep your cholesterol levels down .

Before prescribing medicine for your cholesterol problem, your doctor will probably try to control it by changing your diet. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their cholesterol levels by carefully following a special diet and by adding exercise to their daily routine. Medicine is prescribed only when additional help is needed, and is effective only when used together with a modified diet and exercise .

Rosuvastatin may be taken with or without food .

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For high cholesterol and atherosclerosis:
  • For oral dosage form (tablets):
    • Adults—5 to 40 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor .

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride levels and to decide if you should continue to take it .

Check with your doctor immediately if you think that you may be pregnant. HMG-CoA reductase inhibitors may cause birth defects or other problems in the baby if taken during pregnancy. Do not breastfeed while you are using this medicine .

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine .

Do not use excessive amounts of alcohol while taking rosuvastatin. This could cause side effects on the liver .

Stop taking this medicine and check with your doctor immediately if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These could be symptoms of a serious muscle problem .

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Dark-colored urine

fever

muscle cramps or spasms

muscle pain or stiffness

muscle pain, tenderness, wasting, or weakness

unusual tiredness or weakness

Incidence not known

Abdominal or stomach pain

clay-colored stools

skin rash

unpleasant breath odor

vomiting of blood

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Body aches or pain

congestion

cough

dry or sore throat

headache

hoarseness

runny nose

tender, swollen glands in the neck

trouble with swallowing

voice changes

Less common

Accidental injury

accumulation of pus, swollen, red, or tender area of infection near a tooth

acid or sour stomach

arm, back, or jaw pain

arthritis

back pain

belching

bladder pain

bloated

bloody or cloudy urine

blurred vision

bruising

burning feeling in chest or stomach

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain or discomfort

chest tightness or heaviness

chills

constipation

depression

diarrhea

difficult or labored breathing

difficult, burning, or painful urination

difficulty having a bowel movement (stool)

difficulty with moving

discouragement

dizziness

dry mouth

excess air or gas in stomach or intestines

excessive muscle tone

fast, irregular, pounding, or racing heartbeat or pulse

fatigue

fear

feeling faint

feeling of constant movement of self or surroundings

feeling of warmth or heat

feeling sad or empty

flatulence

flushed, dry skin

flushing or redness of skin especially on face and neck

frequent urge to urinate

fruit-like breath odor

full feeling

general feeling of discomfort or illness

heartburn

increased hunger

increased thirst

increased urination

indigestion

infection

irritability

itching skin

joint pain

lack of appetite

lack or loss of strength

large, flat, blue or purplish patches in the skin

light-headedness

loss of appetite

loss of consciousness

loss of interest or pleasure

lower back or side pain

muscle tension or tightness

nausea

neck pain

nerve pain

nervousness

noisy breathing

pain

pain or swelling in the arms or legs without any injury

pain or tenderness around the eyes and cheekbones

pain, swelling, or redness in the joints

painful or difficult urination

pale skin

passing gas

pounding in the ears

sensation of spinning

shivering

shortness of breath

sleeplessness

slow heartbeat

sneezing

sore throat

stomach pain, discomfort, tenderness, or upset

stuffy nose

sweating

swelling of the hands, ankles, feet, or lower legs

tightness in the chest

trouble concentrating

trouble sleeping

troubled breathing

unable to sleep

unexplained weight loss

unusual bleeding or bruising

vomiting

wheezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.