Rosuvastatin (Oral route)
HMG-COA Reductase Inhibitor
Uses of This Medicine:
Rosuvastatin is used together with a proper diet 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. It may also be used to prevent certain types of heart and blood vessel problems in patients with risk factors for heart problems.
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.
This medicine 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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of rosuvastatin in children. However, safety and efficacy have not been established in children younger than 10 years of age.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rosuvastatin in the elderly. However, elderly patients are more likely to have age-related muscle problems, which may require caution in patients receiving rosuvastatin.
|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.|
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.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
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.
- Eslicarbazepine Acetate
- Fenofibric Acid
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Estradiol Cypionate
- Estradiol Valerate
- Ethinyl Estradiol
- Ethynodiol Diacetate
- Medroxyprogesterone Acetate
- Oat Bran
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
- Liver disease, history of—Use with caution. May cause side effects to become worse.
- Asian descent—May need a lower dose of this medicine.
- Convulsions (seizures), not well-controlled or
- Dehydration or
- Electrolyte deficiency or disorder, severe or
- Endocrine disorder, severe or
- Hypotension (low blood pressure) or
- Hypothyroidism (underactive thyroid), inadequately treated or
- Kidney disease, severe or
- Major surgery or trauma, recent or
- Metabolic enzyme deficiency or disorder, severe or
- Sepsis (severe infection)—Patients with these conditions may be at risk for muscle or kidney problems.
- Diabetes—Use with caution. May make this condition worse.
- Liver disease, active or
- Liver enzymes, elevated—Should not be used in patients with these conditions.
Proper Use of This Medicine:
Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, or do not use it 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.
In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's orders about any special diet.
This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Talk to your doctor if you have any questions.
Swallow the tablet whole. Do not break, crush, or chew it. You may take this medicine with or without food.
If you need to take an antacid that contains aluminum and magnesium (e.g., Maalox®), take the antacid at least 2 hours after you take rosuvastatin.
Do not drink large amounts of alcohol while taking rosuvastatin. This could cause side effects on the liver.
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 oral dosage form (tablets):
- For high cholesterol and atherosclerosis:
- Adults—5 to 40 milligrams (mg) once a day.
- Children 10 to 17 years of age—5 to 20 mg per day.
- Children younger than 10 years of age—Use and dose must be determined by your doctor.
- For high cholesterol and atherosclerosis:
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.
However, do not take 2 doses of this medicine within 12 hours.
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. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine if you have a major surgery, major injury, or you develop other serious health problems.
Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness. These could be symptoms of serious muscle problems such as myopathy or immune-mediated necrotizing myopathy (IMNM).
Call your doctor right away if you have dark-colored urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.
Call your doctor right away if you get a headache, stomach pain, vomiting, dark-colored urine, loss of appetite, weight loss, general feeling of tiredness or weakness, light-colored stools, upper right stomach pain, or yellow eyes or skin. These could be symptoms of liver damage.
Do not stop or change your dose without checking first with your doctor, even if you are feeling well.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- Dark-colored urine
- muscle cramps or spasms
- muscle pain, stiffness, 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
- More common
- Body aches or pain
- dry or sore throat
- runny nose
- tender, swollen glands in the neck
- trouble 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
- bladder pain
- bloated or full feeling
- bloody or cloudy urine
- blurred vision
- burning feeling in the chest or stomach
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or discomfort
- chest tightness or heaviness
- difficult or labored breathing
- difficult, burning, or painful urination
- difficulty with moving
- dry mouth
- excess air or gas in the stomach or intestines
- excessive muscle tone
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling faint
- feeling of constant movement of self or surroundings
- feeling of warmth or heat
- feeling sad or empty
- flushed, dry skin
- flushing or redness of the skin especially on the face and neck
- fruit-like breath odor
- general feeling of discomfort or illness
- increased hunger
- increased thirst
- increased urination
- itching skin
- lack of appetite
- lack or loss of strength
- loss of appetite
- loss of consciousness
- loss of interest or pleasure
- muscle tension or tightness
- neck pain
- nerve 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
- pale skin
- passing gas
- pounding in the ears
- sensation of spinning
- shortness of breath
- slow heartbeat
- stomach pain, discomfort, tenderness, or upset
- stuffy nose
- swelling of the hands, ankles, feet, or lower legs
- trouble concentrating
- trouble sleeping
- troubled breathing
- unable to sleep
- unexplained weight loss
- unusual bleeding or bruising
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:
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:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 11/4/2014