Pronunciation:

roe-soo-va-STAT-in

Brand Names:

• Crestor
• Ezallor

Dosage Forms:

• Tablet
• Capsule

Classifications:

Therapeutic—

Antihyperlipidemic

Pharmacologic—

HMG-COA Reductase Inhibitor

Uses of This Medicine:

Rosuvastatin is used together with a proper diet to lower bad cholesterol (LDL) and triglycerides (fats) in the blood, and to increase your good cholesterol (HDL). It is also used to treat adults who cannot control their cholesterol levels by diet and exercise alone. Rosuvastatin 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:

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of rosuvastatin tablet or capsule in children 7 years of age and older. However, safety and efficacy have not been established in children younger than 7 years of age.

Older adults—

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, liver, kidney, or heart problems, which may require caution in patients receiving rosuvastatin.

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—

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.

• Abiraterone Acetate
• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Amprenavir
• Atazanavir
• Bezafibrate
• Boceprevir
• Capmatinib
• Ciprofibrate
• Clofibrate
• Cobicistat
• Colchicine
• Cyclosporine
• Daptomycin
• Darolutamide
• Darunavir
• Dasabuvir
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Elacestrant
• Elagolix
• Elbasvir
• Elexacaftor
• Eluxadoline
• Enasidenib
• Encorafenib
• Eslicarbazepine Acetate
• Febuxostat
• Fenofibrate
• Fenofibric Acid
• Fosamprenavir
• Fostamatinib
• Gemfibrozil
• Glecaprevir
• Grazoprevir
• Indinavir
• Ledipasvir
• Leflunomide
• Leniolisib
• Lopinavir
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Peroxide
• Magnesium Trisilicate
• Midostaurin
• Momelotinib
• Niacin
• Nirmatrelvir
• Ombitasvir
• Paritaprevir
• Pibrentasvir
• Pirtobrutinib
• Regorafenib
• Ritonavir
• Rolapitant
• Saquinavir
• Simeprevir
• Sofosbuvir
• Tafamidis
• Telaprevir
• Teriflunomide
• Trofinetide
• Velpatasvir
• Voxilaprevir
• Warfarin

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.

• Acenocoumarol
• Amiodarone
• Dicumarol
• Eltrombopag
• Fostemsavir
• Itraconazole
• Oat Bran
• Pectin
• Phenprocoumon
• Tipranavir

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
• Liver disease, history of—Use with caution. May cause side effects to become worse.

• Asian descent—May need a lower dose of this medicine.

• 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
• Seizures, not well-controlled 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 leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Swallow the tablet whole. Do not break, crush, or chew it.

To use the capsule:

• Swallow the capsule whole. Do not crush or chew it. If you have trouble swallowing, you may open it and mix the contents with 1 teaspoon of soft food (eg, applesauce, or chocolate or vanilla pudding). Take this mixture within 1 hour, without chewing. Do not save the mixture for later use. Throw away any unused mixture.
• You may also take the capsule using a nasogastric tube. To use:
  • Open the capsule and empty the contents into a 60-milliliter (mL) catheter syringe. Add 40 mL of water. Do not use any other liquid.
  • Replace the plunger and shake the syringe for 15 seconds. The granules may start dissolving.
  • Attach the syringe to a nasogastric tube and deliver the contents into the stomach.
  • Flush the tube with an additional 20 mL of water to get all of the medicine.
  • Throw away any unused mixture.

If you need to take an antacid that contains aluminum and magnesium (eg, Maalox®), take the antacid at least 2 hours after using rosuvastatin.

Do not drink large amounts of alcohol while using rosuvastatin. This could cause side effects on the liver.

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 oral dosage form (capsules or tablets):
  • For atherosclerosis:
    • Adults—5 to 40 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor.
  • For heterozygous familial hypercholesterolemia:
    • Adults—5 to 40 milligrams (mg) once a day.
    • Children 10 to 17 years of age—5 to 20 mg per day.
    • Children 8 to 9 years of age—5 to 10 mg per day.
    • Children younger than 8 years of age—Use and dose must be determined by your doctor.
  • For homozygous familial hypercholesterolemia:
    • Adults—At first, 20 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
    • Children 7 to 17 years of age—20 mg once a day.
    • Children younger than 7 years of age—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.

However, do not take 2 doses of this medicine within 12 hours of each other.

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. Blood and urine tests may be needed to check for unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine while you are pregnant can harm your unborn baby. 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 if you develop other serious health problems.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These may be symptoms of serious muscle problems, such as myopathy or immune-mediated necrotizing myopathy (IMNM).

Call your doctor right away if you have dark 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.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

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:

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:

More common

Difficulty in moving

joint pain or swelling

muscle pain, cramps, spasms, or stiffness

Less common

Blurred vision

chest pain, discomfort, tightness, or heaviness

difficult, burning, or painful urination

dry mouth

fast, irregular, pounding, or racing heartbeat or pulse

flushed, dry skin

fruit-like breath odor

increased hunger

increased thirst

increased urination

loss of consciousness

muscle tension or tightness

nausea

slow heartbeat

stomachache

sweating

trouble breathing

unexplained weight loss

unusual tiredness or weakness

vomiting

Rare

Dark urine

fever

Incidence not known

Black, tarry stools

bleeding gums

bloating

bloody urine

chest tightness

chills

clay-colored stools

constipation

cough

general feeling of tiredness or weakness

headache

hives, itching, skin rash

hoarseness

indigestion

irritation

joint swelling

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

light-colored stools

loss of appetite

muscle tenderness, wasting, or weakness

pains in the stomach, side, or abdomen, possibly radiating to the back

pinpoint red spots on the skin

redness of the skin

stomach pain, continuing

swelling of the eyelids, face, lips, hands, or feet

trouble swallowing

unpleasant breath odor

unusual bleeding or bruising

upper right abdominal or stomach pain

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

dry or sore throat

runny nose

tender, swollen glands in the neck

voice changes

Less common

Accidental injury

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

arm, back, or jaw pain

belching

bladder pain

burning feeling in the chest or stomach

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

diarrhea

discouragement

dizziness

excess air or gas in the stomach or bowels

excessive muscle tone

fear

feeling faint

feeling of constant movement of self or surroundings

feeling of warmth or heat

feeling sad or empty

flushing or redness of the skin, especially on the face and neck

general feeling of discomfort or illness

heartburn

lack of appetite

lack or loss of strength

lightheadedness

loss of interest or pleasure

neck pain

nerve pain

nervousness

pain or swelling in the arms or legs without any injury

pain or tenderness around the eyes and cheekbones

passing gas

pounding in the ears

sensation of spinning

shivering

sneezing

stomach discomfort, tenderness, or upset

stuffy nose

trouble concentrating

trouble sleeping

Incidence not known

Confusion

forgetfulness

memory loss

nightmares

swelling of the breasts or breast soreness in both females and males

unsteadiness or awkwardness

weakness in the arms, hands, legs, or feet

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.