Pronunciation:

roe-soo-va-STAT-in, e-ZET-i-mibe

Brand Names:

• Roszet

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antihyperlipidemic, HMG-COA Reductase Inhibitor Combination

Pharmacologic—

HMG-COA Reductase Inhibitor

Uses of This Medicine:

Rosuvastatin and ezetimibe combination is used together with a proper diet to lower bad cholesterol (LDL) in the blood. It is also used alone or together with other medicines to treat homozygous familial hypercholesterolemia (HoFH).

Rosuvastatin is an HMG-CoA reductase inhibitor or statin and ezetimibe is a cholesterol absorption inhibitor. This medicine will reduce the absorption of cholesterol from foods and the production of cholesterol in your body.

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

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rosuvastatin and ezetimibe combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems and have a higher risk for muscle problems, which may require caution in patients receiving rosuvastatin and ezetimibe combination.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

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
• Cholestyramine
• Ciprofibrate
• Clofibrate
• Cobicistat
• Colchicine
• Colesevelam
• Colestipol
• 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.

• Diabetes or
• Muscle problems—Use with caution. May make these conditions worse.

• Electrolyte disorders, severe or
• Endocrine disorders, severe or
• Hypothyroidism (underactive thyroid), inadequately treated or
• Kidney disease, severe or
• Major surgery or trauma, recent or
• Metabolic disorders, severe or
• Seizures, not well-controlled or
• Sepsis (severe infection)—Patients with these conditions may be at risk for muscle or kidney problems.

• Liver disease, active—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

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 these instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not crush, break, chew, or dissolve it. You may take this medicine with or without food.

If you are taking darolutamide together with rosuvastatin and ezetimibe combination, your dose should not be higher than 5 milligrams (mg) rosuvastatin and 10 mg ezetimibe per day, unless otherwise directed by your doctor. Do not use more than 10 mg rosuvastatin and 10 mg ezetimibe per day together with regorafenib. When used together with higher doses of rosuvastatin and ezetimibe combination, these medicines may increase your risk of muscle injury.

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

If you are also using cholestyramine (Questran®), take it at least 4 hours before or 2 hours after you take this medicine.

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 (tablets):
  • For high cholesterol or homozygous familial hypercholesterolemia (HoFH):
    • Adults —At first, one tablet with 5 milligrams (mg) rosuvastatin and 10 mg ezetimibe once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg rosuvastatin and 10 mg ezetimibe per 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.

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 and to decide if you should continue to take it. Blood and urine 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.

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, including myopathy or immune-mediated necrotizing myopathy (IMNM).

Check with 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.

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.

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

Arm, leg, or back pain

bloating

body aches or pain

chills

constipation

cough

darkened urine

diarrhea

ear congestion

fast heartbeat

fever

general feeling of discomfort or illness

headache

hives, itching

hoarseness

indigestion

irritation

lack or loss of strength

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

loss of appetite

loss of voice

nausea

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

redness of the skin

runny or stuffy nose

shivering

sneezing

sore throat

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

tightness in the chest

trouble breathing or swallowing

trouble sleeping

unusual tiredness or weakness

vomiting

yellow eyes or skin

Incidence not known

Black, tarry stools

bleeding gums

blistering, peeling, loosening of the skin

blood in the urine or stools

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

clay-colored stools

dizziness

gaseous stomach pain

indigestion

light-colored stools

muscle tenderness, wasting, or weakness

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red, irritated eyes

sores, ulcers, or white spots in the mouth or on the lips

stomach fullness

unpleasant breath odor

unsteadiness or awkwardness

unusual bleeding or bruising

vomiting of blood

weakness in the arms, hands, legs, or feet

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:

Less common

Pain or tenderness around the eyes and cheekbones

Incidence not known

Confusion

forgetfulness

memory loss

nightmares

problems with memory

sleeplessness

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

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.