Rosuvastatin and ezetimibe (Oral)

Rosuvastatin and ezetimibe combination is used along with a proper diet to lower bad cholesterol (LDL) in the blood. It can also be used alone or 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.

It is very important that your doctor checks your progress at regular visits. This will help your doctor see if the medicine is working properly and decide if you should keep taking 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 prevent pregnancy. If you think you may be 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 feel unusually tired or have a fever. These may be signs of serious muscle problems, including myopathy or immune-mediated necrotizing myopathy (IMNM).

Check with your doctor immediately if you have dark urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These could be signs of a serious muscle problem called rhabdomyolysis, which can lead to kidney issues.

Check with your doctor right away if you experience pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellowing of the eyes or skin. These could be signs 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 major surgery, a major injury, or if you develop other serious health problems.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks and benefits must be carefully considered. This is a decision you and your doctor will make together. For this medicine, the following points should be taken into account:

Allergies

Inform your doctor if you have ever experienced any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients closely.

Pediatric

There have not been appropriate studies on how age affects the use of rosuvastatin and ezetimibe combination in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of rosuvastatin and ezetimibe combination in this age group. However, elderly patients are more likely to have age-related liver, kidney, or heart issues and may face a higher risk of muscle problems, which could require caution when using rosuvastatin and ezetimibe combination.

Breast Feeding

Studies on breastfeeding women have shown harmful effects on infants. An alternative medication should be prescribed, or you should stop breastfeeding while taking this medicine.

Interactions with Medicines

Some medicines should never be used together, while others may be used together with caution. If you are taking this medicine, it's especially important that your healthcare professional knows if you are using any of the medicines listed below. The following interactions are notable and do not include all possible interactions.

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency of use for one or both:

• 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 increase the risk of certain side effects, but using both may be the most effective treatment for you. If both medicines are prescribed, your doctor may adjust the dose or frequency of use for one or both:

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may occur. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Be sure to inform your doctor if you have any other medical problems, especially:

• Alcohol abuse, or a history of it
• Liver disease, history of—Use with caution. May worsen side effects.
• Asian descent—May need a lower dose of this medicine.
• Diabetes or
• Muscle problems—Use with caution. May worsen these conditions.
• Severe electrolyte disorders or
• Severe endocrine disorders or
• Hypothyroidism (underactive thyroid), not well-controlled or
• Severe kidney disease or
• Recent major surgery or trauma or
• Severe metabolic disorders or
• Uncontrolled seizures or
• Sepsis (severe infection)—Patients with these conditions may be at risk for muscle or kidney issues.
• Active liver disease—Should not be used in patients with these conditions.

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.

In the U.S.

• Roszet

Available Dosage Forms:

• Tablet

Therapeutic Class: Antihyperlipidemic, HMG-COA Reductase Inhibitor Combination

Pharmacologic Class: HMG-COA Reductase Inhibitor

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.