Ezallor (Oral)

Rosuvastatin is used along with a proper diet to lower bad cholesterol (LDL) and triglycerides (fats) in the blood, and to raise your good cholesterol (HDL). It is also used to help adults who cannot control their cholesterol levels with diet and exercise alone. Rosuvastatin may help prevent or slow down health issues, like atherosclerosis (hardening of the arteries), caused by fats blocking the blood vessels. It may also be used to prevent certain heart and blood vessel problems in patients with risk factors for heart issues.

Rosuvastatin is part of a group of medicines called HMG-CoA reductase inhibitors, or statins. It works by blocking an enzyme that the body needs to make cholesterol, which lowers the amount of cholesterol in the blood.

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 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 taking 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 major surgery, a 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.

In deciding to use a medicine, the risks of taking it must be compared to the benefits it may provide. This is a choice you and your doctor will make together. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies done so far have not shown any specific problems that would limit the use of rosuvastatin tablet or capsule in children 7 years of age and older. However, safety and effectiveness have not been established in children younger than 7 years of age.

Geriatric

Studies done so far have not shown any specific problems that would limit the use of rosuvastatin in elderly patients. However, older adults are more likely to have age-related issues with muscles, liver, kidneys, or heart, which may require caution when taking rosuvastatin.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may adjust the dose or take other precautions. When you are taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on 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 necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you take 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 increase the 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 take one or both of the medicines.

• 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 due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Make sure to tell 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.

• Dehydration or
• Severe electrolyte deficiency or disorder, or
• Severe endocrine disorder, or
• Low blood pressure (hypotension), or
• Inadequately treated underactive thyroid (hypothyroidism), or
• Severe kidney disease, or
• Recent major surgery or trauma, or
• Severe metabolic enzyme deficiency or disorder, or
• Poorly controlled seizures, or
• Severe infection (sepsis)—Patients with these conditions may be at risk for muscle or kidney problems.

• Diabetes—Use with caution. May worsen this condition.

• Active liver disease, or
• Elevated liver enzymes—Should not be used in patients with these conditions.

Along with its intended effects, this medicine may cause some unwanted effects. Not all of these side effects will occur, but if they do, you 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. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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.

In the U.S.

• Crestor
• Ezallor

Available Dosage Forms:

• Tablet
• Capsule

Therapeutic Class: Antihyperlipidemic

Pharmacologic Class: HMG-COA Reductase Inhibitor

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.

• Rosuvastatin or Atorvastatin: What’s the better choice for you?