Atorvastatin And Ezetimibe (Oral Route)

    Atorvastatin And Ezetimibe (Oral Route)

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    Description and Brand Names of Atorvastatin And Ezetimibe (Oral Route)

    US Brand Name

    1. Liptruzet

    Descriptions

    Ezetimibe and atorvastatin combination is used together with a proper diet to treat high cholesterol and triglyceride (fats) levels in the blood. This medicine may help prevent medical problems (eg, heart attack, stroke) caused by clogged blood vessels. It is also used to treat a condition called homozygous familial hypercholesterolemia (HoFH).

    Ezetimibe is a cholesterol absorption inhibitor and atorvastatin is an HMG-CoA reductase inhibitor, or statin. These medicines 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.

    This product is available in the following dosage forms:

    • Tablet

    Before Using Atorvastatin And Ezetimibe (Oral Route)

    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.

    Pediatric

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

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of atorvastatin and ezetimibe combination in the elderly. However, elderly patients are more likely to have muscle weakness, which may require caution in patients receiving this medicine.

    Pregnancy

    Breastfeeding

    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.

    Drug Interactions

    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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Posaconazole

    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.

    • Atazanavir
    • Bezafibrate
    • Ciprofibrate
    • Clarithromycin
    • Clofibrate
    • Cobicistat
    • Colchicine
    • Conivaptan
    • Crizotinib
    • Cyclosporine
    • Dabrafenib
    • Dalfopristin
    • Danazol
    • Daptomycin
    • Darunavir
    • Diltiazem
    • Domperidone
    • Erlotinib
    • Erythromycin
    • Eslicarbazepine Acetate
    • Fenofibrate
    • Fenofibric Acid
    • Fentanyl
    • Fluconazole
    • Fosamprenavir
    • Fusidic Acid
    • Gemfibrozil
    • Indinavir
    • Itraconazole
    • Ketoconazole
    • Lopinavir
    • Mibefradil
    • Nefazodone
    • Nelfinavir
    • Niacin
    • Piperaquine
    • Primidone
    • Quinupristin
    • Saquinavir
    • Simeprevir
    • Telaprevir
    • Telithromycin
    • Tipranavir
    • Troleandomycin
    • Verapamil

    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.

    • Amiodarone
    • Amprenavir
    • Azithromycin
    • Bexarotene
    • Black Cohosh
    • Boceprevir
    • Bosentan
    • Cholestyramine
    • Clopidogrel
    • Colestipol
    • Cyclosporine
    • Digoxin
    • Efavirenz
    • Eltrombopag
    • Etravirine
    • Fenofibrate
    • Fosphenytoin
    • Interferon Beta
    • Oat Bran
    • Pectin
    • Phenytoin
    • Pioglitazone
    • Quinine
    • Rifampin
    • St John’s Wort
    • Voriconazole

    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. 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Grapefruit Juice

    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
    • Diabetes or
    • Hypothyroidism (underactive thyroid) or
    • Kidney disease or
    • Liver disease, history of or
    • Stroke, recent or
    • Transient ischemic attack, within the last 6 months – Use with caution. May cause side effects to become worse.
    • Hypotension (low blood pressure) or
    • Infection, acute and severe or
    • Kidney disease (severe), history of or
    • Major surgery or
    • Metabolic, endocrine, and electrolyte disorders or
    • Seizures, uncontrolled or
    • Trauma – Patients with these conditions may be at risk for muscle or kidney problems.
    • Liver disease, active or
    • Liver enzymes elevated – Should not be used in patients with these conditions.

    Proper Use of Atorvastatin And Ezetimibe (Oral Route)

    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.

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

    If you are taking certain medicines to lower cholesterol (eg, cholestyramine, colesevelam, colestipol, Questran®, Welchol®), take Liptruzet™ 2 hours before or 4 hours after taking these medicines.

    Do not drink more than 1.2 liters of grapefruit juice per day.

    Do not drink large amounts of alcohol with this medicine. This could cause unwanted effects on the liver.

    This medicine comes with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

    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 and triglycerides:

        • Adults – At first, one tablet per day. Your doctor may increase your dose as needed. However, the dose is usually not more than 10 milligrams (mg) of ezetimibe and 80 mg of atorvastatin.
        • Children – Use and dose must be determined by your doctor.
      • For homozygous familial hypercholesterolemia (HoFH):

        • Adults – One tablet per day. Each tablet contains 10 milligrams (mg) of ezetimibe and 40 mg of atorvastatin or 10 mg of ezetimibe and 80 mg of atorvastatin.
        • Children – Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    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.

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep your medicine in the foil pouch until you are ready to use it. After opening the foil pouch, store it in a dry place and protect from moisture and light. Once a tablet is removed, slide the blister card back into its plastic case. Throw away any unused tablets 30 days after opening the foil pouch.

    Precautions

    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 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 could be symptoms of serious muscle problems, such as myopathy or immune-mediated necrotizing myopathy (IMNM).

    Check with 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.

    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, a major injury, or 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 Atorvastatin And Ezetimibe (Oral Route)

    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:

    Less common

    1. Abdominal or stomach pain
    2. confusion
    3. difficult breathing
    4. difficulty with moving
    5. irregular heartbeat
    6. muscle, joint, or bone pain
    7. muscle stiffness
    8. muscle weakness
    9. nausea or vomiting
    10. nervousness
    11. numbness or tingling in the hands, feet, or lips
    12. shortness of breath
    13. weakness or heaviness of the legs

    Incidence not known

    1. Black, tarry stools
    2. blistering, peeling, or loosening of the skin
    3. blood in the urine or stools
    4. chills
    5. dark-colored urine
    6. diarrhea
    7. fever
    8. gaseous abdominal or stomach pain
    9. general tiredness and weakness
    10. hives, welts, or skin rash
    11. itching
    12. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    13. light-colored stools
    14. severe nausea or vomiting
    15. sores, ulcers, or white spots in the mouth or on the lips
    16. swelling of the eyes, face, or inside of the nose
    17. unsteadiness or awkwardness
    18. unusual bleeding or bruising
    19. unusual tiredness or weakness
    20. yellow eyes and 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:

    Less common

    1. Cough
    2. dizziness
    3. feeling of warmth
    4. pain or tenderness around the eyes and cheekbones
    5. redness of the face, neck, arms, and occasionally, upper chest
    6. stuffy or runny nose
    7. sudden sweating
    8. tightness in the chest

    Incidence not known

    1. Being forgetful
    2. bloating burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
    3. chills
    4. constipation
    5. discouragement
    6. fast heartbeat
    7. feeling sad or empty
    8. irritability
    9. lack of appetite
    10. loss of interest or pleasure
    11. loss of memory
    12. pains in the stomach, side, or abdomen, possibly radiating to the back
    13. tiredness
    14. trouble concentrating
    15. trouble sleeping

    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.