Atorvastatin and ezetimibe

Name: Atorvastatin and ezetimibe

Proper Use of atorvastatin and ezetimibe

Take atorvastatin and ezetimibe 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.

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

In addition to atorvastatin and ezetimibe, 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. You may take atorvastatin and ezetimibe with or without food.

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 atorvastatin and ezetimibe. This could cause unwanted effects on the liver.

Dosing

The dose of atorvastatin and ezetimibe 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 atorvastatin and ezetimibe. 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 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 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 atorvastatin and ezetimibe, 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 blister pack until you are ready to use it. After opening the blister pack, store it in a dry place and protect from moisture and light. Once a tablet is removed, slide the blister card back into its folded card.

Precautions While Using atorvastatin and ezetimibe

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 atorvastatin and ezetimibe 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 atorvastatin and ezetimibe. You may need to stop using atorvastatin and ezetimibe 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.

atorvastatin and ezetimibe Side Effects

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
  • Abdominal or stomach pain
  • confusion
  • difficult breathing
  • difficulty with moving
  • irregular heartbeat
  • muscle, joint, or bone pain
  • muscle stiffness
  • muscle weakness
  • nausea or vomiting
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • weakness or heaviness of the legs
Incidence not known
  • Black, tarry stools
  • blistering, peeling, or loosening of the skin
  • blood in the urine or stools
  • chills
  • dark-colored urine
  • diarrhea
  • fever
  • gaseous abdominal or stomach pain
  • general tiredness and weakness
  • hives, welts, or skin rash
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • severe nausea or vomiting
  • sores, ulcers, or white spots in the mouth or on the lips
  • swelling of the eyes, face, or inside of the nose
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • 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
  • Cough
  • dizziness
  • feeling of warmth
  • pain or tenderness around the eyes and cheekbones
  • redness of the face, neck, arms, and occasionally, upper chest
  • stuffy or runny nose
  • sudden sweating
  • tightness in the chest
Incidence not known
  • Being forgetful
  • bloating burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chills
  • constipation
  • discouragement
  • fast heartbeat
  • feeling sad or empty
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • loss of memory
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • tiredness
  • trouble concentrating
  • 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.

In Summary

Commonly reported side effects of atorvastatin/ezetimibe include: arthralgia, diarrhea, and nasopharyngitis. Other side effects include: upper respiratory tract infection, urinary tract infection, insomnia, limb pain, muscle spasm, musculoskeletal pain, myalgia, and nausea. See below for a comprehensive list of adverse effects.

For Healthcare Professionals

Applies to atorvastatin / ezetimibe: oral tablet

Dermatologic

Postmarketing reports: Angioedema, bullous rashes (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), rash, urticaria[Ref]

Endocrine

Common (1% to 10%): Hot flushes (2%)[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea (4.1 to 6.8%), abdominal pain (3%), nausea (3 to 4%), dyspepsia (4.7%)[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection (5.7%)[Ref]

Hematologic

Postmarketing reports: Thrombocytopenia, elevated creatine phosphokinase[Ref]

Hepatic

Common (1% to 10%): ALT increased (5%), AST increased (4%)
Postmarketing reports: Hepatitis, cholelithiasis, cholecystitis, fatal and nonfatal hepatic failure[Ref]

Hypersensitivity

Postmarketing reports: Anaphylaxis, hypersensitivity reactions[Ref]

Immunologic

Common (1% to 10%): Influenza (2%)[Ref]

Metabolic

Common (1% to 10%): Hyperkalemia (2%)[Ref]

Musculoskeletal

Common (1% to 10%): Musculoskeletal pain (3.8 to 4%), arthralgia (3 to 6.9%), pain in extremity (2.7 to 6%), myalgia (3.5%), muscle spasms (3%), muscle weakness (2%)
Postmarketing reports: Myopathy/rhabdomyolysis, necrotizing myopathy (rarely), injury, poisoning and procedural complication, tendon rupture[Ref]

Nervous system

Common (1% to 10%): Dizziness (2 to 6%), insomnia (3%), fatigue (2.4%)
Postmarketing reports: Headache, paresthesia, peripheral neuropathy, amnesia, memory impairment, confusion, depression[Ref]

Respiratory

Common (1% to 10%): Coughing (2 to 3%), bronchitis (2%), sinusitis (2 to 2.8%), upper respiratory tract infection (4.3%), nasopharyngitis (up to 8.3%), pharyngolaryngeal pain (up to 2.3%)[Ref]

Some side effects of atorvastatin / ezetimibe may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Atorvastatin / ezetimibe Pregnancy Warnings

Serum cholesterol and triglycerides increase during normal pregnancy. Lipid-lowering drugs offer no benefit during pregnancy, because cholesterol and cholesterol derivatives are needed for normal fetal development. Atherosclerosis is a chronic process, and discontinuation of lipid-lowering drugs during pregnancy should have little or no impact on long-term outcomes of primary hypercholesterolemia. Animal studies at high human doses were not teratogenic but there was decreased pup survival at birth, neonate, weaning, and development was delayed. Rare reports of congenital anomalies have been received following intrauterine exposure to atorvastatin. There are no adequate and well-controlled studies in human pregnancy. FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

FDA pregnancy category: X Use of atorvastatin-ezetimibe is contraindicated. Women of childbearing potential should be encouraged to use adequate contraception.

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