Atorvastatin-ezetimibe

Ezetimibe reduces the amount of cholesterol absorbed by the body.

Atorvastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins."

Atorvastatin and ezetimibe is a combination medicine that reduces blood levels of "bad" cholesterol, such as low-density lipoprotein (LDL), apolipoprotein-B (apo-B), triglycerides, or non-high-density lipoprotein (non-HDL).

Atorvastatin and ezetimibe is used together with a low-fat diet and other treatments to lower total cholesterol in adults with familial hypercholesterolemia (an inherited type of high cholesterol).

It is not known whether atorvastatin and ezetimibe reduces your risk of heart disease.

Atorvastatin and ezetimibe may also be used for purposes not listed in this medication guide.

You should not use this medicine if you have active liver disease or abnormal liver function tests.

Do not use atorvastatin and ezetimibe if you are pregnant or if you could become pregnant. Use effective birth control.

Do not breast-feed while using this medicine.

You should not use this medicine if you are allergic to atorvastatin (Lipitor) or ezetimibe (Vytorin, Zetia), or if you have:

• active liver disease;
• abnormal liver function tests; or
• if you are pregnant or breast-feeding.

To make sure this medicine is safe for you, tell your doctor if you have:

• a thyroid disorder;
• a history of liver or kidney disease;
• a history of liver problems caused by alcohol;
• gallbladder disease or a history of gallstones;
• low blood pressure;
• a history of blood clot or stroke, including "mini-stroke" (TIA);
• diabetes;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
• untreated or uncontrolled seizures;
• if you drink large amounts of alcohol; or
• if you are older than 65.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use atorvastatin and ezetimibe if you are pregnant. Use effective birth control. Stop using the medicine and tell your doctor right away if you become pregnant.

It is not known whether atorvastatin and ezetimibe passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

1-10%

Increased ALT (5%)

Increased AST (4%)

Musculoskeletal pain (4%)

Abdominal pain (3%)

Nausea (3%)

Arthralgias (3%)

Muscle weakness (2%)

Dizziness (2%)

Hyperkalemia (2%)

Hot flushes (2%)

Coughing (2%)

Bronchitis (2%)

Sinusitis (2%)

Postmarketing Reports

Blood and lymphatic system disorders: Thrombocytopenia

Nervous system disorders: Headache; paresthesia; peripheral neuropathy, cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion)

Gastrointestinal disorders: Pancreatitis

Skin and subcutaneous tissue disorders: Angioedema; bullous rashes (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis); rash; urticaria

Musculoskeletal and connective tissue disorders: Myopathy/rhabdomyolysis, immune-mediated necrotizing myopathy

Injury, poisoning and procedural complications: Tendon rupture

Immune system disorders: Anaphylaxis; hypersensitivity reactions

Hepatobiliary disorders: Hepatitis; cholelithiasis; cholecystitis; fatal and nonfatal hepatic failure

Psychiatric disorders: Depression

Laboratory abnormalities: Elevated CPK

Respiratory system: Interstitial lung disease

Contraindications

Hypersensitivity

Active liver disease or unexplained elevated transaminases

Women who are pregnant or may become pregnant

Breast feeding women

Cautions

Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria reported; coadministration with cyclosporine and strong CYP3A4 inhibitors increases this risk

Myopathies, including rare reports of immune-mediated necrotizing myopathy have occurred; temporarily withhold or discontinue if acute, serious symptoms suggestive of myopathy occur

May increase liver enzymes levels; measure levels before initiating and repeat as clinically indicated; if serious liver injury, hyperbilirubinemia, or jaundice occurs, interrupt therapy and permanently discontinue if alternate etiology is not found

Increased HbA1c and fasting serum glucose levels reported