Ezetimibe

Ezetimibe is a prescription drug used as therapy with lipid-altering agents and should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone have been inadequate.

Ezetimibe is available under the following different brand names: Zetia.

Dosages of Ezetimibe:

Adult and Pediatric Dosages:

Tablets

• 10 mg

Dosage Considerations – Should be Given as Follows:

Hypercholesterolemia

Adult Dosage:

• 10 mg orally each day

Pediatric:

• Children under 10 years: safety and efficacy not established
• Children over 10 years: 10 mg orally each day

Dosing Considerations

• Overdose management: Treatment should be supportive

Dosing Modifications

Renal impairment

• Monotherapy: No dosage adjustment is required
• Moderate to severe: Renal impairment is a risk factor for statin-associated myopathy; caution when coadministered with doses of simvastatin exceeding 20 mg

Hepatic impairment

• Mild (Child-Pugh class A): Dose adjustment not necessary
• Moderate to severe (Child-Pugh class B or C): Not recommended

Common side effects of ezetimibe include:

• cough
• diarrhea
• fatigue
• headache
• increased alanine aminotransferase (ALT)
• increased gamma-glutamyl transferase (GGT)
• increased liver transaminases (with HMG-CoA reductase inhibitors; greater than 3 times upper limit of normal; 1%)
• influenza
• joint pain
• muscle pain
• pain in extremities
• cold symptoms (runny or stuffy nose, sneezing, sore or scratchy throat)
• sinusitis
• upper respiratory tract symptoms

Postmarketing side effects of ezetimibe include:

• abdominal pain
• acute inflammatory skin eruption
• back pain
• depression
• dizziness
• elevated creatine phosphokinase (CPK)
• gallstones
• headache
• hepatitis/liver function test abnormalities (liver function tests elevated slightly higher in combination with statin than with statin alone)
• hypersensitivity reactions (severe allergic reaction, rapid swelling, rash, hives)
• inflammation of the gallbladder
• joint pain
• low blood platelet count
• muscle pain/severe muscle breakdown
• nausea
• numbness and tingling
• pancreatitis

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

Ezetimibe has no known severe interactions with other drugs.

Serious interactions of ezetimibe include:

• cyclosporine

Moderate interactions of ezetimibe include:

• cholestyramine
• sofosbuvir/velpatasvir

Minor interactions of ezetimibe include:

• fenofibrate
• fenofibrate micronized
• fenofibric acid
• gemfibrozil

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

This medication contains ezetimibe. Do not take Zetia if you are allergic to ezetimibe or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Ezetimibe?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Ezetimibe?"

Cautions

• Use caution in patients with mild hepatic impairment or severe renal impairment
• Cholelithiasis reported (when coadministered with fabric acid derivatives)
• Rule out secondary causes of hyperlipidemia before therapy

Pregnancy and Lactation

• Use ezetimibe with caution during pregnancy if the benefits outweigh the risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done
• It is unknown if ezetimibe is excreted into breast milk; use caution if breastfeeding. Consult your physician.
• Pregnant or breastfeeding women should seek the advice of a health professional before using over-the-counter drugs