Additionally, the following side effects have been reported in general use: allergic reactions (which may require treatment right away) including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing, rash, and hives; raised red rash, sometimes with target-shaped lesions; joint pain; muscle aches; alterations in some laboratory blood tests; liver problems; stomach pain; inflammation of the pancreas; nausea; dizziness; tingling sensation; depression; headache; gallstones; inflammation of the gallbladder. Zetia is a medicine used to lower levels of total cholesterol and LDL (bad) cholesterol in the blood. Zetia may not be right for you. Administration of Zetia with a statin is effective in improving serum total-C, LDL-C, Apo B, non-HDL-C, TG, and HDL-C beyond either treatment alone. The incidence of consecutive increased transaminases (≥3 × ULN) was higher in patients receiving Zetia administered with statins (1.3%) than in patients treated with statins alone (0.4%). are breastfeeding. Reproductive findings occur at lower doses in combination therapy compared to monotherapy. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Updated 11/2019. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. See FDA-Approved Patient Labeling (Patient Information). Crestor, Lipitor, Praluent, Livalo, ezetimibe, Nexlizet, Nexletol, atorvastatin, simvastatin, rosuvastatin. Do not use Zetia for a condition for which it was not prescribed. Race: Based on a meta-analysis of multiple-dose pharmacokinetic studies, there were no pharmacokinetic differences between Black and Caucasian subjects. Zetia and any statin or fibrate that the patient is taking concomitantly should be immediately discontinued if myopathy is diagnosed or suspected. In a preclinical study in dogs, ezetimibe increased cholesterol in the gallbladder bile [see Nonclinical Toxicology (13.2)]. Select one or more newsletters to continue. Data sources include IBM Watson Micromedex (updated 2 Nov 2020), Cerner Multum™ (updated 2 Nov 2020), ASHP (updated 23 Oct 2020) and others. Zetia (ezetimide) [Package insert]. Ezetimibe-glucuronide mean Cmax values of 45 to 71 ng/mL were achieved between 1 and 2 hours (Tmax). Zetia, administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in adult patients with mixed hyperlipidemia. In rat studies, exposure to total ezetimibe in nursing pups was up to half of that observed in maternal plasma. Ezetimibe has a different mechanism of action and lowers blood cholesterol by reducing the absorption of cholesterol from the intestine. There are no adequate and well-controlled studies of ezetimibe in pregnant women. In oral (gavage) fertility studies of ezetimibe conducted in rats, there was no evidence of reproductive toxicity at doses up to 1000 mg/kg/day in male or female rats (~7 × the human exposure at 10 mg daily based on AUC0–24hr for total ezetimibe). What should I tell my doctor before and while taking Zetia? If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and the lack of known clinical benefit with continued use during pregnancy. The results of the study at Week 6 are summarized in Table 3. Ask your doctor if you need diet information. Following oral administration of 14C-ezetimibe (20 mg) to human subjects, total ezetimibe (ezetimibe + ezetimibe-glucuronide) accounted for approximately 93% of the total radioactivity in plasma. Ezetimibe was found to have an ED50 value of 0.5 µg/kg/day for inhibiting the rise in plasma cholesterol levels in monkeys. All patients starting therapy with ezetimibe should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness. It may be easier to remember to take your dose if you do it at the same time every day, such as with breakfast, dinner, or at bedtime. Read this information carefully before you start taking Zetia® and each time you get more Zetia. The way Zetia works is different from other classes of cholesterol-reducing compounds such as statins, bile acid sequestrants, fibric acid derivatives, or plant stanols. In a multicenter, double-blind, placebo-controlled, clinical study in patients with mixed hyperlipidemia, 625 patients were treated for up to 12 weeks and 576 for up to an additional 48 weeks. No dosage adjustment is necessary in patients with renal impairment [see Clinical Pharmacology (12.3)]. Risk for skeletal muscle toxicity increases with higher doses of statin, advanced age (>65), hypothyroidism, renal impairment, and depending on the statin used, concomitant use of other drugs. Zetia can be taken at any time of the day, with or without food, as long as it is taken consistently and at the same time each day. Last updated on Nov 23, 2020. The hypocholesterolemic effect of ezetimibe was evaluated in cholesterol-fed Rhesus monkeys, dogs, rats, and mouse models of human cholesterol metabolism. Zetia does not help you lose weight. See your doctor regularly to check your cholesterol level and to check for side effects. Multiple-dose studies of ezetimibe given in combination with statins in rats and rabbits during organogenesis result in higher ezetimibe and statin exposures. Hepatic Impairment: After a single 10-mg dose of ezetimibe, the mean AUC for total ezetimibe was increased approximately 1.7-fold in patients with mild hepatic impairment (Child-Pugh score 5 to 6), compared to healthy subjects. HDL cholesterol is called "good" cholesterol because it keeps the bad cholesterol from building up in the arteries. Zetia can be taken alone or in combination with other medications that also lower cholesterol, such as statins or fenofibrate. Copyright 1996-2020 It is important that you keep taking Zetia even if you do not feel sick. Zetia may be used to lower cholesterol alone or in combination with a statin or fibrate. The Cmax value of ezetimibe was increased by 38% with consumption of high-fat meals. The combination of Zetia and atorvastatin or simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. Zetia (ezetimibe) is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The most common adverse reactions in the group of patients treated with Zetia that led to treatment discontinuation and occurred at a rate greater than placebo were: The most commonly reported adverse reactions (incidence ≥2% and greater than placebo) in the Zetia monotherapy controlled clinical trial database of 2396 patients were: upper respiratory tract infection (4.3%), diarrhea (4.1%), arthralgia (3.0%), sinusitis (2.8%), and pain in extremity (2.7%).