Continue to follow a cholesterol-lowering diet while taking Zetia. In clinical trials, the incidence of creatine phosphokinase (CPK) >10 × ULN was 0.2% for Zetia vs. 0.1% for placebo, and 0.1% for Zetia coadministered with a statin vs. 0.4% for statins alone. If cholelithiasis is suspected in a patient receiving Zetia and fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered [see Adverse Reactions (6.1) and the product labeling for fenofibrate]. There were no CPK elevations >10 × ULN in any of the treatment groups. We comply with the HONcode standard for trustworthy health information -, Drug class: cholesterol absorption inhibitors. It is not known if Zetia is safe and effective in children younger than 10 years of age. In rat studies, exposure to total ezetimibe in nursing pups was up to half of that observed in maternal plasma. Tell your doctor if you are having these or any other medical problems while on Zetia. Do not give Zetia to other people, even if they have the same condition you have. Zetia is not recommended in patients with moderate to severe hepatic impairment [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3)]. However, do not take more than one dose of Zetia a day. In oral (gavage) embryo-fetal development studies of ezetimibe conducted in rats and rabbits during organogenesis, there was no evidence of embryolethal effects at the doses tested (250, 500, 1000 mg/kg/day). Zetia is contraindicated in the following conditions: Concurrent administration of Zetia with a specific statin or fenofibrate should be in accordance with the product labeling for that medication. NDC 66582-414-74 bottles of 500 Minimal oxidative metabolism (a phase I reaction) has been observed in all species evaluated. In rats, increased incidences of common fetal skeletal findings (extra pair of thoracic ribs, unossified cervical vertebral centra, shortened ribs) were observed at 1000 mg/kg/day (~10 × the human exposure at 10 mg daily based on AUC0–24hr for total ezetimibe). If you forget to take Zetia, take it as soon as you remember. A 104-week dietary carcinogenicity study with ezetimibe was also conducted in mice at doses up to 500 mg/kg/day (>150 × the human exposure at 10 mg daily based on AUC0–24hr for total ezetimibe). Zetia belongs to a class of drugs called Lipid-Lowering Agents, 2-Azetidinones. If you would like more information, talk with your doctor. The changes in lipid endpoints after an additional 48 weeks of treatment with Zetia coadministered with fenofibrate or with fenofibrate alone were consistent with the 12-week data displayed above. provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Zetia reduces total-C, LDL-C, Apo B, non-HDL-C, and TG, and increases HDL-C in patients with hyperlipidemia. Race: Based on a meta-analysis of multiple-dose pharmacokinetic studies, there were no pharmacokinetic differences between Black and Caucasian subjects. The effect of Zetia on cardiovascular morbidity and mortality has not been determined. [See USP Controlled Room Temperature.] Patients should discuss all medication, both prescription and over-the-counter, with their physician. A 104-week dietary carcinogenicity study with ezetimibe was conducted in rats at doses up to 1500 mg/kg/day (males) and 500 mg/kg/day (females) (~20 × the human exposure at 10 mg daily based on AUC0–24hr for total ezetimibe). Zetia (ezetimibe) is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The empirical formula is C24H21F2NO3. When used as monotherapy, no dosage adjustment of Zetia is necessary. The absolute bioavailability of ezetimibe cannot be determined, as the compound is virtually insoluble in aqueous media suitable for injection. Of the 2396 patients who received Zetia in clinical studies, 669 (28%) were 65 and older, and 111 (5%) were 75 and older. Subscribe to newsletters for the latest medication news, new drug approvals, alerts and updates. Zetia reduces the buildup of fats, cholesterol, and other substances on the artery walls (this process is known as atherosclerosis) and if taken long term it may reduce the risk of heart disease. No. Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. The degree of increase in ezetimibe exposure may be greater in patients with severe renal insufficiency. For a more effective reduction in triglycerides levels, ezetimibe can be taken with a statin. Upper respiratory tract infections, diarrhea, joint pain, sinusitis, tiredness, and pain in the extremities (2.7%) are the most common side effects reported, occurring in less than 5% of people. All rights reserved. You need to do this promptly, because on rare occasions, these muscle problems can be serious, with muscle breakdown resulting in kidney damage. The results of the study at Week 6 are summarized in Table 3. In humans, ezetimibe is rapidly metabolized to ezetimibe-glucuronide. In addition, Zetia had no clinically meaningful effect on the plasma concentrations of the fat-soluble vitamins A, D, and E (in a study of 113 patients), and did not impair adrenocortical steroid hormone production (in a study of 118 patients). In patients treated with cyclosporine, the potential effects of the increased exposure to ezetimibe from concomitant use should be carefully weighed against the benefits of alterations in lipid levels provided by ezetimibe. The risk of this occurring is increased when taking certain types of medication. No evidence of mutagenicity was observed in vitro in a microbial mutagenicity (Ames) test with Salmonella typhimurium and Escherichia coli with or without metabolic activation. Approximately 78% and 11% of the administered radioactivity were recovered in the feces and urine, respectively, over a 10-day collection period. There are no adequate and well-controlled studies of ezetimibe in pregnant women. In toxicity studies, a pharmacokinetic interaction of ezetimibe with statins (parents or their active hydroxy acid metabolites) was seen in rats, dogs, and rabbits. LDL cholesterol is called "bad" cholesterol because it can build up in the wall of your arteries and form plaque.