The presence of muscle symptoms and a CPK level >10 × the ULN indicates myopathy. Zetia may be used to lower cholesterol alone or in combination with a statin or fibrate. NDC 66582-414-54 bottles of 90 No evidence of clastogenicity was observed in vitro in a chromosomal aberration assay in human peripheral blood lymphocytes with or without metabolic activation. ever had liver problems. Zetia reduces total-C, LDL-C, Apo B, non-HDL-C, and TG, and increases HDL-C in patients with hyperlipidemia. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Zetia is used to treat high cholesterol. High LDL cholesterol is a major cause of heart disease and one of the causes for stroke. For a complete list of all side effects, click here. Patients have experienced severe muscle problems while taking Zetia, usually when Zetia was added to a statin drug. The combination of Zetia with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in hepatic transaminase levels. Last updated on Nov 23, 2020. anti-androgen medications such as darolutamide, anti-cancer medications such as entrectinib, statins, such as atorvastatin or simvastatin (increased risk of side effects). Most patients who developed rhabdomyolysis were taking a statin prior to initiating Zetia. However, because renal impairment is a risk factor for statin-associated myopathy, doses of simvastatin exceeding 20 mg should be used with caution and close monitoring when administered concomitantly with Zetia in patients with moderate to severe renal impairment. Zetia works to reduce the amount of cholesterol your body absorbs. Patients were randomized to receive placebo, Zetia alone, 160-mg fenofibrate alone, or Zetia and 160-mg fenofibrate in the 12-week study. As with all other cholesterol-lowering medication, Zetia should be taken in conjunction with lifestyle changes including a cholesterol-lowering diet and a weight management plan. May be used in combination with atorvastatin or simvastatin to reduce elevated total-C and LDL-C levels in patients with Homozygous Familial Hypercholesterolemia (HoFH), in addition to other lipid-lowering treatments. 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). Dosage Form: tablet. You should stay on a cholesterol-lowering diet while taking this medicine. For Zetia to have cardiovascular benefits you need to take it regularly and long term. Zetia coadministered with fenofibrate significantly lowered total-C, LDL-C, Apo B, and non-HDL-C compared to fenofibrate administered alone. Keep taking Zetia unless your doctor tells you to stop. 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). Because statins decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, Zetia in combination with a statin may cause fetal harm when administered to pregnant women. Zetia is available as a tablet for oral administration containing 10 mg of ezetimibe and the following inactive ingredients: croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, povidone USP, and sodium lauryl sulfate NF. In humans, ezetimibe is rapidly metabolized to ezetimibe-glucuronide. Ezetimibe is used to treat high cholesterol. In a 14-day, multiple-dose study (10 mg daily) in patients with moderate hepatic impairment, the mean AUC values for total ezetimibe and ezetimibe were increased approximately 4-fold on Day 1 and Day 14 compared to healthy subjects. Maximal to near maximal response is generally achieved within 2 weeks and maintained during chronic therapy. Take Zetia at least 4 hours after cholestyramine, colestipol, and colesevelam; or 2 hours before. [See USP Controlled Room Temperature.] The numbers of patients exposed to coadministration therapy as well as fenofibrate and ezetimibe monotherapy were inadequate to assess gallbladder disease risk. Zetia does not cause an increase or a decrease in blood pressure. There was no substantial deviation from dose proportionality between 5 and 20 mg. Zetia may not be suitable for some people including pregnant women and should not be used in combination with a statin in people with active liver disease, with unexplained persistent elevations in hepatic transaminase levels, in women who are pregnant or intending to become pregnant, and in breastfeeding women. Multiple-dose studies of ezetimibe given in combination with statins in rats and rabbits during organogenesis result in higher ezetimibe and statin exposures. Research has not yet determined if Zetia reduces the risk of hospitalization or death from cardiovascular disease. Zetia reduces total-C, LDL-C, Apo B, non-HDL-C, and TG, and increases HDL-C in patients with hyperlipidemia. In this multicenter, double-blind, placebo-controlled, 8-week trial, 37 patients with homozygous sitosterolemia with elevated plasma sitosterol levels (>5 mg/dL) on their current therapeutic regimen (diet, bile-acid-binding resins, statins, ileal bypass surgery and/or LDL apheresis), were randomized to receive Zetia (n=30) or placebo (n=7). 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%). Important information. You should refer to the prescribing information for Zetia for a complete list of interactions. Uses for Zetia Intestinal cholesterol is derived primarily from cholesterol secreted in the bile and from dietary cholesterol. For more information about cholesterol, see the "What should I know about high cholesterol?" It is not known if Zetia is safe and effective in children younger than 10 years of age. The empirical formula is C24H21F2NO3. Protect from moisture. When given with simvastatin in patients with moderate to severe renal impairment (estimated glomerular filtration rate <60 mL/min/1.73 m2), doses of simvastatin exceeding 20 mg should be used with caution and close monitoring [see Use in Specific Populations (8.6)]. 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. The mean baseline LDL-C value was 225 mg/dL (range: 161–351 mg/dL) in the Zetia coadministered with simvastatin group compared to 219 mg/dL (range: 149–336 mg/dL) in the simvastatin monotherapy group. Subscribe to newsletters for the latest medication news, new drug approvals, alerts and updates. Patient Information about Zetia (zĕt´-ē-ă) Overview; Side Effects; Dosage; FAQ; Professional; Tips; Interactions; More; Commonly used brand name(s) In the U.S. Zetia; Available Dosage Forms: Tablet; Therapeutic Class: Antihyperlipidemic. Zetia has a well-documented safety profile. 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. Also, Zetia has not been studied in patients younger than 10 years of age or in pre-menarchal girls. Zetia does not cause weight loss or weight gain. It belongs to a class of drugs called cholesterol absorption inhibitors. 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. If you have active liver disease, do not take Zetia while taking cholesterol-lowering medicines called statins.

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