Animal studies on the use of ezetimibe in monotherapy have shown no evidence of direct or indirect harmful effects on pregnancy, embryofoetal development, birth or postnatal development (see section 5.3). What will it do for me? Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Keep Ezetrol 10 mg out of the reach of children and away from pets. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. With Viagra, there is a higher risk of vision changes than with Cialis. Most patients who developed rhabdomyolysis were taking a statin concomitantly with Ezetrol. Posted by Giovanni Tea at 11:20 AM. Ezetimibe. Each tablet contains 55 mg of lactose monohydrate. Nevertheless, this study design did not allow for a separate contribution of the monocomponent ezetimibe to efficacy to significantly reduce the risk of major vascular events in patients with CKD. What EZETROL is and what it is used for, 2. The pharmacokinetics of ezetimibe are similar between children 6 years and adults. 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Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750mg/5mL Due to Potential Bacillus Cereus Contamination in the Product, Ascend Laboratories LLC. This leaflet was last revised in November 2022. Patients had an LDL-C 125 mg/dL ( 3.2 mmol/L) at the time of presentation with ACS if they had not been taking lipid-lowering therapy, or 100 mg/dL ( 2.6 mmol/L) if they had been receiving lipid-lowering therapy. Ezetrol is in a new class of lipid-lowering compounds that selectively inhibit the intestinal absorption of cholesterol and related plant sterols. In a multicenter, double-blind, controlled clinical study (ENHANCE), 720 patients with heterozygous familial hypercholesterolaemia were randomised to receive ezetimibe 10 mg in combination with simvastatin 80 mg (n = 357) or simvastatin 80 mg (n = 363) for 2 years. Among statin-treated patients not at LDL-C goal at baseline (~82%), significantly more patients randomised to Ezetrol achieved their LDL-C goal at study endpoint compared to patients randomised to placebo, 72% and 19%, respectively. The incremental low-density lipoprotein cholesterol (LDL-C) reduction due to adding Ezetrol to cholestyramine may be lessened by this interaction (see section 4.2). For further information call emc accessibility on 0800 198 5000 . Qualitative and quantitative composition 3. These measures will help protect the environment. The Simvastatin and Ezetimibe for the Treatment of Aortic Stenosis (SEAS) study was a multi-center, double-blind, placebo-controlled study with a median duration of 4.4 years conducted in 1873 patients with asymptomatic aortic stenosis (AS), documented by Doppler-measured aortic peak flow velocity within the range of 2.5 to 4.0 m/s. Pharmacokinetic data in the paediatric population < 6 years of age are not available. Ezetrol combined with simvastatin significantly reduced the risk of stroke and any revascularisation, with non-significant numerical differences favouring Ezetrol combined with simvastatin for nonfatal MI and cardiac death. 0800 198 5000. Zetia belongs to a class of drugs called Lipid-Lowering Agents, 2-Azetidinones. Enter other medications to view a detailed report. Will I have the same side effects? www.medbroadcast.com/drug/getdrug/Ezetrol, are allergic to ezetimibe or any ingredients of the medication, have active liver disease or unexplained, persistently abnormal tests of liver function and are also taking a "statin" medication for cholesterol (e.g., atorvastatin, pravastatin, simvastatin), persistent muscle pain, aches, or weakness, or brown urine, signs of gallbladder problems (such as sudden, severe abdominal pain, nausea, vomiting), signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen), symptoms of liver damage (such as yellow skin or eyes, dark urine, abdominal pain, severe fatigue, pale stools, or general itchiness), signs of a severe allergic reaction (such as severe rash, swollen face, or difficulty breathing), fibrates (e.g., fenofibrate, gemfibrozil). More common. Ezetimibe is usually only taken once per day and you can take it with or without food. All statins are contraindicated (should never be used) in pregnant and nursing women. All material copyright MediResource Inc. 1996 2023. Common ezetimibe side effects when this medicine is used with a statin may include: Common ezetimibe side effects when this medicine is used alone may include: These side effects were reported to occur in at least 2% of patients in studies (at least 2 out of every 100 patients and greater than placebo or a statin alone). In co-administration trials, the incidence was 1.3% for patients treated with Ezetrol co-administered with a statin and 0.4% for patients treated with a statin alone. Pregnancy & lactation. It lowers cholesterol levels by decreasing the body's ability to absorb cholesterol from the digestive system. Below is a text only representation of the Patient Information Leaflet (ePIL). Nonmedicinal ingredients:croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. On This Page Indications and Usage Dosage and Administration Dosage Forms and Strengths Contraindications Warnings and Precautions Adverse Reactions/Side Effects Drug Interactions Mild side effects may include temporary reactions like: If these side effects do not go away or are concerning to you, contact your doctor right away. Your pharmacist may be able to advise you on managing side effects. Zetia (ezetimibe)is a medicine used to lower levels of total cholesterol and LDL (bad) cholesterol in the blood. The safety and efficacy of Ezetrol administered with fibrates have not been established. Terms and conditions of use. What you need to know before you take EZETROL. Ezetrol is orally active and has a mechanism of action that differs from other classes of cholesterol-reducing compounds (e.g. The safety and efficacy of Ezetrol co-administered with doses of simvastatin above 40 mg daily have not been studied in paediatric patients 10 to 17 years of age. It is not known if Zetia is safe and effective in children younger than 10 years of age. LDL-C reduction and safety profile are comparable between elderly and young subjects treated with Ezetrol. You may need to read it again. Dosage/Direction for Use. These trials were not suited for comparison of rare adverse drug reactions. When Ezetrol is administered with a statin, the dosage instructions for the statin in children should be consulted. You should check with your doctor or pharmacist if you are not sure. Secondary analyses included the same composite analyzed for the full cohort randomised (at study baseline or at year 1) to Ezetrol combined with simvastatin (n = 4650) or placebo (n = 4620) as well as the components of this composite. Smoothie. You should not use a statin with ezetimibe if you are pregnant, trying to become pregnant or are breastfeeding. At one year, the average LDL-C for patients continuing on therapy was 53.2 mg/dL (1.4 mmol/L) for the ezetimibe/simvastatin group and 69.9 mg/dL (1.8 mmol/L) for the simvastatin monotherapy group. Common Mild Serious Other FAQs Ezetimibe (brand name: Zetia) is a prescription medicine that can be used in combination with a statin or fenofibrate to treat high cholesterol. He armed himself with a balaclava, latex gloves, condoms . Patients were randomised 1:1 to receive placebo or co-administered ezetimibe 10 mg and simvastatin 40 mg daily. If you become pregnant while taking this medication, contact your doctor immediately. In a multicentre, double-blind, placebo-controlled, clinical study in patients with mixed hyperlipidaemia, 625 patients were treated for up to 12 weeks and 576 patients for up to 1 year. If you miss a dose of this medication, skip the missed dose and continue with your regular dosing schedule. It may also be used with additional cholesterol-lowering medications known as "statins" or fenofibrate when either therapy alone is not sufficient to reduce cholesterol to desired levels. Fewer patients had ischemic cardiovascular events in the ezetimibe / simvastatin group (n = 148) than in the placebo group (n = 187) (hazard ratio, 0.78; 95% CI, 0.63 to 0.97; p = 0.02), mainly because of the smaller number of patients who underwent coronary artery bypass grafting. The primary endpoint was the composite of major cardiovascular events (MCE) consisting of cardiovascular death, aortic valve replacement (AVR) surgery, congestive heart failure (CHF) as a result of progression of AS, nonfatal myocardial infarction, coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), hospitalisation for unstable angina, and nonhaemorrhagic stroke. there is a problem if you take it ? Corresponding incidence rates for cholecystectomy were 0.6% (0.0, 3.1) and 1.7% (0.6, 4.0) for fenofibrate monotherapy and Ezetrol co-administered with fenofibrate, respectively (see sections 4.4 and 4.5). is voluntarily recalling Dabigatran Etcxilate Capsules. In pregnant rabbits a small number of skeletal deformities (fused thoracic and caudal vertebrae, reduced number of caudal vertebrae) were observed. Ask your doctor or pharmacist for advice before taking any medicine. 3. The incidence of myopathy/rhabdomyolysis was 0.2% in patients treated with Ezetrol combined with simvastatin and 0.1% in patients treated with placebo. Ezetrol significantly lowered the two major plant sterols, sitosterol and campesterol, by 21% and 24% from baseline, respectively. In connection with that filing, the company ISSUE:The FDA is requiring several updates to the prescribing information for both immediate-release (IR) and extended release/long acting (ER/LA) opioid pain Purpose: To inform the public, including patients and health care practitioners, that manufacturers are marketing and distributing amniotic fluid eyedrops to March 31, 2023 Piscataway, NJ, Camber Pharmaceuticals, Inc. is voluntarily recalling lot # E220182 of Atovaquone Oral Suspension, USP 750mg/5mL to the March 22, 2023 - Parsippany. Studies on rats have shown that ezetimibe is secreted into breast milk. LDL-C reduction and safety profile are comparable between men and women treated with Ezetrol. Drug class: cholesterol absorption inhibitors, Cold symptoms such as stuffy nose, sneezing, sore throat (3.7%), Severe muscle damage, muscle pain or weakness (rhabdomyolysis, myopathy), Liver damage or increases in liver enzyme levels, Gallstones; inflammation of the gallbladder, Serious skin reactions (Erythema Multiforme). Patients may also receive adjunctive treatments (e.g. Minimal oxidative metabolism (a phase I reaction) has been observed in all species evaluated. There were no elevations of CPK ( 10 X ULN). No comments: Post a Comment. When used alone, the following side effects were reported: Common: abdominal pain; diarrhoea; flatulence; feeling tired. All patients starting therapy with Ezetrol should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness (see section 4.8). Do not give this medication to anyone else, even if they have the same symptoms as you do. 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