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. Treatment with Ezetrol is not recommended in patients with moderate (Child-Pugh score 7 to 9) or severe (Child-Pugh score > 9) liver dysfunction (see sections 4.4 and 5.2). It can seriously over time. 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). This includes any possible side effects not listed in this leaflet. These measures will help protect the environment. Prior to the hospitalisation for the qualifying ACS event, 34% of the patients were on statin therapy. Pregnancy & lactation. Ezetimibe is usually only taken once per day and you can take it with or without food. Efficacy and safety of Ezetrol in patients 6 to10 years of age with heterozygous familial or non-familial hypercholesterolaemia have been evaluated in a 12-week placebo-controlled clinical trial. Concomitant administration of ezetimibe (10 mg once daily) had no significant effect on bioavailability of warfarin and prothrombin time in a study of twelve healthy adult males. USP 75 mg and 150 mg to the March 3, 2023 -- Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. Ezetimibe had no effect on the fertility of male or female rats, nor was it found to be teratogenic in rats or rabbits, nor did it affect prenatal or postnatal development. How does this medication work? Speak to your doctor about how any drug interactions are being managed or should be managed. The co-administration of ezetimibe with lovastatin resulted in embryolethal effects. Children <6 years: The safety and efficacy of Ezetimibe in children aged < 6 years has not been established. No dosage adjustment is necessary for renally impaired patients. The key secondary endpoints were composites of subsets of the primary endpoint event categories. Mean maximum plasma concentrations (Cmax) occur within 1 to 2 hours for ezetimibe-glucuronide and 4 to 12 hours for ezetimibe. It is not known whether ezetimibe is excreted into human breast milk. Ezetrol is in a new class of lipid-lowering compounds that selectively inhibit the intestinal absorption of cholesterol and related plant sterols. Ezetrol significantly lowered the two major plant sterols, sitosterol and campesterol, by 21% and 24% from baseline, respectively. When Ezetrol is co-administered with a statin, please refer to the SPC for that particular medicinal product. Zetia (ezetimibe)is a medicine used to lower levels of total cholesterol and LDL (bad) cholesterol in the blood. The risk of haemorrhagic stroke for ezetimibe coadministered with higher potency statins in long-term outcome studies has not been evaluated. It is used for patients who cannot control their cholesterol levels by cholesterol lowering diet alone. Some of the toxic effects were more pronounced than observed during treatment with statins alone. Do not throw away any medicines via wastewater or household waste. If cholelithiasis is suspected in a patient receiving Ezetrol and fenofibrate, gallbladder investigations are indicated and this therapy should be discontinued (see sections 4.5 and 4.8). Each tablet contains 10 mg ezetimibe. Pharmacotherapeutic group: Other lipid modifying agents, ATC code: C10A X09. A double-blind, randomised, 12-week study enrolled 50 patients with a clinical and/or genotypic diagnosis of HoFH, who were receiving atorvastatin or simvastatin (40 mg) with or without concomitant LDL apheresis. With ezetimibe 10 mg in combination with simvastatin 80 mg or simvastatin 80 mg alone, intima-medial thickening increased by 0.0111 mm and 0.0058 mm, respectively, over the study's 2 year duration (baseline mean carotid IMT 0.68 mm and 0.69 mm respectively. At Week 33, results were consistent with those at Week 6 and significantly more patients receiving Ezetrol and 40 mg simvastatin (62%) attained the NCEP AAP ideal goal (< 2.8 mmol/L [110 mg/dL]) for LDL-C compared to those receiving 40 mg simvastatin (25%). When suggestions are available use up and down arrows to review and ENTER to select. Pregnancy:This medication should not be used during pregnancy unless the benefits outweigh the risks. It can be used by itself or with other medicines to treat high cholesterol, and is used alongside a diet and exercise plan. Ezetimibe is not recommended for children less than 10 years of age. Smoothie. A series of preclinical studies was performed to determine the selectivity of ezetimibe for inhibiting cholesterol absorption. Reported adverse experiences have not been serious. You should not use a statin with ezetimibe if you are pregnant, trying to become pregnant or are breastfeeding. Additionally, when used with a statin, the following side effects were reported: Common: elevations in some laboratory blood tests of liver function (transaminases); headache; muscle pain, tenderness or weakness. Check with your doctor as soon as possible if any of the following side effects occur: Stop taking the medication and seek immediate medical attention if any of the following occur: Some people may experience side effects other than those listed. Below is a text only representation of the Patient Information Leaflet (ePIL). It allows continued monitoring of the benefit/risk balance of the medicinal product. Results for the two treatment groups were similar for TG and HDL-C (-6% vs. +8%, and +2% vs. +1%, respectively). Last updated on Jul 1, 2021. There were no lipid entry criteria. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. In addition, Ezetrol, added to on-going statin therapy, significantly decreased total-C, Apo B, TG and increased HDL-C, compared with placebo. Date of revision of the text 6. 1. 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). This is calledpancreatitis. Low blood pressure warning: This drug can cause very low blood. Date of first authorisation/renewal of the authorisation 10. The expiry date refers to the last day of that month. About ezetimibe. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Very common (may affect more than 1 of 10 patients), Common (may affect up to 1 of 10 patients), Uncommon (may affect up to 1 of 100 patients), Rare (may affect up to 1 of 1,000 patients). 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. If you become pregnant while taking this medication, contact your doctor immediately. The first look at the 'middle aged Love Island' set has been released, which has already been nicknamed the 'Viagra House' by locals after single parents searched for love If this combination is used, your liver function should be monitored by your doctor. Issues Voluntary Nationwide Recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity, Pharmedica USA LLC Issues Voluntary Worldwide Recall of Purely Soothing 15% MSM Drops Due to Non-Sterility, Global Pharma Healthcare Issues Voluntary Nationwide Recall of Delsam Pharma Artificial Eye Ointment Due to Possible Microbial Contamination, nanoMaterials Discovery Corporation Issues Voluntary Nationwide Recall of its Alcohol Antiseptic 80% Alcohol Solution, Volt Candy Issues Voluntary Nationwide Recall of PrimeZen Black 6000 Capsules Due to Presence of Sildenafil and Tadalafil, Infants at Risk for Aluminum Toxicity with Unapproved Potassium Phosphates Drug Product, Public Notification: Alfia Weight Loss Capsules Contain Hidden Drug Ingredient, FDA Warns Consumers Not to Purchase or Use EzriCare Artificial Tears Due to Potential Contamination, IBSA Pharma Inc. Issues Voluntary Nationwide Recall of Select Lots of Tirosint-Sol (levothyroxine sodium) Oral Solution Due to Subpotency, Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene UPDATED, Spectrum Laboratory Products, Inc. Issues Voluntary Worldwide Recall of Epinephrine (L-Adrenaline) USP Bulk Active Pharmaceutical Ingredient (API) Due to Discoloration of Product. Ezetrol co-administered with an HMG-CoA reductase inhibitor (statin) is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia who are not appropriately controlled with a statin alone. No dosage adjustment is necessary for patients with mild hepatic impairment. Check with your doctor if you notice any symptom that worries you while you are taking this medication. In a study of eight post-renal transplant patients with creatinine clearance of > 50 mL/min on a stable dose of ciclosporin, a single 10-mg dose of Ezetrol resulted in a 3.4-fold (range 2.3- to 7.9-fold) increase in the mean AUC for total ezetimibe compared to a healthy control population, receiving ezetimibe alone, from another study (n = 17). The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium, sodium laurilsulfate, magnesium stearate. Additionally, the following side effects have been reported in general use: dizziness; muscle aches; liver problems; allergic reactions including rash and hives; raised red rash, sometimes with target-shaped lesions (erythema multiforme); muscle pain, tenderness or weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); inflammation of the pancreas often with severe abdominal pain; constipation, reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopaenia); tingling sensation; depression: unusual tiredness or weakness; shortness of breath. 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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. Patients with Coronary Heart Disease and ACS Event History. The co-administration of ezetimibe and statins was not teratogenic in rats. - ezetrol more drug_warnings_recalls My mother has too many problems and have done some research on this point. View Vitamin B12 disease interactions (4) Medications known to interact with Vitamin B12 Note: Showing generic names only. Ezetrol administered alone or co-administered with a statin: The following adverse reactions were observed in patients treated with Ezetrol (n = 2396) and at a greater incidence than placebo (n = 1159) or in patients treated with Ezetrol coadministered with a statin (n = 11308) and at a greater incidence than statin administered alone (n = 9361). Approximately 78% and 11% of the administered radioactivity were recovered in the faeces and urine, respectively, over a 10-day collection period. Long-term carcinogenicity tests on ezetimibe were negative. 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. The significance of these data for humans is not known. a hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood. At week 12, Ezetrol significantly reduced total-C (-21% vs. 0%), LDL-C (-28% vs. -1%), Apo-B (-22% vs. -1%), and non-HDL-C (-26% vs. 0%) compared to placebo. A recall is a voluntary action taken by a company at any time to remove a defective . This study was not designed to compare treatment groups for infrequent events. There was no excess of myopathy or rhabdomyolysis associated with Ezetrol compared with the relevant control arm (placebo or statin alone) (see section 4.4). You can take it with or without food. EZETROL lowers levels of total cholesterol, bad cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Do not take EZETROL together with a statin if: 6. Ciclosporin concentrations should be monitored in patients receiving Ezetrol and ciclosporin (see section 4.5). 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. In a couple of weeks, rock overlords Queens Of The Stone Age will return with their new album In Times New Roman; we've already posted the singles "Emotion Sickness" and "Carnavoyeur Tell your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding before starting ezetimibe treatment. Ezetimibe can cause the breakdown of muscle tissue, which can rarely lead to kidney failure. 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 or 6), compared to healthy subjects. Adverse reactions were usually mild and transient. No such interactions occurred in the clinical studies. The IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) was a multicenter, randomised, double-blind, active-control study of 18,144 patients enrolled within 10 days of hospitalisation for acute coronary syndrome (ACS; either acute myocardial infarction [MI] or unstable angina [UA]). No clinical data are available on the use of Ezetrol during pregnancy. 10 mg once daily. At Week 6, Ezetrol co-administered with simvastatin (all doses) significantly reduced total-C (38% vs 26%), LDL-C (49% vs 34%), Apo B (39% vs 27%), and non-HDL-C (47% vs 33%) compared to simvastatin (all doses) alone. Post-marketing Adverse reactions were derived from reports containing Ezetrol either administered alone or with a statin. Fibrates may increase cholesterol excretion into the bile, leading to cholelithiasis. However, rhabdomyolysis has been reported very rarely with Ezetrol monotherapy and very rarely with the addition of Ezetrol to other agents known to be associated with increased risk of rhabdomyolysis. The product code (s) for this leaflet is: PL 19945/0001. Do not take a double dose to make up for a missed one. White to off-white, capsule-shaped tablets, approximately 2.60 mm thick, debossed with 414 on one side. Risk for skeletal muscle toxicity increases with higher doses of statin, advanced age (>65), hypothyroidism, renal impairment, and depending on the . Some patients were receiving other treatments (e.g. Generic name: sildenafil citrate Dosage form: tablet, film coated Drug class: Impotence agents Medically reviewed by Drugs.com. On May 30, 2023, the FDA posted information about medications containing semaglutide marketed for type 2 diabetes or weight loss. To address continuing concerns of misuse, abuse, addiction, and overdose of prescription stimulants, the U.S. Food and May 4, 2023 -- Family Dollar is initiating a voluntary retail level product recall of certain over-the-counter drug products regulated by the U.S. Food and May 1, 2023 -- FDA is warning consumers to not purchase or use Nose Slap and Soul Slap products, which are unapproved drugs marketed to promote alertness and April 27, 2023, Parsippany, NJ -- Teva Pharmaceuticals USA, has initiated a voluntary nationwide recall of specific lots of various strengths of Fentanyl April 27, 2023 -- TruVision Health LLC is recalling the dietary supplement products listed below because they contain the unapproved dietary ingredients April 26, 2023 Gurnee, IL, Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. Aortic valve replacement was performed in 267 patients (28.3%) in the ezetimibe / simvastatin group and in 278 patients (29.9%) in the placebo group (hazard ratio, 1.00; 95% CI, 0.84 to 1.18; p = 0.97). Older patients may have a greater risk for liver or kidney impairment or other factors that may impact ezetimibe safety. These measures will protect the product from moisture. Uncommon: elevations in some laboratory blood tests of liver (transaminases) or muscle (CK) function; cough; indigestion; heartburn; nausea; joint pain; muscle spasms; neck pain; decreased appetite, pain, chest pain, hot flush; high blood pressure. The safety and efficacy of the combined use of EZETROL and certain cholesterol lowering medicines, the fibrates have not been established. This includes any possible side effects not listed in this leaflet. Queens of the Stone Age will bring Phantogram, Viagra Boys, the Armed, and Savages' Jehnny Beth along for the ride on their fall North American tour, which will begin Aug. 3 in Sterling Heights, Mi. Ezetimibe crossed the placental barrier in pregnant rats and rabbits given multiple doses of 1000 mg/kg/day. If your doctor has recommended a dose different from the one above,do not change the way that you are taking the medication without consulting your doctor. The corresponding LDL-C reductions were significantly different (25% and 4% for Ezetrol versus placebo, respectively). You should stay on your cholesterol lowering diet while taking this medicine. Also tell them about any supplements you take. Ask your doctor or pharmacist for advice before taking any medicine. In the Study of Heart and Renal Protection (SHARP) (see section 5.1), involving over 9000 patients treated with a fixed dose combination of Ezetrol 10 mg with simvastatin 20 mg daily (n = 4650) or placebo (n = 4620), the safety profiles were comparable during a median follow-up period of 4.9 years. Unit dose push-through blisters of clear polychlorotrifluoroethylene/PVC coated aluminium in packs of 50, 100 or 300 tablets. For incremental cardiovascular event reduction in patients with coronary heart disease and ACS event history, Ezetrol 10 mg may be administered with a statin with proven cardiovascular benefit. Will I have the same side effects? Uses. Will I Have The Same Side Effects? Npoje s vysokm obsahom antioxidantov, ako s vitamny C a E, preukzatene zlepuj erektiln funkciu tm, e brnia pokodeniu buniek, produkujcich oxid dusnat," hovor Pearlmanov. Side effects. How to store EZETROL It is important to take this medication exactly as prescribed by your doctor. 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