New prescribing recommendations for simvastatin june 2011. Mrk, known as msd outside the united states and canada, announced today that the u. Bidil is indicated for the treatment of heart failure as an adjunct to standard therapy in selfidentified black patients to improve. Only your doctor can determine if vytorin is right for you. Vytorin is a combination of ezetimibe and simvastatin that is used for treating high levels of cholesterol in the blood. Ezetimibesimvastatin vytorin treatment national hiv. Full prescribing information 1 indications and usage yosprala, a combination of aspirin and omeprazole, is indicated for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are. Selected cautionary information about vytorin ezetimibe and. Rytary carbidopa and levodopa extendedrelease capsules, for oral use initial u. Highlights of prescribing information these highlights do not include all the information needed to use zetia safely and effectively.
Merck receives complete response letter from the u. The information on this site is intended for health care professionals in the united states and is not intended for the general public. Highlights of prescribing information these highlights do. If you would like more information, talk with your doctor. Vytorin ezetimibe and simvastatin tablets, for oral use. Ezetimibesimvastatin marketed as vytorin information fda. These highlights do not include all the information needed. Vytorin is a combination of two different types of cholesterollowering drugs. Until further information is available, healthcare professionals and caregivers should continue to monitor patients taking vytorin as outlined in the prescribing information. Prescribing information, clinical studies, and slide decks all materials are available for download in their original formats as pdf or powerpoint. Vytorin is a prescription medicine that contains 2 cholesterol lowering medicines. See full prescribing information for coartem tablets. This site is intended only for residents of the united states, its territories, and puerto rico.
The physician prescribing information also is available. Vytorin reduces total cholesterol and low density lipoprotein ldl or bad cholesterol while it increases high density lipoprotein hdl or good cholesterol. Vytorin is used together with a lowfat diet and other treatments to lower total cholesterol in adults and children who are at least 10 years old. Patient information vytorin vitorin ezetimibe and simvastatin. Vytorin ezetimibesimvastatin drug medicine information. Highlights of prescribing information these highlights do not include all the information needed to use vytorin safely and effectively. Replace the system after 5 years if continued use is desired. Nitrostat is a nitrate vasodilator indicated for relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. Full prescribing information 1 indications and usage kyleena is indicated to prevent pregnancy for up to 5 years. The ezetimibe component of vytorin lowers blood cholesterol by blocking the absorption of. See full prescribing information for nitrostat nitrostat nitroglycerin sublingual tablet initial u.
Vytorin should be restricted to patients who have been taking vytorin 1080 mg for 12 months or more without evidence of muscle toxicity 1080 mg po qd. All other brand or product names are trademarks or registered marks of their respective owners. Fda rejects proposed chronic kidney disease indication for vytorin. Vytorin prescribing information whitehouse station, nj. Vytorin ezetimibesimvastatin firsttime generic professionals. Vytorin should not be combined with drugs that decrease its elimination, such as erythromycin, ketoconazole, itraconazole, and clarithromycin. Cases of myopathy, including rhabdomyolysis, have been reported with simvastatin coadministered with colchicine, and caution should be used when prescribing vytorin with colchicine. For current information on vytorin, please see simvastatin information. In patients with ckd and gfr pdr drug summaries are concise pointofcare prescribing, dosing and administering information to help phsyicans more efficiently and accurately prescribe in their practice pdr s drug summaries are available free of charge and serve as a great resource for us based mds, dos, nps and pas in patient practice. Prescribing information ezetimibesimvastatin marketed as vytorin contact fda. Spach, md principal investigator mountain west aetc professor of medicine division of infectious diseases.
A search of a drug database and the prescribing information for vytorin, shows that it is not likely to affect blood glucose sugar control. Ezetimibesimvastatin marketed as vytorin information. Highlights of prescribing information these highlights do not include all the information needed to use rytary safely and effectively. Fda rejects proposed chronic kidney disease indication for.
Ezetimibe simvastatin vytorin use during pregnancy. Vytorin should not be taken by pregnant women or nursing mothers. Highlights of prescribing information these highlights do not include all the information needed to use coartem tablets safely and effectively. View vytorin storage conditions for details to ensure optimal shelflife. This leaflet answers some common questions about vytorin.
Please read warnings and precautions in the prescribing information for additional information. Full prescribing information 1 indications and usage mayzent is indicated for the treatment of relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults. Highlights of prescribing information these highlights do not include all the information needed to use viibryd safely and effectively. You may print out the form and fill it out by hand using a black ballpoint pen. Highlights of prescribing information vytorin safely and effectively. Highlights of prescribing information skeletal muscle. Both the physicianprescriber and the patient must sign. Description view vytorin description for details of the chemical structure and excipients inactive components. It does not take the place of talking to your doctor or pharmacist. Ezetimibesimvastatin vytorin contains ezetimibe, a selective inhibitor of. This information does not take the place of talking with your doctor about your medical condition or your treatment. Prescribing information ezetimibesimvastatin marketed as vytorin consumer information.
Take the completed application to your physicianprescriber. Vytorin is not indicated to reduce major cardiovascular events in patients with chronic kidney disease. The addition or withdrawal of these agents in patients on phenytoin therapy may require an adjustment of the phenytoin dose to achieve optimal clinical outcome. See full prescribing information lowering treatments. Highlights of prescribing information these highlights. Vytorin is available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of. Dosing of vytorin in patients with renal impairmentckd. New prescribing recommendations for simvastatin june 2011 by janelle sheen, pharm. The fda urges both healthcare professionals and patients to report side effects from the use of vytorin to. Use caution when prescribing vytorin with a fenofibrate, and immediately discontinue both drugs if myopathy is diagnosed or suspected. Please read the accompanying patient information for vytorin and discuss it with your doctor. Vytorin ezetimibe and simvastatin tablets, for oral use initial u. It is not known whether this medicine reduces your risk of heart disease.
Viibryd vilazodone hydrochloride tablets, for oral use initial u. You can ask your pharmacist or doctor for information about vytorin that is written for health professionals. You should not use vytorin if you have active liver disease or abnormal liver function tests. These highlights do not include all the information needed to use vytorin safely and effectively. Highlights of prescribing information macular edema. This patient information summarizes the most important information about vytorin. These highlights do not include all the information needed to use mavenclad safely and effectively. The prescribing information for vytorin currently states that no incremental benefit of vytorin on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication. These highlights do not include all the information needed to use for vytorin. Please see prescribing information for vytorin ezetimibesimvastatin at. Find patient medical information for vytorin 1040 oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings.
1274 1153 627 140 875 362 348 689 1296 856 469 431 712 90 1237 318 1255 808 257 1063 997 62 152 1489 1173 707 570 962 1159 449 560 882 699