Olivier, J. L. Anaphylactic reaction to inulin: first identification of specific IgEs to an inulin protein compound. Insert the spike end of an infusion set through the same puncture site created by the transfer device in the stopper of the vial of reconstituted Activase. Peel the clear plastic hanger from the vial label. Hang the Activase vial from the resulting loop. Coagulation tests and measures of fibrinolytic activity may be unreliable during Activase therapy, unless specific precautions are taken to prevent in vitro artifacts. When present in blood at pharmacologic concentrations, Activase remains active under in vitro conditions, which can result in degradation of fibrinogen in blood samples removed for analysis.
Simvastatin acid is a substrate of the transport protein OATP1B1. Concomitant administration of medicinal products that are inhibitors of the transport protein OATP1B1 may lead to increased plasma concentrations of simvastatin acid and an increased risk of myopathy. These data do not include patients treated with the Activase accelerated infusion. HeFH were randomized to receive either ezetimibe coadministered with simvastatin or simvastatin monotherapy.
Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. All patients recovered without sequelae. Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high cholesterol or triglycerides do not feel sick.
LDL apheresis in these patients or if such treatments are unavailable. In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism underactive thyroid. You may also be more likely to develop this condition if you are of Chinese descent and you take high-dose ezetimibe and simvastatin while also taking medication that contains niacin Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others. James H. Stein, MD, co-chairman of the cardiology meeting and associate professor of medicine at the University of Wisconsin Medical School in Madison, says the findings are a wake-up call.
Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. You may need to take ezetimibe and simvastatin on a long-term basis for the treatment of high cholesterol. You may need to stop using simvastatin for a short time if you have surgery or a medical emergency. This drug is more popular than comparable drugs. It is available in generic and brand versions. Lab tests, including blood cholesterol levels, liver function, and creatine phosphokinase CPK blood levels, may be performed while you take Vytorin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Chagnon JP, Cerf M "Simvastatin-induced protein-losing enteropathy. Contact your doctor or health care provider right away if any of these apply to you. How should I take ezetimibe and simvastatin Vytorin?
You should not take ezetimibe and simvastatin if you are allergic to it, if you have liver disease, or if you are pregnant or breast-feeding. Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Resources for HEALTHCARE PROFESSIONALS ONLY. In extensive cases, systemic corticosteroids those taken in pill or other form to affect your body are used, though not continuously since they can cause significant side effects like bone thinning. But short-term " therapy" often has good results. Approximately 78% and 11% of the administered radioactivity were recovered in the feces and urine, respectively, over a 10-day collection period. Ezetimibe was the major component in feces and accounted for 69% of the administered dose, while ezetimibe-glucuronide was the major component in urine and accounted for 9% of the administered dose. Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Initiate treatment as soon as possible but within 3 hours after symptom onset. Streptokinase plus heparin regimen. NDC 66582-311-82 bottles of 1000 If repackaged in blisters, then opaque or light-resistant blisters should be used. Vials DO NOT USE IF VACUUM IS NOT PRESENT. Patients with these conditions may be at risk for muscle or kidney problems.
The availability of the β-hydroxyacid to the systemic circulation following an oral dose of simvastatin was found to be less than 5% of the dose, consistent with extensive hepatic first-pass extraction. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not take ezetimibe and simvastatin if you are pregnant. Stop taking this medication and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking ezetimibe and simvastatin. After oral administration, ezetimibe is absorbed and extensively conjugated to a pharmacologically active phenolic glucuronide ezetimibe-glucuronide. Heckers H, Dittmar K, Schmahl FW, et al. Inefficiency of cynarin as therapeutic regimen in familial type II hyperlipoproteinaemia. What are the ingredients in Vytorin? In a rat model, where the glucuronide metabolite of ezetimibe ezetimibe-glucuronide was administered intraduodenally, the metabolite was as potent as ezetimibe in inhibiting the absorption of cholesterol, suggesting that the glucuronide metabolite had activity similar to the parent drug. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims. No clinically significant pharmacokinetic interaction was seen when ezetimibe was coadministered with simvastatin. No specific pharmacokinetic drug interaction studies with Vytorin have been conducted other than the following study with NIASPAN Niacin extended-release tablets. Vytorin is to be used only by the patient for whom it is prescribed. Do not share it with other people. This Patient Information summarizes the most important information about Vytorin. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Vytorin that is written for health professionals. It works by blocking an enzyme that is necessary for your body to make cholesterol. Lowering cholesterol levels in the blood reduces the chance of heart disease, heart attacks, and strokes. Vytorin has not been shown to reduce heart attacks or strokes more than simvastatin alone. HMG-CoA reductase inhibitory activity increases the risk of myopathy and rhabdomyolysis, particularly with higher doses of Vytorin. Keep out of the reach of children.
Simvastatin occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase above ten times the upper limit of normal ULN. Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. The risk of myopathy is increased by high levels of statin activity in plasma. If these rare effects occur, talk to your doctor. Ezetimibe and simvastatin may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking ezetimibe and simvastatin. Many of the patients who have developed rhabdomyolysis on therapy with simvastatin have had complicated medical histories, including renal insufficiency usually as a consequence of long-standing diabetes mellitus. Such patients taking Vytorin merit closer monitoring. Rudski L, Rabinovitch MA, Danoff D "Systemic immune reactions to HMG-CoA reductase inhibitors - Report of 4 cases and review of the literature.
In this limited controlled study, there was no significant effect on growth or sexual maturation in the adolescent boys or girls, or on menstrual cycle length in girls. It is possible that some side effects of Vytorin may not have been reported. AA can affect men, women, and children. It often appears as well-defined circular bald patches on the scalp. Many people will get just one or two patches, but for some the hair loss can be extensive. Unfortunately, children who develop AA before puberty are most likely to develop more extensive and persistent hair loss. Use and dose must be determined by your doctor. Adzet T. Action of an artichoke extract against carbon tetrachloride-induced hepatotoxicity in rats. Taking Vytorin with certain other medicines may affect each other causing side effects. Vytorin may affect the way other medicines work, and other medicines may affect how Vytorin works. Orsi A, Sherman O, Woldeselassie "Simvastatin-associated memory loss. If serious bleeding occurs, terminate the Activase infusion. Institute parenteral anticoagulation near the end of or immediately following the Activase infusion when the partial thromboplastin time or thrombin time returns to twice normal or less. In rat studies, exposure to ezetimibe in nursing pups was up to half of that observed in maternal plasma. It is not known whether ezetimibe or simvastatin are excreted into human breast milk. All patients received 160 mg chewable aspirin administered as soon as possible, followed by 160-325 mg daily. Some medical conditions may interact with Vytorin. The information on this page is not a substitute for the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that a drug or drug combination is safe, effective or appropriate for any given patient. Drugs. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Treating high cholesterol along with a cholesterol-lowering diet. It may also be used for other conditions as determined by your doctor. The mechanism of interaction is unknown. There are 1417 other drugs known to interact with amlodipine ingredient of exforge There are 60 other drugs known to interact with ezetimibe ingredient of vytorin. There are 381 other drugs known to interact with simvastatin ingredient of vytorin. There are 751 other drugs known to interact with valsartan ingredient of exforge. Your doctor would normally be conversant with these details. Weiland HH, Kindler K, Kranzl Ch, and et al. Uber den Einfluss von Cynarin auf Hyperlipidamien unter besonderer Berucksichtigung des Typs II Hypercholesterinamie. The opinions expressed in WebMD User-generated content areas like communities, reviews, ratings, or blogs are solely those of the User, who may or may not have medical or scientific training. These opinions do not represent the opinions of WebMD. User-generated content areas are not reviewed by a WebMD physician or any member of the WebMD editorial staff for accuracy, balance, objectivity, or any other reason except for compliance with our Terms and Conditions. If you also take a bile acid sequestrant eg, cholestyramine, colestipol, colesevelam do not take it within 4 hours before or 2 hours after taking Vytorin. Check with your doctor if you have questions. Vytorin has been approved by the FDA. Intention-to-treat analysis on all SHARP patients ever allocated to Vytorin or placebo. Inegy throughout the following leaflet. Your doctor should do fasting blood tests to check your cholesterol while you take Vytorin. Your doctor may change your dose of Vytorin if needed. How should I store Vytorin? Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ezetimibe and simvastatin combination in the elderly. However, elderly patients are more likely to have age-related muscle problems, which may require caution in patients receiving ezetimibe and simvastatin combination. It is not known whether simvastatin is excreted in human milk. Because a small amount of another drug in this class is excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women taking simvastatin should not nurse their infants. Women who are breastfeeding should be advised to not use Vytorin. Patients who have a lipid disorder and are breastfeeding should be advised to discuss the options with their healthcare professional.
In other patients, elevations in liver function tests were transient and returned to normal with continued simvastatin therapy. Invert the two vials so that the vial of Activase is on the bottom upright and the vial of SWFI is upside-down, allowing the SWFI to flow down through the transfer device. Possibility of causal treatment of bile duct diseases with an artichoke preparation. This may not be a complete list of all interactions that may occur. Ask your health care provider if Vytorin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine. Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents generally will be coded AB if a study is submitted demonstrating bioequivalence. This medicine is available only with your doctor's prescription. Vytorin has not been shown to reduce heart attacks or strokes more than simvastatin alone. ChoquetKastylevsky G, Kanitakis J, Dumas V, Descotes J, Faure M, Claudy A "Eosinophilic fasciitis and simvastatin. All patients starting therapy with Vytorin or whose dose of Vytorin is being increased should be advised of the risk of myopathy, including rhabdomyolysis, and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing Vytorin. Vytorin therapy should be discontinued immediately if myopathy is diagnosed or suspected. In most cases, muscle symptoms and CK increases resolved when simvastatin treatment was promptly discontinued. Periodic CK determinations may be considered in patients starting therapy with Vytorin or whose dose is being increased, but there is no assurance that such monitoring will prevent myopathy. Tell your doctor about all the medicines you take, including any prescription and nonprescription medicines, vitamins, and herbal supplements. When used together with higher doses of simvastatin, these medicines may increase your risk of muscle injury and could result in kidney problems. Take Inegy in the evening. You can take it with or without food. Vytorin doses increased HDL-C significantly more than the corresponding milligram-equivalent statin dose of atorvastatin. The effects of Vytorin on TG were similar to the effects seen with atorvastatin.
AUC 0-24hr for total ezetimibe. There were no statistically significant increases in tumor incidences in drug-treated rats or mice. Adam G and Kluthe R. Cholesterinsenkender Effect von Cynarin. Vytorin is administered in oral tablet form in the evenings once per day. Numerous other drugs may interact with Vytorin. Our Vytorin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Marakis G, Walker AF, Middleton RW, et al. Artichoke leaf extract reduces mild dyspepsia in an open study. COOR6; R6, R7 and R8 are H, lower alkyl or aryl-substituted Ic R9 is lower alkyl, aryl or aryl-substituted lower alkyl; are disclosed, as well as a method of lowering serum cholesterol by administering said compounds, alone or in combination with a cholesterol biosynthesis inhibitor, pharmaceutical compositions containing them; and a process for preparing them.
People with just one or two patches of AA often have a full and spontaneous recovery within two years whether or not they receive treatment. However, about 30% of individuals find the condition persists and becomes more extensive, or they have repeated cycles of hair loss and re-growth. Kraft K. Artichoke leaf extract- recent findings reflecting effects on lipid metabolism, liver and gastrointestinal tracts. Both simvastatin and its β-hydroxyacid metabolite are highly bound approximately 95% to human plasma proteins. When radiolabeled simvastatin was administered to rats, simvastatin-derived radioactivity crossed the blood-brain barrier. Ask your healthcare professional how you should dispose of any medicine you do not use. Simvastatin", "medicare_seo_page": "Medicare coverage and pricing details for Vytorin. Learn more about Medicare prescription drug plans and savings with GoodRx. Concomitant food administration high-fat or non-fat meals had no effect on the extent of absorption of ezetimibe when administered as 10-mg tablets. The C max value of ezetimibe was increased by 38% with consumption of high-fat meals. ULN occurred in two 2% individuals in the ezetimibe coadministered with simvastatin group and in zero individuals in the simvastatin monotherapy group. But when the participants on stopped their medication, both CRP and LDL "bad" cholesterol shot up to pretreatment levels. Cyclosporine or Danazol: The risk of myopathy, including rhabdomyolysis is increased by concomitant administration of cyclosporine or danazol. As your body gets used to the medicine these side effects may disappear.
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What is the most important information I should know about ezetimibe and simvastatin Vytorin? Use only the accompanying Sterile Water for Injection SWFI USP without preservatives. Do not use Bacteriostatic Water for Injection, USP. All patients starting therapy with Vytorin should be advised of the risk of myopathy, including rhabdomyolysis, and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing Vytorin. In clinical studies in patients with AIS Studies 1 and 2 the incidence of intracranial hemorrhage, especially symptomatic intracranial hemorrhage, was higher in Activase-treated patients than in placebo patients.
Gaist D, Jeppesen U, Andersen M, Garcia Rodriguez LA, Hallas J, Sindrup SH "Statins and risk of polyneuropathy: a case-control study. Koldziej, B. Protective properties of artichoke Cynara scolymus against oxidative stress induced in cultured endothelial cells and monocytes. Life Sci. Ezetimibe and simvastatin is usually taken once daily in the evening, with or without food. Your doctor may occasionally change your dose to make sure you get the best results.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Fatal cases of hemorrhage associated with traumatic intubation in patients administered Activase have been reported. Vytorin should be used with extreme caution in CHILDREN younger than 10 years old; safety and effectiveness in these children have not been confirmed.
Limitation of Use: The risk of stroke may outweigh the benefit produced by thrombolytic therapy in patients whose AMI puts them at low risk for death or heart failure. Inegy is not expected to interfere with your ability to drive or to use machinery. The risk of myopathy, including rhabdomyolysis, is greater in patients on simvastatin 80 mg compared with other statin therapies with similar or greater LDL-C-lowering efficacy and compared with lower doses of simvastatin.