The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims. The interaction of Activase with other cardioactive or cerebroactive drugs has not been studied. Anticoagulants and antiplatelet drugs increase the risk of bleeding if administered prior to, during, or after Activase therapy.
Combination of these drugs with Vytorin is contraindicated. If short-term treatment with strong CYP3A4 inhibitors is unavoidable, therapy with Vytorin must be suspended during the course of treatment. 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.
Food and Drug Administration. 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. Initiate treatment as soon as possible but within 3 hours after symptom onset. HMG-CoA reductase inhibitory activity increases the risk of myopathy and rhabdomyolysis, particularly with higher doses of Vytorin. These data do not include patients treated with the Activase accelerated infusion.
Its regulatory action on blood cholesterol and on blood lipoproteins in human atherosclerotic disease. Keep Vytorin and all medicines out of the reach of children. Yurdakok M, Gurakan B, Ergin H, Kirazli S "Plasma concentrations of granulocyte colony stimulating factor in preterm infants in the first few hours of life.
HMG-CoA reductase. Inhibition of HMG-CoA reductase is a basis for an assay in pharmacokinetic studies of the β-hydroxyacid metabolites active inhibitors and, following base hydrolysis, active plus latent inhibitors total inhibitors in plasma following administration of simvastatin. The major active metabolites of simvastatin present in human plasma are the β-hydroxyacid of simvastatin and its 6'-hydroxy, 6'-hydroxymethyl, and 6'-exomethylene derivatives. What should I tell my doctor before and while taking Vytorin? The mean C max and AUC of niacin increased 9% and 22%, respectively. While concomitant NIASPAN decreased the mean C max of total ezetimibe 1% and simvastatin 2% it increased the mean C max of simvastatin acid 18%. In addition, concomitant NIASPAN increased the mean AUC of total ezetimibe 26% simvastatin 20% and simvastatin acid 35%. Cases of myopathy, including rhabdomyolysis, have been reported with simvastatin coadministered with colchicine, and caution should be exercised when prescribing Vytorin with colchicine. Plasma concentration-time profiles exhibit multiple peaks, suggesting enterohepatic recycling. Pittler MH, White AR, Stevinson C, Ernst E. Effectiveness of artichoke extract in preventing alcohol-induced hangovers: a randomized controlled trial. Ask your doctor or pharmacist for a list of these medicines if you are not sure. Fintelmann V. Therapeutic profile and mechanism of action of artichoke leaf extract: hypolipemic, antioxidant, hepatoprotective and choleretic properties. 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. Following an oral dose of 14C-labeled simvastatin in man, 13% of the dose was excreted in urine and 60% in feces. Bundy R, Walker AF, Middleton RW, et al. Artichoke leaf extract reduces symptoms of irritable bowel syndrome and improves quality of life in otherwise healthy volunteers suffering from concomitant dyspepsia: a subset analysis. The hair loss can be quite sudden, developing in a matter of a few days and it may happen anywhere on the scalp. The patch is usually smooth bald skin with nothing obvious to see beyond the absence of hair. F Activase may be used within 8 hours following reconstitution. Discard any unused solution after administration is complete. Patients must have health insurance and their insurance must cover the qualifying medication for which they seek assistance.
It works by reducing the amount of cholesterol made by the liver. Do NOT take more than the recommended dose without checking with your doctor. Because the below reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Schreiber VJ, Erb W, Wildgrube J, and Bohle E. Die fakale ausscheidung von gallensauren und lipiden des menschen bei normaler und medikamentos gesteigerter cholerese. What is the most important information I should know about ezetimibe and simvastatin Vytorin? If you have any further questions, ask your doctor or pharmacist. Do not add any other medication to infusion solutions containing Activase. Your pharmacist can provide more information about ezetimibe and simvastatin. If serious bleeding occurs, terminate the Activase infusion. Vytorin is a combination of 2 medicines. Ezetimibe is an antihyperlipidemic agent. It works by reducing the amount of cholesterol that your body absorbs from your diet. Simvastatin is an HMG-CoA reductase inhibitor or "statin. Reported adverse experiences have not been serious. Alteplase is a serine protease responsible for fibrin-enhanced conversion of plasminogen to plasmin. It produces limited conversion of plasminogen in the absence of fibrin. Some researchers who were not involved in the study said back then that they wondered whether Vytorin and Zetia lowered cholesterol but did not reduce heart attacks or strokes. The results released Monday appeared to indicate that bringing a patient's cholesterol lower does appear to reduce heart incidents. Following administration of 100 mg Activase, there is a decrease 16%-36% in circulating fibrinogen. United States and its territories. Indications, uses and warnings on Drugs.
General Information about the safe and effective use of Vytorin. This information should not be used to decide whether or not to take Vytorin or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Vytorin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Vytorin. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Vytorin. Vytorin. See the end of this leaflet for a complete list of ingredients in Vytorin. Pedersen TR, Kjekshus J, Berg K, Haghfelt T, Faergeman O, Thorgeirsson G, Pyorala K, Miettinen T, Wilhelmsen L, Olsson AG, Wedel "Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study 4S. NDC 66582-313-86 bottles of 5000 If repackaged in blisters, then opaque or light-resistant blisters should be used. Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Products meeting necessary bioequivalence requirements. The initial volume of distribution approximates plasma volume. Following Activase administration, patients are at increased risk of bleeding internally or externally. Ezetimibe localizes at the brush border of the small intestine and inhibits the absorption of cholesterol, leading to a decrease in the delivery of intestinal cholesterol to the liver.
Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. Medicines should not be disposed of via wastewater or household waste. Inegy contains the active substances ezetimibe and simvastatin. Asian, because a different dose may be applicable to you. Possibility of causal treatment of bile duct diseases with an artichoke preparation.
In this study, depending upon the scale, the favorable outcome of minimal or no disability occurred in at least 11 per 100 more patients treated with Activase than those receiving placebo. Study results demonstrated consistent functional and neurological improvement within all four stroke scales as indicated by median scores. When such reactions occur, they usually respond to conventional therapy. Folkert Asselbergs, MD, PhD, of the University Medical Center Groningen in The Netherlands. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. 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. Product Information. Zetia ezetimibe. If you get any side effects, talk to your doctor, pharmacist or nurse. Store in the original package in order to protect from moisture and light. Vanpuijenbroek EP, Dubufvereijken PWG, Spooren PFMJ, Vandoormaal JJ "Possible increased risk of rhabdomyolysis during concomitant use of simvastatin and gemfibrozil. It is possible that some side effects of Vytorin may not have been reported. The patient must also be a US resident. Vytorin should not be taken by pregnant women or nursing mothers.
Asselbergs tells WebMD. "Statin withdrawal leads to a rapid and significant increase in CRP, independent of the parallel increase. Inegy is not expected to interfere with your ability to drive or to use machinery. FDA product labels and may differ in countries outside the USA. Every effort has been made to ensure that the information provided on this page is accurate, up-to-date and complete, but no guarantee is made to that effect. Drugs. At 1 year, the mean LDL-C was 26% lower in the simvastatin arm and 38% lower in the Vytorin arm relative to placebo. 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. AUC after an 80-mg oral dose. Liver carcinomas were significantly increased in high-dose females and mid- and high-dose males with a maximum incidence of 90% in males. The incidence of adenomas of the liver was significantly increased in mid- and high-dose females. Drug treatment also significantly increased the incidence of lung adenomas in mid- and high-dose males and females. Adenomas of the Harderian gland a gland of the eye of rodents were significantly higher in high-dose mice than in controls. Phan T, Mcleod JG, Pollard JD, Peiris O, Rohan A, Halpern JP "Peripheral neuropathy associated with simvastatin. LDL-C-lowering treatments that provides greater LDL-C lowering. AA, the hair follicles, are not completely destroyed and can re-grow if the inflammation subsides. This drug may infrequently cause muscle problems which can rarely lead to a very serious condition called rhabdomyolysis. 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. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Vytorin for a condition for which it was not prescribed. Do not give Vytorin to other people, even if they have the same condition that you have. It may harm them. Inegy is available in blister packs containing 28 tablets.
The usual maximum dose for the simvastatin in this medication is 40 milligrams a day. If you have been instructed by your doctor to take more than 40 milligrams of simvastatin, continue on that same dose. However, promptly talk with him or her about the risks and benefits of your higher dose. Vytorin is contraindicated in patients with active liver disease or unexplained persistent elevations in hepatic transaminases. AUC 0-24hr for total ezetimibe. Vytorin should be used with extreme caution in CHILDREN younger than 10 years old; safety and effectiveness in these children have not been confirmed. Stein moderated a news conference to release the findings at the annual meeting of the American College of Cardiology. If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not drink large amounts of alcohol with this medicine. This could cause unwanted effects on the liver. The most frequent adverse reaction associated with Activase in all approved indications is bleeding. Vytorin may harm your unborn baby. If you are a woman of childbearing age, you should use an effective method of birth control to prevent pregnancy while using Vytorin. If you become pregnant while taking Vytorin, stop taking Vytorin and call your doctor. If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Chariot P, Abadia R, Agnus D, Danan C, Charpentier C, Gherardi RK "Simvastatin-induced rhabdomyolysis followed by a MELAS syndrome. Hg or lower for 24 hours. In the primary intent-to-treat analysis, 639 15. S-4-hydroxyphenyl-2-azetidinone. The empirical formula is C 24H 21F 2NO 3 and its molecular weight is 409. Havranek JM, Wolfsen AR, Warnke GA, Phillips PS "Monotherapy with ezetimibe causing myopathy. Relative to the fasting state, the plasma profiles of both active and total inhibitors of HMG-CoA reductase were not affected when simvastatin was administered immediately before an American Heart Association recommended low-fat meal.
Call your doctor right away if you get a headache, stomach pain, vomiting, dark-colored urine, loss of appetite, weight loss, general feeling of tiredness or weakness, light-colored stools, upper right stomach pain, or yellow eyes or skin. These could be symptoms of liver damage. The incidence of myopathy, including rhabdomyolysis, was highest during the first year and then notably decreased during the subsequent years of treatment. In this trial, patients were carefully monitored and some interacting medicinal products were excluded. Each 100 mg Activase vial 58 million IU is packaged with diluent for reconstitution 100 mL Sterile Water for Injection, USP and one transfer device: NDC 50242-085-27. It is recommended that liver function tests be performed before the initiation of treatment with Vytorin, and thereafter when clinically indicated. There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including simvastatin. AUC for total ezetimibe and ezetimibe increased approximately 4-fold compared to healthy subjects. Does Vytorin 10-20 oral have side effects?
Store at room temperature between 68-77 degrees F 20-25 degrees C away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Activase is a tissue plasminogen activator produced by recombinant DNA technology. It is a sterile, purified glycoprotein of 527 amino acids. It is synthesized using the complementary DNA cDNA for natural human tissue-type plasminogen activator obtained from a human melanoma cell line. Activase is a sterile, white to off-white, lyophilized powder for intravenous administration after reconstitution with Sterile Water for Injection, USP. 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. Chinese patients who are taking large amounts of niacin greater than 1 gram or 1000 milligrams per day together with this medicine may have an increased risk for muscle injury. Some received IV heparin on arrival to the emergency room prior to enrollment and randomization. Mannarino, E. Artichoke juice improves endothelial function in hyperlipemia. Read the Patient Information Leaflet if available from your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
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Reconstitute using aseptic technique. Do not add other medication to solutions containing Activase. The use of the Truven Health products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Truven Health and Drugs. Bleeding events other than intracranial hemorrhage were noted in the studies of AIS and were consistent with the general safety profile of Activase.
Do not take fusidic acid while using this medicine. Store Vytorin at room temperature, between 68 and 77 degrees F 20 and 25 degrees C. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vytorin out of the reach of children and away from pets. Vytorin contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin, an HMG-CoA reductase inhibitor. Remove the protective cap from the other end of the transfer device. DO NOT INVERT THE VIAL OF SWFI.
What happens if I overdose Vytorin? Pulmonary Embolism: Pulmonary reembolization, pulmonary edema, pleural effusion, thromboembolism, hypotension. These events may be life threatening and may lead to death. Fever has also been reported. 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.
Cyclosporine or Danazol: The risk of myopathy, including rhabdomyolysis is increased by concomitant administration of cyclosporine or danazol. There are no adequate and well-controlled studies in pregnant women. Tell your doctor if you have severe lung disease. The recommended total doses for acute myocardial infarction AMI is based on patient weight, not to exceed 100 mg, regardless of the selected administration regimen accelerated or 3 hour, described below. 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.