As the world moves towards fashion and modelling, the problem most people face (especially women who want to keep form and shape) is cholesterol (fat). Many people, due to poor eating habit have been diagnosed with obesity (accumulation of cholesterol). Not only do cholesterol makes you appear overweight, when it accumulates in the blood vessels, it disturbed the normal flow of blood. If the quantity of blood reaching the brain and the heart is reduced, the serious brain damage and heart attack may be the next problem. You certainly don’t want this to happen to you. This is why you need Vytorin.
Description of Vytorin
These two qualitative substances simvastatin and ezetimibe are contained in the drug Vytorin. The percentage of cholesterol stocked in the body reduces with ezetimibe. The class of medicine known as HMG CoA reductase statins is where Simvastatin belongs (statins are substances that slow down the body’s production of cholesterol and also help in eliminating excess cholesterol from your arteries) or inhibitors. Simvastatin and ezetimibe are blended to form (Vytorin) which decreases the blood levels of "bad" cholesterol (LDL, which means low-density lipoprotein,) and triglycerides, meanwhile increasing levels of "good" cholesterol (high-density lipoprotein, or HDL). The reduction of the total cholesterol in adults and children who are ten years old is made possible as a result of the combined use of Vytorin with a low-fat diet and other treatment. So hard is it to determine if Vytorin uses reduce your risk of heart disease. The prescribing information for Vytorin states that no incremental benefit of Vytorin on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been set up.
Possible side effects of Vytorin
Vytorin helps most people with increase cholesterol, but it may have unwanted side effects in a few people. All drugs can have side effects. More often they are serious, most of the time they are not. You may need medical therapy if you get some of the side effects of Vytorin. See your doctor regularly to check your cholesterol level and to check for side effects Vytorin. Your doctor should do blood tests to check your liver before you start taking Vytorin and if you have any symptoms of liver problems while you take Vytorin. Call your doctor straightaway if you have the following symptoms of liver problems.
Hypersensitivity reactions also have been publicized. The most severe potential side effects of Vytorin are liver damage and muscle inflammation or breakdown. The simvastatin ingredient of Vytorin is a statin. Therefore it shares side effects Vytorin such as liver and muscle damage, associated with statins. Intense liver damage caused by statins is rare. Sometimes, statins cause abnormalities of liver tests, and, therefore, occasional measurement of liver tests in the blood is recommended for all statins. Abnormal tests often return to normal, though a statin is continued, however, if the abnormal test value is more than three times the upper limit of normal, the statin automatically is stopped. Liver tests have to be measured before Vytorin is started and periodically thereafter or if there is a medical concern about liver damage.
Allergic reactions consisting of; lips, tongue, and/or throat that may cause difficulty in breathing or swallowing, swelling of the face, which may require treatment right away triggers the following Vytorin side effects.
- · Rash
- · Hives
- · Raised red rash
- · Sometimes with target-shaped lesions
- · Joint pain
- · Muscle pain
- · Alterations in some laboratory blood tests
- · Liver problems (sometimes serious)
- · inflammation of the pancreas
- · Nausea
- · Dizziness
- · Tingling sensation
- · Depression
- · Gallstones
- · Inflammation of the gallbladder
- · Trouble sleeping
- · Poor memory
- · Memory loss
- · Confusion
- · Erectile dysfunction
- · Breathing problems couple with persistent cough and/or shortness of breath or fever are indicators of Vytorin side effects
Muscle pain and damage. Muscle pain has been one of the most common issues raised by people who have taken Vytorin. You may feel this pain as tiredness or weakness in your muscles and soreness. The pain can be a severe or it can be mild discomfort, enough to make your daily activities difficult. Adequately, most randomized controlled studies of Vytorin reviled that, people taking statins develop muscle pain at the same rate as people taking placebo. But up to 29 percent of the people who begin taking statins report muscle pain and many discontinue statins because of it, and thus an indicator of Vytorin side effects. Many of these people do well when they are switched to a different variety of statin. Very rarely, statins can cause life-threatening muscle damage called rhabdomyolysis (rab-doe-my-OL-ih-sis). Rhabdomyolysis can cause intense muscle pain, liver damage, kidney failure and death. The risk of very serious side effects Vytorin is highly low, and calculated in a few situations per million of patients taking statins. Rhabdomyolysis can happen when you take statins in combination with certain medicines, or if you take a higher dose of statins.
Neurological side effects: The problem of memory loss or confusion while taking statins have been reported by FDA. However, there is a reversal of these side effects Vytorin immediately you stop taking the treatment. There is limited evidence to demonstrate a cause-effect, but talk to your doctor if you encounter memory loss or confusion while taking statins. There has also been a proof that statins may help with brain function-in patients with dementia, for instance. This is still being researched. Don't stop taking your statin treatment before talking to your doctor.
Vytorin have been associated with increases in HbA1c and fasting serum glucose levels that are viewed in diabetes. There are also post-marketing archives of forgetfulness, memory loss, confusion, memory impairment and amnesia. Signs may start 1 day to years after starting treatment and resolve within a median of 3 weeks after stopping the statin.
In a situation where you notices any medical problems while taking vytorin do not hesitate to call your health care expert. This is not a complete list of the side effects of Vytorin. For a complete list, call your doctor or pharmacist.
Warnings and Precautions of Vytorin
In clinical tests, there was no excess of myopathy or rhabdomyolysis associated with ezetimibe compared with the relevant control arm (placebo or HMG-CoA reductase inhibitor singularly). However, rhabdomyolysis and myopathy are known adverse reactions to HMG-CoA reductase inhibitors and other lipid-lowering drugs. In clinical tests, the incidence of CK is greater than 10 X the upper limit of normal [ULN] was 0.2% for Vytorin. Simvastatin, like other inhibitors of HMG-CoA reductase, sometimes provokes myopathy actions as weakness or tenderness, muscle pain, alongside creatine kinase above 10 X ULN. Myopathy occasionally operates the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and few consequences has happened. The danger of myopathy is multiplied by increasing levels of HMG-CoA reductase inhibitory activity in plasma. As with other HMG-CoA reductase inhibitors, the danger of rhabdomyolysis /myopathy is dose associated. About 41,050 patients were cured with simvastatin, with 24,747 (approximately 60%) treated for a period of four years, the situation of myopathy was exactly 0.02%,0.08% and 0.53% in 20, 40 and 80 mg/day, following a clinical test database result. In these tests, patients were diligently followed-up and some interacting medicinal products were excluded. All patients starting therapy with Vytorin or whose dose of Vytorin is being increased should be advised of the risk of myopathy and told to report promptly any excruciating muscle pain, weakness or tenderness .Vytorin treatment has to be discontinued immediately if myopathy is suspected or diagnosed.
ii) Because Vytorin has simvastatin, the danger of rhabdomyolysis/myopathy is accelerated by concomitant use of Vytorin with the following:
Potent inhibitors of CYP3A4: Simvastatin, just like many other inhibitors of HMG-CoA reductase, is an element of cytochrome P450 3A4 (CYP3A4). When simvastatin is applied with an efficacious inhibitor of CYP3A4, higher plasma levels of HMG-CoA reductase inhibitory activity can increase the risk of myopathy and rhabdomyolysis, particularly with higher doses of simvastatin. The use of Vytorin concomitantly with the potent CYP3A4 inhibitors ketoconazole, itraconazole, clarithromycin, erythromycin, HIV protease inhibitors, telithromycin, large quantities or nefazodone, of grapefruit juice (greater than one quarter daily) should be forwarded to the background. Simultaneous usage of other drugs labeled as having a potent inhibitory effect on CYP3A4 should be avoided unless the benefits of combined therapy go beyond the increased risk. Once it is detected that treatment with itraconazole, erythromycin, ketoconazole, elithromycin or clarithromycin is unaviodadle, treatment with Vytorin should be called off during the course of treatment.
iii) Other drugs:
Gemfibrozil, particularly with higher doses of Vytorin: There is an increased risk of myopathy when simvastatin is used concomitantly with fibrates (especially gemfibrozil). The use of gemfibrozil and simvastatin together should be avoided, except the merits are likely to exceed the increased risks of this drug combination. The dose of simvastatin should not go above 10 mg daily in patients receiving concomitant medication alongside gemfibrozil. Therefore, even though not approved, if Vytorinis used in connection with gemfibrozil, the max dose should be 10/10 mg daily. Other lipid-lowering drugs (other fibrates or greater than and equal to 1 g/day of niacin): Caution should be used when prescribing other fibrates or lipid-lowering doses (greater than or less than 1 g/day) of niacin alongside Vytorin, as these elements can produce myopathy when given singularly. The effectiveness and safety of Vytorin administered with other fibrates or (greater than or less than 1 g/day) of niacin have not been established. Therefore, the benefit of further alterations in lipid levels by the combined use of Vytorin with other fibrates or niacin should be carefully weighed against the potential risks of these drug combinations.
Uses of Vytorin
The indications and uses of Vytorin are explained below. 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. There is adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non pharmacologic measures alone has been inadequate due tablet treatment. As such this first category exemplifies Vytorin uses.
i) Primary hyperlipidemia
Vytorinis indicated for the reduction of elevated total low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C),Apo lipoprotein B (Apo B), cholesterol (total-C), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. The uses of Vytorin are most effective in this category.
ii). Homozygous Familial Hypercholesterolemia (HoFH)
Vytorin is indicated for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an affiliate to other lipid-lowering therapies (for instance, if such treatments are unavailable or LDL apheresis). Therapy with lipid-altering agents should be a component of multiple risk-factor intervention in individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lipid altering elements should be applied in addition to an appropriate diet (including restriction of saturated fat and cholesterol) and when the response to diet and other non-pharmacological measures have been inadequate. Prior to initiating therapy of Vytorin, elementary causes for dyslipidemia (i.e., hypothyroidism, obstructive liver disease, diabetes, drugs that increase LDL-C, chronic renal failure, and decrease HDL-C (progestins, corticosteroids and anabolic steroids), should be excluded or, if possible, treated. A lipid file should be executed to measure total-C, LDL-C, HDL-C and TG. For TG levels greater than 400 mg/dL( greater than 4.5 mmol/L), LDL-C concentrations should be determined by ultracentrifugation. At the time of hospitalization for an acute coronary occurrence, lipid tips should be taken within 24 hours of admission. These values can serve the medical personnel on initiation of LDL-lowering therapy before or at discharge. This portrays an important segment in the uses of Vytorin as well as Vytorin uses.
ii) Limitations of Use
So far, there is no additional benefit of Vytorin on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been set up. Vytorin has not been researched in Fredrickson type I, III, IV, and V dyslipidemias and therefore showcases Vytorin uses.
Dosage of Vytorin
It is needful patients to be placed on a standard cholesterol-lowering diet before administering Vytorin and should continue on this diet during treatment with Vytorin. The importance of individualizing the dose of Vytorin to the recommended goal of therapy, the patient’s response, and the baseline LDL-C level.
i) Recommended dosing
10/10 mg/day to 10/40 mg/day appears to be the normal dosage range. The approved normal beginning dosage is 10/10 mg/day or 10/20 mg/day. Vytorin should be administered as a single dose in the evening, without or with food. Sick persons who need a larger reduction in LDL-C (greater than 55%) may be started at 10/40 mg/day. After titration of Vytorin or initiation, lipid heights may be evaluated after 2 or more weeks and dosage substituted, if the need arises.
ii) Restricted dosing for 10/80 mg
As a result of the rising risk of myopathy, comprising grhabdomyolysis, particularly within the first year of treatment, use of the 10/80-mg dosage of Vytorin has to be restricted to patients who have been taking Vytorin 10/80 mg chronically (for instance, for twelve months or more) without proof of muscle toxicity. As for the patients that are presently tolerating the 10/80-mg dose of Vytorin who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an alternative statin or statin-based regimen with less potential for the drug-drug interaction. In view of the accelerated danger of myopathy, comprising rhabdomyolysis, linked with the 10/80-mg dose of Vytorin, patients not being able to reach their LDL-C objective utilizing the 10/40-mg dose of Vytorin should not be titrated to the 10/80-mg dose, yet should be placed on substituted LDL-C-Iowering treatment(s) that provides greater LDL-C lowering.
iii) Co-administration with Other Drugs
Patients taking verapamil,diltiazem or amiodarone:
- The percentage of Vytorin should not go above 10/10 mg/day for patients taking amlodipine or ranolazine
- The percentage of Vytorin should not go above 10/20 mg/day for patients taking Bile Acid Sequestrants
- DosageofVytorinshould happen both greater than and equal to 2 hours before or greater than and equal to 4 hours after administration of a bile acidsequestrant.
iv) Patients with homozygous familial hypercholesterolemia
Vytorin 10/40 mg/day in the night is the approved dose of Vytorin with homozygous familial hypercholesterolemia. Vytorin should be taken as an associate to other lipid-lowering therapy (for instance, LDL apheresis) if such treatments or in these patients are unavailable.
v) Patients with hepatic impairment
No dosage of Vytorin adjustment is necessary in patients with mild hepatic impairment.
vi). Patients with renal impairment
No dosage adjustment is necessary in patients with mild or moderate renal impairment. However, for sick persons with severe renal inadequacy, Vytorin should not be commenced except the patient has already tolerated treatment with simvastatin at a dose ofhigher or 5 mg. Care should be applied when Vytorin is given to these patients, and they should be closely monitored.
vii). Chinese patients taking lipid-modifying doses ( greater than and equal 1 g/day niacin) of niacin-containing products because of an elevated danger for myopathy in Chinese sick persons taking simvastatin 40 mg co-administered with lipid-modifying doses ( greater than and equal 1 g/day niacin) of niacin-containing goods, caution should be used when treating Chinese sick persons with Vytorin doses exceeding 10/20 mg/day co-administeredwith lipid-modifying doses (greater than and equal 1 g/day niacin) of niacin-containing products. Because the danger for myopathy is dose-associated, Chinese patients should not be givenVytorin10/80 mg co-administered with lipid-modifying doses of niacin-containing products. The cause of the high danger of myopathy is not known. It is also not known if the danger for myopathy with co-administration of simvastatin with lipid-modifyingdoses of niacin-containing products observed in Chinese patients applies to other Asian patients.
viii). Geriatric Patients
No dosage substitution is relevant in geriatric patients
Dosage Forms and Strengths of Vytorin
- Vytorin10/10, (ezetimibe 10 mg/simvastatin 10 mg tablets) are white to off-white capsuleshaped tablets with code “311” on one side.
- Vytorin 10/20, (ezetimibe 10 mg/simvastatin 20 mg tablets) are white to off-white capsuleshaped tablets with code “312” on one side.
- Vytorin 10/40, (ezetimibe 10 mg/simvastatin 40 mg tablets) are white to off-white capsuleshaped tablets with code “313” on one side.
- Vytorin10/80, (ezetimibe 10 mg/simvastatin 80 mg tablets) are white to off-white capsuleshaped tablets with code “315” on one side.
Overdose of Vytorin
No specific treatment of overdosage with Vytorin can be approved. In the situation of symptomatic, an overdose, supportive measures should be employed.
Storage conditions of Vytorin
Store at 20-25°C (68-77°F). Keep container tightly closed. Storage of 10,000, 5000, and 2500 count bottles Store bottle of 10/20, 5000 Vytorin10/40, 10,000 Vytorin10/10 and 2500 Vytorin 10/80 capsule-shaped tablets at 20-25°C (68-77°F). Store in an original container until the momentof use. When product container is separated, re-constitute into a lightresistant and tightly-closed container. All contents must be repackaged immediately upon opening.
Use in specific populations
Vytorin is contraindicated in women who are or may become pregnant. Lipid-lowering drugs provideno benefit during pregnancy, due to the fact that cholesterol and cholesterol derivatives are needed for normal fetal growth. Atherosclerosis is a critical process, and discontinuation of lipid-lowering medicines during pregnancy has little impact on long-term outcomes of primary hypercholesterolemia therapy. There are no sufficient and well-controlled studies of Vytorin use during pregnancy; however, there are few reports of congenital anomalies in infants exposed to statins in utero. Animal reproduction researches on simvastatin in rats and rabbits showed no evidence of teratogenicity. Serum cholesterol and triglycerides rise during normal pregnancy, as well as cholesterol or cholesterol derivatives are essential for fetal development. Because statins, such as simvastatin, reduce cholesterol synthesis and likelythe synthesis of other biologically active substances derived from cholesterol, Vytorin may cause fetal harm when given to a pregnant woman. If Vytorin is taken during pregnancy or if the patient becomes pregnant while taking this medicine, the patient should be apprised of the degree of hazard to the fetus. Women of childbearing potential, who need Vytorin treatment for a lipid disorder, should be advised to apply effective contraception. For women wanting to conceive, discontinuation of Vytorin should be taken into account. If pregnancy happens, Vytorin should be immediately discontinued to avoid Vytorin side effects.
ii) Nursing mothers
Still too difficult to confirm if excreted in human milk. Because a small amount of another medicine in this class is excreted in human milk and because of the potential for serious adverse reactions innursing infants, women under simvastatin should not nurse their babies. When we consider the significance of the drug to the mother, a decision should be made whether to discontinue nursing or discontinue the drug respectively. In rat studies, exposure to ezetimibe in nursing pups was up to half of that observed in maternal plasma. Still too difficult to confirm if ezetimibe or simvastatin are excreted in human milk. Because a small proportion of another drug in the same class as simvastatin is excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women who are nursing have to stop taking Vytorin.
iii) Geriatric use
Of the 10,189 patients who received Vytorin in clinical studies, 3242 (32%) were 65 and older (this included 844 (8%) who were 75 and older). No overall differences in efficacy or safety were observed between these subjects and younger subjects, and other published clinical experience has not identified differences in responses between the elderly and younger patients but greater sensitivity of some older individuals cannot be ruled out. Since advanced age (greater than and equal to 65 years) is a predisposing factor for myopathy, Vytorin should be prescribed with care in the elderly. Vytorin should be prescribed with caution in the elderly due to the fact that advanced age (greater than and equal 65 years) is a predisposing factor for myopathy, alongside rhabdomyolysis. Within the clinical trial of patients treated with simvastatin 80 mg/day, patients greater than and equal to 65 years of age had an increased risk of myopathy, including rhabdomyolysis, in relations with patients less than 65 years of age.
A disclaimer: The purpose of this article is to provide you with the most current and relevant information of the Durela drug. Therefore this article should not substitute for medical advice from a physician.