Last Updated on February 19, 2017 by Dr.Derek Fhisher
Most popular brand: Zocor
Active ingredient: Simvastatin
Available dosage forms: 5, 10, 20, 40 mg
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Simvastatin general information
Despite the fact that medications are supposed to earn a medical condition more manageable, they sometimes possess the opposite effect. On the opposite hand, fatigue could be experienced by about 4.5% of the individuals who are on this drug, according to clinical studies. Therefore, such men and women should exercise caution when using this drug. It must be consumed just on the prescription of the registered medical practitioner. As a way to pinpoint the best medication for you, you’ll need to think about your present physical state. Ultimately, maintain a pain diary.
If there are any unpleasant effects talk with your doctor who needs to prescribe an alternate medication. Ergo, this drug really should not be used, unless it’s prescribed by the physician. It should be noted that the usage of this drug is contraindicated in some instances. With highly low degree of sodium within the blood Hence it is recommended to speak with your physician before taking Trileptal to stop other uneventful things to take place. The psychiatrist will lower your dose during the next few weeks. Alcohol consumption needs to be avoided if you’re taking amlodipine besylate.
Lexapro weight changes aren’t seen in each individual taking the drug. Under the effect of the drug, the mind becomes used to high degrees of serotonin. Regular consumption of the drug can also result in joint pain. In addition, intake of over one drug simultaneously can end up being harmful to the body. We shall now examine the negative effects this drug can have on the body.
Some diabetes drugs possess the unpleasant capability to cause weight gain. Healthy diet and normal exercise help lower the seriousness of the symptoms. Diabetics even need to check psychological drugs. Additionally It may cause several gastrointestinal or digestive problems in a few individuals. Sometimes this medication can lead to mood swings. You’re pregnant or breastfeeding.
Pregnant and breastfeeding women, along with those attempting to conceive should talk to their own physician about the use of the hypertension medication. Then, pregnant women shouldn’t apply this cream, unless it’s recommended by the physician. In rare instances, the side effects might occur despite this type of gradual decrease. The initial purpose of therapy would be to reach symptomatic control by means of a minimum dose of glucocorticoids. The professional will prescribe the best doses, reducing it gradually, to be able to curtail the withdrawal symptoms.
Nightmares and vivid dreams also have been reported in certain individuals, following the discontinuation of Lexapro. You could be sensitive to Lexapro and the psychiatrist should check into the issue immediately. Side effects might appear anytime during the plan of medication. The dose needs to be increased in case the symptoms aren’t well controlled within one week. Seizures related to levothyroxine could also indicate prescription overdose. The physician will administer particular medications that may nullify the effects.
Although it is very effective in the therapy for high blood pressure, like quite a few other medications, additionally it may generate a few unwanted side effects in certain people. Prescribed just for external or dermatologic usage, this cream is advised for individuals affected by skin infections resulting from fungus or yeast. Some health care conditions will really prevent the usage of certain diabetes medicines. Also, there are specific foods that certainly must be avoided whenever you are on medication. These must be carefully weighted to make sure the risk of the side effects is significantly less in relation to the help it could offer.
Active – active substance / start: simvastatin
Avestatin; Aktalipid; Aterostat; Vasilip; Vero – simvastatin; Zovatin; Zocor (Zocor forte); Zorstat; Levomir; Ovenkor; Simvageksal; Simvakard; Simvakol; Simvalimit; simvastatin; Simvastatin – Vero; Simvastol; Simvor; Simgal; Simla; Simplakor; Sinkard; Holvasim.
simvastatin – cholesterol-lowering drug, an inhibitor of HMG – CoA (HMG – CoA) reductase. It is used for hypercholesterolemia, hypertriglyceridemia, coronary heart disease (to slow the progression of coronary atherosclerosis, reduce the risk of acute coronary death).
Active – active substance:
simvastatin / Simvastatin.
Properties / Action:
Simvastatin – cholesterol-lowering drug, an inhibitor of HMG – CoA (HMG – CoA) reductase.
Simvastatin is a cholesterol-lowering drug, derived synthetically from a fermentation product of Aspergillus terreus.
Simvastatin exerts an inhibitory effect on the 3 – hydroxy – 3 – methylglutaryl – coenzyme A (HMG – CoA) – reductase, the enzyme that catalyzes the initial rate-limiting step in cholesterol biosynthesis. Simvastatin reduces total cholesterol in the blood plasma of low density lipoproteins (LDL) and very low density lipoprotein (VLDL). Simvastatin also causes an increase in the cholesterol content of high density lipoprotein (HDL) cholesterol and lowering of plasma triglyceride content.
It is believed that the use of simvastatin should not cause the accumulation in the body of potentially toxic sterols. Furthermore, HMG – CoA also easily metabolized back to acetyl – CoA which is involved in the biosynthesis of many processes in the body.
conducted studies of the therapeutic effects of simvastatin on primary hypercholesterolemia in which diet assignment was insufficient. Simvastatin is highly effective in reducing total and LDL cholesterol levels in patients with heterozygous familial and non-familial forms of hypercholesterolemia, and mixed with hyperlipidemia, increased when the cholesterol is a risk factor. A noticeable effect is achieved in two weeks, the maximum therapeutic effect – after 4 – 6 weeks after the start of treatment. The effect was maintained with continued treatment. Upon termination of therapy with simvastatin total cholesterol levels returned to baseline levels observed prior to treatment.
In experimental studies on animals, after administration of the drug inside, simvastatin with high selectivity accumulate in the liver, where its concentration is significantly higher than concentrations in other tissues. Simvastatin quickly extracted from the blood at the first passage through the liver (the principal place of his actions), then excreted in the bile. The content of the active form of simvastatin in human systemic circulation is less than 5% of an oral dose, 95% of this amount is bound to proteins state.
Primary and secondary hypercholesterolemia
Coronary Heart Disease
In patients with coronary heart disease Simvastatin is appointed for the purpose of:
Dosage and administration:
Before taking Simvastatin patient must assign a standard hypolipidemic diet, which must be observed during treatment with the drug.
The initial dose is usually 10 mg once daily in the evening. Patients with mild to moderate hypercholesterolemia initial dose may be reduced to 5 mg. If necessary, dose selection can be performed at intervals of at least 4 weeks, up to 40 mg once a day in the evening. The maximum recommended dose is 80 mg / day.
By reducing LDL levels below 75 mg / dl (1.94 mmol / L) or plasma total cholesterol below 140 mg / dl (3.6 mmol / l) should be reduced dose.
Coronary artery disease:
When coronary heart disease starting dose is 20 mg once daily in the evening.
If you need to adjust the dose selection should be carried out as described above.
Simvastatin is effective both as a monotherapy and in combination with bile acid sequestrants.
At the same time taking sick immunosuppressive drugs maximum dose of simvastatin should not exceed 10 mg per day.
Doses in renal failure:
Since simvastatin dose excreted in the urine is low, there is no need for dose adjustment in patients with moderate to severe renal impairment. In patients with severe renal function impairment (creatinine clearance less than 30 ml / min), a starting dose of simvastatin should be 5 mg and should carefully evaluate whether the use of the drug in doses exceeding 10 mg.
There were several cases of overdose up to 450 mg per day. At the same time the patients were no specific symptoms and complications. We used general therapeutic treatments.
Use during pregnancy and lactation:
Simvastatin is contraindicated during pregnancy.
Atherosclerosis is a chronic process, and a break in receiving lipid-lowering medication during pregnancy should have little impact on the result of long-term therapy of primary hypercholesterolemia. Moreover, cholesterol and its derivatives are essential for the development of the fetus, especially for the synthesis of steroids and cell membranes. Given the ability of inhibitors of HMG – CoA reductase such as simvastatin, decrease cholesterol biosynthesis and possibly other derivatives, the purpose of these drugs to pregnant women may have an adverse effect on fetal development.
There are a few reports of congenital anomalies in children born to mothers during pregnancy treated with inhibitors of HMG – CoA reductase.
simvastatin can be assigned to women of childbearing age only when their pregnancy is not planned. If the patient becomes pregnant while taking simvastatin, it should be discontinued and the potential risk to the fetus.
It is not known whether simvastatin is released and its derivatives, with the mother’s milk. Given that many drugs are excreted in breast milk, and taking into account the potential risk of developing severe side effects, women taking simvastatin should abandon breastfeeding.
The safety and effectiveness in children have not been established.
Currently, simvastatin is not recommended for children.
Assign the elderly:
During the controlled clinical trials found that patients over 65 years of effectiveness of the drug, estimated to reduce total cholesterol and LDL was identified similar to the general population . In these patients no increase in the number of adverse reactions.
Familial hypercholesterolemia homozygotes:
In patients with homozygous familial hypercholesterolemia with LDL receptors are completely absent, and simvastatin treatment in such cases is ineffective.
Simvastatin does not have a significant effect gipotriglitseridemicheskim and not the drug of choice in cases where the increase of triglycerides – a violation of the basic (eg, hyperlipidemia, type I, IV, V)
For Simvastatin is characterized by good tolerability; most of the side effects is negligible and transient in nature. Less than 2% of patients discontinued participation in the controlled clinical trials because of their side effects caused by simvastatin.
part of the intestine: nausea, diarrhea, constipation, flatulence, very rarely pancreatitis, elevated liver transaminases, alkaline phosphatase and gamma – glutamine – transpeptidase.
From the CNS: headache, paresthesia, insomnia.
Allergic reactions: rarely rash, pruritus, photosensitivity, rarely – polymyalgia rheumatica, eosinophilia.
Other: myalgia, rhabdomyolysis, increased CPK, in rare cases, myopathy.
During the investigation of the influence of the Scandinavian simvastatin survival (Scandinavian Simvastatin Survival Study), which involved 4444 patients, safety and tolerability in the groups of patients treated with simvastatin (n = 2221) 20 – 40 mg daily or placebo (n = 2223), were comparable.
The impact of the drug on laboratory findings:
The significant and sustained increases in the levels of plasma transaminases occurred rarely. Marked increase in the concentration of alkaline phosphatase and gamma – glutamyl. Liver function abnormalities were mild and transient in nature.
Special instructions and precautions:
The effect on the liver:
In clinical trials in a few adult patients who received simvastatin, was found significant persistent elevations in plasma transaminases (more than three times the upper limit of normal). For temporary or complete cessation of the drug transaminase content gradually returned to baseline. These violations were not accompanied by jaundice or other clinical symptoms. Some of these patients, a violation of liver function were diagnosed before treatment with simvastatin and / or they used a significant amount of alcohol.
Prior to the appointment of the drug, and periodically during treatment should be investigated liver function in all patients. Patients receiving a daily dose of simvastatin 80 mg, should be carried out once in the study for three months. Particular attention should be given to patients with elevated transaminases in blood plasma. They should immediately make repeated measurements of these indicators, and in the course of treatment repeat tests more often. If you have a tendency to increased levels of plasma transaminases, especially if their levels are consistently higher than the upper limit of normal in more than three times, the treatment should be stopped.
The drug is used with caution in patients who consume substantial quantities of alcohol, as well as a history of liver disease. Progressive liver disease or increased levels of plasma transaminases is a contraindication to treatment with simvastatin.
When receiving simvastatin, like other lipid-lowering drugs, there may be a slight increase in serum transaminases levels (less than three times the upper limit of normal). These changes were observed at the beginning of treatment with simvastatin, are transient in nature, they are not accompanied by any symptoms. Consequently, there is no need to remove the drug.
The effect on the muscles supporting – motor system:
In the treatment of simvastatin in patients noted a slight transient increase in the concentration of creatine kinase striated muscle, which usually has no clinical significance. Treatment of inhibitors of HMG – CoA reductase can occasionally cause myopathy (less than 0.1%). If the patient diffuse myalgia, muscle twitching, and / or a significant increase in creatine kinase levels (more than 10 times from the upper limit of normal) can talk about the development of myopathy. Patients should be made aware that they should immediately inform your doctor about the appearance of their unexplained muscle pain, increased sensitivity, and muscle weakness. With a significant increase in the level of creatine kinase, or diagnosis of myopathy is suspected, it should stop the drug.
It is known that the risk of myopathy when receiving inhibitors HMG – CoA reductase is increased in patients receiving concomitant therapy as immunosuppressive drugs, including cyclosporine s; fibric acid or a lipid-lowering doses of niacin (nicotinic acid). There are few reports of severe cases of rhabdomyolysis with acute renal failure secondary. Consequently, qs – Dimo comprehensively assess the possible benefits and the risk of concurrent therapy with simvastatin and immunosuppressive drugs, fibric acid, or lipid-lowering doses of niacin (nicotinic acid). Joined case where a patient who had undergone a kidney transplant and receive cyclosporine and simvastatin, after the introduction of systemic antimycotic drug itraconazole and appeared muscle weakness and significantly increased levels of creatine kinase. Another patient with a renal graft, a short time to receive cyclosporine and other inhibitors of HMG – CoA reductase, an increase in itraconazole dose developed rhabdomyolysis and renal failure. Inhibitors of HMG – CoA reductase and a number of azole means antimikoznye inhibit the biosynthesis of cholesterol at various stages. In patients receiving cyclosporins, if necessary, the appointment of a number of azole antimikoznyh drugs should temporarily discontinue treatment with simvastatin. Careful monitoring of patients not receiving cyclosporin, but in need of concomitant treatment of azole derivatives.
You should refrain or completely discontinue treatment inhibitors HMG – CoA reductase inhibitors in patients with acute significant violations, indicating the development of myopathy or suspected renal failure due to rhabdomyolysis.
The impact on vision:
It is believed that cataract develops as a result of aging and not a result of drug therapy. Recent data obtained in the course of long-term clinical trials, the impact of simvastatin deny the lens of the human eye.
Co-administration of simvastatin and indirect anticoagulants may lead to increased action of the latter.
In two clinical studies, one in normal volunteers and the other in hypercholesterolemic patients, simvastatin 20 – 40 mg / day increases the effect of coumarin anticoagulants: the prothrombin time, presented as an international standard ratio (International Normalized Ratio – INR) increased by initial 1.7 to 1.8 and from 2.6 to 3.4 and in volunteers studies of patients, respectively.
patients receiving coumarin anticoagulants, prothrombin time should be determined before starting therapy with simvastatin and then often enough during the initial period of treatment in order to ensure that no significant changes in prothrombin time.
Since prothrombin time stabilization can control it at intervals taken in the treatment of coumarin anticoagulants.
If you want to change the dose of simvastatin, the procedure must be repeated in the same order.
Therapy with simvastatin did not cause bleeding or changes in prothrombin time in patients not taking coagulants.
Other concomitant treatment:
When concomitant administration of simvastatin with fibric acid derivatives, with immunosuppressants, niacin, nicotinic acid, azole antifungals derivatives (ketoconazole, itraconazole.) fibrates or erythromycin th the risk of myopathy and rhabdomyolysis is increased.
Enhances hepatotoxicity of alcohol and drugs have a negative effect on the liver.
List B. The temperature is not above 30 ° C; avoid temporary exposure to temperatures above 50 ° C.
Keep in a dry, protected from light, out of reach of children.
Terms of pharmacy holiday – prescription.
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