Simvastatin
Drug Name: Generic Zocor ( Simvastatin )
Generic Zocor ( simvastatin ) is used along with an overall diet plan in order to reduce blood cholesterol in patients with high blood cholesterol levels. Zocor can significantly reduce the amount of LDL ("bad") cholesterol in the blood while simultaneously
raising the levels of HDL-C ("good") cholesterol.
Drug Uses:
Zocor ( Simvastatin) is used along with an overall diet plan to lower the patients level of cholesterol and reduce the risk of heart attack. Zocor, less known for its active ingredient Simvastatin. Simvastatin has been proven to help reduce patients' LDL cholesterol
and triglyceride levels significantly, as well as help in maintaining the low levels in the long run. Zocor ( Simvastatin ) may also be prescribed for other reasons: it has been proven to reduce the risk of heart attack and stroke in high-risk patients such
as diabetics or heart patients, regardless of their blood cholesterol levels.
Drug Class Mechanism:
Zocor belongs to a class of drugs known as statins, which work by blocking an enzyme in the liver that is used in the production of LDL ("bad") cholesterol. The body then produces less LDL, and the level of LDL cholesterol in the blood decreases
How Taken:
Generic Zocor (simvastatin ), just like the brand counterpart should be taken one to three times a day with or without food,
Missed Dose:
In case of a missed dosage no special action should be taken. Continue taking your Zocor ( Simvastatin ) as directed and consult your doctor.
Drug Name: Generic Zocor ( Simvastatin )
Indications:
Hypercholesterolaemia:
Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as a therapy to diet when response to diet or other non-pharmacological treatments (exercise, weight reduction) is inadequate.
Treatment of homozygous familial hypercholesterolemia as a therapy to diet or other lipid-lowering treatments (eg. LDL apheresis) or if such treatments are not suitable.
Cardiovascular Prevention:
Reducing cardiovascular morbidity and mortality in patients with clinically manifest atherosclerosis or diabetes, with normal or elevated cholesterol levels, as a combination therapy in correction of other risk factors or other therapies cardioprotection.
Dosage and administration:
The usual dose ranges from 5-80 mg simvastatin per day, administered orally in a single dose in the evening. Dosage adjustments, if necessary, be performed at intervals of less than 4 weeks, up to a maximum dose of 80 mg simvastatin per day
taken orally in a single dose in the evening. Dose of 80 mg simvastatin is only recommended in patients with severe hypercholesterolaemia and at high risk for cardiovascular complications.
Hypercholesterolaemia:
Patients should follow a standard cholesterol-lowering diet, to be continued while taking simvastatin. The usual starting dose is 10-20 mg simvastatin per day, administered orally in a single dose in the evening. Patients who require a greater reduction in
LDL-C (more than 45%) can start with 20-40 mg simvastatin per day taken orally in a single dose in the evening. If necessary, dose adjustment should be performed as mentioned above.
Homozygous familial hypercholesterolemia:
Based on the results of controlled clinical trials, the recommended dosage is 40 mg simvastatin per day administered simvastatin 80 mg simvastatin in the evening or day divided as follows: 20 mg simvastatin in the morning, 20 mg simvastatin and 40 mg
simvastatin at noon evening. In these patients, simvastatin should be used as an adjunct to other lipid-lowering treatments (eg. LDL apheresis) or when such treatments are unavailable.
Cardiovascular Prevention:
The usual dose is 20 to 40 mg simvastatin per day, administered orally in a single evening intake in patients at high risk of coronary heart disease (with or without hyperlipidaemia). Drug treatment can be started simultaneously with diet and
exercise. If necessary, simvsatatin dose adjustment should be performed as mentioned above.
Concomitant Therapy:
simvastatin is effective alone or in combination with bile acid sequestrants. The dose of simvastatin should be administered 2 hours before or 4 hours after administration of bile acid sequestrants. In patients receiving cyclosporine, gemfibrozil, other fibrates
(except fenofibrate) or lipid-lowering doses of niacin (3 1 g daily) with simvastatin , the maximum dose of simvastatin should not exceed 10 mg per day. In patients taking amiodarone or verapamil in combination with simvastatin, the maximum dose of
simvastatin should not exceed 20 mg simvastatin daily.
Dosage in renal failure:
In patients with moderate renal impairment adjustment is required. In patients with severe renal impairment (creatinine clearance below 30 ml / min) should be reconsidered doses over 10 mg simvastatin per day and, though it is considered that such doses are
required, simvastatin administration should be made with caution.
Simvastatin Contraindications:
· Hypersensitivity to simvastatin and any component of the product.
· Active liver disease or unexplained persistent elevations of serum transaminases.
· Pregnancy and Lactation
Pregnancy and lactation:
Pregnancy:
Simvastatin is contraindicated during pregnancy. Safety in pregnancy has not been established. No controlled clinical trials were made with simvastatin in pregnant women. Rarely received reports of congenital anomalies following intrauterine exposure to HMG-CoA
reductase. However, an analysis of 200 pregnancies exposed to simvastatin in the first quarter or other HMG-CoA reductase related, followed prospectively, showed a comparable incidence of congenital malformations in the general population. The number of pregnancies
was statistically sufficient to exclude an increase of 2.5 times or more in the incidence of birth defects calculated. Although there is no evidence that the incidence of birth defects in offspring of patients taking simvastatin or another HMG-CoA reductase
inhibitor differs from that seen similar to the general population, maternal treatment with Zocor (
simvastatin ) may reduce mevalonatului which is a precursor of cholesterol biosynthesis . Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have great impact on the risk of long associated hypercholesterolemia.
For these reasons simvastatin should not be administered to pregnant women trying to become pregnant or suspect they are pregnant. Treatment with simvastatin should be discontinued during pregnancy or up to clear detection of a possible pregnancy.
Nursing:
It is not known whether simvastatin or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the high potential of developing serious adverse reactions, women treated with simvastatin should not breast-feed
their children.
Effects on ability to drive or operate machinery:
Simvastatin has no or negligible influence on ability to drive or operate machinery. However, when driving or operating machinery should be taken into account that dizziness has been reported rarely in post-marketing experience with simvastatin.
Investigations:
Rare: elevation of serum transaminases (alanine aminotransferase, aspartate aminotransferase, g-glutamyl transpeptidase), elevated alkaline phosphatase, increased serum CK.
Overdose:
There have been few reports of overdose with simvastatin, the maximum dose taken was 3.6 g. No patients showed symptoms and all have recovered without sequelae. In the event of an overdose there is no specific treatment. In case of overdose are measures of
general symptomatic and supportive.
Primary hypercholesterolemia and combined hyperlipidemia:
In studies comparing the efficacy and safety of simvastatin in doses of 10, 20, 40 and 80 mg simvastatin daily in patients with hypercholesterolemia, the reduction of LDL-C the most important was 30, 38, 41 and 47%, respectively. In studies in patients with
hyperlipidaemia combined (mixed) with 40 mg simvastatin and 80 mg simvastatin daily reduced triglycerides was 28 and 33% (placebo: 2%) and increased HDL-C was 13 and 16% (placebo: 3%).
Pharmacokinetic properties:
Simvastatin is an inactive lactone that is hydrolyzed in vivo to a corresponding beta-hydroxyacid, a potent inhibitor of HMG-CoA reductase. Hydrolysis occurs mainly in the liver, the rate of hydrolysis in human plasma is very small.
Absorption:
Simvastatin is well absorbed and showed high selectivity for the liver, where it reached much higher concentrations than in other tissues. Simvastatin is retained solid first pass through the liver, the main site of action, then excreted in the bile. After
oral administration of simvastatin, the amount recovered as the active form in the systemic circulation is less than 5% of the administered dose. Maximum plasma concentration of active inhibitor are achieved 1-2 hours after administration. Concomitant food
intake does not affect absorption. The pharmacokinetics of a single or multiple doses of simvastatin showed that the product does not accumulate after multiple dosing.
Elimination:
Simvastatin is a substrate for CYP3A4. Major metabolites of simvastatin present in human plasma are the beta-hydroxyacid and four additional active metabolites. After an oral dose of radioactive simvastatin, 13% of the radioactivity was excreted in urine and
60% in faeces in 96 hours. This product is excreted in faeces via bile as unabsorbed product. After an injection i.v. beta-hydroxyacid metabolite with, half-life was 1.9 hours. On average, only 0.3% of the administration i.v. was excreted in urine as a deterrent.
Preclinical safety:
Based on pharmacodynamic data from clinical trials in animals, repeat dose toxicity, genotoxicity and carcinogenicity, it was shown that there is another risk for patients can be achieved by a pharmacological mechanism. Maximally tolerated doses of simvastatin
in rats and rabbits did not produce birth defects, nor did they affect fertility, reproductive function or neonatal development.
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