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Simvatin medicine is made in tablet form, with the main ingredient being Simvastatin and other excipients. The drug is used to treat hypercholesterolemia and reduce the risk of death in patients with coronary artery disease.
1. Uses of the drug Simvatin
Simvatin drug has the following strengths: Simvatin 10mg (contains 10mg Simvastatin and excipients), Simvatin 20mg (contains 20mg Simvastatin and excipients). Simvastatin is a lipid-lowering drug synthesized from the fermentation products of Aspergillus terreus. After oral administration, Simvastatin (which is an inactive lactone) is hydrolyzed to the corresponding beta-hydroxy acid form. This is an HMG-CoA reductase inhibitor. This enzyme can catalyze the conversion of HMG-CoA to mevalonate, an early step in cholesterol biosynthesis.
Indications for use of Simvatin:
Treatment of hypercholesterolemia: Simvastatin is indicated as adjunctive therapy in a diet to reduce total cholesterol, apolipoprotein B, LDL-cholesterol and triglycerides in patients with unresponsive hypercholesterolemia. adequate response to diet or other non-pharmacological treatments. In addition, Simvastatin also increases HDL-cholesterol (good cholesterol), thereby reducing the LDL/HDL ratio and the total cholesterol/HDL ratio; Treatment of coronary artery disease: In patients with coronary artery disease and hypercholesterolemia, Simvastatin is indicated for use in reducing the risk of coronary death, reducing the risk of coronary revascularization surgery (dilation) coronary artery disease and bypass surgery), slowing the progression of coronary atherosclerosis (including reducing the growth of new lesions, reducing the phenomenon of complete obstruction); Other indications: Simvastatin is also used as an adjunct to diet and other treatment modalities to reduce elevations in total cholesterol, apolipoprotein B, and LDL-cholesterol in patients with familial hypercholesterolemia. homozygous inheritance (when the disease does not respond to other treatments). Contraindications to the use of Simvatin:
Co-administration of Simvastatin with strong CYP3A4 inhibitors such as: erythromycin, itraconazole, telithromycin, clarithromycin, HIV protease inhibitors, nefazodone, telaprevir, boceprevir, gemfibrozil, posaconazole, cyclosporin, danazol; Patients with hypersensitivity, allergy to one of the components of the drug; People with advanced liver disease, persistent elevation of serum transaminases (unknown cause); People with myopathy secondary to the use of other lipid-lowering drugs; Pregnant and lactating women.
2. Usage and dosage of Simvatin
Usage: Orally.
Dosage:
Treatment of hypercholesterolemia: Usual starting dose: 10mg/time/day, used in the evening. Patients with mild or moderate hypercholesterolemia can be started with a dose of 5m. Dosage adjustments can be made if necessary, and should be done only after a period of not less than 4 weeks of treatment. Dosage can be increased to 40mg/time/day, taken in the evening. In patients with severe hypercholesterolemia, unresponsive to 40 mg/day and at high risk of cardiovascular disease, the dose may be increased to 80 mg/day; Patients taking Simvastatin with Amiodarone should not exceed 20mg/day; If the concentration of LDL-cholesterol is less than 75mg/dL (1.94mmol/L) or total plasma cholesterol is less than 140mg/dL (3.6mmol/L), it is necessary to reduce the dose of Simvastatin; Familial hypercholesterolemia with homozygous inheritance: 40mg/time/day in the evening or 80mg/day in 3 divided doses 20mg - 20mg 40mg in the evening. Simvastatin should be used as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) in these patients when other therapies cannot be used; Coronary artery disease: The starting dose is 20mg/time/day, taken in the evening. If necessary, the dose of the drug can be adjusted as described above; Combination therapy: Simvastatin is effective either alone or in combination with bile acid agglutinators. If the patient is taking fibrate, cyclosporin or niacin with Simvastatin, the maximum dose is 10mg/day; Patients with Renal Impairment: Since Simvastatin is not extensively excreted by the kidneys, no dose adjustment is required in patients with moderate renal impairment. In patients with severe renal impairment (creatinine clearance less than 30ml/min), doses above 10mg/day should be carefully evaluated and used with caution; Hepatic impairment: No dose adjustment is required in patients with mild hepatic impairment. In patients with moderate and severe hepatic impairment, the drug should not be used. *Note:
It is necessary to treat with the lowest dose that the drug is effective. After that, if necessary, the dose of the drug can be adjusted according to the needs and response of each patient by increasing the dose at intervals of not less than 4 weeks, combined with monitoring for adverse drug reactions, especially especially those that are harmful to the muscle system; Patients should strictly follow a standard cholesterol-lowering diet prior to taking Simvastatin and continue to follow this diet during treatment with Simvastatin. Overdose: Currently, there is no specific treatment for overdose of Simvatin. When an overdose occurs, the patient is treated symptomatically and supportively. All patients can recover from drug overdose without leaving any sequelae.
Missed dose: If you forget to take a dose of Simvatin, the patient should notify the doctor immediately to receive the most appropriate advice.
3. Side effects of the drug Simvatin
When using Simvatin, patients may experience some side effects as follows:
Common: Constipation, flatulence, diarrhea, headache, abdominal pain, nausea, dizziness, blurred vision, weakness weakness, insomnia, musculoskeletal pain. Liver function test results increased to 3 times the upper limit of normal but were largely asymptomatic and reversible upon discontinuation of the drug; Uncommon: Myopathy (combined muscle weakness and increased plasma creatine phosphokinase), skin rash, sinusitis, rhinitis and cough; Rare: Myositis, rhabdomyolysis, cognitive impairment (confusion, dementia), acute renal failure secondary to myoglobinuria, elevated HbA1c, hyperglycemia. Patients should promptly notify the doctor about the side effects when using Simvatin for advice on the most appropriate management measures.
4. Be careful when using Simvatin
Before and while taking Simvatin, patients should note:
Consider using Simvatin in patients with risk factors for muscle damage. Simvatin medicine can cause adverse reactions to the muscle system, especially in patients with many risk factors such as people over 65 years old, people with kidney disease, people with uncontrolled hypothyroidism. It is recommended to closely monitor for adverse reactions during the use of the drug; Simvastatin may increase serum creatine phosphokinase and transaminase levels. This condition should be kept in mind for the differential diagnosis of chest pain in patients being treated with Simvastatin; Simvastatin should be temporarily discontinued in any patient with serious acute conditions suggesting a possible myopathy or risk factors for the development of renal failure secondary to rhabdomyolysis, hypotension. pressure, severe acute infection, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders, uncontrolled epilepsy; Liver enzyme tests should be performed prior to initiation of treatment with Simvastatin and in cases of clinical indications requiring subsequent testing; Careful monitoring of creatine kinase (CK) in the following cases: Before starting treatment, it is necessary to test CK in patients with impaired renal function, hypothyroidism, a personal or family history of myopathy. transfusion, history of myopathy due to previous use of fibrate or statins, history of liver disease or heavy alcohol consumption, elderly (over 70 years of age) with risk factors for rhabdomyolysis, potential for drug interactions, some special patients,... In these cases, it is advisable to weigh the benefits and risks and monitor the patient clinically during treatment with Simvatin. If the CK test result is more than 5 times the upper limit of normal, Simvastatin should not be used; During treatment with Simvastatin, the patient should notify the doctor when there are muscle symptoms such as muscle pain, weakness, muscle stiffness, ... When these symptoms are present, the patient should be tested. CK so that appropriate intervention measures can be taken; Simvastatin should be used with caution in patients who drink a lot of alcohol and have a history of liver disease; Should carefully monitor the side effects of Simvatin in elderly patients, with renal failure and hypothyroidism; Do not use Simvastatin in pregnant women. Simvastatin should only be used in women of childbearing age when it is certain that these patients are not capable of conceiving. If the patient becomes pregnant while taking the drug, Simvastatin should be discontinued immediately, the patient should be informed of the risk of toxicity to the fetus; It is not known whether Simvastatin or its metabolites are excreted in human milk, so it is best not to administer this drug to a nursing mother. If taking the drug, the mother should not breast-feed; In clinical trials in patients over 65 years of age receiving Simvastatin, there was no marked increase in adverse events. Therefore, the usual drug can be used in this group of patients; Currently, the efficacy and safety of Simvastatin in children under 18 years of age have not been established, so it is best not to use the drug for this group of patients; Simvatin drug can cause blurred vision, headache, dizziness, ... should be careful when driving, operating machinery.
5. Simvatin drug interactions
Drug interactions can affect the effectiveness of the treatment or increase the side effects. Therefore, the patient should inform the doctor about the drugs / supplements they are using, and their medical history. In addition, patients must not stop taking, start taking a drug, or change the dose or use of any medicine without the permission of the doctor.
Some drug interactions of Simvatin include:
Increased risk of muscle damage when Simvastatin is used concomitantly with drugs: Gemfibrozil, other fibrate-lowering cholesterol, colchicine, high-dose niacin (over 1g/day); Co-administration of Simvastatin with strong CYP3A4 inhibitors such as erythromycin, itraconazole, telithromycin, clarithromycin, HIV protease inhibitors, nefazodone, telaprevir, boceprevir, gemfibrozil, posaconazole, cyclosporin, danazol may increase the concentration of Simvastatin, increase the risk of myopathy; Avoid concurrent use of large amounts of grapefruit juice (more than 1 liter/day) while taking Simvastatin; Simvastatin should not be used more than 10mg per day when used in combination with Verapamil, dronedaron, diltiazem. Contraindications to the combination of these drugs with preparations containing Simvastatin 20mg or more; Do not use more than 20mg Simvastatin per day when used in combination with Amlodipine, Amiodarone, Ranolazine; Concomitant use of statin lipid-lowering drugs (including Simvastatin) with drugs for hepatitis C and HIV may increase the risk of muscle damage, most seriously rhabdomyolysis, kidney failure, kidney failure, even death; Simultaneous administration of simvastatin and digoxin resulted in a slight increase in digoxin plasma concentrations (less than 0.3 mg/mL) (by performing a digoxin radioimmunoassay) compared with co-administration of placebo and digoxin. Therefore, appropriate monitoring is recommended when initiating treatment with Simvastatin in patients receiving digoxin; Simvastatin slightly enhances the anticoagulant effect of coumarin anticoagulants. Simvastatin treatment did not cause bleeding or change in prothrombin time in patients not taking anticoagulants. When prescribed to use Simvatin, patients should strictly follow the doctor's instructions on how to use and dose the drug. This ensures effective treatment and prevents the risk of adverse reactions.
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