Silvasten Davi Pharm has lowered blood lipids (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Simvastatin, ezetimibe

Ingredient

Composition informationContent
Simvastatin20mg
Ezetimibe10mg

Uses

Indications

Silvasten drugs are indicated in the following cases:

Treatment of lipid changes should only be a component in many interventions in patients at high risk of atherosclerosis due to hyperlesterol. Lipid changes should be used to support diets (restricting saturated fat and cholesterol) and when responded to a diet and non -drug -free therapy is incomplete.

Increasing primary blood cholesterol

Silvasten is designated to reduce total cholesterol, low density lipoprotein cholesterol (LDL-C), apolipoprotein (APO B), triglycerides (TG) and Lipoprotein cholesterol are not high density (Non-HDL-C), and increase lipoprotein cholesterol high dormitory (HDL-C) in patients with cholesterol patients with cholesterol patients with cholesterol patients with cholesterol patients Hopatic family or not) or increase mixed blood lipids.

Hypertension of family blood hematoma (HOFH)

Silvasten is indicated to reduce total cholesterol and LDL-C in patients with homozygous family hypertension as a supportive therapy for other cholesterol therapy (such as LDL separation) or otherwise other therapies.

limited indications

There is no increase in the benefit of a member combined with the incidence of cardiovascular disease and cardiovascular death compared to simvastatin. The combined tablet has not been studied on disorders of blood lipid lipids I, III, IV and V Fredrickson.

Pharmacokology

Pharmacological group: HMG-CAA Reductase inhibitors combined with other lipid air conditioners.

ATC code: C10BA02 (Simvastatin and Ezetimibe).

Plasma cholesterol has two origin: exogenous origin (absorbed from the intestine) and endogenous origin (self -synthetic body). Silvasten is a combination of simvastatin and ezetimibe, which reduces plasma cholesterol with both inhibiting absorption and synthesis.

Simvastatin

Pharmacological group: Anti-hyperkemotic lipid hyperglycemia (HMG-CoA Reductase inhibitors, Statin group).

ATC code: C10AA07.

After drinking, Simvastatin-a non-activity lactone-hydrolyzed in the liver form 3-hydroxyacid form, with strong inhibition activity HMG-CoA Reductase (3 hydroxy-3-methylutaryl-coenzyme a reductase). This enzyme catalyzes the process of converting HMG-COA into Mevalonic acid, which is the early stage and the speed limit in the cholesterol biosynthesis path.

Simvastatin shows the effect of reducing LDL-C in both patients with normal and increased LDL-C levels. LDL is made up of VLDL and is mainly catabolized by LDL receptors with high affinity. The mechanism of reducing the LDL-C level of SIMVASTATIN may be involved in both reduced VLDL-C concentration and LDL receptor sensor, resulting in a decrease in synthesis and increased catabolism of LDL-C. Apolipoprotein B also decreased significantly when treated with simvastatin. In addition, simvastatin also increases moderate HDL-C and reduces the total triglyceride in plasma. Results reduced the rate of total cholesterol/ HDL-C and LDL-C/ HDL-C.

ezetimibe

Pharmacological group: Other lipid air conditioning groups.

ATC code: C10AX09.

Ezetimibe belongs to the new lipid lowering group, inhibitors inhibit the absorption of cholesterol and plant sterols in the small intestine. Ezetimibe is active when taken orally and has a different mechanism of other groups of hypoglycemic drugs (such as statins, bile acid -mounted drugs (resin), fibric acid derivatives, and plant stanols). The target molecule of Ezetimibe is sterol, Niemann-Pick C1-Like 1 (NPC1L1), which plays a role in the absorption of cholesterol and phytosterol in the small intestine.

Ezetimibe localized at the brush brush and inhibit cholesterol absorption, reducing cholesterol's transportation in the small intestine to the liver, while the sterines reduce cholesterol biosynthesis in the liver, and when used in combination, the two different mechanisms for supplementary effects in the hypoglycine effect.

pharmacokinetics

There is no significant pharmacokinetic interaction when coordinating Ezetimibe with simvastatin.

Simvastatin and Ezetimibe combined with pharmacokinetics similar to when taking two Simvastatin and Ezetimibe individuals.

Simvastatin

absorption

Simvastatin metabolizes and eliminates initially through strong liver, the amount of metabolites with 3-hydroxyacid activity is found during the circulation after taking a dose of Simvastatin, accounting for less than 5% of oral dose.

pharmacokinetics of active inhibitors and sums of plasma inhibitors are not affected when taking simvastatin right before low -fat meals.

Distribution

both simvastatin and 3-hydroxyacid form with human plasma proteins (95%). The peak concentration of the inhibitor reaches 1.3 - 2.4 hours after drinking. When the mouse for the mouse to drink Simvastatin has a distant isotope, the derivative of the radio isotope of Simvastatin passes through the bloody barrier.

Metabolism

Simvastatin is an inactive lactone, easy to hydrolyze in vivo forming 3 hydroxyacid form, a strong HMG-Coa Reductase inhibitor. Hydrolysis occurred mainly in the liver, the hydrolysis rate in human plasma is very slow.

HMG-CoA Reductase inhibitors are used as a basis for assessing 3-hydroxyacid metabolic pharmacokinetics (inhibited active substances) and of the sum of plasma inhibitors after taking simvastatin. The main metabolites present in human plasma are 3-hydroxyacid of simvastatin and 6'-hydroxy derivatives, 6'-Hydroxymethyl and 6'-Examethylen.

In Simvastatin people are well absorbed and undergoing metabolism and elimination in the liver. The metabolism and elimination in the liver depend on the rate of blood flow in the liver. The liver is a place to metabolize and eliminate the main, with most of the excretion of the drug through bile. Therefore the amount of active substance in the circulation is low.

After intravenous metabolic 3-hydroxyacid metabolic, the average selling time is 1.9 hours.

Elimination

Simvastatin is put into liver cells under the active mechanism of OatP1B1 transportation.

In humans, after taking 1 dose of Simvastatin marks 14C, 13% of the dosage excreted through the urine and 60% over the part for 96 hours. The amount of elimination drugs in the feces includes the amount of drugs absorbed in the bile and the amount of drugs is not absorbed. After intravenous metabolic 3-hydroxyacid metabolic substance, an average of about 0.3% of the injection dose is eliminated through urine in the form of inhibitor.

ezetimibe

absorption

After drinking, Ezetimibe is quickly absorbed and combined into Ezetimibe Glucuronid. The maximum concentration in plasma (CMAX) reaches about 1-2 hours after drinking for ezetimibe -glucuronid, and about 4-12 hours after drinking for ezetimibe. Food does not affect the bioavailability of Ezetimibe.

Distribution

Ezetimibe and Ezetimibe-Glucuronid associated with plasma proteins at 99.7% and 88 ~ 92%.

Metabolism

Ezetimibe is metabolized mainly in the small intestine and liver through a combination of glucuronid. Ezetimibe and Ezetimibe -Glucuronid are the main compounds found in plasma, Ezetimibe accounts for 10-20% and Ezetimibe -Glucuronid accounts for 80 - 90% of the total amount of drugs in plasma. Both Ezetimibe and Ezetimibe-Glucuronid are slowly eliminated from plasma due to the intestinal cycle. The half-life of Ezetimibe and Ezetimibe-Glucuronid is about 22 hours.

Elimination

After taking 14C-Ezetimibe (20 mg), about 93% Ezetimibe is present in plasma. After 48 hours, no longer found drugs present in plasma. About 78% and 11% are found in feces and urine within 10 days.

Special subjects

Children

Ezetimibe: Ezetimibe pharmacokinetics similar to children 10 - 18 years old and adults. There is no complete information about the pharmacokinetics of the form of children's combination (see more "Causes of caution when taking the drug").

Elderly

Simvastatin: In a study, there are 16 elderly people (70 - 78 years old) using Simvastatin at a dose of 40mg/ day, the average level of HMG -COA inhibition in the elderly increases about 45% compared to 18 people aged 18 - 30 years old.

Ezetimibe: The plasma concentration of Ezetimibe is 2 times higher in the elderly (> 65 years) compared to young people (18 to 45 years old). The effect of reducing LDL-C and the safety of the drug is equivalent to the elderly and young people.

Hepatic failure

Ezetimibe: Ezetimibe's AUC increases in patients with liver failure. No dose adjustment in patients with mild liver failure (Child -Pugh from 5 to 6). Due to the unknown effect of AUC increases in patients with medium liver failure (Child-Pugh from 7-9) or severe (Child-Pugh> 9), it is not recommended to use ezetimibe in this patient.

kidney failure

Simvastatin: Dynamic pharmacokinetic research on other statins has the same elimination line with simvastatin showing that with the same system of system exposure can increase in patients with severe renal impairment.

Ezetimibe: In patients with severe renal impairment (CLCR

In patients with kidney transplantation and using many drugs, including cyclosporin, exposure to ezetimibe increased by 12 times.

Gender

Ezetimibe: Plasma concentrations in women are slightly higher than men (about 20%). The effectiveness of LDL-C and the safety of the drug is equivalent to men and women. No need dose by gender.

polymorphic genotypes

Simvastatin: In people with genotype SLCO1B1 C.521T> C, OATP1B1 has lower activity. The average exposure of metabolites has a major activity, Simvastatin acid is 120% in people with heterozygous (CT) and 221% in people with homozygous alenes (CC) compared to people with the most common genotype (TT). Alen C has a frequency of 18% in European population. In polymorphic gene SLCO1B1, there is a risk of increasing system exposure to simvastatin, which can increase the risk of muscle pattern.

Before taking Silvasten Davi Pharm has lowered blood lipids (4 blisters x 7 tablets)

How to use

Silvasten is used orally, once a day in the evening, not affected by food. Do not quit the tablet.

Patients should follow a low -cholesterol diet when starting to use the drug and continue according to this diet during treatment.

Dosage

Adults

The usual dose is 1 tablet/day.

Simvastatin dose should be adjusted to each patient based on plasma lipid levels. It is advisable to start treating with the lowest dose that the drug works, then if necessary, can adjust the dose according to the needs and response of each person by increasing the dose of each time apart from less than 4 weeks and must monitor the harmful reaction of the drug, especially the reaction is harmful to the muscle system.

The starting dose of simvastatin is usually 10mg or 20mg/day, increasing the dose after 4 weeks if necessary, the maximum dose is 80mg/day. Due to the risk of unwanted effect, the maximum dose of 40mg is only used when necessary and under the monitoring of specialists.

Silvasten is a combination tablet containing Simvastatin 20mg Ezetimibe 10mg, used to replace Simvastatin 20mg and Ezetimibe 10mg individually or used to coordinate Ezetimibe when treated with Simvastatin 20mg does not achieve treatment goals. Silvasten is not suitable for other dosage indications.

Elderly

No dose adjustment in these patients.

Children

Starting treatment should be conducted under the monitoring of a specialist.

Children> 10 years old (puberty: boys have tanner> II and girls at least 1 year after menstruation)

Clinical information in children (10 - 17 years old) is limited. Simvastatin dose should be adjusted to each patient, the starting dose is usually 10mg/day, maximum of 40mg/day.

Children

It is not recommended to use Silvasten in children

Patients with liver failure

No dose adjustments in patients with mild liver failure (Child Pugh 5 - 6). It is not recommended to use Silvasten in patients with average liver failure (Child-Pugh 7-9) and severe (Child-Pugh> 9). Contraindications for patients with progressive liver disease or prolonged serum transaminase for unknown reasons.

Patients with renal failure

No dose adjustment in patients with mild renal impairment (glomerular filtration level> 60ml/min/1.73m2). In patients with chronic renal failure and with glomerular filtration

Used with Amiodaron, Amlodipin, Ranolazin: Do not use more than 20mg of simvastatin/day.

Simultaneous use of Verapamil, Diltiazem, Droneedaron: Contraindications.

Simultaneous use of Lomitapid: Do not use simvastatin more than 40mg when combined with Lomitapid.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Silvasten

In case of overdose, symptomatic treatment and support. Simultaneous use of Ezetimibe (1000mg/kg) and simvastatin (1000mg/kg) are well tolerated in the study of acute toxicity when taken in rats and mice. There is no signs of clinical toxicity on research animals. LD50 predicts both mice is simvastatin> 1000mg/kg, Ezetimibe> 1000mg/kg.

Simvastatin

Only a few overdose shifts are reported. The highest dose used is 3.6g. All patients recover without sequelae.

ezetimibe

In clinical research using Ezetimibe 50mg/day over 15 healthy people in 14 days, or 40mg/day on 18 patients with hypercholesterolemia within 56 days, the drug is well tolerated.

A few cases of overdose Ezetimibe have been reported, most of them have unwanted effects. Unwanted effects are not serious. When an overdose, patients should be treated with symptoms and applied supportive measures when necessary.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when forgetting a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

When using Silvasten, you may experience unwanted effects (ADR).

The unwanted effect of a higher coordination member than Placebo.

Common (1/100

  • Biochemical: increased ALT or AST, increased blood care.
  • biochemical: hyperburin blood bilirubin, hyperuricemia, gamma-glutamyltransferase, Inr, proteinuria, weight loss.
  • nerve: dizziness, headache. Itching. 1/10)

  • Biochemical: Increase ALT or AST.
  • biochemical: increased blood bilirubin; hyperkemia, gamma-glutamyltransferase. four limbs.
  • Blood and lymph: Thrombocytopenia, anemia vessel. Pain. Including a few manifestations: Evala, lupus -like syndrome, low muscle pain, multiple muscle inflammation, vasculitis, platelets, eosinophilia, increasing the speed of red blood cells, arthritis and joint pain, urticaria, light sensitivity, fever, redness, shortness of breath and fatigue.

    There have been some rare reports of cognitive decline (for example: dementia, forgetfulness, memory loss, confusion) related to the use of statin. Cognitive decline has been reported to all statins. Often not serious, and capable of restoring statin, with the time of symptoms of change (from 1 day to many years) and the ability to recover different symptoms (on average 3 weeks).

    HBA1C and Glucose blood glucose have been reported with statins including simvastatin.

    In addition, the following unwanted effects are also reported to a few statins:

  • Sleep disorders, including nightmares.
  • Sexual dysfunction. It is necessary to closely monitor and recommend the patient to notify the doctor with unwanted effects when using the drug.

    Instructions on how to handle ADR

    When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

  • Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    Contraindicated

    Silvasten drugs contraindicated in the following cases:

  • Patients with susceptible to simvastatin, ezetimibe or any ingredients of the drug.

    Patients with progressive liver disease or prolonged serum transaminase without unknown cause.

    Used with strong Inhibitors CYP3A4 (such as Itraconazol, Ketoconazole, Posaconazole, Voriconazole, Erythromycin, Clarithromycin, Telithromycin, HIV Protease inhibitors (such as Nelfinavir), BoCeprevir, Telaprevid, Nefazrondon, GemfibroDon, GemfibroDon, GemfibroDon, GemfibroDon, GemfibroDon, GemfibroDon, GemfibroDon, GemfibroDon Cyclosporin, Danazol and drugs containing COBICISTAT).

    Collaborate with Verapamil, Diltiazem, Droneedaron.

    Do not use simvastatin more than 40mg when combined with lomitapid.

    Precautions when using

    before and during treatment with statin, it is recommended to combine blood cholesterol control by measures such as diet, weight loss, exercise, and treatment of diseases that may be the cause of lipid hyperplation. Periodically check blood lipids and adjust the dosage according to the patient's response to the drug. The goal of treatment is to reduce LDL cholesterol, so it is necessary to use LDL cholesterol levels to start treatment and evaluate treatment. Only when the LDL cholesterol is not tested, will the total cholesterol use to monitor treatment.

    muscle/muscle disease

    muscle disease and muscle pilot have been reported when using ezetimibe. Most of the pattern reports occur in patients using Ezetimibe in combination with statin. However, muscle pattern is very rare in patients using Ezetimibe monomers as well as when used simultaneously Ezetimibe with other drugs may increase the risk of muscle pattern. The risk of muscle pattern increases when the activity inhibits HMG-COA Reductase in high plasma.

    Consider muscle disease in any patient who is treating statin and has a muscular pain, a weak muscle or a pain in the pain, and has an increase in serum levels (5 times larger than the normal limit of normal). Statin therapy must be stopped if serum concentration increases or if diagnosed or suspected of muscle disease. If muscle aches do not increase or increase moderate serum (

    Statin therapy must be suspended or stop in any patient who shows signs of acute and severe muscle disease or has risk factors prone to acute renal impairment due to muscle pattern, such as severe acute bacterial infections, hypotension, surgery and large trauma, abnormal metabolism, endocrine, electrolytes or uncontrolled convulsions.

    Reduce the function of transport protein

    Reducing the function of the liver's transport protein in the liver may increase the exposure to the system of simvastatin acid and increase the risk of muscle disease and muscle pattern. The cause may be due to inhibition due to drug interactions (such as cyclosporin) or in patients with SLCO1B1 C.521T> c.

    Track Creatin Kinase (CK)

    Consider monitoring Creatinin Kinase (CK) in the case:

    Before treatment

    CK tests should be conducted in the following cases: impaired renal function, women, hypothyroidism, history of themselves or families suffering from genetic muscle disease, a history of muscle disease due to the use of statin or fibrat before, a history of liver disease or drinking a lot of alcohol, elderly patients (> 70 years old) have risk factors for muscle pattern, the possibility of drug interactions and some special patients. In these cases, the benefits/risks should be considered and clinically monitored when treated with statin.

    If CK test results> 5 times ULN should not start statin treatment.

    During Statin treatment

    Patients need to immediately notify muscle pain, muscle weakness or muscle spasms for unknown causes, especially with discomfort and fever ... When there are these manifestations, the patient needs to do CK test to take appropriate interventions.

    liver enzyme

    In clinical trials, a small number of people who take ezetimibe combined with simvastatin see significantly increasing serum transaminase (> 3 times ULN). Recommended the liver enzyme test before starting treatment and in the case of clinical indications for testing requests later (such as suggested manifestations with liver damage). Periodic monitoring of liver function as previously recommended often does not help because of severe liver damage due to rare statin use and unpredictable in every patient, cautious when using simvastatin in severe alcoholic patients or a history of liver disease. Simvastatin should be stopped or reduced if serum transaminase concentration is 3 times the upper limit of normal levels. Note that the ALT may have muscle origin, so if ALT increases with CK, it can be a muscle disease.

    Hepatic failure

    Due to the unknown effect when increasing the concentration of ezetimibe in patients with medium or severe liver failure, it is not used for these patients.

    diabetes

    Statin groups may increase blood sugar, HBA1C in some patients. Blood sugar monitoring in patients is at risk, and appropriate treatment if hyperglycemia. Benefits of reducing the risk of cardiovascular events greater than the risk of diabetes, should not stop treating statin.

    Children

    Safe and effective when using Simvastatin and Ezetimibe in children from 10 to 17 years old with hyperplobe hyperplanded hyperplanded family heterosexuals have been assessed in a clinical study in boys (tanner> II) and girls at least 1 year after menstruation.

    In this study, there was no effect on the development and maturity of boys and girls, or the menstrual effect on the menstrual cycle of girls. However, the influence of ezetimibe on development and maturity when used for prolonged> 33 weeks has not been studied.

    Ezetimibe has not been studied in children

    Effective when using Ezetimibe prolonged children

    Fibrats

    There is no information on the safety and effectiveness of Ezetimibe in combination with Fibrat.

    Simultaneously used with anticoagulant drugs

    When using Silvasten with warfarin or anticoagulant drugs, or fluindion, it is necessary to monitor Inr cautiously.

    Interstitial lung disease

    There has been an interstitial lung disease report with some statins, including simvastatin, especially when long -term treatment. Expressions may include shortness of breath, dry cough and health impairment (fatigue, weight loss and fever). If there is a suspected patient with interstitial lung disease, the statin should be stopped.

    Other cautions

    Only use statin for women of reproductive age when they are certainly not pregnant and only in the case of hypercesting blood cholesterol is very high without responding to other drugs.

    Silvasten contains lactose, patients with galactose intolerance, lapp lactase deficiency or glucose-galactose absorption disorders should not be used.

    The ability to drive and operate machinery

    Note that the use of the drug can cause dizziness, so it is necessary to be cautious when driving.

    or operate machinery while there are still symptoms.

    Pregnancy

    Silvasten

    Contraindicated Silvasten in pregnant women, women intend to get pregnant or suspect pregnancy, only use statin for women of reproductive age when they are certainly not pregnant and only in the case of hypercesting very high blood cholesterol without responding to other drugs. There is no information about the use of simvastatin/ezetimibe combination formats in pregnant women. Animal research shows reproductive toxicity.

    ezetimibe

    There is no information about using ezetimibe in pregnant women. Using Ezetimibe mono -treatment on pregnant animals does not see the indirect and direct harmful effects on pregnant animals, fetal development, childbirth and development after birth.

    Simvastatin

    There is no sufficient information about the safety of simvastatin on pregnant women. Because statins reduce cholesterol synthesis and maybe many other substances with biological activity derived from cholesterol, the drug can be harmful to the fetus if used for pregnant women. So contraindicated use of statin during pregnancy.

    Breastfeeding period

    ezetimibe distributed into animal milk, whether the drug is distributed into human milk or not. Contraindicated use of Silvasten in breastfeeding women.

    Drug interaction

    Pharmacological interaction

    Interaction with blood lipid medications can cause muscle disease.

    Increase the risk of muscle damage when using statin simultaneously with the following drugs:

  • gemfibrozil.

    Fibrat increases cholesterol elimination through bile, causing gallstones. Dog research, ezetimibe increases cholesterol in bile in gallbladder. Clinical effects on people are unknown, do not recommend sharing silvasten with fibrat.

    Pharmacokinetic interaction

    Interactions can increase the risk of muscle and muscle disease.

    Strong CYP3A4 inhibitors such as otraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV Protease inhibitors (such as Nelfinavir), Boceprevir, Telaprevir, NefazODon, and other cobicists, drugs and drugs Gemfibrozil, Cyclosporin, Danazol: Contraindications.

    Other fibrats, fusidic acid: do not recommend coordination.

    Niacin high doses (nicotinic acid)> 1g/day: Do not recommend coordination in Asian patients.

    verapamil, diltiazem, droneedarone: Do not use more than 10mg of simvastatin/day. Contraindicated in combination with preparations with simvastatin> 20mg.

    Amidodaron, Amlodipin, Ranolazine: Do not use more than 20mg of simvastatin/day.

    Lomitapid: In patients with homosexual cholesterol hypertension, do not use more than 40mg of simvastatin/day.

    Grapefruit juice: Avoid using large amounts of grapefruit juice (> 1l/day).

    The effect of other drugs on Silvasten

    Niacin: Shared Niacin with a combination of simvastatin/ezetimibe 20/10mg slightly increased absorption of niacin and nicotinuric acid, ezetimibe, simvastatin, simvastatin acid.

    ezetimibe

    Anti -acid drugs: reduces Ezetimibe absorption, but does not affect the bioavailability of ezetimibe. This absorption reduction is not clinical significance.

    cholestyramin: When used with Ezetimibe, it can reduce the absorption of Ezetimibe.

    cyclosporin: simultaneously use Ezetimibe with cyclosporin, increasing blood concentration of both special drugs in patients with severe renal impairment. Should be cautious when starting to use ezetimibe for patients who are taking cyclosporin.

    Fibrat groups: Sharing Ezetimibe with Fenofibrat or Gemfibrozil increases the total concentration of Ezetimibe to 1.5 and 1.7 times respectively. Although the above interaction is considered to have no clinical significance. Contraindicated with Gemfibrozil, is not recommended to use with other fibrats.

    Simvastatin

    CYP3A4 inhibitor: Simvastatin is the substrate of CYP3A4. Used with CYP3A4 inhibitors increases the risk of muscle disease and muscle pattern due to increased HMG-Coa Reductase inhibitors in serum.

    Contraindicated to use with strong Inhibitors CYP3A4 (such as Itraconazol, Ketoconazole, Posaconazol, Voriconazole, Erythromycin, Clarithromycin, Telithromycin, HIV Protease inhibitors (such as Nelfinavir), Boceprevir, Telapreviron, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon Gemfibrozil, Cyclosporin, Danazol and drugs containing cobicistat).

    Be cautious when combined with weaker CYP 3A4 inhibitors such as fluconazole, there is a muscle pattern report when shared. Be cautious when coordinating with the average inhibitor CYP 3A4.

    Avoid using large amounts of grapefruit juice (> 1l/day).

    Protease inhibitors of HIV and hepatitis C (HCV): Concomitance the clinical lipid medications of Statin group with HIV and hepatitis C (HCV) can increase the risk of muscle damage, the most serious muscle, kidney damage leads to renal failure and can be fatal.

    Amiodaron, Amlodipin, Ranolazin: Do not use more than 20mg of simvastatin/day when used in combination.

    Fusidic acid: increases the risk of muscle disease and muscle pattern when shared. Shared, increasing the serum concentration of both medications. The mechanism is not well understood. Do not use simvastatin with fusidic acid. The case has been recorded when using the same two drugs. Statin should be stopped during the time of using fusidic acid. Statin can be used after 7 days after stopping fusidic acid. When it is necessary to use fusidic acid in patients who are taking statin (severe infection), consider based on patient condition and must be closely monitored.

    Lomitapid: Used in combination can increase the risk of muscle disease and muscle pattern. In patients with hyperlested cholesterol of the family, do not use a combination of simvastatin/ezetimibe more than 40/10mg daily.

    Oatp1b1 shipping protein inhibitors: similarly used with OatP1B1 inhibitors may increase the risk of muscle disease and muscle pattern caused by simvastatin.

    Colchicin: Used in combination can increase the risk of muscle disease and muscle pattern.

    Rifampicin: Due to the CYP3A4 touch rifampicin, in patients using prolonged rifampicin, simvastatin may be ineffective.

    Niacin: There has been a report on muscle pattern when using a combination of simvastatin with niacin (> 1g/day).

    Bile acid -mounted resins: It can significantly reduce the bioavailability of statin when taken with, so the time to use these two drugs must be apart.

    The effect of Silvasten on the pharmacokinetics of other drugs

    Anticoagulant: Need to monitor the patient's INR when used simultaneously with warfarin, anticoagulant drugs, or fluindion.

    Ezetimibe does not touch Cytochrom P450 enzyme, no clinical pharmacokinetic interactions have any clinical significance with metabolic drugs by cytochrom P450 1A2, 2D6, 2C8, 2C9, and 3A4, or N-acetyltransferase.

    Simvastatin does not inhibit CYP3A4. Therefore, simvastatin does not affect the plasma concentration of metabolites through CYP3A4.

    Children: Interactive research is only done on adults.

  • Storage

    In a dry place, avoid light, the temperature does not exceed 30 ° C.

    Expiry date: 36 months from the date of manufacture. Do not use overdue drugs stated on the packaging.

    Manufacturer: Dat Vi Pharmaceutical Joint Stock Company.

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