Simvastatin Stella 20mg Medicine Treatment of hypercholesterol blood (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Simvastatin

Ingredient

Composition information	Content
Simvastatin	20mg

Uses

indications

Simvastatin Stella is indicated in the following cases:

Treatment of primary blood cholesterol or mixed blood lipid disorders, in the form of support for diet, when the body's response to a diet and other non -drug treatments (exercise, weight loss) is not enough. LDL) Or when these measures are inappropriate. Terreus. Simvastatin, which is an inactive lacton, after drinking is hydrolyzed into the corresponding Beta hydroxy acid. This is a reducing enzyme inhibitor 3 - hydroxy - 3 - methylglutaryl Coenzyme A (HMG - CoA). This enzyme catalyzes HMG - COA reactive reaction into Mevalonate, initially limiting cholesterol biosynthesis.

Simvastatin has been shown to reduce the level of LDL - C both normal and when increased. LDL is made from very low density protein (VLDL) and is mainly catabolized by high pressure LDL receptors. Simvastatin's LDL lowering mechanism may include reducing the level of VLDL - C and LDL receptor sensor, leading to reduction in production and increased catabolism of LDL - C. Apolipoprotein B also significantly reduced in the treatment process with Simvastatin. In addition, simvastatin also increases moderate HDL C and reduces plasma tg. The result of these changes is to reduce the ratio of total cholesterol/HDL - C and LDL - C/HDL - C.

Dynamic pharmacokinetics

The pharmacokinetic properties have been evaluated in adults. There is currently no pharmacokinetic data in children and teenagers.

absorption

In humans, simvastatin is well absorbed. The presence of beta - hydroxyacid in the circulatory system after a dosage of Simvastatin is found below 5% of the dose. The maximum concentration of active inhibitors is about 1-2 hours after taking Simvastatin. Food does not affect absorption.

Distribution

Simvastatin and metabolites are connected to protein> 95%. Pharmacokinetics when using single -dose and multi -dose Simvastatin shows that there is no accumulation of drugs occurring after multiple doses.

Metabolism

Simvastatin is an inactive lactone, easily hydrolyzed in vivo into beta - hydroxyacid corresponding, a strong inhibitor of HMG - COA Reductase. The hydrolysis process takes place mainly in the liver; In humans, the hydrolysis rate in plasma is very slow. In humans, Simvastatin is initially metabolized in the liver.

The metabolism of the liver depends on the blood flow in the liver. The liver is the initial acting position of the active form. Simvastatin is a substrate of CYP3A4. In humans, the main metabolites of simvastatin in plasma are beta - hydroxyacid and four additional metabolites.

Elimination

In humans, after taking the doses of Simvastatin marking radioactive, 13% of the active ingredient marked radioactive is found in urine and 60% in stool within 96 hours. The amount found in the fission shows the amount of drugs absorbed equivalent to the amount of excreted drugs in the bile as well as the amount of drugs that are not absorbed. After intravenously metabolic of beta - hydroxyacid metabolic, its waste sale time is 1.9 hours on average. Simvastatin is actively transported to liver cells by OatP1B1 transportation.

Before taking Simvastatin Stella 20mg Medicine Treatment of hypercholesterol blood (3 blisters x 10 tablets)

How to use

use Simvastatin Stella oral single dose in the evening.

Dosage

Simvastatin medicine is used at the lowest starting dose, then if necessary, can adjust the dose according to the needs and response of each person by increasing the dose of each other no less than 4 weeks apart and must monitor the harmful reactions of the drug, especially the harmful reactions to the muscle system.

Patients should follow a standard low cholesterol diet before starting treatment with simvastatin and should maintain this regime during treatment.

The usual starting dose of simvastatin is 10 - 20mg oral in the evening; The starting dose of 40mg can be used for patients at high risk of cardiovascular disease. Need to adjust the dose each spaced no less than 4 weeks to the maximum dose of 80mg x 1 time/day in the evening. Patients with hyperplastic hyperplasia hyperplasia can be treated at a dose of 40mg x 1 time/day in the evening, or 80mg daily is divided into 3 times: 20mg, 20mg and a dose of 40mg in the evening.

Patients with renal impairment: The starting dose is recommended by 5mg x 1 time/day and the dose of over 10mg x 1 time/day should be used cautiously.

Do not use more than 10mg of simvastatin/day when used in combination with: Verapamil, Diltiazem, Droneedaron. Contraindicated combination of these drugs with drugs with simvastatin content ≥ 20mg.

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

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? All patients recover without sequelae.

Management: There is no specific treatment in case of overdose. In this case, symptomatic treatment and supportive measures should be taken.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Simvastatin Stella you can experience unwanted effects (ADR).

Common

Digestive: diarrhea, constipation, flatulence, abdominal pain and nausea. Drugs.

Uncommon:

Neurological - muscle and bone: muscle disease (combining muscle weakness and increasing the level of creatin kinase (CK) plasma).

Neuros - muscles and bones: muscle inflammation, muscle pilot, leading to secondary acute renal failure due to myoglobinuria.

Add some unwanted effects when using Statin drugs:

Cognitive decline (such as memory loss, confusion ...).

Hyperglycemia.

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

Simvastatin Stella drugs are contraindicated in the following cases:

Hypersensitivity to simvastatin or any ingredients of the drug. Clarithromycin, Telithromycin, Protease inhibitors of HIV, BoCeprevir, Telaprevir, Nefazodon, Posaconazol, Gemfibrozil, Cyclosporin and Danazol).

Be cautious when using

enzyme tests before starting statin treatment and in the case of clinical indications for testing later.

It is necessary to consider when taking drugs belonging to the statin group for patients with risk factors leading to muscle damage. The statin group is at risk of harmful reactions to the muscle system such as muscle atrophy, muscleitis, especially for patients with risk factors such as patients over 65 years old, patients with unproven thyroid diseases, patients with kidney disease. Need to closely monitor the harmful reactions during drug use.

Simvastatin may increase the levels of creatin phosphokinase and transaminase. It should be noted that this condition is different from the diagnosis of chest pain in patients being treated with simvastatin.

Before treatment, Creatin Kinase (CK) test should be conducted in the following cases: impaired renal function, hypothyroidism, self -history or family history of genetic muscle disease, a history of muscle disease due to statin or fibrat before, a history of liver disease and/or drinking lots of alcohol, elderly patients (> 70 years old) have muscle risk factors that can increase the amount of compatibility in soy plasma. Drugs and some special patients. In these cases, the benefits/risks should be considered and monitor patients clinically when treated with statin. If the results of CK test> 5 times the upper limit of normal levels, do not start treatment with statin.

During the process of statin treatment, the patient needs to do CK test when there are muscle manifestations such as muscle pain, muscle weakness or muscle hardness.

Simvastatin can cause muscle disease and muscle diseases, especially with higher doses, need to be used carefully for patients at risk of muscle -solving, and especially for patients who are taking drugs that increase plasma simvastatin levels, need to stop using drugs if creatin phosphokinase increases significantly or if diagnosed.

Need to use caution for patients who drink a lot of alcohol and/or have a history of liver disease before.

Elderly patients: Because elderly patients often impaired renal function, should pay special attention to kidney function before starting treatment with simvastatin and from there later in this age group.

Children: Simvastatin's safety and effectiveness has not been evaluated in girls before puberty or in children under 10 years old.

The ability to drive and operate machinery

Simvastatin does not affect or negligible on the ability to drive and operate machinery. However, when driving or operating machinery, it should be noted that the dizziness has been reported during the circulation of the drug, though rare.

pregnancy

has not determined the safety of the drug in pregnant women. Because simvastatin reduces cholesterol synthesis and maybe other products of cholesterol biosynthesis chain, the drug can be harmful to the fetus when used for pregnant women. Therefore, contraindicated use of simvastatin during pregnancy.

Breastfeeding period

It is unknown whether it is simvastatin or metabolic substance is excreted into breast milk. Due to many serious potential reactions from simvastatin for infants, do not take medicine for breastfeeding women.

Drug interaction

CYP3A4 strong inhibitors: Increases the risk of muscle disease and muscle pattern due to increasing the activity of HMG-COA reducing enzymes in plasma when treated with simvastatin.

HIV Protease inhibitors: Concomplifying the use of blood lipids and statins with HIV and hepatitis C (HCV) can increase the risk of muscle damage, the most serious is muscle pattern, kidney damage leading to kidney failure and can be fatal.

Amiodaron, Verapamil and Danazol: The risk of muscle diseases and muscle awards increases when using simultaneously Amiodaron, Verapamil or Danazol with high doses of Simvastatin.

amlodipine and fusidic acid: increase the risk of muscle disease.

rifampicin: Reduce the area under the curve of simvastatin.

Coumarin anticoagulant: bleeding and prolonging prothrombin time has been reported in patients using simvastatin.

Grapefruit juice: Increases the concentration of simvastatin in plasma. Avoid using large amounts of grapefruit juice (> 1 liter (= 1.4 liters)/day).

gemfibrozil, other fibrat blood cholesterol medications, high doses (> 1 g/day), colchicin: increased risk of muscle lesions.

HIV and hepatitis C (HCV): increases the risk of muscle damage, the most serious is muscle pattern, kidney damage leads to kidney failure and can be fatal.

Storage

In closed packaging, dry place. The temperature does not exceed 30 ° C.

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