Simvastatin Stella 10mg treatment for lipid disorders (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Simvastatin

Ingredient

Composition information	Content
Simvastatin	10mg

Uses

Indications

Simvastatin Stella 10 mg is indicated in the following cases:

Treatment of primary blood cholesterol or mixed blood lipid disorders. The drug is used in the form of dietary support, when the body's response to the diet and other treatments for non -drug treatment (exercise, weight loss) is not enough.

Treatment of homozygous hyperplasia hyperplasia as a support for a diet and other lipid reduction measures (such as LDL separation) or when these measures are not appropriate.

Triglyceride treatment. Aspergillus Terreus. Simvastatin, which is an inactive lacton, after drinking is hydrolyzed into the corresponding beta-hydroxyacid. This is a 3-Hydroxy-3-Methylutayl-Coenzyme A inhibitor (HMG-COA). This enzyme catalyzes HMG-COA to Mevalonate, initially limiting cholesterol biosynthesis.

Pharmacokinetic

Simvastatin is an inactivated lacton that is easily hydrolyzed on Vivo into the corresponding acid form, a beta-hydroxyacid inhibitor of HMG-CAA, Simvastatin is a substrate of Cytochrom P450 CyP3A4 copper and powerful metabolism via the liver, the first position of the liver, the first position of the first impact of the liver. This substance.

less than 5% of oral doses in the circulatory system in the form of active metabolites. Both simvastatin and beta-hydroxyacid metabolites are associated with plasma proteins about 95%.

Simvastatin is mainly eliminated by biliary tract into the form of chemical substances. About 10 to 15% are found in urine, mainly in the form of active loss.

The waste sale time of beta-hydroxyacid metabolites is 1.9 hours.

Before taking Simvastatin Stella 10mg treatment for lipid disorders (3 blisters x 10 tablets)

How to use

Take oral, take a single dose in the evening.

Dosage

The single dose of 5 - 80mg/day in the evening. Adjust the dose, if needed, are done in a period of not less than 4 weeks to a maximum dose of 80mg/day, use a single dose in the evening.

The 80mg dose is only recommended in patients with severe hypercholesteroline hypertension and is at higher risk of cardiovascular complications that do not meet lower doses of treatment and when expected benefits are higher than potential risks.

Hyper cholesterol increases

Patients should follow a standard diet to reduce cholesterol, and continue this diet during treatment with simvastatin. Adjust the dose, if necessary, are implemented as prescribed above.

Based on the results of controlled clinical research, the recommended starting dose is 40 mg/day in the evening. Simvastatin must not exceed 40 mg/day.

Cardiovascular Prevention

The usual dose of simvastatin is 20 - 40 mg/day, the only dose in the evening in patients with high risk of coronary heart disease (CHD, with or not increasing blood lipids). Time

Simvastatin is effective when used alone or in combination with drugs attached to bile acid.

In patients using Amiodaron, Amlodipin, Verapamil, Diltiazem simultaneously with simvastatin, simvastatin dose should not exceed 20 mg/day.

Patients with kidney damage

There is no need to adjust the dose in medium renal failure patients.

No dose adjustment.

Children

For children and teenagers (boys and tanner II or higher and girls with menstrual periods for at least one year, 10-17 years old) suffered from hyperlested hypertension cholesterol, the starting dose is usually recommended for 10mg x 1 time/day in the evening. Eat this during the treatment of simvastatin. The dose should be used depending on the individual based on the purpose of recommendations for treatment for children. The dose adjustment must be performed within 4 weeks or more. Experience using simvastatin in children before puberty is limited.

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 10 mg you may experience unwanted effects (ADR).

Rare, 1/10000

Blood and lymphatic system: Anemia.

nerve: headache, paresthesia, dizziness, peripheral nerve pain.

digestive: constipation, abdominal pain, flatulence, indigestion, diarrhea, nausea, vomiting, pancreatitis.

Hepatitis: Hepatitis.

Skin and subcutaneous tissue: rash, itching, hair loss.

Bone muscle, connective tissue and bone: muscle disease (including muscle inflammation), muscle pepper still has or without kidney failure, muscle pain, muscle cramps. Systemic: weakness.

Clearly hypersensitivity syndrome has been reported rare including a number of manifestations: Evana, lupus -like syndrome, rheumatoid pain, dermatitis, vasculitis, thrombocytopenia, eosinophilia, gaining blood maple speed (ESR), arthritis and joint pain, urticaria, sensitive to light, fever, redness and discomfort.

Very rare, ADR

Mental: Insomnia.

Neurology: Memory reduction.

Liver: Liver failure and death.

Unknown frequency

Mental: depression.

Respiratory, chest and mediastinum: lung disease.

Muscle muscle, connective tissue and bone: muscle necrosis through the immune intermediaries, tendon diseases, sometimes complications due to tendon breaks.

Breeding and breast system: erectile dysfunction.

Relevant studies:

Rare: Increasing serum transaminase (Alanin Aminotransferase, Aspartat Aminotransferase, Y-Glutamy Transpeptidase), alkaline phosphatase; Increase serum ck concentration.

Increases HBA1C concentration and blood glucose when hungry has been reported to statins, including simvastatin.

has a rare report on cognitive impairment (such as dementia, forgetting, forgetting, memory loss, confusion) related to the use of statin, including Simvastatin. The reports are generally not serious, and recover when stopping statin with different symptoms onset (1 day to many years) and disappearing symptoms (on average 3 weeks).

In addition, the following unwanted effects have been reported to some statins:

Sleep disorders, including nightmares.

Sexual dysfunction. diabetes: Frequency depends on whether or not there are risk factors (blood glucose at 25.6 mmol/l, BMI (> 30 kg/m), hypertension, History of hypertension).

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

Simvastatin Stella 10mg contraindicated drug in the following cases:

Hypersensitivity to simvastatin or any ingredients of the drug.

Active liver disease or serum transaminase persistent without explaining.

Pregnant and lactating women.

Do not use more than 10mg of simvastatin/day when used in combination with: verapamil, diltiazem, droneedaron. And contraindicent for these drugs with preparations with simvastatin content> 20 mg.

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

Precautions when using

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

Simvastatin may increase the levels of creatin kinase 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, CK tests 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 the use of statin or fibrat before, a history of liver disease and/or drinking lots of alcohol, elderly patients (> 70 years old) with risk factors for medication, such as adherent medications and medications, such as adherent agents and drugs, such as adherent agents and drugs, such as adherent agents and drugs, such as adherent agents and drugs, such as adherent agents and medications, such as adherent drugs and drugs, such as adherent drugs and drugs, such as adherent drugs and drugs, such as adherent drug concentration special. In these cases, the benefits/risks should be considered and monitor patients clinically when treated with statin. If the test results CK> 5 times the upper limit of the normal level, do not start treating with statin.

During statin treatment, patients need to test CK when there are muscle manifestations such as muscle pain, muscle weakness or stiff muscle.

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 growth. Lipid quantification must be conducted periodically with no less than 4 weeks, and adjust the dose 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.

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 kidney failure due to muscle pattern such as severe acute bacterial infections, hypotension, surgery and large injuries, abnormalities of hormonal metabolism, electrolytes or uncontrolled convulsions.

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: The safety and effectiveness of simvastatin has not been evaluated in girls before puberty or in children under 10 years old. Simvastatin Stella 10 mg contains lactose, should not use this drug for patients with rare genetic problems galactose intolerance, total lactase enzyme deficiency or glucose-galactose.

The ability to drive and operate machinery

Simvastatin does not affect or negligible on the ability to drive and operate machinery.

Pregnancy

has not determined the safety of drugs 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

Strong Cytochrom P450 3A4 (iTraconazol, Ketoconazol, Erythromycin, Clarithromycin, HV-Protease inhibitors, Boceprevir, Telaprevir, Nefazodon, Posaconazol, Gemfrozol, GemfiBro, Cyclosporin, Danazol): Increasing the risk of muscle disease and muscle award due to increased HMG-COA Reductase inhibitors during treatment with simvastatin.

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.

cyclosporin, gemfibrozil: increase the area under the curve of simvastatin.

anticoagulant drugs: bleeding and prolonged time prothrombin 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/day).

When using blood cholesterol - a statin group simultaneously with: gemfibrozil, other fibrat blood cholesterol medications, high doses (> 1g/day), colchicin: increase the 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

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

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