Tormeg-20 Mega We Care medicine prevents cardiovascular disease and increases blood fat (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Atorvastatin

Ingredient

Composition information	Content
Atorvastatin	20mg

Uses

indications

Tormeg drugs are indicated in the following cases:

Treatment of lipid changes should only have a part of many risk factors for participating in people with a significant risk of increasing atherosclerosis due to hypercholesterol. Therapy is recommended as a support for diet that limits saturated fat and cholesterol and other non -drug treatments that have not met the requirements. In patients with coronary artery disease or there are many risk factors for coronary artery disease, Atorvastatin can be started simultaneously with diet.

Preventing cardiovascular disease

In patients with no clear clinical signs of coronary heart disease, but there are many risk factors for coronary heart disease such as age, smoking, hypertension, HDL - C low or family history with coronary heart disease, Atorvastatin is designated to:

Reduce the risk of myocardial infarction.

Reduce the risk of stroke.

Reduce the risk of coronary re -ventilation or angina.

For patients with type 2 diabetes and there is no clear clinical sign of coronary heart disease, but there are many risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, Atorvastatin is designated to:

Reduce the risk of myocardial infarction.

Reduce the risk of stroke.

For patients with clear clinical signs of coronary heart disease, Atorvastatin is indicated to:

Reducing the risk of non -fatal myocardial infarction.

Reduce the risk of death from stroke and non -fatal stroke.

Reduce the risk of vascular re -vessel method.

Reduce the risk of hospitalization due to heart failure.

Reduce the risk of angina.

Hematoma

Atorvastatin is designated:

Support for a diet to decrease C - Total, LDL - C, APOB, and TG and increase HDL - C in patients with main blood cholesterol (heterozygous families and homozygous) and mixed blood lipid disorders (Fredrickson type IIA and IIB).

is a drug that supports the diet in treatment in patients with TG Thanh (Fredrickson Type IV).

For patients with the main blood betalipoprotein (Fredrickson type III) disorder without responding to a diet.

Reduces C - Total and LDL - C in patients with hypercholesterol hygiene by homozygous family as a drug that supports other lipid treatment (e.g., LDL separation) or if the treatment is not effective.

is a supportive medicine for a diet to reduce C - Total, LDL - C and APO B level in boys and girls postmenarchal, from 10 to 17 years old, increased cholesterol due to heterozygous family genetics if after a full test of diet treatment, there are the following results: LDL - C remaining> 190mg/DLL - CLO The active family history of cardiovascular disease early or harmful or many other cardiovascular risk factors presence in pediatric patients.

Shelf limit

Atorvastatin has not been studied under abnormal conditions of lipoprotein is mainly due to increased chylomicons (type I and V).

Pharmacokic

Atorvastatin as well as some of its metabolites, with pharmacological activity in humans. The liver is the main active place and is the main place to synthesize cholesterol and LDL clearance. The dosage of drugs is more correlated with reducing LDL - C than the drug concentration in the organs. The dosage for each patient must be based on treatment.

Mechanism of action

Atorvastatin is a selective competitive inhibitor at the enzyme HMG - CoA Reductase, limited enzyme transfer 3 - hydroxy - 3ethylglutaryl - Coenzyme A into Mevabonate, a precursor of sterol, including cholesterol. Cholesterol and trilglycerides circulate in the blood as part of the lipoprotein complex. By super centrifugal method, these complexes are separated into HDL (high density lipoprotein), IDL (Lipoprotein intermediate density), LDL (low density lipoprotein), and VLDL (Lipoprotein very low density.

triglycerid (TG) and cholesterol in the liver are combined into VLDL and release plasma to distribute to peripherals. LDL is formed from VLDL and is catabolized mainly through high -loving LDL receptors. Clinical and pathological research shows that the high plasma concentration of total cholesterol (C total), LDLCHOLesterol (LDL - C), Apolipoprotein B (APO B) promotes atherosclerosis in humans and is a risk factor for developing cardiovascular diseases, while increasing HDL -C levels reduces the risk of cardiovascular disease.

Atorvastatin reduces C - total. LDL - C and APO B in patients with hyperlested blood cholesterol (FH) of the zygote and heterozygous, non -genetic hypermens and mixed blood lipid disorders. Atorvastalin also reduces VLDL - C and TG and increases the production of HDL - C and Apolipoprotein A - 1. Atorvastatin reduces C - Total, LDL - C, VLDL - C and APO B, TG and non -HDL -C -HDL -C lipids in patients only increases blood triglycerides.

Atorvastatin reduces lipoprotein medium density cholesterol (LDL - C) in patients who accumulate b - lipoprotein in the blood. Like LDL, lipoproteins are rich in cholesterol -rich triglycerides, including VLDL, average density lipoprotein (IDL) and other lipids, which can also promote atherosclerosis.

High plasma triglycerides are often found in a trio of low HDL - C ratio and small LDL particles when combined with non -lipid metabolic risk factors for coronary heart disease. Thus, the total tg in plasma is not necessarily shown as an independent risk factor in coronary heart disease. Moreover, it has not been determined to be independent of the increase in HDL or lower TG for the risk of coronary artery and cardiovascular disease.

pharmacokinetic

absorption

Atorvastatin is quickly absorbed after oral, maximum plasma concentrations are achieved within 1 to 2 hours. The level of absorption increases proportional to the dose of Atorvastatin. Atorvastatin tablets are biological equivalent to the form of solution. The absolute bioavailability of Atorvastatin is about 12% and the bioavailability of the HMG - CoA Reductase enzyme inhibitor effect is about 30%. Low bioavailability is thought to be total clearance in the gastrointestinal mucosa or first metabolism in the liver.

Distribution

The distribution volume of Atorvastatin is about 381L. 98% Atorvastatin binds to plasma proteins.

Metabolism

Atorvastatin is converted by Cytochrome P450 3A4 into Ortho and Para hydroxylation derivatives and other products of oxidation beta. In vitro, HMG inhibitor - Coa Reductase by the metabolites of ortho and para hydroxylation equivalent to the ability to inhibit HMG - COA Reductase of Atorvastatin. About 70% of HMG - CoA Reductase inhibitors are due to active metabolites.

Elimination

Atorvastatin and metabolites of Atorvastatin are the substrate of P - Glycoprotein. Atorvastatin is eliminated mainly in bile after the metabolism in the liver or outside the liver. However, the drug undergo negligible intestinal cycle. Atorvastatin average sale time in plasma is about 14 hours. HMGCOA Reductase inhibitors inhibit activity is about 20 to 30 hours due to the contribution of active metabolites.

Special subjects

Elderly

Atorvastatin concentration in a healthy older plasma is higher than in young people while the influence on lipid can be compared to those who are healthy.

Children

There is no data in children.

Gender

Atorvastatin concentration in plasma in women is different from men (CMAX is about 20% higher and 10% lower AUC); However, there is no clinical difference in the effect of reducing LDL - C of Atorvastatin between men and women.

kidney failure

Kidney disease does not affect plasma concentrations or the effect of reducing LDL - C of Atorvastatin, so adjusting the dose in patients with kidney dysfunction is not necessary.

Artificial dialysis

While studies have not been conducted in patients with end -stage renal disease, the hemorrhage is not expected to significantly increase the clearance of Atorvastatin because the drug is strongly connected to plasma proteins.

Hepatic failure

In patients with chronic liver disease due to alcohol, the plasma concentration of Atorvastatin increases significantly. CMAX and AUC increases 4 times higher in patients with Childs - Pugh A. Cmax and AUC increases about 16 times and 11 times higher, respectively, in patients with Childs - Pugh B.

Before taking Tormeg-20 Mega We Care medicine prevents cardiovascular disease and increases blood fat (3 blisters x 10 tablets)

How to use

Oral drugs.

Atorvastatin can be used for a single dose at any time of the day, along with food or no food.

Dosage

hyperlipidemia (homozygous family and not by family genetics) and mixed blood lipid disorders (Fredrickson type ILA and ILB)

Atorvastatin starting dose is recommended for 10mg or 20mg once a day. Patients who request a large amount of LDL - C (greater than 45%) may start at a dose of 40mg once a day. The dose range of Atorvastatin from 10 - 80mg once a day.

Hyperty cholesterol caused by heterozygous families in children (10 - 17 years old)

Atorvastatin starting dose is recommended for 10mg/day, the maximum dose is recommended for 20mg/day (the dose higher than 20mg has not been studied in children).

Hyper cholesterol hyperglycemia

Atorvastalin dose in patients with hypertonic hypertonic hypertension from 10 to 80mg daily. Atorvastatin should be used as a drug that supports other lipid treatment (eg LDL) or if the treatment is not available.

Simultaneous treatment with other lipid medications

Atorvastatin can be used with synthetic bile acids. The combination of HMG - COA Reductase inhibitors (Statin group) and Fibrates groups in general should be used cautiously.

Dosage in patients with renal failure

Kidney disease does not affect plasma concentrations also does not affect the reduction of LDL - C of Atorvastatin, so adjusting the dose in patients with kidney dysfunction is not necessary.

Dosage in patients using cyclosporine, clarithromycin, otraconazole or combining a Ritonavir and Saquinavir or Lopinavir with Ritonavir

For patients with cyclicine, treatment should be limited to 10mg of Atorvastatin once a day. In patients using clarithromycin, iTraconazole or in patients with HIV that are using the combination of ritonavir and saqinavir or lowavir and ritonavir, Atorvastatin's doses exceed 20mg, appropriate clinical assessment is proposed to ensure the lowest dose of AtorVaslatin necessary.

Increased risk of muscle lesions when using statin simultaneously with the following drugs: Gemfibrozil, other fibrat blood cholesterol medications, high -dose niacin (> 1g/day), Colchicin.

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? In case of overdose, patients need to be treated symptoms and supportive measures. Due to the high combination of drugs with blood protein, hemorrhage does not significantly increase Atorvastatin clearance.

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 Tormeg 20mg, you may experience unwanted effects (ADR).

5 most common side effects in patients treated with Atorvastatin, muscle pain, diarrhea, nausea, increased aminotransferase alanine and increased liver enzymes, can lead to stop treatment and occur at a place of placebobplane than the placebo group.

Also encounter side effects such as: cognitive decline (dementia, confusion ...), hyperglycemia, HBA1C.

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

Tormeg drugs are contraindicated in the following cases:

Progressive liver disease with persistent liver enzymes cannot find the cause.

Hypersensitivity to any ingredients of the drug.

Pregnant women.

Women who are pregnant or may be pregnant.

Women who are breastfeeding.

Precautions when used

do liver enzyme test before starting treatment with Atorvastatin and in the case of clinical indications for testing later.

Consider monitoring Creatin Kinase (CK) in the case of

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 or drinking lots of alcohol, elderly patients (> 70 years old) with risk factors for muscle pattern, the possibility of drug interactions and some special patients. 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 notify when there are muscle manifestations such as muscle pain, stiffness, muscle weakness ... When these manifestations, patients need to test CK to take appropriate interventions.

skeletal muscle

A few cases of muscle pepper still accompanied by secondary acute renal failure resulted in a muscle that was reported to Atorvastatin and other drugs in this group. History of renal failure may be a risk factor for the development of muscle pattern. These patients need to be more closely monitoring for skeletal effects.

Atorvastatin, like other statins, sometimes cause muscle diseases, has detected such as muscle pain, muscle weakness combined with increased creatine phosphokinase (CPK)> 10 times ULN. Use high doses of Atorvastatin simultaneously with some drugs such as cyclosporine and powerful inhibitors CYP3A4 (such as clarithromycin, otraconazole and HIV protease inhibitors) increase the risk of muscle/muscle pattern.

Treatment with Atorvastatin should be temporarily suspended or have stopped him in any patient who is in severe acute muscle disease, or has potential risk factors for the development of secondary renal failure leading to muscle pattern (for example, severe infections, hypotension, surgery, trauma, metabolic disorders, endocrinology and serious electrolytes, and non -control episodes).

Increased risk of muscle damage when using statin simultaneously with the following drugs: Gemfibrozil, other fibrat blood cholesterol medications, high bureaucrats (> 1g/day), Colchicin.

Liver dysfunction

Statin, like some other lipid therapy, is related to liver function abnormalities.

Recommendations to do liver function tests before and 12 weeks after the beginning of treatment and when increasing the dose, and periodically (for example, half a year) after that. Liver enzyme changes usually occur in the first 3 months of treatment with Atorvastatin.

Patients with transaminase increases should be monitored until there are no abnormalities left. The dose should be reduced or stop using Atorvastatin, when ALT or AST donated> 3 times limited to normal.

Atorvastatin should be used cautiously in patients who drink plenty of alcohol or have a history of liver disease.

contraindicated with Atorvastatin for patients with progressive liver disease or increased transaminase for unknown cause.

Endocrine function

HBA1C increases and serum glucose concentration has been reported with HMG - CoA Reductase drugs, including Atorvastatin.

Be cautious if a statin is used with the drugs that can reduce the concentration or activity of endogenous steroid hormones, such as ketoconazole, spironolacton, and cimetidine.

Used in recent stroke patients or rays

For patients with bleeding stroke before or Lacunar in the infarction area, the balance between risks and benefits of Atorvastatin 80mg is uncertain and the risk of hemorrhage stroke should be carefully considered before starting treatment.

muscle pain

All patients who started treatment with Atorvastatin should be notified of the risk of muscle disease and promptly reported muscle pain, muscle weakness for unknown causes. The risk of this side effect increases when taking some drugs in the same group or drinking more grapefruit juice (> 1L) than the necessary amount. They should draft a doctor about all drugs, including prescription drugs and not prescribed.

liver enzymes

Recommendations to do liver function tests before and 12 weeks after the beginning of treatment and when increasing the dose, and periodically (for example, half a year) after that.

Pregnant women

Women of reproductive age should be advised to use an effective method of pregnancy to avoid pregnancy while using Atorvastatin. Discuss with patients about future pregnancy plans and discuss when to stop Atorvastatin if they are trying to conceive. Patients should be advised to stop taking Atorvastatin and see a doctor if they want to get pregnant.

Women who are breastfeeding

Women who are breastfeeding need advice not to use Atorvastatin. Patients with lipid disorders and breastfeeding, need to be consulted by health experts.

used for special subjects

Use for children

Safety and effectiveness in patients 10-17 years old with hypercemolic hyperglycemia has been assessed in a controlled clinical trial for 6 months in teenagers and girls.

Used for the elderly

Old age (> 65 years old) is a dangerous factor for muscle disease, Atorvastatin should be used cautiously in the elderly.

Hepatic failure

Atorvastatin is contraindicated for patients with progressive liver disease including increased liver transaminase.

The ability to drive and operate machinery

There has been no report on the effect of reducing the ability to drive and use dangerous machines of Atorvastatin.

Pregnancy

Contraindications.

Breastfeeding period

Contraindications.

Drug interaction

The risk of muscle disease during treatment with statins is increased when used simultaneously with fibric acid, niacin, cyclosporin or strong CYP3A4 inhibitors (for example Clarithromycin, HIV and iTraconazol inhibitors).

Strong CYP3A4 inhibitors

Simultaneous use of Atorvastatin with strong CYP 3A4 inhibitors can lead to increased plasma concentrations of Atorvastatin. The degree of interaction and ability to effect depends on different effects on CYP 3A4.

Clarithromycin

Atorvastatin's

AUC increases significantly when using Atorvastatin 80mg with Clarithromycin (500mg twice daily) compared to using Atorvastatin alone. Therefore, in patients using clarithromycin, should be cautious when menu atorvastatin exceeds 20mg.

combination of protease inhibitors

Atorvastatin's

AUC increases significantly when using Atorvastatin 40mg with combination of Ritonavir and Saquinavir (400mg twice daily) or Atorvastatin 20mg with Lopinavir and Ritonavir (400mg + 100mg twice daily) compared to using Atorvastatin alone. Therefore, patients are taking HIV Protease inhibitors should be cautious when using Atorvastatin exceeding 20mg.

Simultaneous use of statin lipid medications with HIV and hepatitis C (HCV) can increase the risk of muscle damage, the most serious muscle, kidney damage leading to kidney failure and may be fatal.

Avoid using Atorvastatin with Tipranavir + Ritonavir, Telaprevir.

Use carefully and if necessary, the lowest dose of Atorvastatin should be used: Lopinavir + ritonavir.

Not more than 20mg atorvastatin/day: Darunavir + Ritonavir, Fosamprenavir, Fosamprenavir + Ritonavir, Saquinavir + Ritonavir.

Not more than 40mg atorvastatin daily: nelfinavir.

iTraconazole

The AUC of Atorvastatin increases significantly when using Atorvastatin 40mg with Itraconazole 200mg. Therefore, patients are taking otraconazole, should be cautious about the use of Atorvastatin doses exceeding 20mg.

grapefruit juice

Grapefruit juice contains one or more CYP3A4 inhibitors and can increase the concentration of Atorvastatin's plasma, especially drinking grapefruit juice excessively (> 1.2L per day).

cyclosporin

The AUC of Atorvastatin increases significantly when using Atorvastatin 10mg and Cyclosporin 5.2mg/kg/day compared to Atorvastatin alone. In case of need to treat atorvastatin with cyclosporin, the atorvastatin dose should not exceed 10mg.

gemfibrozil

Due to the increased risk of muscle diseases, when HMG - Coa Reductase inhibitors are used simultaneously with Gemfibrozil, should be avoided atorvastatin simultaneously with Gemfibrozil.

Other fibrat blood cholesterol medications

Atorvastatin should be cautious when used simultaneously with other fibrats.

High doses (> 1g/day)

The risk of skeletal effect increases as Atorvastatin is used in combination with niacin, in this case, the dose of Atorvastatin should be reduced.

rifampin

or other Cytochrome P4503A4 induction drugs. Simultaneous use of Atorvastatin with cytochrome P4503A4 (e.g. Efavirenz, Rifampin) can lead to a sharp decrease in the concentration of Atorvastatin in plasma.

digoxin

When combined with multi -dose atorvastatin and digoxin, increase about 20% of plasma digoxin concentrations in a stable state. Patients who are using digoxin should be monitored appropriately.

Oral contraceptive pills

Simultaneous use of Atorvastatin with oral contraceptives will increase the AUC value of Norethindron and Ethinyl Estradiol. This increase should be considered when choosing birth control pills for women who are taking Atorvastatin.

warfarin

Atorvastatin has no clinical effects on prothrombin when used for patients with prolonged warfarin treatment.

colchicin

Cases of muscle disease, muscle pilot, have been reported to Atorvastatin in combination with colchicin, and should be cautious when prescribing Atorvastatin with Colchicin.

Storage

Store less than 30 ° C in a dry place. Avoid light and damp.

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