Tormeg-10 mega We Care medicine prevents cardiovascular disease, increases blood fat (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Atorvastatin

Ingredient

Composition information	Content
Atorvastatin	10mg

Uses

Indications

Tormg-10 drugs are indicated in the following cases:

Treatment of lipid changes should only have part of many risk factors for participating in people at risk of significantly 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.

Cardiovascular disease prevention treatment

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, low HDL-C, 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 reinvestment or angina.

For type 2 diabetics and no clear clinical signs of coronary heart disease, but there are many risk factors for coronary heart disease such as retinopathy, diuretic albumin, smoking or hypertension. Atorvastatin is assigned to:

Reduce the risk of myocardial infarction.

Lam reduces the risk of stroke.

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

Reduce 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.

For increased blood fat, Atorvastatin is designated:

Support for diet to reduce partial parts, LDL-C, APOB and TG and increase HDL-C in patients with hypertonic blood cholesterol (heterozygous families and contractual homozygous) and mixed blood lipid disorders (Fredrickson La and IIB).

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

For patients with betalipoprotein (Fredrickson type III) disorders (Fredrickson III) without responding to a diet.

Reduce the part and LDL-C in patients with cholesterol hyperplasia due to homozygous family genetic as a drug that supports other lipid treatment (e.g., LDL) or if the treatment is not effective.

is a supportive medicine for a diet to reduce the part, LDL-C, and APO B level in boys and children postmenarchal, from 10 to 17 years old, increase cholesterol due to heterozygous family genetics if after a full test of diet treatment, the following results are 160mg/dl. Having a positive family history of early or two or more risks of purple -risk risks present in pediatric patients.

Expenditure limit: Atorvastatin has not been studied under abnormal conditions of lipoprotein abnormalities are mainly due to increased chylomicons (Fredrickson type I and V).

Pharmacokological

Atorvastatin, as well as some of its metabolic substances, has 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 the reduction of LDL-C rather 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 HMG enzyme - CoA Reductase, limited enzyme transfer 3 - hydroxy - 3 ethylglutaryl - Coenzyme A into Mevalonate, a precursor of sterol, including cholesterol. Cholesterol and triglycerides 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 (very low density lipoprotein).

triglycerid (TG) VA cholesterol in the liver is combined into VLDL and releases 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 (total C), LDL-cholesterol (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.

In animals, Atorvastatin reduces cholesterol and lipoprotein levels by inhibiting the HMG-COA Reductase enzyme and the process of synthesizing cholesterol in the liver and increasing the amount of LDL receptor in liver surface cells to increase the reabsorption and catabolism of LDL. Atorvastatin also reduces the production of LDL and the number of LDL particles. Atorvastatin reduces LDL-C in some patients with hypercholesterol hypercesting due to homosexual families (FH), some rare people respond to other lipid drugs.

A series of clinical studies have shown that increasing the concentration of parts, LDL-C, APO B (an LDL-C cell membrane complex) promotes atherosclerosis in humans. Similarly, reducing HDL-C levels (and transporting it, APO a) is associated with the development of atherosclerosis. Epidemiology investigations have established the incidence of the disease and the mortality rate of cardiovascular disease directly affects the concentration of C-Section and LDL-C and vice versa with the concentration of HDL-C.

Atorvastatin reduces partial parts. LDL-C and APO B in patients with hyperlested blood cholesterol (FH) of the zygote and heterozygous, non-genetic hyperchemical hyperglycemia and mixed blood lipid disorders. Atorvastalin also reduces VLDL-C and TG and increases the production of HDL-C VA Apolipoprotein A-1. Atorvastatin reduces partial parts, LDL-C, VLDL-C and APO B, TG, and non-HDL-C lipids and increases HDL-C in patients who only increase blood triglycerides. Atorvastatin reduces lipoprotein average cholesterol (LDL-C) in patients who accumulate β-lipoprotein in blood.

Like LDL, lipoprotein -rich cholesterol -rich lipoprotein, including VLDL, average density VLDL, Lipoprotein (IDL), and other lipids, can 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. The sale time of HMG - CoA Reductase inhibitors is about 20 to 30 hours due to the contribution of active metabolites.

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

How to use

oral.

Dosage

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

Atorvastatin starting dose is recommended for 10mg or 20mg once a day. Patients who require 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.

Atorvastatin can use a single dose at any time of the day, along with food or no food. Atorvastatin's start and maintenance dose should depend on the characteristics of each patient as well as the patient's treatment and response purpose. After starting or by Atorvastatin titration, lipid concentration should be analyzed within 2-4 weeks and adjust the dose accordingly.

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). Dosage should depend on the patient for the purpose of the therapy. The adjustment of the dose should be done for 4 weeks or longer.

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 inhibitors - COA Reductase (Statin group) and Fibrates group in general should be used cautiously.

Dosage in patients with renal failure

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

Dosage in patients using cyclosporine, clarithromycin, iTraconazole, or a combination of a ritonavir and saquinavir or lowavir 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 used in combination of Ritonavir and Saquinavir or Lopinavir and Ritonavir, Atorvastatin's doses exceeded 20mg, appropriate clinical assessments are proposed to ensure the lowest dose of Atorvastatin 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 high combination of drugs with plasma proteins, hemorrhage does not significantly increase Atorvastatin clearance.

What to do when forgetting a dose? If it is nearly time to take the next dose, skip the forgotten dose and take medicine at the next recommended dose. Do not take double dose to compensate for the forgotten dose.

Side Effects

When using Tormeg-10, you may experience unwanted effects (ADR).

The most common: muscle pain, diarrhea, nausea, aminotransferase alanine and increased liver enzymes, can lead to stopping treatment and occurs at a place of placebobplane.

The most reported side effects (2%and larger than the placebo group) do not have the causal relationship in patients treated with Atorvastatin in the placebo control tests (N = 8755) are: nasopharyngitis (8.3%), joint pain (6.9%), diarrhea (6.8%), quartet pain (6%).

Other adverse reactions are reported in placebo -control studies including:

The whole body includes fatigue, fever.

Digestive system: abdominal discomfort, belching, flatulence, hepatitis, cholestasis.

musculoskeletal system: musculoskeletal pain, muscle fatigue, neck pain, swelling.

Metabolism and nutrition: increased transaminase, liver function abnormalities, hyperplasia alkaline phosphate, increased creatine phosphokinase, hyperglycemia.

Nervous system: nightmares.

Respiratory system: nosebleeds.

Skin and appendages: urticaria.

Special senses: blurred vision, tinnitus.

Genital urinary system: Urine with white blood cells.

In addition, there are also side effects such as: cognitive decline (dementia, confusion ...), hyperglycemia, HBA1C.

Instructions on how to handle ADR

Notify the doctor with unwanted effects when using.

Warnings

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

Contraindicated

Tormg-10 drugs contraindicated in the following cases:

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

Hypersensitivity to any ingredients of the drug.

Be cautious when using

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

Consider monitoring Creatin Kinase (CK) in the case:

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 a lot of alcohol, elderly patients (> 70 years old) with risk factors for muscle pattern, drug -related ability 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 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 pattern accompanied by secondary acute renal failure leads to the urinary muscle that has been reported to Atorvastatin and with 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 monitored 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 suspended or stopped completely 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, endocrine and serious electrolytes).

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.

Liver dysfunction

Statin, like some other lipid therapy, is related to liver function abnormalities. The persistent increase (> 3 times on normal (ULN) occurs 2 or more times) serum transaminase occurs in 0.7% of patients taking Atorvastatin in clinical trials. The incidence of these abnormalities is 0.2%, 0.2%, 0.6%, and 2.3%corresponding to Atorvastatin 10, 20, 40 and 80mg content.

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. The dose should be reduced or stop using Atorvastatin, when ALT or AST persisted> 3 times on normal, Atorvastatin should be used cautiously in patients who drink a lot of alcohol or have a history of liver disease. Contraindications to 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. Statins interfere with cholesterol synthesis and theoretically can exhaust the production of adrenal steroids or gonads. Clinical studies show that Atorvastatin does not reduce plasma cortisol basic concentrations or reduce adrenal gland reserves. The effects of statin on the fertility of men have not been studying the sufficient number of patients. The effects, if any, on the pituitary -genital axis in premenopausal women are not known. Be careful if a statin is used simultaneously with drugs that reduce the concentration or activity of endogenous steroid hormones, such as ketoconazole, spironolacton, and cimetidine.

Used in recent stroke patients or rays

In an analysis of stroke groups in patients without coronary artery disease that has recent stroke or rays, there is a high percentage of hemorrhagic stroke in patients starting at the dose of 80mg Atorvastatin compared to the placebo group. Increasing risk of paying special attention in patients with previous hemorrhage stroke or Lacunar infarction (stroke) at the time of research. For patients with bleeding stroke before or Lacunar in the infarction area, the balance between risk and benefits of Atorvastatin 80mg is uncertain and the risk of hemorrhagic 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 the dose increases and periodically (for example: half a year) then.

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 nursing lactation, need to be consulted by medical 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. Patients treated with Atorvastatin have common side effects similar to patients treated with placebo. The most common side effects are observed that both groups, regardless of the cause and effect assessment, are infections. The dose greater than 20mg has not been studied in these patients. Young women must be consulted on appropriate methods of contraception during Atorvastatin treatment. Atorvastatin has not been studied in clinical trials related to puberty or patients younger than 10 years old.

Used for the elderly

Of the 39,828 patients treated with Atorvastatin in clinical studies, 15,813 (40%) of patients> 65 years old and 2800 (7%) of patients> 75 years old. In general, there is no difference in safety and effectiveness that have been observed between these subjects and the objects later and other clinical reports also do not identify the difference in response to the treatment between elderly patients and younger patients, but cannot eliminate sensitivity in the elderly is higher. Old age (≥ 65 years) is a risk 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

Atorvastatin is contraindicated in women with or may be pregnant. Cholesterol and triglycerides increased serum during normal pregnancy. Blood lipid medications are not beneficial during pregnancy because cholesterol and cholesterol derivatives needed for the normal development of the fetus. Atherosclerosis is a chronic process and discontinuing using blood lipid medications during pregnancy requires little impact on the long -term consequences of blood cholesterol treatment.

There is no complete research and well controlled the use of Atorvastatin during pregnancy. There are few reports or birth defects after the uterus is exposed to statins.

Statin can be harmful to the fetus when used for pregnant women. Atorvastatin should only be used for women of pregnancy when these patients are very difficult to conceive and have been informed about potential dangers. If women are pregnant while using Atorvastatin, they must be stopped immediately and the patient is advised again about potential dangerous lips for the fetus and lack of clinical benefits that are known to continue using drugs during pregnancy.

Breastfeeding period

It is not known whether Atorvastatin will be excreted in breast milk, but a small amount of other drugs in the same group goes into breast milk. Because other drugs in the group have gained breast milk and because the statins are likely to cause serious side effects for nursing babies, women who need to treat atorvastatin should be advised not to breastfeed.

Drug interaction

The risk of muscle disease during treatment with statins is increased when used simultaneously with fibric acid derivatives, niacin, cyclosporin, or strong CYP 3A4 inhibitors (for example: Clarithromycin, Protease HIV, and iTraconazole inhibitors).

Strong CYP3A4 inhibitors

Atorvastatin is metabolized by cytochrome P450 3A4. Simultaneous use of Atorvastatin with strong CYP 3A4 inhibitors can lead to increased plasma concentrations of Atorvastatin. The degree of interaction and ability to depend 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 prescribing the dose of 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 the atorvastatin doses 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 leads to renal failure and can be fatal. (See table below)

Statin

Protease inhibitors with interactions

Application recommendations atorvastatin Ritonavir

Telaprevir avoid using Atorvastatin. Ritonavir

fosamprenavir

fosamprenavir + ritonavir

saqinavir + ritonavir not more than 20mg atorvastatin/day. atorvastatin/day.The AUC of Atorvastatin increases significantly when using Atorvastatin 40mg with Itraconazole 200mg. Therefore, patients are taking otraconazole, should be careful to use the doses of Atorvastatin in excess of 20mg.

grapefruit juice

Grapefruit juice contains one or more CYP 3A4 inhibitors and can increase the plasma concentration of Atorvastatin, especially drinking grapefruit juice excessively (> 1.2L per day).

cyclosporin

Atorvastatin and metabolites of Atorvastatin are the substrates of OATP1B1 transportation. Oatp1b1 inhibitors (e.g. cyclosporin) may increase the bioavailability of Atorvastatin. AUC of Atorvastatin increases significantly when using Atorvastatin 10mg and cyclosporin 5.2mg/kg/day compared to the use of 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 disease/muscle disease when HMG-Coa Reductase inhibitors are used simultaneously with Gemfibrozil, should avoid simultaneous use of Atorvastatin with Gemfibrozil.

Other fibrat blood cholesterol medications

It is known that the risk of muscle disease during treatment with HMG-CoA Reductase inhibitors increases when used simultaneously with other fibrats, Atorvastatin should be cautious when used simultaneously with other fibrats.

High doses (> 1g/day)

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

Rifampin or other Cytochrome P450 3A4 induction drugs

Simultaneous use of Atorvastatin with cytochrome P450 3A4 (e.g. efavirenz, rifampin) can lead to a sharp decrease in the level of Atorvastatin in plasma. Due to the double -sided interaction mechanism of rifampin, it is recommended to take Atorvastatin simultaneously with rifampin, because the use of Atorvastatin once after using Rifampin is associated with significant reduction in plasma atorvastatin levels.

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 does not have a significant clinical effect on prothrombin when used for patients with long 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 under 30 ° C in a dry place. Avoid light and moist.

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