A.T atorvastatin 20mg An Thien treats hyperlipidemia, preventing cardiovascular disease (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Atorvastatin
Ingredient An Thien Pharmaceutical Joint Stock Company

Ingredient

Composition information	Content
Atorvastatin	20mg

Uses

Indications

A.T atorvastatin 20mg is indicated in the following cases:

Hypergathed blood lipid treatment

Atorvastatin được chỉ định để làm giảm cholesterol toàn phần, LDL - cholesterol, apolipoprotein B và triglycerid ở người lớn, thanh thiếu niên và trẻ em trên 10 tuổi tăng cholesterol máu nguyên phát bao gồm tăng cholesterol máu gia đình kiểu dị hợp tử (loại IIa) hoặc tăng lipid máu hỗn hợp (loại IIb), dùng như một liệu pháp hỗ trợ khi bệnh nhân không đáp ứng đầy đủ với chế độ Diet and other non -drug therapies (exercise, weight loss).

Atorvastatin is designated to reduce total cholesterol and LDL - cholesterol in adults with hyperlested hypertension of the family -type homozygous type: Use to support other lipid treatments (such as LDL blood extract) or when these therapies are not suitable.

Cardiovascular Prevention

Preventing cardiovascular events in patients with high cardiovascular disease.

Pharmacokology

Atorvastatin is a selective inhibitor and competition HMG-CoA Reductase, is an enzyme that catalyzes the conversion process 3-hydroxy-3-methyl-glutaryl-coenzyme A into Mevalonate, a precursor of cholesterol. Triglycerides and cholesterol in the liver will synthesize lipoprotein very low density (VLDL) and allocate into plasma to bring to peripheral tissue. The low density lipoprotein (LDL) is formed from VLDL and is mainly catabolized by high -level LDL receptors.

Atorvastatin reduces cholesterol and lipoprotein levels by inhibiting HMG - CoA Reductase and biosynthesis, cholesterol in the liver while increasing the number of LDL receptors on the cell surface in the liver to enhance LDL degradation.

Atorvastatin reduces LDL production and the number of LDL particles. Atorvastatin increases production and increases the LDL receptor activity along with a change that brings benefits of the quality of LDL particles circulating in the blood. Atorvastatin is effective in reducing LDL - C in patients with hypertwell hyperplasia, population group often does not respond to other blood lipid medications.

Atorvastatin has been shown to reduce the concentration of total cholesterol (30 - 46%), LDL - C (41 - 61%), Apolipoprotein B (34 - 50%), and triglycerides (14 - 33%) while increasing HDL - C and Apolipoprotein A1 in a dose response. These results are suitable in patients with hypertension hyperplasia, hypertonic hypercholesterol without family, and mixed lipids, including insulin -dependent diabetes patients.

Reducing total cholesterol, LDL - C, Apolipoprotein B has been shown to reduce the risk of complications and cardiovascular death.

pharmacokinetic

absorption

Atorvastatin is quickly absorbed after oral, maximum drug concentration in plasma (CMAX) is achieved within 1-2 hours. The absorption increases proportional to the dose of Atorvastatin. After drinking, the bioavailability of Atorvastatin film tablets is 95 - 99% compared to oral solution. The absolute bioavailability of Atorvastatin is about 12% and the whole body uses the HMG - CoA Reductase inhibitor activity is about 30%. Low -body bioavailability is thought to be due to the elimination in the gastrointestinal mucosa and/or first metabolism in the liver.

Distribution

The average distribution of Atorvastatin is about 381 liters. More than 98% Atorvastatin binds to plasma proteins.

Metabolism

Atorvastatin is metabolized by cytochrom P450 3A4 to form Ortho and Parahydroxy and other beta - oxidant products. These products continue to be glucuronid. Invitro, HMG inhibitor - COA Reductase of ortho and parahydroxy metabolites equivalent to Atorvastatin. About 70% of HMG inhibitors - CoA Reductase is due to active metabolites.

Elimination

Atorvastatin is excreted mainly through bile and/or liver metabolism. However, Atorvastatin does not seem to experience significant guts. Atorvastatin's semi -discharged plasma is about 14 hours. The sale time of metabolites has HMG - CoA Reductase inhibitors about 20 to 30 hours.

Elderly

Atorvastatin concentration and higher active plasma metabolites in healthy elderly people.

kidney failure

Kidney pathology does not affect the concentration of plasma or treatment effects of Atorvastatin and active metabolites.

Hepatic failure

Atorvastatin concentration and active metabolites in plasma increased significantly (about 16 times for CMAX and about 11 times for AUC) in patients with chronic liver disease due to alcohol (Child - PUGH B).

SLCO1B1 polymorphism: The absorption into the liver of all HMG - Coa Reductase inhibitors includes Atorvastatin that needs OatP1B1 transport protein. In patients with polymorphic SLCO1B1, the risk of increased contact of Atorvastatin, this can lead to an increased risk of muscle pattern. Polymorphism in OATP1B1 encryption gene (SLCO1B1 C.521cc) is associated with Atorvastatin's contact increase (AUC) to 2.4 times compared to patients without this genotype variant (C.521TT).

Before taking A.T atorvastatin 20mg An Thien treats hyperlipidemia, preventing cardiovascular disease (3 blisters x 10 tablets)

How to use

Atorvastatin 20mg is taken or taken once a day, drinking whole tablets with a glass of water, can be taken at any time of the day, with or without food.

Dosage

recommendations to start treatment 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 each spaced no less than 04 weeks and must monitor the harmful reactions of the drug, especially the harmful reactions to the muscle system.

Atorvastatin when used in combination with Amiodaron: Do not use more than 20 mg/day.

Need to follow a diet to reduce cholesterol. The dose prescribed by the physician or the following dose:

Initial dose: 10 mg/day. The dose can be adjusted (if necessary) after 4 weeks of treatment. The dose may be increased but not more than 80 mg/day.

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? When an overdose of the patient should be treated with symptoms and apply supportive measures when necessary. Should monitor liver function and ck concentration. Hemolysis may not benefit. Because most Atorvastatin binds to plasma proteins, hemolysis may not significantly increase the clearing of Atorvastatin.

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. Note that it should not be used double the prescribed dose.

Side Effects

When using A.T Atorvastatin 20mg, you may experience unwanted effects (ADR).

Common, 1/100

Infection: Nasomitis.

Immune: allergic reactions.

Metabolism: hyperglycemia.

Neurology: headache.

Respiratory: nosebleeds, sore throat and larynx.

Digestive system: constipation, flatulence, indigestion, nausea, diarrhea.

musculoskeletal and connective tissue: muscle pain, joint pain, pain in the limb, muscle spasm, joint swelling, back pain.

Testing: Unusual liver function test, increased blood creatin kinase.

Uncommon, 1/1000

Metabolism: Hypoglycemia, weight gain, anorexia.

Mental: Insomnia, nightmares.

Neurological: dizziness, paresthesia, dementia, decrease or loss of sensation, taste disorders.

Eyes: blurred vision.

ears and vestibular disorders: Tinnitus.

Digestive system: dry mouth, upper and lower abdominal pain, pancreatitis, heartburn.

liver - bile: hepatitis.

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

musculoskeletal and connective tissue: neck pain, muscle fatigue.

General: fatigue, weakness, chest pain, peripheral edema, fever.

Testing: White blood cells in urine positive.

Rare, 1/10,000

Blood and lymphatic system: platelets.

Neurological: peripheral neuropathy.

Eye: visual disorders.

liver: stasis.

Skin and subcutaneous tissue: Evaluation, water polished dermatitis include diverse roses, Stevens-Johnson syndrome, poisoned epidermal necrosis.

musculoskeletal and connective tissue: muscle disease, muscle inflammation, muscle pattern, tendon pain, sometimes tendon breaks.

Very rare, ADR

Immune: Anaphylaxis.

ears and vestibular disorders: hearing loss.

liver - bile: liver failure.

Reproduction: Big breast.

Side effects unknown frequency meet

musculoskeletal and connective tissue: Mechanical necrosis through immunity.

Children: often have the following unwanted effects:

Neurology: headache.

Digestive system: abdominal pain.

Testing: increased alanin aminotransferase, increased blood phosphokinase.

In addition, some other unwanted effects have been reported with a few statins:

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

Increase HBA1C sex dysfunction.

Depression.

A few cases of interstitial pneumonia, especially for long -term use.

diabetes. The frequency will depend on risk factors (thrilling blood sugar ≥5.6 mmol/l, BMI> 30 kg/m2, increase triglycerides, hypertension history).

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

A.T atorvastatin 20mg contraindicated in the following cases:

Hypersensitivity to any ingredients of the drug.

Caution when using

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

impact on the liver

Recommended the liver enzyme test before starting atorvastatin treatment and in case of clinical indications for testing later. Atorvastatin dose should be discontinued when serum transaminase concentration increases tripled with the upper limit of normal levels.

Be careful when using Atorvastatin in severe alcoholic patients and/or a history of liver disease.

Bone effects: Atorvastatin, such as other HMG-COA Reductase inhibitors, can cause muscle pain, muscle inflammation, and muscle disease that can progress to muscle and muscle threatening characteristic by increasing creatin kinase (CK) significantly (> 10 times the upper limit of normal levels), hyperlobobin blood and urine can lead to renal impairment.

measure the concentration of creatin kinase (ck)

Do not measure the concentration of CK after exertion or the presence of a certain cause increases the CK because this may falsify the results. If CK concentration before treatment> 5 times the upper limit of normal level (ULN) should not start treatment with Atorvastatin.

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 and/or drinking lots of alcohol, elderly patients (> 70 years old) with risk factors for muscle pattern, special 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, stiff muscle, muscle weakness, ... When these manifestations, patients need to test CK to take appropriate interventions.

Patients must be required to promptly report muscle pain, cramps, or muscle weakness, especially when accompanied by abnormal or fever.

If the symptoms occur while the patient is being treated with Atorvastatin, the concentration should be measured, if the concentration of CK> 5 times ULN, the treatment should be stopped.

If symptoms of severe and daily discomfort, even if CK concentration increases ≤ 5 x ULN, stop treatment should be considered.

If the symptoms are improved and the CK concentration returns to normal, it is recommended to reuse Atorvastatin with the lowest doses and closely monitoring.

Must stop treatment with Atorvastatin stating the concentration of CK increased> 10 x ULN, or if diagnosed or suspected of the pattern.

Simultaneously used with other drugs

Nguy cơ tiêu cơ vân tăng lên khi atorvastatin được dùng đồng thời với các thuốc có thể làm tăng nồng độ của atorvastatin trong huyết tương như chất ức chế mạnh CYP3A4 hoặc protein vận chuyển (ciclosporin, telithromycin, clarithromycin, delayirdin, stiripentol, ketoconazol, voriconazol, itraconazol, Posaconazole and HIV protease inhibitors include Ritonavir, Lopinavir, Atazanavir, Indinavir, Darunavir ...). The risk of muscle disease can also increase when used simultaneously with Gemfibrozil and other fibrats, BoCeprevir, Erythromycin, Niacin, Ezetimib, Telaprevir, or Tipranavir/Ritonavir. If possible, treatment should be considered and replaced with non -interactive drugs.

Using with CYP3A4 enzyme inhibitors may increase the concentration of Atorvastatin in plasma, leading to an increased risk of muscle and muscle disease. When used in combination with amiodarone, do not use more than 20 mg/day because it increases the risk of muscle elimination symptoms. For patients who have to take a dose of over 20 mg/day to be effective for treatment, the doctor may choose other antacidin drugs (such as pravastatin).

There have been very rare reports of immunompered muscle necrosis (IMNM) during or after treatment with some statin drugs. Clinically, the characteristic of IMNM is prolonged weakened muscle and increased creatin concentration of creatin even though stopping statin treatment. In case of simultaneous use of these drugs with Atorvastatin is necessary, the benefits and risks of treatment and should be carefully considered. When the patient is used, the drugs increase the concentration of Atorvastatin in plasma, the maximum dose of atorvastatin is recommended. In addition, in the case of strong CYP3A4 inhibitors, the starting dose of lower Atorvastatin should be considered and need appropriate clinical monitoring.

Concomitance the use of Atorvastatin and Fusidic acid is not recommended, so the temporary death of Atorvastatin may be considered during the treatment of fusidic acid.

Children

Safety of drugs on development in children has not been established.

Patients with interstitial lung disease

If using Atorvastatin, especially long -term use, is at risk of interstitial pneumonia with symptoms of shortness of breath, they are anchindled, impaired general health (fatigue, weight loss, fever). If the patient is found to develop interstitial lung disease, statin is discontinued.

Patients with diabetes

Statin may increase blood sugar, for patients at high risk such as 5.6 - 6.9 mmol/l, BMI> 30 kg/m2, increased triglycerides, hypertension needs to monitor both biochemical and clinical.

Autodity warning

The drug contains lactose. Patients with rare genetic problems of galactose tolerance, lactase deficiency or malposure - Galactose should not use this drug.

The ability to drive and operate machinery

A.T atorvastatin 20mg has not significantly affected the ability to drive or operate machinery.

Pregnancy

Contraindicated in pregnant women.

Breastfeeding period

Contraindicated in breastfeeding women.

Drug interaction

The effect of combined medications on Atorvastatin

Atorvastatin is metabolized by Cytochrom P450 3A4 and is a substrate of OATP1B1 transport protein. Concentrated use of CYP3A4 inhibitors or transport proteins can lead to increased Atorvastatin levels in plasma and increase the risk of muscle disease. This risk can also increase when using Atorvastatin simultaneously with other drugs that are likely to cause muscle disease, such as Fibric and Ezetimib acid derivatives.

CYP3A4 inhibitors

Strong CYP3A4 inhibitors have been shown to significantly increase the concentration of Atorvastatin. Simultaneously using strong CYP3A4 inhibitors (e.g. ciclosporin, telithromycin, clarithromycin, delavirdin, stiripentol, ketoconazole, voriconazole, otraconazole, posaconazol and HIV protease inhibitors include ritonavir, lowazir, actazanavir, indora Darunavir, etc.) should be avoided if possible. In case of simultaneous use of these drugs with Atorvastatin is inevitable, the starting and maximum dose should be used and appropriate clinical monitoring.

Moderate CYP3A4 inhibitors

For example, erythromycin, diltiazem, verapamil and fluconazole) may increase the level of Atorvastatin in plasma. Increased risk of muscle disease has been observed when using erythromycin combined with statin. Interactive research assess the impact of Amiodaron or Verapamil to Atorvastatin has not been done. Both Amiodaron and Verapamil are CYP3A4 inhibitors and simultaneously used with Atorvastatin can lead to increased contact of Atorvastatin. Therefore, the maximum dose should be considered and clinically considered appropriately when used simultaneously with moderate CYP3A4 inhibitors. Appropriate clinical monitoring is recommended after or after adjusting the dose of CYP3A4 inhibitors.

CYP3A4 induction drug

Simultaneous use of Atorvastatin with Cytochrom P450 3A (Efavirenz, Rifampin) drugs can reduce the level of Atorvastatin in plasma. Due to the dual interaction mechanism of rifampin (Cytochrom P450 3A touch and inhibit the OatP1B1 transport protein), the same use of Atorvastatin with Rifampin at the same time is recommended, but the use of Atorvastatin is slow after using Rifampin related to significant reduction of Atorvastatin concentration in plasma. The effect of rifampin on Atorvastatin concentration in liver cells is unknown and if used simultaneously inevitable, patients need to use it at the same time and be carefully monitored about effectiveness.

Transport protein inhibitors

Transport protein inhibitors (eg ciclosporin) may increase Atorvastatin's contact with unknown mechanism. If used simultaneously, it is inevitable, reduces the dose and needs clinical monitoring.

gemfibrozil/derivative of fibric acid

Use single fibrats sometimes related to mechanical problems, including muscle pattern. This risk increases when using simultaneously derivatives of fibric acid and atorvastatin. If used simultaneously, the lowest dose of Atorvastatin to achieve the goal of treatment should be used and the patient needs to be monitored appropriately.

ezetimib

Use single -rise ezetimibs sometimes related to muscle problems, including muscle pattern. This risk increases when used simultaneously Ezetimib and Atorvastatin. Appropriate clinical monitoring is recommended.

Colestipol

Atorvastatin concentration and lower -active plasma metabolites (about 25%) when Colestipol is used simultaneously with Atorvastatin. However, the lipid lowering effect is larger when used in combination with Atorvastatin and Colestipol rather than using a single medicine.

Fusidic acid

Interactive studies atorvastatin and fusidic acid have not been done. As with other statins, muscle problems, including muscle pepper, have been reported in post -marketing experience when using Atorvastatin and Fusidic acid simultaneously. The mechanism of this interaction is not known. Patients should be closely monitored and should stop temporarily treat Atorvastatin.

colchicin

Despite the unorcined atorvastatin and colchicin interaction research, cases of muscle disease have been reported when treating atorvastatin with colchicin, and should be cautious when prescribing Atorvastatin with Colchicin.

The influence of Atorvastatin on other combined treatment products

digoxin

When digoxin and atorvastatin 20 mg are used at the same time, the concentration of digoxin in a stable state increases slightly. Patients using digoxin should be monitored appropriately.

birth control pills

Simultaneous use of Atorvastatin with oral contraceptives can increase the concentration of Norethindron and Ethinyl Estradiol in plasma.

warfarin

Statin may increase the effects of warfarin. Prothrombin must be determined before starting to use statin and regular monitoring in the first stage of treatment to ensure no change in prothrombin time.

Children

Interactive studies are only done in adults. The level of interaction in children is not known to be recommended on the interaction between Atorvastatin and the Protease inhibitors of HIV and HCV

tipranavir + ritonavir, telaprevir: Avoid using Atorvastatin.

lopinavir + ritonavir: Use carefully and if necessary, the lowest atorvastatin dose should be used.

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

nelfinavir: not more than 40 mg atorvastatin/day.

Storage

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

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