A.T atorvastatin 10mg An Thien treats total cholesterol, LDL - Cholesterol (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 informationContent
Atorvastatin10mg

Uses

indications

Atorvastatin 10 mg AT 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.

Pharmacokological

Atorvastatin is a selective inhibitor and competition HMG - CoA Reductase, is the catalytic enzyme in 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 pharmacokinetics

absorption: Atorvastatin is quickly absorbed after drinking, the maximum concentration of drugs 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 increase 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 10mg An Thien treats total cholesterol, LDL - Cholesterol (3 blisters x 10 tablets)

How to use

Atorvastatin is used 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 by doses of each other no less than 04 weeks and must monitor the harmful reactions of the drug, especially harmful reactions to the body system.

Patients should follow a diet that reduces cholesterol before starting atorvastatin treatment and should maintain this diet during treatment.

Atorvastatin's dose should be calibrated according to the patient's LDL - C value and response.

The normal starting dose is 10 mg once a day. The distance between the dose adjustments does not exceed 4 weeks. The maximum dose is 80 mg once a day.

Children: Hyper cholesterol should be treated by a doctor who has experience in treating hyperlipidemia in children and patients should be re -evaluated more often to assess the treatment progress.

Increasing cholesterol and increased lipids

Recommended doses for most patients is 10 mg once a day. The drug has a response to 2 weeks of treatment, and the maximum treatment is usually achieved within 4 weeks. Response is maintained in chronic treatment.

Use 1 tablet Atorvastatin 10 mg at

Patients should be started with Atorvastatin 10 mg daily. The dose should be personalized and adjusted every 4 to 40 mg per day. After that, the dose may be up to 80 mg daily or use a drug associated with bile acid combined with Atorvastatin 40 mg once a day.

Initial dose: Use 1 tablet Atorvastatin 10 mg at.

Adjust the dose to 40 mg

  • 4 Atorvastatin 10 mg tablets per day.

    • 2 tablets of atorvastatin 20 mg at AT daily.

    Adjust the dose to 80 mg

  • 8 Atorvastatin tablets 10 mg per day.
  • 4 tablets of Atorvastatin 20 mg at AT daily.

    • Atorvastatin dose in patients with hyperlested hypertly cholesterol is 10 - 80 mg per day. Atorvastatin should be used for other lipid reduction treatments (such as blood extract) or when other therapies are inappropriate.

  • Atorvastatin 10 mg AT: 1 - 8 capsules/day.
  • Atorvastatin 20 mg AT: 1 - 4 tablets/day.

    • The initial recommended dose is 10 mg/day. Higher doses may be necessary to achieve LDL - C concentration according to the current instructions.

    Initial doses: Use 1 tablet Atorvastatin 10 mg per day.

    Children

    For patients from 10 years old and over

    Initially recommended dose is 10 daily, can be adjusted up to 20 mg per day.

    Adjust the dose according to the response and tolerance of each patient. Safety information for children to treat with a dose of over 20 mg is limited.

    Initial dose: Use 1 tablet Atorvastatin 10 mg at AT daily, can increase to 2 tablets of atorvastatin 10 mg at AT daily or 1 Atorvastatin 20 mg AT daily.

    Children under 10 years old

    Experience is limited, so Atorvastatin 10 mg AT is not indicated in the treatment of patients under 10 years old.

    No need to adjust the dose in patients with renal failure.

    Atorvastatin should be used carefully in patients with hepatic impairment. Atorvastatin is contraindicated in patients with active liver disease.

    Elderly patients

    Effective and safe in patients over 70 years of age using the same recommended doses as in the common population.

    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 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 Atorvastatin 10 mg AT, you may experience unwanted effects (ADR).

    Common, 1/100

  • Infection: Nasomitis.
    • immune: allergic reactions. Metabolism: Hyperglycemia. nerve: 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: Extraordinary liver function test, hyperkema blood kinase.

    • Uncommon, 1/1000

  • Metabolism: hypoglycemia, weight gain, anorexia.
  • Mental: Insomnia, nightmares.
    • Neurological: dizziness, paresthesia, memory loss, reduction 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: thrombocytopenia.
    • nerve: peripheral neuropathy. Eye: visual disorders.

    liver: stasis.

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

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

    • Very rare, ADR

  • Immune: Anaphylaxis.
  • ear and vestibular disorders: hearing loss.
    • liver - bile: liver failure.
  • Reproduction: Big breast.

    • Side effects unknown frequency meet

  • musculoskeletal and connective tissue: muscle necrosis through immunity.

    • Children often have the following unwanted effects

  • Neurological: headache.
  • Digestive system: abdominal pain.
  • Testing: increased alanin aminotransferase, increased blood phosphokinase.

    • In addition, some other unwanted effects have also been reported to a few statins

  • Cognitive decline (such as dementia, confusion ...).
  • Increase HBA1C sex dysfunction.
    • depression.

    Some 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

    Atorvastatin 10 mg AT is contraindicated in the following cases:

  • Hypersensitivity to Atorvastatin or any other ingredient of the drug.

    • Patients with active liver disease or serum transaminases levels persistent exceeding 3 times the upper limit of normal levels that cannot be explained.

    Pregnant women, nursing women and women with the potential for pregnancy without using appropriate contraception.

    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 treatment with Atorvastatin and in the case of clinical indications for testing requests later. Atorvastatin dose should be discontinued when serum transaminase concentration increases tripled with the upper limit of normal levels.

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

    Bone impact

    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) clearly (> 10 times the upper limit of normal levels), hyperklobin blood and urine Myoglobin 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 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, the history of liver disease and/or drinking a lot of alcohol, elderly patients (> 70 years old) have special risks of medication and drug -related 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, muscle stiffness, muscle weakness, ... When there are these manifestations, patients need to do CK test 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 of CK should be measured, if the concentration of CK> 5 times ULN, the treatment should be stopped.
  • If the symptoms of severe and daily discomfort are daily, even if the CK level increases to ≤ 5 x ULN, the stop treatment should be considered.
  • If the symptoms are improved and the CK concentration returns to normal, should reuse Atorvastatin with the lowest dose and closely monitor.
  • 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

  • Increasing risk of muscle pattern when Atorvastatin is simultaneously used with drugs that may increase the concentration of Atorvastatin in plasma such as strong inhibitors CYP3A4 or shipping protein (Ciclosporin, Telithromycin, Clarithromycin, DelayIrdin, Stiripentol, Ketoconazol, Voriconazol, Voriconazol, Voriconazol, Voriconazole, Voriconazol, Voriconazol, Voriconazol, Voriconazol, Voriconzol, Voriconzol, Voricon, Voricon, Voricon, Voricone Itraconazole, 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 has been a very rare report on immunomperous 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.
  • Simultaneous 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

    Atorvastatin is not significantly affected by 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 10 mg are used at the same time, the concentration of digoxin is in a slight increase. 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 degree 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 20 mg atorvastatin/day.
    • nelfinavir: not more than 40 mg atorvastatin/day.

    Storage

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

    Other drugs

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