Essovas 10mg Assopharma Medicine Treatment for Hypertotoly Blood Cholesterol (3 blisters x 10 tablets)

Notify the physician the unwanted effects when using the drug.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

Effects on the liver:

The liver enzyme test should be tested before starting with Atorvastatin and in the case of clinical indications for testing later.

should conduct liver function tests when patients have any signs or symptoms of liver damage.

Patients with increased transaminase levels should be monitored until those abnormalities are resolved.

Should reduce the dose or stop Atorvastatin when transaminase increases above 3 times the upper limit of normal and prolonged level.

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

Preventing the risk of rules due to positive decrease in cholesterol levels (SparCl):

In post-ho analysis in the group of stroke groups of patients without coronary artery disease with stroke or transient brain anemia (recent rays) shows a higher rate of cerebral hemorrhage in patients starting with the dose of Atorvastatin 80mg than the placebo group.

Studies show that a special risk in patients with a history of cerebral hemorrhage or hole infarction.

For patients with a history of cerebral hemorrhage or infarction, when not sure that the risk and benefits of the atorvastatin dose of 80 mg should be considered, it is necessary to carefully consider the risk of brain hemorrhage before starting treatment.

Effects on skeletal muscle system:

As well as other HMG-Coa Reductase inhibitors, Atorvastatin can rarely affect the musculoskeletal system and cause muscle pain, myocarditis and muscle diseases that can lead to muscle pattern, a life-threatening situation characterized by increased creatin kinase level (CK) acute (> 10 times the upper limit of normal level), Myoglobin, which can lead to blood and myoglobin can lead to impaired impairment. Kidney.

Consider tracking 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) have risk factors for muscle panodauma, 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 results of CK test> 5 times the upper limit of normal levels, do not start treatment with statin.

During treatment:

Patients must notify aside when there are manifestations of muscle pain, stiffness, or muscle weakness, especially if there is complication of fever or weakness. When there are these manifestations, patients need to test CK to take appropriate interventions.

It is necessary to stop treating when the CK level increases significantly (> 5 times the upper limit of normal level).

If muscle symptoms become severe and disadvantage for daily activities, even if the concentration of CK has dropped ≤ 5 times the upper limit of normal levels, should consider stopping the drug.

If the symptoms have recovered and the CK level has returned to normal, can consider using Atorvastatin or replace it with other statins with the lowest dose and closely monitor the patient.

It is necessary to stop using Atorvastatin as soon as there is a clinical sign of increasing the concentration of CK (> 10 times the upper limit of the normal level), or if the diagnosis or suspicion of a muscle pattern.

Creatin kinase quantitative (CK):

Do not measure CK immediately after stressful sports practice or when present for any reason may cause CK increase because this will make it difficult to explain the value obtained. If CK concentration increases significantly compared to the initial level (> 5 times the upper limit of normal level), the results should be measured within 5-7 days later.

Coordination with other drugs:

Nguy cơ tiêu cơ vân tăng lên khi atorvastatin được dùng đồng thời với một số thuốc có thể gây tăng nồng độ atorvastatin trong huyết tương do ức chế mạch CYP3A4 hoặc các protein vận chuyển (như các thuốc cyclosporin, telithromycin, clarithromycin, delavirdin, stiripentol, ketoconazol, voriconazol, itraconazol, Posaconazol).

Increased risk of muscle lesions when coordinating statin with gemfibrozil and other fibrat blood cholesterol, high -dose niacin (> 1 g/day), colchicin, erythromycin, ezetimib (see the "drug interaction" section).

Simultaneous use of Atorvastatin with HIV and hepatitis C drugs (HCV) including Tipranavir, Ritonavir, Telaprevir, Lopinavir, Darunavir, Fosamprenavir, Saquinavir, ... can also increase the risk of causing muscle damage, the most seriousness is muscle pattern, kidney and damage, which leads to depression and can be caused by death. Drugs ”).

If possible, replacement (non -interactive) treatments should be used instead of these drugs.

Very rare report on immune necrosis through cell intermediaries (IMNM) during or after treatment with some statins. The clinical feature of IMNM is the limb muscle weakness and prolonged serum increases despite the Statin treatment.

In the case of the combination of these drugs with Atorvastatin is necessary, careful consideration of the benefits and risks of this combination.

When using these drugs, the concentration of Atorvastatin in plasma increases, encouraging the use of Atorvastatin at maximum doses. In addition, for strong CYP3A4 inhibitors, Atorvastatin starts lower doses and clinical monitoring appropriately.

No simultaneous recommendation atorvastatin and fusidic acid, thus suspend Atorvastatin during the use of fusidic acid.

Children:

There is no data on children's safety.

Interstitial lung disease:

The exception of interstitial lung disease has been reported to some statins, especially for long -term treatment. Symptoms include shortness of breath, dry cough and general health impairment (fatigue, weight loss and fever). If the patient suspects the progression of interstitial lung disease, the statin should be discontinued.

diabetes:

Some evidence suggests that the statin increases blood sugar and in some patients at high risk of diabetes, can lead to hyperglycemia, then need to take care of as patients with diabetes. However, this risk is not significant compared to the cardiovascular risk of statin, so it is not a reason to stop treatment. Patients with risk (glucose at 5,6 - 6.9 mmol/l, BMI> 30 kg/m, increase triglycerides, hypertension) should be clinically monitored and biochemical according to general instructions.

excipients:

Assovas contains lactose. Patients with rare genetic galactose intolerance, Lapp Lactose deficiency, or Glucose-Galactose should not use this drug.

The effect of drugs on driving and operating machinery

Atorvastatin has not significantly affected the ability to drive and operate machinery.

Use drugs for women during pregnancy and lactation

contraindicated to use Atorvastatin for pregnant and lactating women. Women are likely to be pregnant, so they should use appropriate contraception during treatment with Atorvastatin.

Interactive drug

The effect of shared drugs on Atorvastatin

Atorvastatin is metabolized by Cytochrome P450 3A4 (CYP3A4) and is a substrate for protein transport. The combination of drugs with CYP3A4 inhibitors or protein transport can lead to increased plasma Atorvastatin levels and increase the risk of muscle disease.

Increased risk of muscle damage when using statin simultaneously with gemfibrozil, other fibrat blood cholesterol medications, high -dose niacin (> 1 g/day), colchicin and ezetimib. If it is required to use these drugs, the dose should be reduced and closely monitor patients.

CYP3A4 inhibitors:

CYP3A4 strong inhibitors: significantly increasing the concentration of Atorvastatin (Please see more information about the effects of the combined treatment drugs on Atorvastatin's dynamics in the instructions for the usage of the drug -attached drug).

Should be avoided with strong CYP3A4 inhibitors (such as cyclosporin, telithromycin, clarithromycin, delavirdin, stiripentol, ketoconazole, voriconazole, otraconazole, posaconazole) if possible.

Simultaneous use of Atorvastatin with HIV and hepatitis C drugs (HCV) including Tipranavir, Ritonavir, Telaprevir, Lopinavir, Darunavir, Fosamprenavir, Saquinavir, ... can also increase the risk of causing muscle damage, the most serious hypertrophy of muscle pattern, kidney damage leads to depression.

In case of shared Atorvastatin with the above drugs, Atorvastatin should start at a lower doses and maximum dose of Atorvastatin should be considered and patients need appropriate clinical monitoring.

Average CYP3A4 inhibitors: (For example, erythromycin, diltiazem, verapamil and fluconazole) may increase the concentration of Atorvastatin in plasma (see more information about the effects of coordinated medications on Atorvastatin in the instructions for using drug -attached drugs). The coordination of erythromycin with statin increases the risk of muscle disease that has been observed.

Research on assessing the interaction of Amiodaron or Verapamil on Atorvastatin has not been done. Both Amiodaron and Verapamil are CYP3A4 inhibitors and when combined with Atorvastatin can increase interaction with Atorvastatin. Therefore, the maximum dose of Atorvastatin should be used and clinically monitoring appropriately when combined with moderate CYP3A4 inhibitors. Clinical monitoring should be properly monitored after starting or after adjusting the dose of inhibitors.

CYP3A4 induction drugs:

Use Atorvastatin combination with cytochrom P450 A3 (such as Efavirenz, Rifampin, St. John's Wort) can reduce Atorvastatin levels in plasma with different levels. Atorvastatin should be used simultaneously with rifampin due to the dual interactive mechanism of rifampin (induction with Cytochrom P450 3A and inhibit the absorption liver cells Oatp1b1V1V). Therefore, the delay in using Atorvastatin after using Rifampin will significantly reduce the level of Atorvastatin in plasma. The effect of rifampin on Atorvastatin concentration on liver cells has not been well known, if it is required to use the combination of these two drugs, the patient should be carefully monitored.

Protein transportation inhibitors:

Protein transportation inhibitors (such as cyclosporin) may increase Atorvastatin's contact rate (see Table 1). The effectiveness of inhibiting the absorption of liver transportation on Atorvastatin levels in liver cells is not known. If it is required to use these two drugs, the dosage is required and the patient closes tightly.

Colestipol:

Atorvastatin concentration and its metabolites in plasma are reduced by about 25% when used with Colestipol. However, the effect on lipid is higher when using atorvastatin with colestipol compared to each individual medicine.

Fusidic acid:

Studies on interaction between Atorvastatin and Fusidic acid have not been conducted. As with other statins, the effects on the muscle, including muscle pepper, have been reported after simultaneous use of Atorvastatin and Fusidic Acid. The mechanism of this interaction has not been well known. Patients should be carefully monitored and may need to suspend Atorvastatin.

The influence of Atorvastatin on other drugs:

digoxin:

When simultaneously use multi -dose Digoxin and Atorvastatin 10mg, the stable concentration of digoxin increases slightly. Patients should be carefully monitored if using digoxin.

Oral contraceptive pills:

Simultaneous use of Atorvastatin with oral contraceptives will increase the levels of norethindron and ethinyl oestradiol in plasma.

warfarin:

Simultaneous use of Atorvastatin 80mg daily with warfarin causes a decrease in prothrombin time by about 1.7 seconds in the first 4 days and return to normal within 15 days of Atorvastatin treatment.

Although it is very rare for interacting with clinical anticoagulic drugs that have been reported, prothrombin should be determined before starting atorvastatin and regularly checking in the early stages of treatment to ensure that there is no significant change in prothrombin.

After the time prothrombin is stable, it is still advisable to continue monitoring periodically for patients using anticoagulant drugs.

Children:

Interactive studies between drugs are only conducted in adults. The level of interaction in children is unknown.

The cavalry of the drug:

Due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.