Atozet medicine 10mg/20mg MSD prevents cardiovascular diseases, treats primary blood cholesterol (3 blisters x 10 tablets)

Cases of muscle disease, including muscle pepper, have been reported when Atorvastatin is simultaneously used with colchicin and should be cautious when prescribing Atozet with Colchicin.

Should suspend or stop treating with Atozet in any patient who has an acute, serious condition suggesting a muscle disease or a risk factor that makes it prone to secondary kidney failure due to muscle pilot (for example, severe infections, hypotension, surgery, metabolic disorders, endocrine disorders, heavy electrolytes and uncontrolled convulsions).

liver enzyme

In simultaneous use tests in patients using Ezetimibe with Atorvastatin, observing a continuous transaminase (> = 3 times the upper limit of normal level [ULN]).

Atorvastatin, like another lipid reducing treatment book, is associated with biochemical abnormalities in liver function.

Recommended the implementation of liver enzyme tests before starting Atozet treatment and repeated when clinically indicated. There has been a after -sales report of fatal and non -fatal liver failure in patients using statins, including Atorvastatin. If the liver damage is serious with clinical symptoms and/or increased blood bilirubin or jaundice occurs during Atozet treatment, it is necessary to stop treating immediately. If there is no other cause, do not reuse Atozet.

Be careful when using Atozet in patients with a lot of alcohol and/or a history of liver disease. Persistent liver disease or persistent transaminase is not explained as contraindicated use of Atorvastatin.

Endocrine function

Statin interferes with cholesterol synthesis and theoretical surface can reduce the production of adrenal steroids and/or sex steroids. Clinical studies have shown that Atorvastatin does not reduce the basic plasma cortisol levels or reduce adrenal reserves. The effect of statin on male fertility has not been studied with the appropriate number of patients. The effects, if any, to the pituitary-genitals in the premenopausal women are not known. Be careful when Atozet is used simultaneously with drugs that can reduce the concentration or activity of endogenous steroid hormones such as ketoconazole, spironolacton and cimetidine.

Hepatic failure

Due to the unknown effect of the increase in ezetimibe concentration in patients with average liver or severe liver failure, Atozet is not recommended in these patients.

Fibrats

gemfibrozil: avoid simultaneous use of Atozet with gemfibrozil.

Fenofibrat: Be careful when prescribing Atozet and Fenofibrat because Fenofibrat can cause muscle disease when used alone. If the gallstones are suspected in patients being treated with Atozet and Fenofibrat, the gallbladder is needed and should consider treating other lipids.

Other fibrats: simultaneous use of ezetimibe with other fibrats has not been studied. Therefore, using Atozet and other fibrats are not recommended.

Fusidic acid

Patients being treated with fusidic acid simultaneously with Atozet may have a high risk of muscle disease/muscle pattern. The use of fusidic acid is not recommended. In patients where the use of fusidic acid is considered necessary, should stop using Atozet during treatment with fusidic acid. In special cases, the use of Fusidic acid is long, for example in the treatment of severe infections, the need for simultaneous use of Atozet and Fusidic acid should only be considered on the basis of each case under tight medical supervision.

anticoagulants

If used simultaneously atozet with warfarin, other anticoagulants, or fluindion, international standardized ratio (INR) should be followed appropriately.

Used in new patients with stroke or transient ischemic attack (ray)

In a post-post analysis of the study on stroke prevention by actively reducing the agricultural cholesterol (SparCl) using Atorvastatin 80mg compared to the placebo in 4,731 subjects without coronary artery disease (CHD) that has a stroke or transient ischemic anemia (ray) within the previous 6 months, a higher rate of stroke due to the higher hemorrhage is seen in the ATORVASTATIN 80MG group placebo. The rate of stroke due to hemorrhage is similar to treatment groups. The rate of stroke due to non -fatal bleeding is significant in the group using Atorvastatin compared to the placebo group. Some basic characteristics, including stroke due to hemorrhage and a hole stroke when put into research related to a higher rate of stroke due to hemorrhage in the Atorvastatin group.

Interstitial lung disease

Some exceptions of interstitial lung disease have been reported with a few statins, especially with long -term therapy. Signs can cover shortness of breath, dry cough and general health reduction (fatigue, weight loss and fever). If the patient is suspected of developing interstitial lung disease, statin should be discontinued.

diabetes

Some evidence that statin is a group of drugs that increase blood glucose and in some patients, at high risk, they will have future diabetes, statin can cause a level of hyperglycemia that treats diabetes officially.

However, a decrease in cardiovascular risk with statin is superior to this risk and therefore is not the reason for stopping treatment with statin. Patients with risk (glycemia at 5,6-6.9mmol/l, body mass index (BMI)> 30kg/m2, increased triglycerides, hypertension) should be monitored both clinically and biochemical according to national instructions.

excipients

Atozet contains lactose. Patients with rare genetic diseases in tolerance Galactose, Lapp Lactase enzyme deficiency, or poorly collected glucose-galactose should not use this medication.

Use in children

There is no enough data on safe and effective Atozet use in children's patients.

The effect of the drug on the ability to drive and operate machinery

There has been no research on impact on the ability to drive and operate machinery. However, some adverse effects have been reported to Atozet that can affect the ability to drive or operate machinery of some patients. The response of each patient changing to Atozet may change.

Use drugs for women during pregnancy and lactation

Women are likely to be pregnant

Women who are likely to be pregnant should use appropriate contraception during treatment.

Pregnant women

Atherosclerosis is a chronic process and the stopping of the drug that reduces lipid during pregnancy has a little impact on the long -term treatment results of primary hypercholesterolem.

Atozet

contraindicated use of Atozet in pregnant women. Atozet should only be used for women of reproductive age when the patient is very difficult to conceive and has been notified of the possible dangers. If the patient is pregnant while taking this medication, the treatment must be stopped and notify the patient about the dangers that may occur for the fetus. ezetimibe

There is no clinical data on cases of pregnant women using drugs.

When Ezetimibe is used with Atorvastatin, it does not observe the teratogenic effect in studies on the development of embryo in pregnant rats, in pregnant rabbits, observed a low percentage of skeletal deformities.

atorvastatin

There is no adequate and well -controlled research on the use of Atorvastatin during pregnancy. There have been rare reports of birth defects after being exposed to the uterus. In an assessment of about 100 cases of pregnancy is monitored in the time in women who use other statins, the rate of birth defects, spontaneous miscarriage and fetus/death/death at birth does not exceed the expected rate in the general population. However, this study can only rule out an increase in the risk of birth defects 3-4 than the foundation ratio. In 89% of these cases, drug treatment begins before pregnancy and stops in the first 3 months of pregnancy when pregnancy has been determined.

nursing mothers

Rat studies have shown that Ezetimibe and Atorvastatin are excreted in mouse milk. It is unclear whether ezetimibe or Atorvastatin will excrete in breast milk, so women who are breastfeeding are not used atozet.

Drug interaction

Atozet

Do not observe the pharmacokinetic interaction with clinical significance when Ezetimibe is used simultaneously with Atorvastatin.

interact with CYP3A4

In preclinical studies, it has shown that ezetimibe does not induce the enzymes metabolic enzymes Cytochrom P450. It is not observed that the clinical pharmacokinetic interactions between Ezetimibe and drugs have been metabolized by Cytochrom P4501A2,2D6,2C8,2C9 and 3A4 or N-acetyltransferase.

Atorvastatin is metabolized by cytochrom P450 3A4. Simultaneous use of Atorvastatin with Cytochrom P450 3A4 inhibitors can lead to increased Atorvastatin levels in plasma. The degree of interaction and potential depends on the change of effect on Cytochrom P450 3A4.

Cytochrom P3A4 inhibitors increase the risk of muscle disease by reducing the elimination of Atozet's Atorvastatin ingredients.

Clarithromycin: The area under the curve (AUC) of Atorvastatin increases significantly when using the 80mg Atorvastatin period with clarithromycin (500mg, 2 times/day) compared to the unique Atorvastatin. Therefore, in patients using Clarithromycin, caution should be cautious when the Atozet dose exceeds 10/20mg.

Combining protease inhibitors: AUC of Atorvastatin increases significantly when using Atorvastatin simultaneously with some combined forms of HIV's protease inhibitors as well as Telaprevir is a protease inhibitor of hepatitis C virus compared to the unique Atorvastatin. Therefore, in patients who are taking Tipranavir plus ritonavir are protease inhibitors of HIV or Telaprevir are protease inhibitors of the hepatitis C virus, should avoid using Atozet simultaneously, in patients taking Lopinavir plus ritonavir are protease inhibitors of HIV, need to be cautious when prescribing the Atozet applications and should use the lowest -to -do doses of patients with the patients of the drug inhibitors inhibitors inhibitors inhibitors inhibitors The protease of HIV Saquinavir plus Ritonavir, Darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, or boceprevir is a protease inhibitor of hepatitis C virus, Atozet dose should not exceed 10/20mg and need to be cautious when used in patients using NELFINAVIR Atozet should not exceed 10/40mg and recommend closely clinical monitoring. Itraconazole: The area under the curve (AUC) of Atorvastatin increases significantly when using Atorvastatin 40mg and iTraconazole 200mg simultaneously. Therefore, in patients who are taking Itraconazole, caution should be careful when Atozet dose exceeds 10/20mg.

Grapefruit juice: contains one or more CYP 3A4 inhibitors and can increase the concentration of Atorvastatin in plasma, especially when drinking too much grapefruit juice (> 1.2 liters/day).

Cyclosporin: In a study in 8 patients after kidney transplantation, Creatinine clearance> 50ml/minute with a stable dose of cyclosporin, a single dose of 10mg Ezetimibe has led to an average increase of ezetimibe of all 3.4 times (about 2,3,7.9 times) compared to a healthy control group from another study (N = 17). In another study, a patient with severe kidney failure (clearly 13.2ml of creatinine/minute/1.73m2), which is using many drugs, including cyclosporin, has shown a total concentration of ezetimibe 12 times higher than simultaneous control groups. In a two -stage cross -study study in 12 healthy subjects, using ezetimibe 20mg/day for 8 days with a single dose of Cyclosporin 100mg on Saturday, which led to the average AUC increase of Cyclosporin 15% (from 10% reduction to an increase of 51%) compared to a single dose of Cyclosporin 100mg single -use Atorvastatin and the transformations of AtorVastatin are the mechanicals OATP1B1. Oatp1b1 inhibitors (eg cyclosporin) may increase the bioavailability of Atorvastatin. Atorvastatin's AUC increases significantly when using Atorvastatin, 10mg and Cyclosporin 5.2mg/kg/day compared to the unique Atorvastatin use. Atozet period should be avoided with cyclosporin.

Other interactions

Antacisletes: Concentrated with antacids reduces the absorption rate of ezetimibe but does not affect the bioavailability of ezetimibe. This reduced absorption rate is not considered clinical significance.

Simultaneous use of Atorvastatin with an acid -containing anti -acid and aluminum hydroxid oral mixture reduces the plasma concentration of Atorvastatin and metabolites with activity of about 35%; However, the LDL-C reduction does not change.

Cholestyramin: Concentrated with cholestyramin reduces the average ezetimibe (ezetimibe + ezetimibe glucuronide) by 55%. The additional reduction of LDL-C plus ezetimibe to Cholestyramin may be reduced by this interaction.

Fibrats:

gemfibrozil: Due to an increased risk of muscle disease/muscle pilot when using HMG-Coa Reductase inhibitors with Gemfibrozil, should avoid simultaneous use with gemfibrozil.

In a pharmacokinetic study, the use of the same time with Gemfibrozil increases the total ezetimibe level about 1.7 times. This increase is not considered clinical significance. There is no clinical data.

fenofibrat: Due to the risk of muscle disease while treating with HMG-CoA Reductase inhibitors increased when used in time with fenofibrat, Atozet should be used cautiously when using the same time with fenofibrat.

In a pharmacokinetic study, simultaneously used with Fenofibrat increases the total ezetimibe level about 1.5 times. This increase is not considered clinical significance.

Other fibrats: The safety and effectiveness of ezetimibe are used with other fibrats that have not been determined. Fibrat can increase the secretion of cholesterol into bile, leading gallstones. In a clinical study in dogs, Ezetimibe increases cholesterol in the gallbladder. Although the meaning of this preclinical discovery is unclear, the simultaneous use of Atozet with other fibrats is not recommended until the use in patients is studied.

Fusidic acid: The risk of muscle disease/muscle pattern may increase when used simultaneously with fusidic acid.

Amiodaron: Atozet dose should not exceed 10/20 mg/day in patients taking this medication simultaneously with Amiodaron.

Anticoagulant: Concomitance Ezetimibe (10mg, 1 time/day) has no significant effect on the bioavailability of warfarin and prothrombin time in a study in 12 healthy adult men. There has been a after -sales report on increased international standardization ratio (INR) in patients using Ezetimibe along with Warfarin or Fluindion. Most patients are also taking other drugs.

Atorvastatin does not have a significant influence on prothrombin when used for patients being treated with long -term warfarin.

The influence of AtoZet on prothrombin has not been studied.

Breast anti -cancer protein inhibitors (BCRP): Atorvastatin is a substrate of the transportation system to BCRP. Concomitant use with BCRP inhibitors (such as Elbasvir and Grazoprevir) may increase the level of Atorvastatin in plasma and increase the risk of muscle disease; Therefore, the atorvastatin dose may be adjusted. Simultaneous use of Elbasvir and Grazoprevir with Atorvastatin increases the level of Atorvastatin in plasma by 1.9 times due to CYP3A and/or BCRP inhibitors; Therefore, Atozet should not be used more than 10/20mg daily for patients who are using the same time with products containing elbasvir or grazoprevir.

Cytochrom P450 3A4 induction drugs: simultaneous use of Atorvastatin with drugs that cause Cytochrom P450 3A4 (eg Efavirenz, Rifampin) can lead to reduced changes in Atorvastatin concentration in plasma. Due to the dual interactive mechanism of rifampin, simultaneous use of Atorvastatin with rifampin, because of the late use of Atorvastatin after using Rifampin is associated with a significant reduction in the plasma Atorvastatin levels.

Antyrin: Because Atorvastatin does not affect the pharmacokinetics of antipipin, interacting with other drugs that are transformed through this iszyme cytochrom is not expected.

Colestipol: Atorvastatin concentration in plasma decreased by about 25% when used simultaneously Colestipol with Atorvastatin. However, the LDL-C decrease is greater when Atorvastatin and Colestipol are used simultaneously compared to when used for each single drug.

Digoxin: When simultaneously use many doses of Atorvastatin and Digoxin, the concentration of digoxin in a stable state increases to about 20%. Patients who are using Digoxin are carefully monitored.

Oral contraceptives: simultaneously taking Atorvastatin with an oral contraceptive that increases the AUC value of Norethindron and Ethinyl estradiol about 30% and 20%. This increase when choosing oral contraceptives for a woman who is using Atorvastatin.

Amlodipin: In a study of drug-medication interaction in healthy subjects, the time of Atorvastatin 80mg and Amlodipin 10mg has led to an increase of 18% in Atorvastatin levels without clinical significance.

Niacin: The risk of muscle effects may increase when used at the same time atozet with niacin; Atozet dose should be considered in this case.

Colchicin: Cases of muscle disease, including muscle pepper, have been reported when using Atorvastatin simultaneously with colchicin and should be cautious of the monkey prescribed atqzet with colchicin.