ATIZET Plus 10 mg An Thien Treatment of hypercholesterol blood cholesterol (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Ezetimibe, simvastatin
Ingredient An Thien
Ingredient
| Composition information | Content |
| Ezetimibe | 10mg |
| Simvastatin | 20mg |
Uses
Indications
Primary blood cholesterol treatment: Atizet Plus (Ezetimib/Simvastatin) is indicated as additional treatment and diet to reduce total cholesterol (partial part), Lipoprotein low dense lipoprotein (LDL-C), Apolipoprotein B (APOL B). Triglyceride (TG), and cholesterol lipoprotein is not high (non-HDL-C), and to increase cholesterol lipoprotein high density (HDL-C) in patients with primary hypercholesterol (heterozygous family and non-family-nature) or mixed hyperlipidemia.
Treatment for patients who treated monomeries but not completely controlled.
Patients used a statin and ezetimib.
Hyper cholesterol hyperplasia treatment (HOFH): Atizet Plus is indicated to reduce the increase of total cholesterol and LDL-C in adult patients with hofh. Atizet Plus should be used for other blood lipid reduction treatments (such as LDL filtering) in these patients or if these treatments are not available.
Pharmacokology
Atizet Plus (Ezetimib/Simvastatin) is a blood lipid drug that inhibits cholesterol absorption, biological sterols in the intestine and inhibits endogenous cholesterol synthesis.
Plasma cholesterol is made up of intestinal absorption and endogenous synthesis. Atizet Plus contains Ezetimib and Simvastatin, two lipid lowering components with additional mechanisms. Atizet Plus reduces total cholesterol, LDL-C, APO B, TG and Non-HDL-C, increases HDL-C through double inhibition of cholesterol's absorption and synthesis.
ezetimib
Ezetimib inhibits cholesterol absorption from the intestine. Ezetimib is effective when taken orally and has mechanisms that are different from cholesterol medications of other groups (such as statins, bile secretion inhibitors (resin), fibric acid derivatives and stanols of plant origin), responsible for absorbing cholesterol and phytosterol from the intestine.
Ezetimib localized on the shore of the small intestine and inhibit the absorption of cholesterol, resulting in a decrease in the transport of cholesterol from the intestine into the liver: Statins reduce cholesterol synthesis in the liver and these two separate mechanisms complement each other to reduce cholesterol.
Simvastatin
Simvastatin is an inactive lactone. After oral, Simvastatin is hydrolyzed in the liver into B-Hydroxyacid, which has a strong impact on the inhibition of HMG-COA enzyme inhibitors (3 hydroxy-3 methylutaryl coa reductase). This enzyme catalyzes the conversion of HMG-COA into Mevalonate, which is the first step and is a speed limit step during cholesterol biosynthesis.
Simvastatin has been shown to reduce LDL-C levels both normal and when increased. LDL-C is formed from very low molecular weight protein (VLDL) and is catabolized mainly by high-level LDL receptors. The mechanism of reducing LDL, of Simvastatin may be due to reduced cholesterol levels of VLDL (VLDL.-C) and LDL receptor irritation, resulting in reduced production and increased LDL-C. Apolipoprotein B also decreased significantly during treatment with simvastatin. Moreover, Simvastatin increases moderate HDL-C and reduces plasma tg. The result of these changes is to reduce the ratio of all HDL-C cholesterol and the LDL-C/HDL-C ratio.
pharmacokinetic
absorption
ezetimib
After taking Ezetimib, it is quickly absorbed and combined into a substance that has the effect of Ezetimib-Glucuronid. Maximum plasma concentration (CMAX) reaches about 1 to 2 hours for Ezetimib-Glucuronid and 4 to 12 hours for Ezetimib.
Use the same food (high -fat or non -fat meals) does not affect the ezetimib's oral bioavailability when taking Ezetimib 10mg.
Simvastatin
The presence of β-hydroxyacid during the circulation after taking Simvastatin is found below 5% of the dose in accordance with the initial step metabolism in the liver. The main metabolites of simvastatin in human plasma are β-hydroxyacid and additional metabolites. When hungry, both active inhibitors and total inhibitors in plasma are not affected if using simvastatin right before meals.
distribution
ezetimib
ezetimib and ezetimib-glucuronid linked to plasma proteins are 99.7% and 88 to 92%.
Simvastatin
Both simvastatin and β-hydroxyacid are linked to human serum protein (95%). Pharmacokinetics when using single dose and multi -dose Simvastatin do not see the accumulation of drugs. In the pharmacokinetic studies above the maximum serum concentration of the inhibitors that appear 1.3 hours to 2.4 hours after use.
transformation
ezetimib
Ezetimib is basically metabolized in the small intestine and liver thanks to a combination with glucuronid (stage II reaction) and then excreted through bile. Minimum oxidation metabolism (stage I reaction) in all research species. Ezetimib and Ezetimib-Glucuronid are the main metabolic components of the drug determined in plasma, accounting for about 10 to 20% and 80 to 90% of the total number of drugs in plasma. Ezetimib and Ezetimib-Glucuronid are eliminated from plasma slowly with significant reuse in the gut. Ezetimib and Ezetimib-Glucuronid's
Simvastatin
Simvastatin is an inactive lactone, quickly hydrolyzed in vivo into β-hydroxyacid corresponding, a strong inhibitor of HMG-CoA Reductase enzyme. Hydrolysis occurred mainly in the liver, the rate of hydrolysis in human plasma is very slow. In humans, Simvastatin is well absorbed and strongly transformed in the liver. The sale time of β-hydroxyacid metabolites after an average intravenous injection is 1.9 hours.
Elimination
ezetimib
In humans, after drinking 14C-Ezetimib (20mg), the total ezetimib accounts for about 93% of the total active ingredient that marks radioactive in plasma.
found 78% and 11% of the active ingredient marked radioactive in feces and urine obtained for 10 days. After 48 hours, no active ingredient marks radioactive in plasma.
Simvastatin
In humans, after taking a dose of simvastatin marking radioactive, 13% of the active ingredient marked radioactive excreted into the urine and 60% into the feces within 96 hours. The amount found in the decentralization shows the amount of drugs absorbed and excreted into equivalent substances in the bile as well as the amount of drugs that are not absorbed. After an intravenous dose of β-hydroxyacid metabolic substances, only 0.3% of the intravenous dose is excreted into the urine in the form of inhibitors.
Before taking ATIZET Plus 10 mg An Thien Treatment of hypercholesterol blood cholesterol (3 blisters x 10 tablets)
How to use
only use Atizet Plus for adults, not for children.
Patients should have a cholesterol diet before starting to use Atizet Plus and should continue to diet during treatment. Dosage should be concretized for each patient based on the initial LDL-C level, the purpose of treatment and response of the patient.
Should drink Atizet Plus only once in the evening, with or not food.
Dosage
recommendations to start treatment with the lowest dose that the drug works.
Atizet Plus dose (Ezetimib/Simvastatin corresponds to 10/20mg) 1 capsules once in the evening.
Mimeting treatment with other drugs
Atizet Plus should be used before ≥ 2 hours or after ≥ 4 hours when using a drug attached to bile acid.
In patients with Amiodaron, Amlodipin, Verapamil, Diltiazem, Niacin Lower Lipid (≥ 1g/day), and with Atizet Plus, Atizet Plus dose should not exceed 1 tablet/day (Ezetimib/simvastatin corresponding to 10/20mg)
Patients with renal failure
No need to do the dose in patients with moderate renal impairment. Do not use drugs for patients with severe renal impairment (creatinine clearance ≤ 30ml/min).
Patients with liver failure
No dose adjustment in mild liver impairment patients (Child - Pugh 5 or 6). Atizet Plus should not be used for medium-sized liver impaired patients (Child-Pugh 7 to 9) or severe liver failure (Child-Pugh> 9).
Elderly patients
No dose adjustment.
Children
Not used for children under 10 years old but the drug may also be considered for treatment for children over 10 years old.
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 using overdose? There is no complication of the castle. LD50 of ezetimib ≥ 1000mg/kg and simvastatin ≥ 1000mg/kg.
In studies, high doses of Ezetimib also do not cause serious problems. Among the cases of overdose have been reported, these symptoms are either mild or non -existent. There is no serious problem.
Simvastatin
A few cases of overdose have been reported, the maximum dose is 3.6g. All patients recover without sequelae.
If an overdose of Atizet Plus, gastric lavage or vomiting. Dialysis may not be able to remove medicine. The treatment may also be related to supporting care, which includes the treatment of symptoms caused by an overdose, including:
Intravenous infusion (IV).
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 Atizet Plus, you may experience unwanted effects (ADR).
Common, ADR> 1/100
Uncommon, 1/1000 Skin and subcutaneous tissue: itching, rash. Not determined frequency 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
Contraindicated
ATIZET Plus drug is contraindicated in the following cases:
Pregnant women and nursing women.
Use in combination with gemfibrozil, cyclosporin, or danazol. Secondary muscle disease due to the use of other lipid medications. Mechanical and muscle pilot Precautions when using
As well as other HMG-COA reducing enzymes inhibitors, the risk of muscle and muscle pilot is related to simvastatin dose. In patients who begin to use Atizet Plus, they should notify patients at risk of muscle pathology and advise patients to immediately notify any muscle pain, muscle fatigue or muscle weakness that cannot be determined. Should stop using Atizet Plus immediately, if diagnosed or suspected of muscle disease.
Reduce the function of transport protein
Reducing the function of liver Oatp transport protein may increase contact with the system of simvastatin acid and increase the risk of muscle disease, muscle pattern. The reduction of function may be the result of inhibition of drug interaction (eg ciclosporin) or in patients with genotypes of SLCO1B1 C.521T> c.
Patients with SLCO1B1 alen gene (C.521T> c) encrypt for an OatP1B1 protein that is less active, which means increasing contact (AUC) of simvastatin acid and increasing the risk of muscle disease. The risk of high doses of Simvastatin (80mg) related to muscle disease is about 1%, without genetic testing.
Based on clinical trial results, in the person carrying the Alen C (CC) homozygous gene, which is treated with the dosage of Simvastatin 80 mg, is at risk of 15% in muscle disease in a year, while in the person who carries the heterozygous gene (CT) is 1.5%. The corresponding risk is 0.3% in patients with the most common genotype (TT). The genotype of allele is considered as part of the benefit assessment - the risk before prescribing simvastatin 80mg for each patient and avoiding high doses in patients with CC genotype. However, the absence of this genotype does not exclude muscle disease can still occur.
measurement of Creatin Kinase concentration (CK): Do not measure the concentration of CK after exertion or the presence of a certain cause increases 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 simvastatin.
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, 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 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 these manifestations of patients need to do CK test to take appropriate interventions.
Assessment of risks affecting muscle due to drug interaction
The risk of muscle diseases and muscle pattern increases significantly when using Atizet Plus simultaneously with strong inhibitors CYP3A4 (such as Itraconazol, Ketoconazole, Posaconazol, Voriconazole, Erythromycin, Clarithromycin, Telithromycin, Protease HIV (Nelfinavir), Boceprevir, Boceprevirvirvir, Bocepinavir) Telaprevir, Nefazodon, a drug containing COBICISTAT), as well as Ciclosporin, Danazol, and Gemfibrozil. Contraindications when used simultaneously with these drugs.
Due to the composition of the drug containing simvastatin, the risk of muscle disease and muscle pattern also increased significantly when used simultaneously with other fibrats, niacin (≥ 1g/day) or simultaneous use with amiodaron, amlodipine, verapamil or diltiazem. The risk of muscle disease including muscle pattern may increase when used simultaneously with fusidic acid. For HOFH patients, this risk may increase when used simultaneously with Lomitapid.
Patients taking medium -sized drugs with CYP3A4 simultaneously with Atizet Plus, especially high -dose Atizet Plus, may have a high risk of muscle disease. When using Atizet Plus simultaneously with a moderate CYP3A4 inhibitor (increasing AUC about 2-5 times), adjusting the dose may be necessary. For some moderate CYP3A4 inhibitors (eg Diltiazem), the maximum dose of Atizet Plus is 10/20mg.
The safety and effectiveness of Atizet Plus when used simultaneously with fibrat has not been studied. The risk of muscle disease increases when simvastatin is used simultaneously with fibrats (especially gemfibrozil). Therefore, contraindicated when using Atizet Plus simultaneously with Gemfibrozil and simultaneous use with other fibrats is not recommended.
Patients with interstitial lung disease
If using simvastatin, especially long -term use, there is a risk of interstitial pneumonia with symptoms of dyspnea, dry cough, general health decline (fatigue, weight loss, fever). If the patient is found to develop interstitial lung disease, statin is discontinued.
Evaluation of liver function
Liver function tests are done before starting treatment with Atizet Plus and then clinical indications. The patient increased by 10/80mg dose should be tested before adjusting the dose, 3 months after adjusting the dose 10/80mg and periodically (half a year) in the first year of treatment. Special attention in patients with high serum transaminase concentration and in these patients, measurements must be repeated in time and more often after that. If there is an increase in transaminase level. Especially the transaminanse concentration increases to 3 x ULN and persistent, should stop the drug.
If the liver damage is serious with clinical symptoms or increased blood bilirubin or jaundice during treatment with Atizet Plus, should temporarily stop the drug. If an alternative disease is not found, do not start treating with Atizet Plus.
Atizet Plus should be used cautiously in patients drinking a lot of alcohol.
Patients with liver failure
Due to the unknown effect of increased ezetimib exposure in medium or severe liver failure patients. Atizet Plus is not recommended to use in this patient group.
Patients with diabetes
Statin can increase blood sugar, for patients with high risk such as blood sugar at 5.6 to 6.9mmol/I, BMI ≥ 30kg/m2, increase triglycerides, hypertension to monitor both biochemistry and clinical.
Children
Ezetimib's efficiency and safety in combination with Simvastatin in patients from 10 to 17 years old with hyperlested hyperlested blood cholesterol has been assessed in a controlled clinical trial in adolescence boys and girls at least after a year of puberty. As a result, the drug usually does not affect the growth or growth of sex in young men or women, or any effect on the menstrual cycle in women.
However, the effect of ezetimib for a 33 -week treatment for the growth and sexual growth has not been studied.
The safety and effectiveness of Ezetimib in combination with simvastatin dose per 40mg is not studied in children from 10 to 17 years old.
Ezetimib has not been studied in patients who are less than 10 years old.
The long -term effect of Ezetimib's treatment in patients under 17 years of age to reduce the incidence of disease and death in adulthood has not been studied.
anticoagulants
If Atizet Plus is simultaneously used with warfarin, anticoagulant drugs Coumarin or fluindion, international normalization ratio (INR) should be monitored appropriately.
Autodity warning
Colonel contains lactose, should not be used for patients with galactose intolerance, L.App Lactase deficiency, Glucose - Galactose absorption disorder.
The ability to drive and operate machinery
Atizet does not affect or affect the ability to drive or operate machinery. However, some unwanted effects such as dizziness can occur, be cautious when driving or operating machines while taking the drug.
Pregnancy
Atizet Plus is contraindicated for pregnant women. There is no clinical data on the use of Atizet Plus during pregnancy.
Breastfeeding period
Atizet Plus is contraindicated to use during breastfeeding. Rat studies have shown that Ezetimib is excreted into breast milk. It is not known whether the active ingredients of Atizet Plus are excreted in breast milk.
Drug interaction
Pharmacological interaction
Interaction with lipid medications can cause muscle disease when used single
The risk of muscle disease, including muscle pattern, increases during simultaneous use of simvastatin with fibrat. In addition, there is simvastatin pharmacokinetic interaction with gemfibrozil leading to an increase in simvastatin levels in plasma. The rare case of muscle/muscle disease has been observed when Simvastatin in combination with high -dose lipid niacin (≥ 1g/day).
Fibrat can increase the secretion of cholesterol into bile, leading to gallstones.
pharmacokinetic interaction
Contraindications
Strong CYP3A4 inhibitors (such as Itraconazol, Ketoconazole, Posaconazol, Voriconazol, Erythromycin, Clarithromycin, Telithromycin, HIV Protease Inhibit HIV (Nelfinavir), Boceprevir, Telaprevir, NefazODOD, Cobicistat) Ciclosporin, Danazol, and Gemfibrozil.
Interactions do not recommend shared
Other fibrats, fusidic acid, niacin with a dose of ≥ 1g/day (for Asians).
Interactions need to monitor the dose adjustment
Amiodaron, Amlodipin, Verapamil, Diltiazem, Niacin (≥ 1g/day): daily doses of Atizet Plus do not exceed 10/20mg.
Lomitapid: For HOFH patients, daily ATIZET Plus dose does not exceed 10/40mg.
Grapefruit juice and fruits of citrus: Avoid drinking when using Atizet Plus.
Average inhibitors CYP3A4
Patients taking other drugs that are thought to have the average CYP3A4 inhibitory effect in combination with special ATIZET Plus when using high -dose Atizet Plus, can increase the risk of muscle pathology.
Other fibrats
Used in combination with fenofibrat increases the total concentration of Ezetimib about 1.5 - 1.7 times but does not have clinical significance. Has evaluated the safety and effectiveness of Ezetimib in combination with unpaid fenofibrats. Fibrats can cause increased cholesterol elimination into bile, causing gallstones.
Fusidic acid
Patients who are treating Fusidic acid combined with Atizet Plus may increase the risk of muscle disease. The patient should be closely monitored with Atizet Plus with Fusidic Acid. Should consider can temporarily suspend Atizet Plus.
Simvastatin increases the effects of warfarin and blood digoxin levels. Patients using simvastatin and warfarin or digoxin should be carefully monitored.
cholestyramin reduces Ezetimib's absorption, so Atizet Plus should be used two hours ago or at least four hours after using cholestyramin.
Increased risk of muscle damage when using statin simultaneously with colchicin.
Transport protein inhibitors: Increases the concentration of simvastatin in plasma thus increasing the unwanted effect on the muscle.
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 leading to kidney failure and may be fatal.
Storage
Store in a dry place, the temperature does not exceed 30 ° C, avoiding light.
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