Gonsa Atzeti 10mg medicine Dat Vi Phu Treatment for hyperlipidemia (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Atorvastatin, Ezetimibe
Ingredient
| Composition information | Content |
| Atorvastatin | 10mg |
| Ezetimibe | 10mg |
Uses
indications
Gon sa atzeti drugs are indicated in the following cases:
Treatment of rawemical lipid lipids.
gon sa atzeti is designated to reduce total cholesterol, LDL cholesterol (LDL-C), Apolipoprotein B (APO B), Triglycerid (TG) and Non-HDL-CHOLesterol (Non-HDL-C) in patients with primary hyperplasia lipid hyperemia (hyperlipidemia heterozygous family and non-family-growing lipids) Diet when using a diet that reduces saturated fat, cholesterol and other non -drug methods that do not respond appropriately.
The indicated limit: There is no increase in the benefits of cardiovascular disease and death of the combination of Atorvastatin/Ezetimibe compared to Atorvastatin.
The combination of not being studied on blood lipid lipid disorders I, III, IV and V Fredrickson.
Pharmacokology
Mechanism of action
Plasma cholesterol is derived from intestinal absorption and endogenous synthesis. Gon SA Atzeti contains Ezetimibe and Atorvastatin, two substances that reduce blood lipids with many different mechanisms.
ezetimibe
Pharmacological group: Other lipid regulating drug groups.
ATC code: C10AX09.
Ezetimibe reduces plasma cholesterol levels by inhibiting cholesterol absorption in the small intestine. The effect of Ezetimibe is the protein to transport sterol, Niemann Pick C1-Like 1 (NPC1L1), involved in the absorption of cholesterol and phytosterol in the intestine. Ezetimibe does not cause clinical effects on the concentration of oil -soluble vitamins (vitamins A, D and E) and does not reduce the synthesis of steroid hormones. Ezetimibe does not inhibit cholesterol synthesis in the liver or increases secretion of bile acid. Ezetimibe is distributed at the mucosa surface of the small intestine and inhibits cholesterol absorption, resulting in a decrease in the supply of cholesterol from the intestine into the liver. This reduces liver cholesterol and reduces blood cholesterol levels. This mechanism of action adds to the cholesterol reduction mechanism of the group of statins.
Atorvastatin
Pharmacological group: HMG-COA Reductase inhibitors.
ATC code: C10AA05.
Atorvastatin reduces cholesterol and plasma lipoprotein levels by inhibiting HMG-COA Reductase synthesizing cholesterol in the liver and increasing the amount of LDL receptor on the surface of liver cells, enhancing the arrest and catabolic LDL; Atorvastatin also reduces the synthesis of LDL and the number of LDL sub -fertilizers.
Dynamic pharmacokinetics
absorption
ezetimibe
After drinking, Ezetimibe is absorbed and largely converts into an active compound (ezetimibe-glucuronid).
Atorvastatin
Maximum concentration in plasma is reached from 1-2 hours after drinking. The level of absorption is proportional to the dose of Atorvastatin. Absolute bioavailability of Atorvastatin (original drug) is approximately 14% and the HMG-CoA Reductase inhibitors are about 30%. Low bioavailability is due to metabolism in the gastric - intestinal mucosa and/or first metabolism through the liver. Atorvastatin's plasma concentrations are lower (about 30%, both CMAX and AUC) when taking the drug in the evening compared to the morning. However, the reduction of LDL-C levels is the same regardless of the time of medication during the day.
combined drugs atorvastatin/ezetimibe can be used or not accompanied by food.
distribution
ezetimibe
ezetimibe and ezetimibe-glucuronid are well linked with plasma protetin (> 90%).
Atorvastatin
The average distribution of Atorvastatin is approximately 381 liters. Atorvastatin is connected to plasma proteins more than 98%. The percentage of drugs in plasma is approximately 0.25, which shows that the drug is low in red blood cells. Based on mouse observation, Atorvastatin can be excreted on M sữa milk.
metabolism and elimination
ezetimibe
Ezetimibe is mainly metabolized through the small intestine and liver through the glucuronid complex and then through bile and excreted through the kidneys. A small number of metabolic processes by oxidation have been observed on all test species. . In humans, Ezetimibe is quickly converted into ezetimibe-glucuronid. Ezetimibe and Ezetimibe -Glucuronid are commonly detected in plasma compounds, accounting for about 10-20% and 80 - 90% of the total number of drugs in plasma. Both Ezetimibe and Ezetimibe-Glucuronide are eliminated from plasma with the sale time of about 22 hours for both Ezetimibe and Ezetimibe-Glucuronid. Ezetimibe is the main component in the feces and accounts for about 69% of the dose, while Ezetimide-Glucuronid is the main component in the urine and accounts for about 9% of the doses of Ezetimibe used.
Atorvastatin
Atorvastatin is converted into Ortho-and Para-Hydroxy derivatives or oxidative products. On Vitro, the HMG-CoA Reductase inhibitor of the ortho-and para-hydroxide metabolism is equivalent to Atorvastatin. About 70% of HMG-CoA Reductase inhibitors are due to active metabolites. Research on in vitro shows the importance of metabolism through cytochrom P450 3A4, the level of Atorvastatin in plasma increases when used with erythromycin, a CYP 3A4 inhibitor. Atorvastatin and metabolites are excreted mainly through bile after metabolism in the liver and/or outside the liver; However, the drug does not go through the gut liver cycle.
Average semi -discharged plasma time in humans is about 14 hours, but the time for HMG -CoA Reductase inhibitors to inhibit half is half of it is from 20-30 hours due to active metabolites. After drinking, it is more than 2% of the atorvastatin doses found in the urine.
Before taking Gonsa Atzeti 10mg medicine Dat Vi Phu Treatment for hyperlipidemia (3 blisters x 10 tablets)
How to use
gon sa atzeti used by oral at any time of the day, may be taken or not accompanied by food. Should drink whole tablet, do not chew, grind or dissolve before drinking.
Patients should follow a low -cholesterol -diet when starting to use the drug and continue this diet during treatment.
Used with other drugs
Bile acid -catching substances: Gon sa atzeti should be taken 2 hours before or 4 hours compared to the time of using bile acid -catching drugs.
cyclosporin, clarithromycin, otraconazole and some protease inhibitors.
Patients are using cyclosporin or HIV protease inhibitors (tipranavir plus ritonavir) or hepatitis C Protease (Telaprevir) inhibitors should avoid using Gon SA Atzeti.
Patients are using Lopinavir with Ritonavir, cautious when indicating Gon SA Atzeti and should be used in the lowest doses effectively.
Patients who are taking Clarithromycin, Itraconazole or HIV patients are taking Saquinavir plus ritonavir, Darunavir with ritonavir, fosamprenavir or fosamprenavir with ritonavir Ezetimibe/atorvastatin dose should be limited to 10/20 mg.
Patients use Nelfinavir or BoCeprevir, Ezetimibe/Atorvastatin dose should be limited to 10/40 mg and the clinical assessments needed to ensure the lowest doses used effectively.
amiodaron
When used in combination with amiodaron, an atrovastatin overdose should not be used for 20 mg/day.
Other lipid medications
Do not recommend combining gon sa atzeti with gemfibrozil.
Dosage
Starting dose: 1 tablet/ day.
After 2 weeks of starting treatment, the lipid concentration is required to adjust the corresponding dose. Dosage should be adjusted to each patient based on plasma lipid levels.
Should 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 of each batch spaced no less than 4 weeks and monitoring the harmful reactions of the drug, especially the harmful reaction to the muscle system.
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?
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
Common, ADR> 1/100
Uncommon, 1/1,000 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
Gon SA Atzeti is contraindicated in the following cases:
Hypersensitivity to Atorvastatin, Ezetimibe or any ingredients of the drug.
Being progressed by liver or increasing liver transaminase for unknown reasons for a long time.
Women who are pregnant or planning pregnancy.
Women who are breastfeeding or breastfeeding plans.
Caution when using
muscle disease/muscle syndrome atorvastatin
Cases of rare patterns accompanied by secondary acute renal failure due to myoglobin urine have been recorded when using Atorvastatin and other drugs in the same group. History of renal failure may be a risk factor for muscle pattern syndrome. These patients need to be closer to the effects on the musculoskeletal system. Atorvastatin, like other statins, sometimes cause muscle disease, such as muscle pain or muscle weakness accompanied by an increase in creatin phosphokinase (CPK)> 10 times the above limit (ULN). The simultaneous use of high doses of Atorvastatin with certain drugs such as cyclosporin and strong CYP3A4 inhibitors (such as clarithromycin, otraconazole and protease inhibitors in HIV treatment) increases the risk of muscular diseases/muscle syndrome.
There have been rare reports on muscle necrosis through the immunity (IMNM), an autoimmune disease, related to the use of statin. IMNM is characterized by: muscle weakness and increased the concentration of creatinine kinase in serum, this condition remains despite stopping statin treatment; Muscle biopsy shows necrotic muscles but there is no sign of inflammation; Improved symptoms when using immunosuppressive agents.
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, muscle, muscle weakness ... When there are these manifestations, the patient needs to do CK test to take appropriate interventions.
The risk of muscle disease when treating with statins increases when used simultaneously with cyclosporin, fibric acid derivatives, erythromycin, clarithromycin, telaprevir, a combination of protease inhibitors, including Saquinavir with Ritonavir, Lopinavir with Ritonavir, Tipranavir with Ritonavir, Darunavir, Darunavir, Darunavir, Darunavir, Darunavir, Darunavir, Darunavir, Darunavir, Darunavir, Darunavir With Ritonavir, Fosamprenavir, Fosamprenavir plus Ritonavir, Niacin, or Azol type anti -fungal drugs. Doctors consider treatment combined with gon sa atzeti and derivatives Fibric acid, erythromycin, clarithromycin, a combination of Saquinavir and Ritonavir, Lopinavir with Ritonavir, Darunavir with Ritonavir, Fosamprenavir, or Fosamprenavir plus ritonavir, niacol -anti -niacol -anti -niacol -anti -mushroom. Treatment benefits and potential risks should be considered and should carefully monitor patients with signs of muscle pain, muscle tension or muscle weakness, especially in the first months of treatment and during the stage of increasing the dose of one of the two drugs. The starting dose and the maintenance dose should be lower when used simultaneously with the above drugs. Consider conducting regular creatin phosphokinase tests but does not guarantee that closely monitoring will prevent the appearance of severe muscle pain.
Some cases of muscle disease, including muscle pepper have been reported when using Atorvastatin at the same time with Colchicin, should be careful when appointing Gon SA Atzeti with Colchicin. Gon SA Atzeti should be suspended in patients with severe acute muscle disease or have a risk factor for secondary renal impairment due to muscle pilot (for example: severe bacterial infections, low blood pressure, new surgery, trauma, metabolic disorders, endocrine, electrolytes and uncontrolled epilepsy).
ezetimibe
In clinical trials, there is no increase in muscle disease and muscle syndrome related to Ezetimibe when compared to the control group (placebo or monochromatic statin). However, muscle disease and muscle syndrome are still known as an unwanted reaction of statin and other lipid medications. In clinical trials, the rate of creatin> 10 times the above limit is 0.2% in the ezetimibe group compared to 0.1% in the placebo group and 0.1% for ezetimibe group combining statin compared to 0.4% in the monolithic statin group. The risk of toxicity for skeletal muscles increases when using high doses of statin, elderly patients (> 65), hypothyroidism, kidney failure, and depending on the statin used, simultaneously used other drugs.
Data on Ezetimibe's circulation process, in case of muscle disease and muscle pepper syndrome have been reported. Most patients with Co Van Tieu Van used statin before starting ezetimibe. However, Co Van pepper has been reported with Ezetimibe therapy and use Ezetimibe along with agents related to increased risk of muscle pattern, such as fibric acid derivatives. Simultaneous use of Gon SA Atzeti with fenofibrat should be stopped immediately when there are signs or doubt of muscle diseases. The presence of muscle symptoms and creatin levels of phosphokinase> 10 times the above limit is indicated for muscle disease.
liver enzyme
Atorvastatin
Statins, like some other lipid reduction therapies, are involved in abnormalities of biochemical index of liver function. The prolonged increased liver enzyme (> 3 Uln and appears 2 or more) occurs in 0.7% of patients using Atorvastatin in clinical trials. These abnormalities are 0.2%, 0.2%, 0.6% and 2.3% for 10, 20, 40 and 80 mg atorvastatin dose. A patient in Atorvastatin clinical trials have been jaundice. Increasing liver function test indicators do not cause jaundice or clinical signs and symptoms of other patients. When the dose is reduced or stopped, the transaminase concentration returns to or close to the level before treatment and does not leave sequelae. 18 of the 30 patients with prolonged high liver enzyme levels continue to be treated with atorvastatin at lower doses.
ezetimibe
In control clinical studies, the rate of increased liver transaminase level (> 3 times ULN) is similar between Ezetimibe (0.5%) and placebo (0.3%). In the combined clinical studies of Ezetimibe simultaneously with Atorvastatin, the rate of increased liver transaminase level (> 3 times the above limit) is 0.6% for patients treated with ezetimibe and atorvastatin. Increasing transaminase levels often have no symptoms, unrelated to biliary stasis, and return to normal after stopping treatment.
atorvastatin/ezetimibe
Recommended the implementation of liver enzyme tests before starting treatment with Gon SA Atzeti and repeats according to clinical instructions. After the drug circulated on the market, there was a rare report on liver failure (maybe death or no) in patients using statin, including Atorvastatin. If there is serious liver damage to clinical symptoms and/or increase blood or jaundice bilirubin or jaundice during treatment with Gon SA Atzeti, stop the drug in time. If there is no other cause, do not use Gon SA Atzeti. Gon SA Atzeti should be used cautiously in patients who drink a lot of alcohol and or have a history of liver disease. Contraindicated use of Gon SA Atzeti for patients with progressive liver disease or increased transaminase for unknown cause.
Endocrine function
HBA1C increases and blood sugar levels have been reported with HMG-CAA Reductase inhibitors, including Atorvastatin.
Statins prevents cholesterol synthesis and theoretically can impair the adrenal glands and/or sex. Clinical studies have shown that the statin does not reduce plasma cortisol levels or impair the adrenal glands and ezetimibe does not reduce the production of adrenal steroid hormones. The effect of statin on male fertility has not been studied in the full number of patients. Influence, if any, on the pituitary - genital axis in premenopausal women is still unknown. Be careful when using Gon SA Atzeti simultaneously with drugs that can reduce the activity of endogenous steroid hormones such as ketoconazole, spironolacton, and cimetidine.
Using drugs in new patients with stroke or stroke
In a stroke prevention study due to a decrease in cholesterol (sparcl) with Atorvastatin 80 mg compared to the placebo, performed in 4731 patients without chronic cardiovascular disease with stroke or stroke for 6 months, the rate of stroke due to brain bleeding is higher in the Atorvastatin 80 mg compared to the placebo (2.3% Atorvastatin compared to 1.4% of the placebo).
Central nerve poisoning
Atorvastatin
The cerebral hemorrhage was seen in the female dog for about 3 months at a dose of 120 mg/kg/day. Cerebral hemorrhage and optic nerve damage have been observed in another bitch group using Atorvastatin within 11 weeks with a dose of 280 mg/kg/day before death in a state of depression. The dose of 120 mg/kg/day leads to 16 times the exposure of the whole body than the user for the maximum dose for people 80 mg/day. Damage to blood vessels in the central nervous system, characterized by bleeding, edema and single cells invading outside the vascular areas have been observed in dogs when treated with other drugs in the same group.
Use children's drugs
It is unclear the safety and effectiveness of the drug in children's patients.
Using medicine for the elderly
Efficiency and safety of Atorvastatin/Ezetimibe are similar between these patients and young people. The higher sensitivity of some elderly people cannot be excluded. Because elderly (> 65 years old) is a risk factor for muscle disease, caution should be careful when indicating Gon Sa Atzeti for the elderly. No need to adjust the dose of Gon SA Atzeti in the elderly.
Patients with liver failure
Contraindicated use of Gon SA Atzeti for patients with liver disease or increased liver transaminase continuously unknown cause.
Patients with renal failure
History of kidney failure may be a risk factor for muscle disease associated with statin. Need to closely monitor the effects on skeletal muscle in this patient group. No need to adjust the dose of Gon SA Atzeti in patients with renal failure.
Warning related to excipients
Gon SA Atzeti contains lactose (cellactose 80), patients with rape disorders are galtose tolerance, lactase deficiency or glucose-galactose absorption disorders should not use this drug. Gon SA Atzeti contains castor oil that can cause abdominal pain, diarrhea and polysorbat 80 that can cause allergies.
The ability to drive and operate machinery
The undesirable effects of Gon SA Atzeti can affect the ability to drive and operate machinery. Be careful when driving and operating machinery until you know the effect of Gon Sa Atzeti on you.
Pregnancy
Contraindicated for pregnant women or pregnancy plans. Cholesterol and triglyceride concentrations increase during normal pregnancy, cholesterol and cholesterol derivatives needed for fetal development. Atherosclerosis is a chronic process and disruption of using blood lipid drugs during pregnancy less affecting the results of primary hypercholesteroline treatment therapy.
There are no full research on the use of Atorvastatin/Ezetimibe in pregnant women. However, in a few cases, birth defects have been observed when exposed to the statin group in the uterus. Statin can be harmful to the fetus when used in pregnant women. Because Gon SA Atzeti contains Atorvastatin, the drug is used for women of reproductive age only when patients use effective methods of contraception and have been notified of the potential risks of the drug.
If women are pregnant while taking the drug, it is necessary to stop immediately and notify the patient again about potential risks to the fetus and the lack of knowledge about clinical benefits when continuing to use the drug.
The period of breastfeeding
contraindicated for women who are breastfeeding. In mice studies show that Ezetimibe and Atorvastatin can be excreted in milk. It is not clear that the possibility of the drug is excreted through human milk, but a small amount of drugs in the same group as Atorvastatin has been discovered in human milk.
Because the risk of unwanted effects occurs in newborns, women who are using Gon SA Atzeti are not breastfeeding.
Drug interaction
The risk of muscular diseases while treating with statin groups increases when used in combination with the derivatives of fibric acid, niacin with the dose to regulate blood lipid, cyclosporin and powerful CYP 3A4 inhibitors (such as Clarithromycin, HIV Protase and ITRAConazole inhibitors). Strong inhibitors Cytochrom P450 3A4 Atorvastatin are metabolized by cytochrom P450 3A4. Using Atorvastatin simultaneously with strong CYP3A4 inhibitors can increase the level of Atorvastatin in plasma. The level of interaction and increased efficiency depends on the inhibition effect on CYP3A4. Because Gon SA Atzeti contains Atorvastatin, the risk of muscle diseases caused by Gon SA Atzeti increases when used simultaneously with:
Clarithromycin: Patients who are using Clarithromycin should use the combination of Ezetimibe/Atorvastatin with a dose not exceeding 10/20 mg.
Protease inhibitors: AUC of Atorvastatin increases significantly when used with HIV Protease inhibitors, as well as hepatitis C Protease inhibitors compared to the single Atorvastatin. Therefore, HIV patients are using Tipranavir plus ritonavir or hepatitis C patients using Telaprevir, should avoid using Gon SA Atzeti. In HIV patients using Lopinavir plus ritonavir, cautious when using Gon SA Atzeti and the lowest dose possible. In patients using Saquinavir with Ritonavir, Darunavir with Ritonavir, Fosamprenavir or Fosamprenavir with Ritonavir, the dose of Ezetimibe/Atorvastatin should not exceed 10/20 mg and should be cautious when used. In HIV patients who are using Nelfinavir or hepatitis C patients using BoCeprevir, the combination of Ezetimibe/ Atorvastatin should not exceed 10/40 mg and clinically closely monitoring.
Itraconazole: AUC of Atorvastatin increases significantly when using 40 mg Atorvastatin with ITRACONAZOL 200 mg. Therefore, patients who are using iTraconazole should not use the combination of Ezetimibe/ Atorvastatin in excess of 10/20 mg.
cyclosporin
Atorvastatin and Atorvastatin metabolites are the substrate of OatP1B1 transport protein. Oatp1b1 inhibitors (eg cyclosporin) may increase the bioavailability of Atorvastatin. AUC of Atorvastatin increases significantly when using Atorvastatin 10 mg and cyclosporin 5.2 mg/kg/day compared to the single atorvastatin group. In addition, Ezetimibe and Cyclosporin use simultaneously can increase the exposure to both Ezetimibe and Cyclosporin. Ezetimibe exposure level may increase in patients with severe renal failure. It is recommended not to simultaneously use Gon SA Atzeti and cyclosporin.
Grapefruit juice beam
Grapefruit juice contains ingredients that can inhibit CYP3A4 and increase the concentration of Atorvastatin in plasma, especially when using grapefruit juice in excess of 1.2 liters/ day.
gemfibrozil
Due to the increased risk of muscle pepperstorming diseases, when using HMG-CoA Reductase and Gemfibrozil inhibitors, Gon SA Atzeti and Gemfibrozil should avoid simultaneous use. Other fibrat blood cholesterol medications due to increased risk of muscular diseases when using HMG-CoA Reductase and Fenofibrat inhibitors, so be careful when using SA Atzeti Gon simultaneously with Fenofibrat.
Fenofibrats may increase cholesterol secretion into bile, leading to gallstones. If the disease is suspected of gallstones in patients using Gon SA Atzeti and a fenofibrate, the gallbladder tests should be indicated and consider changing blood lipid therapy.
High doses (> 1 g/day)
Risk of skeletal muscle effects increases when using simultaneously SA Atzeti and Niacin, which should be considered to reduce the dose of Gon SA Atzeti in this case.
dioxin
When using many doses of Atorvastatin and Digoxin simultaneously, plasma digoxin concentrations can increase to about 20%. The patient is using digoxin should be closely monitored.
Oral contraceptives
Simultaneous use of Atorvastatin and oral contraceptives can increase the AUC of Norethindron and Ethinyl Estradiol. It should be noted this when choosing birth control pills for women who are using Gon SA Atzeti.
Rifampin and CYP3A4 induction substances
Simultaneous use of Atorvastatin and CYP3A4 touch substances (such as Efavirenz, Rifampin) can lead to reduced concentration of Atorvastatin in plasma. Due to the double interactive mechanism of rifampin, the simultaneous use of SA Atzeti and Rifampin Gon, the delay of Atorvastatin absorption after taking Rifampin is associated with a significant reduction in plasma atorvastatin levels.
colchicin
Cases of muscle disease, including muscle pepper, have been reported when using Atorvastatin and Colchicin simultaneously, cautious when indicating Atorvastatin with Colchicin.
cholestyramin
Simultaneous use with cholestyramine reduces the ezetimibe AUC by 55%. The effect of reducing LDL-C due to Ezetimibe may be limited due to this interaction.
anticoagulants Coumarin
When using simultaneously Gon SA Atzeti and Warfarin, it is recommended to monitor the international normalization index (INR).
amiodaron
When used in combination with amiodaron, the atorvastatin should not be taken more than 20mg/day because of the increased risk of muscle pattern. For patients who have to take a dose of over 20 mg/day to be effective for treatment, the doctor may choose another statin (such as pravastatin).
Storage
In a dry place, avoiding light, the temperature does not exceed 30 ° C.
Other drugs
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