Insuat 20mg Savi medicine for hyperlipidemia, prevent cardiovascular events (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Atorvastatin
Ingredient
Thành phần cho 1 viên
| Composition information | Content |
| Atorvastatin | 20mg |
Uses
Indications
Insuat 20 drugs are indicated in the following cases:
Blood lipid hypertrial treatment:
Atorvastatin is indicated as a supplement for a diet to reduce total cholesterol levels, LDL-C, APO B and Triglycerides and HDL-C growth in primary hypercholesterol patients (whether or not heterozygous family) and mixed blood lipid disorders (Fredrickson type ILA and IIB).
Supplementing the diet in hypertriglyceride (Fredrickson type IV).
Treatment of betalipoprotein disorders (Fredrickson type III) does not respond to a diet.
Reducing total cholesterol and LDL-C in patients with homozygous family cholesterol as a supplement for other blood lipid lipids (such as LDL Apheresis) or if there is no other appropriate treatment.
Supplementing the diet to reduce total cholesterol, LDL-C and APO B in children from 10-17 years old to increase heterozygous family blood cholesterol if after the diet changes still have the following characteristics:
Preventive cardiovascular events:
In people with hypercholesterolemia, there is no clear clinical manifestation of coronary artery disease but there are many risk factors such as age, smoking, hypertension, low LDL-C or early family history of coronary artery disease, the drug is indicated to:
Atorvastatin reduces total cholesterol levels, LDL-C and VLDL-C (Very Low Density Lipoprotein-Cholesterol) in plasma. The drug also tends to reduce the concentration of triglycerides and increase HLD -C (high density lipoprotein (cholesterol) in plasma.In addition, Atorvastatin also has a number of other effects such as: slowing down the process of progress and/or retreating atherosclerotic atherosclerosis and/or carotid artery; Reducing blood pressure in humans hypertension and hyperglycemic cholesterol; Anti -inflammatory activity in hypercholesteroline blood hyperiemia, accompanied or does not accompany coronary artery disease; may increase bone density.
The effect of regulating blood lipids is more correlated with dosage than with plasma concentrations.
Dynamic pharmacokinetics
absorption
Atorvastatin is quickly absorbed after oral, the maximum plasma drug concentration is achieved within 1-2 hours. The level of absorption and concentration of Atorvastatin increases proportional to the dosage of Atorvastatin. Atorvastatin tablet form is 95-99% of the solution. The absolute bioavailability of Atorvastatin is about 14% and the system of systemic use of the HMG-CAA reducing enzyme inhibitors is about 30%. Low body bioavailability is due to the purification in the gastrointestinal mucosa and/or first metabolism in the liver. Although food reduces the absorption rate of about 25% when rated by the maximum concentration (CMAX) and about 9% when assessed by the area under the curve (AUC: Area Under Curve), the LDL-C decrease is unchanged when Atorvastatin is taken at the same time as food or not. Plasma Atorvastatin concentration after taking the evening in the evening is lower in the morning when used in the morning (about 30% for CMAX and AUC). However, the effectiveness of LDL-C reduction is the same regardless of the time when taking the drug during the day (see the dose and how to use).
distribution
The average distribution of Atorvastatin is about 381 liters. Over 98% of Atorvastatin is connected to plasma proteins. The ratio of plasma red blood cells is approximately 0.25, showing the absorbency into low red blood cells.
transformation Atorvastatin is converted mainly into hydroxy derivatives at Ortho and Para positions and oxidized products at beta. In vitro, the inhibition of HMG-CoA enzyme inhibitors of metabolic substances through the hydroxylation pathway in the Ortho and Para position is equivalent to the inhibition of Atorvastatin. About 70% of the plasma inhibitors of HMG-COA enzyme are caused by active metabolites. In vitro, studies show the importance of Atorvastatin metabolism by Cytochrom P450 3A4 in the liver, suitable for the level of Atorvastatin in humans after using simultaneously with Erythromycin, a known inhibitor of this Isozym (see caution and drug interaction). In animals, the metabolic of ortho-hydroxy will undergo additional glucuronide.
excretion
Atorvastatin and its metabolites are excreted mainly through bile after the metabolism in the liver and/or outside the liver. However, the drug does not go through the intestinal cycle. Atorvastatin average plasma semi-discharged time in humans is about 14 hours, but half of the time of HMG-CAA reducing enzyme inhibitors is 10-20 hours due to the contribution of active metabolites. Under 2% of the oral atorvastatin is found in the urine.
Special patient groups
Elderly: Atorvastatin concentration in the older, healthy ( Children: Pharmacokinetic studies have not been conducted in children.
Sex: Atorvastatin concentration in plasma in women is different from men (about 20% higher for CMAX and about 10% lower for AUC). However, there is no clinical difference in clinical effect on the effectiveness of treatment on blood lipids between men and women.
Kidney failure: Kidney pathology does not affect the concentration of drugs in plasma or the effectiveness of treatment of Atorvastatin. Therefore, it is not necessary to adjust the dosage in patients with renal impairment (see dosage and usage).
Hemorrhage: Although studies have not been conducted in end -stage renal impairment patients, hemorrhage has no hope to significantly increase the clearance of Atorvastatin because the drug is strongly connected to plasma proteins.
Hepatic failure: Atorvastatin concentration in plasma increases significantly in patients with chronic liver disease due to alcohol, about 16 times for CMAX and 11 times for AUC (see contraindicated). Sloc1b1 polymorphic polymorphism: HMG-COA Reductase inhibitors are transported into the liver by OatP1B1 transport protein. In patients with SLCO1B1 polymorphic genes, they are at risk of increasing Atorvastatin levels, which can lead to increased risk of muscle pattern. Oatp1b1 coding gene (SLCO1B1 C. 521cc) is related to the increase of AUC 2.4 times higher than people without this genotype (c. 521tt). Reducing the absorption in the liver due to genetics can also occur in these patients. The consequences are not well known.
Before taking Insuat 20mg Savi medicine for hyperlipidemia, prevent cardiovascular events (3 blisters x 10 tablets)
How to use
can take Insuact 20 tablets at any time of the day, at meals or hungry. For a dose of 10 mg, the Insuation 20 can be pierced on the carved line on the tablet.
Patients need a reasonable diet before conducting treatment with Atorvastatin, and should maintain this diet during Atorvastatin treatment. Dosage
Patients should be changed to a standard diet to reduce cholesterol before taking the drug and should continue this diet even when taking the drug.
Dose should be individualized based on LDL-C levels, treatment goals and response to patients.The usual dose is 10 mg/day. The dose should be adjusted every 4 weeks. The maximum dose of 80 mg/day.
hyperlipidemia (whether or not the family is heterozygous) and mixed lipid disorders (Fredrickson type IA and ILB):
The recommended starting dose is 10-20 mg/time/day. Patients who have to reduce LDL-C (more than 45%) may start at a dose of 40 mg/time/day. About 10-80 mg/time/day. The starting dose and the maintenance dose should be individualized based on the goals of treatment and response to each person according to the NCEP (National Education Program: National Education Program on Cholesterol). After starting treatment or after each dose adjustment, check the lipid level within 2-4 weeks to adjust the dose accordingly.
Increase the heterozygous family cholesterol in children (10-17 years old):
The recommended starting dose is 10 mg/day, the maximum dose is 20 mg/day (the dose of over 20 mg/day has not been studied in children from 10-17 years old). The dosage should be individualized based on the goals of treatment (according to the instructions for treatment of NCEP). Should re -evaluate every 4 weeks.
Increase family homozygous family:
The usual dose is from 10-80 mg/day. Insuat 20 should be used as a complementary measure for other methods of lowering blood lipids (such as LDL Apheresis) or if there is no other appropriate treatment.
Prevention of cardiovascular events:
According to Tien Phat Backup test, the dose is usually 10 mg/day. Higher doses may be taken to reach the LDL-C level according to the current instructions.
Coordinate with blood lipid reduction therapy:
can be combined with solin bile acid. Combining HMG-COA inhibitors (Statin) with fibrat can be used but need to be cautious.
People with kidney failure:
Kidney disease does not affect plasma concentrations and reduces the LDL-C of Atorvastatin, so there is no need to adjust the dose for people with impaired renal function.
People who are using ciclosporin, clarithromycin, iTraconazole, or protease inhibitors:
do when using overdose? If overdose, symptomatic treatment and necessary support measures. Need to do functional assessment tests and monitor serum ck concentration when overdose. Because the drug is strongly connected to plasma proteins, it is not expected to increase the clearance of Atorvastatin by hemorrhage. What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double doses to compensate for missed dose.
Side Effects
When using the drug often has unwanted effects (ADR) such as:
Common, 1/10> ADR ≥ 1/100:
Very rare, ADR immunity: Anaphylaxis.
Notify the physician with unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Insuat 20 drug contraindicated in the following cases:
Be cautious when using
need to be very careful when taking the drug for patients in the following cases:
Before and during Atorvastatin, try to control hyperchemical hypertension with appropriate diet, exercise, weight loss in obese patients and treat diseases that may be the cause of lipid hypertension.
Liver function: Like the medications that lower blood lipids in the same group, the moderate increase (> 3 times the upper limit of the normal level) of serum transaminase can be seen when treated with Atorvastatin. When stopping the drug, Transaminase will return to the level before treatment. The liver enzyme test is needed before starting statin treatment and in the case of clinical indications for testing later (as if there is a suggestion, there is a liver damage). Caution should be used in patients with alcohol and/or a history of liver pathology. Liver disease is progressing or increasing persistent transaminase unexplained as contraindicated for the use of Atorvastatin (see contraindicated).
Bone muscle system: Muscle pattern accompanied by secondary acute renal failure and Myoglobinuria has been reported (rare) when using Atorvastatin and other drugs in the same group. History of kidney disease is a risk factor for muscle eligibility. Pay attention to monitor side effects on these patients.
Consider monitoring Creatin Kinase (CK) in the case:
Atorvastatin treatment should temporarily reduce the dose or stop treatment in a group of patients with severe and acute disease that suggest to myocarditis or patients with risk factors for acute renal impairment developed by secondary renal impairment after a dramatic myoglobin (such as severe acute infections, hypotension, surgery, trauma, severe metabolic disorders, hormonal disorders, no seizures).
The risk of muscle disease during Atorvastatin treatment will increase when used simultaneously with gemfibrozil, other fibrat blood cholesterol medications, high doses of niacin (> 1 g/day), colchicin, or antifungal drugs Azol.
Be cautious when using statin lipid medications with HIV and hepatitis C (HCV) because it may increase the risk of muscle damage, most serious is muscle pattern, kidney damage leading to kidney failure and can be fatal.
Grapefruit juice can increase the bioavailability of Atorvastatin, increasing muscle risk.
Endocrine: HBA1C increases and hungry blood sugar have been reported with HMG-CoA Reductase inhibitors, including Atorvastatin.
Statin affects cholesterol synthesis and theoretically can reduce the production of steroids in the adrenal gland. Clinical studies show that Atorvastatin does not affect the level of cortisol in the body and reserves in the adrenal gland. The effect of Atorvastatin on male fertility has not been studied on the appropriate number of patients. The effects on the pituitary-lust axis in women have not been evaluated. Precautions when using statin simultaneously with drugs that reduce endogenous hormone secretion such as ketoconazole, spironolacton and cimetidine.
Diabetes: Some evidence shows that blood sugar statin in some patients, increases the risk of future diabetes. However, statin should not be stopped for the benefit of reducing cardiovascular risk due to statin, which is greater than the risk of hyperglycemia. Patients are at high risk (5,6-6.9 mmol/l, BMI> 30 kg/m, hypertension, increased triglycerides) should be clinically and clinically monitored.
Central nervous toxicity: Cerebral hemorrhage has been observed in an individual dog that is treated for 3 months at a dose of 120 mg/kg/day. The dose of 120 mg/kg/day causes an increase in AUC about 16 times compared to the dose of 80 mg/day in humans. Cerebral hemorrhage and optic neurological degeneration have been observed in other bitches in a state of dying after 11 weeks of treatment with increasing dose to 280 mg/kg/day. In a 2 -year study, observing convulsions in two male dogs. No nerve damage in the mouse is not seen when treated within 2 years with a dose of up to 400 mg/kg/day.
Preventive stroke provision by sharply reducing cholesterol levels (SparCl: Stroke Prevention by Aggressive Reduction In Cholesterol Levels): In the analysis of experimental stroke in patients without coronary artery disease recently or with air anemia, Atorvastatin 80 mg has a higher hemorrhage rate than a placebo. The risk of an increase in people with a history of hemorrhagic stroke or defect infarction. For patients with a history of hemorrhagic stroke or defect infarction, the benefits and risks of the use of Atorvastatin 80 mg have not been assessed firmly and should consider the risk of causing hemorrhagic stroke at the beginning of treatment.
Interstitial lung disease: has been reported in some statins, especially when used for prolonged use. Symptoms include: shortness of breath, dry cough and health impairment (fatigue, weight loss and fever). If the patient is suspected of developing interstitial lung disease, the drug should be stopped immediately.
The effect of drugs on driving and operating machinery
Atorvastatin does not affect the ability to drive and operate machinery.
Using drugs for women during pregnancy and lactation
Using drugs for pregnant women:
Contraindicated Insuat 20 in pregnant women. Safety has not been set in pregnant women. There are no clinical trials that have been performed in pregnant women. There have been rare reports on the birth defects of the fetus after exposure to HMG-coa reductase inhibitors in the uterus. Animal studies have shown reproductive toxicity.
Mothers using Atorvastatin may reduce the fetal meevalonate level, which is a pre -synthetic precursor cholesterol. Atherosclerosis is a chronic, prolonged process, so the stopping of using lipid medication during pregnancy has a little impact on the long -term risk of hypercholesteroline hyperchemical. Because of the above causes, do not use Insuat 20 in pregnant women, are planning to get pregnant or suspected of being pregnant. Insuation 20 should be stopped during pregnancy or until it is determined not to be pregnant.
Women of reproductive age should use appropriate contraception while being treated with Atorvastatin.
Use medicine for breastfeeding women:
It is unknown whether Atorvastatin and its metabolites will be secreted into human milk. In mice, Atorvastatin concentrations and metabolites are active in milk equivalent to plasma concentrations. Due to the potential of serious side effects, nursing should not be breastfeeding while taking insuCT 20. Contraindicated atorvastatin during breastfeeding.
In animal studies, Atorvastatin does not affect fertility in both male and female.
Drug interaction
The effect of other drugs on Atorvastatin:
Atorvastatin is metabolized by cytochrom P450 3A4 and is a substrate of transport proteins. Concentrated use of CYP 3A4 inhibitors or shipping proteins may increase Atorvastatin levels and increase muscle disease risk. The risk also increases when using Atorvastatin simultaneously with other drugs capable of causing muscle disease such as the derivatives of fibric acid and ezetimib.
CYP3A4 inhibitors
Strong CYP3A4 inhibitors cause significant increase in Atorvastatin levels. The coordination of strong CYP3A4 inhibitors (such as Ciclosporin, Telithromycin, Clarithromycin, Delavirdin, Stiripentol, Ketoconazol, Voricazol, Itraconazol, Posaconazol and HIV Ritonavir, Lopinavir, Lopinavir, actazanavir, indomavir, indomavir, indomavir, indomavir, indomavir, indoma Darunavir ...). In case of compulsory use, it is advisable to consider the starting dose, the maximum dose appropriately and closely monitor patients.
medium inhibitors CYP3A4 (erythromycin, diltiazem, verapamil and fluconazole) may increase the plasma concentration of Atorvastatin. The risk of increased muscle disease has been observed when used in combination with erythromycin and statin. Researching and assessing the interaction of Amiodaron or Verapamil on Atorvastatin has not been done. Amiodaron and Verapamil are known to inhibit CYP3A4 and the same use with Atorvastatin can cause increased Atorvastatin levels. Therefore, it is necessary to consider lowering atorvastatin doses and should monitor patients closely when used in combination with CYP3A4 inhibitors. Should follow the appropriate clinical monitoring after starting or after adjusting the dose of inhibitors.
CYP3A4 induction
Use atorvastatin combination with CYP3A4 induction substances (such as Efavirenz, Rifampin, St. John's Wort) can reduce Atorvastatin levels in plasma. Due to the double interactive mechanism of Rifampin (P450 3A touch and inhibition of transport protein absorption in OATP1B1 liver), the sharing of Atorvastatin and Rifampin is recommended, because of the time of taking atorvastatin after drinking Rifampin causes atorvastatin concentration. However, it is not known the effect of rifampin on the concentration of Atorvastatin in liver cells, so if they have to be used together, the patient should be carefully monitored about the effectiveness of the drug.
Transport protein inhibitors
Transport protein inhibitors (such as ciclosporin) may increase Atorvastatin levels. It is unknown the effect of the inhibitor of transportation protein absorption in the liver on the concentration of Atorvastatin in liver cells. If shared, should reduce the dose and monitor patients carefully.
gemfibrozil/Fibric acid leading
The solitary use of fibrats is related to side effects, including pattern. Increased risk when used with Atorvastatin. If this combination must be used, the lowest dose of Atorvastatin should be used and need to monitor the patient appropriately.
ezetimib
Ezetimib also causes side effects, including muscle pattern. Therefore, the risk of side effects on muscle will increase when used in combination with ezetimib with Atorvastatin. Should follow the appropriate patient.
Colestipol
When used with Colestipol, Atorvastatin's concentration and its metabolites are reduced. However, when using this combination, the effect of lowering blood lipids increases compared to when using each single drug.
cholestyramin
Atorvastatin concentration in plasma decreases (about 25%) when using cholestyramin along with Atorvastatin. However, the effectiveness of treatment on blood lipids when using 2 drugs is higher when only 1 of 2 drugs.
Fusidic acid
The risk of muscle disease, including muscle pattern, may increase when sharing fusidic acid with statin. The mechanism of this interaction has not been clarified. There have been reports on cases of muscle pattern (some deaths) when using this combination. Atorvastatin should be stopped during treatment with fusidic acid.
colchicin
Although the drug interaction between Atorvastatin and Colchicin has not been studied, there have been reports of some muscle lesions when used this combination. Therefore, it is necessary to be cautious when indicated for the patient to use this combination.
antacid
Simultaneous use of Atorvastatin with oral antacid contains magnesi and aluminum hydroxyd, which will reduce the concentration of Atorvastatin in plasma by about 35%, however, the effect of the drug on the effectiveness of LDL-C does not change.
Pomelo juice
Using pressed grapefruit juice (there are many ingredients inhibited CYP 3A4) with Atorvastatin may increase the concentration of drugs in the blood.
niacin
The risk of side effects may increase when using atorvastatin with niacin, should consider reducing the dose of Atorvastatin in this case.
The influence of Atorvastatin on other drugs:
digoxin
Simultaneous use of Atorvastatin and Digoxin increases plasma digoxin concentrations in a stable state of nearly 20%. Proper monitoring of patients who are using digoxin.
Oral contraceptives
Concentrated with oral contraceptive pill contains Norethindron and Ethinyl Estradiol increases the AUC of Norethindron and of Ethinyl Estradiol nearly 20%. When choosing contraceptives for women who are taking Atorvastatin should consider this.
wafarin
In the clinical research in patients with long -term wafarin therapy, the combination of Atorvastatin 80 mg daily with wafarin reduces PT (prothrombin time) by about 1.7 seconds during the first 4 days and returns to normal after 15 days of treatment with Atorvastatin. Although the surface is very rare for drug interaction with anticoagulants, PT should also be checked before taking Atorvastatin in patients who are taking anticoagulants and should be monitored regularly during the early stages of the treatment process to ensure no major change in PT. When PT has stabilized, patients taking anticoagulants are recommended to monitor PT periodically. If the dose changes or stops atorvastatin, this process is needed. Atorvastatin is known not to bleed or change PT in non -anticoagulants.
Other drugs
In clinical studies, when concurrent Atorvastatin with antihypertensive drugs and estrogen replacement therapy, there is no clinical adverse drug interaction.
Storage
Leave a cool place, avoid light, temperatures below 30⁰C.
To be out of reach of children, read the instructions carefully before use.
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