Lipistad 20 Stella tablets for hypertonic blood cholesterol (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Atorvastatin
Ingredient
| Composition information | Content |
| Atorvastatin | 20mg |
Uses
Indications
Atorvastatin are appointed to support the diet in the treatment of patients with total cholesterol hypertrophy (C - total), low density lipoprotein cholesterol (LDL - C), ApoLipoprotein B (APO B) and Triglycerides (TG) and help increase cholesterol lipoprotein (HDL - HDL - HDL - HDL - HDL - HDL - HDL C) In patients with primary blood cholesterol hypercemolity (hyperlested hyperlemical and non -family family cholesterol), hyperlipidemia in combination (mixed) (group IIA and IIB according to the classification of Fredrickson), hyperlly blood triglycerides (group IV, according to the classification of Fredrickson) and in patients with betaliprotein blood (III III groups) have a full response to the diet.
Atorvastatin is also indicated to reduce C - Total and LDL - C in patients with hypercholesterolemia hyperlested family.
Provisions of cardiovascular complications
For patients who do not show clinical cardiovascular disease (CVD), and patients with or without blood lipid disorders, but there are risk factors for coronary heart disease (CHD) such as smoking, high blood pressure, diabetes. HDL - C is low, or patients with a family history of early coronary artery disease, Atorvastatin is designated to:
Reduce the risk of pulse and angina.
For patients with clinical coronary artery disease, Atorvastatin is appointed to:
In children (10-17 years old)
Atorvastatin is assigned to support diets to reduce total cholesterol, LDL - C, and APO B in boys and girls who have menstruation from 10 to 17 years old with hyperlestolic hypertension hypertension and after treatment with appropriate diet patients still have the following characteristics:
There is a family history of early cardiovascular disease or at least 2 other cardiovascular risk factors.
Pharmacology
Atorvastatin is a competitive inhibitor and selects HMG - CoA reducing enzyme, an enzyme that determines the level of HMG -converted cholesterol synthesis into Mevalonate, a precursor of sterols, including cholesterol. In patients with hyperchemical hypercholesterol and heterozygous family, blood cholesterol hyperplasia, and mixed blood lipid disorders, Atorvastatin reduces C - total, LDL - C, and APO B. Atorvastatin also reduces cholesterol lipoprotein very low density (VLDL - C) and Triglycerid, HDL - C. Atorvastatin reduces cholesterol and plasma lipoprotein by inhibiting HMG -reducing enzymes - CoA Reductase and cholesterol synthesis in the liver and by increasing the number of LDL receptors in the liver on the surface cell to increase the process of LDL recovery and metabolism.
Atorvastatin reduces the production process of LDL and the number of LDL sub -fertilizers, increasing and maintaining the activity of LDL receptors.
Pharmacokinetics
absorption
Atorvastatin is quickly absorbed after drinking, the peak of plasma is reached within 1 to 2 hours. The level of absorption and concentration of Atorvastatin in plasma increases proportional to the dose of Atorvastatin. Atorvastatin tablets for bioavailability equal to 95-99% of the solution form. The absolute bioavailability of Atorvastatin is approximately 14% and the whole body uses the activity of the HMG - COA elimination inhibitor activity is approximately 30%. Low body bioavailability is due to the clearance of the gastrointestinal mucosa and or the first metabolism through the liver before the common circulation. The effectiveness of LDL - C reduction is the same regardless of what time is taking medicine during the day.
Distribution
Average distribution of Atorvastatin is approximately 381 L. The ratio of cohesion to the plasma protein of Atorvastatin> 98%. The ratio between drug concentration in red blood cells/plasma concentration is approximately 0.25; This shows the poor penetration of the drug in red blood cells.
Metabolism
Atorvastatin is converted mainly into hydroxy derivatives at Ortho and Para positions and products of oxidation in beta.
Elimination
Atorvastatin and its metabolites are excreted mainly after bile after being metabolized in the liver and/or outside the liver; However, the drug does not seem to have a cycle of re -circulating the gut. The average selling time in the plasma of Atorvastatin in humans is approximately 14 hours, but the sale time of inhibitory activity for HMG - COA enzymes is 20-30 hours due to the contribution of active metabolites. Under 2% of Atorvastatin dose is found in urine after drinking.
Special target groups
Elderly
Atorvastatin concentration in plasma in elderly (> 65) healthy subjects is higher (approximately 40% for CMAX and 30% for AUC) compared to young people.
Children
Atorvastatin's oral clearance in children is similar to adults when converted according to the correlation of body mass.
Gender
Atorvastatin concentration in plasma in other women (approximately 20% higher than CMAX and 10% lower for AUC) compared to men. However, there is no clinical difference in action on lipid between men and women.
kidney failure
Nephrotic disease has no effect on plasma concentrations or acting on lipids of Atorvastatin. Therefore, it is not necessary to adjust the dose in patients with renal failure.
Dialysis jurors
Dialycar fertilizer can significantly increase the clearance of Atorvastatin because the drug has a high ratio of cohesion with plasma proteins.
Hepatic failure
Atorvastatin'splasma concentrations are significantly increased (approximately 16 times for CMAX and 11 times for AUC) in patients with chronic liver disease due to drinking.
Before taking Lipistad 20 Stella tablets for hypertonic blood cholesterol (3 blisters x 10 tablets)
How to use
Before conducting treatment with Atorvastatin, it is necessary to try to control blood cholesterol hyperplasia by a reasonable diet, exercise and lose weight in obese patients, and treat basic diseases. Patients should maintain a standard diet to reduce cholesterol during Atorvastatin treatment.
The dose is from 10 mg to 80 mg once daily. Atorvastatin doses can be used at any time of the day, whether or not food is accompanied by food. The starting and maintenance dose should be concretized for each patient depending on the initial LDL - C level, the goals of treatment, and the patient's response. After the beginning of treatment and/or during the standard dose process of Atorvastatin, the lipid concentration is needed for 2 to 4 weeks and follow the dose adjustment accordingly.
Need to adjust the dose on each patient object according to the recommended treatment goals. The adjustments must be made over 4 weeks or more. The adjustment of the dose up to 80 mg daily is based on research data in adults and limited clinical data from children's studies with hyperlested hypercholesteroline hypertension.
There is little data on safety and efficiency in children with hyperlested hypercholesterol, which is heterosexual from 6 to 10 years old obtained from open label studies. Atorvastatin is not indicated for treatment for patients under 10 years old.
Used in patients with liver failure
Should be cautious when using Atorvastatin in patients with liver failure. Contraindications to use Atorvastatin in patients with progressive liver disease.
Used in patients with renal failure
Kidney disease does not affect the concentration of Atorvastatin in plasma or the level of LDL - C reduction of Atorvastatin. Due to measurement without adjusting the dose in these patients.
Used on elderly
The safety and effectiveness of the drug in patients over 70 years of age using the recommended dose is similar to the general group.
Dosage
Increasing primary blood cholesterol and hyperlipidemia (mixed)
Most patients are controlled at a dose of 10 mg atorvastatin once a day. The treatment responds clearly within 2 weeks, and the maximum response is usually achieved within 4 weeks. This response is maintained during long -term use.
Hyper cholesterol is homozygous
Atorvastastenn dose in patients with hypercholesteroline hypercholesterol patients with homozygous family is 10 mg to 80 mg/day. In these patients, Atorvastatin should be used in combination with other blood lipid therapies (such as LDL transmission) or used when there are no other therapies.
Cardiovascular Prevention
In the main test of cardiovascular prevention, the dose is 10 mg/day. The dose can be increased to reach cholesterol levels (LDL - C) according to the current instructions.
Children
Hyper cholesterol
The use of drugs in children should only be performed by experienced doctors in the treatment of hyperlipidemia in children and should regularly assess the treatment process. For patients with hypercholesteroline hypercholester that is heterosexual from 10 years of age and older, the initial starting dose of Atorvastatin is 10 mg daily. Daily dose can be increased to 80 mg according to the response and tolerance.
What do do when overdose? If an overdose occurs, patients need to be treated with symptoms and take supportive measures if necessary. Because Atorvastatin is strongly connected to plasma proteins, dialysis is difficult to significantly increase the clearance of Atorvastatin. 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
Infections and parasites.
Common, 1/100 The immune system: allergic reactions. Uncommon, 1/1000 Mental: nightmares, insomnia. Hepatitis: Hepatitis. Skin and subcutaneous tissue: urticaria, skin rash, itching, hair loss. Testing: White cells in urine. Rare, 1/10000 Molecularity: cholestasis. Skin and subcutaneous tissue: Neuritis, dermatitis including diverse roses, Stevens - Johnson syndrome and poisoned epidermal necrosis. Very rare, ADR Not determined frequency As well as other HMG - Coa Reductase inhibitors, there has been reports to increase serum transaminase levels in patients with Atorvastatin. These changes are usually mild, transient and do not need to interrupt treatment. Transaminase in serum increases significantly clinical (> 3 times on normal limits) at 0.8% of patients using Atorvastatin. This condition is related to the dose and can recover in all patients. Creatin Kinase (CK) concentration in serum increases more than 3 times the upper limit of normal level at 2.5% of patients using Atorvastatin, similar to other HMG - CoA Reductase inhibitors in clinical trials. The concentrations are 10 times higher than normal at 0.4% of patients treated with Atorvastatin. Children Pediatric patients from 10 to 17 years old are treated with Atorvastatin with unwanted effects that are generally similar to patients using placebo, unwanted effects most often observed in both groups, regardless of whatever reasons, are infections. Not observing a significant clinical impact on the growth and maturity of gender monitored in a 3 -year study based on evaluation of maturity and overall development, evaluation in the period of puberty tanner, and measurement of height and weight. Safety characteristics and tolerance in children are similar to the known safety characteristics of Atorvastatin in adults. The following unwanted effects have been reported to some statins
Warnings
Contraindicated
Lipistad 20 contraindications in the following cases:
Pregnant, nursing or being able to get pregnant without using adequate contraception. Only use Atorvastatin for women of reproductive age when those patients are definitely not pregnant and after being notified of the risks possible for the embryo.
Be cautious when using
influence on the liver
As well as other lipid medications in the same group, after Atorvastatin treatment has reported the case of increased serum transaminase transaminase (exceeding 3 times the upper limit of normal level [ULN]).
When reducing the dose of Atorvastatin or interrupting or stopping treatment with Atorvastatin, Transaminase returns to the original level before treatment. Most patients continue to be treated with Atorvastatin with a decrease in doses without any sequelae.
Need to test the liver enzyme before starting statin treatment as well as when clinical requirements. Patients with increased transaminase need to be monitored for this abnormalities to be resolved. If ALT or AST increases higher than 3 times the upper limit of the normal level persists, the dose is needed or stop using Atorvastatin.
Be careful when using Atorvastatin in patients who drink a lot of alcohol and/or have a history of liver disease. Contraindicated to use Atorvastatin for patients with progressive liver disease or persistent transaminase increased.
Muscle effects
There have been muscle pain reports in patients using Atorvastatin. Creatin phosphokinase (CPK) should be tested before treatment in the following cases: kidney dysfunction, hypothyroidism, self -history or family history of genetic muscle disease, a history of muscle disease due to the use of statin or fibrat before, the history of liver disease and/or drinking alcohol, elderly patients (> 70 years old) have muscle risk factors. If CPK results> 5 times limited to normal levels, do not start statin treatment.
muscle disease, identified as muscle pain or muscle weakness, accompanied by increased creatin phosphokinase (CPK)> 10 times the upper limit of normal levels (ULN), should be considered in any patient with spreading muscle pain, sensitivity or muscle weakness and/or significantly increased CPK. It is necessary to advise patients to report immediately if they have pain, sensitivity, weakness, and weakness, especially with fatigue or fever. Should stop treatment with Atorvastatin if the CPK appears significantly increased or if there is a diagnosis or suspicion of muscle disease.
The risk of muscle disease during treatment with drugs in this group will increase when used with cyclosporin, Fibric acid, erythromycin, niacin, antifungal drugs Azol, Colchicin, Telaprevir, Boceprevir or combine Tipranavir/Ritonavir. Many of the drugs on the metabolic inhibitors at Cytochrom P450 3A4 and/or drug transport process.
CYP3A4 is the first iszyme of the liver to be known to participate in Atorvastatin biological metabolism. Doctors considering the combination treatment between Atorvastatin and Fibric Acid, Gemfibrozil, Erythromycin, immunosuppressants, Azol group antifungal drugs, or using high -dose Niacin blood lipid medications (> 1 g/day), Colchicin should consider carefully the benefits and risks of patients with pain and symptoms muscle, sensitive pain or muscle weakness, especially in the first months of the treatment and in any stage of adjusting the dose increases of both drugs.
Therefore, it is necessary to consider the starting dose and the maintenance dose is lower when indicated at the same time atorvastatin with the above mentioned drugs. Atorvastatin and fusidic acid should not be used simultaneously, so it is recommended to temporarily stop atorvastatin while using fusidic acid.
Like other drugs in this group, there are reports (very rare) cases of muscle destruction accompanied by secondary acute renal failure after Myoglobinuria. History of renal failure may be a risk factor for increased muscle destruction. Strict control of the skeletal muscle effects on these patients.
Temporarily stop or stop the treatment with Atorvastatin in any patient with acute and serious conditions suggesting that there is muscle disease or risk factors that easily lead to secondary renal failure after muscle destruction (for example: severe acute bacterial infections, large reducing blood pressure, large surgery, trauma, metabolic disorders, endocrinology and heavy electrolytes.
Hemorrhagic stroke
Post analysis - Hoc of a clinical study on 4731 patients without coronary disease, have stroke or transient ischemic anemia (ray) in the previous 6 months and start using Atorvastatin 80 mg shows that the rate of stroke hemorrhage in the group using Atorvastatin 80 mg is higher than the placebo group (55 patients using Atorvastatin compared to 33 patients with placebo). Patients with hemorrhagic stroke on the list seemed at risk of increased recurrent hemorrhage stroke (7 patients using Atorvastatin compared to 2 patients using placebo). However, patients treated with Atorvastatin 80 mg, any type of stroke (265 compared to 311) and coronary artery disease (123 compared to 204) are less common.
Endocrine function
There have been reports on increasing levels of hemoglobin A1C (HBA1C) and blood sugar when hungry with reducing enzyme inhibitors 3 - hydroxy - 3 - methylglutaryl - Coenzyme A (HMG - CoA), including Atorvastatin. However, the risk of hyperglycemia is lowered by a decrease in blood vessel risk to the statin group.
It is necessary to consider when taking drugs in the patin group in patients with risk factors leading to muscle damage. The statin is at risk of unwanted effects on muscle systems such as muscle atrophy, muscleitis, especially for patients with risk factors such as patients over 65 years old, untrained thyroid patients, patients with kidney disease. Need to closely monitor unwanted effects during drug use.
Before treatment, Creatin Kinase (CK) test should be conducted in case of drug interactions and on some special patients. In these cases, it is necessary to consider benefits/risks and monitor patients clinically when using statin. In the process of stator treatment, patients need to notify the doctor when there are muscle manifestations such as muscle pain, stiff muscle, muscle weakness ... When there are these manifestations, the patient needs to do CK test to take appropriate interventions.
Mimeting treatment with other drugs
Increasing risk of musculoskeletal patterns when Atorvastatin is used simultaneously with some drugs that can increase the level of Atorvastatin in plasma such as strong inhibitors of CYP3A4 or shipping protein (e.g. cyclosporin, telithromycin, clarithromycin, delavirdin, stiripentol, ketoconazole, iTraconol, iTraconol, iTraconol, iTraconol, iTraconol, iTraconol, iTraconol, iTraconol, iTraconol, iTraconol, Itraconazol, Itraconazol, Itraconazol, Itraconazol, Itraconazol, Itraconazol, Itraconazol, Itraconazol, Itraconazol, ITRACONAZO Posaconazole and HIV protease inhibitors include Ritonavir, Lopinavir, Atazanavir, Indinavir, Darunavir, ...). The risk of muscle disease can also increase when using Gemfibrozil simultaneously and other fibric acid derivatives, BoCeprevir, Erythromycin, Niacin, Ezetimib, Telaprevir, or Tipranavir/Ritonavir combination.
Do not simultaneously use Atorvastatin with systemic preparations of fusidic acid or within 7 days after stopping treatment with fusidic acid. In patients with body fusidic acid, statin should be discontinued during fusidic acid treatment. The report has been reported (including a number of deaths) in patients who are used to combine Fusidic and Stastin acids.
Statin treatment may continue seven days after the last dose of fusidic acid. In exceptional cases, if you need to use a long -term body fusidic acid, for example, to treat severe infections, you should only consider using Atorvastatin and Fusidic acid on each specific case and under tight medical supervision.
Children
No significant clinical effects on growth and gender growth in a 3 -year study based on evaluation of maturity and total development, evaluation in the period of puberty tanner, and height and weight measurement.
Interstitial lung disease
Special combination with interstitial lung disease has been reported to some statins, especially when long -term treatment. Typical characteristics may include shortness of breath, dry cough and overall health impairment (fatigue, weight loss and fever). If a patient is suspected of an interstitial lung disease, the statin should be discontinued.
excipients
Lipistad contains lactose excipients. This drug should not be used for patients with genetic problems that are not exposed to galactose, deficiency of total lactase enzymes or poor absorption of glucose - galactose.
Pregnant women
contraindicated atorvastatin during pregnancy is likely to be pregnant, so use adequate contraception. Only use Atorvastatin for women of reproductive age if these patients are definitely not pregnant and after being notified of risks that may occur for embryos.
breastfeeding women
contraindicated atorvastatin during breastfeeding. It is not known whether this drug is excreted through breast milk or not. Due to the possibility of unwanted effects for children who are breastfeeding, mothers are using Atorvastatin should not breastfeed.
The effect of drugs on driving ability, operating machinery
unknown.
Drug interaction
The effect of drugs simultaneously with Atorvastatin
Atorvastatin is metabolized by Cytochrom P450 3A4 (CYP3A4) and is a substrate of transport protein, such as the protein that transports the absorption agent of OATP1B1 liver cells. Concentrated use with drugs that are CYP3A4 inhibitors or transport proteins may increase the level of Atorvastatin in plasma and increase the risk of muscle disease. The risk can also increase when using Atorvastatin simultaneously with other drugs capable of causing muscle disease such as the derivatives of fibric acid and ezetimib.
CYP3A4 inhibitors
The strong CYP3A4 inhibitor has been shown to significantly increase Atorvastatin levels. Strong CYP3A4 inhibitors should be avoided (for example: cyclosporin, telithromycin, clarithromycin, delavirdin, stiripentol, ketoconazole, voriconazol, posaconazol and protease inhibitors including ritonavir, lowazirvir, attackavir ...) if they have ...) form. In case of unavoidable use of these drugs with Atorvastatin, it is advisable to consider reducing the starting dose, maximum dose and should be appropriate clinical monitoring for patients.Average CYP3A4 inhibitors (for example, erythromycin, diltiazem, verapamil and fluconazole) can increase atorvastatin levels in plasma. Both Amiodaron and Verapamil are known to inhibit the activity of CYP3A4 and when used simultaneously with Atorvastatin can increase Atorvastatin's exposure level. Therefore, it is advisable to consider reducing the maximum dose of Atorvastatin and the clinical monitoring should be appropriate for patients when used simultaneously with moderate CYP3A4 inhibitors. Should follow the appropriate clinical monitoring after starting or after adjusting the dose of the inhibitor.
CYP3A4 induction
Simultaneous use of Atorvastatin with Cytochrom P450 3A (e.g. efavirenz, rifampicin, st. Due to the double interactive mechanism of rifampicin (Cytochrom P450 3A touch and the transport protein of OATP1B1 liver cells), it is advisable to use atorvastatin at the same time with rifampicin.
Transport protein inhibitors
Transport protein inhibitors (e.g. cyclosporin) may increase the body exposure level of Atorvastatin. It is unknown the effect of the transport protein of liver cells on the concentration of Atorvastatin in liver cells. If it is impossible to avoid simultaneous use, it is advisable to reduce the dose and monitor the clinical effect to achieve efficiency.
gemfibrozil/derivatives of fibric acid
FIRATE SIGNALS Sometimes it also leads to muscle -related events, including muscle pattern. The risk of these events may increase when using simultaneously derivatives of fibric acid with Atorvastatin. If it is impossible to avoid simultaneous use, the lowest dose of Atorvastatin should be used to achieve treatment goals and patients should be monitored appropriately.
ezetimib
Ezetimib solitary use can lead to mechanical events, including muscle pattern. Therefore, the risk of these events may increase when used simultaneously with Ezetimib and Atorvastatin. Clinically monitor these patients appropriately.
Atorvastatin's plasma concentrations and its activity metabolites decrease (Atorvastatin concentration ratio: 0.74) when simultaneously used Colestipol with Atorvastatin. Tuy nhiên, ảnh hưởng lên lipid cao hơn khi dùng đồng thời atorvastatin và colestipol so với khi dùng đơn độc một trong hai thuốc này.
Fusidic acid
The risk of muscle disease, including muscle pattern, may increase when used simultaneously, fusidic acid with a body. There has been a report that has a pattern (including some deaths) in patients using these drugs.
If you need to treat with all over the body, it is necessary to stop treating with Atorvastatin during fusidic acid treatment.
colchicin
Although interactive studies between Atorvastatin and Colchicin have not been conducted, there have been reports of muscle disease when used simultaneously atorvastatin with colchicin and cautious when prescribing Atorvastatin with Colchicin.
The effect of Atorvastatin on other drugs is used simultaneously Digoxin
When using simultaneous doses of digoxin and atorvastatin 10 mg, digoxin concentration in a stable state increases slightly. Patients using digoxin should be followed appropriately.
Oral contraceptives
Simultaneous use of Atorvastatin with an oral oral contraceptive that increases the concentration of norethindron and ethinyl estradiol in plasma.
warfarin
Simultaneous use atorvastatin 80 mg daily with warfarin reduces about 1.7 seconds prothrombin time in the first 4 days of medication, this level returns to normal within 15 days of Atorvastatin treatment.Storage
Store in closed packaging, dry place, temperature not exceeding 30 ° C
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