Vaslor medicine 20mg Davi Pharm reduces cholesterol and triglycerides (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Atorvastatin

Ingredient

Composition information	Content
Atorvastatin	20mg

Uses

Indications

Vaslor drug - 20 indications for treatment in the following cases:

Atorvastatin is designated to use with diets to reduce total cholesterol, LDL - cholesterol, apolipoprotein B and triglycerides in high -cholesterol patients with primary blood, high cholesterol due to genetics or mixed blood lipids.

Atorvastatin is designated to support diet to treat serum high triglycerides. Atorvastatin is indicated to treat patients with beta lipoprotein disorders without adequate response to diet.

Preventive disease disease: Reducing the risk of myocardial infarction in adults with high blood pressure without clinical coronary artery disease, but at least 3 risks of coronary artery disease such as age above 55, men, smoking, type 2 diabetes, left ventricular hypertrophy, specific abnormalities on electrocardiograms, proteinuria, ratio of total cholesterol in plasma with high molecular weight ≥ 6, 6 or 6, or 6 -molecular weight, 6 or 6, or 6 -molecular weight have coronary artery disease before adulthood.

Pediatric patients (10 - 17 years old): Use support with a diet to reduce total cholesterol, low molecular weight cholesterol and reduce APO.B level in boys and girls who have had the first menstrual period (10 - 17 years old), have high disease cholesterol hypon zonetic genetic blood, if after the full testing is treated with diet mode, the results of the test as follows: Or LDL-C maintains ≥ 160 mg/dl and family history of cardiovascular disease before adulthood, or at least 2 risk factors for cardiovascular disease in children.

Pharmacokic of

Atorvastatin is a synthetic lipid, which is a reducing enzyme inhibitor 3 - Hydroxy - 3 - methylglutararl - Coenzyme A (HMG -COA). This enzyme catalyzes the transformation of HMG-COA into Mevalonate, is an early stage and limits the speed of cholesterol biosynthesis.

In patients with high cholesterol or heterozygous genetic cholesterol, non -genetic cholesterol -high forms of blood cholesterol and mixed blood lipid disorders, Atorvastatin reduces total amount of cholesterol, low molecular weight lipoprotein lipoprotein (LDL - C) and Apolipoprotein B (APO B). Atorvastatin also reduces lipoprotein cholesterol lipoprotein with very low molecular weight (VLDL - C) and triglycerides (TG) and increases the lipoprotein cholesterol lipoprotein with high molecular weight (HDL - C).

pharmacokinetics

Absorption

Atorvastatin absorbs quickly after drinking, reaching the peak concentration (CMAX) in plasma within 1 to 2 hours. The level of absorption increases proportional to the dose.

After drinking, Atorvastatin is about 95 - 99% of the film -based film cover of oral solution.

Absolute bioavailability of Atorvastatin is approximately 12% and the system of systemic inhibitors inhibitors HMG-CoA Reductase is about 30%.

Low body can be cleared by the clearance of the gastrointestinal tract mucosa and/ or first metabolism through the liver.

Distribution

The average distribution of Atorvastatin is approximately 381L. Atorvastatin binds plasma protein over 98%.

Atorvastatin body oil should pass through the bloody barrier.

Metabolism

Atorvastatin is converted by Cytocrom P450 3A4 into O-and P-Hydroxylation derivatives and many different oxidant beta products.

In addition to other roads, these products continue to be metabolized by glucuronids.

In vitro, HMG-Coa Reductase inhibitor by O-and P-Hydroxylation metabolites equivalent to Atorvastatin.

About 70% of the HMG-CoA Reductase inhibitors during circulation are due to active metabolic.

Elimination

Atorvastatin is mainly eliminated through bile after metabolism by the liver and/ or outside the liver. However, Atorvastatin undergo negligible gut liver cycle.

Average elimination of Atorvastatin plasma is about 14 hours. Half activity of HMG-CoA Reductase inhibitors about 20 to 30 hours due to the contribution of active metabolites.

pharmacokinetics on special subjects

Elderly

Atorvastatin concentration and its metabolites in plasma in healthy elderly people are higher than young people, but the effect on lipid is equivalent to young patients.

Children

Some children's studies show that the oral clearance of Atorvastatin in children is similar to adults, calculated by weight. The reduction of LDL - C and the corresponding total cholesterol has been observed in the concentrations of Atorvastatin and O - Hydroxyatorvastatin.

Gender

Atorvastatin concentration and its metabolites in women are different from men (women: CMAX is about 20% higher and about 10% lower AUC). These differences have no clinical significance, so there is no clinical significance on lipid effects between women and men.

kidney failure

Kidney disease does not affect the concentration and effects on lipids of Atorvastatin and its active metabolites.

Hepatic failure

Atorvastatin concentration and its active metabolites in plasma increases significantly (increasing by cmax about 16 times and about 11 times) in patients with chronic liver disease (Child - PUGH B).

polymorphism SLCO1B1

Absorb in the liver of HMG - CoA Reductase inhibitors, including atorvastatin, is related to the transport of OATP1B1. In SLCO1B1 polymorphic people, there is a risk of increased Atorvastatin levels, which may increase the risk of muscle pattern. Oatp1b1 encryption gene (SLCO1B1 C.521cc) is related to an increase in Atorvastatin concentration 2.4 times (AUC) compared to people without this genotype variant (C.521TT). Absorption in the liver decreases because genes can also occur in these patients. The consequences of this effect are unknown.

Before taking Vaslor medicine 20mg Davi Pharm reduces cholesterol and triglycerides (4 blisters x 7 tablets)

How to use

Vaslor drug - 20 Used oral, swallowed pills with water.

You can take the medicine at any time of the day, or not with the same meal. However, should take medicine at the same time of the day.

The doctor will determine the appropriate medication time for you. Consult your doctor if you feel the effect of the drug is too strong or too weak.

Dosage

General

Before Atorvastatin treatment, try to control high cholesterol with appropriate diet, exercise and lose weight in obese patients and treat health problems. Patients should continue to follow a standard diet that lowers cholesterol while treatment with Atorvastatin.

The recommended starting dose is 10 or 20 mg, oral 1 time/day. Patients need to reduce LDL - C (≥45%) may start using 40 mg, orally 1 time/day. Dosage range from 10 to 80 mg, taken 1 time/day.

Can use Atorvastatin 1 time/day on any time empty, sometimes full or hungry. The dosage should be adjusted for each patient depending on the level of LDL - C, the purpose of the patient's treatment and response.

After starting and/or adjusting the dose of Atorvastatin, the lipid level should be tested for 2-4 weeks and adjust the dose accordingly. Must monitor the unwanted effects of the drug, especially the harmful reactions to the muscle system.

Cardiovascular disease prevention: recommended dose is 10mg x 1 time/ day.

High cholesterol and high blood lipid cholesterol: Most patients are controlled at 10mg atorvastatin, taken once a day. Clear treatment within 2 weeks and maximum response is usually achieved within 4 weeks. This response is maintained when long -term treatment.

High cholesterol of blood genetics: In a study in patients with high cholesterol -cholesterol, the majority of patients responded to the dose of 80mg Atorvastatin: decreased over 15% of low molecular weight cholesterol (18 - 45%).

Pediatric patients with hyperglycemic cholesterol (10 - 17 years old): The recommended starting dose: 10 mg/day; The maximum recommended dose is 20 mg/day (the dose of over 20 mg has not been studied in these patients). Dosage should be adjusted depending on the purpose of treatment. The dose should be adjusted at a distance of ≥ 4 weeks.

Use drugs on special subjects:

Children: The experience of treatment for children is limited to Atorvastatin doses up to 80mg/ day. There are no reports on biochemical or clinical abnormalities in these patients.

Elderly: There is no difference in safety and effectiveness in elderly patients compared to all patients.

Patients with liver failure: See the contraindications and caution.

Patients with renal failure: Kidney disease does not affect plasma concentration or reducing cholesterol low molecular weight of Atorvastatin. So do not need to adjust the dose.

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 expert

What to do when overdose? When an overdose, patients need to be treated with symptoms and necessary supportive measures.

Should test liver function and monitor serum CPK. Because Atorvastatin is linked to a lot of plasma proteins, hemorrhage may not increase the clearance of Atorvastatin.

What to do when forgetting 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 dose to compensate for missed dose.

Side Effects

Unwanted effects (ADR) when using Vaslor - 20 that you may encounter.

Common

Infections and parasites: Nasomy throat. flow.

Metabolism and nutrition: Lower blood glucose, weight gain, anorexia.

Mental: nightmares, insomnia. pancreas.

Rare

Blood and lymphatic system: platelet reduction. Link: muscle disease, muscle inflammation, muscle pilot, tendon injury, sometimes there are complications due to blood vessel rupture.

Very rare

immunity: Anaphylaxis.

muscle - bone and connective tissue: Mechanical necrosis through immunity. These changes are usually mild, transient and no need to stop treatment. This increase in dosage and recovery in all patients. The concentration of more than 10 times on normal limits is encountered in 0.4% of patients treated with Atorvastatin.

Children

Children 10-17 years old treated with Atorvastatin have unwanted effects similar to patients treated with placebo, the most unwanted effect has been reported in both patients, regardless of the cause and effect assessment, is infection. Safety information and tolerance in children's patients similar to adults.

Instructions on how to handle ADR

Notice immediately to the doctor or pharmacist the harmful reactions encountered when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Vaslor drug - 20 Contraindications in the following cases:

Patients with hypersensitivity to any component of the drug.

Precautions for use

Effects on the liver

should conduct liver function tests before the beginning of treatment and periodically later. Patients need to be tested for liver function when there are any signs or symptoms that suggest liver damage.

Patients increase the concentration of transaminase to be monitored until the abnormalities are resolved.

If transaminase increases 3 times higher than the normal limit (ULN), should reduce the dose or stop treatment with Atorvastatin.

Be cautious when taking Atorvastatin in patients drinking a lot of alcohol and/ or a history of liver disease.

Renuming prophylaxis by sharply reducing cholesterol levels (SparCl)

In a post -testing analysis on mutant subgroups in patients without coronary artery disease (CHD) with stroke or recent brain anemia (TIC) recently, the risk of hemorrhage in patients starting treatment with Atorvastatin 80mg is higher than placebo.

The risk increases more in patients who have had previous hemorrhagic stroke or hole infarction.

For patients who have had previous hemorrhagic strokes or defective infarction, the balance between the risk and benefits of Atorvastatin 80mg is not certain, and should carefully consider the risk of hemorrhagic stroke before the beginning of treatment.

Muscle impact

As other HMG-Coa Reductase inhibitors, Atorvastatin can sometimes affect skeletal muscles and cause muscle pain, muscle inflammation and muscle diseases, which can progress to muscle and muscle, a condition that can be fatal, characterized by a significant increase in creatin kinase (CK) (> 10 times ULN), Myoglobin blood and myoglobin, can be impaired.

There have been very rare reports that have muscle necrosis through the immunity (IMNM) during or after treatment with some statins.

IMNM is clinically characterized by prolonged thigh muscle weakness and increased serum creatin concentration, not out of treatment with statin.

Before treatment

Be cautious when taking Atorvastatin for patients with risk factors for muscle pattern. Measure the level of creatin kinase before starting treatment for patients with the following conditions:

Renal failure.

Hypothyroidism.

There is a personal history or family with genetic disorders.

History of muscle poisoning with statin or fibrat before.

There is a history of liver disease or drinking a lot of alcohol.

In the elderly (> 70 years old), it is recommended to consider the need for the above assessment, depending on the risk factors for existing muscle and elimination.

Conditions that can increase the concentration of drugs in plasma, such as interactions and on special objects.

In these conditions, the risks should be considered in relationships with treatment benefits, and clinical monitoring recommendations.

If the concentration of Creatin Kinase is significantly (> 5 times ULN) at the beginning, it should not start treatment.

Tracking Creatin Kinase: Should not measure creatin kinase after high intensity exercise or when there is any other reliable cause causing increased creatin kinase because it can affect the test. If Creatin Kinase concentration increases significantly compared to the original (> 5 times ULN), it is advisable to measure within 5 to 7 days to confirm the results.

during treatment

Ask the patient to promptly notify the doctor if there is muscle pain, cramps or weakness, especially when there is an uncomfortable or fever.

If these symptoms appear while patients are being treated with Atorvastatin, patients need to be evaluated for the level of creatin kinase, if Creatin Kinase increases significantly (> 5 times ULN), should stop treatment.

If the symptoms of severe and daily discomfort are, even if the creatin kinase concentration increases ≤ 5 times ULN, should consider stopping treatment.

If the symptoms are resolved and the creatin kinase level returns to normal, then the reuse of Atorvastatin or a replacement statin may be considered at the lowest dose and under close supervision.

Stop treatment with Atorvastatin if Creatin Kinase increases significantly clinically (> 10 times ULN) or if diagnosed or suspected of pattern.

Mimeting treatment with other drugs

Increasing risk of muscle pattern when using Atorvastatin simultaneously and some drugs can increase plasma Atorvastatin levels such as strong CYP3A4 inhibitors or shipping proteins (such as Ciclosporin, Telithromycin, Clarithromycin, Delavirdin, Stiripentol, Ketoconazol, Voriconazol, ITRACONZIL, ITRACONZOL,,,, ITRACONZOL,, ITRACONZOL,,, ITRACONZOL,, ITRACONZOL,, ITRACONZOL,, ITRACONZOL,, ITRACONZOL,, ITRACONZOL,,,,,, ITRACONZOM 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, boceeprevir, erythromycin, niacin, ezetimib, telaprevir, or tipranavir/ ritonavir. If possible, alternative (non -interactive) should be considered instead of the above drugs.

If the concurrent use of the above drugs with Atorvastatin is necessary, carefully consider the benefits and risks of simultaneous treatment. Patients with simultaneous use of drugs that increase Atorvastatin levels, recommend to reduce the dose of Atorvastatin to the lowest doses effectively. In addition, consider reducing the starting dose of Atorvastatin and appropriate clinical monitoring in patients taking strong CYP3A4 inhibitors.

Atorvastatin is not used simultaneously with fusidic acid preparations for systemic effects or within 7 days after stopping treatment with fusidic acid. If the use of fusidic acid is really necessary, it is necessary to stop treating with Atorvastatin during treatment with fusidic acid.

There has been a report of muscle pattern (including some deaths) in patients with combination of fusidic acid and statins. It is recommended that patients seek medical support immediately if there are muscle weaknesses, pain or pain sensitivity.

Can continue to reuse the statins after 7 days of stopping fusidic acid. In some special cases, it is necessary to use prolonged fusidic acid, such as in the treatment of severe infections, it is necessary to consider combining atorvastatin and fusidic acid in each specific case and under close medical supervision.

Interstitial lung disease

There has been an interstitial lung disease report when using some statins in some cases, especially when treated for prolonged treatment. The expression may include breathing, dry cough and general health decline (fatigue, weight loss and fever).

Stop using medication if there is a suspected patient with interstitial pneumonia.

diabetes

Some evidence shows that statins may increase blood glucose and in some patients, at high risk of future diabetes, can increase blood glucose causing diabetes. However, the benefits of reducing cardiovascular risk thanks to statin are superior to blood sugar risks, so do not stop treating with statin. Patients with high risk (Glucose blood glucose at 5.6 to 6.9 mmol/l, BMI> 30 kg/m2, increased triglycerides, hypertension) should be closely monitored both clinically and biochemical.

Warning and caution related to excipients

Preparations containing lactose, patients with rare genetic diseases galactose tolerance, Lapp Lactase deficiency or glucose-Galactose absorption disorders should not be used.

Preparations containing Polysorbat 80 can cause allergies.

Vaslor contains castor oil that can cause abdominal pain, diarrhea.

The ability to drive and operate machinery

Atorvastatin has not significantly affected the ability to drive and operate machinery. However, it is necessary to be cautious.

Pregnancy

contraindicated to use Atorvastatin during pregnancy. The safety of the drug in pregnant women has not been proven. Animal research shows reproductive toxicity.

Atorvastatin treatment for pregnant women can reduce the concentration of Mevalonate's fetus, a premature biosynthesis of cholesterol. Atherosclerosis is a chronic process and the stopping of the use of hypoglycemia drugs during pregnancy often has little effect on the risk of long -term associated with primary cholesterol. Treatment should be temporarily suspended with Atorvastatin during pregnancy or until the patient is not pregnant.

Breastfeeding period

unknown Atorvastatin or its active metabolites go into breast milk or not, in mice, Atorvastatin levels and its active metabolites in plasma are similar to breast milk.

To avoid the risk of unwanted effects for children, it is recommended not to breastfeed during medication.

contraindicated use in nursing women.

Drug interaction

The impact of simultaneous use of Atorvastatin

Atorvastatin is metabolized by Cytocrom P450 3A4 (CYP3A4) and is a substrate of transport protein like OatP1B1 transport protein.

Concentrated with CYP3A4 inhibitors or transportation proteins can increase plasma Atorvastatin levels and increase the risk of muscle disease.

The risk may also increase when using Atorvastatin simultaneously with other drugs that can also cause muscle disease such as fibric acid derivatives and ezetimib

CYP3A4 inhibitors

Strong CYP3A4 inhibitors may significantly increase Atorvastatin levels. If possible, should avoid simultaneous use of strong CYP3A4 inhibitors (such as Ciclosporin, Telithromycin, Clarithromycin, Delavirdin, Stiripentol, Ketoconazol, Voricazol, Itraconazol, Posaconazol and HIV protease inhibitors include Ritonavir, Lopinavir, AcazanAr, Atazana Indinavir, Darunavir ...).

If it is necessary to use simultaneously, it is advisable to consider reducing the starting dose and maximum dose of Atorvastatin and patients should be appropriate clinical monitoring.

Average CYP3A4 inhibitors (such as erythromycin, diltiazem, verapamil and fluconazole) may increase plasma Atorvastatin levels.

Therefore, consider the minimum dose of Atorvastatin and appropriate clinical monitoring when used simultaneously with the average Atorvastatin inhibitors. Appropriate clinical monitoring recommendations after the beginning and when adjusting the dose of CYP3A4 inhibitors.

CYP3A4 induction drugs

Simultaneous use of Atorvastatin with CYP3A4 induction drugs (such as Efavirenz, Rifampin, St. John’s Wort) can reduce plasma Atorvastatin levels. Due to the dual interaction mechanism of rifampin (CYP3A4 inhibitors and OatP1B1 transport protein), simultaneous use of Atorvastatin and Rifampin are recommended, because the delay of the use of Atorvastatin after using Rifampin is involved in reducing the concentration of blood Atorvastatin. However, the effect of rifampin on Atorvastatin concentration in the liver is unknown, if the use simultaneously inevitable, the patient should be carefully monitored effectively. Transport protein inhibitors (such as ciclosporin) may increase Atorvastatin levels.

gemfibrozil/ Fibric acid derivatives

Only use fibrats sometimes related to mechanical events, including muscle pattern. The risk of these events may increase when using fibric acid derivatives simultaneously with Atorvastatin.

If it is necessary to use Atorvastatin with fibric acid derivatives, the lowest -dose of Atorvastatin should be used and monitor the appropriate patient.

ezetimibe

Only use Ezetimibe sometimes related to mechanical events, including muscle pattern. This risk may increase when using Ezetimibe simultaneously with Atorvastatin. Appropriate clinical monitoring recommendations for these patients.

Colestipol

Atorvastatin concentration and its active metabolites in a lower plasma (radioactive Atorvastatin concentration: 0.74) when simultaneously used Colestipol with Atorvastatin.However, the effect on lipid when using Atorvastatin with Colestipol is higher than when using only one of the two drugs.

Fusidic acid

The risk of muscle disease, including muscle pattern, may increase when using fusidic acid system with systemic sugars with statins.

The mechanism of this interaction is unclear. There has been a report on Co Van (including some deaths) in patients with simultaneous use of fusidic acid and statin.

If treated with fusidic acid is really necessary, should stop treating with Atorvastatin during treatment with fusidic acid.

colchicin

Be cautious when using due to a report on muscle disease

The impact of Atorvastatin on simultaneous drugs

Digoxin: When using simultaneously, repeat the Digoxin and 10mg Atorvastatin, the concentration of stable stable Digoxin increases. Proper monitoring for patients who are using digoxin.

Oral contraceptive pills: Attvastatin simultaneous use with oral contraceptives can increase the concentration of Norethindron and Ethinyl oestradiol plasma.

Warfarin: Prothrombin should be proceeded before starting Atorvastatin in patients taking coagulants and frequent treatment during the first time to ensure no significant change in prothrombin time occurs. Atorvastatin is not related to bleeding or changing the time of prothrombin in patients who do not take antifinal drugs.

Pediatric: drug interactions - Drugs are only done on adults. Drug interaction in children is unknown. Drug interactions and related warnings atorvastatin in adults should be considered for children.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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