Atorvastatin 20mg Domesco medicine for hyperlipidemia, preventing cardiovascular disease (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Atorvastatin
Ingredient Atherosclerosis, blood fat, high blood cholesterol

Ingredient

Composition information	Content
Atorvastatin	20mg

Uses

Indications

Atorvastatin 20mg Domesco is indicated in the following cases:

Atorvastatin is assigned to support the diet in the treatment of patients with total cholesterol hypertrophy (C-Section), low density lipoprotein cholesterol (LDL-C), apolipoprotein B (APO B), triglycerides (TG) and help increase cholesterol lipoprotein high dilling (HDL-C) (hyperlest cholesterol is heterozygous and unmarried family), hyperlipidemia (mixed) (group LLA and II BTHOTE OF FREDRICSON CLASSIFICATION), hyperlly blood triglycerides (Group IV, according to the classification of Fredrickson) and in patients with Beta Lipoprotein (group III according to Fredrickson classification) Eat.

Atorvastatin is also indicated to reduce partial and LDL-C in patients with hypercholesteroline hypercholesterol.

Provisions of cardiovascular complications

For patients without manifestations of cardiovascular disease (CVD) Clinically clinically and patients with or without blood lipid disorders, but there are risk factors for coronary artery disease (CHD) such as smoking, hypertension, diabetes, low HDL-C or patients with family history patients with early coronary coronary artery disease, Atorvastatin is indicated for:

Reduce the risk of death from coronary artery disease and heart infarction (Mi).

Reducing the risk of regulation.

Reduce the risk of pulse and angina.

For patients with clinical coronary artery disease, Atorvastatin is indicated to:

Reduce the risk of myocardial infarction.

Reduce the risk of stroke.

Reduce the risk of vascular re -vessel process.

Reduce the risk of hospitalization due to congestive heart failure (CH F).

Reduce the risk of angina.

In children (10 - 17 years old)

Atorvastatin is assigned to support the diet to reduce the whole cholesterol, LDL-C, and APO B in boys and girls who have menstrual periods from 10-17 years old have hyperlested hypertension blood cholesterol and after treatment with appropriate diet patients still have the characteristics: LDL-C levels still> 190mg/DL and have a family history with early arterial disease or at least 2 other cardiovascular risk factors.

Pharmacokological

Atorvastatin belongs to the group of blood lipid regulatory drugs. Atorvastatin is a competitive inhibitor with three hydroxymethylglutaryl coenzyme (HMG - CoA) Reductase, is the HMG -coa -coa catalyst enzyme into Mevalonic Acid, the precursor of cholesterol.

Atorvastatin inhibits HMG - CoA Reductase reduces cholesterol synthesis in the liver and reduces the concentration of cholesterol in the cell. This stimulates increased LDL-cholesterol receptors on the liver cell membrane, thus increasing the clearance of LDL from circulation. Atorvastatin reduces all cholesterol levels, LDL-C and VLDL-C in plasma.

The drug also tends to reduce the concentration of triglycerides and increase HDL-C in plasma.

In addition, Atorvastatin also has anti -atherosclerotic effects. Most have proved to slow down the process of progress and retreat atherosclerosis or carotid artery. The current mechanism of action is not fully known, but this effect can be independent of the effect of regulating blood lipids.

Vascular effect: Atorvastatin lower blood pressure in people with hypertension and hyperglycemia. The effect of reducing blood pressure may be associated with the recovery of the endothelial dysfunction caused by Atorvastatin, activating the endothelial oxidation oxidation and reducing plasma Aldosteron concentration.

Anti -inflammatory effects: In people with hypercholesterolemia, with or without coronary artery disease, Atorvastatin may have anti -inflammatory activity. Statin therapy in these patients reduces the CRP plasma (C-Reactive protein) plasma concentrations. CRP levels also decrease in patients with normal cholesterol with high CRP levels before treatment. Effects for CRP levels are not correlated with changing LDL-C levels. Recent studies show that reducing the level of CRP may reduce the risk of relapse or death from coronary artery causes.

Effect for bone: Atorvastatin may increase bone density.

The effect of regulating blood lipids is more corresponding to the dosage than with plasma concentrations.

pharmacokinetic

absorption

After drinking, Atorvastatin quickly absorbs and strongly transformed in the liver. Absolute bioavailability of atorvastatin 14%. Time to reach the peak concentration of 1-2 hours. The food changes the whole body of Atorvastatin after drinking. Food reduces the speed or level of absorption, but due to low reduction, it does not change the clinical change in the effects of blood lipid regulation.

Plasma concentration in plasma may be related to day and night, taking Atorvastatin in the evening, causing the peak concentration in plasma and the area under the concentration - time curve (AUC) decreased by 30-60%. Despite reduced bioavailability, Atorvastatin's blood lipid regulation effects in the evening do not change and slightly higher than drinking in the morning.

For the elderly, aged 65 and older, the plasma concentration of Atorvastatin may be higher than the young but does not change the effect of regulating blood lipid.

For mild kidney failures (Creatinin clearance coefficient 61 - 90ml/min): Atorvastatin pharmacokinetics do not change much.

In people with liver failure, Atorvastatin can accumulate in plasma.

Distribution

Atorvastatin is distributed mainly into the liver, 1 part into tissues (spleen, kidney, adrenal glands). Atorvastatin binds 88 - 99% with plasma proteins, mainly albumin. Atorvastatin can pass the placenta and distribute to breast milk.

Elimination

Atorvastatin is strongly metabolized in the liver due to the microsom cytochrom P450 (CYP) enzyme system, mainly due to isenzyme 3A4 (CYP 3A4). Selling Atorvastatin 14 hours. However, there is no correlation between pharmacokinetic parameters and treatment time (at least 24 hours). Selling waste time in long plasma, Atorvastatin can accumulate in plasma. Atorvastatin is eliminated through urine (2 - 20% of the dose) and fertilizer (60 - 90% of the dose).

Before taking Atorvastatin 20mg Domesco medicine for hyperlipidemia, preventing cardiovascular disease (2 blisters x 10 tablets)

How to use

Take oral use.

Can use atorvastatin doses 20mg at any time of the day, accompanied by food.

Dosage

Dosage for adults

Starting 10mg, once a day.

Adjust the dose every 4 weeks, if necessary and if tolerated.

Maintenance dose 10mg - 40mg/day. If necessary, the dose can be increased, but not more than 80mg/day.

Note that patients use Atorvastatin in combination with the following drugs:

When used in combination with amiodaron, do not use more than 20mg/day.

When used in combination with ciclosporin, a maximum dose of 10mg, 1 time/day.

When using Clarithromycin combination, start 10mg, 1 time/day and a maximum of 20mg, 1 time/day.

When used in combination with otraconazole, start 10mg, 1 time/day and up to 40mg, 1 time/day.

Be cautious when used in combination with (ritonavir + lopinavir) with a dose of over 20mg, 1 time/day.

Do not use more than 20mg atorvastatin/day when used simultaneously with (Darunavir + Ritonavir), Fosamprenavir, (Fosamprenavir + Ritonavir), (Saquinavir + Ritonavir).

Do not use more than 40mg atorvastatin/day when used with nelfinavir.

*Recommendation to 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 time apart for no less than 4 weeks and must monitor the harmful reactions of the drug, especially the harmful reactions 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 overdose? Due to the strong drug associated with plasma proteins, the hemorrhage does not expect 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

When using Atorvastatin 20mg Domesco, you may experience unwanted effects (ADR).

The unwanted frequency of effects is defined as follows: Very common (ADR> 1/10), common (1/100

Infections and parasites

Common: rhinitis - throat.

Blood disorders and lymphatic systems

Rare: platelet reduction.

immune system disorders

Common: Allergic reactions.

Very rare: hypersensitivity.

Nutrition and metabolic disorders

Common: Hyperglycemia.

Less: Hypoglycemia, weight gain, anorexia.

Mental disorders

Less: nightmares, insomnia.

Nervous system disorders

Common: headache.

Less: dizziness, paresthesia, decrease feeling, taste, memory loss.

Rare: peripheral neuropathy.

Eye disorders

Less: blurred vision.

Rare: visual disorders.

Disorders of ear and internal ears

Less: tinnitus.

Very rare: hearing loss.

Respiratory, chest and mediastinum disorders

Common: Sore throat - laryngeal, nosebleeds.

Disorders of the digestive system

Common: constipation, flatulence, indigestion, diarrhea, nausea.

Less: vomiting, upper and lower abdominal pain, belching, pancreatitis.

Liver disorders

Uncommon: hepatitis.

Very rare: liver failure.

Skin and tissue disorders

Few: urticaria, skin rash, itching, hair loss.

Rare: Neuritis, water glossy dermatitis includes: diverse persimmons, Stevens-Johnson syndrome and poisoned epidermal necrosis.

Disorders of musculoskeletal and connective tissue

Common: muscle pain, joint pain, limb pain, muscle spasticity, joint swelling, back pain.

Less: neck pain, muscle fatigue.

Rare: muscle disease, muscle inflammation, muscle pattern, tendon trauma, sometimes complications into tendons.

Unknown: immune necrosis.

Reproductive and mammary disorders

Very rare: female mammary glands.

Systemic disorders and medical condition

Less: Difficult, weakness, chest pain, peripheral edema, exhaustion, fever.

Testing

Common: abnormal liver function, increased blood kinase.

Uncommon: white blood cells in urine.

As with other HMG-COA Reductase inhibitors, there has been reports to increase serum transaminase concentration 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 levels at 2.5 % of patients using Atorvastatin, similar to other HMG-CoA Reductase inhibitors in clinical trials. The concentrations of 10 times higher than normal at 0.4 % of patients are treated with Atorvastatin (see the cautious part when used).

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 commonly observed in both groups, regardless of whatever reasons, are bacterial 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:

Genital dysfunction. pressure).

Instructions on how to handle ADR

Notify the doctor 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

Atorvastatin 20mg Domesco contraindicated in the following cases:

Hypersensitivity to any ingredients of the drug.

Progressive or persistent liver disease does not explain serum transaminase exceeding the upper limit of normal levels (ULN).

Pregnant, breastfeeding, or being able to get pregnant without using adequate contraception. Only use Atorvastatin for women at the age of the monkey yard, those patients are certainly not pregnant and after the monkey has been informed about the possible risks to the embryo.

Caution when using

before and during treatment with Atorvastatin, it is recommended to control blood cholesterol by measures such as diet, weight loss, exercise and treatment of diseases that can be the cause of lipid growth. Periodic lipid quantification and dosage adjustment according to the patient's response to the drug. The goal of treatment is to reduce LDL cholesterol so it is necessary to use LDL cholesterol levels to start treatment and evaluate treatment. Only when the LDL cholestrol is not tested, will the total cholesterol use to monitor treatment.

In clinical trials, a few people who take Atorvastatin have significantly increased serum transaminase (> 3 normal limits). When stopping the drug in this patient, the transaminase concentration often lowered the level before treatment. Some of these patients before treatment with Atorvastatin had abnormal liver function test results or drinking a lot of alcohol. Recommended the liver enzyme test before starting statin treatment and in case of clinical indications for testing later. Caution should be used in patients with a lot of alcohol and a history of liver disease.

Must suspend or stop using Atorvastatin in any patient who manifests itself in acute and severe muscle disease or has risk factors prone to acute renal failure due to muscle retention still such as severe acute bacteria, hypotension, surgery and large injury, abnormalities in metabolism, endocrine, electrolytes or uncontrolled shock.

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 or drinking a lot of alcohol, elderly patients (> 70 years old) with risk factors for muscle pattern, drug -related ability and some special patients. In these cases, the benefits/risks should be considered and monitor patients clinically when treated with statin. If the results of CK test> 5 times the upper limit of normal levels, do not start treatment with statin.

During statin treatment, patients need to notify when there are muscle manifestations such as muscle pain, stiffness, muscle weakness ... When these manifestations, patients need to do CK test to take appropriate interventions.

Only use Atorvastatin for women of reproductive age when they are certainly not pregnant and only in the case of hypercholesteroline blood cholesterol very high without responding to other drugs.

The ability to drive and operate machinery

unknown.

Pregnancy

contraindicated atorvastatin during pregnancy. Women are likely to be pregnant, so they should use sufficiently pushed 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 period

contraindicated atorvastatin during breastfeeding. It is not known whether this drug is excreted through breast milk or not. Because of the possibility of unwanted effects for children who are breastfeeding, mothers are using Atorvastatin should not breastfeed.

Medicinal interaction

Atorvastatin is metabolized by Cytochrom P450 3A4 (CYP3A4) and is a substrate of transport protein, such as the transport protein of the liver cells OATP1 BI. The use of piles with drugs is CYP3A4 inhibitors or shipping protein may increase the level of Atorvastatin in plasma and increase the risk of muscle disease. The risk can increase when using Atorvastatin period with other drugs capable of causing muscle disease such as the derivatives of fibric acid and ezetimib.

Medications that have the ability to interact when using Atorvastatin: CYP3A4 inhibitors or touch, shipping protein inhibitors, gemfibrozil/other substances of fibric acid, ezetimid, fusidic acid, colchicin, digoxin, oral contraceptive pills, warfarin ...

Details of drug interaction please look closely at the instructions for using the drug with the product.

Storage

In a dry place, temperatures below 30 ° C, avoid light.

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