Lipvar 10 DHG Pharma Lipid Lipid (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Atorvastatin

Ingredient

Composition information	Content
Atorvastatin	10mg

Uses

indications

Lipvar 10 drugs are indicated in the following cases:

Total cholesterol increases, LDL cholesterol, apolipoprotein B and triglycerides in patients with primary blood cholesterol (hyperlested hyperlemomic blood heterozygous and non -family family), mixed hyperlipidemia (group IIA and IIB as classified by Fredrickson), increased blood triglyceride (II group IV according to Fridickson group) Without adequate response to the diet. Overcoming, reducing the risk of cardiovascular disease. CoA into mevalonate, precursor of cholesterol. Atorvastatin reduces lipoprotein and plasma cholesterol by inhibiting the synthesis of cholesterol in the liver and by increasing the number of LDL receptors (low density lipoprotein) in the liver on the cell surface, thereby increasing the removal and degradation of LDL.

Atorvastatin reduces the strongest LDL cholesterol (25 - 61%) compared to any drug used alone, and proved prospects for patients who need to reduce cholesterol, which is now only achieved when combined with drugs. Atorvastatin increases the concentration of HDL cholesterol (high density lipoprotein) from 5 - 15% and thus lowering LDL/HDL ratios and total/HDL cholesterol. Atorvastatin also reduces plasma triglycerides at level 10 - 30% by increasing the clearance of VLDL (Lipoprotein very low density) residues thanks to the LDL receptor.

In clinical studies, evidence suggests that statins significantly reduce coronary artery events, all cardiovascular events have existed and reduce the total number of deaths in people with coronary artery disease.

pharmacokinetics

Atorvastatin is quickly absorbed after oral, maximum concentration of the drug in plasma is achieved within 1-2 hours. The level of absorption and concentration of Atorvastatin increases proportional to oral dosage. Although food reduces the speed and level of absorption of the drug, the effectiveness of treatment is unchanged when Atorvastain is taken at the same time as the food or not. Atorvastatin concentration in plasma after taking the evening medication is lower in the evening when used in the morning. However, the effectiveness of the drug is the same regardless of the time when taking the drug during the day.

Atorvastatin has a ratio of cohesion to plasma protein> 98% with the medium distribution volume of 81 L. Atorvastatin converted through CYP3A4 into hydroxy -meters in Ortho, Para and oxidation at Beta, nearly 70% of HMG -COA enzyme inhibitors are caused by active metabolites. Atorvastatin is eliminated mainly through the bile, the sale time is about 14 hours and half of the time of activity is from 20-30 hours.

Pharmacokinetics on special object groups

Elderly: Atorvastatin concentration in plasma is higher than the young group, but there is no difference in the effectiveness of treatment between these groups.

Children: Similar to adults.

Sex: Atorvastatin concentrations and active chemical substances are usually higher than men, but there is no clinical significance in treatment.

Renal failure: Kidney disease does not have an effect on plasma concentrations or acting on lipids of Atorvastatin.

Hepatic failure: Atorvastatin and metabolic concentration has a significant increase in the group of subjects with liver disease due to alcoholism.

Before taking Lipvar 10 DHG Pharma Lipid Lipid (3 blisters x 10 tablets)

How to use

Take oral use.

Can be taken at any time of the day, drink with food or not.

Dosage

Before conducting treatment with Atorvastatin, it is necessary to try to control blood cholesterol increased by a reasonable diet, exercise and weight loss in obese patients, and treat basic diseases. Patients should maintain a diet that reduces cholesterol during treatment.

Dosage should be concretized for each patient depending on the initial LDL - C level, treatment goals, and patient response.

The normal starting dose is 10 mg, which can be adjusted after at least 4 weeks. The maximum dose is 80 mg/day.

Increasing primary blood cholesterol and hyperlipidemia (mixed)

Most patients are controlled at a dose of 10 mg atorvastatin once a day. Response treatment appears within 2 weeks and maximum response is usually achieved within 4 weeks. This response is maintained during long -term use.

Hypertlycathy blood cholesterol is heterosexual

The starting dose is 10 mg daily. Dosage should be concretized and adjusted every 4 weeks of lane 40 mg/day. The dose may then be increased to 80 mg or the 40 mg dose in combination with bile acid -mounted plastic.

Hyper cholesterol is homozygous

There is not much data on this patient object. Dosage from 10 to 80 mg/day. In these patients, Atorvastatin should be used as a drug in combination with other blood lipid therapies or use when there is no other measure.

Prevention of cardiovascular diseases

The dose is 10 mg/day. Higher doses may be necessary to achieve LDL goals according to some current instructions.

Patients with impaired renal function

No dose adjustment.

Patients with impaired liver function

Need to use caution, Atorvastatin contraindicated in patients with progressive liver disease.

Used in the elderly

Patients over 70 years of age use recommended doses for efficiency and safety equivalent to other subjects.

Serious lipid disorders in pediatric patients

Only under the close supervision of experienced experts. For children> 10 years old, the recommended starting dose in this group is 10 mg Atorvastatin every day. The dose may increase to 20 mg of Atorvastatin per day depending on the ability to respond and tolerance. There is not much information for the use of doses higher than 20 mg. Do not use to treat children

or as directed by the physician.

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 do

do when using overdose? If there is an overdose of symptoms and necessary support measures. Due to the strong plasma protein -mounted drugs, there is no hope to increase the clearance of Atorvastatin by the method of blood accumulation.

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 Lipvar 10, you may experience unwanted effects (ADR).

Common

Infections: Nasomitis.

immune: allergic reactions.

Metabolism and nutrition: hyperglycemia.

Respiratory: Sore throat, nosebleeds.

digestive: diarrhea, constipation, pushing, abdominal pain, nausea. central nervous system: headache, dizziness, blurred vision, insomnia, weakness.

Neuropathy and bone: muscle pain, joint pain, muscle spasm, back pain.

Less

Metabolism and nutrition: Hypoglycemia, weight gain, anorexia.

Mental: nightmares, insomnia.

nerve: dizziness, paresthesia, sensory disorders, quickly forget.

Eyes: blurred vision.

ears: tinnitus.

digestive: vomiting, abdominal pain, pancreatitis, belching.

Hepatitis: Hepatitis.

Skin subcutaneously: urticaria, itching, rash, hair loss.

muscle: neck pain, muscle fatigue.

Rare

Platelet decrease, peripheral neuropathy, visual disorders, biliary obstruction, angioedema. Steven - Johnson syndrome, muscle disease, muscle pepper, hernia.

Very rare

Sensitive shock, hearing loss, liver failure, big breasts in men.

Some other unwanted effects

Cognitive decline (such as dementia, confusion ..), HBA1C, increasing transaminase.

Instructions on how to handle ADR

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

Lipvar 10 contraindicated drug in the following cases:

Hypersensitivity to any ingredient of the drug. The liver disease is active or serum transaminase persists on 3 normal limits that cannot be explained.

Patients who are being treated with Tipranavir and Ritonavir, or with Telaprevir.

Pregnant women or women of reproductive age do not use appropriate contraception, nursing women.

Be cautious when using

Before starting treatment with Atorvastatin, it is recommended to combine blood cholesterol control by measures such as diet, weight loss, exercise, and treatment of diseases that can be the cause of lipid hypertension. Proceed with periodic lipid quantification, and adjust the dosage according to the patient's response to the drug. Use LDL - C concentration to start treatment and evaluation of treatment.

do liver enzyme test before starting statin treatment and in case of clinical indications for testing later.

influence on the liver

It is necessary to check the liver function before starting treatment and periodically. Patients with any signs or symptoms associated with liver damage also need testing. Patients with increased transaminase should be monitored until this abnormal is resolved. If ALT or AST increases higher than 3 times the upper limit of normal levels persistently, the dose should be reduced or stop using Atorvastatin. Atorvastatin should be used carefully in patients who drink a lot of alcohol and/or have a history of liver disease.

Hemorrhagic stroke

For patients with a history of hemorrhagic stroke, the balance between benefits and the risk of using 80 mg of Atorvastatin is unclear, so the risk of hemorrhage must be closely monitored before the first treatment.

influence on the skeletal muscle system

Like other HMG - Coa Reductase inhibitors, Atorvastatin has an impact on the musculoskeletal system, causing muscle pain, muscle inflammation, muscle dysplasia that can lead to muscle pattern (characterized by an increase in creatinine kinase (CK)> 10 times the upper limit of normal levels), Myoglobin and Myoglobin condition in blood causing kidney failure.

Consider according to 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 diseases, a history of muscle disease due to the previous use of statine or fibrat, a history of liver disease and/or drinking lots of alcohol, elderly patients (> 70 years old) with special risks of medication and drugs. 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 stiffness, muscle weakness ... When there are these manifestations, patients need to test CK to take appropriate interventions.

Share drugs

Increased risk of muscle element when using Atorvastatin with CYP3A4 inhibitors, Protein transportation or protease inhibitors of HIV virus (such as cyclosporin, clarithromycin, ketoconazole, indinavir, darunavir ..). The risk of muscle diseases also increases when using atorvastatin with gemfibrozil or fibric and some derivatives. Therefore, other measures should be used to replace these groups of drugs. In case of common use, the benefits and risks must be considered for a rational use (for example, reducing the dose of Atorvastatin when used with CYP3A4 inhibitors).

Risk of interstitial lung disease

There have been a number of reports on interstitial pneumonia when using long -term statins. Characteristic signs include shortness of breath, cough and health impairment (fatigue, fever, weight loss). It is necessary to stop treating with statins if the patient has signs of interstitial pneumonia.

Diabetes risk

There are some evidence of statin hyperglycemia on some thin patients with risk of diabetes later. However, this risk is small compared to the effect of preventing atherosclerosis so there is no need to stop treating with statin. Patients with hypertension, hyper triglycerides have BMI> 30, blood sugar from 5.6 - 6.8 mmol/l should be closely monitored.

excipients

Due to lactose excipients in the ingredients, lipvar should not be used in patients with lactose tolerance, lactase deficiency or glucose - galactose absorption disorders.

The ability to drive and operate machinery

Caution when driving and operating machinery because the drug can cause headaches, dizziness.

Pregnancy

Need to use appropriate contraception during treatment.

Atorvastatin is contraindicated during pregnancy. Safety on pregnant women has not been determined, there is no clinical research control for Atorvastain in pregnant women. Rarely there are reports on urgent birth defects after exposure to HMG - COA Reductase inhibitors. Animal studies have shown the toxicity of the drug for the reproductive system. The mother treated with Atorvastatin will reduce the level of meevalonate (the precursor of the fetal cholesterol synthesis).

Atherosclerosis is a chronic process and the discontinuation of lipid lowering during pregnancy has a very small impact on the long -term risk of blood cholesterol hypercacting.

Therefore, Atorvastatin should therefore be used in pregnant women, preparing to get pregnant or suspected of being pregnant. Atorvastatin treatment should be suspended during pregnancy until sure that the patient is not pregnant.

The period of breastfeeding

has not determined whether Atorvastatin and the metabolites are excreted through breast milk. In mice in the plasma concentrations of Atorvastatin and metabolites are equivalent in milk. Due to the risk of serious side effects, women use Atorvastatin should not be breastfeeding. Atorvastatin is contraindicated in this object.

Drug interaction

affects drug groups to Atorvastatin

CYP3A4 inhibitors

These substances strongly increase the concentration of Atorvastatin in the blood, so they should be avoided (for example, cyclosporin, clarithromyecin, delavirdin, ketoconaol, voriconazole, iTraconazol, posaconazol and HIV protease inhibitors include ritonavir, loopinavir, Atazanavir, indomavir, indoavir,,,,,, indo, Darunavir ..). When it is necessary to coordinate, it is necessary to consider the starting dose and maximum dose of Atorvastatin, and clinically monitoring in patients.

Moderate CYP3A4 inhibitors (erythromycin, diltiazem, verapamil and fluconazole) may increase the concentration of Atorvastatin in plasma. The combination of erythromycin with statin has been shown to increase the risk of muscle diseases. Therefore, when coordinated, it is necessary to consider reducing the starting dose of Atorvastatin, and clinically monitoring in patients at the beginning or after adjusting the dose of these inhibitors.

CYP3A4 induction

Combining Atorvastatin with CYP3A4 induction drugs (Efavirenz, Rifampin ..) can lead to reduced Atorvastatin concentration in plasma. Due to the dual interactive mechanism of rifampin, the combination of Atorvastatin with Rifampin is recommended, using Atorvastatin after Rifampin can significantly reduce the Atorvastatin concentration in plasma. The effect of rifampin on Atorvastatin concentration in liver cells is not well known, however, if it is necessary to use combination of these two drugs, it should be carefully monitored on its effectiveness in the patient.

Transport protein inhibitors

Cyclosporin inhibitors may increase the body's Atorvastatin reception. Its effects on Atorvastatin concentration in liver cells are unknown. If it is necessary to combine, need to reduce the dose and clinical monitoring in patients.

gemfibrozil, Fibitimib acid derivatives, azitimib, colestipol, fusidic acid and colchicin

Using fibrats, single ezitimib sometimes occurs muscle problems, including muscle pattern. This risk may increase if used in combination with Atorvastatin. If used simultaneously, it is necessary to follow the clinical patient. When using Atorvasfatin and Colestipol simultaneously, Atorvastatin levels in plasma and active metabolites are reduced (about 25%).

However, the effectiveness of lipid reduction is better when combined compared to the single use of each type. There is no study on interaction between Atorvastatin and Fusidic Acid. Simultaneous use of Atorvastatin and Fusidic acid also causes muscle problems. Inhibition of this interaction is not known.

Need to monitor closely in patients and if necessary, Atorvastatin can be suspended. Although there has been no interaction research between alorvastatin and colchicin, there have been reports on the case of patients with muscle diseases when treating atorvastatin with Colchicin. So be careful when prescribing these two drugs.

The influence of Atorvastatin on other drugs

digoxin

When combining multi -dose Digoxin and 10 mg atorvastatin, the stable concentration of digoxin increases slightly. Need closely monitoring on patients using digoxin.

Oral contraceptives

Simultaneously used with Atorvastatin causes increased plasma concentrations of norethindron and ethinyl oestradiol.

wafarin

A clinical study in patients with long -term treatment with warfarin, the combination of Atorvastatin 80 mg daily with warfarin will cause a slight decline in prothrombin time in the first 4 days and will return to normal within 15 days of treatment. Although very rare reports between clinical interactions between anticoagulants and Atorvastatin are needed, prothrombin should be determined before and during treatment with Atorvastatin in patients who have taken anticoagulant drugs. Atorvastatin does not cause bleeding or changes in prothrombin time in patients who do not use anticoagulants.

Storage

In a dry place, the temperature does not exceed 30 ° C, avoiding light.

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