Lipiget 10mg Getz tablet supports diets in reducing cholesterol (1 blister x 10 tablets)

Dosage form Box of 1 blister x 10 tablets
Specifications Atorvastatin

Ingredient

Composition information	Content
Atorvastatin	10mg

Uses

indications

10 mg lipiget medicine is indicated in the following cases:

Supplement the diet to reduce the level of Total - C, LDL - C, Apolipoprotein B and Triglyceride rising and to increase HDL - C in patients with primary blood cholesterol (heterozygous families and not belonging to the lineage) and Blood lipid disorders mixed (hyperlipoproteinason IIB). Family blood cholesterol is as a supplementary measure for diets and other non -drug or lipid treatments (for example, reducing LDL - C) or if the treatments are not available or insufficient. Treatment of adequate diet LDL - C still has 190 mg/dl or LDL - C still has 160 mg/dL with a positive family history of early cardiovascular disease and/or two or more risk factors for CVD in children. Methyl Glutaryl - Coenzyme A (HMG - COA) Reductase, enzyme is responsible for limiting the speed of HMG conversion - COA into Mevalonate, the precursor of sterol, including cholesterol.

The main location of HMG inhibitor activity - CoA Reductase is the liver. The inhibition of cholesterol synthesis in the liver leads to the regulation of LDL receptors and increases LDL catabolism. There are also some LDL production reductions due to the very low density lipoprotein (VLDL) lipplotein (VLDL), the precursor of LDL - cholesterol.

Atorvastatin reduces total cholesterol, LDL - cholesterol and APO B in patients with hypertonic hypertension and heterozygous, hyperplasary hyperlucer, mixed blood lipid disorders. Atorvastatin also reduces VLDL - cholesterol and triglycerides, and increases HDL - Cholesterol and Apolipoprotein A1.

pharmacokinetics

Absorption

Atorvastatin is quickly absorbed after drinking, the maximum concentration in plasma occurs within 1 to 2 hours. The level of absorption increases corresponding to the dose of Atorvastatin. The absolute bioavailability of Atorvastatin is about 12% and the system of systemic inhibitors HMG - CoA Reductase is about 30%.

The ability to supply low body is thought to be due to the previous body clearance in the gastrointestinal mucosa and/or metabolized through the first liver. Although the food reduces the rate and level of drug absorption corresponds to about 25% and 9%, according to CMAX and AUC, the LDL - C decrease is similar whether Atorvastatin is used or without food. Atorvastatin concentration in plasma is lower (about 30% for CMAX and AUC) after taking the evening drug compared to the morning. However, the reduction of LDL - C is the same regardless of the daily use of the drug.

Distribution

The average distribution volume of Atorvastatin is about 381 liters. Atorvastatin binds 98% to plasma protein. The ratio of plasma/plasma ratio is approximately 0.25 indicated that the drug is attached to the red blood cells.

Metabolism

Atorvastatin is metabolized by Cytochrome P450 Isoenzyme CYP3A4 into Ortho - and parahydroxylation derivatives and different beta oxidation products. The inhibition in the test tube for HMG - COA Reductase by the metabolites of ortho - and parahydroxylation is equivalent to Atorvastatin. About 70% of circulating inhibitors for HMG - CoA Reductase is due to active metabolites.

Elimination

Atorvastatin and its metabolites are excreted mainly in bile after the metabolism in the liver and/or outside the liver. The average selling time in Atorvastatin's plasma is about 14 hours, but the sale time of HMG inhibitor activity - CoA Reductase is 20 to 30 hours due to the contribution of active metabolites.

Before taking Lipiget 10mg Getz tablet supports diets in reducing cholesterol (1 blister x 10 tablets)

How to use

Patients should be applied to the standard cholesterol diet before lipiget and should continue this diet during lipiget treatment.

Dosage

Hyper cholesterol (heterozygous and non -family families) and mixed blood lipid disorders (type IIA and IIB)

) The recommended starting dose is 10 mg or 20 mg x 1 time/day. Patients who need to reduce LDL - C (more than 45%) may start at a dose of 40 mg x 1 time/day. The dose range is 10 mg to 80 mg once daily. Lipiget can be used as a single dose at any time of the day, along with food or not. The starting dose and the maintenance dose of lipiget should be personalized depending on the characteristics of the patient such as the goal of treatment and response. After starting and/or when lipiget titration should analyze lipid concentration within 2 to 4 weeks and adjust the dose accordingly.

Hyperized blood cholesterol in children (10 - 17 years old)

Lipiget recommended starting dose is 10 mg x 1 time/day, the maximum recommended dose is 20 mg daily. Adjustment should be done in a period of 4 weeks or more.

Hydromatbol of homozygous family blood

Lipiget dosage in homozygous patients is 10 mg to 80 mg daily. Lipiget should be used as a supplement for other lipid treatments (for example, LDL reducing method) in these patients or if such treatments are not available.

kidney failure

Kidney disease does not affect plasma concentrations or decreased LDL - C of Atorvastatin. Therefore, adjusting the dose in patients with renal dysfunction is not necessary.

Hepatic failure

In patients with alcoholic liver disease, Atorvastatin levels in plasma increases significantly. CMAX and AUC are both 4 times higher in patients with Childs - Pugh A. Cmax and AUC increasing by 16 times and 11 times in patients with Childs - PUGH B.

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?

In case of an overdose, the patient must be closely monitored on the signs or symptoms of the harmful reaction and conduct appropriate symptomatic treatment.

What to do when you forget 1 dose? If it is nearly time to take the next dose, skip the forgotten dose and take medicine at the next recommended dose. Do not take double dose to compensate for the forgotten dose.

Side Effects

When using lipiget 10 mg , you may experience unwanted effects (ADR).

Atorvastatin is usually well tolerated. Side effects are often reported including constipation , flatulence, indigestion, abdominal pain, headache, dizziness, nausea, muscle pain, diarrhea , weakness and insomnia, skin rash, infection.

The following additional adverse effects have been reported very rare: pancreatitis, hepatitis, hypersensitivity syndrome including angioedema, pain or muscle weakness associated with high serum CPK levels.

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

Lipiget 10 mg is contraindicated in the following cases:

Sensitive to any ingredients of this drug.

Patients with active liver disease or increased persistent serum transaminase.

Be cautious when using

Before starting treatment with Atorvastatin, it is necessary to try to control hypercesting blood cholesterol by diet, exercise and appropriate weight loss in obese patients and other basic health problems.

Abnormal liver function

HMG inhibitors - CoA Reductase, like some other lipid therapy, are related to the biochemical abnormalities of liver function. Liver function tests should be performed before the beginning of treatment, 6 weeks and 12 weeks after the beginning of treatment and any dose increase, and periodically.

Change liver enzymes usually occurs during the first three months of Atorvastatin treatment. Patients developed increased transaminase levels should be monitored until abnormalities resolve. If the increase in dosage and can reverse ALT or serum AST> 3 times the upper limit of normal levels still exist, recommend the dose reduction or stop use of Atorvastatin. The drug should be used cautiously in patients who drink a lot of alcohol and/or have a history of liver disease.

skeletal muscle

Atorvastatin treatment should temporarily stop or stop in any patient with acute and serious condition suggesting muscle disease with risk factors leading to the development of secondary renal failure after muscle pepper (for example, severe acute infections, hypotension, large surgery, severe trauma, hormonal disorders, endocrine and electrolytes, and uncontrolled convulsions). Patients should promptly report any muscle pain, pain or muscle weakness, especially if there is an uncomfortable or fever.

The ability to drive and operate machinery

There is no report.

Pregnancy

Atorvastatin should only be used for women of reproductive age when these patients are unable to conceive and have been notified of potential risks. Women should use adequate contraception while using Atorvastatin.

The safety of Atorvastatin during pregnancy has not been established and contraindicated for use during pregnancy.

The period of breastfeeding

It is not recommended to use Atorvastatin during breastfeeding because it is likely to cause serious side effects in breastfed babies.

Drug interactions

cyclosporine, Fibel acid derivatives, erythromycin, Azole or Niacin antifungal drugs: The risk of muscle disease while treating with drugs in HMG - COA inhibitors will increase when used simultaneously these drugs.

Antacisletes: A reduction in plasma Atorvastatin levels may occur when used with oral antacids containing magnesium and aluminum hydroxid, but the reduction of LDL - cholesterol is not changed.

Digoxin: When using many doses of Atorvastatin and Digoxin simultaneously, plasma digoxin concentrations in a stable state increase by about 20%. Patients using digoxin should be followed appropriately.

erythromycin: Atorvastatin concentration in plasma increases by about 40% when simultaneously used atorvastatin and erythromycin, a known Cytochrome P450 inhibitor.

Oral contraceptives: Shared Atorvastatin and oral contraceptives increase the AUC value of Norethindrone and Ethinyl Estradiol to about 30% and 20%. These increase should be considered when choosing an oral contraceptive for a woman who is taking Atorvastatin.

Storage

Storage below 30 ° C.

Avoid sunlight and moisture.

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