Ezvasten Davipharm medicine treats increased cholesterol (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Atorvastatin, Ezetimibe

Ingredient

Composition informationContent
Atorvastatin20mg
Ezetimibe10mg

Uses

indications

Ezvasten drugs are indicated in the following cases:

Hematuria hypertension:

Reduce low molecular weight cholesterol, increased cholesterol with high weight.

Coronary artery treatment:

In patients with coronary artery disease in combination with hypercholesterolemia, Ezvasten is indicated to reduce the risk of coronary artery death, reduce non -fatal myocardial infarction, reduce the risk of blood vessel regeneration, slow down atherosclerosis, reduce new lesions.

Pharmacokic

Plasma cholesterol has two origin: exogenous origin (absorbed from the intestine) and endogenous origin (the body synthesized). Ezvasten is a combination of two substances Ezetimibe and Atorvastatin, which reduces plasma cholesterol by both inhibiting absorption and synthesis.

ezetimibe:

Ezetimibe lower blood cholesterol by inhibiting the absorption of cholesterol in the small intestine.

atorvastatin:

Atorvastatin is a synthetic lipid lowering, which is a 3-hydroxy-3-methylutaryl-coenzymic-methylutaryl-coenzyme (HMG-CoAA). This enzyme catalyzes the HMG-CAA transformation into Mevalonate, is an early stage and limits the speed of cholesterol biosynthesis, in patients with high blood cholesterol or heterozygous genetics, non-genetic cholesterol forms due to genetics and mixed blood lipid disorders, Atorvastatin reduces the volume of consistent cholesterol, lipoprotein cholesterol lipoprotein (LDL-C) and Apolipoprotein B (APO B). Atorvastatin also reduces cholesterol lipoprotein with very low molecular weight (VLDL-C) and triglycerides (TG) and increases the lipoprotein cholesterol lipoprotein with high magnetic weight (HDL-C).

pharmacokinetics

absorption:

ezetimibe

After drinking, Ezetimibe is quickly absorbed and combined into the Ezetimibe-Glucuronid form. The maximum concentration in plasma (CMAX) reaches about 1-2 hours after drinking for ezetimibe -glucuronid, and about 4 -12 hours after drinking for ezetimibe. Food does not affect the bioavailability of Ezetimibe.

Atorvastatin

Atorvastatin is quickly absorbed by oral, maximum concentration in plasma is achieved within 1-2 hours. The amount of Atorvastatin is absorbed and the plasma concentration increases according to the dose ratio. Atorvastatin tablets have 95-99% bioavailability compared to the form of solution. The absolute bioavailability of Atorvastatin is about 14% and the HMG-CoA Reductase elimination effect is about 30%.

The low bioavailability is due to the clearance of the gastrointestinal mucosa before entering the body and the first metabolism in the liver. Although the food reduces the speed and the amount of drugs absorbed by 25% and 9%, according to CMAX and AUC, the reduced low molecular weight cholesterol is similar to each other when Atorvastatin is taken at full or hungry. The plasma concentration of Atorvastatin is lower (about 30% for CMAX and AUC) when taking the drug in the afternoon compared to taking the medicine in the morning. However, the reduction of cholesterol weight is similarly low, regardless of the medication at the day of the day.

Distribution:

ezetimibe

Ezetimibe and Ezetimibe-Glucuronid associated with plasma proteins at 99.7% and 88 ~ 92%.

Atorvastatin

The average distribution of Atorvastatin is about 381 L. Over 98% Atorvastatin binds to plasma proteins. The ratio of red blood cells/ plasma is about 0.25, showing less absorbent drugs into red blood cells.

Metabolism:

ezetimibe

Ezetimibe is metabolized mainly in the small intestine and liver through a combination of glucuronid. Both Ezetimibe and Ezetimibe-Glucuronid are slowly eliminated from plasma due to the intestinal cycle. The half-life of Ezetimibe and Ezetimibe-Glucuronid is about 22 hours.

Atorvastatin

Atorvastatin is widely converted into Ortho-, parahydroxy-and many oxidant products. In vitro, the inhibition of HMG-CoA reducing enzyme by the ortho-parahydroxy metabolites- equivalent to Atorvastatin. About 70% of HMG-CAA eliminating enzyme inhibitors in the circulatory system are due to active metabolites. In vitro studies propose the importance of Atorvastatin metabolism with cytochrome P450 3A4 in the liver, due to increased plasma concentrations of Atorvastatin in humans after using at the same time as erythromycin is this enzyme inhibitor.

In vitro studies also show that Atorvastatin is a weak inhibitor of Cytochrom P450 3A4. Simultaneous use with Atorvastatin does not significantly increase the plasma concentration of terfenadin, a compound that is clearly metabolized by P450 3A4. Therefore, Atorvastatin will not significantly change the pharmacokinetics of other cytochrom P450 3A4 substrates, in animals, ortho-hydroxy metabolites undergo gluconide.

Era:

ezetimibe

After drinking, 14C-Ezetimibe (20mg), about 93% Ezetimibe is present in plasma. About 78% and 11% are found in feces and urine within 10 days. After 48 hours, there is no drug present in plasma.

Atorvastatin

Atorvastatin and metabolites are excreted mainly through bile after the metabolism in the liver or outside the liver. However, the drug does not seem to go through the gut cycle. The average selling time in the plasma of Atorvastatin in humans is about 14 hours, but the half -life of the HMG -CoA reducing enzyme inhibits 20-30 hours due to the contribution of active metabolites. After drinking, less than 2% of Atorvastatin's dose is found in urine.

Before taking Ezvasten Davipharm medicine treats increased cholesterol (4 blisters x 7 tablets)

How to use

oral medication.

Dosage

Patients should follow a low -cholesterol diet when starting to use the drug and continue according to this diet during treatment. Dosage should be adjusted to each patient based on plasma lipid level.

Should 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 batch of no less than 4 weeks apart and must monitor the harmful reaction of the drug, especially the harmful reaction to the muscle system.

Dosage for adults:

usually 1 - 4 capsules x 1 time/day. Starting should be used at 1 tablet 1 time/day. After 2 weeks, check the plasma lipid concentration. If necessary, adjust the dose.

Patients with liver failure:

Unsurting the dose adjustments in patients with mild liver failure.

Patients with renal failure:

Unsurprisingly adjustable or moderately adjustable dose do the dose in patients. However, for patients with severe renal impairment, this drug can only be used if the patient can intolerize atorvastatin at a dose of 5mg or higher. Should be cautious when taking the drug for these patients and should monitor patients carefully.

Elderly patients:

Unnecessary adjustment of the dose in elderly patients.

Patients who are taking cyclosporin:

For patients who are taking cyclosporin, this drug can only be used if the patient may intolerize atorvastatin at a dose of 5mg or more, but should not be used more than ½ tablet x 1 time/day.

Patients who are taking Amiodaron or Verapamil:

In patients using Amiodaron or Verapamil, do not use more than 1 capsule 1 time/day.

Patients who are taking HIV, hepatitis c:

Interactive protease inhibitors recommendation of prescription recommendations

Telaprevir

Avoid using Ezvasten

fosamprenavir

fosamprenavir + ritonavir

saquinavir + ritonavir

Neither of 1 tablet/day 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?

There is no specific treatment for ezvasten overdose. When taking overdose, patients should be treated with symptoms, and the necessary support methods.

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. Do not drink twice as prescribed.

Side Effects

When using Ezvasten, you may experience unwanted effects (ADR).

Atorvastatin

Common, ADR> 1/100

  • Digestive: diarrhea, constipation, flatulence, abdominal pain and nausea.
  • Central nerve: headache, dizziness, blurring, insomnia, weakness. 1/100
  • Neurological - muscle and bone: muscle disease (combining muscle weakness and increased content of plasma creatin phosphokinase (CPK)).

    Neuros - muscles and bones: muscle inflammation, muscle pilot, leading to secondary acute renal failure due to myoglobinuria.

    In addition, there are some unwanted effects:

  • Cognitive decline (such as memory loss, confusion ...).
  • Hyperglycemia.

    Ezetimibe is often well tolerated. The most unwanted effects include headache, abdominal pain, diarrhea, other digestive disorders, hypersensitivity reactions including erythema and angioedema, fatigue, chest pain, and joint pain have also been reported. Unexpected effects rarely occur including hyper enzyme or hepatitis, pancreatitis, thrombocytopenia, gallstones, cholecystitis. Muscle pain has occurred in patients using Ezetimibe alone or when added to a statin. Ezemitibe must be discontinued when suspected of having muscle disease or creatin phosphokinase increased significantly.

    Combining Ezetimibe/Atorvastatin

    Unwanted effects when combining two medications similar to the single Atorvastatin. However, the frequency of increasing transaminase is slightly higher than when using Atorvastatin.

    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

    Ezvasten drugs contraindicated in the following cases:

  • Patients sensitive to any ingredient of the drug.
  • Active liver disease or increased transaminase prolonged unexplained cause.
  • Patients with moderate and severe liver failure.
  • Pregnant and lactating women.

    • Be cautious when used

    Hepatic dysfunction: HMG-CAA eliminating enzyme inhibitors, like some other lipids, causes biochemical abnormalities in liver function. Liver disease is active or increased for unexplained transaminase, which is contraindicated by Atorvastatin. Recommended the liver enzyme test before starting treatment with atorvastatln and in the case of clinical indications for testing later.

    skeletal muscle: It is necessary to consider when taking drugs belonging to the statin group for patients with risk factors leading to muscle damage. The drug in the statin group is at risk of causing harmful therapy for muscle systems such as muscle atrophy, muscle inflammation, especially for patients with risk factors such as patients over 65 years old, patients with untreated thyroid diseases, patients with kidney disease, closely monitoring harmful judges during the use of drugs.

    There are reports on some cases of bonding and weak muscle globin.

    Consider monitoring Creatin Kinase (CK) in the case:

    Before treatment, CK tests should be conducted in the following cases: impaired renal function, hypothyroidism, history of patients or a history of genetic muscle disease, a history of muscle disease due to the use of statin or fibrat before, a history of liver disease and/or drinking lots of alcohol, elderly patients (> 70 years old) have risk factors for muscle pattern, special possibility of drug interaction. 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.

    Monitoring patients during medication. If there are symptoms such as fatigue, muscle weakness, should stop using the drug.

    The ability to drive and operate machinery

    The drug can cause headaches, dizziness, blurred vision, insomnia ... So be careful when driving or operating machinery.

    Pregnancy

    Contraindicated in pregnant women.

    Lactation period

    Contraindicated in breastfeeding women.

    Drug interaction

    Atorvastatin

    Should be cautious when used in combination with niacin or immunosuppressive drugs.

    Increase the risk of muscle damage when using statin simultaneously with the following drugs:

  • cyclosporin.

    HIV treatment, hepatitis C: Concomitance the use of statin lipid medications with HIV and hepatitis C (HCV) can increase the risk of injury, the most serious is the muscle pattern, kidney damage leading to kidney failure and can cause death.

    CYP3A4 enzyme inhibitors: Used with CYP3A4 enzyme inhibitors may increase the concentration of Atorvastatin in plasma, leading to an increased risk of muscle and muscle disease.

    Amiodaron: When used with amiodaron, do not use more than 20mg of atorvastatin/day because of the increased risk of muscle pattern. For patients who have to take a dose of over 20mg/day to be effective for treatment, the doctor may choose another statin (such as pravastatin).

    Coumarin derivatives: Statin groups slightly increase the anticoagulant effect of cooumarin, in patients who are taking anticoagulant drugs, should determine prothrombin before and during Atorvastatin treatment.

    antacids: Use Atorvastatin simultaneously with antacids containing magnesi and aluminum hydroxyd, plasma concentration of Atorvastatin is reduced by about 35%. However, the effect of reducing cholesterol weight low does not change.

    Antyrin: Because Atorvastatin does not affect the pharmacokinetics of antipipin, there is no interaction with other drugs metabolized through the same type of cytochrom.

    Colestipol: When using Colestipol with Atorvastatin, Atorvastatin's concentration is reduced by about 25%. However, the effect on lipid increases when using Atorvastatin and Colestipol compared to when using a separate drug.

    Digoxin: When using multiple doses of digoxin and 10mg atorvastatin simultaneously, plasma digoxin concentrations in a stable state are not affected. However, Digoxin concentration increased by about 20% when using digoxin with 80 mg atorvastatin daily. Should follow the appropriate monitoring for patients using digoxin.

    erythromycin/clarithromycin: simultaneously use Atorvastatin and erythromycin (500mg x 4 times/day) or Clarithromycin (500mg x 2 times/day) is Cytochrom P450 3A4 inhibitors: Increased plasma concentration of Atorvastatin.

    azithromycin: simultaneously use Atorvastatin (10mg x 1 time/ day) and azithromycin (500 mg x 1 time/ day) does not change the serum level of Atorvastatin.

    terfenadin: simultaneously using Atorvastatin and Terfenadin does not create a significant influence on the pharmacokinetics of Terfenadin.

    Oral contraceptive: Concomitance with oral contraceptive pills contains norethindron and ethinyl estradiol, increasing the value of the area under the concentration - time (AUC) curve (AUC) of Norethindron and Ethinyl estradiol is about 30% and 20%. This increase should be considered when choosing oral contraceptives for women to use Atorvastatin.

    warfarin: A drug interactive study between Atorvastatin and Warfarin has been conducted: There is no clinical interaction.

    cimetidin: A study of drug interaction between Atorvastatin and Cimetidin has been conducted, without clinical significant interactions.

    amlodipine: The pharmacokinetics of Atorvastatin are not changed when used simultaneously atorvastatin 80mg and amlodipine 10mg in a stable state.

    ezetimibe

    Colestyramin reduces the absorption of ezetimibe and should not be used at the same time during the day. Cyclosporin can increase the concentration of the ezetimibe in plasma, so careful monitoring if the patient shares these two drugs, the Ezetimibe effect can be larger in patients with severe renal impairment.

    • Storage

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

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