Ezenstatin medicine 10/10 Agimexpharm treat hypercholesterol blood (4 blisters x 7 tablets)

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

Ingredient

Composition informationContent
Ezetimibe10mg
Atorvastatin10mg

Uses

indications

Ezenstatin medicine 10mg/10mg indicated treatment in the following cases:

  • Preventing cardiovascular events in patients with coronary artery disease with a history of acute coronary syndrome (ACS: Acute Coronary Syndrome), previously treated or untreated with statin. In patients:
  • Increasing primary cholesterol (hyperlested blood cholesterol is heterozygous and non -family) or mixed blood lipid disorders when:
  • The patient is not controlled appropriately when using statin. Deathly hyperlested blood cholesterol: In patients with adult hyperlested blood cholesterol-type blood cholesterol or support for other lipid reducing treatments (such as blood ldl).

    Code ATC: C10BA05

    Plasma cholesterol has two origin: exogenous origin (absorbed from the intestine) and endogenous origin (self -synthetic body).

    Ezenstatin is a combination of two substances Ezetimib and Atorvastatin, which reduces plasma cholesterol by both inhibiting the absorption and synthesis of cholesterol.

    ezetimib:

    Ezetimib reduces blood cholesterol by inhibiting the absorption of cholesterol in the small intestine.

    Ezetimib localized at the brush edge of the small intestine and inhibit cholesterol absorption, leading to a decrease in cholesterol transportation from the intestine into the liver. This helps reduce cholesterol storage in the liver and increases the clearance of cholesterol from the blood; This separate mechanism adds the effects of statins.

    atorvastatin:

  • Atorvastatin is a competitive inhibitor with hydroxymethylglutaryl Coenzym (HMG - COA) Reductase, preventing HMG - CoA into Mevalonate, the precursor of cholesterol, thus inhibiting cholesterol biosynthesis, reducing cholesterol in liver cells, stimulating LDL receptor synthesis (low -lipoprotine lipoprotine) Increases LDL transport from blood, resulting in a decrease in plasma cholesterol levels. Normal dose, HMG - CoA Reductase is not completely inhibited, so there is still enough meevalonic acid for many metabolic processes. Many, which is now only achieved when combined with drugs. VLDL (Lipoprotein is very low density) residues thanks to the LDL receptor. In clinical studies, evidence suggests that Atorvastatin significantly reduces coronary artery events, all cardiovascular events have existed and reduces the total number of deaths in people with coronary artery disease (with a history of angina or acute myocardial infarction) and people with plasma cholesterol 5.5 mmol/liter or higher. Cell in coronary events.

    ezetimib

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

    Atorvastatin

    Atorvastatin is quickly absorbed after drinking and is not affected by food. Peak concentration in plasma is achieved in 1-2 hours. The absolute bioavailability of Atorvastatin is about 14%.

    distribution

    ezetimib

    Ezetimib and Ezetimib-Glucuronid bond with plasma proteins at 99.7% and 88-92%.

    Atorvastatin

    Over 98% Atorvastatin is connected to plasma proteins.

    transformation

    ezetimib

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

    Atorvastatin

    Atorvastatin is mainly metabolized in the liver (> 70%) by the microsom cytochrom P450 (CYP) enzyme system, mainly due to isoenzyme 3A4 (CYP 3A4) into substances with or non -active metabolites.

    Elimination

    ezetimib

    After taking 14 C-Ezetimib (20 mg), about 93% Ezetimib is present in plasma. About 78% excreted through feces and 11% excreted through urine within 10 days. After 48 hours, there is no drug present in plasma.

    Atorvastatin

    Atorvastatin eliminates many feces, excreted through the kidney

    • Before taking Ezenstatin medicine 10/10 Agimexpharm treat hypercholesterol blood (4 blisters x 7 tablets)

    How to use

    Patients need to follow a standard diet, low cholesterol, before taking the drug and continue to maintain this diet during treatment.

    Can take the only dose at any time of the day, at a meal or hungry. Because the synthesis of cholesterol in the liver occurs mainly at night, taking medicine in the evening will increase the drug effect.

    Patients should swallow the whole pill, not crushed, dissolved or chewed.

    Dosage

    recommendations 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 patient by increasing the dose each spaced no less than 04 weeks, until reaching the desired LDL cholesterol level, or when the maximum dose is reached and must monitor the harmful reactions of the drug, especially the harmful reactions of the basic system.

    Adults

  • The recommended starting dose is 10/10 mg/day or 10/20 mg/day. After 2 weeks, check the plasma lipid concentration. If necessary, adjust the dose. If necessary, the dose can be increased, but the dose of Atorvastatin does not exceed 80 mg/day.

    • Special objects

    Patients with liver failure:

  • Unnecessary to adjust the dose in patients with mild liver failure.

    • Patients with renal failure:

  • Unnecessarily adjust the dose in patients with mild or moderate renal failure (creatinine clearance

    Elderly patients:

  • Unnecessary adjustment of the dose in elderly patients.

    • 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?

    Overdose:

  • The overdose document of Atorvastatin and Ezetimib in humans is limited.

    Currently there is no specific treatment when using Atorvastatin overdose.

    In case of overdose, patients need symptomatic treatment, and supportive measures when necessary. Should monitor liver function and ck concentration. Due to the strong drug associated with plasma proteins, the hemorrhage does not expect significantly increasing statin.

    Actively monitor for timely management measures.

    In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

    What to do when you forget 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 Ezenstatin 10mg/10mg that you may encounter:

    generally ezenstatin is well tolerated, the rate of stopped drugs lower than other lipid medications.

    Harmful reactions are grouped by frequency: Very common (ADR ≥ 1/10), common (1/100 ≤ ADR

    Common

  • Digestive: diarrhea, constipation, flatulence, abdominal pain and nausea, about 5%of patients. The upper limit of normal, in 2% of the patient, but mostly have no symptoms and recover when stopping the drug.
  • Neurological - muscle and bone: muscle disease (combining muscle weakness and increased content of plasma creatin phosphokinase (CPK)).
  • Central nerve: Cognitive decline (such as dementia, confusion ...). Can increase the risk of developing diabetes.

    • Instructions on how to handle ADR

    Serum enzyme changes often occur in the first months of ezenstatin treatment because the drug ingredient has a statin.

    Patients with high serum aminotransferase must monitor the second liver function test to confirm the results and monitor treatment until the abnormalities return to normal. If the concentration of aminotransferase (transaminase) serum AST or ALT (GOT or GPT) persists more than 3 times the upper limit of normal, it is necessary to stop treating with ezenstatin.

    Advise patients to immediately report any manifestation such as muscle pain for unknown reasons, cramps or muscle weakness, especially if accompanied by discomfort or fever.

  • If any of these symptoms occur in patients during treatment, CPK test should be done. If the rate increases significantly (> 5 times the upper limit of normal), it is advisable to stop taking the drug. Closely close.

    • Warnings

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

    contraindicated

    Ezenstatin medicine 10mg/10mg contraindicated in the following cases:

  • Patients with hypersensitivity to Atorvastatin, Ezetimib or any excipients of the drug.

    Be cautious when using

    Consider when taking this drug (because the drug contains a statin group) for patients with risk factors leading to muscle damage. The drug in the statin group is at risk of causing harmful reactions to the muscle system 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. Need to closely monitor the harmful reactions during drug use.

    Before starting treatment, it is necessary to eliminate the causes of hypercholesterol blood cholesterol such as: under -control diabetes, thyroid disobsius, kidney syndrome, blood protein disorders, biliary liver disease, due to some other drugs, alcohol addiction and total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides.

    Must conduct periodic lipid quantification, with a distance of less than 4 weeks, and adjust the dosage according to the patient's response to the drug.

    The goal of treatment is to reduce LDL cholesterol. Therefore, it is necessary to use LDL cholesterol levels to start treatment and evaluate treatment. Only when the LDL cholesterol is not tested, will the total cholesterol use to monitor treatment.

    Try to control blood cholesterol with appropriate diet, exercise, lose weight in obese patients and treat other basic diseases.

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

    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, the history of liver disease and/or drinking a lot of alcohol.

    In these cases, the benefits/risks should be considered and monitor patients clinically when treated with insulin. 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, muscle stiffness, muscle weakness ... When there are these manifestations, patients need to do CK test to take appropriate interventions.

  • only use this medication for women of reproductive age when they are certainly not pregnant and only in the case of hypercesting blood cholesterol is very high without responding to other drugs. Patients with rare genetic problems in tolerance Galactose, Lapp Lapp Lactase or Glucose-Galactose should not take this drug.

    • Use drugs for pregnant and lactating women

    Pregnancy:

    Contraindicated to use this drug for pregnant women. There is no clinical data on the use of Ezetimib and Atorvastatin during pregnancy.

    Women who are likely to be pregnant or are using contraception should consult a doctor carefully before treatment with this drug. Do not use this medication if suspected of pregnancy.

    There is no information on the toxicity of the fetus.

    Breastfeeding period:

    Do not know whether the drug is excreted in breast milk or not so contraindicated use of this medication in breastfeeding women.

    The ability to drive and operate machinery

    There is no evidence of the effect of the drug on the ability to drive, operate machinery. However, it should be noted that side effects such as headache, dizziness, blurred vision may occur during the medication period.

    Interactive drug

    Interactive drugs with other drugs and other types of interactions

    The risk of muscle disease during long -term treatment with this drug is increased (due to containing ezetimib and atorvastatin) when taken simultaneously with the derivatives of fibric acid, niacin, cyclosporin, or powerful CYP3A4 inhibitors (for example, Clarithromycin, HIV and ITRACONazol inhibitors).

    Cytochrom CYP3 A4 inhibitors: Avoid treating this combination of drugs with cyclosporin, erythromycin, gemfibrozil, otraconazole, ketoconazole (due to Cytochrom CYP3 A4), with Niacin at the dose of lipid (> 1g/day), with Colchicin and with other fibrat medications for fibrat blood groups Causing muscle and muscular inflammation.

    Coumarin derivatives: Atorvastatin can increase the effect of warfarin. Prothrombin must be determined before starting this medication and regular monitoring in the early stages of treatment to ensure no change in prothrombin time.

    Bile acid -mounted plastic: Atorvastatin and bile acid -mounted plastic (Cholestyramin, Colestipol) have a supplementary mechanism for each other; Combining these groups of drugs has a plus effect on LDL cholesterol. However, this group of drugs can significantly reduce the bioavailability of Atorvastatin when taken with them, so the time to use these two drugs must be about 2 hours apart to avoid clear interaction due to the drug attached to the plastic.

    Other lipid medications: limit this combination of drugs with other lipid medications because of the ability to increase the risk of muscle disease.

    Although there is no clinical interaction studies in clinical interaction, there is no clinical significant interaction with Atorvastatin with enamel inhibitors, angiotensin, beta blockers, calcium channel blockers, diuretics and nonsteroidal anti -inflammatory drugs.

    rifampin: rifampin reduces Atorvastatin levels when combined. If combined with 2 drugs, those drugs must be taken at the same time, because taking atorvastatin after taking rifampin reduces many plasma Atorvastatin levels.

    diltiazem: Increases the concentration of Atorvastatin in plasma, at risk of muscle fiber, kidney failure.

    Oral contraceptive pills: Concomitance with oral contraceptives containing norethindron and ethinyl estradiol increases 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.

    antacids: Use Atorvastatin simultaneously with antacids containing magnesi and aluminum hydroxyd, plasma concentration of Atorvastatin is reduced by about 35%. When taking the same antacids of Ezetimib's absorption, it does not affect the bioavailability of Ezetimib. The reduction of this absorption rate is considered without clinical significance.

    Protease inhibitors of HIV and hepatitis C (HCV): The simultaneous use of Atorvastatin with protease inhibitors of HIV and hepatitis C (HCV) can increase the risk of the most serious muscle damage, which is pattern, kidney damage leading to kidney failure and can be fatal, so it is necessary to reduce the dose of Atorvastatin as recommended in the following table:

    Statin Protease inhibitors with interactions recommendation of prescription recommendations
    Avoid using Atorvastatin

    - Fosamprenavir + ritonavir

    - Saquinavir + Ritonavir

    Not more than 20 mg atorvastatin/day

    - Nelfinavir not more than 40 mg atorvastatin/day

    Due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.

    Storage

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

    Other drugs

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

    The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

    count views

    Popular Keywords