ATOVZE 20/10 Savi Treatment for Hypered Blood Cholesterol (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Atorvastatin, Ezetimibe
Ingredient Savi Pharma

Ingredient

Composition information	Content
Atorvastatin	20mg
Ezetimibe	10mg

Uses

Indications

ATOVZE medicine 20/10 indicates treatment in the following cases:

Increasing raw blood cholesterol: Reducing total cholesterol, reducing low density lipoprotein (LDL-C: Low density lipoprotein cholesterol), reduction of low density lipoprotein (non-hdl-c: non-high density lipoprotein cholesterol), reduced apolipoprotein B, decreased triglycerid Cao (HDL-C: High Density Lipoprotein Cholesterol) in patients with primary blood cholesterol (heterozygous heterozygous and non-family nature) or mixed hyperlipidemia.

Hypoglycemia of homozygous blood from home (HOFH: Homozygous Familial Hypercholesterolemia): Reducing total cholesterol and LDL-C in patients with hofh. Use complementary for other blood lipid reduction treatments.

Pharmacokology

ATC code: C10BA05.

Pharmacological group: Blood lipid drugs.

Plasma cholesterol is derived from intestinal absorption and endogenous synthesis. ATOVze 20/10 is a combination of two atorvastatin and ezetimib substances that reduce plasma cholesterol with a double mechanism: both inhibit the absorption of cholesterol in the intestine, while inhibiting endogenous cholesterol synthesis.

Atorvastatin: is a synthetic lipid lowering, inhibiting HMG-CoA Reductase, this is an enzyme that catalyzes HMG-CAA to Mevalonic Acid, is a precursor of cholesterol.

HMG-CAA Reductase inhibitors reduce cholesterol synthesis in the liver and reduce cholesterol levels in cells.

Ezetimib: localized at the brush edge of the small intestine and inhibit the absorption of cholesterol in the intestine, the feces from the target of Ezetimib are sterol, Niemann-Pick C1-Like I (NPCILI), which is involved in the absorption of cholesterol in the intestinal cholesterol. In 2 -week clinical research on 18 high blood cholesterol patients, Ezetimib inhibits 54% cholesterol absorbed in the intestine compared to placebo.

pharmacokinetics

atorvastatin

absorption: Atorvastatin absorbs quickly after oral, maximum concentration in plasma is achieved after about 1-2 hours. Atorvastatin absorption level corresponds to the dose.

Distribution: mainly distributed into the liver, the average distribution of Atorvastatin is about 400 liters. 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.

Metabolic: widely converted into Ortho-, parahydroxy-and many oxidant products. In vitro, HMG-Coa Reductase inhibitor by the metabolites of Ortho- and Parahydroxy- equivalent to Atorvastatin.

About 70% of HMG-CoA Reductase inhibitors in the circulatory system are due to active metabolites. In vitro studies prove the importance of Cytochrom P450 3A4 during the metabolism of Atorvastatin, due to increased plasma concentrations of Atorvastatin in humans after using at the same time as erythromycin is this enzyme inhibitor.

Elimination: Atorvastatin and its metabolites are excreted mainly into bile after metabolism through the liver and/or outside the liver. However, the drug does not go through the intestinal cycle. Half of the lifetime elimination in Atorvastatin's plasma in humans is about 14 hours, but half -life elimination of HMG -CAA Reductase inhibitors is about 20-30 hours due to the main metabolites of Atorvastatin. Under 2% Atorvastatin is found in the urine.

ezetimib

Absorption: Ezetimib is quickly absorbed after oraled and combined into Ezetimib-Glucuronid. The maximum concentration in plasma is achieved after about 1-2 hours when drinking for ezetimib -glucuronid and about 4-12 hours after drinking for ezetimib.

Distribution: About 90% Ezetimib and Ezetimib-Glucuronid bound with plasma proteins.

Metabolism and elimination: Ezetimib is metabolized mainly in the small intestine and liver through a combination of glucuronid (phase II metabolism). Ezetimib and Ezetimib - Glucuronid are the two main types of metabolic of the drug found in plasma. Respectively 10 - 20% and 80 - 90% of the total number of drugs in plasma, both Ezetimib and Ezetimib -Glucuronid are slowly eliminated from plasma through the intestinal cycle.

Half lifetime elimination in the plasma of Ezetimib and Ezetimib-Glucuronid is about 22 hours. After taking 14C-Ezetimib at a dose of 20 mg, about 93% Ezetimib is found in plasma. After 48 hours, there is no medicine in plasma.

Before taking ATOVZE 20/10 Savi Treatment for Hypered Blood Cholesterol (3 blisters x 10 tablets)

How to use

oral medication, swallowing tablets, should not break, suck or chew the pill. You can take medicine before or after eating, should take the medicine at a certain time of the day.

If you are using Colestyramin or Colestipol, you should take Atovze 20/10 at least 2 hours ago or at least 4 hours after taking these drugs.

Dosage

Initial dose: The usual starting dose of the Atorvastatin/Ezetimib combination (Atovze) is usually 10/10 mg/day (*) or 20/10 mg/day (1 Atovze tablet 20/10). In case of reduction of ≥ 55% of the amount of LDL-C in the blood, the starting dose is 40/10 mg/day (*).

Patients with homozygot cholesterol from home: Atovze dose is 40/10 mg/day (*) or 80/10 mg/day (*).

After about 2 weeks of treatment, it is necessary to check the blood lipid concentration to adjust the ATOVZE dose accordingly.

Special subjects:

Elderly: Dosage like a healthy young.

Children: There is no research to evaluate the safety and effectiveness of children used for children.

Renal failure: Patients with renal impairment do not need to adjust the dose of Atovze, but renal failure is likely to increase the risk of muscle disease problems, so it must monitor the effects of the drug on muscle.

(*): Using Atovze preparations with appropriate content.

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? Patients with signs of overdose should be monitored with serum creatinine, urea nitrogen in the blood, myoglobin urine and do liver function assessment tests.

Some clinical studies have been conducted in 15 healthy people using Ezetimib at a dose of 50 mg/day that lasts 14 days and another study conducted in 18 high blood cholesterol patients with the dose of Ezetimib 40 mg/day lasting 56 days. The results showed that ezetimib tolerated well.

In case of an overdose of Atorvastatin may use activated carbon within 1 hour when an overdose occurs. Patients who are not fully awake can use activated carbon through the steaming tube by nasal. People with patterns should use 0.9% salt to maintain the amount of urine from 2-3 ml/kg/hour. Diuretics can also be used if needed to maintain urine. Because Atorvastatin is strongly linked to plasma proteins, the hemorrhage is ineffective.

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

Evaluate safety when combining Ezetimib and Atorvastatin in more than 2,400 patients in 7 clinical trials. Overall ezetimib and atorvastatin are well tolerated.

Common, ADR ≥ 1/100

Digestive system: diarrhea, constipation, flatulence, abdominal pain and nausea, about 5%of patients. joints, muscle weakness.

Neurological - muscle and bone: muscle disease combines muscle weakness and increased content of plasma creatin phosphokinase. Kinh: dizziness, headache, taste, paresthesia.

Central nervous system: Memory decrease, forgetfulness, memory loss, confusion, recovery when stopping the drug. There is an increase in the risk of developing diabetes.

Reports on other side effects:

Samples and lymphatic disorders: platelet reduction.

Nervous system: peripheral neuropathy Man.

Pancreatitis: Stop taking the drug.

Changes in serum liver enzyme concentration usually occur in the first months of statin treatment. Any patient who has a high serum transaminase must monitor the second liver function test to confirm the results and monitor treatment until the abnormalities return to normal. If the serum transaminase concentration AST or ALT (GOT or GPT) persists more than 3 times the upper limit of normal, it is necessary to stop treating with statin.

Advice patients to use statin immediately report any manifestation such as muscle pain for unknown reasons, sensitivity and muscle weakness, especially if accompanied by discomfort or fever. Statin therapy must be discontinued if the CPK concentration increases significantly, 10 times higher than the upper limit of normal and if diagnosed or suspected is muscle disease.

Warnings

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

Contraindicated

ATOVZE drugs 20/10 contraindications in the following cases:

Patients with hypersensitivity to any ingredients of the drug. Due to the use of cholesterol medications or high blood triglycerides.

Caution when used

The drug is at risk of causing harmful reactions to the muscle system such as muscle atrophy, muscleitis, especially for patients with risk factors such as elderly patients, patients with uncontrolled thyroid diseases, patients with renal disease. Need to closely monitor the harmful reactions during drug use.

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, 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 taking the risk of muscle pattern, the possibility of drug interactions 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 Atorvastatin treatment, patients need to notify when there are muscle manifestations such as muscle pain, stiffness, muscle weakness ... When there are these manifestations, patients need to test CK to take appropriate interventions.

In clinical trials shows that some patients taking serum transaminase (> 3 normal limits). Therefore, it is necessary to conduct liver function tests before treatment and redo if there are suggestions for liver damage. Caution should be used in patients who drink a lot of alcohol and/or have a history of liver disease.

The risk of muscle disease during Atorvastatin treatment will increase when used simultaneously, gemfibrozil, other fibrat blood cholesterol medications, high -dose niacin (> 1g/day), colchicin.

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

Preparation of drugs contains Lactose excipients. Patients with rare genetic problems such as galactose tolerance, lactase deficiency or malposive glucose-galactose should not take this drug.

The effect of the drug on the ability to drive and operate machinery

has reported on the impact of the drug on the ability to drive and operate machinery. Be careful when driving or operating dangerous machines.

Use drugs for women during pregnancy and lactation

Pregnant women

Atovze 20/10 contraindicated for pregnant women.

Cholesterol and triglycerides may increase during pregnancy, blood lipid medications do not work in this case, cholesterol and substances of cholesterol needed for the normal development of the fetus. However, there has been no full research on the use of ATOVze 20/10 during pregnancy, there has been a report on birth defects, miscarriage when using other statins. Stop using Atovze 20/10 immediately if you are detected pregnancy. People of reproductive age only use Atovze 20/10 in case of difficulty conceiving or after being fully notified of the risk of poisoning of the drug to the fetus.

breastfeeding women

Do not know if the drug is excreted in breast milk or not, because there may be harmful side effects with babies, breastfeeding people should not not use Atovze 20/10.

Interactive drug

Cytochrom P450 inhibitors 344

erythromycin/clarithromycin: simultaneously used with erythromycin or clarithromycin leads to increased plasma Atorvastatin levels. Patients using CCLARITHROMYCIN, Atovze dose must not exceed 20/10 mg/day.

HIV -resistant protease and gold inhibitors

Combined Tipranavir + Ritonavir or Telaprevir: Avoid using Atorvastatin.

Combining Lopinavir + Ritonavir: Use carefully and if necessary, the lowest atorvastatin dose should be used.

Combining Darunavir + Ritonavir; Fosamprenavir + Ritonavir, Saquinavir + Ritonavir, Fosamprenavir: Use no more than 20 mg atorvastatin/day.

nelfinavir: Use no more than 40 mg atorvastatin/day.

Itraconazole: simultaneously use Atorvastatin at 20 - 40 mg and Itraconazole 200 mg, increasing the AUC value of Atorvastatin. Using iTraconazole, Atovze dose should not exceed 20/10 mg.

diltiazem hydrochloride: simultaneously use Atorvastatin 40mg and diltiazem 240 mg, increasing the concentration of Atorvastatin in plasma.

Cytochrom P450 344 induction drugs

Atorvastatin is metabolized by cytochrom P450 3A4.

At the same time, Atorvastatin is concentrated with Cytochrom P450 3A4 (e.g. efavirenz, rifampicin, phenytoin), which can lead to reducing the concentration of Atorvastatin in plasma.

antacids

Ezetimib's absorption antacids but does not affect the bioavailability of ezetimib. Using Atorvastatin simultaneously with acid -containing antacids containing Magnesi and aluminum ions, the concentration of Atorvastatin in plasma is reduced by about 35%. However, the effect of reducing LDL-C does not change.

Fibrats

Fibrat can increase the secretion of cholesterol into bile, leading to gallstones. In a clinical study in dogs, Ezetimib increases cholesterol in the gallbladder. The patient should not be used simultaneously on October 20 with Fenofibrat because it may increase the risk of muscle disease. Should not use AtoVze 20/10 with Gemfibrozil because it can increase Ezetimib concentration about 1.7 times.

Bile acid -mounted plastic

Concentrated with bile acid -mounted resins can significantly reduce the bioavailability of Atorvastatin, so the time to use these two drugs must be apart.

Colestipol: When using Colestipol with Atorvastatin, Atorvastatin's concentration in plasma is reduced by about 25%. However, when using Atorvastatin and Colestipol simultaneously, the LDL-C effect increases compared to when using a separate drug.

Colestyramin: Reduce the AUC value of total Ezetimib (Ezetimib and Ezetimib-Glucuronid) by 55%.

anticoagulants

In a study in 12 healthy young people, simultaneously used with Ezetimib 10 mg/day does not significantly affect the bioavailability of warfarin and prothrombin time. But there has been a report on the International Normalized Ratio-inr) in patients with ezetimib supplements to Warfarin or Fluindion therapy. Most of these patients also take other drugs. Patients using Atovze 20/10 with anticoagulants need to monitor prothrombin time and international normalization index.

Fusidic acid

The risk of muscle disease including muscle pattern may increase when used simultaneously with fusidic acid. The plasma concentration of both drugs increases.

colchicin

There have been cases of reporting after using atorvastatin with colchicin that can cause muscle diseases.

niacin

Simultaneously used with high doses (> 1g/day) may increase the risk of skeletal muscle effects, should consider reducing atorvastatin dose.

digoxin

Simultaneous use of digoxin with Atorvastatin may increase the plasma concentration of digoxin to about 20%.

Transport inhibitors

Simultaneous use atorvastatin 10 mg and cyclosporin 5.2 mg/kg/day significantly increase the AUC value of Atorvastatin. Because red should avoid combination of two clinical drugs.

Oral contraceptives

Concentrated with oral contraceptives contains Morethindron and Ethinyl estradiol, increasing the AUC value of Norethindron and Ethinyl Estradiol about 30% and 20%. This increase should be considered when choosing a spare contraceptive pills for women who are using drugs containing Atorvastatin.

grapefruit juice

Grapefruit juice contains one or more ingredients inhibitors of Cytochrom P450 3A4 and can increase the concentration of Atorvastatin in plasma, especially in people who drink grapefruit juice excessively (> 1.2 liters/day).

Daily drinkers when using Atovze 20/10 may increase the risk of problems related to liver disease.

Storage

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

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