Simze Plus 20mg/10mg Pharmacy 3-2 improves the level of total cholesterol (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Simvastatin, ezetimibe

Ingredient

Composition information	Content
Simvastatin	20mg
Ezetimibe	10mg

Uses

indications

Simze Plus drugs are indicated in the following cases:

Treatment to improve total cholesterol levels, LDL cholesterol, triglycerides, HDL cholesterol, support nutrition in primary hypercholesterol patients caused by increased lipoprotein cholesterol lipoprotein (LDL). Reducing low molecular weight cholesterol lipoprotein (LDL) in patients who both increase cholesterol and increase blood triglycerides. Mevalonate, precursor of cholesterol. Simvastatin inhibits cholesterol biosynthesis, reduces cholesterol in liver cells, stimulates LDL receptor synthesis (low density lipoprotein) and thereby increasing LDL transport from blood. The final result of these biochemical processes reduces cholesterol levels in plasma, at normal doses, HMG - CoA Reductase is not completely inhibited, so there is enough Mevalonic acid for metabolic processes.

Simvastatin reduces LDL levels very effectively, lowering LDL cholesterol from 25% to 45% depending on the dose. Simvastatin increases the concentration of HDL cholesterol (high density lipoprotein) from 5 to 15% and thus lowering LDL/HDL ratios and total/HDL cholesterol. Simvastatin also reduces plasma triglycerides at a lower level (10% to 30%) by increasing the clearance of VLDL (Lipoprotein very low density) residual by LDL receptor.

Response treatment with simvastatin can be seen within 1-2 weeks after starting the drug and usually reaches up to 4-6 weeks. Maintain maintenance during long -term treatment.

Ezetimib: Inhibit cholesterol absorption in the small intestine, reducing the amount of cholesterol from the intestine into the liver. Ezetimib reduces total cholesterol, LDL - C, APO B and TG, and increases HDL - C in patients with hypercholesterol.

Combining Ezetimib with HMG - Coa Reductase inhibitors is effective in improving total cholesterol, LDL - C, APO B, TG, HDL - C in plasma.

Dynamic pharmacokinetics

related to simvastatin

absorption

Simvastatin quickly absorbed is a precursor with a strong initial metabolism to become active metabolites. The bioavailability of simvastatin is low because it is strongly metabolized for the first time in the liver (> 60%). The peak concentration of serum is within 1.3 to 2.4 hours.

Distribution

Simvastatin binds to 95%plasma proteins. Simvastatin loves fat should pass through the blood - brain barrier.

Metabolism

The main metabolic drug in the liver (> 70%) into metabolites with or non -activity. After taking Simvastatin is hydrolyzed in the liver forming Beta - Hydroxyacid, inhibits the enzyme to eliminate the whole HMG - COA.

Elimination

The drug is eliminated mainly through stool, eliminated through the kidneys 13%.

related to ezetimlb

absorption

After drinking, Ezetimib is absorbed and widely combined with phenolic glucuronid with pharmacological activity (ezetimib - glucuronid). With a single dose of 10 mg in adults when hungry, the average peak concentration (CMAX) of ezetimib in plasma is 3.4 to 5.5 ng/mL achieved in 4 to 12 hours (TMAX). The average peak concentration (CMAX) of Ezetimib - Glucuronid 45 to 71 ng/ml is achieved from 1 to 2 hours (Tmax).

Food does not affect the absorption level of ezetimib when taking 10 mg. The CMAX values of Ezetimib increased by 38% with the consumption of high -fat meals. Ezetimib can take medicine during or away from meals.

Distribution

Zetimib and Ezetimib - Glucuronid are high (90%) with plasma proteins.

Metabolism

Ezetimib is mainly metabolized in the small intestine and liver through the form in combination with glucuronid (stage II reaction) then through bile.

Elimination

ezetimib excreted through the kidneys.

Before taking Simze Plus 20mg/10mg Pharmacy 3-2 improves the level of total cholesterol (3 blisters x 10 tablets)

How to use

Simze Plus can be used or not in the same food and at the same time with statin medications.

Dosage

Usual dose: 1 tablet daily, in the evening.

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 person by increasing the dose of each batch of no less than 4 weeks apart and must monitor the harmful reactions of the drug, especially the harmful reactions to the muscle system.

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 overdose? Due to the strong drug associated with plasma proteins, the hemorrhage does not expect to significantly increase the clearance of simvastatin.

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

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

Common, ADR> 1/100

Digestive system: diarrhea, abdominal pain, constipation, flatulence.

musculoskeletal system: back pain, joint pain.

Systemic: Awareness decline (such as dementia, confusion), hyperglycemia, HBA1C.

Uncommon, 1/1000

Digestive system: Nausea, pancreatitis, hepatitis.

musculoskeletal system: muscle disease or muscle pattern.

Rare, 1/10000

Body: Hypersensitivity reaction, including angioedema and skin rash, rarely occur.

Instructions on how to handle ADR

Changes in liver enzyme levels in Huyet Thanh usually occur in the first months of simvastatin treatment.

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 simvastatin.

Must report as soon as there is any brain form such as muscle pain for unknown reasons, sensitive pain and muscle weakness, especially if accompanied by discomfort or fever. Simvastatin must be stopped 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

Simze Plus drugs contraindicated in the following cases:

Do not use simvastatin combination with HMG inhibitors - CoA Reductase in patients with liver disease active or increased serum transaminase level for unknown cause.

Do not use Simvastatin in combination with strong CYP3A4 inhibitors such as: Itraconazole, Ketoconazole, Erythromycin, Clarithromycin, Telithromycin, HIV Protease inhibitors, Boceprevir, Telaprevir, Nefazodon, Posaconazol, GemfiBro, cyclosporin, danazol.

Patients with hypersensitivity to any ingredients of the drug.

Pregnant women, nursing women.

Caution when using

Before starting treatment with statin, it is necessary to eliminate the causes of hypercholesterol blood cholesterol (for example, under controlled diabetes, thyroid defect, nephrotic syndrome, blood protein disorders, biliary obstruction, due to some other drugs, alcoholism) and quantitative cholesterol quantitative, ldl cholesterol, cholesterol, cholesterol, cholesterol.

Periodic lipid quantification must be conducted at a distance of no less than 4 weeks and adjust the dose according to the response of the patient with the drug. The goal of treatment is to reduce LDL cholesterol so 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.

In clinical trials, a small number of adult patients drink statin see significantly increasing serum transaminase (> 3 normal limits). When stopping the drug in these patients, Transaminase concentration often lowered to the level before treatment. A few of these patients before treatment with statins have abnormal liver function test results and/or drink plenty of alcohol.

Therefore, it is necessary to conduct liver enzyme tests before starting treatment with simvastatin and in case of clinical indications for testing later. Caution should be used in patients who drink a lot of alcohol and/or have a history of liver disease.

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 diseases, a history of muscle disease due to the use of simvastatin or previous fibrat, a history of liver disease and/or drinking lots of alcohol, elderly patients (> 70 years) special.

In these cases should consider benefits/risks and monitor patients clinically when treated with simvastatin. If the test results CK> 5 times the upper limit of the normal level, do not start treatment with simvastatin.

During simvastatin treatment, patients need to notify when there are muscle manifestations such as muscle pain, hard muscle, muscle weakness. When there are these manifestations, patients need to test CK to take appropriate interventions.

Statin therapy must be suspended or stop in any patient who shows signs of acute and severe muscle disease or has risk factors prone to acute renal impairment due to muscle pattern, such as severe acute bacterial infections, hypotension, surgery and large trauma, abnormal metabolism, endocrine, electrolytes or uncontrolled convulsions.

only use simvastatin 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.

The ability to drive and operate machinery

does not affect.

Pregnancy

Simvastatin reduces cholesterol synthesis and maybe many other substances with biological activity derived from cholesterol, so the drug can be harmful to the fetus if used for pregnant women. So contraindicated use of simvastatin during pregnancy.

The period of breastfeeding

Simvastatin is distributed into milk. Because the potential has a serious unwanted effect for breastfeeding children, should be contraindicated to use simvastatin in nursing mothers.

Drug interaction

Increased risk of muscle lesions when using simvastatin simultaneously with the following drugs: Gemfibrozil, other fibrat blood cholesterol, high -dose niacin (> 1 g/day), Colchicin.

The simultaneous use of simvastatin blood lipid medications with HIV and hepatitis C (HCV) can increase the risk of muscle damage, the most serious muscle, kidney damage leading to renal failure and may be fatal.

Avoid using large amounts of grapefruit juice (grapefruit juice) (> 1 liter/day).

Do not use more than 10 mg of simvastatin/day when used in combination with: verapamil, diltiazem, droneedaron (contraindicated combination of these drugs with preparations with simvastatin content of 20 mg).

Do not use more than 20mg of simvastatin/day when used in combination with: amiodaron, amlodipine, ranolazin.

Storage

Leave a cool dry place, temperatures below 30 ° C, avoid light.

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