Nasrix Davipharm tablets for hypertrial cholesterol (4 blisters x 7 tablets)
Dosage form Box of 4 blisters x 7 tablets
Specifications Simvastatin, ezetimibe
Ingredient
| Composition information | Content |
| Simvastatin | 20mg |
| Ezetimibe | 10mg |
Uses
Indications
Nasrix drug are indicated in the following cases:
Nasrix is indicated as a supportive therapy with diet to treat hypercholesterol blood and family (family and non -family heterosexual) or hyperlipidemia mixed with mixed blood lipids when appropriate coordination treatment:
Pharmacy
Simvastatin
After drinking, Simvastatin - a non -activity lactone - hydrolyzed in the liver forming P - Hydroxyacid, strong inhibition activity HMG - CoA Reductase (3 -Hydroxy - 3 - Methylglutaryl - Coenzym A Reductase). This enzyme catalyzes HMG -COA conversion into Mevalonic acid, is the early stage and the speed limit in the cholesterol biosynthesis path.
Simvastatin shows the effect of reducing LDL - C in both patients with normal and increased LDL -C levels. LDL is made up of VLDL and is mainly catabolized by LDL receptors with high affinity. The mechanism of reducing the LDL -C concentration of Simvastatin may be related to the reduction of VLDL - C levels and the LDL receptor sensor, leading to LDL -C. C. Apolipoprotein B also decreased significantly when treated with Simvastatin. In addition, simvastatin also increases moderate HDL - C and reduces the total triglyceride in plasma. Results reduced the ratio of total cholesterol/HDL - C and LDL - C/HDL - C.
ezetimibe
Ezetimibe belongs to the new lipid lowering group, inhibitors inhibit the absorption of cholesterol and plant sterols in the small intestine. Ezetimibe is active when taken orally and has a different mechanism of other groups of hypoglycemic drugs (such as statins, bile acid -mounted drugs (resin), fibric acid derivatives, and plant stanols). The target molecule of Ezetimibe is the shipping of sterol, niemann - pick cl - like 1 (NPC1L1), which plays a role in the absorption of cholesterol and phytosterol in the small intestine.
Ezetimibe localized at the brush brush and inhibit the absorption of cholesterol, reducing cholesterol's transportation in the small intestine to the liver, while the sterins reduce cholesterol biosynthesis in the liver, and when used in combination, the two different mechanisms for supplementary effects in the lower effect of blood lipid lowering.
pharmacokinetics
There is no significant pharmacokinetic interaction when coordinating Ezetimibe with simvastatin.
Simvastatin and Ezetimibe combined with pharmacokinetics similar to taking two Simvastatin and Ezetimibe tablets separately.
Simvastatin
absorption
Simvastatin metabolizes and eliminates initially through a strong liver, the amount of metabolites with P - hydroxyacid activity is found during the circulation after taking a dose of simvastatin, accounting for less than 5% of oral dose. The pharmacokinetics of the active inhibitor and the sum of plasma inhibitors are not affected when taking simvastatin right before low -fat meals.
Distribution:
both simvastatin and P - hydroxyacid form with human plasma proteins (95%). The peak concentration of the inhibitor reaches 1.3 - 2.4 hours after drinking. When the mouse for the mouse to drink Simvastatin has a distant isotope, the derivative of the radio isotope of Simvastatin passes through the bloody barrier.
Metabolism
Simvastatin is an inactive lactone, easy to hydrolyze in vivo to form a P - hydroxyacid form, a strong HMG - Co A Reductase inhibitor. Hydrolysis occurred mainly in the liver, the hydrolysis rate in human plasma is very slow.
HMG - COA Reductase inhibitors are used as a basis for evaluating pharmacokinetics P - hydroxyacid metabolites (inhibited active substances) and of sum of plasma inhibitors after taking simvastatin. The main metabolites present in human plasma are p - hydroxyacid of simvastatin and derivatives 6 - hydroxy, 6 - hydroxylethyl and 6 - Exomethylene.
In Simvastatin people are well absorbed and undergoing metabolism and elimination in the liver. The metabolism and elimination in the liver depend on the rate of blood flow in the liver. The liver is a place to metabolize and eliminate the main, with most of the excretion of the drug through bile. Therefore the amount of active substance in the circulation is low. After intravenous metabolic injection P - hydroxy acid, the average selling time is 1.9 hours.
Elimination
Simvastatin is put into liver cells by active mechanism with OatP1B1 transportation. In humans, after taking 1 dose of Simvastatin marks 14C, 13% of the dosage is excreted through the urine and 60% in feces for 96 hours. The amount of elimination drugs in the feces includes the amount of drugs absorbed in the bile and the amount of drugs is not absorbed. After injection of the metabolic p - hydroxyacid metabolic substance, the average only about 0.3% of the injection dose is eliminated through the urine in the form of inhibitor.
ezetimibe
absorption
After drinking, Ezetimibe is quickly absorbed and combined into Ezetimibe - Glucuronid. The maximum concentration in plasma (CMAX) is 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.
Distribution
Ezetimibe and Ezetimibe - Glucuronid associated with plasma proteins at 99.7% and 88 ~ 92%.
Metabolism
Ezetimibe is metabolized mainly in the small intestine and liver through a combination of glucuronid. Ezetimibe and Ezetimibe - Glucuronid are the main compounds found in plasma, Ezetimibe accounts for 10-20% and Ezetimibe - Glucuronid accounts for 80 - 90% of the total amount of drugs in plasma. 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.
Elimination
After taking 4C - Ezetimibe (20mg), about 93% Ezetimibe is present in plasma. After 48 hours, no longer found drugs present in plasma. About 78% and 11% are found in feces and urine within 10 days.
Special subjects
Children
Ezetimibe: Ezetimibe pharmacokinetics similar to children 10 - 18 years old and adults.
There is no adequate information about the pharmacokinetics of the form of coordination in children.
Elderly
Simvastatin: In a study, 16 elderly (70 - 78 years old) use Simvastatin at a dose of 40mg/day, HMG - Mg - Mg - Average inhibitor level in the elderly increases about 45% compared to 18 people aged 18 - 30 years old.
Ezetimibe: The plasma concentration of Ezetimibe is 2 times higher in the elderly (> 65 years) compared to young people (18 to 45 years old). The effect of reducing LDL - C and the safety of the drug is equivalent to the elderly and young people.
Hepatic failure
Ezetimibe: Ezetimibe's AUC increases in patients with liver failure. No dose adjustment in mild liver failure (Child - PUGH from 5 - 6). Due to the unknown influence of AUC increases in patients with average liver failure (Child - Pugh from 7-9) or severe (Child - Pugh> 9), it is not recommended to use Ezetimibe on this patient.
kidney failure
Simvastatin: Studying kinetics on other statins has the same elimination line with simvastatin showing that with the same system of system exposure can increase in patients with severe renal impairment.
Ezetimibe: In patients with severe renal failure (CLCR
In patients with kidney transplantation and using many drugs, including cyclosporin, exposure to ezetimibe increased by 12 times.
Gender
Ezetimibe: Plasma concentrations in women are slightly higher than men (about 20%). The effectiveness of LDL - C and the safety of the drug is equivalent to men and women. No need dose by gender.
polymorphic genotypes
Simvastatin: In people with genotype SLCO1B1 C.521T> C, OATP1B1 has lower activity. The average exposure of metabolites has a major activity, Simvastatin acid is 120 % in people with alleles of alleles (CT) and 221 % in people with alien to be homozygous (CC) compared to people with the most common genotype (TT). Alen C has a frequency of 18% in European population. In polymorphic gene SLC01B1 genetic type, there is a risk of increasing system exposure to simvastatin, which can increase the risk of muscle pattern.
Before taking Nasrix Davipharm tablets for hypertrial cholesterol (4 blisters x 7 tablets)
How to use
Nasrix is used orally, once a day in the evening, not affected by food. Do not break the pill.
Patients should follow a low -cholesterol diet when starting to use the drug and continue according to this diet during treatment.
Dosage
Adults:
The usual dose is 1 tablet/day.
Simvastatin dose should be adjusted to each patient based on plasma lipid levels. It is advisable to start treating 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 time apart from less than 4 weeks and must monitor the harmful reaction of the drug, especially the reaction is harmful to the muscle system.
The starting dose of simvastatin is usually 10mg or 20mg/day, increasing the dose after 4 weeks if necessary, the maximum dose is 80mg/day. Due to the risk of unwanted effect, the maximum dose of 40mg is only used when necessary and under the monitoring of specialists.
Nasrix tablets are a combination of Simvastatin 20mg/Ezetimibe 10mg, used to replace Simvastatin 20mg and Ezetimibe 10mg individually or used to coordinate Ezetimibe when treated with Simvastatin 20mg does not achieve treatment goals. Nasrix is not suitable for other dosage indications.
Elderly:
No dose adjustment in these patients.
Children:
Starting treatment should be conducted under the monitoring of a specialist.
Children over 10 years old (puberty: Boys have the number of tanner> II and girls at least 1 year after menstruation):
Clinical information in children (10 - 17 years old) is limited. Simvastatin dose should be adjusted to each patient, the starting dose is usually 10mg/day, maximum of 40mg/day.
Children under 10 years old:
It is not recommended to use Nasrix in children under 10 years old because they are not enough data on safety and effectiveness. Experience in children before puberty is limited.
Patients with liver failure:
No dose adjustment in mild liver failure patients (Child - Pugh 5 - 6). It is not recommended to use Nasrix in patients with average liver impairment (Child - Pugh 7 - 9) and severe (Child - Pugh> 9). Contraindications for patients with progressive liver disease or prolonged serum transaminase for unknown reasons.
Patients with renal failure:
No dose adjustments in patients with mild renal impairment (glomerular filtration level> 60ml/min/1.73 m2). In patients with chronic renal failure and the glomerular filtration rate
Used with Amiodaron, Amlodipin, Ranolazin: Do not use more than 20mg of simvastatin/day.
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? Simultaneous use of Ezetimibe (1,000mg/kg) and simvastatin (1,000mg/kg) are well tolerated to study acute toxicity when taken in rats and mice. There is no signs of clinical toxicity on research animals. LD90 predicts for both mice are simvastatin> 1,000mg/kg, ezetimibe> 1,000mg/kg.
Simvastatin
Only a few overdose shifts are reported, the highest dose used is 3.6g. All patients recover without sequelae.
ezetimibe
In clinical research using Ezetimibe 50mg/day over 15 healthy people in 14 days, or 40mg/day on 18 patients with hypercholesterolemia within 56 days, the drug is well tolerated.
A few cases of overdose Ezetimibe have been reported, most of them have unwanted effects. Unwanted effects are not serious. When an overdose, patients should be treated with symptoms and applied supportive measures when necessary.
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. Note that it should not be used double the prescribed dose.
Side Effects
When using Nasrix medicine , you may experience unwanted effects (ADR).
The unwanted effect of the coordinated member is higher than the placebo
Common (1/100 Uncommon (1/1000 Neurological: Dizziness, headache . Skin and subcutaneous tissue: rash, itching. Body: weakness, fatigue, peripheral edema. The unwanted effect of the coordinated member is higher than the single statin. Common (1/100 Uncommon (1/1,000 Skin and subcutaneous tissue: itching, rash, urticaria . Experience after bringing the drug to the market Skin and subcutaneous tissue: Hair loss, diverse pink rash, hypersensitivity reactions, including rash, urticaria, anaphylactic reaction, angioedema. musculoskeletal: cramps, muscle disease (including muscle inflammation), muscle pattern with or not accompanied by acute renal failure, tendon disease, sometimes tendon rupture complications, muscle necrosis through immunity (IMNM). Rarely reports of hypersensitivity syndrome include a few of the following manifestations: Evala, lupus -like syndrome, low muscle pain, multiple muscle inflammation, vasculitis, plateletic decline, eosinophilia, increased red blood cell deposit speed, arthritis and urticaria, light sensitivity, fever, redness, shortness of breath and fatigue. There have been some rare reports of cognitive decline (for example: dementia, forgetfulness, memory loss, confusion) related to the use of statin. Cognitive decline has been reported to all statins. Often not serious, and have the ability to recover when stopping using statin, with a change of symptoms of symptoms (from 1 day to many years) and the ability to recover different symptoms (on average 3 weeks). HBA1C increases and serum sugar levels have been reported with statins including simvastatin. In addition, the following unwanted effects are also reported to a few statins: Sexual dysfunction. 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
Nasrix drug contraindicated in the following cases:
Used with Verapamil, Diltiazem, Dronedaron.
Precautions when using
before and during treatment with statin, it is recommended to combine blood cholesterol control by measures such as diet, weight loss, exercise, and treatment of diseases that may be the cause of lipid hyperplation. Periodically check blood lipids and adjust the dosage according to the patient's response to the drug. The goal of treatment is to reduce LDL cholesterol, so it is necessary to use LDL cholesterol levels to start agreement and evaluate treatment. Only when the LDL cholesterol is not tested, will the total cholesterol use to monitor treatment.
muscle/muscle disease
muscle disease and muscle pilot have been reported when using ezetimibe. Most of the pattern reports occur in patients using Ezetimibe in combination with statin. However, muscle pattern is very rare in patients using Ezetimibe monomers as well as when used simultaneously Ezetimibe with other drugs may increase the risk of muscle pattern. The risk of muscle pattern increases when the activity inhibits HMG - COA Reductase in high plasma.
Consider muscle disease in any patient who is treating statin, which has a spreading muscle pain, a weakness or a pain in the pain or has an increase in serum levels (5 times larger than the normal limit of normal). Statin therapy must be stopped if serum concentration increases or if diagnosed or suspected of muscle disease. If muscle aches do not increase or increase moderate serum (
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.
Reducing the function of transport protein: Reducing the function of Oatp transport protein in the liver can increase the exposure of Simvastatin acid system and increase the risk of muscle disease and muscle pattern. The cause may be due to inhibition due to drug interactions (such as cyclosporin) or in patients with SLCO1B1 C.521T> c.
Track Creatin Kinase (CK)
Creatinin Kinase (CK) should not be measured after a strong sports practice or another cause that can cause CK increase. If the CK concentration increases significantly (> 5 times ULN: the normal limit), the test is redefined within 5-7 days. If the test results show that CK> 5 times ULN, should not be treated with simvastatin.
Before the testing of CK tests should be conducted in the following cases: impaired renal function, women, hypothyroidism, a history of themselves or families with genetic muscle disease, a history of muscle disease due to the use of statin or previous fibrat, a history of liver disease or drinking lots of alcohol, elderly patients (> 65 years old) with risk factors for muscle pattern, the possibility of drug interactions and some special patients. In these cases, the benefits/risks should be considered and clinically monitored when treated with statin.
If CK test results> 5 times ULN should not start statin treatment.
During Statin treatment
Patients need to immediately notify muscle pain, muscle weakness or muscle spasms for unknown causes, especially with discomfort and fever. CK concentration should be checked in patients. Stop the drug if the concentration CK> 5 times ULN or if the symptoms are severe and cause inconvenience for daily activities (even if the concentration of CK
There have been reports that are very rare for necrotic muscle diseases through the immunity (IMNM) during and after treatment with statin. IMNM clinically characterized by recent muscle weakness and increased serum creatin kinase although the patient has stopped treating with statin.
If symptoms are resolved and the concentration of CK returns to normal, consider using nasrix or converted via drugs containing other statins at the lowest doses effectively and needs closely monitoring.
Treatment with statin should temporarily stop a few days before the surgery or other medical interventions.
liver enzyme
In clinical trials, a small number of people who take ezetimibe combined with simvastatin see significantly increasing serum transaminase (> 3 times ULN). Recommended the liver enzyme test before starting treatment and in case of clinical indications for testing requirements later (such as the suggested manifestations with liver damage).
Periodic monitoring of liver function as previously recommended often does not help because of the serious liver damage due to rarely and unpredictable statins in every patient, need to be cautious when using simvastatin in severe alcoholic patients or a history of liver disease. Simvastatin should be stopped or reduced if serum transaminase concentration is 3 times the upper limit of normal levels. Note that the ALT may have muscle origin, so if ALT increases with CK, it can be a muscle disease.
Hepatic failure
Due to the unknown effect when increasing the concentration of ezetimibe in patients with medium or severe liver failure, it is not used for these patients.
diabetes
Statin groups can increase blood sugar, HBA1C in some patients, need to monitor blood sugar in patients at risk, and take appropriate treatment if increased blood sugar. Benefits of reducing the risk of cardiovascular events greater than the risk of diabetes, should not stop treating statin.
Children
Safe and effective when using Simvastatin and Ezetimibe in children from 10-17 years old with hyperplobe hyperplanded family heterozygous blood has been assessed in a clinical study in boys (tanner> n) and girls at least 1 year after menstruation.
In this study, there was no image that was damaged on the development and maturity of boys and girls, or influenced by the menstrual cycle of girls. However, the influence of ezetimibe on development and maturity when used for prolonged> 33 weeks has not been studied.
Ezetimibe has not been studied in children under 10 years old or girls who have not had menstruation.
Effective when using ezetimibe to pull in children in the 17th year of children to reduce disease and death when adults have not been studied.
Fibrats
There is no news about the safety and effectiveness of Ezetimibe in combination with Fibrat.
Concentrated with anticoagulant drugs: When using Nasrix with warfarin or anticoagulants, Coumarin, or Fluindion, should be monitored in an Inr carefully.
Interstitial lung disease
There has been an interstitial lung disease report with some statins, including simvastatin, especially when long -term treatment. Expressions may include shortness of breath, dry cough and health impairment (fatigue, weight loss and fever). If there is a suspected patient with interstitial lung disease, the statin should be stopped.
Other cautions
Only use statin 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.
Nasrix contains lactose, patients with galactose intolerance, lactase deficiency or glucose absorption disorders - galactose should not be used.
The ability to drive and operate machines
Note that the use of the drug may cause dizziness, so it is necessary to be cautious when driving or operating machines while there are still symptoms.
Pregnancy
Contraindicated Nasrix in pregnant women, women intend to get pregnant or suspect pregnancy, only statin for women of reproductive age when they are certainly not pregnant and in case of hypoglycemia very high without responding to other drugs. There is no information about the use of simvastatin/ezetimibe combination formats in pregnant women. Animal research shows toxicity on reproduction.
ezetimibe
There is no information on the use of ezetimibe in pregnant women, using Ezetimibe monomers on pregnant animals does not see indirect and direct harmful effects on pregnant animals, fetal development, birth and development after birth.
Simvastatin
There is no sufficient information about the safety of simvastatin on pregnant women. Because statins reduce cholesterol synthesis and maybe many other substances with biological activity derived from cholesterol, the drug can be harmful to the fetus if used for pregnant women. So contraindicated use of statin during pregnancy.
Breastfeeding period
ezetimibe distributed into animal milk, whether the drug is distributed into human milk or not. Contraindicated Nasrix on breastfeeding women.
Drug interaction
Pharmacological interaction
Interaction with blood lipid medications can cause muscle disease.
The risk of muscle disease, including muscle pattern, increases when using simvastatin with fibrat. In addition, pharmacokinetic interaction between simvastatin and gemfibrozil increases the concentration of simvastatin in plasma. There have been rare reports of muscle disease/muscle pepper when using simvastatin combination with niacin (1g/day).
Fibrat increases cholesterol elimination through bile, causing gallstones. Dog research, ezetimibe increases cholesterol in bile in gallbladder. Clinical effects on people are unknown, do not recommend sharing Nasrix with fibrat.
pharmacokinetic interaction
nasrix
Niacin: Shared Niacin with a combination of simvastatin/ezetimibe 20/10mg slightly increased absorption of niacin and nicotinuric acid, ezetimibe, simvastatin, simvastatin acid.
ezetimibe
Anti -acid drugs: reduces Ezetimibe absorption, but does not affect the bioavailability of ezetimibe. This absorption reduction is not clinical significance.
cholestyramin: When used with Ezetimibe, it can reduce the absorption of Ezetimibe.
cyclosporin: simultaneously use Ezetimibe with cyclosporin, dissipating blood concentrations of both special drugs in patients with severe renal impairment. Should be cautious when starting to use ezetimibe for patients who are taking cyclosporin.
Fibrat groups: Sharing Ezetimibe with fenofibrat or gemfibrozil increases the total level of ezetimibe to 1.5 and 1.7 times. Although the above interaction is considered to have no clinical significance. Contraindicated with Gemfibrozil, is not recommended to use with other fibrats.
Simvastatin
CYP3A4 inhibitor: Simvastatin is the substrate of CYP3A4. Used with CYP3A4 inhibitors increases the risk of muscle disease and muscle pattern due to increased HMG inhibition activity - coa reductase in serum.
Contraindicated to use with strong Inhibitors CYP3A4 (such as Itraconazol, Ketoconazole, Posaconazole, Voriconazole, Erythromycin, Clarithromycin, Telithromycin, HIV Protease inhibitors (such as Nelfinavir), BoCeprevr, Telaprevron, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon, Nefazodon Gemfibrozil, Cyclosporin, Danazol and drugs containing cobicistat).
Be cautious when combined with weaker CYP3A4 inhibitors such as fluconazole, there is a muscle spend report when shared. Caution when coordinating with medium inhibitors CYP3A4.
Do not use with grapefruit juice.
Amiodaron, Amlodipin, Ranolazin: Do not use more than 20mg of simvastatin/day when used in combination.
Fusidic acid: increases the risk of muscle disease and muscle pattern when shared. Shared, increasing the serum concentration of both medications. The mechanism is not well understood. Do not use simvastatin with fusidic acid. The case has been recorded when using the same two drugs. Statin should be stopped during the time of using fusidic acid. Statin can be used after 7 days after stopping fusidic acid. In case of using fusidic acid in patients who are using statin (severe infection), consider based on patients and must be closely monitored.
Lomitapid: Used in combination can increase the risk of muscle disease and muscle pattern. In patients with hyperlested cholesterol of the family, do not use a combination of simvastatin/ezetimibe more than 40/10mg daily.
Oatp1b1 shipping protein inhibitors: similarly used with OatP1B1 inhibitors may increase the risk of muscle disease and muscle pattern caused by simvastatin.
Colchicin: Used in combination can increase the risk of muscle disease and muscle pattern.
Rifampicin: Due to the CYP3A4 induction rifampicin, in the use of prolonged rifampicin, Simvastatin may be ineffective.
Niacin: There is a report on muscle disease/muscle pepper when using a combination of simvastatin with niacin (> 1g/day).
Bile acid -mounted resins: It can significantly reduce the bioavailability of statin when taken with, so the time to use these two drugs must be apart.
The effect of nasrix on the pharmacokinetics of other drugs
Anticoagulants: It is necessary to monitor the patient's INR when used simultaneously with warfarin, anticoagulant drugs, or fluindion. Ezetimibe does not touch Cytochrom P450 enzyme, no clinical pharmacokinetics interaction with metabolic drugs by Cytochrom P450 1A2, 2D6, 2C8, 2C9, and 3A4, or N - Acetyltransferase.
Simvastatin does not inhibit CYP3A4. Therefore, simvastatin does not affect the plasma concentration of metabolites through CYP3A4.
Children: Interactive research is only done on adults.
Storage
In a dry place, avoid light, the temperature does not exceed 30 ° C.
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