Rotinvast 20 Agimexpharm drugs reduce total cholesterol (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Rosuvastatin

Ingredient

Composition information	Content
Rosuvastatin	20mg

Uses

indications

Rotinvast 20 drugs are indicated in the following cases:

Increasing cholesterol (lialinema including hyperlested hyperlly heterozygous family genus) or mixed blood lipid disorders (type 1lb): is a supportive therapy for diet when the patient does not fully respond to diet and other non -drug therapies (such as physical exercise, weight loss). Mixed blood lipids (ILB type), hyper triglycerides (type IV): is a supportive therapy for a diet when the patient does not fully respond to the diet and other non -drug therapies (such as exercise, weight loss). France supports the diet if after the diet of LDL-C> 190 mg/dl or> 160mg/dl and has a family history of early cardiovascular disease or has 2 or 3 other cardiovascular risk factors. LDL-CHOLesterol, total cholesterol, and APOB. Reductase, is the catalyst of the conversion process 3-hydroxy-3-methylglutaryl coenzym A into Mevalonate, a precursor of cholesterol. The main acting position of rosuvastatin is the liver, the target organs reduce cholesterol.

Rosuvastatin increases the number of LDL receptors on the cell surface in the liver, thus increasing the absorption and catabolism of LDL and inhibiting VLDL synthesis in the liver, thus reducing VLDL and LDL components.

Pharmaceutical impact

Rosuvastatin reduces LDL-cholesterol levels, total cholesterol and triglycerides and increases HDL-cholesterol. The drug also reduces APOB, Non HDL-C, VLDL-C, VLDL-TG and increases APOA-I (see Table 1). Rosuvastatin also reduces the ratio of LDL-C/HDL-C, C full/HDL-C, Non HDL-C/HDL-C and APOB/APOA-1.

Table 1 - Responding to the dose in patients with hypercholesterol hypertrophy.

(LIA and ILB type) (the change in the bottle (%) compared to before treatment).

dose

The number of patients

ldl-C

all the whole

HDL-C

Non HDL-C

APO-B

APOA-I

-7

-5

-3

-7

-3

-45

-33

-35

-44

-38

-52

-36

-10

-48

-42

-55

-40

-23

-51

-46

-63

-46

-28

-60

-54

Optimal response is usually reached about 4 weeks and is maintained later.

Clinical effectiveness

Rosuvastatin has been shown to be effective in adult patients with hypercholesterol, whether or not there is hyperemia, any race, gender or age and in special patients such as diabetes or hypercholesterol patients.

In clinical studies with a certain number of patients, RosuVastatin proves to be effective in reducing triglycerides when used in combination with fenofibrat and increasing HDL-C levels when used in combination with Niacin.

Rosuvastatin has not been shown to prevent complications related to lipid abnormalities such as coronary artery disease because studies on decreased mortality and reduce the rate of pathology when using rosuvastatin is being conducted.

Pharmacokinetics

absorption

Rosuvastatin's peak plasma concentration is about 5 hours after drinking. Absolute bioavailability of about 20%.

Distribution

Rosuvastatin widely distributed in the liver is the main place for cholesterol and LDL-C clearance. The distribution of rosuvastatin is about 134 L. About 90% of rosuvastatin combined with plasma proteins, mainly with albumin.

Metabolism

Rosuvastatin is less metabolized (about 10%). In vitro studies on metabolism use liver cells of humans to identify that rosuvastatin is a weak substrate for metabolism through cytochrom P450. CYP2C9 is the main enzyme involved in the metabolism, 2C19, 3A4 and 2D6 participating at a lower level.

The main metabolites are identified as N-Desmethyl and Lacton. N-Desmethyl metabolites have a weaker activity about 50% than rosuvastatin while lacton form is not clinically active. Rosuvastatin accounts for more than 90% of HMG-COA Reductase inhibitors in circulation.

Elimination

About 90% of rosuvastatin dose is eliminated in a constant form (including the active ingredient that is absorbed and not absorbed) and the rest is excreted into urine. About 5% are excreted into unchanged urine. Selling time for plasma is about 19 hours. The sale time does not increase when using a higher dosage. The average plasma clearance is about 50 liters/hour (the variable coefficient is 21.7%).

Like other HMG-CoA Reductase inhibitors, the elimination of rosuvastatin from the liver is related to the transportation of the OATP-C membrane. This transportation is important in eliminating rosuvastatin from the liver.

linear

Rosuvastatin's contact level is calculated by concentration and time increased proportional to the dose. There is no change in pharmacokinetic parameters after daily doses.

Special patient groups

Age and gender: The impact of age or gender on the pharmacokinetics of rosuvastatin is negligible in terms of clinical.

Race: Pharmacokinetic studies show that AUC and CMAX increased by about twice in Asian subjects (Japan, China, Philippines, Vietnam and South Korea) compared to the Western white people. The influence of genetic and environmental factors on this change has not been determined. A pharmacokinetics analysis by population shows that there is no clinical difference in pharmacokinetics in white and black groups.

Renal failure: Research on kidney failure at different degrees shows that the kidney disease from mild to medium does not affect the level of rosuvastatin or N-Desmethyl metabolites in plasma. Patients with severe renal impairment (plasma creatinine clearance Hepatic failure: In research on liver damage to different levels, there is no evidence of rising exposure of rosuvastatin by concentration and time in patients with Child-Pugh = 7. However, 2 patients with Child-Pugh scores are 8 and 9 with the contact level of RosuVastatin in the size of the concentration and the minimum time with the minimum of the child-pulp score. than. Inexperienced in patients with Child-Pugh> 9.

Before taking Rotinvast 20 Agimexpharm drugs reduce total cholesterol (3 blisters x 10 tablets)

How to use

Take oral use. Before starting treatment, the patient must follow a standard diet to reduce cholesterol and continue to maintain this regime during treatment. Use consensus instructions for lipid disorders to adjust the dose of rosuvastatin for each patient according to the patient's treatment and response goals.

Dosage

The starting dose of Rosuvastatin is recommended from 5 to 10 mg, taken once a day and most patients are controlled at this starting dose. If necessary, the dose can be gradually increased by 4 weeks up to 20 mg.

Dynamic pharmacokinetic research in Asian races conducted in the US shows 2 times the ability to absorb more than white people. Therefore, it is advisable to consider the starting dose of 5 mg when taking drugs for Asian patients.

Rosuvastatin dose of 40 mg should only be used for patients with severe blood cholesterol hyperplasia patients with high risk of cardiovascular disease without achieving treatment goals at a dose of 20 mg. These patients must be closely monitored. However, it is not used for patients at high risk of muscle disease, including people who are taking fibrates, and Asian patients.

Patients with hypertension hypertly cholesterol type: The recommended starting dose is 20 mg used once a day. Responding to treatment is estimated from LDL-Cholesterol levels before extract.

Patients with hyperlemical hypertension hyperlested blood cholesterol (from 10 to 17 years old):

The usual dose is from 5 - 20 mg/day. The maximum dose is 20 mg/day. The dose is determined specifically for each patient depending on the goals of treatment. Adjust the dose must be done with a distance of at least 4 weeks.

Patients with severe renal impairment: (CrCl

rosuvastatin can be used anytime of the day, during or away from meals.

Monitor the harmful reactions of the drug, especially the harmful reactions to the muscle system.

Be cautious and adjust the dose of rosuvastatin when used in combination with the protease inhibitors of HIV and hepatitis C (HCV): Atazanavir; Atazanavir + Ritonavir, Lopinavir + Ritonavir: maximum 10 mg of rosuvastatin 1 time/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?

There is no specific treatment for overdose. When an overdose, patients should be treated with symptoms and applied supportive measures when necessary. Should monitor liver function and ck concentration. Hematoparoology does not enhance rosuvastatin clearance.

What to do when forgetting a 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

Adultery reactions are recorded when using normal and fleeting rosuvastatin. In control clinical studies, less than 1.4% of patients treated with rosuvastatin withdrew from research due to adverse event.

The frequency of adultery reactions is as follows:

Common

Nervous system disorders: headache, dizziness.

Skin and tissue disorders: itching, rash and urticaria.

Rare

The immune system disorder: Hypersensitivity reactions including angioedema.

impact on the kidneys

proteinuria, detected by the test strip and the main origin from the renal tubules, has been recorded in patients treated with rosuvastatin. The change in the amount of proteinuria from no or only traces to positive ++ or higher has been noticed in impact on the mechanical system

Like other HMG-CoA Reductase inhibitors, there have been reports on cases of muscle pain and muscle spent accompanied by secondary acute renal failure leading to myoglobinuria.

Increased CK concentration at the dose observed in a few patients using rosuvastatin, most cases are mild, asymptomatic and transient. If the concentration of CK increases (> 5xuln), the treatment should be temporarily suspended.

impact on the liver

Like other HMG-CoA Reductase inhibitors, increasing transaminase at the dose recorded in a small number of patients using rosuvastatin. Most cases are light, no symptoms and transparency.

Cognitive decline (such as memory loss, confusion).

Hyperglycemia.

Increase HBA1C.

Notify the doctor with unwanted effects when using the drug.

Warnings

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

Contraindicated

Rotinvast 20 Contraindicated for use in the following cases:

Patients with hypersensitivity to rosuvastatin or any excipients of the drug. Because HMG-CA Reductase inhibitors reduce cholesterol synthesis and maybe the synthesis of other biological activity is the derivative of cholesterol, Rosuvastatin can cause harm to the fetus. Mom. The mother who is breastfeeding is not allowed to take medicine or vice versa.

Be cautious when using

Patients should immediately report to the doctor to treat signs or symptoms of muscle pain, fatigue, fever, dark urine, nausea or vomiting during the use of the drug.

Effects on the kidneys

proteinuria, detected by the test strip and is mainly derived from the renal tubules, has been recorded in patients treated with high doses of rosuvastatin, especially at 40 mg. Most of this situation is transient or occasionally occurs. Proteinuria is not a warning sign of acute or progressive kidney disease. It is necessary to evaluate the kidney function during monitoring of patients who have been treated 40 mg.

Muscle effects

Like other HMG-Coa Reductase inhibitors, skeletal effects such as causing muscle pain and muscle disease have no complications. And very rare cases of muscle pattern that sometimes related to kidney damage have been recorded in patients treated with rosuvastatin.

The effect on the mechanical system: Like other HMG - Coa Reductase inhibitors, there have been reports on cases of muscle pain and muscle pattern accompanied by secondary acute kidney failure leading to myoglobinuria. These risks can occur at any dose but increase at the highest dose (40 mg).

The risk of increased muscle disease when using simultaneously rosuvastatin with other lipid medications (fibrates or niacin), gemfibrozil, cyclosporin, lopinavir/ritonavir, or atazanavir/ritonavir.

measure the concentration of creatin kinase (ck).

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, elderly patients (> 70 years old) have special risks of medication and drug -related patients. In these cases, the benefits/risks should be considered and monitor patients clinically when treated with rosuvastatin. If CK test results> 5 times the upper limit of normal levels, do not start treatment with rosuvastatin.

During Rosuvastatin treatment, patients need to notify when there are muscle manifestations such as muscle pain, stiff muscle, muscle weakness ... When there are these manifestations, patients need to test CK to take appropriate interventions. Rosuvastatin should be discontinued if CK concentration increases significantly (> 5xuln) or severe muscle symptoms and daily discomfort (even if CK

Periodic monitoring of CK concentrations in patients with no symptoms that are not guaranteed to detect muscle disease.

In clinical trials, there is no increase in the increase in the effects of some patients using rosuvastatin and other medications simultaneously. However, the incidence of increased muscle and muscle disease has been seen in patients using other HMG-CAA Reductase inhibitors simultaneously simultaneously with the derivatives of fibric acid including gemfibrozil, cyclosporin, nicotinic acid, antifungal group Azol, enzyme inhibitors and macrolid macrolid groups.

Gemfibrozil increases the risk of muscle disease when used simultaneously with some HMG - coa reductase inhibitors. Therefore, the combination of rosuvastatin and gemfibrozil is not recommended. The use of a combination of rosuvastatin with fibrates or niacin to achieve further change of lipid levels should be carefully considered between benefits and risks that may occur due to these combinations.

Do not use rosuvastatin for patients with acute serious condition, suspicion of muscle disease or can lead to the development of secondary renal failure due to muscle pepper (such as blood infections, hypotension, great surgery, injury, electrolyte disorders, endocrine and severe conveys; or uncontrolled convulsions).

influence on the liver

Like other HMG-COA Reductase inhibitors, caution should be used when using rosuvastatin in severe alcoholic patients and/or a history of liver disease.

The liver function tests are recommended before treatment and 3 months after starting treatment with rosuvastatin or when increasing the dose. Rosuvastatin should be stopped or reduced if serum transaminase concentration is 3 times the upper limit of normal levels.

For patients with secondary hypercolular hyperglycemia due to thyroid discharge or nephrotic syndrome, these diseases must be treated before starting to use rosuvastatin.

Race: Dynamic pharmacokinetic studies show that there is an increase in average level of contact with drugs calculated by concentration and time in patients in Asia compared to the Western white people.

The ability to drive and operate machinery

There is no information on the effect of drugs on driving and operating machinery.

Pregnancy

Rosuvastatin is contraindicated in pregnant women. Women may be pregnant should use appropriate contraceptive measures when taking the drug.

Potential risks caused by HMG-CoA Reductase inhibitors will dominate the benefits of Rosuvastatin treatment during pregnancy. Animal studies show that there are evidence of limited toxicity on the reproductive system. If the patient is pregnant while treating with rosuvastatin, the drug should be stopped immediately.

Lactation period

Contraindicated in breastfeeding women.

Drug interaction

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

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

Cyclosporin: simultaneously use rosuvastatin with cyclosporin, the AUC values of rosuvastatin are 7 times higher than that of this value in healthy volunteers. Simultaneous use of rosuvastatin and cyclosporin does not affect plasma cyclosporin levels.

Coumarin anticoagulant: Like other HMG-COA Reductase inhibitors, starting to treat or increase the dose of rosuvastatin in patients treated simultaneously with coagulants of Coumarin (such as warfarin) that can increase the Inr value. Stopping or reducing the dose of rosuvastatin may reduce the INR. In such cases, the Inr value should be monitored.

Gemfibrozil: Like other HMG-CoA Reductase inhibitors, simultaneously use rosuvastatin with gemfibrozil, which increases 2 times the CMAX and AUC indicators of Rosuvastatin. Avoid combining 2 drugs together. If the dose of rosuvastatin dose should not exceed 20 mg/time/day.

Antacids: Use Rosuvastatin simultaneously with antacids containing aluminum and magnesium hydroxyd, which reduces about 50% of the plasma rosuvastatin levels in plasma. When taking antacids 2 hours after using rosuvastatin, the plasma rosuvastatin levels will be reduced less. The clinical correlation of this interaction is still unclear.

erythromycin: simultaneously use rosuvastatin with erythromycin, reducing 20% AUC (0-T) and 30% cmax of rosuvastatin. This interaction may be due to erythromycin increasing intestinal motility.

Oral contraceptives/hormone replacement therapy (HRT): simultaneous use of rosuvastatin with contraceptive pill that increases 26% AUC of Ethinyl Estradiol and 34% AUC of Norgestrel. It should be noted that increasing the concentration of these substances in plasma when choosing birth control pills.

There is no pharmacokinetic data on patients using rosuvastatin and HRT. Therefore, it is not possible to rule out the possibility of the same effect. However, the combination has been widely used in women in clinical trials and has been well tolerated.

Other drugs:

Data from studies on specialized drug interaction shows that there is no clinical interaction when used with digoxin or fenofibrat.

enamel cytochrom P450: The result from In vitro and in vivo tests proves that RosuVastatin is not an inhibitor or an enzyme that cytochrom P450. Moreover, Rosuvastatin is a weak substrate for these enzymes. There is no significant clinical interaction between rosuvastatin and fluconazole (CYP2C9 and CYP3A4 inhibitors) or ketoconazole (CYP2A6 and CYP3A4 inhibitors). Simultaneous use of otraconazole (CYP3A4 inhibitor) and rosuvastatin increases 28% AUC of rosuvastatin. This increase is not considered clinical significance. Therefore, there is no drug interaction due to metabolism through cytochrom P450.

Storage

Cool dry storage, avoid light, temperature below 30⁰C.

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