Rosutrox 20mg Biofarm medicine for hypercholesterol and prevent cardiovascular events (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Rosuvastatin

Ingredient

Composition information	Content
Rosuvastatin	20mg

Uses

indications

Rosutrox 20mg drug is indicated in the following cases:

blood cholesterol treatment

Increasing cholesterol (type IIA including hypercoleral hyperlly heterozygous family genus) or mixed blood lipid disorders (type IIB) for adults and children aged 6 and older: is a supportive therapy for diet when the patient does not fully respond to diet and other non -drug therapies (such as exercise, weight loss).

Hypersensitivity to household blood and homozygouss for adults and children aged 6 and older: Use to support diets and other lipid reduction treatments (such as blood ldl extract) or when these therapies are not appropriate.

Prevention of cardiovascular events

Preventing cardiovascular events as further assistance with the adjustment of other risk factors for adults and children aged 6 and older.

Pharmacokology

Mechanism of impact:

Rosuvastatin belongs to a group of blood lipid regulators. Rosuvastatin is also known as HMG-Coa Reductase inhibitors, because of the selective competitive inhibitor with HMG-Coa Reductase, is HMG-CAA to the Mevalonic Acid, a precursor of cholesterol. The main impact agency of rosuvastatin is the liver.

Rosuvastatin increases the amount of LDL-cholesterol receptor on the liver cell membrane, enhances the absorption and rhetorical of LDL-cholesterol; Inhibiting the synthesis of VLDL-Cholesterol in the liver, thus reducing the total amount of LDL-Cholesterol and VLDL-Cholesterol.

Pharmaceutical effects:

Rosuvastatin reduces the amount of LDL-cholesterol, total cholesterol, triglycerides and increases HDL-cholesterol. It also reduces the amount of APOB, cholesterol without high density lipoprotein (Nonhdl-Cholesterol), VLDL-Cholesterol, VLDL-Triglyceride, increasing APOA-1 amount. Rosuvastatin also reduces the rate of LDL-Cholesterol/HDL-Cholesterol, total cholesterol/HDL-Cholesterol, Nonhdl-Cholesterol HDL-Cholesterol and APOB/APOA-I.

The therapeutic effect gained in the first week of treatment and 90% of the maximum response achieved in 2 weeks. The maximum response is usually achieved after 4 weeks and is maintained later.

Dynamic pharmacokinetics

absorption: After drinking, the maximum level of rosuvastatin in plasma is about 5 hours. Absolute bioavailability of about 20%.

distribution: rosuvastatin is distributed mainly into the liver, which is the main place to synthesize cholesterol and clear the LDL-cholesterol. The distribution of rosuvastatin is about 134 liters. About 90% of rosuvastatin is linked to plasma proteins, mainly albumin.

metabolic: 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 cytochrome P450. CYP2C9 is the main metabolic enzyme, 2C19, 3A4 and 2D6 involved in a lower metabolism. 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 the dose of rosuvastatin are eliminated in non -metabolic forms (including active ingredients that are absorbed and not absorbed) and the rest is secreted into urine. About 5% are excreted into urine in the form of non -metabolic. Selling time for plasma is about 19 hours. The sale time does not increase at higher doses. 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 through the OATP-C membrane. This transportation is important in eliminating rosuvastatin from the liver.

linear:

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

Special object groups:

Race: Pharmacokinetics research shows that AUC and the maximum concentration (CMAX) in Asians (Japan, China, Philippines, Vietnam and South Korea) are about 2 times higher than the white people. In Indians, pharmacokinetics research shows that AUC and CMAX are about 1.3 times higher than white people.

Renal failure: In research on kidney failure at different degrees, it shows that the kidney disease from mild to medium does not affect the level of rosuvastatin or the metabolite of N-Desmethyl in plasma. Patients with severe renal impairment (plasma creatinine clearance

Hepatic failure: In research on liver damage to many different levels, there is no evidence of increasing the contact level of rosuvastatin by concentration and time in the group with Child-Pough scores ≤ 7. However, in the group with Child-Pugh scores of 8 and 9 with RosuVastatin exposure levels calculated by concentration and time of minimum of the minimum number of child-pul's scores. No research in patients with Child-Pugh scores greater than 9.

Before taking Rosutrox 20mg Biofarm medicine for hypercholesterol and prevent cardiovascular events (4 blisters x 7 tablets)

How to use

oral medication, use as directed by your doctor.

Dosage

Dosage in case of treatment:

blood cholesterol treatment

Before starting treatment, the patient must follow a standard diet to reduce cholesterol and continue to maintain this regime during treatment. The dose of treatment should be adjusted for each patient according to the patient's treatment and response goals, using current treatment instructions.

Rosuvastatin can be used at any time of the day, during or away from meals. The recommended starting dose is 5 mg or 10 mg once a day in both untreated patients with statin or has been treated with HMG-CoA Reductase inhibitors. The starting dose choice should carefully consider the patient's cholesterol level and the cardiovascular risk as well as the potential risks of adverse reactions. If necessary, the dose level can be adjusted after 4 weeks. Increasing the dose to 40 mg should only be used for patients with severe hypercholesterolemia that is at high risk of cardiovascular disease (especially patients with hypertonic blood cholesterol without achieving treatment targets at a dose of 20 mg and these patients need to be monitored regularly.

Prevention of cardiovascular events

In the study reducing the risk of cardiovascular complications, the dose is 20 mg daily

Children:

Indications for children should only be done by doctors.

Children and teenagers from 6 to 17 years old:

In children and adolescents with hypercholester hyperplasia heterozygous, the normal starting dose is 5 mg/day.

In children 6 - 9 years old with hyperlested hypertension blood cholesterol, the usual dose range is 5 - 10 mg orally once a day. The safety and effectiveness of the dose higher than 10 mg have not been studied in this age group.

For children from 10 to 17 years old with hyperlested hypertension blood cholesterol, the usual dose range is 5 - 20 mg orally once a day. The safety and effectiveness of the dose higher than 20 mg have not been studied in this age group.

Dose adjustment should be conducted according to the response of each individual and the ability to tolerate children, according to pediatric treatment recommendations.

Experience in using drugs in children with homozygous blood cholesterol is limited to a small group of children from 8 to 17 years old.

The dose of 40 mg is not suitable for children.

Children under 6 years old:

Safety and effectiveness of drug use in children under 6 years old have not been studied. Therefore, Rosuvastatin is not recommended for children at this age.

Elderly:

The initial dose recommends 5 mg for patients over 70 years old. There is no need for any other dose adjustment to the elderly.

Patients with renal failure:

No need to adjust the dose in patients with mild to medium renal failure. The recommended starting dose is 5 mg in medium renal impairment patients (Creatinine clearance

Patients with liver failure:

There is no increase in the concentration of rosuvastation in the blood calculated by concentration and time in patients with Child-Pugh scores ≤7. However, the level of exposure to the drug has been recorded in patients with Child-Pugh 8 and 9 scores. In these patients, they should consider the evaluation of kidney function. There is no study in patients with Child-Pugh scores on 9. Contraindicated use of rosuvastatin for patients with liver disease developed.

Race:

Increase the level of contact with rosuvastatin according to concentration and time seen in Asians. The initial dose recommended for Asians is 5 mg/day, the indications for Asians must be less than 40 mg/day. Contraindicated dose of 40 mg/day for Asians.

Patients with muscle disease factors:

The initial dose recommends is 5 mg/day. Contraindicated dose 40mg/day for these patients.

Simultaneous treatment:

Rosuvasatin is a substrate of many different transport proteins (such as OATP1B1 and BCRP). The risk of muscle disease (including muscle atrophy) increases when rosuvastatin is used simultaneously with drugs that may increase rosuvastatin levels in plasma due to interaction with shipping proteins (such as ciclosporin). Whenever possible, it is necessary to consider other alternatives and if necessary, consider temporarily stop using rosuvastatin. In case of simultaneous use of rosuvastatin and other drugs is inevitable, the adjustment of the dose of rosuvastatin should be carefully considered based on the benefits and risks of simultaneous treatment.

Note: With doses less than 10 mg, this form of preparation is inappropriate. Please refer to other types of preparation containing the same active ingredient.

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? If overdose, symptomatic treatment and necessary support measures. Because the drug is strongly connected to plasma proteins, hemorrhage does not have a significant effect in increasing rosuvastatin clearance.

In case of 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 doses to compensate for missed dose.

Side Effects

When using the drug, there are common unwanted effects (ADR) such as:

Common, ADR> 1/100:

Digestive: diarrhea, constipation, flatulence, abdominal pain, nausea in about 5% of patients. More than 3 times the upper limit of normal at 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)).

Neurological - muscular and bone: muscle inflammation, muscle pilot, leading to secondary acute renal failure due to myoglobinuria. HBA1C.

Instructions on how to handle ADR:

Notify the physician the 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

Rosutrox drugs contraindicated in the following cases:

Patients with hypersensitivity to rosuvastatin or any ingredients of the drug. Breastfeeding women.

The dose of 40 mg is contraindicated to patients with money for muscle disease, muscle atrophy. These factors include:

Moderate kidney failure (Creatinine clearance below 60 ml/min);

Hypertman; In plasma can occur;

Asians;

and use fibrates.

Be cautious when using

Please see more information about the drug in the instruction sheet of the use of the drug attached.

Before starting treatment with rosuvastatin, it is necessary to eliminate the causes of blood cholesterol hypercectration (for example, under controlled diabetes, hypogonutrasis, nephrotic syndrome, blood protein disorders, biliary liver disease, due to some other drugs, alcoholism) and need quantitative cholesterol, LDL-cholesterol, HDL-cholesterol and triglyceride. Periodic lipid quantification must be conducted, 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 so it is necessary to use LDL-cholesterol levels to start treatment and evaluate treatment. Only when LDL-Cholesterol cannot be 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. Some of these patients before treatment with statins have abnormal liver function test results and/or drink a lot of alcohol. Therefore, it is necessary to conduct liver enzyme tests before starting statin treatment and in case of clinical indications for testing later. Caution should be used in patients with a lot of alcohol and or 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 muscle disease, a history of muscle disease due to statin or fibrat before, a history of liver disease and/or drinking lots of alcohol, elderly patients (> 70 years old) with risk factors for medication and some 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.

It is necessary to consider when taking rosuvastatin for patients with risk factors leading to muscle damage. Rosuvastatin is at risk of causing harmful reactions to muscle systems such as muscle atrophy, especially for patients with risk factors such as patients over 65 years old, patients with unproven thyroid diseases, patients with kidney disease. Need to closely monitor the harmful reactions during drug use.

Rosuvastatin 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, such as severe acute bacterial infections, hypotension, surgery and large trauma, hormonal abnormalities, electricity, electrolytes or uncontrolled convulsions.

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.

Only use rosuvastatin for women of reproductive age when they are certainly not pregnant and only in the case of hyperlestoly blood cholesterol very high without responding to other drugs.

Increased risk of muscle damage when using rosuvastatin simultaneously with the drugs:

gemfibrozil;

other fibrat blood cholesterol medications;

Concomitance the use of rosuvastatin with HIV and hepatitis c (HCV) (Atazavir, Atazanavir + Ritonavir, Lopinavir + Ritonavir) can increase the risk of muscle damage, the most serious is muscle pattern, kidney damage leading to kidney failure and may cause death.

Effects on the kidneys: The effect on the kidneys of the proteinuria, detected by the test strip and the main origin from the renal tubules, has been recorded in patients treated with high -dose rosuvastatin, especially at 40mg dose, most of this condition is transient or occasionally occurs. Proteinuria is not a warning sign of acute or progressive kidney disease. Need to assess the kidney function during monitoring of patients who have been treated by 40mg.

Effects on the liver: Like other HMG-COA Reductase inhibitors, be careful when using rosuvastatin in severe alcoholic patients and/or a history of liver disease.

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

In patients with secondary hypercholesterolemia due to thyroid discharge or nephrotic syndrome, these diseases must be treated before starting Rosuvastatin.

Interstitial lung disease: The special case of interstitial lung disease has been reported to some statins, especially when long -term treatment. Expressions may include shortness of breath, dry cough and general health decline (fatigue, weight loss and fever). If there is suspect that the patient has developed interstitial lung disease, it is advisable to stop treating with statin.

Diabetes: Some evidence shows that statins are a group of drugs that increase blood sugar and in some patients at high risk of future diabetes, can cause increased blood sugar levels to the point where it is necessary to officially treat diabetes.

However, this risk does not exceed the benefits of reducing cardiovascular risk to statins and therefore is not the reason to stop treating statin. Patients with risk (blood sugar at 5,6 - 6.9 mmol/l, BMI> 30 kg/m2, increased triglycerides, hypertension) should be monitored both clinically and biochemical under national instructions.

In Jupiter study, the overall frequency reports of diabetes are 2.8% in the rosvastatin group and 2.3% in the placebo group, mainly in patients with blood sugar at 5,6 - 6.9 mmol/l.

Lactose intolerance: Patients with rare genetic problems are galactose intolerance, Lapp Lactase or Glucose-Galactose

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

should be cautious because RosuVastatin can cause unwanted effects: headache, dizziness, blurred vision.

Using drugs for women during pregnancy and lactation

rosuvastatin 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 rosuvastatin during pregnancy.

Many statins are distributed into milk. Due to the serious unwanted potential for breastfeeding children, contraindicated use of rosuvastatin in breastfeeding women.

Interactive drug

often experience more muscle and muscle pilot in patients with combination treatment of rosuvastatin with cyclosporin, erythromycin, otraconazole, ketoconazole (due to Cytochrom CYP3A4 inhibitors).

Increased risk of muscle lesions when using rosuvastatin simultaneously with drugs: gemfibrozil, other fibrate blood cholesterol medications, high -dose niacin (> 1 g/day), colchicin.

Concomitance use of rosuvastatin with HIV and hepatitis C (HCV) (Atazavir, Atazanavir + Ritonavir, Lopinavir + Ritonavir) may increase the risk of muscle damage, the most serious is muscle pattern, kidney damage leading to kidney failure and may cause death. The maximum dose of rosuvastatin is 20mg/day when used simultaneously with these drugs.

Rosuvastatin may increase the effects of warfarin. Prothrombin must be determined before starting to use statin and regular monitoring in the first stage of treatment to ensure no change in prothrombin time.

Bile acid -mounted resins can significantly reduce Rosuvastatin's bioactivity when taken. So the time to use these 2 drugs must be apart.

Although there is no clinical interaction studies in clinical interaction, but not

There are clinical significant interactions when using statin along with angiotensin transfer enzyme inhibitors, beta blockers, calcium channel blockers, diuretics and nonsteroidal anti -inflammatory drugs.

ERETIMIB: Concomitance 10 mg of Rosuvastatin and 10 mg Ezetimib leads to an increase of 1.2 AUC value of rosvastatin in hypercholesterol patients with blood cholesterol. Can not exclude pharmacological interaction, in terms of adverse effects, between rosuvastatin and ezetimib.

Antacids: Use Rosuvastatin simultaneously with antacids containing aluminum and magnesium hydroxid, reducing about 50% of plasma rosuvastatin levels. 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.

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 oral contraceptives. There is no pharmacokinetic data on patients using rosuvastatin and HRT simultaneously and therefore cannot exclude the same possibility. However, the combination has been widely used in women in clinical trials and has been well tolerated.

Storage

Store at temperatures below 30 ° C.

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