Rosuvas Hasan 10 medicine for hypercholesteroline blood (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Rosuvastatin

Ingredient

Composition information	Content
Rosuvastatin	10mg

Uses

Indications

Rosuvas Hasan 10 is indicated in the following cases:

Rawemic blood cholesterol (LLA) including hyperlyonic hypergly heterozygic or mixed blood lipid disorders (type IIB): 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). Supporting diets and other lipid reduction treatments (such as blood ldl extract) or when these therapies are not appropriate.

Rosuvastatin is a selective and competitive inhibitor HMG -COA 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 surface of the cell in the liver, thus increasing the absorption and catabolism of LDL, inhibiting the synthesis of VLDL in the liver, thus reducing VLDL and LDL components.

Pharmaceutical impact

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

Table 1: Responding to the dose in patients with hyperplation hypercholesterol (LLA and LLB type) (average change (%) compared to before treatment).

Instructions for using drugs

dose

The number of patients

ldl-C

Toan

Part

HDL-C

young

HDL-C

APOB

APOA-L

Pharmacy

-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 hypereminemia, any racial, gender or age and in special patients such as diabetes or hypertension patients with household blood cholesterol.

From phase research data III, RosuVastatin proves effective in treatment in most patients with hypercholesterol blood cholesterol of LLA and Lib (average LDL -C before treatment about 4.8 mmol/l) according to the treatment goals of the European Vascular Atheroscleric (European AtherosClerosis Society - EAS 1998) EAS's treatment goals have been achieved on LDL-C concentration (

In a major study, 435 patients with hyperlested hyperlemic hyperplasia have been used for rosuvastatin from 20 to 80 mg according to the dose increasing adjustment design. It is seen that all the doses of rosuvastatin have beneficial effects on lipid parameters and achieve treatment goals. After adjusting the daily dose of 40 mg (12 weeks of treatment), LDL-C decreased by 53%. 33% of patients achieve EAS goals for LDL-C concentration (

In an open study, adjusting the dose gradually, 42 patients with genetic hypercholesteroline hyperplasia patients are evaluated for response to the treatment of Rosuvastatin 20 - 40 mg. All researchers have a decrease in the average LDL-C is 22%.

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.

pharmacokinetic

absorption

Rosuvastatin's peak plasma concentration is about 5 hours after drinking, bioavailability 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 the person who determines that rosuvastatin is a weak substrate for metabolism through cytochrom P450. CYP2C9 is the main enzyme involved in 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 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 l/hour (the variable coefficient is 21.7%). Like other HMG -CoA Reductase inhibitors, the transportation of rosuvastatin through the liver requires the transportation of Oatp - C. This transportation is important in eliminating rosuvastatin through 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 patient groups

Age and gender: The impact of age or gender on the pharmacokinetics of rosuvastatin is not clinically related.

Race: Pharmacokinetic studies show that AUC is about 2 times in Asians compared to white people living in the West. 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: In research on people with kidney failure at different degrees, it shows that the kidney disease from mild to medium does not affect the concentration 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 increasing the level of contact of rosuvastatin by concentration and time in patients with Child - PUGH 7 scores. However, 2 patients with Child - PUGH scores are 8 and 9 with the contact level of RosuVastatin calculated by the minimum of the minimum number of Child - Pgh Inexperienced in patients with Child - Pugh> 9.

Before taking Rosuvas Hasan 10 medicine for hypercholesteroline blood (2 blisters x 14 tablets)

How to use

Rosuvas Hasan 10 can be used at any time of the day, during or away from meals.

Dosage

Before the beginning of treatment, the patient must follow the standard diet of cholesterol reduction and continue to maintain this regime during treatment. Adjust the dose according to the patient's treatment and response goals.

Dosage

The recommended starting dose is 5 mg or 10 mg, orally once a day for both patients who have never used Statin groups and patients from the use of HMG-Coa Reductase inhibitors to use Rosuvastatin. The selection of the starting dose should pay attention to the level of cholesterol of each patient, the later cardiovascular risk as well as the possibility of unwanted effects.

can increase the dose every 4 weeks if needed, up to 40 mg/day.

For patients with severe blood cholesterol hyperplasia is at high risk of cardiovascular disease (especially patients with hyperlestolemia blood cholesterol) without achieving treatment effect at 20 mg can increase the dose to 40 mg and must be monitored regularly by a specialist. Atazanavir, Atazanavir and Ritonavir, Lopinavir and Ritonavir.

Children

Safety and efficiency in children have not been set up. Experience in taking drugs in children is limited to a small group of children (greater than or 8 years old) with hyperlested family blood cholesterol. Therefore, rosuvastatin is not recommended for children.

Elderly

No dose adjustment.

Patients with renal failure

No dose adjustment in patients kidney failure from mild to medium. Contraindicated for patients with severe renal failure.

Patients with liver failure

The level of contact with RosuVastatin by concentration and time does not increase in patients with Child - PUGH scores smaller than or equal to 7. Inexperienced in patients with Child - Pugh scores above 9. Do not use rosuvastatin for patients with progressive liver disease.

Race

Increase the level of exposure to drugs calculated by concentration and time recorded in Asian patients. This should be considered when deciding the dose for Asian -based patients.

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? When an overdose, patients should be treated with symptoms and applied supportive measures when necessary. Liver function should be monitored and creatin kinase levels. Blood decomposition may not benefit.

What to do when forgetting 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 Rosuvas Hasan 10 , you may experience unwanted effects (ADR).

The adverse reactions are recorded when using rosuvastatin is usually mild and transient. In control clinical studies, less than 4% of patients treated with rosuvastatin withdrew from research due to adverse event. Rarely hypersensitive reactions including angels.

Nervous system disorders: Common headaches , dizziness. Rarely: muscle disease, muscle pattern.

General disorders: Common weakness.

The impact on the kidneys: proteinuria, detected by the test strip and has the main origin from the renal tubules 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 muscle - bone system: such as muscle pain, muscle disease and some rare cases of muscle pattern have been recorded for patients treated with rosuvastatin at all doses and especially at the doses of> 20 mg.

Increased creatin kinase levels at the dose observed in patients using rosuvastatin; Most of the mild cases, no symptoms and transparency. If creatin kinase levels increase (> 5 x ULN), temporary treatment.

Acting on the liver: Like other HMG-CoA Reductase inhibitors, increasing transaminase at the dose recorded in a few patients using Rosuvastatin; Most cases are light, no symptoms and transparency.

Experience in the circulation of drugs: In addition to the above -mentioned reactions, the unwanted events are also recorded during the circulation of Rosuvastatin:

Bile liver disorders: Very rare jaundice, hepatitis. Rarely: increased liver enzymes.

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

Rosuvas Hasan 10

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

Patients with muscle disease.
Precautions when using

The effect on the kidneys
proteinuria has been recorded in patients treated with rosuvastatin at high doses, especially at 40 mg, most of this condition is transient or occasionally occurs. Proteinuria is not a warning sign of acute or progressive renal disease, need to assess the kidney function during the monitoring time of patients who have been treated at a dose of 40 mg.
Muscle effects
Musculosa effects such as muscle pain, muscle disease and some rare cases of muscle pattern have been recorded in patients treated with rosuvastatin at all doses, especially at doses of over 20 mg.
measurement of Creatin Kinase concentration (CK): Do not measure the concentration of CK after exertion or when there is the presence of a certain cause that can increase CK because this may falsify the results. If the test results are higher before treatment (5 x ULN) and still repeat after 5-7 days, do not start treatment with rosuvastatin.
Consider monitoring Creatin Kinase (CK) in the case:
Before treatment: CK test should be conducted in the following cases:

impaired renal function.

The possibility of drug interactions and some special patients.

In these patients, the risk and benefits of treatment and clinical monitoring must be considered. If CK test results> 5 times the upper limit of normal levels should not start treatment with rosuvastatin.
During treatment: Ask patients to immediately report the symptoms of muscle pain, muscle, muscle weakness or non -explanation, especially if accompanied by fatigue or fever. CK concentration should be measured in these patients. Rosuvastatin should be discontinued if the CK concentration increases significantly (> 5 x ULN) or the symptoms of severe muscle and daily discomfort, although the CK concentration is smaller than or equal to 5 x ULN. If these symptoms are no more and the CK concentration returns to normal levels, it is advisable to consider Rosuvastatin reuse or another HMG-CoA Reductase inhibitor at the lowest doses and closely monitor.
Increased incidence of muscle and muscle inflammation has been seen in patients using other HMG-CoA Reductase inhibitors simultaneously with the derivatives of fibric acid including gemfibrozil, cyclosporin, nicotinic acid, antifungal group Azol, enzyme inhibitors and macrolid antibiotics. The use of a combination of rosuvastatin with fibrats or niacin to achieve a change in lipid concentration should be carefully considered between benefits and risks that may occur due to these combinations. Combination between rosuvastatin and gemfibrozil is not recommended.
Do not use rosuvastatin for patients with acute serious condition, suspicion of muscle disease or can lead to secondary renal failure due to muscle pilot (such as blood infections, hypotension, surgery, trauma, hormonal disorders and severe metabolism, or uncontrolled convulsions).
influence on the liver
Like other HMG-CoA Reductase inhibitors, caution should be used when using rosuvastatin in patients with severe alcoholism and/or a history of liver disease.
Exzy liver test before starting treatment with rosuvastatin and in case of clinical indications for testing later. Rosuvastatin should be stopped or reduced if serum transaminase concentration is 3 times the upper limit of normal levels.
Secondary cholesterol hyperplasia patients due to thyroid discharge or nephrotic syndrome must be treated before starting rosuvastatin.
The ability to drive and operate machinery

Studies to determine the effects of rosuvastatin on driving and operating the machine have not been performed. However, based on the characteristics of pharmaceutical force, Rosuvastatin cannot affect these possibilities. When driving or operating the machine should note that dizziness may occur during treatment.
Pregnancy

Rosuvastatin is contraindicated in pregnant and lactating women. Women may be pregnant should use appropriate contraception.
Because cholesterol and other cholesterol biosynthesis products are necessary for fetal development, the potential risk due to HMG-CAA 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.
Breastfeeding period

In mice, rosuvastatin excreted in milk. There is no corresponding data on human excretion.
Rosuvastatin is contraindicated on pregnant and lactating women.
Drug interaction

cyclosporin: simultaneously use rosuvastatin with cyclosporin, the AUC values of rosuvastatin are 7 times higher than this value in healthy volunteers but does not affect cyclosporin levels in plasma.
Vitamin K antagonists: Like other HMG-COA Reductase inhibitors, when starting to treat or increase the dose of rosuvastatin in patients treated simultaneously with vitamin K antagonists (such as warfarin) can increase the Inr value (blood coagulation index). Stopping or reducing the dose of rosuvastatin may reduce the INR. In such cases, the Inr value should be monitored.
gemfibrozil and other fibrat blood cholesterol medications, high doses (> 1 g/day), Colchicin: simultaneously used with rosuvastatin increases the risk of muscle lesions.
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 oral contraceptives. There is no pharmacokinetic data on patients using rosuvastatin with HRT at the same time, so it is not possible to rule out the possibility of the same effect. However, this combination has been widely used in women in clinical trials and has been well tolerated.
Digoxin: Based on data from specialized drug interactions, there is no clinical interaction when used with Digoxin.
Cytochrom P450: The result from In Vitro and In Vivo tests proves that RosuVastatin is not an inhibitor or cytochrom P450 inhibitor. Moreover, Rosuvastatin is a weak substrate for these isenzymes. Do not record clinical related interactions 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.
HIV and HVC's protease inhibitors: similarly used with rosuvastatin may increase the risk of muscle damage, the most serious is muscle pattern, kidney damage leads to kidney failure and can be fatal.

Storage

Store in a dry place, less than 30 ° C.

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