Bonzacim 10 celogen pharma drugs reduce total cholesterol (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Rosuvastatin
Ingredient High blood fat, high blood cholesterol

Ingredient

Composition information	Content
Rosuvastatin	10mg

Uses

Indications

Bonzacim 10 drugs are indicated in the following cases:

Supplementing the diet to reduce total cholesterol, LDL-C, APOB, NonHDL-C, Triglycerides and HDL-C increase in patients with primary blood cholesterol (heterozygous and non-family) and mixed lipid disorders (Fedridkson group II A and II B). There is an increase in triglyceride content (Fredickson Group IV). Learning

rosuvastatin is a selective and HMG-CoA-Reductase inhibitor who is a catalyst enzyme for 3-oH-3-glutaryl coezymic A to Mevalonate is the precursor of cholesterol, studying in vitro on animals and studying In vitro on animal culture cells of animals and people showing strongly imported and selected to purify and filter. The effect of the liver, is the target tissue for cholesterol reduction. Researching both In Vitro and In Vivo shows that Rosuvastatin is anti -lipid disorders in 2 paths.

First, increase the number of LDL-C receptors in the liver at the cell surface to increase the collection and catabolism of LDL.

Secondly, Rosuvastatin inhibits the synthesis of VLDL in the liver, reducing the number of platelets of VLDL and LDL.

pharmacokinetic

absorption

Clinical pharmacological research on humans, the peak concentration in plasma reaches 3-5 hours after taking the drug. Both the peak concentration (CMAX) and the area under the curve (AUC) increased at the same rate as when increased. Absolute bioavailability of about 20%.

Take Rosuvastatin and food to reduce the absorption rate of about 20%, through CMAX reviews but no effect on the level of AUC assessment. Rosuvastatin concentration in plasma is not different when drinking in the morning or afternoon. The decrease in LDL-C is noticeable when using rosuvastatin when hungry or full, excluding the time of medication during the day.

Distribution

The average distribution (VD) volume of rosuvastatin stability is about 134L. Rosuvastatin attaches 88% to plasma proteins, mainly attached to albumin. This attachment is recovered and independent and drug concentration in plasma.

Metabolism

Rosuvastatin metabolizes mainly, about 10% of the markers are found as metabolites. The main metabolites are N-Desmethyl Rosuvastatin through the catalyst of CYP 2C9 and In Vitro research has shown that N-Desmethyl Rosuvastatin has only 1/6-1/2 of HMG-CAA-RUDACTASE EFFECTS thanks to Mother RosuVastatin.

Elimination

After drinking, rosuvastatin and metabolic substances are mainly discharged in feces (90%). Sales time (T/2) is about 19 hours.

After intravenous injection, about 28% of the purification of the whole body is through the kidney and 72% through the liver.

Before taking Bonzacim 10 celogen pharma drugs reduce total cholesterol (3 blisters x 10 tablets)

How to use

Take oral use.

Dosage

Take Rosuvastatin daily from 5 to 40mg. The dosage is required depending on the individual's purpose and response. The recommended starting dose is 10mg per day. But for people who do not need to reduce much LDL-C or people who may have muscle risk factors, it is recommended to start at a dose of 5mg daily.

After the beginning or titration of rosuvastatin should analyze lipid - blood levels for 2-4 weeks and adjust the dose accordingly.

Children

Safety and efficiency in children have not been set up. Experience in taking drugs in children is limited to some children (8 years old or more) with hyperlested blood cholesterol. Therefore, rosuvastatin should not be used.

Elderly

The starting dose of 5mg is used for patients> 70 years old. No dose adjustment in these patients.

Patients with renal failure

No need to adjust the dose in patients with mild to medium renal failure. Patients with moderate renal impairment (Creatinine clearance

Dosage recommended when used simultaneously with protease inhibitors of HIV and HCV

Interactive protease inhibitors:

Atazanavir.

Lopinavir + Ritonavir.

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 is overdose, symptomatic treatment and supportive measures. The dialysis is not significantly increasing the purification of rosuvastatin.

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 Bonzacim 10, you may experience unwanted effects (ADR).

generally rosuvastatin well tolerated. The reaction is often mild and temporary. The common unwanted side effects are:

muscle pain, constipation, fatigue, abdominal pain, nausea.

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

Bonzacim 10 contraindications in the following cases:

Hypersensitivity to the ingredients of the preparation.

Do not use rosuvastatin in people with progressive liver disease or when there is a modified transaminase in serum (without interpretation).

Patients with severe renal failure (creatinine clearance

Patients with muscle disease.

Pregnant and lactating women, women are likely to be pregnant but do not use appropriate contraception.

Caution when using

Before treatment with Bonzacim, it is necessary to eliminate the causes of blood cholesterol (e.g. under control diabetes, armoral insecticide, kidney damage syndrome, blood protein disorders, biliary obstruction disorders, due to some other drugs, alcoholism) and quantitative cholesterol quantitative ldl, cholesterol ldl, cholesterol HDL, cholesterol and cholesterol and cholesterol HDL, cholesterol and cholesterol trigycerid.

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 the factory uses 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.

It is necessary to consider when taking drugs belonging to the statin group for patients with risk factors leading to muscle damage. Need to closely monitor harmful rules during the use of drugs.

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, a history of liver disease or drinking lots of alcohol, elderly patients (> 70 years old) have risk factors for muscle pattern, drug -specific ability.

In these cases, risk benefits should be considered and monitor patients clinically when treated with statin. If the results of CK test> 5 times the upper limit of normal levels, do not start treatment with statin.

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

It is necessary to do liver enzyme tests before starting statin treatment and in case of clinical indications for testing later.

Use 20mg of Rosuvastatin for serious renal failure (CLCR

The ability to drive and operate machinery

The drug does not affect the ability to drive and operate machinery.

Pregnancy

The level of safety in pregnant women has not been recorded, so they only use the drug during pregnancy when the desired effect is more than the harmful effects caused by the drug.

Therefore contraindication to pregnant women, women are likely to be pregnant but do not use appropriate contraception.

Breastfeeding period

A small amount of drugs into breast milk. Because the drug has the ability to inhibit HMG-CoA Reductase, therefore can seriously affect breastfeeding babies.

Therefore contraindicated for breastfeeding women.

Drug interaction

CYP 3A4

In vitro and in vivo data shows that RosuVastatin's purification does not depend on CYP 3A4 at clinical use, this is confirmed in studies with familiar CYP 3A4 inhibitors (ketoconazole, erythromycin, iTraconzlole).

ketoconazole

Ketoconazole combination (each time 200mg, twice a day, used for 7 days) with rosuvastatin (80mg) does not increase the concentration of rosuvastatin in plasma.

erythromycin

Combining erythromycin (500mg each time, 4 times a day, used for 7 days) with rosuvastatin reduces 20% AUC and 31% CMAX of Erythromycin but these reduced decline are clinical significance.

iTraconazole

Itraconazole (each time 200mg, once a day, used for 5 days) increases 39% and 28% of rosuvastatin with the corresponding dose of 10mg and 80mg, but this increase is not clinical significance.

cyclosporine

Cyclosporine combination with rosuvastatin remains significantly changing cyclosporine levels in plasma. However, Rosuvastatin's CMAX increased by 11 times and AUC increased by 7 times compared to the data met in healthy people. These increase are clinical significance.

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 after drinking. So the time to use these 2 drugs must be apart.

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

Concomitance the use of rosuvastatin with HIV-treated drugs (inhibitors of HIV-Protease) and hepatitis C (HCV): increases the risk of muscle damage, most serious is muscle pattern, kidney damage leading to kidney failure and death.

Storage

Store in a cool dry place, avoid light.

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