Bonzacim 20 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

Uses

indications

Bonzacim 20 drug is indicated in the following cases:

Supplement the diet to reduce total cholesterol, LDL - C, APOB, NonHDL - C, Triglycerides and increase HDL - C in patients with primary cholesterol hypertrophy (heterozygous and non -family) and lipid -blood -mixed blood (Fredrickson group II A and II B).

Additional diet to treat patients with increased triglyceride content (Fredrickson Group IV).

Reducing total cholesterol, LDL - C and APOB in hypercholesterol -hyperplasia - Family homozygous blood, to supplement other lipid - blood reduction treatments (for example, LDL - C filter) or when these methods are not valid.

Pharmacy

Rosuvastatin is a selective and competitive inhibitor HMG-COA-RUDUCTASE is the catalyst enzyme for 3-Oh-3-methyl-glutaryl coenzyme to Mevalonate is the precursor of cholesterol, studying Vitro in animals and in vires in animal cultivation cells for animals and people in animals for animal cells culture cells Seeing strongly merged and selected rosuvastatin with the effect of the liver, the target tissue for cholesterol reduction. Researching both in vitro and in vivo shows that Rosuvastatin against lipid -blood disorders - blood in two roads. Firstly, increase the number of LDL -C receptors in the liver at the surface of the cell to increase the collection and catabolism of LDL. Secondly, Rosuvastatin inhibits the synthesis of VLDL in the liver, reducing the number of VLDL and LDL.

Dynamic pharmacokinetics

absorption: Clinical pharmacological research on humans, 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 assessment but no effect on the level of AUC's absorption. 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 daily use of the drug.

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

Metabolism: Rosuvastatin is weak, 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's research has shown that N-Desmethyl Rosuvastatin has only 1/6-1/2 of HMG-CAA-RUDACTASE MOODS OF ROSUVASTATIN Mother. In general> 90% of HMG-CoA-Reduectase inhibitors are relying on the mother Rosuvastatin.

Elimination: After drinking, rosuvastatin and metabolic substances are mainly discharged in feces (90%). The waste 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.

Race: The research of Crestor -based drugs shows a 2 times an average increase in AUC and CMAX when using Asians (Japan, China, Philippines, Vietnam and South Korea) compared to white people, Asians - India using AUC and CMAX medium -sized drugs 1.3 times higher than white people. There is no clinical related difference in pharmacokinetics between white and black people.

Before taking Bonzacim 20 Celogen Pharma drugs reduce total cholesterol (3 blisters x 10 tablets)

How to use

Take oral use.

Dosage

oral Rosuvastatin daily from 5 to 40 mg. The dose should be used depending on the individual based on the patient's treatment and response purposes. Due to the characteristics of pharmacokinetics, the starting dose for Asians is 5 mg and should not be used by 40 mg. After starting and/or titration rosuvastatin should analyze lipid - blood levels for 2-4 weeks and adjust the dose accordingly.

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

gemfibrozil.

Other fibrat blood cholesterol medications.

Simultaneous use of rosuvastatin with HIV and hepatitis c (HCV) hepatitis (HCV) can increase the risk of muscle damage, most serious is muscle pattern, kidney damage leading to kidney failure and can be fatal. Recommendation: When using simultaneously Rosuvastatin with protease inhibitors such as Atazanavir, Atazanavir VA Ritonavir, Lopinavir and Ritonavir, limited to the maximum dose of rosuvastatin of 10 mg once a 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 is required to treat symptoms and take 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 20, you may experience unwanted effects (ADR).

generally rosuvastatin well tolerated. The reaction is often mild and temporary. Clinical research on 10,275 patients, 3.7% have to stop the drug due to the reaction related to rosuvastatin, the harmful phenomena due to rosuvastatin are muscle pain, constipation, fatigue, abdominal pain, nausea.

Common, 1/100

Endocrine system disorders: diabetes type 1.

Nervous system disorders: headache, dizziness.

Cognitive decline (such as dementia, confusion ...).

hyperglycemia.

Increase HBA1C.

Skin and subcutaneous tissue disorders: itching, rash, urticaria.

Rare, 1/10000

The immune system disorder: Hypersensitivity reaction, including angioedema.

Gastrointestinal disorders: Pancreatitis.

muscle, bone and connective tissue disorders: muscle inflammation and muscle pattern.

Very rare, ADR

Nervous system disorders: polymenitis, dementia.

Liver disorders: jaundice, hepatitis, increased transaminase, increased HBA1C.

musculoskeletal disorders: joint pain.

Kidney disorders: Bleeding.

Notice immediately to the doctor when encountering the unwanted effects of the drug.

Warnings

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

Contraindicated

Bonzacim 20 contraindicated drug in the following cases:

Hypersensitivity to the ingredients of the preparation.

Be cautious when using

do liver enzyme test before starting treatment with rosuvastatin and in the case of clinical indications for testing later.

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 diseases, a history of muscle disease due to the use of RosuVastatin or previous fibrat, a history of liver disease and/or drinking alcohol, elderly patients (> 70 years old) with physical risks, possibly risk -intensive patients, and some common risks of drug risk special. 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.

Before the beginning of using rosuvastatin, blood cholesterol should be controlled by proper diet and physical exercise, weight loss in obese people and basic diseases treatment.

Use 20 mg of Rosuvastatin for serious renal failure (CLCR

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

gemfibrozil.

Other fibrat blood cholesterol medications.

Concomitance the use of rosuvastatin with HIV and hepatitis C (HCV) can increase the risk of muscle damage, the most seriousness is muscle pattern, kidney damage leading to kidney failure and can be fatal. Recommendation: When using simultaneously rosuvastatin with protease inhibitors such as Atazanavir, Atazanavir and Ritonavrr, Lopinavir and Ritonavir, limited to the maximum dose of rosuvastatin of 10 mg once a day.

The ability to drive and operate machinery

The drug can cause side effects on the nerves (headache, dizziness), muscle impact (muscle aches), so be careful when driving and operating machinery.

Pregnancy

Contraindicated Rosuvastatin for pregnant women.

breastfeeding period

Contraindicated Rosuvastatin for nursing women.

Drug interaction

CYP 3A4: Viro and in vivo printing data shows the purification of rosuvastatin regardless of CYP 3A4, at clinical use, this is confirmed in studies with CYP 3A4 inhibitors (ketoconazol, erythromycin, iTraconazole).

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

erythromycin: Combining erythromycin (500 mg each time, 4 times a day, used for 7 days) with rosuvastatin reduces 20% AUC and 31% CMAX of Erythromycin but these decreases are not clinically significant.

iTraconazole: Itraconazole (200 mg each time, once a day, used for 5 days) increases 39% and 28% AUC of rosuvastatin with the corresponding dose of 10 mg and 80 mg, but this increase has no clinical significance.

fluconazole: Fluconazole combination (once a day 200 mg used 11 days) with rosuvastatin (80 mg) increased 14% AUC of rosuvastatin, but not clinical significance.

cyclosporin: Cyclosporin combination with rosuvastatin remains significantly changing cyclosporin 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.

Vitamin K antagonistic drugs: 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 or a Coumarin anticoagulant that can increase INR. Stop medication or reducing the dose of rosuvastatin can lead to reduced Inr. Therefore closely monitor Inr in these patients.

HIV inhibitors and hepatitis C: Although the exact mechanism of interaction is not clear, the simultaneous use of protease inhibitors may increase the effects of rosuvastatin, increasing the risk of muscle damage, the most serious is the muscle pattern, kidney damage leads to renal failure and may be fatal. Therefore, rosuvastatin should therefore be used for HIV patients who are taking protease inhibitors. Recommendation: When using simultaneously rosuvastatin with protease inhibitors such as Atazanavir, Atazanavir and Ritonavir, Lopinavir and Ritonavir, limited to the maximum of the maximum dose of rosuvastatin of 10 mg/day.

Gemfibrozil and other blood lipid products: simultaneously use rosuvastatin and gemfibrozil to increase by 2 times CMAX and AUC of rosuvastatin. 40 mg contraindicated for patients who use these drugs simultaneously, and should only start at a dose of 5 mg.

antacids: Concentrated with rosuvastatin with antacids containing aluminum and magnesium hydroxid led to a decrease in plasma rosuvastatin levels by about 50%.

contraceptive pills: simultaneous use of rosuvastatin and birth control pills that increase the AUC of ethinyl estradiol and Norgestrel 26% and 34% respectively. Increased concentrations should be considered when choosing contraceptives.

Simultaneous use of rosuvastatin with drugs: gemfibrozil, other fibrat blood cholesterol medications, high -dose niacin (> 1 g/day), colchicin increases the risk of muscle damage.

Storage

Store in a cool dry place, avoid light, temperatures below 30 ° C.

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