Vasulax-10 micro medication for lipid disorders (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Rosuvastatin

Ingredient

Composition information	Content
Rosuvastatin	10mg

Uses

indications

Vasula-10 drugs are indicated in the following cases:

Treatment in combination with diet to reduce total cholesterol, LDL - C, APOB, Non HDL - C, Triglycerid and increase HDL - C in patients with primary hypercholesterol (heterozygous and non -family) and lipid -mixed blood disorders (Fredrickson group II A and II B).

Treatment in combination with diet to treat patients with increased triglyceride content (Fredrickson Group IV).

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

Preventive disease prevention.

Pharmacokology

rosuvastatin is a selective and competitive inhibitor HMG-CoA Reductase is the catalyst enzyme for 3-OH-3-Methylglutaryl Coenzyme A to Mevalonate, Premodage of cholesterol, In vitro research on animals and researching Vitro in animal culture cells and people showing Rosvastatin cells. Strong and selective with the effect of the liver, the target tissue for cholesterol reduction.

Research both In vitro and In Vivo shows that Rosuvastatin against lipid -blood disorders - blood in two paths. Firstly, increase the number of LDL -C receptors in the liver in 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 VLDL and LDL.

Pharmacokinetics

absorption

Clinical pharmacological research on humans, peak plasma concentrations for 3-5 hours after taking medicine.

Absolute bioavailability of about 20%.

Take Rosuvastatin and food reduces the absorption rate of about 20% through evaluation, but does not affect the level of absorption through AUC assessment.

Distribution

The average distribution (VD) of rosuvastatin 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 catalysts of CYP2C9 and In Vitro's research has proven that N-Desmethyl Rosuvastatin has only 1/6-1/2 inhibiting HMG-COA-RUDUCTAS OF ROSUVASTATIN Mother.

In general, more than 90% of HMG-CoA Reductase inhibitors are rosse of mother Rosuvastatin.

Elimination

After drinking, rosuvastatin and metabolic substances are mainly discharged through feces (90%).

Sell waste time (T1/2) 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

Dynamic pharmacokinetic studies show that AUC increased by about twice in Japanese people living in Japan and Chinese living in Singapore compared to the white Western people.

The effects of genetic and environmental factors on this change have not been determined.

A pharmacokinetic analysis by population shows that there is no clinical difference in pharmacokinetics in white and black people.

Before taking Vasulax-10 micro medication for lipid disorders (3 blisters x 10 tablets)

How to use

Patients need to follow a low-cholesterol diet, before taking HMG-CoA Reductase inhibitors and must continue to maintain this diet during treatment. Because the synthesis of cholesterol in the liver occurs mainly at night, taking medicine in the evening will increase the drug effect.

Dosage

Starting dose and daily maintenance dose are: 5 mg up to 40 mg.

Medicine coordination:

Statin and plastic with bile acid (cholestyramin, colestipol) have the mechanism of supplementary effects for each other, combining these groups of drugs that have a plus effect on LDL cholesterol.

When using statins along with bile acid -mounted plastic, such as cholestyramin, the statin must be taken at bedtime, 2 hours after taking plastic to avoid clear interaction due to the drug attached to the plastic. Restricting statin coordination with other lipid medications because of the ability to increase muscle disease.

Prevention of cardiovascular events:

Initial dose 10 - 20 mg/day.

Maintenance dose: 5 - 40 mg/day.

Children: Safety and efficiency in children have not been established. Experience in using drugs in children is limited to a small group of children> 8 years old with hyperlested family blood cholesterol. Therefore, Rosuvastatin is not recommended for children during this time.

Elderly: No dose adjustment.

Patients with renal impairment: No dose adjustment in patients with mild to medium renal failure. Contraindicated use of rosuvastatin for patients with severe renal failure.

Patients with liver failure: Contraindicated using rosuvastatin for patients with liver disease developing. Do not use 40 mg in Asians.

Adjust the dose of statin according to the needs and response of each person by increasing the dose of each time spaced no less than 4 weeks, until the desired LDL cholesterol concentration, or when the maximum efficiency is achieved.

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

Common, ADR> 1/100

muscle and bone: muscle pain, joint pain.

Neurological: headache, dizziness, blurred vision, insomnia, weakness.

Digestive: diarrhea, constipation, flatulence, abdominal pain and nausea.

Liver: The test results of liver function increases more than 3 times the upper limit of normal, but mostly have no symptoms and recover when stopping the drug.

Uncommon, 1/1000

muscle and bone: muscle inflammation, muscle pepper.

Kidney: secondary acute renal failure due to myoglobinuria.

DA: Ban Da.

Respiratory: rhinitis, sinusitis, sore throat, cough.

Instructions on how to handle ADR

Changes in serum liver enzyme levels usually occur in the first months of statin treatment.

Patients with high serum transaminase concentration must monitor the second liver function test to confirm the results and monitor treatment until the abnormalities return to normal.

If the serum transaminase concentration AST or ALT (GOT or GPT) is persisted to more than 3 times the upper limit of normal, it is necessary to stop treating with statin.

Advice patients to use statin immediately report any manifestation such as muscle pain for unknown reasons, sensitivity and muscle weakness, especially if accompanied by discomfort or fever.

Must stop the statin therapy if the CPK concentration increases significantly, 10 times higher than the upper limit of normal and if diagnosed or suspected is muscle disease.

Warnings

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

contraindicated

Vasulax drug is contraindicated in the following cases:

Hypersensitivity to HMG-CAA Reductase inhibitors or any ingredients of the preparation.

Pregnant women, nursing women.

Active liver disease or serum transaminase persistent without explaining.

Women have the ability to get pregnant without using appropriate contraception.

Severe kidney failure.

muscle lesions.

are using ciclosporin.

Do not take the dose of 40 mg in Asians.

Be cautious when using

recommend the liver enzyme test before starting statin treatment and in case of clinical indications for testing later.

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 and/or drinking lots of alcohol, elderly patients (> 70 years old) with risk factors for muscle patterns, drugs that occur with special patients.

In these cases, the benefits/ risks 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, stiffness, muscle weakness ... When these manifestations, patients need to do CK test to take appropriate interventions.

Before and during treatment with statin, it is recommended to combine blood cholesterol control by measures such as diet, weight loss, exercise, and treatment of diseases that may be the cause of lipid growth. Periodic lipid quantitative, and adjust the dose 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 responding to treatment.

Only when the LDL cholesterol is not tested, will the total cholesterol use to monitor treatment.

In clinical trials, a few patients who take statins have increased significantly. Serum transaminase (> 3 normal limits). When stopping the drug in these patients, Transaminase concentration often lowered to the level before treatment. Caution should be used in patients who drink a lot of alcohol and/ or have a history of liver disease.

Statin 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 due to muscle pattern, such as severe acute bacterial infections, hypotension, surgery and large trauma, abnormal metabolism, endocrine, electrolytes or uncontrolled convulsions.

Effects on the kidneys:

proteinuria, detected by the test strip and mainly derived from the renal tubules, has been recorded in patients treated with high doses of 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 evaluate kidney function during monitoring of patients who have been treated 40mg.

influence on the liver:

Like other HMG-CoA Reductase inhibitors, be careful when using rosuvastatin in patients with severe alcoholism 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.

Race: Pharmacokinetic studies show that there is an increase in the level of exposure to drugs calculated by concentration and time in Japanese and Chinese patients compared to the Western white people.

Interstitial lung disease:

Special cases with interstitial lung disease have been reported in some statins, especially for long -term treatment.

Symptoms may include shortness of breath, cough without sputum and general health decline (fever, weight loss, fatigue). Statin should be stopped if the patient is suspected to have an interstitial lung disease.

diabetes:

Some evidence that statins are a group of drugs that increase blood glucose and in some patients, there is a high risk of future diabetes.

However, this risk is not as big as the benefits of reducing cardiovascular risk by statin and therefore it is not the reason for stopping treatment with statin.

Patients with genetic problems of galactose intolerance, lactase deficit or poor absorption of glucose-galactose should not use this drug.

The ability to drive and operate machinery

The drug can cause fatigue, headache, insomnia, so be careful when driving and operating machinery after taking the drug.

Pregnancy

Contraindications during pregnancy. Only use statin for women of reproductive age when they are certainly not pregnant and only in the case of hypercesting blood cholesterol is very high without responding to other drugs.

The period of breastfeeding

contraindicated use of drugs during breastfeeding.

Drug interaction

Increased risk of muscle lesions when using statin simultaneously with the following drugs:

gemfibrozil.

Other fibrat blood cholesterol medications.

High doses (> 1 g/day).

Colchicin: Concomitance the use of statin lipid medications with HIV and hepatitis C (HCV) hepatitis (HCV) such as Atazanavir, Atazanavir in combination with Ritonavir, Lopinavir in combination with Ritonavir can increase the risk of muscle damage, the most serious is muscle pattern, kidney damage leading to insufficiency and death. Therefore, the maximum limit of rosuvastatin dose is 10mg/day if used simultaneously with those drugs.

rifampin reduces Atorvastatin levels when combined. Producer Atorvastatin said that if combined with two drugs, those drugs must give at the same time, because atorvastatin after giving rifampicin will reduce plasma Atorvastatin concentrations.

diltiazem: Increases the concentration of Atorvastatin, lovastatin, simvastatin in plasma, at risk of muscle fiber, kidney failure.

Statin 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 the bioavailability of statin when taken. So the time to use these 2 drugs must be apart.

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.

Gemfibrozil: Like other HMG-CoA Reductase inhibitors, simultaneously use rosuvastatin with gemfibrozil, 2 times the CMAX and AUC indicators of Rosuvastatin.

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.

Oral contraceptive pills/hormone replacement therapy (HRT):

Simultaneously using Rosuvastatin with birth control pills 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 simultaneously Rosuvastatin and HRT and so it is not possible to exclude the same possibility.

However, the combination has been widely used in women in clinical trials and has been well tolerated.

Cancer toxicity, mutations and affect fertility.

Storage

Storage: Store in a cool dry place, avoid light. Temperature below 30 ° C.

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