LDNIL medicine 10

Dosage form Box of 3 blisters x 10 tablets
Specifications Rosuvastatin

Ingredient

Composition information	Content
Rosuvastatin	10mg

Uses

Indications

LDNIL 10 drugs are indicated for the following cases:

Symptoms of blood cholesterol hyperpactive symptoms

Children

Add to the diet to reduce total cholesterol levels, LDL-C and APO B in children and teenagers aged 8 to 17 years old with hyperlemed hypertension blood cholesterol (HEFH) and LDL-C greater than 190 mg / dL, or LDL-C greater than 160 mg / dL and have a family history of early cardiovascular disease or have 2 or more risk factors.

Support for diets to reduce LDL-C, total cholesterol, Non HDL-C and APOB in children and adolescents from 7 to 17 years old with hyperlesto hyperlested hypertension (HOFH) in single therapy or with other lipid treatments (for example: LDL cholesterol reduction).

Adults

To reduce LDL-C, total cholesterol and APO B in adults with hyperlested blood cholesterol as a supportive measure for other lipid treatments (e.g. LDL reduction) or used in single therapy if such treatments are not available.

Cardiovascular Prevention

The main preventive disease prevention of atherosclerosis: To reduce the risk of myocardial infarction (MI), stroke, vasoconstrictor procedure and angina in adults without a history of coronary heart disease (CHD) but there are many risk factors for CHD.

Secondary prevention in patients with atherosclerotic cardiovascular disease: To reduce the risk of NMCT, stroke, vascular tricks and angina in adults with a history of CHD.

Pharmacokology

Mechanism of impact

Rosuvastatin is a selective and competitive inhibitor on HMG-Coa Reductase, is the catalyst of 3-hydroxy-3-methylutaryl coenzyme A into Mevalonate, a precursor of cholesterol. The main action position of rosuvastatin is the liver, the target organs reduce cholesterol.

Rosuvastatin increases the number of LDL receptors on the cell surface in the liver, thus increasing the absorption and catabolism of LDL and inhibiting VLDL synthesis in the liver, thus reducing VLDL and LDL components.

Rosuvastatin reduces LDL-cholesterol levels, total cholesterol and triglycerides and increases HDL-cholesterol. The drug also reduces APO B, Non HDL-C, VLDL-C, VLDL-C, VLLL-TG and increases A-I APO. Rosuvastatin also reduces the ratio of LDL-C/HDL-C, C full/HDL-C, Non HDL-C/HDL-C and APOB/APOA-I.

pharmacokinetic

absorption

Rosuvastatin's peak plasma concentration is about 5 hours after drinking, absolutely bioavailable 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 the metabolism, 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 not 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 liters/hour (the variable coefficient is 21.7%).

Before taking LDNIL medicine 10

How to use

Before starting treatment, the patient must follow a standard diet of cholesterol reduction and continue to maintain this regime during treatment. Rosuvastatin can be used anytime of the day, during or away from meals.

Dosage

Hyper cholesterol treatment

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 dose can be adjusted every 4 weeks if needed. Because the frequency of unwanted effects increases when taking a dose of 40 mg compared to lower doses, the final dose standard up to 40 mg should only be considered for patients with severe blood cholesterol hyperplasia patients with high risk of cardiovascular disease (especially patients with hypercholesterol family blood), without achieving treatment goals at the dose of 20 mg and these patients need to be monitored regularly. It is necessary to have a specialist monitoring when starting a dose of 40 mg.

Provisions of cardiovascular events

In studies reducing the risk of cardiovascular events, the dose is 20 mg daily.

Children: Hyperized hyperlemical hyperlly heterozygic blood on children (from 10 to 17 years old): The usual dose of rosuvastatin is 5-20 mg/day, the maximum recommended dose is 20 mg/day (the larger dose of more than 20 mg has not been studied in this patient group). Adjusting the dose should only be done after a period of 4 weeks.

Hypertly cholesterol hypertension: Experience is limited to a small group of children (8 years old).

Elderly: Should start at a dose of 5 mg once a day in people over 70 years old. No need to adjust the dose due to age.

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 hepatic impairment: The level of contact with rosuvastatin is calculated by concentration and time not increasing in patients with Child-Pugh scores

Asian patients: In Asian patients, consider starting with Rosuvastatin 5 mg/day/day due to increased plasma rosuvastatin levels. Note to increase the level of exposure to drugs in Asian patients when not controlled in sufficient doses of over 20 mg/day.

Used in drug combination treatment

Coordinate with Gemfibrozil: Start with Rosuvastatin 5 mg/time/day. Dosage Rosuvastatin should not exceed 10 mg/time/day.

Coordinate with Atazanavir or Lopinavir and Ritonavir or Atazanavir and Ritonavir: Start with Rosuvastatin 5 mg/time/day. Dosage Rosuvastatin should not exceed 10 mg/time/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? When an overdose, patients should be treated with symptoms and applied supportive measures when necessary. Should monitor liver function and ck concentration. Hemolysis may not benefit.

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

Common, ADR> 1/100

Body: weakness.

Skin: itching, rash and urticaria.

liver - bile: pancreatitis, jaundice, hepatitis, liver enzyme.

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

LDNIL 10 contraindications in the following cases:

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

Patients with progressive liver disease, including increased serum transaminase for unknown reasons, and when serum transaminase concentration increases more than 3 times the upper limit of normal levels (UN).

Patients with severe renal impairment (creatinine clearance

Patients with muscle disease.

Patients are taking ciclosporin.

Contraindicated to use 40 mg in patients with risk factors for muscle disease/muscle pilot. These risk factors include:

Moderate renal failure (Creatinine clearance

Hypothyroidism. In the blood.

The patient is Asian.

Be cautious when using

recommendation of liver enzyme test before starting statin treatment and in 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 genetically diseases, 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) have risk factors for medication and some patients. In these cases, the benefits/risks should be considered and monitor patients clinically when treated with statin. If CK test results> 5 times the upper limit of normal levels, do not start statin treatment.

Effects on the kidneys: proteinuria, detected by the test strip and the main origin from the renal tubules, which have 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. It is necessary to evaluate the kidney function during monitoring of patients who have been treated by 40 mg.

Musculosa effects: The musculoskeletal effects such as causing muscle and muscle pain and some rare cases of muscle pattern have been recorded in patients treated with rosuvastatin at all doses and especially at the dosage> 20 mg.

measurement of Creatine Kinase (CK) concentration: CK levels should not be measured after exertion or when the presence of a certain cause can increase CK because this may falsify the results. If CK concentration increases significantly before treatment (> 5xuln), a test should be done to redefine within 5-7 days. If the test is repeated to determine the level of CK before treatment is still greater than 5xuln, do not start treatment with rosuvastatin.

Before treatment

Like other HMG-CoA Reductase inhibitors, caution should be cautious when using rosuvastatin in patients with factors that can lead to muscle pattern such as:

Renal failure. Tuong.

In these patients, the risk and benefits of treatment and clinical monitoring must be considered. If CK concentration increases significantly compared to before treatment (> 5xuln), it is not advisable to start treatment with rosuvastatin.

during treatment

should ask the patient to immediately report the phenomenon of muscle pain, 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 CK concentration increases significantly (> 5xuln) or severe muscle symptoms and daily discomfort (even if CK

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. Delivering liver enzyme tests are recommended before starting statin treatment and in case of clinical indications for testing later. Rosuvastatin should be discontinued if the serum transaminase concentration is 3 times the upper limit of normal levels. In patients with secondary hypoglycemia 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 Asian patients compared to white people.

Interstitial lung disease: In the exception of interstitial lung disease, it has been reported to some statins, especially when long -term treatment. The manifestations of interstitial lung disease may include shortness of breath, dry cough and general health impairment (fatigue, weight loss and fever). If the patient is suspected of developing interstitial lung disease, Statin therapy should be discontinued.

Diabetes: Some evidence that statin is a group that causes glucose. However, the effect of reducing the cardiovascular risk of statin is greater than this risk, and therefore the risk of hyperglycemia is not the reason to stop treating statin.

The ability to drive and operate machinery

Studies to determine the effects of rosuvastatin on driving and operating the machine have not been performed. When driving or operating the machine, note that dizziness may occur during treatment.

Pregnancy and lactation period

Rosuvastatin contraindicated in pregnant and lactating women.

Medicinal interaction

Transport protein inhibitors: Rosuvastatin is a substrate for specific transport proteins including absorption agents at the ATP1B1 liver and BCRP piercing. Simultaneous use of rosuvastatin with medications inhibitors of these shipping proteins can lead to increased plasma rosuvastatin levels and increase the risk of muscle diseases.

ciclosporin: simultaneously use rosuvastatin with ciclosporin, the AUC values of rosuvastatin are 7 times higher than that of this value in healthy volunteers. Contraindicated rosuvastatin in patients with simultaneous use of ciclosporin.

Protease inhibitors: Although the exact mechanism of unknown interaction, simultaneous use of protease inhibitors can cause rising rosvastatin exposure. Therefore, when coordinating, it is necessary to consider adjusting the dose of rosuvastatin based on an increase in exposure to rosuvastatin: limit the dose of rosuvastatin up to 10 mg once a day.

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. Stopping or reducing the dose of rosuvastatin may reduce the INR. In such cases, the Inr value should be monitored.

Gemfibrozil and other blood lipid medications: simultaneously use rosuvastatin with gemfibrozil, 2 times the C and AUC indicators of Rosuvastatin. Gemfibrozil, fenofibrat, other fibrats and niacin (nicotinic acid) at lipid doses (21 g/day) increase the risk of muscle disease when used simultaneously with HMG-COA Reductase inhibitors, maybe because these drugs can cause muscle disease when used individually. The dose of 40mg is contraindicated for patients to use simultaneously with fibrats. These patients should start at a dose of 5 mg.

Ezetimibe: Use the simultaneous combination of 10 mg Rosuvastatin and 10 mg Ezetimibe leads to 1.2 times the AUC of rosuvastatin in hypercholesteroline hypercholester. Can not exclude pharmacological interaction, side effects, between rosuvastatin and ezetimib.

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.

erythromycin: simultaneously use rosuvastatin with erythromycin, reducing 20% AUC 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.

Fusidic acid: Interactive studies with rosuvastatin and fusidic acid have not been done. As with other statins, muscle -related events, including muscle pattern with rosuvastatin and fusidic acid used simultaneously, have been reported after the drug to the market. Therefore, rosuvastatin combined and fusidic acid is not recommended.

Increased risk of muscle damage when using statin simultaneously with the following drugs: Gemfibrozil. Other fibrat blood cholesterol medications. High doses (> 1g day). Colchicine.

Concentrated use of statin lipid medications with HIV and hepatitis C (HCV) can increase the risk of muscle damage, the most serious muscle, kidney damage leads to renal failure and can be fatal.

Storage

Store in cool dry places, below 30 ° C. Avoid light

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