Orsten 10mg Delta Pharma drugs reduce total cholesterone (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Rosuvastatin

Ingredient

Composition information	Content
Rosuvastatin	10mg

Uses

indications

Orsten 10 mg Delta is indicated in the following cases:

Patients with high blood cholesterol

Treatment combined with diet to reduce the increase of total cholesterol, cholesterol attached to low density lipoprotein (LDL - C), Apolipoprotein B, Triglycerides and to increase cholesterol -attached amounts with high density lipoprotein (HDL - C) in patients with cholesterol of blood cholesterol (Fredrickson tubes IA and IIB).

Treatment combined with diet when the patient has increased triglycerides in serum (Fredrickson tube IV).

Reduce total cholesterol and cholesterol attached to low density lipoprotein in patients with hypertension hypertension, used for treatment in combination with other blood lipid therapies or if not conditions to perform those therapies.

Treatment combined with diet to reduce total cholesterol, cholesterol attached to low density lipoprotein, apolipoprotein B in men and women after puberty, ages 10 to 17, suffer from hyperlyonic hyperlyonic hyper zygote and after a full treatment with the diet of the tests still results as follows:

Cholesterol attached to low density lipoprotein (LDL-C)> 190 mg/dl.
There is a history of cardiovascular disease from a young age.
For adult patients without clinical manifestations of coronary heart disease, but there are many risk factors leading to coronary heart disease such as age, smoking, high blood pressure, HDL - C ratio (cholesterol attached to high density lipoprotein), or a family with a history of early coronary heart disease. Orsten is assigned to:
reduce the risk of myocardial infarction.
reduce the risk of stroke.

Treatment combined with a diet to reduce total cholesterol, LDL-C, slow down the atherosclerotic process in adult patients.

Pharmacokology

Rosuvastatin is a selective and competitive inhibitor on HMG - Coa Reductase, is the catalyst of the conversion process 3 - Hydroxy - 3 - Methylglutaryl - Coenzym A into Mevalonate, a precursor of cholesterol.

cholesterol and triglycerides circulate in the form of a complex with lipoprotein. When the centrifugal, these complexes separate into HDL (high density lipoprotein), LDL (low density lipoprotein), and VLDL (Lipoprotein is very low). Triglyceride (TG) and cholesterol in the liver links to VLDL and entered plasma to distribute to peripheral tissues.

LDL is formed from VLDL and divestment is mainly through high -grieving receptors with LDL. Clinical and pathological studies show that the high concentration of plasma of total cholesterol, cholesterol attached to LDL (LDL - C), and Apolipoprotein B (APOB) causing atherosclerosis in humans and are risk factors for cardiovascular disease development, while cholesterol levels attached to lipoprotein (HDL - C) are related to risk of risk of risk of risk reduction with the risk of risk of causing risk to the risk of risk of causing risk to the risk of disease. circuit.

Pharmacokinetics

absorption

Rosuvastatin's peak plasma concentration is about 5 hours after drinking. Absolute bioavailability is about 20%.

Distribution

Rosuvastatin is mainly distributed in the liver, where cholesterol synthesis and LDL clearance - C. The distribution volume of Rosuvastatin is about 134 liters. About 90% of rosuvastatin combined with plasma proteins, mainly with albumin.

Metabolism

In the body, rosuvastatin metabolizes very little, only 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, 2C19, 3A4 and 2D6 participating at a lower level.

Elimination

About 90% of the dose of rosuvastatin is eliminated in stools in a constant form and metabolites, the rest is secreted into urine. About 5% are excreted into unchanged urine. Sell waste time in plasma is about 19 hours.

Sell waste time does not increase when using higher doses. The average plasma clearance is about 50 liters/hour (the variable coefficient is 21.7%).

Like other HMG - Coa Reductase inhibitors, the elimination of rosuvastatin from the liver is related to the transportation of Oatp - C. This transportation is important in eliminating rosuvastatin from the liver.

Before taking Orsten 10mg Delta Pharma drugs reduce total cholesterone (3 blisters x 10 tablets)

How to use

Orsten 10 mg Delta is an oral medication.

Dosage

Adults

Recommendations to start treatment with the lowest dose that the drug works, then if necessary, can adjust the dose according to the needs and response of each person by increasing the dose of each time spaced no less than 04 weeks and must monitor the harmful reactions of the drug, especially the harmful reactions to the muscle system.

maximum dose of rosuvastatin in the case of simultaneous treatment with the above drugs is 10 mg/1 time/day. It is advisable to guide patients with diet that reduce blood cholesterol according to the standard of Rosuvastatin gas and maintain this diet during treatment.

Can take the drug at any time of the day when hungry or full. The dose depends on the individual based on the concentration of LDL - C, the goals of treatment, and the patient's response. The recommended starting dose is Rosuvastatin 5 mg 1 time/day and most patients are controlled at this starting dose.

If necessary, the dose can be increased to 20 mg after 4 weeks. The increase in the dose to 40 mg should only be used for patients with severe blood cholesterol hypercemolity that is at high risk of cardiovascular disease (especially patients with hypertonic blood cholesterol) without achieving treatment goals at a dose of 20 mg and these patients need to be monitored regularly.

After the starting dose and/or the dose of rosuvastatin, the lipid index should be checked for 2-4 weeks, and adjust the dose according to the test results.

Children

Children from 10 - 17 years old have hyperlemed hypertension blood cholesterol, the normal starting dose is 5 mg per day. The usual dose range 5 - 20 mg x 1 time/day.

Elderly

The starting dose is 5 mg x 1 time/day.

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

Asian patients

According to the pharmacokinetics research in the US in Asian people, the average absorption of rosuvastatin in Asians increases by nearly 2 times higher than the white people. This increase should be considered when deciding to start the starting dose of 5 mg of Rosuvastatin for Asians.

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, patients should be treated with symptoms and applied supportive measures when necessary.

What to do when you forget 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 Orsten 10 mg Delta, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Digestive: diarrhea, constipation, flatulence, abdominal pain, and nausea, about 5% of patients.

Central nerve: headache (4 - 9%), dizziness (3 - 5%), blurred vision (1 - 2%), insomnia, depression.

Neurology - muscle and bone: muscle pain, joint pain.

Liver: The results of the liver function test increases more than 3 times the upper limit of normal, in 2% of the patient, but most of them have no symptoms and recover when stopping the drug.

Neurological - muscle and bone: muscle disease (combining muscle weakness and increased content of plasma creatin phosphokinase (CPK)).

skin: skin.

Respiratory: rhinitis, sinusitis, sore throat, cough.

Rare, 1/10000

Neurological - muscular and bone: muscle inflammation, muscle pilot, leading to secondary acute renal failure due to myoglobinuria.

Instructions on how to handle ADR

Changes in serum liver enzyme concentration usually occur in the first months of statin treatment. Any patient who has a 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 or ALT (GTP or GPT) concentration levels are persistent than 3 times the upper limit of normal, it is necessary to stop treating with statin. The patient should be recommended to immediately report any signs such as muscle pain for unknown reasons, sensitive pain 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

Orsten 10 mg Delta is contraindicated in the following cases:

Patients with hypersensitivity to rosuvastatin or any excipients of the drug. Patients with liver disease, patients with severe renal impairment (creatinine clearance

Patients with muscle disease, patients are taking cyclosporin.

Pregnant and lactating women.

Be cautious when used

Effects on the kidneys: Proteinuria is detected by the test strip and has the main origin from the renal tubules recorded in patients treated with high doses of Rosuvastatin, especially at 40 mg dose.

Muscle effects: Like other HMG - Coa Reductase inhibitors, Rosuvastatin can cause muscle -muscular effects such as muscle pain, muscle weakness. Rosuvastatin should not be used for patients with risk factors such as patients over 70 years old, patients with unproven thyroid diseases, patients with kidney disease.

Effects on the liver: Be careful when using rosuvastatin in patients with severe alcoholism and/or a history of liver disease. Liver enzyme tests should be taken before and when it is started with rosuvastatin treatment and in case of clinical indications for previous testing requirements.

Patients with secondary hypercholesterolemia due to thyroid discharge or nephrotic syndrome, they must be treated before starting to use rosuvastatin.

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 statin or fibrat before, a history of liver disease or drinking lots of alcohol, 70 -year -old patients with risk factors for muscle patterns, drugs and some special patients. In these cases, the benefits or risks should be considered and monitor patients clinically when treated with statin.

If the results of CK> 5 times the upper limit of the normal level, 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 there are these manifestations, patients need to test CK to take appropriate interventions.

The ability to drive and operate machinery

The drug can cause dizziness, blurred vision in some patients (1 - 2%). So be cautious when driving or operating machinery.

Pregnancy

If a patient is pregnant during Rosuvastatin treatment, the drug should be stopped.

Lactation period

There is no data on Rosuvastin excretion into breast milk. Do not use rosuvastatin for breastfeeding women.

Drug interaction

cyclosporin: simultaneous use of cyclosporin and rosuvastatin, AUC of Rosuvastatin increases average 7 times higher but the plasma cyclosporin levels are not affected.

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 or other coagulopathy drugs) 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.

Ezetimib: simultaneously use rosuvastatin and ezetimib without changing the AUC and CMAX of both drugs. However, pharmacological interaction between rosuvastatin and ezetimib, as side effects, cannot be excluded.

Gemibrozil: 2 times the CMAX and AUC indicators of rosuvastatin, increasing the risk of muscle lesions. Fibrat, high -dose hypoglycin cholesterol medications (> 1 g/day), Colchicin also increases the risk of muscle lesions when used simultaneously with rosuvastatin.

Concomplifying the statin lipid medications with HIV and hepatitis C (HCV): Atazanavir, Atanazavir + Ritonavir, Lopinavir + Ritonavir may increase the risk of muscle damage, the most serious is pattern, kidney damage leading to kidney failure and can cause death.

antacids: simultaneous use of rosuvastatin with antacidic drugs containing aluminum hydroxyd and magnesium hydroxyd magnesium reduces about 50% of plasma rosuvastatin levels. This effect will decrease when using antacids after Rosuvastatin 2 hours.

erythromycin: simultaneously use rosuvastatin and erythromycin, reducing 20% AUC and 30% CMAX rosuvastatin.

Oral contraceptives/hormone replacement (HRT) replacement therapy: simultaneous use of rosuvastatin and oral contraceptives that increase the AUC of Ethinyl Estradiol is 26% and of Norgestrel is 34%. It should be noted that increasing the concentration of these drugs in plasma when choosing oral oral medication. There is no pharmacokinetic data on patients using rosuvastatin and HRT simultaneously, so it is impossible to rule out the possibility of the same effect.

Other drugs: There is no clinical interaction when used with digoxin.

enamel cytochrom P450: The result from In vitro and in vivo test shows that rosuvastatin is not an inhibitor or cytochrom P450 inhibitor. Moreover, Rosuvastatin is a weak substrate for these isenzymes. This small increase is considered negligible in terms of clinical.

Storage

Store drugs at temperatures below 30 ° C

Stay out of the reach of children.

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