Rosuvastatin Stella 20mg medicine for hypercholesteroline blood cholesterol (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Rosuvastatin

Ingredient

Composition information	Content
Rosuvastatin	20mg

Uses

indications

Rosuvastatin drugs are indicated in the following cases:

Reduce LDL-cholesterol, apolipoprotein B, triglycerides and increase HDL cholesterol in cases of hyperlipidemia, including primary cholesterol hypercacting (type IIA), mixed lipid disorders (type IIB) and hyperliglycerides (type IV).

Rosuvastatin is used for patients with hypercolular hypercholesterol in homozygous families.

Prevention of cardiovascular events in patients is considered to be at high risk of cardiovascular events for the first time, as a measure to help adjust other risk factors.

Pharmacokic

rosuvastatin selectively inhibits HMG-CoA Reductase competition, is the enzyme that catalyzes 3-hydroxy -3-methylutaryl coenzyme A into Meevalonate, a precursor of cholesterol. The action position of rosuvastatin is the liver, the target organs reduce cholesterol. Rosuvastatin increases the number of LDL receptors on the surface of liver cells, which increases the absorption and catabolism of LDL, inhibits the synthesis of VLDL in the liver, thus reducing VLDL and LDL components.

Rosuvastatin reduces total cholesterol, LDL cholesterol, Apolipoprotein B and total cholesterol without HDL cholesterol in patients with hypercholesteroline hyperplasia patients with homosexuality and heterozygous (FH), non -family hypermens and mixed blood lipid disorders. Rosuvastatin also reduces triglycerides and increases HDL cholesterol.

Dynamic pharmacokinetics

absorption: Rosuvastatin absorbs incomplete through the digestive tract, bioavailability of about 20%. Plasma concentration in plasma is about 5 hours after taking medicine.

Distribution: The drug is widely distributed in the liver, the first position works. Drugs associated with plasma protein about 90%

Metabolism: The drug undergo a limited metabolism, mainly by Cytochrom P450 ISOENZYM CYP2C9.

Elimination: Rosuvastatin's sale time is about 19 hours. About 90% of the dose of rosuvastatin are eliminated in the feces, including absorbed drugs and non -absorbed drugs, the rest is excreted through urine, about 5% of the dosage excreted in the form of unchanged urine.

Before taking Rosuvastatin Stella 20mg medicine for hypercholesteroline blood cholesterol (3 blisters x 10 tablets)

How to use

rosuvastatin is used by oral, used 1 time/day at any time in this, with or not with meals.

Patients should follow a standard low -cholesterol diet before using rosuvastatin and should continue this diet during medication.

Dosage can be carefully adjusted based on the needs and response of the patient, increasing the dose of each other no less than 4 weeks apart.

Dosage

The usual initial dose of rosuvastatin is 5 or 10 mg x 1 time/ day, depending on plasma cholesterol levels, cardiovascular risk factors and unwanted risk factors. If necessary, the dose can increase every 4 weeks/ time to the maximum dose of 20 mg/ time/ day.

The dose of 40 mg/ time/ day can be used under the supervision of medical staff in the case of serious high blood cholesterol patients.

Elderly patients, Asian patients are at risk of muscle disease, should start the starting dose of 5 mg. Patients with ciclosporin should take a maximum dose of 5 mg/ time/ day and in patients with Gemfibrozil or Ritonavir-Boosted Lopinavir a maximum dose of 10 mg/ time/ day.

Patients with significant hypercholesterolemia such as homozygous hypercholesterol patients can start at a dose of 20 mg/ time/ day.

Patients with renal failure (creatinine clearance from 30 to 60 ml/ minute). Should start at a dose of 5 mg/ day/ day and a maximum dose of 20 mg/ day/ day.

Combined with Atazanavir, Atazanavir / Ritonavir and Lopinavir / Ritonavir: Rosder Rosuvastatin dose maximum 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 do

do when overdose? In case of overdose, conduct symptom treatment and use the necessary support measures. Monitor liver function and creatin kinase level. The hemorrhage is not necessarily effective.

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 Rosuvastatin, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Endocrine: Diabetes, hyperglycemia, HBA1C. Mix ...)

Uncommon, 1/1000

Skin and subcutaneous tissue: itching, rash and urticaria.

Rare 1/10000≤ ADR

Immune: Hypersensitivity reactions including angioedema.

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

Rosuvastatin drugs contraindicated in the following cases:

Patients with hypersensitivity to any ingredients of the drug. muscle.

Be cautious when used

The harmful reaction of the drug should be closely monitored, especially the reaction that is harmful to the muscle system.

Consider monitoring creatinin (CK) in the case:

Before treatment: CK test used when patients with impaired renal function, hypothyroidism, history of themselves or families suffer from genetic muscle disorders, history of muscle poisoning due to the use of statin or previous fibrat, a history of liver disease or drinking a lot of alcohol, elderly patients (> 70 years old) have risk factors for muscle pattern, the possibility of drug interactions and some special subjects. These cases should consider benefits and risks, clinical monitoring when using statin. If CK tests> 5 times on normal limits, do not start statin treatment.

During treatment: Patients need to notify the doctor when there are muscle appearance such as muscle pain, stiff muscle, muscle weakness ... When this manifestation is needed to do CK test to take appropriate interventions.

Affects on skeletal muscles:

Mechanical award usually occurs when using 40 mg/ day than at a low dose. Stop using rosuvastatin if the concentration of creatinine kinase has increased significantly or if diagnosed or suspected of muscle disease.

Due to the risk of muscle disease, it is necessary to be cautious in patients over 65 years old, patients with uncontrolled thyroid defects, patients with kidney disease. Need to monitor the harmful reactions of the drug during treatment and notify the doctor as soon as there are signs or symptoms of muscle pain, fatigue, fever, dark urine, nausea or vomiting during the use of the drug.

affect the liver:

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

Affect the kidneys:

transient proteinuria and micronutrients in patients using rosuvastatin. The dose should be considered when the patient is 40 mg/ day, the proteinuria is unknown when the urine test is normal.

Asians:

Pharmacokinetics shows an increase in the level of contact of rosuvastatin approximately twice in Asian patients compared to Cable-Ca patients, which should be considered in Asian patients.

Simultaneous use of statins with HIV, hepatitis C (HCV)

Increased risk of muscle damage, the most serious is muscle pattern, kidney damage leads to kidney failure, which can be fatal.

The ability to drive and operate machinery

has not been recorded. However, based on the pharmaceutical properties, Rosuvastatin cannot affect this ability. When driving or operating machinery, note may occur dizzy during treatment.

Pregnancy

Contraindications because:

Cholesterol and other cholesterol biosynthesis products are necessary for the development of the fetus, the potential risk due to HMG-CAA Reductase inhibitors will be higher than the effectiveness of treatment during pregnancy. Should stop the drug as soon as pregnancy.

Breastfeeding period

rosuvastatin excreted through mouse milk, no data on excretion through breast milk. However, the drug is not used for breastfeeding women.

Drug interaction

ciclosporin: AUC of rosuvastatin increases average 7 times higher.

Vitamin K antagonists ( warfarin or other anticoagulants): may increase the value of international normalization of Inr, which should be monitored.

Ezetimib : Pharmacological interaction and unwanted effects are not excluded unless combined.

Gemfibrozil: Double the CMAX and AUC index of Rosuvastatin. Anti -thread -using 40 mg of rosuvastatin when used with fibrat, should start 5 mg. Increased risk of muscle damage when used with gemfibrozil , other fibrats, niacin> 1g/day, colchicin.

HIV Protease inhibitors: Increasing RosuVastatin levels to 3 times, the maximum dose limit of Rosuvastatin 10 mg/ day.

Antimmin medications: reducing the level of rosuvastatin in plasma.

erythromycin: reducing 20% AUC and 30% cmax of rosuvastatin.

Oral contraceptives/ hormone replacement therapy (HRT): Increasing the AUC of Ethinyl Estradiol and 34% AUC of Norgestrel.

Storage

Store in closed packaging, dry place. The temperature does not exceed 30ºC.

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