Rosuvastatin Stella 10mg 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	10mg

Uses

Indications

Rosuvastatin Stella 10mg medicine is indicated in the following cases:

Reduction of LDL cholesterol, apolipoprotein B, triglycerides and increased HDL cholesterol in cases of hyperlipidemia, including primary blood cholesterol (type IIA), mixed lipid disorders (type IIB) and hyper triglycerides (type IV).

Patient treatment hypercholesteroline blood cholesterol in a homozygous family.

Pharmacology

Rosuvastatin is a selective and competitive inhibitor HMG-COA Reductase, is the 3-hydroxy-3-methylutaryl coenzyme transition process, a precursor of cholesterol. The main action position of rosuvasatatin is the liver, the target organs reduce cholesterol. Rosuvastatin increases the number of LDL receptors on the surface of liver cells, thus increasing the absorption and catabolism of LDL and inhibiting VLDL synthesis 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.

pharmacokinetics

absorption:

Rosuvastatin is incomplete absorption through the gastrointestinal tract with about 20%. Peak concentration in plasma is about 5 hours after drinking.

Distribution - Metabolism:

The drug is widely distributed in the liver, where the first place works, and undergo metabolism is limited, mainly by Cytochrom P450 Isoenzyme CYP2C9. The drug is associated with plasma protein about 90%.

Era:

Rosuvastatin's semi -exhaust time is about 19 hours. About 90% of the dose of rosuvastatin is deducted in the feces, including the absorbed and non -absorbed part, the rest is excreted in the urine; About 5% of the dose is eliminated in the form of unchanged urine.

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

How to use

rosuvastatin stella 10mg is used by oral, with single doses at any time of the day, with or without food.

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 each patient by increasing the dose each spaced no less than 4 weeks. The harmful reaction of the drug should be closely monitored, especially the harmful reactions to the muscle system.

Dosage

The normal initial dose is 5 - 10 mg x 1 time/day, depending on plasma cholesterol levels, cardiovascular risk factors and risk factors that cause unwanted effects. If necessary, the dose can be increased every 4 weeks, to the maximum dose of usually 20 mg x 1 time/day. The dose of 40 mg x 1 time/day can be used under the supervision of experts in the case of severe patients with severe blood cholesterol.

Elderly patients, Asian patients and patients at risk of muscle disease should have a starting dose of 5 mg. Patients using Ciclosporine may take a maximum dose of 5 mg x 1 time/day, and in patients with Gemifibrozil or Ritonavir-Boosted Lopinavir, the maximum dose is 10 mg x 1 time/day.

Patients with blood cholesterol hyperkematoma, such as patients with homozygous blood cholesterol, can start at a dose of 20 mg x 1 time/day.

Patients with renal failure (creatinine clearance from 30 to 60 mlm/min): should start at a dose of 5 mg x 1 time/day and a maximum dose of 20 mg x 1/day.

Combined with Atazanavir, Atazanavir/ Ritonavir and Lopinnavir/ Ritonavir: Limit the dose of rosuvastatin maximum 10 mg x 1 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 forgetting 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 Rosuvastatin Stella 10mg , you may experience unwanted effects (ADR).

Common, ADR> 1/100

Endocrine: diabetes , hypertension, HBA1C. Mix ...)

Uncommon, 1/1000

Skin and subcutaneous tissue: itching, rash and urticaria .

Rare, 1/10000

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 Stella 10mg medicine contraindicated in the following cases:

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

Caution when using

Consider monitoring Creatin Kinase (CK) In the case of: impaired renal function, hypothyroidism, self -history or history of family disorders in genetic disorders, a history of poisoning due to statin or fibrat before, a history of liver disease and/or drinking alcohol, elderly patients (> 70 years old) Some special patients. 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 the doctor when there are muscle manifestations such as muscle pain, stiffness, muscle weakness ... When these manifestations, patients need to test CK to take appropriate interventions.

Muscle effects: Mechanical awards often occur in patients using rosuvastatin at a dose of 40 mg/day compared to low doses. Stop using rosuvastatin if the serum creatin concentration increases significantly or if diagnosed or suspected to have muscle disease. Kidney should be needed while patients over 65 years old, patients with thyroid diseases are not controlled, patients with kidney disease. Patients should immediately notify the doctor to treat signs or symptoms of muscle pain, fatigue, fever, dark urine, nausea or vomiting during the use of the drug.

Effects on the liver: do liver enzyme test before starting statin treatment and in case of clinical indications for testing later.

Effects on the kidneys: Consider to reduce the dose in patients using 40 mg/day with long -term proteinuria of unknown causes when testing for regular urine.

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

Rosuvastatin Stella 10mg contains lactose excipients. This drug should not be used for patients with rare genetic problems galactose intolerance, total lactase enzyme deficiency or poorly absorbent glucose-galactose.

The ability to drive and operate machinery

studies to determine the effect of rosuvastatin on driving and operating machinery has not been done. However, based on the pharmaceutical properties, Rosuvastatin cannot affect this ability. When driving or operating machinery, note that it may occur dizzy during treatment.

Pregnancy

Contraindications. Because cholesterol and other cholesterol biosynthesis products are essential for the development of the fetus, the potential risk due to HMG-CoA Reductase inhibitors will be higher than the treatment effect during pregnancy.

Breastfeeding period

Contraindications. Rosuvastatin is excreted through milk in mice. There is no data on human excretion.

Drug interaction

ciclosporin: simultaneous use of ciclosporin and rosuvastatin, AUC of rosuvastatin increases average 7 times higher but the ciclosporin concentration in plasma is 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 anticoagulant drugs) can increase international normal chemical value (INR). Stopping or reducing the dose of rosuvastatin may reduce INR.

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

Gemfibrozil and other blood lipid medications: simultaneously use rosuvastatin and gemfibrozil, 2 times the AUC and CMAX indicators of Rosuvastatin. Contraindications for 40 mg when combined with Fibrat.

HIV Protease inhibitors (Atazanavir, Atazanavir/ Ritonavir and Lopinnavir / Ritonavir) when combined with Rosuvastatin increase Rosuvastatin concentration 3 times.

antacids: Concomitance antacids with rosuvastatin reduces 20% AUC and 30% cmax of rosuvastatin.

Oral contraceptives/hormone replacement (HRT) replacement therapy (HRT): simultaneously use rosuvastatin and oral contraceptives that increase 26% AUC of Ethinyl Estradiol and 34% AUC of Norgestrel.

Cytochrome P450 enzyme: The result from In vitro and in vivo test shows that RosuVastatin is not an inhibitor or cytochrome p450 inhibitor. Moreover, Rosuvastatin is a weak substrate for these isenzymes. This small increase is considered negligible in terms of clinical.

Storage

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

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