Rossuwell 10 Agio medicine for hypercholesterolemia (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Rosuvastatin

Ingredient

Composition information	Content
Rosuvastatin	10mg

Uses

Indications

Rossuwell 10 are indicated in the following cases:

Treatment of primary blood cholesterol and mixed blood lipid disorders do not respond to diets. Reductase, which inhibits the metabolism of 3-hydroxy-3-methylglutaryl coenzyme A into Mevalonate, a precursor of cholesterol.

Rosuvastatin works mainly in the liver, target organs to reduce cholesterol. Rosuvastatin increases the number of LDL receptors on the surface of liver cells, increases catabolism and absorbs LDL and inhibits the synthesis of VLDL in the liver, thus reducing the number of VLDL and LDL.

Pharmacokinetics

absorption

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

Distribution

Rosuvastatin is distributed mainly in the liver, which is the main organ that synthesizes cholesterol and clearance of LDL-C. The distribution of rosuvastatin is about 134 l. About 90% of rosuvastatin binds to plasma proteins, mainly albumin.

Metabolism

About 10% of Rosuvastatin is metabolized. Studies on Invitro use human liver cells that RosuVastatin is a weak substrate in the metabolism through cytochrome P450. CYP2C9 is the main isenzyme involved in the transformation process, 2C19, 3A4 and 2D6 participating at a lower level.

Elimination

About 90% of rosuvastatin is eliminated in feces in a constant form (including the amount of active ingredients absorbed and not absorbed), the remaining amount is excreted in the urine.

Effect of racial factors

According to the pharmacokinetics research in the US in Asians, Rosuvastatin's AUC and CMAX values in Asians are twice the average of whites. Therefore, the starting dose of 5 mg of rosuvastatin should be used and contraindicated 40 mg of Rosuvastatin for Asians.

Before taking Rossuwell 10 Agio medicine for hypercholesterolemia (3 blisters x 10 tablets)

How to use

oral medication.

Dosage

The recommended starting dose is 5 mg or 10 mg of rosuvastatin orally once a day, and most of the disease is controlled at the starting dose. If necessary, the dose can be increased to 20 mg of rosuvastatin after 4 weeks. Only increased the dose to 40 mg of rosuvastatin for patients with severe hypercholesteroline blood cholesterol and high risk of cardiovascular disease.

Asian patients: The recommended starting dose is 5 mg and contraindicated at 40 mg.

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. In case of overdose, symptomatic treatment and supportive measures when necessary. Need to monitor liver function and ck concentration. Hemorrhage is not 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. Do not drink twice as prescribed.

Side Effects

Unwanted effects (ADR) when using Rossuwell 10 that you may encounter:

Common, ADR> 1/100

Neurology: headache, dizziness.

Digestive: constipation, nausea, abdominal pain.

Muscle, connective tissue: muscle pain.

The whole body and at the position of using the drug: weakness.

Uncommon, 1/1000

Skin and subcutaneous tissue: itching, rash and urticaria.

Rare, 1/10000

Immune: Hypersensitivity reactions including angels.

Bone muscle, connective tissue: muscle disease, muscle pilot.

Unknown frequency

Kidney - urinary: proteinuria.

Liver: Increase liver enzymes.

Other: Cognitive decline (such as memory loss, confusion ...), hyperglycemia, HBA1C.

Instructions on how to handle ADR

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

Contraindicated

Rossuwell 10 Contraindications used in the following cases:

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

Patients with progressive liver disease include increased serum transaminase concentration and unknown cause, and serum transaminase concentration increases more than 3 upper limits of normal levels (ULN).

Patients with severe renal failure (Creatinine clearance

Patients with muscle disease.

Patients who are taking cyclosporin.

Caution when using

impact on the kidneys

proteinuria is detected by the test strip and mainly derived from the renal tubules recorded in patients treated with high doses of rosuvastatin, especially at 40 mg of rosuvastatin. Proteinuria is not a sign of acute or progressive kidney disease.

Need to evaluate kidney function regularly during the time the patient is used 40 mg of rosuvastatin.

Impact on muscle - bone

Like other HMG-CoA Reductase inhibitors, muscle pain and muscle pain have been reported in patients treated with rosuvastatin.

Measuring the concentration of Creatin Kinase (CK): 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 wearing genetic diseases, a history of muscle disease due to the use of statin or fibrat before, the history of liver disease and/or drinking lots of alcohol, elderly patients (> 70 years old) have muscular risk factors. The possibility of drug interactions and some special patients. In these cases, the benefits/risks should be considered and monitor patients clinically when treated with rosuvastatin. If CK test results> 5 times the upper limit of normal levels, do not start treatment with rosuvastatin.

During RosuVastatin treatment, patients need to notify when there are muscle manifestations such as muscle pain, stiff muscle, muscle weakness ... When there are these manifestations, patients need to test CK to take appropriate interventions.

impact on the liver

Like other HMG-COA Reductase inhibitors, caution should be used when using rosuvastatin for patients with severe alcoholism, and/or a history of liver disease. The liver enzyme test should be conducted before starting treatment with rosuvastatin and in the case of clinical indications for testing later.

If serum transaminase concentration is 3 times the upper limit of normal levels, it is necessary to stop or reduce the dose of rosuvastatin. In patients with secondary hypercholesterolemia due to hypothyroidism or nephritis syndrome, conducting treatment before starting rosuvastatin.

The ability to drive and operate machinery

may occur dizziness, dizziness when driving or operating machinery.

Pregnancy

Rosuvastatin is contraindicated for pregnant women. If a patient is found pregnant during RosuVastatin treatment, it is necessary to stop taking the drug immediately.

breastfeeding period

rosuvastatin is contraindicated for breastfeeding women. No data shows rosuvastatin excreted in breast milk.

Drug interaction

cyclosporin

When simultaneously treated rosuvastatin and cyclosporin, the AUC value of rosuvastatin above the average 7 times higher than the AUC value is monitored in healthy volunteers. Simultaneous use of rosuvastatin and cyclosporin does not affect plasma cyclosporine levels.

Vitamin K anti -Vitamins

Similar to other HMG-CoA Reductase inhibitors, when starting to treat or increase the dose of rosuvastatin in patients with simultaneous use with vitamin K anti-vitamin drugs (such as Warfarin) can increase the INR value. Discontinuing or reducing the dose of rosuvastatin may reduce the Inr value. In this case, it is necessary to monitor the value of INR.

gemfibrozil

Like other HMG-COA Reductase inhibitors, simultaneously use rosuvastatin and gemfibrozil to increase the value of CMAX and AUC of rosuvastatin twice.

antacids

Simultaneously use Rosuvastatin along with aluminum antacids and Magnesi Hydroxyd, reducing about 50% of plasma rosuvastatin levels.

erythromycin

Simultaneously use rosuvastatin and erythromycin, reducing 20% of AUC and 30% CMAX concentration of rosuvastatin. Drug interaction may be due to erythromycin that increases bowel motility.

Oral contraceptive drugs for hormone replacement therapy (HRT)

Simultaneous use of rosuvastatin and oral contraceptives that increases 26% AUC of ethinyl oestradiol and 34% AUC of Norgestrel. It should be noted that the level of concentration of these substances in plasma when choosing contraceptives.

Simultaneous use of statin lipid medications with HIV and hepatitis C (HCV) hepatitis

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

The dose of rosuvastatin should not exceed 10 mg/day/day when used simultaneously with protease inhibitors of HIV and HCV (including: Atazanavir, Atazanavir and Ritonavir, Lopinavir and Ritonavir).

Storage

Store in a dry place, avoid light, temperature below 30 ° C.

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