Rosutrox 10mg Biofarm drug treatment for hypercholesterol blood (4 blisters x 7 tablets)

Thận trọng khi sử dụng

Trước khi bắt đầu điều trị với rosuvastatin, cần phải loại trừ các nguyên nhân gây tăng cholesterol máu (thí dụ đái tháo đường kém kiểm soát, thiểu năng giáp, hội chứng thận hư, rối loạn protein máu, bệnh gan tắc mật, do dùng một số thuốc khác, nghiện rượu) và cần định lượng cholesterol toàn phần, LDL-cholesterol, HDL-cholesterol và triglycerid.

Periodic lipid quantification must be conducted, with a distance of less than 4 weeks and adjusting the dosage according to the patient's response to the drug. The goal of treatment is to reduce LDL-Cholesterol so it is necessary to use LDL-cholesterol levels to start treatment and evaluate treatment. Only when LDL-Cholesterol cannot be tested, will the total cholesterol use to monitor treatment.

In clinical trials, a small number of adult patients drink statin see significantly increasing serum transaminase (> 3 normal limits). When stopping the drug in these patients, Transaminase concentration often lowered the level before treatment.

A few of these patients before treatment with statins have abnormal liver function test results and/or drink plenty of alcohol. Therefore, it is necessary to conduct liver enzyme tests before starting statin treatment and in case of clinical indications for testing later. Caution should be used in patients who drink a lot of alcohol and/or have a history of liver disease.

Consider monitoring Creatin Kinase (CK) in the case:

Before treatment, Creatin Kinase (CK) test 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 and/or drinking lots of alcohol, elderly patients (> 70 years old) have physical risks, possibly drugs, and serious risks. special.

In these cases, the benefits/risks should be considered and monitor patients clinically when treated with rosuvastatin. If the CK test is too much> 5 times the upper limit of the normal level, do not start treatment with rosuvastatin.

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

It is necessary to consider when taking rosuvastatin for patients with risk factors leading to muscle damage. Rosuvastatin is at risk of causing harmful reactions to muscle systems such as muscle atrophy, muscleitis, especially for patients with risk factors such as patients over 65 years old, patients with untreated thyroid diseases, patients with kidney disease. Need to closely monitor the harmful reactions during drug use.

Rosuvastatin therapy must be suspended or stop in catching any patient who manifests itself in acute and severe muscle disease or has risk factors prone to acute kidney failure due to muscle pattern, such as severe acute bacterial infection, hypotension, surgery and large injury, abnormalities in metabolism, endocrine, electrolytes or uncontrolled convulsions.

Patients should immediately report to 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 kidneys: The effect on proteinuria, detected by the test strip and the main origin from the renal tubules, has been recorded in patients treated by

high doses of rosuvastatin, especially at 40 mg, 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.

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. Liver function tests are recommended before treatment and 3 months after starting treatment with rosuvastatin. Rosuvastatin should be stopped or reduced if serum transaminase concentration is 3 times the upper limit of normal levels.

In patients with secondary hypercholesteroline hyperglycemia due to thyroid discharge or nephrotic syndrome, these diseases must be treated before starting Rosuvastatin.

Interstitial lung disease: The special case of interstitial lung disease has been reported to some statins, especially when long -term treatment. Manifestations include shortness of breath, dry cough and general health decline (fatigue, weight loss and fever). If there is suspect that the patient has developed interstitial lung disease, it is advisable to stop treating with statin.

Diabetes: Some evidence suggests that statins are a group of drugs that increase blood sugar and in some patients at high risk of future diabetes can cause increased blood sugar levels to the point where they need to officially treat diabetes.

Lactose intolerance: Patients with rare genetic problems are galactose intolerance, Lapp Lactase or Glucose-Galactose

The ability to drive and operate machinery

Caution should be cautious because rosuvastatin can cause unwanted effects: headache, dizziness, blurred vision.

Pregnancy

Rosuvastatin reduces cholesterol synthesis and maybe many other substances with biological activity derived from cholesterol, so the drug can be harmful to the fetus if used for pregnant women. So contraindicated use of rosuvastatin during pregnancy.

The period of breastfeeding

Many statins are distributed into milk. Due to the serious unwanted potential for breastfeeding children, contraindicated use of rosuvastatin in breastfeeding women.

Interactive drug

often experience more muscle and muscle pilot in patients with combination treatment of rosuvastatin with cyclosporin, erythromycin, otraconazole, ketoconazole (due to Cytochrom CYP3A4 inhibitors).

Increased risk of muscle damage when using rosuvastatin simultaneously with drugs: gemfibrozil, other fibrate blood cholesterol medications, high -dose niacin (> 1g/day), colchicin.

Concomitance use of rosuvastatin with HIV and hepatitis C (HCV) (Atazavir, Atazanavir + Ritonavir, Lopinavir + Ritonavir) may increase the risk of muscle damage, the most serious is muscle pattern, kidney damage leading to kidney failure and may cause death. The maximum dose of rosuvastatin is 20 mg/day when used simultaneously with these drugs.

Rosuvastatin may increase the effects of warfarin. Prothrombin must be determined before starting to use statin and regular monitoring in the first stage of treatment to ensure no change in prothrombin time.

Bile acid -mounted resins can significantly reduce Rosuvastatin's bioactivity when taken. So the time to use these 2 drugs must be apart.

Although there is no clinical interaction studies in clinical interaction, there is no clinical interactive manifestation of clinical significance when using statin along with angiotensin enzyme inhibitors, beta blockers, calcium channel blockers, diuretics and nonsteroidal anti -inflammatory drugs.

Ezetimib: simultaneously use 10 mg of rosuvastatin and 10 mg Ezetimib leads to an increase in 1.2 AUC value of rosuvastatin in hypercholesterol patients with blood cholesterol. Can not exclude pharmacological interaction, in terms of adverse effects, between rosuvastatin and ezetimib.

Antacids: Use Rosuvastatin simultaneously with antacids containing aluminum and magnesium hydroxid, reducing about 50% of plasma rosuvastatin levels.

Oral contraceptive pill/hormone replacement therapy (HRT): simultaneous use of rosuvastatin with birth control pills increased by 26% AUC of Ethinyl estradiol and 34% AUC of Norgestrel.