Agirovastin 10 Agimexpharm treatments for hypertonic blood cholesterol (6 blisters x 10 tablets)

Elderly: The starting dose of 5 mg is used for patients> 70 years old. No dose adjustment in these patients.

Patients with renal failure: No dose adjustment in patients with mild to medium renal failure. Patients with moderate renal impairment (Creatinine clearance

Patients with liver failure: The level of body contact with rosuvastatin does not increase in patients with Child-Pugh scores ≤ 7. However, the level of exposure to increased drug has been recorded in patients with Child-Pugh 8 and 9 scores. In these patients, they should consider kidney function assessment. Inexperienced in patients with Child-Pough scores> 9. Contraindicated use Rosuvastatin for patients with liver failure.

Race: In Asian patients, consider the starting dose with rosuvastatin 5 mg/day/day due to increased body contact level with rosuvastatin. The 40 mg dose is contraindicated in this group of patients.

polymorphic gene: Some types of polymorphic genes have been known to increase Rosuvastatin exposure, low starting dose recommended in groups of patients with this polymorphic gene.

Patients with risk factors for muscle disease: The recommended starting dose is 5 mg and contraindicated at the dose of 40 mg.

Used in the treatment of drug combination:

Rosuvastatin is the substrate of many shipping proteins (for example, OATP1B1 and BCRP). The risk of muscle disease (including muscle pepper) increases when used simultaneously with drugs that increase rosuvastatin concentration in plasma due to interaction with transport protein (eg ciclosporin and some protease inhibitors including a combination of ritonavir with Atazanavir, Lopinavir, and/or Tipranavir). If possible, consider alternatives or temporarily stop rosuvastatin if necessary.

In case of compulsory treatment of drug combination, careful consideration between benefits and risks.

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. Should monitor liver function and ck concentration. Blood decomposition may not benefit.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

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.

These risk factors include:

Caution when used

The effect on the kidneys: proteinuria, detected by the test strip and has the main origin from the renal tubules, which has been recorded in patients treated with high doses of rosuvastatin, especially at 40 mg, most of this situation occasionally occurs. Proteinuria is not a warning sign of acute or progressive kidney disease. It is necessary to assess the kidney function during monitoring of patients who have been treated at a dose of 40 mg.

Musculosa effects: The muscle effects such as muscle pain, muscle disease and some rare cases of muscle pattern have been recorded in patients treated rosuvastatin at all doses and especially with the doses of> 20 mg. It is very rare for muscle patterns to be recorded with the use of ezetimib in combination with HMG-CoA Reductase inhibitors. Can not exclude pharmacological interaction and need to be cautious when used combined. As with other HMG-CoA Reductase inhibitors, the reporting rate for muscle pattern is higher than at 40 mg.

measurement of Creatin Kinase concentration: Creatin Kinase (CK) should not be measured after exertion or the presence of a certain Nguyen Nhan can increase CK as this may falsify the results. If the CK concentration increases significantly before treatment (> 5xuln), the test should be performed to redefine within 5-7 days. If the test is repeated to determine the CK level before treatment is still greater than 5xuln, it is not advisable to start treatment with rosuvastatin.

Before treatment: Like with HMG-Coa Reductase inhibitors, rosuvastatin should be carefully indicated in patients with risk factors that can lead to muscle damage, muscle muscle disease, risk factors including:

In these cases, it is necessary to remind the benefits/risks and monitor patients clinically when treated with statin. If CK test results> 5xuln, do not start statin treatment.

During treatment: should ask the patient to immediately report to the doctor the phenomenon of muscle pain, stiffness, muscle weakness or non -explanation, especially if accompanied by fatigue, fever, dark urine, nausea or vomiting during the use of the drug. When there are these manifestations, patients need to test CK to take appropriate interventions. Rosuvastatin should be discontinued if CK concentration increases significantly (> 5xuln) or severe muscle symptoms and daily discomfort (even if CKS5xuln concentration). If these symptoms are no more and the CK concentration returns to normal levels, it is advisable to considering the reuse of rosuvastatin or using another HMG-CoA Reductase inhibitor at the lowest dose and closely monitoring. Periodic monitoring of CK concentrations in patients with no symptoms do not guarantee muscle disease detection. There have been very rare reports on muscle necrotic disease due to immunity (IMNM) during or after statin treatment, including rosuvastatin. IMNM has clinical characteristics that are close muscle weakness and increased serum creatine kinase, which may still exist despite being stopped with statin.

In clinical trials, there is no evidence of the influence on the skeletal muscle system increased in the few patients treated with rosuvastatin simultaneously with other drugs. However, the increase in the rate of muscle and muscular inflammation has been known in patients using HMG-CAA Reductase inhibitors along with fibric acid derivatives including gemfibrozil, ciclosporin, nicotinic acid, Azol antifungal, protease inhibitors and macrolid antibiotics. Gemfibrozil increases the risk of muscle disease when used simultaneously with some HMG-CoA Reductase inhibitors. Therefore, it should not be used in combination with rosuvastatin and gemfibrozil. Benefits on lipid concentration using rosvastatin combination with fibrat or niacin should be carefully considered to the potential risks of those combinations. Contraindications to simultaneously with fibrat at 40 mg.

Rosuvastatin is not used with drugs containing fusidic acid or within 7 days after stopping treatment with fusidic acid. In patients using fusidic acid -acting, it is recommended to stop treating with statin during treatment. There have been reports on Co Van Tieu Van (including a number of deaths) in patients with fusidic acid and combined statin. Patients need to find medical advice immediately if they experience any muscle weakness, pain or sensitivity. Statin therapy can be reused after 7 days from the last dose of fusidic acid. In exceptional cases, long -term use of fusidic acid, for example, to treat severe infections, bravely and rosuvastatin and fusidic acid should only be considered on the basis of each case and under tight medical supervision.

Do not use rosuvastatin for patients with acute serious condition, suspicion of muscle disease or can lead to secondary renal failure due to muscle pepper (such as blood infection, hypotension, surgery, trauma, electrolyte disorders, endocrine and severe conveys, or uncontrolled convulsions).

Effects on the liver: is like other HMG-CoA Reductase inhibitors, need to be cautious when using rosuvastatin in patients with severe alcoholism 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 discontinued if the serum transaminase concentration increases 3 times the upper limit of normal levels. Some reports show that 40 mg dose increases the risk of increased liver transaminase.

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

Race: Pharmacokinetic studies show that there is an increase in the level of exposure to drugs in Asian patients compared to white people.

Protease inhibitors: Concomitance the statin lipid medications with protease inhibitors to treat HIV and hepatitis C (HCV) may increase the risk of muscle damage, the most serious is the muscle and muscle. Kidney damage is the consequence of pattern, which can lead to renal failure and death. Do not recommend using with protease inhibitors.

Interstitial lung disease:

Special cases of interstitial lung disease have been reported to some statins, especially long -term treatment. The manifestations include shortness of breath, they are anhydrous and impaired health (fatigue, weight loss and fever). If the patient is suspected of developing interstitial lung disease, statin should be stopped.

diabetes:

Some evidence suggests that the statin increases blood sugar, in some patients at high risk of future diabetes, they need appropriate care. However, this risk is not worrying compared to reducing the risk of blood vessels using statin and is not a reason to stop treating statin. Patients with risk (fast blood sugar test 5.6 - 6.9 mmol/l, BMI> 30 kg/m2, increased triglycerides, hypertension) should be monitored both clinically and biochemical under national instructions.

Use on children:

The assessment of linear growth (height), weight, BMI (body block index) and secondary characteristics of sexual maturity based on tanner classification in children from 6 to 17 years old using Rosuvastatin are limited to a period of two years. After two years of research, no effect on growth, weight, BMI or sexual maturity were discovered.

In a clinical trial in children and teenagers using rosuvastatin for 52 weeks, more noticeable than the increase of CK> 10xuln and muscle symptoms after exercise or physical activity compared to observation in adult clinical tests.

This drug contains lactose: Patients with rare genetic problems in tolerance Galactose, Lapp lactase or glucose-Galactose are not used by this drug.

Use drugs for women during pregnancy and lactation

Pregnant women: Contraindicated Rosuvastatin during pregnancy. Women are likely to be pregnant, so they should use appropriate contraception. Because cholesterol and other cholesterol biosynthesis are necessary for fetal development, the potential risk due to HMG-COA Reductase inhibitors will dominate the benefits of Rosuvastatin treatment during pregnancy. Animal studies show that there are evidence of limited toxicity on the reproductive system. If the patient is pregnant during Rosuvastatin treatment, he/she must stop the drug immediately.

breastfeeding women: Contraindicated rosuvastatin during the time for children. In mice, rosuvastatin excreted in milk. There is no corresponding data on human excretion.

The effect of the drug on driving, operating machinery

There is no evidence of the effect of the drug on the ability to drive and operate machinery. However, when driving or operating the machine, it should be noted that dizziness may occur during treatment.

Drug interaction

The effect of simultaneous medications on rosuvastatin:

Transport protein inhibitors: Rosuvastatin is the substrate of some transport proteins including the absorption substances in the OATP1B1 liver and the transportation outside the BCRP. Simultaneous use of rosuvastatin with inhibitors of these transport proteins increases plasma Rosuvastatin concentrations, resulting in an increased risk of muscle disease.

ciclosporin: During the treatment process simultaneously with ciclosporin, the AUC value of rosuvastatin averages 7 times higher than in healthy volunteers, does not affect the plasma concentration of ciclosporin. Rosuvastatin is contraindicated in patients using ciclosporin.

Protease inhibitors: Although the interactive mechanism is not well known, this combination may increase the contact with rosuvastatin. In a pharmacokinetic study, simultaneously used 10 mg of Rosuvastatin with 300 mg Atazanavir and 100 mg of Ritonavir in healthy volunteers can increase the AUC of Rosuvastatin to 3 times and increase CMAX to 7 times. The considering the combination after careful consideration of adjusting the dose of rosuvastatin is based on the expected increase level.

gemfibrozil and other lipid remedies: simultaneously use with rosuvastatin to increase the AUC and CMAX of rosuvastatin twice. Based on data from specific interactive studies, there is no related interaction with fenofibrat, however, pharmacological interaction may occur. Gemfibrozil, Fenofibrat, other fibrats and niacin (nicotinic acid) at the dose of lipid (> or equal to 1 g/day) increase the risk of muscle disease when used simultaneously with HMG-COA Reductase inhibitors, maybe because they can lead to muscle diseases when being given alone. The 40 mg dose is contraindicated with simultaneous use with fibrat. These patients should start at a dose of 5 mg.

Ezetimib: simultaneously use 10 mg of rosuvastatin and 10 mg of ezetimib, resulting in 1.2 times the 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: simultaneously use rosuvastatin at recommended doses with aluminum anti -aluminum and Magnesi Hydroxyd containers, leading to reduced rosomastatin levels in plasma by about 50%. This effect has been slightly reduced when antacids are used after taking rosuvastatin about 2 hours. The clinical involvement of this interaction has not been studied.

erythromycin: simultaneously use rosuvastatin and erythromycin, resulting in a 20% reduction of AUC value and 30% reduction of C. rosvastatin value. The cause of this interaction may be due to an increase in the peristalsis of the tree by erythromycin.

Cytochrom P450 enzyme: Results from in vitro and in vivo studies show that Rosuvastatin is not a inhibitor or an enzyme -induced substance Cytochrom P450. In addition, Rosuvastatin is a weak substrate for these isenzymes. Therefore, there is no drug interaction due to intermediate metabolism through Cytochrom P450. There is no clinical related interaction between rosuvastatin and fluconazole (CYP2C9 and CYP3A4 inhibitors) or with ketoconazole (CYP2A6 and CYP3A4 inhibitors).

Interactions need to adjust the dose of rosuvastatin: When it is necessary to treat rosuvastatin with other drug products known to increase exposure to Rosuvastatin, Rosuvastatin dose is needed. Start at a dose of 5 mg once a day, if the expected exposure (AUC) is about 2 times or higher. Rosuvastatin's maximum daily dose should be adjusted to not pass 40 mg daily without interacting with drug products, for example, a 20 mg dose of Rosuvastatin with Gemfibrozil (an increase of 1.9 times) and a dose of 10 mg Rosvastatin with Ritonavir/Atazanavir (3 -fold increase).

The effect of rosuvastatin on simultaneous medications:

Vitamin K antagonists: As well as other HMG-COA transfer inhibitors, the beginning of the treatment or adjustment of rosuvastatin dose in patients treated simultaneously with vitamin K anti-vitamin (warfarin or other Coumarin anticoagulants) can lead to an increase in international standardized ratio (INR). The stop or decrease of the dose of rosuvastatin may reduce the INR. In such situations, the appropriate Inr monitoring is essential.

Oral contraceptive replacement therapy (HRT): simultaneous use of rosuvastatin and oral contraceptives, leading to an increase in Ethinyl estradiol and Norgestrel AUC, both 26% and 34%. Increased plasma drug concentration should be considered when choosing oral contraceptives. There is no pharmacokinetic data in subjects using rosuvastatin and HRT simultaneously and therefore cannot be excluded the same effect. However, this combination is widely used in women in clinical trials and well tolerated.

Other drug products:

Digoxin: Based on data from specific interactive studies, there is no clinical interaction related to digoxin.

Fusidic acid: Interactive studies with rosuvastatin and fusidic acid have not been conducted. The risk of muscle disease includes muscle pattern may be increased by simultaneously using the whole body fusidic acid to the statin. The mechanism of this interaction (whether it is pharmacokinetics or pharmacokinetics, or both) is not known. There has been a report on Tieu Co Van (including some deaths) in this combination patient.

If treated with all -body fusidic acid is necessary, Rosuvastatin treatment should be stopped during the treatment period of fusidic acid.

Children: Interactive research is only done in adults. The level of interaction in the child's population is not known.

The cavalry of the drug:

Due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.