Autifan 20 An Thien treats lipid disorders (3 blisters x 10 tablets)

Immune system: Anaphylaxis.

Nervous system: Perception, loss of sensation, reduced sensitivity. blood vessel: vasculitis.

Pregnant and lactating women.

Caution when using

It is necessary to consider when taking drugs in the statin group for patients with risk factors leading to muscle damage. The drug in the statin group is at risk of causing harmful reactions to the muscle system such as muscle atrophy, especially for patients with risk factors such as patients over 65 years old, patients with untrained thyroid diseases, patients with kidney disease, closely monitoring harmful reactions during the use of drugs.

impact on liver function

Cases of liver function impairment can be fatal when using statins including fluvastatin that have been reported. Although the causal relationship with Fluvastatin treatment has not been determined, patients need advice to report any symptoms or signs of liver failure (such as vomiting, nausea, anorexia, jaundice, brain function decreased, prone to bruising or bleeding) and when the above symptoms should be considered to stop treatment.

Recommended the liver enzyme test before starting statin treatment and in case of clinical indications for testing later. If aspartat aminotransferase (AST) or alanin aminotransferase (ALT) increases more than 3 times the upper limit of normal and prolonged level, it is necessary to stop using fluvastatin. The case is very rare for drugs due to drugs that have been observed and removed after stopping treatment with fluvastatin.

Be careful when using fluvastatin in patients with a history of liver or alcoholism.

Acting on muscle - bone

can cause muscle pain, muscle disease and very rare cases of muscle pattern in patients treated with fluvastatin. In patients with unexplained muscle pain, muscle or muscle weakness, or the increased creatin of Kinase (CK), muscle disease, muscle inflammation or muscle pattern must be considered. Therefore, patients need advice to promptly report the muscle pain of unknown causes, muscle pain or weak muscle, especially if it comes with discomfort or fever.

There have been very rare reports of muscle necrosis through the immunity (IMNM) during or after treatment with some statin drugs. The clinical feature of IMNM is the prolonged weakened speculation and the high levels of creatin kinase, which still exists when stopping statin treatment.

measure the concentration of creatin kinase (ck)

Do not measure the concentration of CK after exertion or the presence of a certain cause increases the CK because this may falsify the results. If CK concentration before treatment> 5 times the upper limit of normal level (ULN) should not start treatment with rosuvastatin.

Consider monitoring Creatin Kinase (CK) in the case of

Before treatment, CK tests 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 the use of statin or fibrat before, a history of liver disease or drinking a lot of alcohol, elderly patients (> 70 years old) with risk factors for muscle pattern, drug -related ability and some special patients. In these cases, the benefits/risks should be considered and monitor patients clinically when treated with statin. If the CK concentration increases> 5 times the upper limit of the normal level, it is necessary to measure within 5-7 days to confirm the results. If the test results CK> 5 times the upper limit of the normal level, do not start treatment with statin.

During statin treatment, patients need to notify when there are muscle manifestations such as muscle pain, stiffness, muscle weakness, cramps ... When there are these manifestations, patients need to test CK to take appropriate interventions. If CK> 5 x ULN concentration, Fluvastatin should be discontinued. If there are serious and daily -causing symptoms, even if the concentration of CK

The risk of muscle disease in patients using immunosuppressants (including ciclosporin), fibrat, nicotinic acid or erythromycin simultaneously with HMG - CoA Reductase inhibitors. The case of muscle disease is reported after concurrent fluvastatin with ciclosporin or colchicin. Fluvastatin should be used carefully in patients in combination with the above drugs.

Fluvastatin is not used simultaneously Fusidic acid uses systemic sugar or within 7 days after stopping treatment with fusidic acid. In patients with mandatory fusidic acid system, Statin treatment should be discontinued during treatment with fusidic acid. There have been reports on muscle disease (including some deaths) in patients using simultaneously fusidic acid and statin. Patients need advice to promptly report to health workers if they experience any symptoms of muscle weakness, muscle pain.

Statin therapy is used after 7 days after the last dose of fusidic acid. In special cases, when it is necessary to use long body fusidic acid, for example, to treat severe bacterial infections, if it is necessary to use fluvastatin, it is necessary to consider each case and under tight medical supervision.

Patients with interstitial lung disease

If using fluvastatin, especially long -term use, can suffer from interstitial lung disease with symptoms of dyspnea, dry cough, general health decline (fatigue, weight loss, fever). If the patient is found to develop interstitial lung disease, statin is discontinued.

Patients with diabetes

Some evidence suggests that statin increases blood glucose and increases the risk of diabetes. However, this risk is not significant compared to reducing the cardiovascular risk of statin, so it is not the reason to stop treating statin. For patients with high risk such as 5.6 to 6.9mmol/l, BMI ≥ 30kg/m2, increased triglycerides, hypertension needs to monitor both biochemistry and clinical.

Children

Children and adolescents with hypertension family blood cholesterol

In patients aged

Fluvastatin is only studied in children 9 years old and older with hyperlested hyperplastic hyperplation. In the case of children before puberty, experience is very limited in this group, the risks and benefits should be carefully assessed before starting treatment.

Hypersensitivity to homozygous family type

There is no data on the use of fluvastatin in patients with hyperlested hypertension.

The ability to drive and operate machinery

Some unwanted effects such as headache, insomnia may occur, if affected by patients should not drive a train, operate machinery or work on high.

Pregnancy

There is not enough data on the use of fluvastatin during pregnancy. HMG - CoA Reductase inhibitors reduce cholesterol synthesis and may reduce biological substances derived from cholesterol, which can be dangerous to the fetus when used for pregnant women. Therefore, Fluvastatin is contraindicated for pregnant women.

Breastfeeding period

Based on clinical data, Fluvastatin is excreted into breast milk. There is not enough information about the effects of fluvastatin in babies. Fluvastatin is contraindicated in nursing women.

Medicinal interaction

Fibrat, Niacin: simultaneous use of fluvastatin with Bezafibrat, Gemfibrozil, Ciprofibrat or high doses of Niacin (> 1g/day) clinically unrelated to the bioavailability of fluvastatin or other blood lipid lowering drugs. Concomitance HMG - Coa Reductase inhibitors with the above drugs have been reported to increase the risk of muscle disease or muscle pattern, so careful consideration of benefits/risks and useful use.

Colchicin: Cases of muscle disease, including muscle pepper, has been reported when using Fluvastatin simultaneously with Colchicin. Should be cautious when prescribing fluvastatin with colchicin.

Fusidic acid: The risk of muscle pattern may increase due to simultaneous use of systemic fusidic acid with statin. The mechanism of this interaction is unclear. There have been reports on Tieu Co Van (including some deaths) in patients who use this combination. If necessary treatment with all over the body, Fluvastatin should be stopped during the treatment of fusidic acid

ciclosporin: Studies in kidney transplant patients show that Fluvastatin's bioavailability (up to 40mg/day) does not increase significantly in patients with stable doses of ciclosporin. Results from another study, of which 80mg of Fluvastatin is used for kidney transplant patients with stable Ciclosporin doses, showing the area under the curve of Fluvastatin (AUC) and maximum concentration (CMAX) increased by 2 times compared to healthy people. Although the increase in the concentration of fluvastatin is not clinically significant, this combination should be used carefully. Start and maintain Fluvastatin dose as low as possible when combined with ciclosporin.

Fluvastatin (40mg and 80mg) does not affect the bioavailability of ciclosporin when used simultaneously.

Warfarin and other Coumarin derivatives: In healthy volunteers, the use of fluvastatin and warfarin (single dose) does not adversely affect Warfarin concentration and prothrombin time compared to using Warfarin single -rise.

Rifampicin (Rifampin): Use fluvastatin on healthy volunteers before treatment with rifampicin (Rifampin), leading to fertility of fluvastatin about 50%. Although there is currently no clinical evidence of the effectiveness of flew -ftidin lipid concentration, in patients with long -term treatment of rifampicin (for example, tuberculosis treatment), the appropriate adjustable dose of fluvastatin should be adjusted to ensure blood lipid effect.

Oral diabetes: For patients using oral sulfonylurea (Glibenclamid (Glybidamid), Tolbutamid) to treat insulin -dependent diabetes (type 2), used in combination with fluvastatin does not change the clinical effect significantly in blood sugar control.

A study in patients with Type 2 diabetes (N = 32), treated with glibenclamids simultaneously with fluvastatin (40mg 2 times/day for 14 days) increasing the average CMAX, AUC, and T1/2 of glibenclamid, respectively, about 50%, 69%and 121%. Glibenclamid (5 - 20mg per day) increases the average CMAX and AUC of fluvastatin, equivalent to 44% and 51%. In this study, there was no change in glucose, insulin and c-peptide levels. However, patients treated simultaneously Glibenclamid (Glyburid) and Fluvastatin, so they continue to be closely monitored when the Fluvastatin dose increases to 80mg daily.

Resin: Fluvastatin should be used for at least 4 hours after using resin (eg cholestyramin) to avoid interaction due to the cohesion of the drug with resin.

Fuconazol: Use fluvastatin on healthy volunteers before treatment with fluconazole (CYP2C9 inhibitor) leads to increased contact concentration and peak concentration of fluvastatin, respectively, about 84% and 44%. Although there is no clinical evidence of the safety of the use of fluvastatin in patients before treatment with fluconazole for 4 days, should be cautious when using Fluvastatin simultaneously with fluconazole.

Antihistamine H2 and proton pump inhibitors: Use a combination of fluvastatin with cimetidine, ranitidin or omeprazole that increases the bioavailability of fluvastatin, but does not mean clinical.

Phenytoin: Phenytoin pharmacokinetic change when used simultaneously with fluvastatin is not clinically significant. Monitor phenytoin concentration in plasma when used simultaneously with fluvastatin.

Cardiovascular drugs: Mobile pharmacokinetic interaction occurs when using Fluvastatin simultaneously with propranolol, digoxin, losartan, clopidogrel or amlodipine. Based on pharmacological data, do not need to monitor and adjust the dose when using Fluvastatin combined with cardiovascular drugs.

Itraconazole and erythromycin: Concomitance Fluvastatin with strong inhibitors P450 CYP3A4 ITRACONAZOL and Erythromycin have a very small effect on the bioavailability of fluvastatin. These enzymes participate very little in the metabolism of fluvastatin, so it is thought that other CYP3A4 inhibitors (such as ketoconazole, ciclosporin) are not likely to affect the bioavailability of fluvastatin.

Cavalry

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