Carhurol 20 drug BRV treats hypercholesterol blood, prevents cardiovascular events (3 blisters x 10 tablets)

Contraindicated 40 mg for patients with elements of muscle pilot disease, these factors include:

Caution when using

Effects on the kidneys

proteinuria has been observed in patients treated at high doses, especially 40 mg, in most cases is transient or continuous. Need to monitor kidney function assessment during the drug use time at a dose of 40 mg.

Effect of skeletal muscle

Muscle effects such as muscle pain, muscle disease and sometimes muscle pepper have been reported in patients treated with this drug in all doses and especially at> 20 mg. It is very rare in the case of a pattern that is reported when using Ezetimib in combination with HMG-COA reducing enzyme inhibitors. But it is not possible to exclude pharmacokinetic interaction and need to be cautious when using combined. As with other HMG-COA eliminating enzyme inhibitors, the rate of pattern is related to drugs is higher than at 40 mg.

monitor Creatine Kinase (CK)

Consider monitoring Creatin Kinase in the following cases:

Before treatment should conduct CK test in the following cases: impaired renal function, hypothyroidism, self -history or family with genetic muscle disease, a history of muscle disease due to the use of statin or fibrat before, the history of liver disease or drinking a lot of alcohol, elderly patients (over 70 years old) has risk factors for muscle panoda, the possibility of drug interactions and some special patients. In these cases, the benefits and risks should be considered and monitor patients clinically when treated with statin. If CK test results> 5 times limited to normal levels, do not start statin treatment.

During statin treatment, patients need to notify the doctor when there are muscle manifestations such as muscle pain, stiff muscle, muscle weakness ... and then need to be tested for CK to take appropriate interventions. However, we should not measure Creatin Kinase after exercise hard or have the presence of another cause that can increase CK interference for reading results.

Effects on the liver

Like other statins, use carefully for patients who drink too much alcohol and or have a history of liver disease.

Recommended the liver function test before starting treatment and 3 months after starting treatment with this drug. It is necessary to stop the drug or reduce the dose if the plasma Trasaminase is 3 times higher than the normal limit. The rate of liver events high when using 40 mg.

race

Pharmacy studies show an increase in exposure rate in Asian subjects compared to white people.

Protease inhibitors

There is an increase in the body exposure to rosuvastatin that has been discovered in patients who use at the same time with protease inhibitors combined with Ritonavir. It is important to consider the benefits of lowering blood lipids with this drug in HIV patients who are using protease inhibitors and the ability to increase the level of rosuvastatin in plasma when they start treatment and increase the dose. Do not use simultaneously with some protease inhibitors unless this dose is adjusted.

interstitial lung disease

There are several special cases with interstitial lungs that have been reported to some statins, especially when long -term treatment. Characteristics may include shortness of breath, dry cough and impaired total condition (fatigue, weight loss and fever). If the patient is suspected of having interstitial lung disease, the drug must be stopped.

diabetes

There are some evidence that states increases blood glucose and in some patients, has a high risk of future diabetes, can cause increased blood sugar levels, although diabetes have been properly treated. However, this risk is highly appreciated by reducing the risk of blood vessels due to statin and therefore is not the reason to stop treating with statin. Patients with high risk (glucose at 5.6 to 6.9 mmol/1, BMI> 30 kg/ml, increased triglycerides, hypertension) should be monitored both clinically and biochemical.Jupiter's study showed that the frequency of diabetes in general was 2.8% in rosuvastatin and 2.3% in the placebo group, mainly in patients with blood sugar at 5.6 to 6.9 mmol/l.

Courmarin and anticoagulants

Be cautious when taking this drug at the same time with anticoagulants because the potential of COUMARIN anticoagulants can cause prothrombin/ INR. Inr should be monitored before this medication and regularly in the early stages of treatment to detect changes to INR.

Children

The assessment of the development of height, weight, BMI, and the characteristics of the gender maturity of Tanner on children aged 6 to 17 when using Rosuvastatin is limited to a two -year period. After two years of treatment, no effect on development, weight, BMI or the development of gender.

In a clinical trial in children and adolescents using rosuvastatin for 52 weeks, the increase in CK> 10 times normal and muscle symptoms after exercise or increased physical activity are more observed than clinical tests in adults.

lactose

Because this product contains Lactose Monohydrate excipients, it is not advisable to use for patients with rare genetic problems in galactose, lactase deficiency, or under absorption of glucose-galactose.

erythrosin Lake coloring

Because the product contains a small amount of erythrosin lake color substance that can cause an allergic reaction or affect the thyroid function.

The effect of the drug on the ability to drive and operate machinery

There has been no research on the effect of the drug on the ability to drive train, operate machinery. Although the drug is less likely to affect the pharmacological, it can cause dizziness in some of these drug users.

Using drugs for women during pregnancy and lactation

contraindicated use for pregnant or lactating women.

Women with potential pregnancy should apply appropriate contraception. If the patient is pregnant during the use of this product, the medication should be stopped immediately.

Drug interaction

The effect of other drugs when used at the same time as rosuvastatin

Transport protein inhibitors:

Rosuvastatin is the substrate of some transport proteins including the absorption agent in OATP1B1 liver and the transportation to BCRP. Using this drug at the same time with drugs that inhibit the transport proteins that can increase rosvastatin levels in plasma and increase the risk of muscle disease.

cyclosporin:

Use this combination of cigarette with ciclosporin, increasing the AUC of rosuvastatin 7 times higher than normal value. Therefore the drug is contraindicated in combination with ciclosporin. This combination does not affect plasma ciclosporin levels.

Protease inhibitors:

Although the exact interactive mechanism is unknown, the use of protease inhibitors and increases the contact of rosuvastatin. For example, in a pharmacokinetic study, using a combination of Rosuvastatin 10 mg and a combination product of two protease inhibitors (300 mg Atazanavir/100 mg Ritonavir) in healthy volunteers increasing the AUC and CMAX of Rosuvastatin 3 times and 7 times. It is possible to consider using this drug in combination with protease inhibitors after considering adjusting the dose of this drug based on the risk of increasing exposure to Rosuvastatin.

gemfibrozil and other lipid products:

Concomitance this medication and Gemfibrozil doubling the CMAX and AUC levels of Rosuvastatin.

Based on data from specialized interactive studies, it shows that there is no ability to interact with pharmacokinetics with fenofibrat, but the pharmaceutical mutual correspondence may occur. Gemfibrozil, fenofibrat, other fibrats and niacin (nicotinic acid) at doses that reduce lipid (1g/day) increase the risk of muscle disease when used simultaneously with HMG-COA reducing enzyme inhibitors, maybe because these substances can cause muscle disease when used separately.

40 mg dose is contraindicated when used at the same time as fibrat. These patients also have to start at a dose of 5 mg.

ezetimib:

Simultaneous use of 10 mg of this drug and 10 mg of ezetimib, increasing the AUC of rosuvastatin 1.2 times in cholesterol hyperplasia objects. The pharmacological interaction, in terms of side effects, between this drug and Ezetimib is not excluded.

antacids:

Concomplifying this medication with aluminum antacids and Magnesi hydroxyd reduces rosophers in plasma rosomes by about 50%. This effect has been reduced when taking antacids for 2 hours after taking this medication. The clinical involvement of this interaction has not been studied.

erythromycin:

Simultaneous use of this medicine and erythromycin reduces the AUC of rosuvastatin by 20%. and reduce cmax by 30%. This interaction may be due to increased intestinal motility caused by erythromycin.

Cytochrom P450 enzymes:

Results from In vitro and in vivo studies show that rosuvastatin is not an inhibitor nor causes induction of cytochrome cytochrome p450. In addition, Rosuvastatin is a weak substrate for these isenzymes. Therefore, it is not possible to cause drug interaction due to the metabolic cytochrom P450. There is no clinical interaction between rosuvastatin and fluconazole (CYP2C9 and CYP3A4 inhibitors) or ketoconazole (CYP2A6 and CYP3A4 inhibitors).

Interactions need to adjust the dose of rosuvastatin:

When a combination of this drug is needed with other drugs, there is a risk of increasing exposure to Rosuvastatin, which is needed to adjust the dose of this drug. If the exposure (AUC) is expected to increase by about twice or higher, it should start this drug at a dose of 5 mg, once a day. The maximum daily dose of the drug should be adjusted so that the exposure to RosuVastatin is expected to not exceed the daily dose of 40 mg and does not cause drug interaction, for example, this drug 20 mg with gemfibrozil (an increase of 1.9 times), and 10 mg with Ritonavir/Atazanavir (an increase of 3.1 times).

The effect of rosuvastatin on drugs used

anti -vitamin K:

As well as other statins, the start of the treatment or increase of the dose of this drug in patients being treated along with vitamin K resistant (such as warfarin or other COMARIN anticoagulants) can increase the INR. Stop or reduce the dose of this drug may reduce the INR. In such situations, INR needs to be monitored properly.

Oral contraceptives/ hormone replacement therapy:

Concomitance this medication and oral contraceptives increases the AUC levels of Ethinyl Estradiol and Norgestrel to 26% and 34% respectively. This increase in plasma concentration should be considered when choosing to use birth control pills. There is no pharmacokinetic data in these drugs and hormone therapy instead and therefore cannot exclude similar effects. However, this combination has been widely used in women in clinical trials and well tolerated.

Other drugs:

Digoxin: Based on data from specialized interactive studies, the drug has no clinical interaction with digoxin.

Fusidic acid: studies on the interaction of rosuvastatin and fusidic acid have not been done. The risk of muscle pathology, including muscle pattern, can increase when used simultaneously with bodyIdic acid with body states. This interactive mechanism (due to pharmacokinetic or pharmacokinetics, or both) is still unknown. There have been reports on Tieu Co Van (including some deaths) in patients using this combination. If the body is needed with fusidic acid, this medication should be stopped during the fusidic acid treatment period.

Children:

Studies on drug interactions have only been conducted in adults. The level of interaction in children is not known.