Ultrox 10mg Nobel medicine for hypercholesterolinem, prevent cardiovascular events (2 blisters x 14 tablets)
Dosage form Box of 2 blisters x 14 tablets
Specifications Rosuvastatin
Ingredient
Thành phần cho 1 viên
| Composition information | Content |
| Rosuvastatin | 10mg |
Uses
indications
Ultrox drugs are indicated in the following cases:
Code ATC: C10A A07
Active mechanism:
Rosuvastatin is a competitive and selective HMG-Coa Reductase inhibitor, 3-hydroxy-3-methylutaryl coenzyme conversion enzyme into Meevalonate, a cholesterol precursor. The main active place of rosuvastatin is the liver, target organs to reduce cholesterol.
Rosuvastatin increases the number of LDL receptors on the surface of liver cells, enhances the absorption and catabolism of LDL and inhibits VLDL synthesis in the liver, thus reducing the total number of VLDL and LDL particles.
Pharmaceutical effects:
Rosuvastatin reduces increased LDL-cholesterol, total cholesterol and triglycerides and increases HDL-cholesterol. Rosuvastatin also reduces APO B, Non-HDL-C, VLDL-C, VLDL-C and APOA-I increase (see Table 3). Rosuvastatin also reduces LDL-C/HDL-C, C/HDL-C total and non-HDL-C/HDL-C and APOB/APOA-I ratio
Table 3: Responding to the dose in patients with primary blood cholesterol (type IIA and ILB) (average change (%) compared to before treatment)
Before taking Ultrox 10mg Nobel medicine for hypercholesterolinem, prevent cardiovascular events (2 blisters x 14 tablets)
How to use
Roads: Oral.
Dosage
Before starting treatment, the patient must follow a standard diet to reduce cholesterol and continue this diet during treatment. The dosage must be adjusted according to the goals of treatment and response of each patient, using the current consensus instructions.
Ultrox can be used at any time of the day, with or without food.
Hyper cholesterol treatment:
The recommended starting dose is 5mg or 10mg/time, taking once a day for both patients who have never used Statin groups and patients to move from another HMG Reductase inhibitor to Ultrox. The starting dose choice should note that the level of cholesterol of each patient and later cardiovascular risk as well as the potential risks of adverse reactions. Adjusting the dose to the next dose can be done after 4 weeks, if necessary. Because the frequency of unwanted effects increases when using 40 mg compared to lower doses (see unwanted effects), the last dose standard up to 40mg should only be considered for patients with severe hypercolular hypercholesterol patients with high risk of cardiovascular disease (especially patients with hypercholesterol family blood cholesterol), people who do not achieve treatment goals at the dose of 20mg and these patients need to be monitored regularly. It is necessary to have a close monitoring of a specialist at the start of a dose of 40mg.
Prevent cardiovascular complications:
In the study reduces the risk of cardiovascular complications, the dose is 20 mg daily.
Pediatric:
Using drugs for children should only be performed by experts.
Children and teenagers from 6 to 17 years old (tanner
In children and adolescents with hyperlemical hypertension hypertension, the normal starting dose is 5 mg/time/day.
Children and adolescents should follow the low cholesterol diet before starting Rosuvastatin treatment; This diet should be continued during Rosuvastatin treatment.
Experience in taking drugs in children with hypertonic blood cholesterol is limited to a small number of children aged 8 to 17 years old.
Rosuvastatin 40 mg is not suitable for use for children.
Children under 6 years old:
Safety and efficiency used in children under 6 years old have not been studied. Therefore, Ultrox is not recommended for children under 6 years old.
used in the elderly:
The starting dose of 5 mg is recommended in patients over 70 years old (see the cautious part). Unnecessary dose adjustment.
Dosage in patients with renal failure:
Unsurting dose adjustment in patients with mild to moderate renal failure. The recommended starting dose is 5 mg in medium renal failure (creatinine clearance
Dosage in patients with liver failure:
There is no increase in the body's body contact level in patients with Child-Pugh scores
However, the increase in the body's body contact level has been observed in patients with Child-Pugh 8 and 9 scores. In these patients, the evaluation of kidney function should be considered (see carefully). Inexperienced drug use in patients with Child-Pugh scores on 9. Ultrox is contraindicated in patients with developing liver disease (see the control item).
Race:
Increase the level of body contact of the drug has been recorded in Asian subjects (see the contraindications, cautious). Therefore, the recommended starting dose should be 5 mg for Asian -based patients. Doses of 40 mg contraindicated in these patients.
genetic polymorphism:
Specific genetic variety is known that it can lead to increased exposure of rosuvastatin. For patients who are known to have such specific polymorphisms, the lower daily Ultrox dose is recommended.
Dosage in patients with factors leading to muscle pathology:
The recommended starting dose is 5 mg in patients with factors leading to muscle pathology (see carefully).
The dose of 40 mg is contraindicated in some of these patients.
simultaneous treatment:
Rosuvastatin is a substrate of different protein transportation (such as OATP1B1 and BCRP). The risk of muscle pathology (including muscle pepper) increases when used simultaneously Ultrox with certain drugs that can increase the level of rosuvastatin in plasma due to interaction with protein transport substances (such as cyclosporin and certain protease inhibitors including a combination of Ritonavir with Atazanavir, Lopinavir, and/or Tipranavir; Drugs)
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 in case of overdose. In case of overdose, patients should be treated for symptoms and supportive measures set up as required. Liver function and CK level to be monitored.
Bloody dysfunction does not seem to be beneficial.
In case of 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 doses to compensate for missed dose.
Side Effects
When using the drug, there are common unwanted effects (ADR) such as:
Based on data from clinical studies and widespread experience after medication, the following table presents the adverse reactions of Rosuvastatin. The adverse reaction listed below is classified by frequency and classification of organ systems (Soc).
The side reaction frequency is ranked as follows: Popular (≥ 1/100 to
Table 2. The adverse reaction is based on data from clinical studies and experience after taking drugs
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Ultrox drugs contraindicated in the following cases:
Contraindicated using simvastatin in combination with strong CYP3A4 inhibitors such as:
Contraindicated combination of Verapamil, Diltiazem, Diltiazem, Diltiazem, Diltiazem, DroneDaron with preparations with simvastatin content ≥ 20 mg.
Ultrox is contraindicated:
The dose of 40 mg is contraindicated in patients with factors leading to muscle muscle disease. These factors include:
Caution when using
influence on the kidneys
proteinuria, detected by checking the test strip and mainly derived from the renal tubules, has been observed in patients treated with high doses of rosuvastatin, especially at 40 mg dose, in some cases only temporary or continuous. Proteinuria is not a sign to predict renal disease progression or acute. The rate of reporting on severe kidney events after using the drug is higher than the 40 mg dose. Need to assess the kidney function during monitoring patients treated at a dose of 40 mg.
Effects on skeletal muscles
Simultaneous use of statin lipid medications with HIV and hepatitis C (HCV) can increase the risk of muscle damage, the most serious muscle, kidney damage leading to kidney failure and may be fatal.
Effects on skeletal muscles such as muscle pain, muscle disease and very rare in the case of muscle pattern have been reported in patients treated rosuvastatin at all doses and especially with> 20 mg.
The very rare case of pattern has been reported when using ezetimibs in combination with HMG-COA reducing inhibitors. Pharmaceutical interaction can occur and should be cautious when using combination.
As with other HMG-Coa Reductase inhibitors, the ratio of muscle patterns related to rosuvastatin is higher after using the drug at the dose of 40 mg.
Consider monitoring Creatin Kinase (CK) in the case:
Creatin Kinase (CK) should not be measured after heavy sports practice or when there is a certain cause that increases CK appropriately because it may falsify the results. If the CK concentration increases significantly to the original (> 5 x ULN), the test should be performed to redefine within 5-7 days. If the tests repeat the CK confirmed before treatment greater than 5 x ULN, do not start treatment with rosuvastatin.
Before treatment, CK tests should be conducted in the following cases:
Ultrox, as with other HMG-COA Reductase inhibitors, must be carefully prescribed in patients with premise factors leading to muscle diseases. These factors include:
During statin treatment, patients need to notify when there are muscle manifestations such as muscle pain, stiffness, muscle weakness ... When these manifestations, patients need to do CK test to take appropriate interventions.
Patients must report muscle pain, muscle weakness or cramps (hard) unexplained cramps immediately, especially if combined with fatigue or fever. CK levels need to be measured in these patients. Treatment should be stopped if the concentration of CK increases significantly (> 5 x ULN) or if there are serious muscle symptoms and daily discomfort (even if the CK level is ≤ 5 x ULN). If the symptoms decrease and the level of CK returns to normal, then consider repeating Ultrox or replacing HMG-COA Reductase inhibitors at the lowest dose and should be closely monitored. Regular monitoring of CK level in patients with no symptoms is not guaranteed to detect muscle disease. There have been very little reports on microscopic necrosis (IMNM) during or after treatment with statin, including rosuvastatin. IMNM has clinical properties such as muscle weakness and high serum creatin, these characteristics still exist despite stopping statin treatment.
In clinical trials, there is no evidence of increased skeletal muscles in the few patients using rosuvastatin and treating simultaneously with other drugs. However, the increase in the rate of muscle and muscle disease has been seen in patients using other HMG-Coa Reductase along with the derivative of fibric acid including gemfibrozil, cyclosporin, nicotinic acid, antifungal group Azole, protease inhibitors and macrolid antibiotics.
Gemfibrozil increases the risk of muscle disease when used simultaneously with some HMG-Coa Reductase drugs. Therefore, the combination of Ultrox and Gemfibrozil does not recommend. The benefits of further changes in lipid concentration due to Ultrox combination with fibrat or niacin should be carefully considered for the hidden risks due to such a combination. The dose of 40 mg is contraindicated when used simultaneously with fibrat.
Combining rosuvastatin with fusidic acid is not recommended. There has been a report of Co Van (including some deaths) in these combined patients.
Ultrox should not be used in any patient tend to have a muscle disease with acute serious condition or the cause of the development of secondary renal failure caused by muscle pilot (such as blood infection, hypotension, surgery, trauma, severe metabolism, hormonal disorders and electrolytes; or uncontrolled convulsions).
influence on the liver
As with other HMG-Coa Reductase inhibitors, Ultrox should be used carefully in patients who drink too much alcohol and/or a history of liver disease.
Recommendations to do liver enzyme tests before starting statin treatment and in clinical indicators require later testing.
Ultrox should stop or reduce the dose if the serum transaminase level is greater than 3 times the upper limit of the normal level. Report the proportion of serious liver events (mainly: increasing the liver transaminase) higher than the 40 mg dose after the use of the drug.
In patients with secondary hyperchemical hypertension due to hypothyroidism or nephrotic syndrome, these hidden diseases need to be treated before starting treatment with Ultrox.
Race
Pharmacokinetics research shows an increase in the level of exposure to drugs in Asian subjects compared to white people (see the dose part, contraindications and pharmacokinetic sections).
Protease inhibitors
Increased body contact with rosuvastatin has been observed in rosvastatin objects simultaneously with different protease inhibitors in combination with Ritonavir.
It is necessary to consider the benefits of lipid lower by using Ultrox in HIV patients using protease inhibitors and the potential to increase plasma Rosuvastatin concentration at the beginning and standard of Ultrox doses in patients treated with protease inhibitors. Concentrated use with certain protease inhibitors is not recommended unless the Ultrox dose is adjusted.
Patients with rare Galactose non-tolerance problems, lactase deficiency or glucose-galactose should not be used.
Ultrox contains yellow excipients Sunset (E110). May cause allergic reactions.
Ultrox contains less than 0.01mg sodium per dose. However, this number of sodium usually does not cause any problem.
Interstitial lung disease
Special cases of interstitial lung disease have been reported in some statins, especially long -term treatment (see unwanted effects). The expression features may include shortness of breath, dry cough and general health impairment (fatigue, weight loss and fever). If the patient is suspected of developing interstitial lung disease, statin treatment should be stopped.
diabetes
Some evidence shows that stator -like blood glucose increases and in some patients, at higher risk of diabetes later, can cause hyperglycemia, so diabetes officially needs appropriate care. This risk, however, is worse by reducing cardiovascular risk to statins and therefore is not the reason to stop treating statin. Patients with risk (glucose at 5.6 - 6.9 mmol/liter, BMI> 30 kg/m2, increased triglycerides, hypertension) should be monitored both clinically and biochemical under national instructions.
In Jupiter research, the frequency of the overall diabetes is reported by 2.8% in the group using rosuvastatin and 2.3% in the placebo group, most in patients with glucose at hunger: 5.6 - 6.9 mmol/liter.
Pediatric population
The assessment of linear development (height), weight, BMI (body block index), and the characteristic of secondary sexual maturity because the tanner level in children from 6 to 17 years old using Rosuvastatin is limited for a period of two years. After two years of research and treatment, there is no effect on growth, weight, BMI or sexual maturity has been discovered (see pharmacological part).
In a clinical trial in children and young people using rosuvastatin for 52 weeks, CK increases> 10 x ULN and muscle symptoms after exercise or increased physical activity has been observed more often than observations in clinical tests in adults (see side effects).
The effect of the drug on driving and operating machinery
studies to determine the effect of rosuvastatin on driving capacity and use of machines have not been conducted.
However, based on the pharmacological characteristics, Rosuvastatin does not affect this ability. When driving or operating machinery, it is necessary to pay attention to it may occur during treatment.
Use drugs for women during pregnancy and lactation
Ultrox contraindicated during pregnancy and lactation.
Women who are likely to be pregnant should use appropriate contraception.
Due to cholesterol and other cholesterol biosynthesis are essential for fetal development, the potential risks caused by HMG-CAA Reductase inhibitors dominate the benefits of Rosuvastatin treatment during pregnancy. Animal studies show that there are evidence of limited to toxicity on reproductive. If the patient is pregnant while using this drug, the drug should be stopped immediately.
Rosuvastatin excreted in mice. There is no data related to excretion into human milk.
Drug interaction
Increased risk of muscle lesions when using statin simultaneously with the following drugs:
Avoid simultaneous use and limit of the dosage when using simultaneously rosuvastastin with some drugs or beverages that can increase the risk of muscle diseases and/or muscle pattern.
Avoid using large amounts of grapefruit juice (grapefruit juice) (> 1 liter day).
Do not use more than 10 mg of simvastatin/day when used in combination with:
Do not use more than 20 mg of simvastatin/day when used in coordination with:
Maximum Rosuvastatin dose limit 10 mg/day when using simultaneously rosuvastatin with protease inhibitors with interaction:
Rosuvastatin interacts with the protease inhibitors of HIV with interaction:
Interactive drugs between statins and protease inhibitors of HIV and hepatitis C (HCV): The simultaneous use of statin lipid medications with HIV and hepatitis C (HCV) can increase the risk of muscle damage, the most seriousness is muscle pattern, kidney damage leading to renal failure and may cause death.
Effect of medications in combination with rosuvastatin:
Protein transportation inhibitors: Rosuvastatin is a substrate for certain protein transportation including absorption of OatP1B1 transportation in the liver and pumping out of the BCRP transportation in the liver. Simultaneous use of rosuvastatin with inhibitors of protein transports can lead to rising rosomastatin levels in plasma and increase the risk of muscle disease (see the dose, cautious and interactive Table 1).
cyclosporin: During the time of treatment simultaneously rosuvastatin with cyclosporin, the AUC value of rosuvastatin average is 7 times higher than the AUC value of Rosuvastatin observed in healthy volunteers (see Table 1). Ultrox is contraindicated in patients with simultaneous use of cyclosporin (see contraindicated section). Simultaneous use does not affect plasma cyclosporin levels.
Protease inhibitors: Although the exact mechanism of interaction is unknown, using protease inhibitors simultaneously increases the contact level of rosuvastatin (see Table 1). For example, in a pharmacokinetic study, used with Rosuvastatin 10 mg and a combination of two protease inhibitors (Atazanavir 300 mg/ritonavir 100 mg) in healthy volunteers related to tripled AUC of Rosuvastatin and an increase of about seven times cmax of Rosuvastatin. The simultaneous use of Ultrox and some combinations of protease inhibitors can be considered after careful consideration of adjusting the Ultrox dose based on the expected increase in the contact level of Rosuvastatin.
Gemfibrozil and other lipid lowering drugs: simultaneous use of rosuvastatin and gemfibrozil, resulting in a 2 -fold increase in CMAX and AUC concentrations of Rosuvastatin (see Causes).
Based on data from specific interactive studies without interactions related to Fenofibrat pharmacokinetics are expected, but a possible pharmaceutical interaction may occur. Gemfibrozil, Fenofibrat, other fibrats and hypadinemia Niacin (nicotinic acid) dose (> or equal to 1 g/day) increase the risk of muscle pathology when used simultaneously with HMGCA Reductase inhibitors, perhaps because they can cause muscle disease when used alone. The dose of 40 mg is contraindicated when used simultaneously with fibrat (see the contraindication and caution). Patients should also start using 5 mg.
Ezetimib: Simultaneous use Rosuvastatin 10 mg with Ezetimib 10 mg leads to an increase of 1.2 AUC of rosuvastatin in hypercholesteroline objects (Table 1). A pharmacokinetic interaction, on side effects, between Ultrox and Ezetimib cannot be excluded (see the cautious part).
antacids: simultaneously use rosuvastatin with antacidic mixture containing aluminum hydroxid and magnesi leads to a decrease in plasma rosuvastatin levels in approximately 50%. This effect is slightly reduced when taking antacids after using Rosuvastatin for 2 hours. The clinical involvement of this interaction has not been studied.
enzyme cytochrom P450: Results from In vitro and in vivo research show that RosuVastatin is not an inhibitor nor the touch substance of Isoenzyme Cytochrom P450. Besides, Rosuvastatin is a poor substrate for these isenzymes.
Therefore, drug interactions due to intermediate metabolites cytochrom P450 are not expected. No clinical interactions have been observed between rosuvastatin and or or fluconazole (CYP2C9 and CYP3A4 inhibitors) or ketoconazole (CYP2A6 and CYP3A4 inhibitors).
Interaction needs to adjust the dose of rosuvastatin (see Table 1): When it is necessary to simultaneously use Ultrox with other drugs, it is known to increase the contact level of rosuvastatin, Ultrox dose should be adjusted. Start with a 5 mg Ultrox dose once a day if the contact level (AUC) is expected to increase by 2 times or higher. The maximum daily Ultrox dose needs to be adjusted so that RosuVastatin's expected contact will not be able to overcome the daily Ultrox 40 mg dose without drug interactions, such as Ultrox 20 mg with Gemfibrozil (an increase of 1.9 times), and the Ultrox 10 mg dose combined with Ritonavir/Atazanavir (increase 3.1 times).
Table 1. The influence of treatment drugs in combination with the contact level of rosuvastatin (AUC; in the order of reduced magnitude) from clinical trials published
Storage
less than 30 ° C, in the original packaging.
Other drugs
- CO-DIOVAN 160/25MG TABLETS
- ESPUMISAN 100 MG/1ML ORAL DROPS EMULSION
- FENACTOL TABLETS 50MG
- Gliolan
- Insulatard
- ZINDACLIN 1% GEL
Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Popular Keywords
- metformin obat apa
- alahan panjang
- glimepiride obat apa
- takikardia adalah
- erau ernie
- pradiabetes
- besar88
- atrofi adalah
- kutu anjing
- trakeostomi
- mayzent pi
- enbrel auto injector not working
- enbrel interactions
- lenvima life expectancy
- leqvio pi
- what is lenvima
- lenvima pi
- empagliflozin-linagliptin
- encourage foundation for enbrel
- qulipta drug interactions