울트록스 10mg 노벨상 고콜레스테롤혈증 치료제, 심혈관계 질환 예방(수포 2개 x 14정)

제형 2개의 블리스 터가 들어있는 상자 x 14정
규격 로수바스타틴

성분

Thành phần cho 1 viên
구성정보콘텐츠
로수바스타틴10mg

용도

indications Ultrox drugs are indicated in the following cases: Treatment of hypercholesterolemia: In adults, adolescents and children 6 years old and older, increased primary blood cholesterol (type IIA, including hyperlested hyperlyonic cholesterol) or mixed blood lipid disorders (ILB type): Ultrox is as a drug that supports diet mode when patients have not fully responded to other non -drug diet modes, such as physical and non -drug treatments (such as non -physical and non -drug treatments (such as non -physical and non -drug modes (such as non -physical and non -drug therapy. weight loss) is not enough. Increasing household blood cholesterol type: Use Ultrox as a supportive drug for a diet and other lipid treatments (such as blood ldl excerpts) or if these treatments are not appropriate. Other risk factors. 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) Dosage The number of patients ldl-c total HDL-C tg Non-HDL-C ароb

복용 전 울트록스 10mg 노벨상 고콜레스테롤혈증 치료제, 심혈관계 질환 예방(수포 2개 x 14정)

이용방법

도로: 구두.

복용량

치료를 시작하기 전에 환자는 콜레스테롤을 줄이기 위한 표준 식이요법을 따르고 치료 중에도 이 식이요법을 계속해야 합니다. 복용량은 현재 합의된 지침을 사용하여 각 환자의 치료 목표와 반응에 따라 조정되어야 합니다.

Ultrox는 음식과 관계없이 하루 중 언제든지 사용할 수 있습니다.

고콜레스테롤 치료:

권장 시작 용량은 5mg 또는 10mg/회이며, 스타틴 계열을 사용한 적이 없는 환자와 다른 HMG 환원효소 억제제에서 Ultrox로 전환하는 환자 모두에게 1일 1회 복용합니다. 시작 용량 선택 시에는 각 환자의 콜레스테롤 수치와 향후 심혈관계 위험, 잠재적인 이상반응 위험을 염두에 두어야 합니다. 필요한 경우 4주 후에 다음 용량으로 용량을 조정할 수 있습니다. 40mg을 사용하면 저용량에 비해 원하지 않는 효과의 빈도가 증가하기 때문에(바람직하지 않은 효과 참조), 최대 40mg의 최종 용량 표준은 심혈관 질환 위험이 높은 중증 고콜레스테롤성 고콜레스테롤 환자(특히 고콜레스테롤 계열 혈중 콜레스테롤 환자), 20mg 용량에서 치료 목표를 달성하지 못하는 환자에 대해서만 고려해야 하며 이러한 환자는 정기적으로 모니터링해야 합니다. 40mg 투여 시작 시 전문의의 면밀한 모니터링이 필요합니다.

심혈관 합병증 예방:

연구에서 심혈관 합병증의 위험을 줄였으며 복용량은 매일 20mg입니다.

소아과:

어린이를 위한 약물 사용은 전문가만이 수행해야 합니다.

6~17세 어린이 및 청소년(태너

고혈압성 고혈압이 있는 소아 및 청소년의 경우 정상 시작 용량은 5mg/회/일입니다.

  • 혈중 콜레스테롤 과다증이 있는 6~9세 어린이의 일반적인 복용량은 1일 1회 5~10mg입니다. 이 모집단에서는 10mg 이상의 용량에 대한 안전성과 유효성이 연구되지 않았습니다. 이 모집단에서 20mg 이상의 용량에 대한 안전성과 유효성은 연구되지 않았습니다.

    어린이와 청소년은 로수바스타틴 치료를 시작하기 전에 저콜레스테롤 식이요법을 따라야 합니다. 이 식이요법은 로수바스타틴 치료 기간 동안 계속되어야 합니다.

    고혈압성 혈중 콜레스테롤이 있는 어린이에게 약물을 복용한 경험은 8~17세의 소수의 어린이에게만 국한됩니다.

    로수바스타틴 40mg은 어린이에게 사용하기에 적합하지 않습니다.

    6세 미만 어린이:

    6세 미만 어린이에게 사용되는 안전성과 효율성은 연구되지 않았습니다. 따라서 6세 미만의 어린이에게는 Ultrox를 권장하지 않습니다.

    노인에게 사용됨:

    70세 이상 환자의 경우 초회용량 5mg이 권장됩니다(주의사항 참조). 불필요한 용량 조정.

    신부전 환자의 복용량:

    경증~중등도 신부전 환자의 경우 용량 조절이 쉽지 않습니다. 중증신부전(크레아티닌 청소율

    간부전 환자의 복용량:

    Child-Pugh 점수

    그러나 Child-Pugh 8점과 9점 환자에서는 신체 접촉 수준의 증가가 관찰되었습니다. 이러한 환자에서는 신장 기능 평가를 고려해야 합니다(주의 깊게 참조). Child-Pugh 점수가 9인 환자의 약물 사용 경험이 부족합니다. Ultrox는 간 질환이 발생한 환자에게는 금기입니다(대조 항목 참조).

    인종:

    아시아인 피험자에게서 약물의 신체 접촉 수준이 증가한 것으로 기록되었습니다(금기 사항, 주의 참조). 따라서 아시아인 환자의 경우 권장 시작 용량은 5mg입니다. 이 환자들에게는 40mg의 용량이 금기입니다.

    유전적 다형성:

    특정 유전적 다양성이 로수바스타틴의 노출을 증가시킬 수 있는 것으로 알려져 있습니다. 이러한 특정 다형성이 있는 것으로 알려진 환자의 경우 Ultrox 일일 복용량을 낮추는 것이 권장됩니다.

    근육 병리를 유발하는 요인이 있는 환자의 복용량:

    근육 병리를 유발하는 요인이 있는 환자의 경우 권장 시작 용량은 5mg입니다(주의 깊게 참조).

    일부 환자에게는 40mg의 용량이 금기입니다.

    동시 처리:

    로수바스타틴은 다양한 단백질 수송(예: OATP1B1 및 BCRP)의 기질입니다. Ultrox를 단백질 수송 물질(예: 사이클로스포린 및 리토나비르와 아타자나비르, 로피나비르 및/또는 티프라나비르의 조합을 포함하는 특정 프로테아제 억제제, 약물)과의 상호 작용으로 인해 혈장 내 로수바스타틴 수준을 증가시킬 수 있는 특정 약물과 동시에 사용하면 근육 병리(근육 후추 포함)의 위험이 증가합니다.

    참고: 위 용량은 참고용일 뿐입니다. 구체적인 복용량은 질병의 상태와 진행 수준에 따라 다릅니다. 적절한 복용량을 위해서는 의사나 전문의와 상담이 필요합니다. 과다복용 시 어떻게 해야 하나요?

    과다복용시 특별한 치료법은 없습니다. 과량투여한 경우, 환자는 증상에 따라 치료를 받아야 하며 필요에 따라 지원 조치를 마련해야 합니다. 간 기능 및 CK 수준을 모니터링합니다.

    혈액 기능 장애는 도움이 되지 않는 것 같습니다.

    위급한 경우에는 즉시 115 응급실에 전화하거나 가까운 보건소를 방문하세요.

    1회 접종을 잊었을 경우 어떻게 해야 하나요? 그러나 다음 복용으로 긴장을 풀 수 있는 시간이 너무 짧다면 복용량을 건너뛰고 약의 달력을 계속 복용하십시오. 놓친 복용량을 보상하기 위해 두 배의 복용량을 사용하지 마십시오.

    • 부작용

    When using the drug, there are common unwanted effects (ADR) such as: Cognitive decline (such as memory loss, confusion ...). Hyperglycemia. In controlled clinical trials, less than 4% of patients with rosuvastatin treatment have been withdrawn from the study due to side effects. 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

    경고

    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: iTraconazole; ketoconazole; erythromycin; HIV; boceprevir; Contraindicated combination of Verapamil, Diltiazem, Diltiazem, Diltiazem, Diltiazem, DroneDaron with preparations with simvastatin content ≥ 20 mg. Ultrox is contraindicated: In patients with hypersensitivity to rosuvastatin or any excipients of the drug. ml/minute). In patients with muscle pathology. The dose of 40 mg is contraindicated in patients with factors leading to muscle muscle disease. These factors include: Moderate kidney failure (Creatinine clearance 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: Power impairment of kidney function. Drugs and some special patients. If CK test results> 5 times the upper limit of normal levels, 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 ... 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: gemfibrozil; other fibrat blood cholesterol medications; 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: verapamil; diltiazem; droneedaron. Do not use more than 20 mg of simvastatin/day when used in coordination with: Amiodaron; Amlodipin; Maximum Rosuvastatin dose limit 10 mg/day when using simultaneously rosuvastatin with protease inhibitors with interaction: Atazanavir; Atazanavir + Ritonavir; Lopinavir + Ritonavir. Rosuvastatin interacts with the protease inhibitors of HIV with interaction: Atazanavir; Atazanavir + Ritonavir; Lopinavir + Ritonavir. 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 The dose of interactive drugs The dose of rosuvastatin

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    기타 약물

    면책조항

    Drugslib.com에서 제공하는 정보의 정확성을 보장하기 위해 모든 노력을 기울였습니다. -날짜, 완전하지만 해당 효과에 대한 보장은 없습니다. 여기에 포함된 약물 정보는 시간에 민감할 수 있습니다. Drugslib.com 정보는 미국의 의료 종사자와 소비자가 사용하도록 편집되었으므로 달리 구체적으로 명시하지 않는 한 Drugslib.com은 미국 이외의 지역에서 사용하는 것이 적절하다고 보증하지 않습니다. Drugslib.com의 약물 정보는 약물을 보증하거나 환자를 진단하거나 치료법을 권장하지 않습니다. Drugslib.com의 약물 정보는 면허를 소지한 의료 종사자가 환자를 돌보는 데 도움을 주고/하거나 이 서비스를 건강 관리에 대한 전문 지식, 기술, 지식 및 판단을 대체하는 것이 아니라 보완으로 보는 소비자에게 제공하기 위해 설계된 정보 리소스입니다. 실무자.

    특정 약물 또는 약물 조합에 대한 경고가 없다고 해서 해당 약물 또는 약물 조합이 해당 환자에게 안전하고 효과적이거나 적절하다는 의미로 해석되어서는 안 됩니다. Drugslib.com은 Drugslib.com이 제공하는 정보의 도움으로 관리되는 의료의 모든 측면에 대해 어떠한 책임도 지지 않습니다. 여기에 포함된 정보는 가능한 모든 용도, 지시 사항, 주의 사항, 경고, 약물 상호 작용, 알레르기 반응 또는 부작용을 다루기 위한 것이 아닙니다. 복용 중인 약에 대해 궁금한 점이 있으면 담당 의사, 간호사 또는 약사에게 문의하세요.

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