Ultrox 10mg 高コレステロール血症に対するノーベル医薬品、心血管イベントの予防 (水疱 2 個 x 14 錠)

剤形 2ブリスター×14錠入り箱
仕様 ロスバスタチン

成分

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成分情報コンテンツ
ロスバスタチン10mg

用途

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

服用する前に Ultrox 10mg 高コレステロール血症に対するノーベル医薬品、心血管イベントの予防 (水疱 2 個 x 14 錠)

使用方法

道路: 口頭。

投与量

治療を開始する前に、患者はコレステロールを減らすために標準的な食事療法に従い、治療中もこの食事を継続する必要があります。投与量は、現在のコンセンサスに基づいた指示に従って、治療の目標と各患者の反応に応じて調整する必要があります。

Ultrox は、食事の有無にかかわらず、一日中いつでも使用できます。

高コレステロールの治療:

推奨される開始用量は 5 mg または 10 mg/回で、スタチン群を使用したことがない患者および別の HMG レダクターゼ阻害剤から Ultrox に移行する患者の両方に 1 日 1 回服用します。開始用量の選択では、各患者のコレステロールのレベル、その後の心血管リスク、および副作用の潜在的なリスクに注意する必要があります。必要に応じて、4週間後に次の用量への用量の調整を行うことができます。 40 mg を使用すると、低用量に比べて望ましくない効果の頻度が増加するため（望ましくない効果を参照）、最終用量標準 40 mg までは、心血管疾患のリスクが高い重度の高コレステロール高コレステロール患者（特に高コレステロール家系血中コレステロール患者）、20 mg の用量では治療目標を達成できない人々にのみ考慮されるべきであり、これらの患者は定期的にモニタリングする必要があります。 40mg の投与を開始する際には、専門家の綿密なモニタリングを受ける必要があります。

心血管合併症の予防:

この研究では心血管合併症のリスクを軽減し、用量は 1 日あたり 20 mg です。

小児:

小児への薬物の使用は専門家のみが行ってください。

6 歳から 17 歳までの子供および青少年 (タンナー

高血糖性高血圧症の小児および青少年の場合、通常の開始用量は 5 mg/回/日です。

  • 血中コレステロールが過剰に上昇している 6 ～ 9 歳の小児の場合、通常の用量は 5 ～ 10 mg を 1 日 1 回です。この集団では、10 mg を超える用量の安全性と有効性は研究されていません。この集団では、20 mg を超える用量の安全性と有効性は研究されていません。

    小児および青少年は、ロスバスタチン治療を開始する前に低コレステロール食に従う必要があります。この食事療法は、ロスバスタチン治療中も継続する必要があります。

    血中コレステロールが高張性の小児で薬を服用した経験があるのは、8 ～ 17 歳の少数の小児に限られています。

    ロスバスタチン 40 mg は小児への使用には適していません。

    6 歳未満の子供:

    6 歳未満の子供に使用される安全性と効率性については研究されていません。したがって、Ultrox は 6 歳未満のお子様には推奨されません。

    高齢者に使用:

    70 歳以上の患者には 5 mg の開始用量が推奨されます (慎重な部分を参照)。不必要な用量調整。

    腎不全患者における投与量:

    軽度から中等度の腎不全患者における確実な用量調整。中等度の腎不全（クレアチニンクリアランスが 60 ml/分未満）の場合、推奨される開始用量は 5 mg です。 40 mg の用量は、中等度の腎不全患者には禁忌です。重度の腎障害のある患者におけるウルトロックスの使用は、すべての用量において禁忌です。

    肝不全患者の投与量:

    チャイルドピュースコアが 7 未満の患者では、身体の接触レベルは増加しません。

    ただし、Child-Pugh スコア 8 および 9 の患者では、体の接触レベルの増加が観察されています。このような患者では、腎機能の評価を考慮する必要があります（よく見てください）。 Child-Pugh スコアが 9 の患者における薬物使用の経験が浅い。ウルトロックスは肝疾患を発症している患者には禁忌です（管理項目を参照）。

    レース:

    アジア人被験者では薬物の身体接触レベルの増加が記録されています (禁忌、注意事項を参照)。したがって、アジア系患者の推奨開始用量は 5 mg である必要があります。これらの患者には 40 mg の用量は禁忌です。

    遺伝子多型:

    特定の遺伝的多様性がロスバスタチンへの曝露の増加につながる可能性があることが知られています。このような特定の多型があることが知られている患者の場合、1 日当たりの Ultrox 用量をより少なくすることが推奨されます。

    筋肉の病変を引き起こす要因がある患者の投与量:

    筋肉の病変を引き起こす要因がある患者の場合、推奨される開始用量は 5 mg です (注意深く参照してください)。

    これらの患者の一部には 40 mg の用量が禁忌です。

    同時治療:

    ロスバスタチンは、さまざまなタンパク質輸送の基質 (OATP1B1 や BCRP など) です。筋肉病変（マッスルペッパーを含む）のリスクは、タンパク質輸送物質（シクロスポリンや、リトナビルとアタザナビル、ロピナビル、および/またはティプラナビルの組み合わせを含む特定のプロテアーゼ阻害剤など、薬剤）との相互作用により、血漿中のロスバスタチンレベルを上昇させる可能性がある特定の薬剤とウルトロックスを同時に使用すると増加します。

    注: 上記の用量は参考用です。具体的な投与量は、病気の状態および進行のレベルによって異なります。適切な用量については、医師または専門家に相談する必要があります。過剰摂取した場合はどうすればよいですか?

    過剰摂取の場合、特別な治療法はありません。過剰摂取の場合、患者は症状の治療を受け、必要に応じて補助措置を講じる必要があります。肝機能とCKレベルを監視します。

    血液機能不全は有益ではないようです。

    緊急の場合は、すぐに 115 緊急センターに電話するか、最寄りの地域の保健ステーションに行ってください。

    1 回分を忘れた場合はどうすればよいですか?ただし、次の服用でリラックスできる時間が短すぎる場合は、服用をスキップし、薬のカレンダーを継続してください。飲み忘れた分を補うために 2 回分を使用しないでください。

    • 副作用

    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

    警告

    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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