Ultrox 10 mg Médicament Nobel pour l'hypercholestérolémie, prévient les événements cardiovasculaires (2 ampoules x 14 comprimés)

Forme pharmaceutique Boîte de 2 ampoules x 14 comprimés
Spécifications Rosuvastatine

Ingrédient

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Informations sur la composition	Contenu
Rosuvastatine	10 mg

Les usages

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

Avant de prendre Ultrox 10 mg Médicament Nobel pour l'hypercholestérolémie, prévient les événements cardiovasculaires (2 ampoules x 14 comprimés)

Comment utiliser

Routes : Orales.

Posologie

Avant de commencer le traitement, le patient doit suivre un régime alimentaire standard pour réduire le cholestérol et poursuivre ce régime pendant le traitement. La posologie doit être ajustée en fonction des objectifs de traitement et de la réponse de chaque patient, en utilisant les instructions consensuelles en vigueur.

Ultrox peut être utilisé à tout moment de la journée, avec ou sans nourriture.

Traitement de l'hyper cholestérol :

La dose initiale recommandée est de 5 mg ou 10 mg/fois, à prendre une fois par jour pour les patients n'ayant jamais utilisé de groupes de statines et pour les patients souhaitant passer d'un autre inhibiteur de l'HMG réductase à Ultrox. Le choix de la dose initiale doit tenir compte du taux de cholestérol de chaque patient et du risque cardiovasculaire ultérieur ainsi que des risques potentiels d'effets indésirables. L'ajustement de la dose à la dose suivante peut être effectué après 4 semaines, si nécessaire. Étant donné que la fréquence des effets indésirables augmente lors de l'utilisation de 40 mg par rapport à des doses plus faibles (voir effets indésirables), la dernière dose standard jusqu'à 40 mg ne doit être envisagée que pour les patients présentant un hypercholestérolémie hypercolulaire sévère présentant un risque élevé de maladie cardiovasculaire (en particulier les patients présentant un hypercholestérolémie familiale), les personnes qui n'atteignent pas les objectifs de traitement à la dose de 20 mg et ces patients doivent être surveillés régulièrement. Il est nécessaire d'avoir une surveillance étroite d'un spécialiste au début d'une dose de 40 mg.

Prévenir les complications cardiovasculaires :

Dans l'étude réduit le risque de complications cardiovasculaires, la dose est de 20 mg par jour.

Pédiatrique :

La consommation de drogues chez les enfants ne doit être effectuée que par des experts.

Enfants et adolescents de 6 à 17 ans (tanneur

Chez les enfants et les adolescents souffrant d'hypertension hyperlémique, la dose initiale normale est de 5 mg/heure/jour.

Chez les enfants de 6 à 9 ans présentant une hypercholestérolémie hyperlipidique, la dose habituelle est de 5 à 10 mg, une fois par jour. La sécurité et l'efficacité d'une dose supérieure à 10 mg n'ont pas été étudiées dans cette population. La sécurité et l'efficacité d'une dose supérieure à 20 mg n'ont pas été étudiées dans cette population.

Les enfants et les adolescents doivent suivre un régime hypocholestérolémiant avant de commencer le traitement par la rosuvastatine ; Ce régime doit être poursuivi pendant le traitement par Rosuvastatine.

L'expérience dans la prise de médicaments chez les enfants souffrant de cholestérol sanguin hypertonique est limitée à un petit nombre d'enfants âgés de 8 à 17 ans.

La rosuvastatine 40 mg ne convient pas aux enfants.

Enfants de moins de 6 ans :

La sécurité et l'efficacité utilisées chez les enfants de moins de 6 ans n'ont pas été étudiées. Par conséquent, Ultrox n'est pas recommandé aux enfants de moins de 6 ans.

utilisé chez les personnes âgées :

La dose initiale de 5 mg est recommandée chez les patients de plus de 70 ans (voir la partie prudence). Ajustement de dose inutile.

Posologie chez les patients atteints d'insuffisance rénale :

Ajustement posologique incertain chez les patients présentant une insuffisance rénale légère à modérée. La dose initiale recommandée est de 5 mg en cas d'insuffisance rénale moyenne (clairance de la créatinine

Posologie chez les patients souffrant d'insuffisance hépatique :

Il n'y a pas d'augmentation du niveau de contact corporel chez les patients présentant des scores de Child-Pugh

Cependant, une augmentation du niveau de contact corporel a été observée chez les patients présentant des scores Child-Pugh 8 et 9. Chez ces patients, l'évaluation de la fonction rénale doit être envisagée (voir attentivement). Utilisation inexpérimentée de médicaments chez les patients avec un score de Child-Pugh sur 9. Ultrox est contre-indiqué chez les patients présentant une maladie hépatique en développement (voir l'élément de contrôle).

Course :

Une augmentation du niveau de contact corporel du médicament a été enregistrée chez des sujets asiatiques (voir les contre-indications, prudence). Par conséquent, la dose initiale recommandée doit être de 5 mg pour les patients asiatiques. Les doses de 40 mg sont contre-indiquées chez ces patients.

polymorphisme génétique :

On sait qu'une variété génétique spécifique peut conduire à une exposition accrue à la rosuvastatine. Pour les patients présentant de tels polymorphismes spécifiques, la dose quotidienne d'Ultrox la plus faible est recommandée.

Posologie chez les patients présentant des facteurs conduisant à une pathologie musculaire :

La dose initiale recommandée est de 5 mg chez les patients présentant des facteurs conduisant à une pathologie musculaire (voir attentivement).

La dose de 40 mg est contre-indiquée chez certains de ces patients.

traitement simultané :

La rosuvastatine est un substrat de transport de différentes protéines (telles que l'OATP1B1 et la BCRP). Le risque de pathologie musculaire (y compris le poivre musculaire) augmente lorsqu'Ultrox est utilisé simultanément avec certains médicaments qui peuvent augmenter le taux de rosuvastatine dans le plasma en raison de l'interaction avec des substances de transport de protéines (telles que la cyclosporine et certains inhibiteurs de protéase, y compris une association de ritonavir avec l'atazanavir, le lopinavir et/ou le tipranavir ; médicaments)

Remarque : la dose ci-dessus est à titre de référence uniquement. La posologie spécifique dépend de l'état et du niveau de progression de la maladie. Pour une dose adaptée, vous devez consulter un médecin ou un médecin spécialiste. Que faire en cas de surdosage ?

Il n'existe pas de traitement spécifique en cas de surdosage. En cas de surdosage, les patients doivent être traités pour détecter les symptômes et des mesures de soutien doivent être mises en place si nécessaire. Fonction hépatique et niveau de CK à surveiller.

Un dysfonctionnement sanglant ne semble pas être bénéfique.

En cas d'urgence, appelez immédiatement le centre d'urgence 115 ou rendez-vous au poste de santé local le plus proche.

Que faire en cas d'oubli d'une dose ? Cependant, si le temps nécessaire pour vous détendre avec la dose suivante est trop court, sautez la dose et continuez le calendrier de traitement. N'utilisez pas de doubles doses pour compenser une dose oubliée.

Effets secondaires

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

Avertissements

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

Conservation

moins de 30°C, dans l'emballage d'origine.

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