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קרסטור ® 40 מ"ג CRESTOR ® 40 MG (ROSUVASTATIN AS CALCIUM)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
פומי : PER OS
צורת מינון:
טבליות מצופות פילם : FILM COATED TABLETS
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Posology : מינונים
4.2 Posology and method of administration Before treatment initiation the patient should be placed on a standard cholesterol-lowering diet that should continue during treatment. The dose should be individualised according to the goal of therapy and patient response, using current consensus guidelines. The recommended start dose is 5 mg or 10 mg orally once daily in both statin naïve or patients switched from another HMG CoA reductase inhibitor. The choice of start dose should take into account the individual patient's cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions (see below). A dose adjustment to the next dose level can be made after 4 weeks, if necessary (see Section 5.1). In light of the increased reporting rate of adverse reactions with the 40 mg dose compared to lower doses (see Section 4.8), a final titration to the maximum dose of 40 mg should only be considered in patients with severe hypercholesterolaemia at high cardiovascular risk (in particular those with familial hypercholesterolaemia), who do not achieve their treatment goal on 20 mg, and in whom routine follow-up will be performed (see Section 4.4). Specialist supervision is recommended when the 40 mg dose is initiated. Crestor may be given at any time of day, with or without food. Paediatric use Crestor is not indicated for children and adolescents under 18 years old. Safety and efficacy have not been established in children. Paediatric experience is limited to a small number of children (aged 8 years or above) with homozygous familial hypercholesterolaemia. Therefore, Crestor is not recommended for paediatric use at this time. Use in the elderly A start dose of 5 mg is recommended in patients >70 years (see section 4.4). No other dose adjustment is necessary in relation to age. Dosage in patients with renal insufficiency No dose adjustment is necessary in patients with mild to moderate renal impairment. The recommended start dose is 5 mg in patients with moderate renal impairment (creatinine clearance of <60 ml/min). The 40 mg dose is contraindicated in patients with moderate renal impairment. The use of Crestor in patients with severe renal impairment is contraindicated for all doses. (see Section 4.3 and Section 5.2). Dosage in patients with hepatic impairment There was no increase in systemic exposure to rosuvastatin in subjects with Child-Pugh scores of 7 or below. However, increased systemic exposure has been observed in subjects with Child-Pugh scores of 8 and 9 (see Section 5.2). In these patients an assessment of renal function should be considered (see Section 4.4). There is no experience in subjects with Child-Pugh scores above 9. Crestor is contraindicated in patients with active liver disease (see Section 4.3). Race Increased systemic exposure has been seen in Asian subjects (see Section 4.3, 4.4 and Section 5.2). The recommended start dose is 5 mg for patients of Asian ancestry. The 40 mg dose is contraindicated in these patients. Genetic polymorphisms Specific types of genetic polymorphisms are known that can lead to increased rosuvastatin exposure (see Section 5.2). For patients who are known to have such specific types of polymorphisms, a lower daily dose of Crestor is recommended. Dosage in patients with pre-disposing factors to myopathy The recommended start dose is 5 mg in patients with predisposing factors to myopathy (see Section 4.4). The 40 mg dose is contraindicated in some of these patients (see Section 4.3). Concomitant therapy Rosuvastatin is a substrate of various transporter proteins (e.g. OATP1B1 and BCRP). The risk of myopathy (including rhabdomyolysis) is increased when Crestor is administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin due to interactions with these transporter proteins (e.g. ciclosporin and certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir; see Sections 4.4 and 4.5).Whenever possible, alternative medications should be considered, and, if necessary, consider temporarily discontinuing Crestor therapy. In situations where co-administration of these medicinal products with Crestor is unavoidable, the benefit and the risk of concurrent treatment and Crestor dosing adjustments should be carefully considered (see Section 4.5).
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
15/05/2006
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קרסטור ® 40 מ"ג