Quest for the right Drug
לוקלמה 10 גר LOKELMA 10 G (SODIUM ZIRCONIUM CYCLOSILICATE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
פומי : PER OS
צורת מינון:
אבקה להכנת תרחיף : POWDER FOR ORAL SUSPENSION
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
Interactions : אינטראקציות
4.5 Interaction with other medicinal products and other forms of interaction Effect of other medicinal products on sodium zirconium cyclosilicate As sodium zirconium cyclosilicate is not absorbed or metabolised by the body, there are no expected effects of other medicinal products on the pharmacologic action of sodium zirconium cyclosilicate. Effect of sodium zirconium cyclosilicate on other medicinal products As sodium zirconium cyclosilicate is not absorbed or metabolised by the body, and does not meaningfully bind other medicinal products, there are limited effects on other medicinal products. Sodium zirconium cyclosilicate can transiently increase gastric pH by absorbing hydrogen ions and can lead to changes in solubility and absorption kinetics for co-administered medicinal products with pH-dependent bioavailability. In a clinical drug-drug interaction study conducted in healthy subjects co-administration of sodium zirconium cyclosilicate with amlodipine, clopidogrel, atorvastatin, furosemide, glipizide, warfarin, losartan or levothyroxine did not result in clinically meaningful drug- drug interactions. Consistent with co-administration of dabigatran with other gastric acid modifiers, dabigatran Cmax and AUC values were approximately 40% lower when co-administered with sodium zirconium cyclosilicate. No dose adjustments or separation of time of dosing are required for any of these medicinal products. However, sodium zirconium cyclosilicate should be administered at least 2 hours before or 2 hours after oral medicinal products with clinically meaningful gastric pH dependent bioavailability. Examples of medicinal products that should be administered 2 hours before or after sodium zirconium cyclosilicate to avoid possible raised gastric pH drug interaction are azole antifungals (ketoconazole, itraconazole and posaconazole), anti-HIV agents (atazanavir, nelfinavir, indinavir, ritonavir, saquinavir, raltegravir, ledipasvir and rilpivirine) and tyrosine kinase inhibitors (erlotinib, dasatinib and nilotinib). Sodium zirconium cyclosilicate can be co-administered without spacing of dosing times with oral medicinal products that do not exhibit pH-dependent bioavailability. In another drug-drug interaction study in healthy volunteers, co-administration of Lokelma 15 g with tacrolimus 5 mg resulted in a decreased tacrolimus AUC and Cmax by 37% and 29% respectively. Therefore, tacrolimus should be taken at least 2 hours before or after Lokelma. In the same study, co- administration of Lokelma and cyclosporin did not show a clinically meaningful interaction.
שימוש לפי פנקס קופ''ח כללית 1994
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תאריך הכללה מקורי בסל
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הגבלות
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מידע נוסף