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דייויגו 10 מ"ג DAYVIGO ® 10 MG (LEMBOREXANT)
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
Interactions : אינטראקציות
7 DRUG INTERACTIONS 7.1 Drugs Having Clinically Important Interactions with DAYVIGO Table 2: Clinically Important Drug Interactions with DAYVIGO Effect of Other Drugs on DAYVIGO Strong, Moderate, and Weak CYP3A Inhibitors Concomitant use with a strong, moderate, or weak CYP3A inhibitor increases Clinical Impact: lemborexant AUC and Cmax which may increase the risk of DAYVIGO adverse reactions [see Clinical Pharmacology (12.3)]. Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inhibitors [see Dosage and Administration (2.2)]. Intervention: The maximum recommended dose of DAYVIGO with weak CYP3A inhibitors is 5 mg [see Dosage and Administration (2.2)]. Strong CYP3A inhibitors: itraconazole, clarithromycin Examples: Moderate CYP3A inhibitors: fluconazole, verapamil Weak CYP3A inhibitors: chlorzoxazone, ranitidine Strong and Moderate CYP3A Inducers Concomitant use with a strong or moderate CYP3A inducer decreases Clinical Impact: lemborexant exposure, which may reduce DAYVIGO efficacy [see Clinical Pharmacology (12.3)]. Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inducers Intervention: [see Dosage and Administration (2.2)]. Strong CYP3A inducers: rifampin, carbamazepine, St. John’s wort Examples: Moderate CYP3A inducers: bosentan, efavirenz, etravirine, modafinil Alcohol Concomitant use of alcohol increases lemborexant Cmax and AUC. Co- administration of DAYVIGO with alcohol produced a numerically greater Clinical Impact: negative impact on postural stability and memory as compared with alcohol alone when assessed near the tmax of DAYVIGO (2 hours post-dose) [see Clinical Pharmacology (12.2)]. Avoid alcohol consumption with DAYVIGO [see Warnings and Precautions Intervention: (5.1)]. Effect of DAYVIGO on Other Drugs CYP2B6 Substrates Concomitant use of DAYVIGO decreases the AUC of drugs that are CYP2B6 Clinical Impact: substrates, which may result in reduced efficacy for these concomitant medications [see Clinical Pharmacology (12.3)]. Patients receiving DAYVIGO and CYP2B6 substrates concurrently should be Intervention: monitored for adequate clinical response. Increasing the doses of CYP2B6 substrates may be considered as needed. Examples: Bupropion, methadone
שימוש לפי פנקס קופ''ח כללית 1994
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