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עמוד הבית / זומיג 2.5 מ"ג / מידע מעלון לרופא

זומיג 2.5 מ"ג ZOMIG 2.5 MG (ZOLMITRIPTAN)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

פומי : PER OS

צורת מינון:

טבליות מצופות פילם : FILM COATED TABLETS

Interactions : אינטראקציות

4.5   Interaction with other medicinal products and other forms of interaction

There is no evidence that concomitant use of migraine prophylactic medications has any effect on the efficacy or unwanted effects of Zomig (for example beta blockers, oral dihydroergotamine, and pizotifen).

The pharmacokinetics and tolerability of Zomig were unaffected by acute symptomatic treatments such as paracetamol, metoclopramide and ergotamine.
Concomitant administration of other 5HT1B/1D agonists within 24 hours of Zomig treatment should be avoided.

Data from healthy subjects suggest there are no pharmacokinetic or clinically significant interactions between Zomig and ergotamine, however, the increased risk of coronary vasospasm is a theoretical possibility. Therefore, it is advised to wait at least 24 hours following the use of ergotamine containing preparations before administering Zomig. Conversely it is advised to wait at least six hours following use of Zomig before administering any ergotamine preparation (see Section 4.3).

Following administration of moclobemide, a specific MAO-A inhibitor, there was a small increase (26%) in AUC for zolmitriptan and a 3-fold increase in AUC of the active metabolite. Therefore, a maximum intake of 5 mg Zomig in 24 hours is recommended in patients taking an MAO-A inhibitor.

Following the administration of cimetidine, a general P450 inhibitor, the half-life of zolmitriptan was increased by 44% and the AUC increased by 48%. In addition the half-life and AUC of the active N-desmethylated metabolite (N- desmethylzolmitriptan) were doubled. A maximum dose of 5 mg Zomig in 24 hours is recommended in patients taking cimetidine. Based on the overall interaction profile, an interaction with inhibitors of the cytochrome P450 isoenzyme CYP1A2 cannot be excluded. Therefore, the same dosage reduction is recommended with compounds of this type, such as fluvoxamine and the quinolone antibiotics (e.g.
ciprofloxacin).

Fluoxetine does not affect the pharmacokinetic parameters of zolmitriptan.
Therapeutic doses of the specific serotonin reuptake inhibitors, fluoxetine, sertraline, paroxetine and citalopram do not inhibit CYP1A2. However, Serotonin Syndrome has been reported during combined use of triptans, and SSRIs (e.g. fluoxetine, paroxetine, sertraline) and SNRIs (e.g. venlafaxine, duloxetine) (see Section 4.4).

As with other 5HTIB/ID agonists, there is the potential for dynamic interactions with the herbal remedy St John’s wort (Hypericum perforatum) which may result in an increase in undesirable effects.


מסגרת הכללה בסל

התוויות הכלולות במסגרת הסל

התוויה תאריך הכללה תחום קליני Class Effect מצב מחלה
ZOLMITRIPTAN
RIZATRIPTAN
SUMATRIPTAN
שימוש לפי פנקס קופ''ח כללית 1994 לא צוין
תאריך הכללה מקורי בסל 01/03/2001
הגבלות תרופה מוגבלת לרישום ע'י רופא מומחה או הגבלה אחרת

בעל רישום

ASTRAZENECA (ISRAEL) LTD

רישום

108 67 29181 00

מחיר

0 ₪

מידע נוסף

עלון מידע לרופא

11.07.21 - עלון לרופא

עלון מידע לצרכן

10.12.12 - עלון לצרכן 12.05.15 - עלון לצרכן אנגלית 11.07.21 - עלון לצרכן עברית 12.05.15 - עלון לצרכן ערבית 07.03.23 - עלון לצרכן אנגלית 07.03.23 - עלון לצרכן ערבית 08.01.12 - החמרה לעלון 25.03.15 - החמרה לעלון 01.12.20 - החמרה לעלון

לתרופה במאגר משרד הבריאות

זומיג 2.5 מ"ג

קישורים נוספים

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