Quest for the right Drug
סימבאלתה 60 מ"ג CYMBALTA 60 MG (DULOXETINE AS HYDROCHLORIDE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
פומי : PER OS
צורת מינון:
אין פרטים : GASTRO RESISTANT CAPSULES
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
2 DOSAGE AND ADMINISTRATION 2.1 Important Administration Instructions Administer CYMBALTA orally (with or without meals) and swallow whole. Do not chew or crush, and do not open the capsule and sprinkle its contents on food or mix with liquids because these actions might affect the enteric coating. Cymbalta should not be administered through a gastric tube either because the pellets may obstruct the tube. If a dose of CYMBALTA is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of CYMBALTA at the same time. 2.2 Dosage for Treatment of Major Depressive Disorder in Adults Administer CYMBALTA at a total dose of 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to CYMBALTA before increasing to 60 mg once daily. While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits. Periodically reassess to determine the need for maintenance treatment and the appropriate dosage for such treatment. 2.3 Dosage for Treatment of Generalized Anxiety Disorder Recommended Dosage in Adults less than 65 Years of Age For most adults less than 65 years of age with GAD, initiate CYMBALTA 60 mg once daily. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to CYMBALYA before increasing to 60 mg once daily. While a 120 mg once daily dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefit. Nevertheless, if a decision is made to increase the dosage beyond 60 mg once daily, increase dosage in increments of 30 mg once daily. Periodically reassess to determine the continued need for maintenance treatment and the appropriate dosage for such treatment. Recommended Dosage in Geriatric Patients In geriatric patients with GAD, initiate CYMBALTA at a dosage of 30 mg once daily for 2 weeks before considering an increase to the target dose of 60 mg/day. Thereafter, patients may benefit from doses above 60 mg once daily. If a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The maximum dose studied was 120 mg per day. 2.4 Dosage for Treatment of Diabetic Peripheral Neuropathic Pain in Adults Administer 60 mg once daily in adults with diabetic peripheral neuropathic pain. There is no evidence that doses higher than 60 mg once daily confer additional significant benefit and the higher dosage is clearly less well tolerated. For patients for whom tolerability is a concern, a lower starting dose may be considered. Since diabetes is frequently complicated by renal disease, consider a lower starting dosage and gradual increase in dosage for patients with renal impairment [see Dosage and Administration (2.7), Use in Specific Populations (8.10)]. 2.5 Dosage for Treatment of Fibromyalgia Recommended Dosage in Adults The recommended CYMBALTA dosage is 60 mg once daily in adults with fibromyalgia. Begin treatment at 30 mg once daily for 1 week, to allow patients to adjust to CYMBALTA before increasing to 60 mg once daily. Some patients may respond to the starting dosage . There is no evidence that dosages greater than 60 mg/day confer additional benefit, even in patients who do not respond to a 60 mg/day dosage, and higher dosages were associated with a higher rate of adverse reactions. 2.6 Dosage for Treatment of Chronic Musculoskeletal Pain in Adults The recommended CYMBALTA dosage is 60 mg once daily in adults with chronic musculoskeletal pain. Begin treatment at 30 mg once daily for one week, to allow patients to adjust to CYMBALTA before increasing to 60 mg once daily. There is no evidence that higher dosages confer additional benefit, even in patients who do not respond to a 60 mg once daily dosage, and higher dosages are associated with a higher rate of adverse reactions [see Clinical Studies (14.6)]. 2.7 Dosage in Patients with Hepatic Impairment or Severe Renal Impairment Avoid use in patients with chronic liver disease or cirrhosis [see Contraindications (4), Warnings and Precautions (5.14) and Use in Specific Populations (8.9)]. Avoid use in patients with severe renal impairment, GFR <30 mL/minute [see Warnings and Precautions (5.14) and Use in Specific Populations (8.10)]. 2.8 Discontinuing CYMBALTA Adverse reactions after discontinuation of CYMBALTA, after abrupt or tapered discontinuation, include: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [see Warnings and Precautions (5.7)]. 2.9 Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with CYMBALTA. Conversely, at least 5 days should be allowed after stopping CYMBALTA before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4)]. 2.10 Use of CYMBALTA with Other MAOIs such as Linezolid or Methylene Blue Do not start CYMBALTA in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4)]. In some cases, a patient already receiving CYMBALTA therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, CYMBALTA should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with CYMBALTA may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.4)]. The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with CYMBALTA is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.4)].
פרטי מסגרת הכללה בסל
השימוש בתרופות לטיפול בכאב נוירופתי יבוצעו בהתאם להנחיות הקליניות המקצועיות המתעדכנות מזמן לזמן על פי המידע העדכני בתחום הטיפול במחלה. התחלת הטיפול בתרופות אלו תיעשה על פי המלצת מרפאת כאב או על פי מרשם של רופא מומחה בכאב או בנוירולוגיה או בסוכרת או בהרדמה או באונקולוגיה
מסגרת הכללה בסל
התוויות הכלולות במסגרת הסל
התוויה | תאריך הכללה | תחום קליני | Class Effect | מצב מחלה |
---|---|---|---|---|
לטיפול בכאב נוירופתי | 01/11/2006 |
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
01/11/2006
הגבלות
תרופה מוגבלת לרישום ע'י רופא מומחה או הגבלה אחרת
מידע נוסף
עלון מידע לצרכן
12.04.18 - עלון לצרכן 09.01.22 - עלון לצרכן אנגלית 09.01.22 - עלון לצרכן עברית 09.01.22 - עלון לצרכן ערבית 15.09.23 - עלון לצרכן עברית 27.10.23 - עלון לצרכן אנגלית 27.10.23 - עלון לצרכן ערבית 28.08.24 - עלון לצרכן עברית 27.09.24 - עלון לצרכן אנגלית 27.09.24 - עלון לצרכן ערבית 21.11.24 - עלון לצרכן עברית 15.06.15 - החמרה לעלון 03.03.16 - החמרה לעלון 28.02.17 - החמרה לעלון 03.05.20 - החמרה לעלון 29.03.21 - החמרה לעלון 15.12.21 - החמרה לעלון 22.10.23 - החמרה לעלון 28.08.24 - החמרה לעלוןלתרופה במאגר משרד הבריאות
סימבאלתה 60 מ"ג