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וולבוטרין 300 מ"ג XR WELLBUTRIN XR 300 MG (BUPROPION HYDROCHLORIDE)
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צורת מתן:
פומי : PER OS
צורת מינון:
אין פרטים : MODIFIED RELEASE TABLETS
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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 Since monoamine oxidase A and B inhibitors also enhance the catecholaminergic pathways, by a different mechanism from bupropion, concomitant use of WELLBUTRIN XR and monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.3) as there is an increased possibility of adverse reactions from their co-administration. At least 14 days should elapse between discontinuation of irreversible MAOIs and initiation of treatment with WELLBUTRIN XR. For reversible MAOIs a 24 hour period is sufficient. The effect of bupropion on other medicinal products Although not metabolised by the CYP2D6 isoenzyme, bupropion and its main metabolite, hydroxybupropion inhibit the CYP2D6 pathway. Co-administration of bupropion and desipramine to healthy volunteers known to be extensive metabolisers of the CYP2D6 isoenzyme resulted in large (2- to 5-fold) increases in the Cmax and AUC of desipramine. Inhibition of CYP2D6 was present for at least 7 days after the last dose of bupropion. Concomitant therapy with medicinal products with narrow therapeutic indices that are predominantly metabolised by CYP2D6 should be initiated at the lower end of the dose range of the concomitant medicinal product. Such medicinal products include certain antidepressants (e.g. desipramine, imipramine), antipsychotics (e.g. risperidone, thioridazine), beta-blockers (e.g. metoprolol), serotonin selective reuptake inhibitors (SSRIs) and Type 1C antiarrhythmics (e.g. propafenone, flecainide). If WELLBUTRIN XR is added to the treatment regimen of a patient already receiving such a medicinal product, the need to decrease the dose of the original medicinal product should be considered. In these cases the expected benefit of treatment with WELLBUTRIN XR should be carefully compared with the potential risks. There have been post-marketing reports of serotonin syndrome, a potentially life-threatening condition, when WELLBUTRIN XR is co-administered with a serotonergic agent, such as Selective Serotonin Reuptake Inhibitors (SSRI) or Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs) (see section 4.4). Drugs which require metabolic activation by CYP2D6 in order to be effective (e.g. tamoxifen), may have reduced efficacy when administered concomitantly with inhibitors of CYP2D6 such as bupropion (see section 4.4). Although citalopram (a SSRI) is not primarily metabolised by CYP2D6, in one study, bupropion increased the Cmax and AUC of citalopram by 30% and 40%, respectively. Co-administration of digoxin with bupropion may decrease digoxin levels. Digoxin AUC 0–24 h was decreased and renal clearance was increased in healthy volunteers, based on a cross-study comparison. Clinicians should be aware that digoxin levels may rise on discontinuation of bupropion and the patient should be monitored for possible digoxin toxicity. The effect of other medicinal products on bupropion Bupropion is metabolised to its major active metabolite hydroxybupropion primarily by the cytochrome P450 CYP2B6 (see section 5.2). Co-administration of medicinal products that may affect the metabolism of bupropion via CYP2B6 isoenzyme (e.g. CYP2B6 substrates: cyclophosphamide, ifosfamide, and CYP2B6 inhibitors: orphenadrine, clopidogrel), may result in increased bupropion plasma levels and lower levels of active metabolite hydroxybupropion. The clinical consequences of the inhibition of the metabolism of bupropion via CYP2B6 enzyme and the consequent changes in the bupropion-hydroxybupropion ratio are currently unknown. Since bupropion is extensively metabolised, caution is advised when bupropion is coadministered with medicinal products known to induce metabolism (e.g. carbamazepine, phenytoin, ritonavir, efavirenz) or inhibit metabolism (e.g. valproate), as these may affect its clinical efficacy and safety. In a series of studies in healthy volunteers, ritonavir (100 mg twice daily or 600 mg twice daily) or ritonavir 100 mg plus lopinavir 400 mg twice daily reduced the exposure of bupropion and its major metabolites in a dose dependent manner by approximately 20 to 80% (see section 5.2). Similarly, efavirenz 600 mg once daily for two weeks reduced the exposure of bupropion by approximately 55% in healthy volunteers. The clinical consequences of the reduced exposure are unclear, but may include decreased efficacy in the treatment of major depression. Patients receiving any of these drugs with bupropion may need increased doses of bupropion but the maximum recommended dose of bupropion should not be exceeded. Other interaction information Administration of WELLBUTRIN XR to patients receiving either levodopa or amantadine concurrently should be undertaken with caution. Limited clinical data suggest a higher incidence of undesirable effects (e.g. nausea, vomiting, and neuropsychiatric events – see section 4.8) in patients receiving bupropion concurrently with either levodopa or amantadine. Although clinical data do not identify a pharmacokinetic interaction between bupropion and alcohol, there have been rare reports of adverse neuropsychiatric events or reduced alcohol tolerance in patients drinking alcohol during bupropion treatment. The consumption of alcohol during WELLBUTRIN XR treatment should be minimised or avoided. There have been no pharmacokinetic studies with bupropion and co-administered benzodiazepines. Based on in vitro metabolic pathways, there is no basis for such an interaction. After coadministration of bupropion with diazepam in healthy volunteers, there was less sedation than when diazepam was administered alone. There has been no systematic evaluation of the combination of bupropion with antidepressants (other than desipramine and citalopram), benzodiazepines (other than diazepam), or neuroleptics. There has also been limited clinical experience with St John’s Wort. Concomitant use of WELLBUTRIN XR and a nicotine transdermal system (NTS) may result in elevations of blood pressure.
שימוש לפי פנקס קופ''ח כללית 1994
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וולבוטרין 300 מ"ג XR
