Wechselwirkungen · Buvidal
Buvidal 64 mg prolonged-release solution for injection Buvidal 96 mg prolonged-release solution for injection Buvidal 128 mg prolonged-release solution for injection Buvidal 160 mg prolonged-release solution for injection · Abschnitt 4.5 · PDF-Seite 24
HOS-140339 · Präparat HOS-098498
Buprenorphine should be used cautiously when co-administered with: • naltrexone and nalmefene: These are opioid antagonists that can block the pharmacological effects of buprenorphine. For opioid-dependent patients currently receiving buprenorphine treatment, naltrexone may precipitate a sudden onset of prolonged and intense opioid withdrawal symptoms. For patients currently receiving naltrexone treatment, the intended therapeutic effects of buprenorphine administration may be blocked by naltrexone. • alcoholic drinks or medicinal products containing alcohol as alcohol increases the sedative effect of buprenorphine (see section 4.7). • benzodiazepines: This combination may result in death due to respiratory depression of central origin. Therefore, dosages must be closely monitored and this combination must be avoided in cases where there is a risk of misuse. Patients should be warned that it is extremely dangerous to self-administer non-prescribed benzodiazepines whilst taking this product, and should also be cautioned to use benzodiazepines concurrently with this product only as directed by their physician (see section 4.4). • gabapentinoids: The concomitant use of Buvidal with gabapentinoids (gabapentin and pregabalin) may result in respiratory depression, hypotension, profound sedation, coma or death. Therefore, dosages must be closely monitored and this combination must be avoided in cases where there is a risk of misuse. Patients should be cautioned to use gabapentinoids concurrently with this product only as directed by their physician (see section 4.4). • Serotonergic medicinal products, such as MAO inhibitors, selective serotonin re-uptake inhibitors (SSRIs), serotonin norepinephrine re-uptake inhibitors (SNRIs) or tricyclic antidepressants as the risk of serotonin syndrome, a potentially life-threatening condition, is increased (see section 4.4). • other central nervous system depressants: Other opioid derivatives (e.g. methadone, analgesics and antitussives); certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, antipsychotics, clonidine and related substances. These combinations increase central nervous system depression. The reduced level of alertness can make driving and using machinery hazardous (see section 4.7). • opioid analgesics: Adequate analgesia may be difficult to achieve when administering a full opioid agonist in patients receiving buprenorphine. The potential for overdose also exists with a full agonist, especially when attempting to overcome buprenorphine partial agonist effects, or when buprenorphine plasma levels are declining (see section 4.4) • Buprenorphine is metabolised to norbuprenorphine primarily by CYP3A4. Interaction with co- administered inducers or inhibitors have been established in studies using transmucosal and transdermal buprenorphine. Buprenorphine is also metabolised to buprenorphine-3β- glucuronide by UGT1A1. • CYP3A4 inhibitors may inhibit the metabolism of buprenorphine resulting in increased Cmax and AUC of buprenorphine and norbuprenorphine. Buvidal avoids first-pass effects and CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, nelfinavir or indinavir, or azole antifungals such as ketoconazole or itraconazole, or macrolide antibiotics) are expected to have less effects on buprenorphine metabolism when co-administered with Buvidal as compared to when co-administered with sublingual buprenorphine. When switching from sublingual buprenorphine to Buvidal, patients may need to be monitored to ensure plasma buprenorphine levels are adequate. Patients already on Buvidal who start treatment with CYP3A4 inhibitors should be treated with weekly Buvidal and be monitored for signs and symptoms of overtreatment. Conversely, if a patient who is concomitantly treated with Buvidal and a CYP3A4
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): indinavir (HOS-084518) pregabalin (HOS-112893) norepinephrine (HOS-090547) nelfinavir (HOS-084520) methadone (HOS-086198) protease (HOS-085623) ketoconazole (HOS-084513) clonidine (HOS-088594) naltrexone (HOS-115836) nalmefene (HOS-115837) gabapentin (HOS-090745) serotonin (HOS-085477) itraconazole (HOS-084516) ritonavir (HOS-084521)
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Version 2025-03-21T17:42:00Z · SHA-256 1ad9ce13109b545d01c45ffd56cec5dc90c2b7294f4e2ae1f7e5e985c1a064eb · Passage a29834a297e58897f230ac85a5938fedfb1c445658da5ff294f0999631e2634e · Zeichen 58–4215 im Abschnitt