Naldebain Drug Interactions

Central Nervous System Depressants: Studies of NALDEBAIN concomitant use with general anesthetic have not been conducted.
Although nalbuphine possesses opioid antagonist activity, there is evidence that in nondependent patients it will not antagonize an opioid analgesic administered just before, concurrently, or just after an injection of nalbuphine. Therefore, patients receiving an opioid analgesic, general anesthetics, phenothiazines, or other tranquilizers, sedatives, hypnotics, other CNS depressants (including alcohol) concomitantly with NALDEBAIN may exhibit an additive effect. When such combined therapy is contemplated, the dose of one or both agents should be reduced.
In phase III studies, all subjects were given local anesthetic (bupivacaine) prior to surgery (99%). 94% of subjects combined using local anesthetics Lidocaine. About 2% subjects used midazolam. Reviewing overall adverse events, administration of local general anesthetic, bupivacaine, lidocaine, propofol and midazolam in combination with NALDEBAIN in phase III studies does not result in clinical significant adverse reactions.
Opioids: Studies of NALDEBAIN concomitant use with opiates have not been conducted. Since NALDEBAIN is nalbuphine's prodrug, the concomitant use with opioids could refer to experiences of nalbuphine hydrochloride. According to references, combinations of nalbuphine and opioids decrease incidence of opioid related side effects, ex: pruritus.
When NALDEBAIN combine used with nalbuphine, the dose of nalbuphine should not exceed 80 mg per day or 20 mg Q6H.
General anesthetic: Studies of NALDEBAIN concomitant use with general anesthetic, including inhaled anesthetic, intravenous administered anesthetic like opioid and benzodiazepine, have not been conducted. Since NALDEBAIN is nalbuphine's prodrug, the concomitant use with general anesthetics could refer to experiences of nalbuphine hydrochloride. According to references, there is no clinical significant safety concern without dosage adjustment of anesthetic.
Benzodiazepines: Due to additive pharmacologic effect, the concomitant use of opioids with benzodiazepines increases the risk of respiratory depression, profound sedation, coma and death.
The concomitant use of opioids and benzodiazepines increases the risk of respiratory depression because of actions at different receptor sites in the central nervous system that control respiration. Opioids interact primarily at μ-receptors, and benzodiazepines interact at GABAA sites. When opioids and benzodiazepines are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists.
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate (see Precautions).
Limit dosage and duration of concomitant use of benzodiazepines and opioids, and follow patients closely for respiratory depression and sedation.
Serotonergic Drugs: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Naldebain if serotonin syndrome is suspected. Examples of serotonergic drugs are selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g. mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) (see Precautions).