According to the indications approved by Health Sciences Authority (HSA): it can be used for the relief of moderate to severe acute postsurgical pain. Therefore, Naldebain can relieve the pain of surgery for cancer patients; however, it is not suggested for chronic cancer pain relief.
*Chronic cancer pain will continuously intensify over the disease process, so the analgesic should be increased accordingly. Naldebain has a ceiling effect; besides, it could induce addiction in opioid users. It is suggested that opioid therapy without the ceiling effect is better for the treatment of chronic cancer pain.
*Ceiling Effect: When the dosage of the drug is increased to a certain level, it doesn’t increase the effect of pain relief.
According to the indications approved by Health Sciences Authority (HSA): it can be used for the relief of moderate to severe acute postsurgical pain. Therefore, it is not suggested to be used to change the dressing for burn injury patients.
Yes, according to the indications approved by Health Sciences Authority (HSA): it can be used for the relief of moderate to severe acute postsurgical pain. Naldebain can be used in the context of a laparoscopy surgery.
Naldebain is listed in class B of the Pregnancy Category (no risk has been shown to the fetus in animal testing, but no control studies have been done on pregnant women). The safety of the drug in pregnancy has not been established and should only be used for a pregnant woman when there is a real need. According to the package insert of Naldebain, the rate of transfer through the placenta is fairly high and rapid. Fetal and neonatal side effects have been reported during pregnancy including fetal bradycardia, respiratory depression, neonatal asphyxia, and weak muscle tone. Hence, it is not suggested to be used for a natural birth, and can be used for C-section after the baby is removed from the mother.
Nalbuphine is only excreted in small amounts through breast milk, as written in the package insert (less than 1% of the administered dosage), which is not clinically significant. We found the relevant literature and calculated in the same way that the percentage of Naldebain excreted through breast milk is 0.33% after 150 mg of injection at the highest blood concentration (16 ng/ml), which is a small dosage that can be used safely.
Naldebain has been approved for the relief of moderate to severe acute postsurgical pain. Obtaining approval for the treatment of chronic pain requires more than three types of validated clinical trials. We are still in the phase of planning and market research, thus Naldebain is not suggested for use in patients with chronic pain.
Naldebain is a kappa-receptor agonist and a mu-receptor antagonist. Methadone and Buprenorphine, which are commonly used in the therapeutic agent of opium addiction, are agonist/partial agonist of mu-receptors. Although Naldebain is a safe and long-acting drug, there have been no clinical trials studying the use of Naldebain in addiction treatment.
Because the onset time of Naldebain is 12 hours, it is suggested that if the patient is hospitalized for same day surgery, the physician should prescribe and administer Naldebain after the patient signs the surgical consent form, and administer an additional dosage of short-acting analgesics to make up for the delayed onset time of Naldebain.
Naldebain is a fixed-dosage, single-use drug, and no clinical studies have been conducted on repeated administration, so it is not necessary to adjust the dosage according to one’s weight.
Naldebain is not currently recommended for use on children under 18 years of age.
