Misuse or abuse of BUTRANS by chewing, swallowing, snorting or injecting buprenorphine extracted from the transdermal system will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death [see Warnings and Precautions 5. Neonatal Opioid Withdrawal Syndrome Prolonged use of BUTRANS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.
Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of buprenorphine. Neonatal Opioid Withdrawal Syndrome Prolonged use of buprenorphine during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.
If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS ]. Reserve concomitant prescribing of buprenorphine and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. Buprenorphine Injection Description Buprenorphine hydrochloride is a partial opioid agonist. Buprenorphine hydrochloride is a white powder, weakly acidic and with limited solubility in water.
Buprenorphine hydrochloride injection is a clear, sterile, injectable agonist-antagonist analgesic intended for intravenous or intramuscular administration. Each mL of buprenorphine hydrochloride injection contains 0. It has the following structural formula: One unusual property of buprenorphine hydrochloride observed in vitro studies is its very slow rate of dissociation from its receptor.
This could account for its longer duration of action than morphine, the unpredictability of its reversal by opioid antagonists, and its low level of manifest physical dependence. Pharmacodynamics Buprenorphine hydrochloride is a parenteral opioid analgesic with 0. Pharmacological effects occur as soon as 15 minutes after intramuscular injection and persist for 6 hours or longer.
Peak pharmacologic effects usually are observed at 1 hour. When used intravenously, the times to onset and peak effect are shortened.
Buprenorphine demonstrates narcotic antagonist activity and has been shown to be equipotent with naloxone as an antagonist of morphine in the mouse tail flick test. Effects on the Central Nervous System The principal action of therapeutic value of buprenorphine is analgesia and is thought to be due to buprenorphine binding with high affinity to opioid receptors on neurons in the brain and spinal cord.
Buprenorphine produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation.
Under usual conditions of use in adults, both buprenorphine hydrochloride and morphine show similar dose-related respiratory depressant effects. At adult therapeutic doses, buprenorphine hydrochloride 0. Buprenorphine causes miosis, even in total darkness.
Pinpoint pupils are a sign of opioid overdose but are not pathognomonic e. Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations. Effects on the Gastrointestinal Tract and Other Smooth Muscle Buprenorphine causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.
Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone is increased to the point of spasm, resulting in constipation.
Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase. Effects on the Cardiovascular System Buprenorphine produces peripheral vasodilation, which may result in orthostatic hypotension or syncope.
Buprenorphine hydrochloride may cause a decrease or, rarely, an increase in pulse rate and blood pressure in some patients. They also stimulate prolactin, growth hormone GH secretion, and pancreatic secretion of insulin and glucagon. Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date.
Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal models. The clinical significance of these findings is unknown.1.
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The International Association for the study of pain defines chronic pain as pain with no biological value, that persists past normal tissue healing. To our knowledge, the effects of buprenorphine on the testicular tissue and spermatogenesis process are currently unknown. Therefore, the present study was designed in order to investigate the histopathological features of mice testicular tissue following buprenorphine administration. Cochrane works collaboratively with contributors around the world to produce authoritative, relevant, and reliable evidence, in the form of Cochrane Reviews.
1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. Clinical experience suggests that, as with any patient taking varied doses of opioids prior to surgery, patients maintained on buprenorphine may proportionally need more opioids for postoperative pain, as compared with opioid-naïve patients.
Buprenorphine can prevent the binding of additional opioid medications to opioid receptors during surgery and was found to have a ceiling effect for analgesia. 2 The goal of this literature review. Buprenorphine has been widely used for post-operative analgesia in laboratory animals. Clinical efficacy has been demonstrated in both subjective and objective pain assessment schemes, however doubts have been expressed as to its value as an analgesic.
Buprenorphine Injection official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions, pharmacology and more.
If the patient's pain score exceeds the NRS 4, they can take the additional rescue medicine, acetaminophen. After the surgery, patient's pain score and quality of life would be recorded sequentially.
The time of recording is postoperative 36 hours, 72 hours, 7 days, 2 .