![]() Two of these studies demonstrated efficacy in patients with low back pain. The FDA approval of Belbuca was based on three 12-week double-blind, placebo-controlled clinical trials in opioid-naïve and opioid-experienced patients with moderate-to-severe chronic low back pain using pain scores as the primary efficacy variable. 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. Prolonged use of Belbuca during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.Accidental exposure to Belbuca, especially in children, can result in fatal overdose of buprenorphine.Instruct patients on proper administration of Belbuca to reduce the risk. Monitor closely, especially upon initiation or following a dose increase. ![]() Serious, life-threatening, or fatal respiratory depression may occur.Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions. Belbuca exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death.Side EffectsĪdverse effects associated with the use of Belbuca may include, but are not limited to, the following:īelbuca comes with the following boxed warning: Mechanism of Actionīelbuca buccal film contains buprenorphine, a partial opioid agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Please see drug label foe dosing in specific populations, conversions from other analgesics/opioids and titrations and maintenance dosing. Doses up to 450 mcg every 12 hours were studied in opioid naïve patients in the clinical trials. Individual titration to a dose that provides adequate analgesia and minimizes adverse reactions should proceed in increments of 150 mcg every 12 hours, no more frequently than every 4 days. Iitiate treatment in opioid naïve patients with a 75 mcg film once daily or, if tolerated, every 12 hours for at least 4 days, then increase dose to 150 mcg every 12 hours. Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse. Belbuca buccal film contains buprenorphine, a partial opioid agonist.īelbuca is specifically indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.īelbuca is supplied as a buccal film for oral administration.
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