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Belbuca
Overview
What is Belbuca?
BELBUCA is a buccal film providing transmucosal delivery of buprenorphine hydrochloride, a partial opioid agonist. BELBUCA is a rectangular bi-layer, peppermint-flavored, buccal film with rounded corners, consisting of a white to off-white backing layer with strength identifier printed in black ink and a light yellow to yellow active mucoadhesive layer containing buprenorphine hydrochloride. The yellow side of the buccal film is applied to the inside of the cheek where it adheres to the moist buccal mucosa to deliver the drug as the film dissolves.
The chemical name of buprenorphine hydrochloride is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-, hydrochloride, [5α, 7α, (S)]. The structural formula is:
The molecular weight of buprenorphine hydrochloride is 504.10; the empirical formula is CHNO∙HCl. Buprenorphine hydrochloride occurs as a white or off white crystalline powder. It is sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. The pKa is 8.5 for the amine function and 10.0 for the phenol function.
BELBUCA is available as 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg buprenorphine per film. The strength of each film is dependent on the buprenorphine concentration in the formulation and the surface area of the film. Unique identifiers and film size for each strength are listed in Table 6.
The active ingredient in BELBUCA is buprenorphine hydrochloride. Each buccal film also contains carboxymethylcellulose sodium USP, citric acid anhydrous USP, hydroxyethylcellulose NF, hydroxypropylcellulose NF, methylparaben NF, monobasic sodium phosphate anhydrous USP, peppermint oil NF, polycarbophil USP, propylene glycol USP, propylparaben NF, sodium benzoate NF, sodium hydroxide NF, saccharin sodium NF, titanium dioxide USP, vitamin E acetate USP, yellow iron oxide, purified water USP, and TekPrint SW-9008 black ink (shellac NF, black iron oxide NF).
What does Belbuca look like?
What are the available doses of Belbuca?
Buccal film available in 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg dosage strengths. ()
What should I talk to my health care provider before I take Belbuca?
How should I use Belbuca?
BELBUCA is 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.
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BELBUCA should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
BELBUCA buccal film is for oral buccal use only and is to be applied to the buccal mucosa every 12 hours.
Instruct patients not to use BELBUCA if the pouch seal is broken or the buccal film is cut, damaged, or changed in any way and to avoid applying BELBUCA to areas of the mouth with any open sores or lesions.
What interacts with Belbuca?
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What are the warnings of Belbuca?
Sorry No Records found
What are the precautions of Belbuca?
Sorry No Records found
What are the side effects of Belbuca?
Sorry No records found
What should I look out for while using Belbuca?
BELBUCA is contraindicated in patients with:
BELBUCA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing BELBUCA, and monitor all patients regularly for the development of these behaviors and conditions .
Serious, life-threatening, or fatal respiratory depression may occur with use of BELBUCA. Monitor for respiratory depression, especially during initiation of BELBUCA or following a dose increase. Misuse or abuse of BELBUCA by chewing, swallowing, snorting or injecting buprenorphine extracted from the buccal film will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death .
Accidental exposure to even one dose of BELBUCA, especially in children, can result in a fatal overdose of buprenorphine .
Prolonged use of BELBUCA 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 .
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death .
What might happen if I take too much Belbuca?
Clinical Presentation
Acute overdosage with BELBUCA is manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen due to severe hypoxia in overdose situations .
Treatment of Overdose
In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen, vasopressors) in the management of circulatory shock and pulmonary edema, as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques.
Naloxone may not be effective in reversing any respiratory depression produced by buprenorphine. High doses of naloxone, 10-35 mg/70 kg, may be of limited value in the management of buprenorphine overdose. The onset of naloxone effect may be delayed by 30 minutes or more. Doxapram hydrochloride (a respiratory stimulant) has also been used.
Because the duration of reversal would be expected to be less than the duration of action of buprenorphine from BELBUCA, carefully monitor the patient until spontaneous respiration is reliably re-established. Even in the face of improvement, continued medical monitoring is required for at least 24 hours because of the possibility of extended effects of buprenorphine.
In an individual physically dependent on opioids, administration of an opioid receptor antagonist may precipitate an acute withdrawal. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.
How should I store and handle Belbuca?
KADCYLA (ado-trastuzumab emtansine) is supplied as:BELBUCA (buprenorphine) buccal films are supplied in cartons containing 60 individual child-resistant foil packages as follows Store at 25°C (77°F), excursions permitted to 15° to 30°C (59°F to 86ºF). [See USP Controlled Room Temperature.] Advise patients to store buprenorphine-containing medications safely and out of sight and reach of childrensee Patient Counseling Information ()].BELBUCA (buprenorphine) buccal films are supplied in cartons containing 60 individual child-resistant foil packages as follows Store at 25°C (77°F), excursions permitted to 15° to 30°C (59°F to 86ºF). [See USP Controlled Room Temperature.] Advise patients to store buprenorphine-containing medications safely and out of sight and reach of childrensee Patient Counseling Information ()].BELBUCA (buprenorphine) buccal films are supplied in cartons containing 60 individual child-resistant foil packages as follows Store at 25°C (77°F), excursions permitted to 15° to 30°C (59°F to 86ºF). [See USP Controlled Room Temperature.] Advise patients to store buprenorphine-containing medications safely and out of sight and reach of childrensee Patient Counseling Information ()].BELBUCA (buprenorphine) buccal films are supplied in cartons containing 60 individual child-resistant foil packages as follows Store at 25°C (77°F), excursions permitted to 15° to 30°C (59°F to 86ºF). [See USP Controlled Room Temperature.] Advise patients to store buprenorphine-containing medications safely and out of sight and reach of childrensee Patient Counseling Information ()].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor.
Non-Clinical Toxicology
BELBUCA is contraindicated in patients with:BELBUCA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing BELBUCA, and monitor all patients regularly for the development of these behaviors and conditions .
Serious, life-threatening, or fatal respiratory depression may occur with use of BELBUCA. Monitor for respiratory depression, especially during initiation of BELBUCA or following a dose increase. Misuse or abuse of BELBUCA by chewing, swallowing, snorting or injecting buprenorphine extracted from the buccal film will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death .
Accidental exposure to even one dose of BELBUCA, especially in children, can result in a fatal overdose of buprenorphine .
Prolonged use of BELBUCA 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 .
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death .
BELBUCA contains buprenorphine, a Schedule III controlled substance. As an opioid, BELBUCA exposes users to the risks of addiction, abuse, and misuse .
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed BELBUCA. Addiction can occur at recommended dosages and if the drug is misused or abused.
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing BELBUCA and monitor all patients receiving BELBUCA for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as BELBUCA, but use in such patients necessitates intensive counseling about the risks and proper use of BELBUCA, along with intensive monitoring for signs of addiction, abuse, or misuse.
Abuse or misuse of BELBUCA by swallowing may cause choking, overdose, and death
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing BELBUCA. Strategies to reduce the risk include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug . Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
The following serious adverse reactions described elsewhere in the labeling include:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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