Buprenorphine

Buprenorphine sublingual tablet is indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine sublingual tablet should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine sublingual tablet, contains buprenorphine, a partial opioid agonist, and is indicated for the treatment of opioid dependence and is preferred for induction. (1) Buprenorphine sublingual tablet should be used as part of a complete treatment plan that includes counseling and psychosocial support. (1)

• Administer buprenorphine sublingual tablet sublingually as a single daily dose
• Strongly consider prescribing naloxone at the time buprenorphine sublingual tablet is initiated or renewed because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose
• To avoid precipitating withdrawal, induction with buprenorphine sublingual tablet should be undertaken when objective and clear signs of withdrawal are evident
• Buprenorphine and naloxone sublingual film or buprenorphine and naloxone sublingual tablet is generally initiated after two days of buprenorphine sublingual tablet titration
• Administer buprenorphine sublingual tablets as directed in the Full Prescribing Information
• Buprenorphine sublingual tablet must be administered whole
• Do not cut, chew, or swallow buprenorphine sublingual tablets
• When discontinuing treatment, gradually taper to avoid signs and symptoms of withdrawal
• Important Dosage and Administration Instructions Buprenorphine sublingual tablet is administered sublingually as a single daily dose
• Buprenorphine sublingual tablet does not contain naloxone and is preferred for use only during induction
• Following induction, buprenorphine and naloxone sublingual film or buprenorphine and naloxone sublingual tablet is preferred due to the presence of naloxone when clinical use includes unsupervised administration. …

Buprenorphine sublingual tablet is supplied as an uncoated round, biconvex, white to off-white tablets in two dosage strengths: buprenorphine 2 mg, and buprenorphine 8 mg. Sublingual tablet: 2 mg buprenorphine and 8 mg buprenorphine. ( 3 )

• The safety and effectiveness of buprenorphine sublingual tablet has not been established
• In pediatric patients

Clinical studies of buprenorphine sublingual tablet, buprenorphine and naloxone sublingual film, or buprenorphine and naloxone sublingual tablet did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. …

• Advise patients to read the FDA-approved patient labeling (Medication Guide)
• Storage and Disposal Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store buprenorphine sublingual tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home [see Warnings and Precautions , Drug Abuse and Dependence ]
• Inform patients that leaving buprenorphine sublingual tablets unsecured can pose a deadly risk to others in the home
• Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. …

• Buprenorphine sublingual tablet is contraindicated in patients with a history of hypersensitivity to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions ]
• Hypersensitivity to buprenorphine

Table 3 includes clinically significant drug interactions with buprenorphine. Table 3. Clinically Significant Drug Interactions Benzodiazepines or other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effects, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death. Intervention: Cessation of benzodiazepines or other CNS depressants is preferred in most cases of concomitant use. In some cases, monitoring in a higher level of care for taper may be appropriate. …

Addiction, Abuse, and Misuse: Buprenorphine can be abused in a similar manner to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits. (5.1) Respiratory Depression: Life-threatening respiratory depression and death have occurred in association with buprenorphine use. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with buprenorphine sublingual tablets. …

The following serious adverse reactions are described elsewhere in the labeling: • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] • Respiratory and CNS Depression [see Warnings and Precautions (5.2, 5.3)] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5)] • Adrenal Insufficiency [see Warnings and Precautions (5.6)] • Opioid Withdrawal [see Warnings and Precautions (5.7, 5.10)] • Hepatitis, Hepatic Events [see Warnings and Precautions (5.8)] • Hypersensitivity Reactions [see Warnings and Precautions (5.9)] • Orthostatic Hypotension [see Warnings and Precautions (5.16)] • Elevation of Cerebrospinal Fluid Pressure [see Warnings and Precautions (5.17)] …

8.1 Pregnancy Risk Summary The data on use of buprenorphine, the active ingredient in buprenorphine sublingual tablets, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure. …

Clinical Presentation The manifestations of acute overdose include pinpoint pupils, sedation, hypotension, hypoglycemia, respiratory depression, and death. Treatment of Overdose In the event of overdose, the respiratory and cardiac status of the patient should be monitored carefully. When respiratory or cardiac functions are depressed, primary attention should be given to the re-establishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. …

9.1 Controlled Substance Buprenorphine sublingual tablet contains buprenorphine, a Schedule III controlled substance under the Controlled Substances Act. 9.2 Abuse Buprenorphine, like morphine and other opioids, has the potential for being abused and is subject to criminal diversion. This should be considered when prescribing or dispensing buprenorphine in situations when the clinician is concerned about an increased risk of misuse, abuse, or diversion. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.