Buprenorphine/Naloxone

DEA Class; Rx

Common Brand Names; Suboxone, Zubsolv, Bunavail, Cassipa

Mixed opiate agonist-antagonist (buprenorphine) combined with naloxone (an opiate antagonist); naloxone is included as an abuse deterrent
Used for induction treatment in patients dependent on heroin or other short-acting opioids who are in opioid withdrawal; also used for maintenance treatment of opioid dependence
Prescribers must comply with the requirements of the Drug Addiction Treatment Act (DATA)

Indicated for the treatment of opiate agonist dependence.

Hypersensitivity

• Headache (28-36.4%)
• Withdrawal syndrome (24-25.2%)
• Insomnia (14-23%)
• Pain (22.4%)
• Nausea (7-15%)
• Hyperhidrosis (14%)
• Asthenia (6.5-14%)
• Constipation (5-12.1%)
• Abdominal pain (11.2%)
• Diarrhea (10%)
• Vasodilation or peripheral edema (9.3%)
• Chills (6-7.5%)
• Vomiting (4-7.5%)
• Postmarketing Reports
• Adrenal insufficiency
• Anaphylaxis
• Serotonin syndrome
• Hepatotoxicity
• Glossodynia
• Glossitis
• Oral mucosal erythema
• Oral hypoesthesia Stomatitis

Significant respiratory depression may occur with therapeutic doses

Use with caution in hypothyroidism, preexisting respiratory compromise, obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve and kyphoscoliosis, myxedema, adrenocortical insufficiency, alcohol intoxication, alcohol withdrawal syndrome, coma, severe renal impairment, geriatric or debilitated patients, delirium tremens, toxic psychoses, kyphoscoliosis, prostatic hypertrophy, urethral stricture, comatose patients, central nervous system (CNS) depression, biliary tract dysfunction, severe hepatic impairment, head injury, intracranial lesions, and intracranial hypertension or conditions in which intracranial pressure (ICP) may be increased

Use caution with concurrent use of other CNS depressants

Respiratory sedation is dose-dependent; usual doses may depress respiration to same degree as 10 mg of parenteral morphine

Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia; opioid use increases risk of CSA in a dose-dependent fashion; in patients who present with CSA, consider decreasing opioid dosage using best practices for opioid taper

Use caution in patients with history of ileus or bowel obstruction

May cause orthostatic hypotension; use caution in patients with hypovolemia, cardiovascular disease, or drugs that may worsen hypertension

Effects in CNS depression may impair ability to perform tasks that require mental alertness

Life-threatening neonatal syndrome may occur in newborns following maternal exposure to opioids; treat according to protocols developed by neonatology experts; prescribers should discuss with patients importance and benefits of management of opioid addiction throughout pregnancy

Data on use of buprenorphine, one of the active ingredients are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure

Caution should be exercised when therapy is administered to nursing women; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition