Indications for DSUVIA:
For use in adults in a certified medically supervised healthcare setting (eg, hospitals, surgical centers, emergency departments) for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use:
Not for home use or for children; discontinue treatment before leaving supervised healthcare setting. Not for use >72hrs. Only for administration by healthcare provider. Reserve for use in patients for whom alternative options have not been or are not expected to be tolerated, or have not or are not expected to provide adequate analgesia.
Do not chew or swallow tab. Avoid eating, drinking, talking for 10mins after dose. Administer via single-dose applicator by healthcare provider. 30mcg SL as needed with ≥1hr between doses; max 12 tabs in 24hrs. Max cumulative daily dose: 360mcg (12 tabs).
Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.
Accidental exposure. REMS program. Life-threatening respiratory depression. Addiction, abuse, and misuse. Cytochrome P450 3A4 interaction. Risks from concomitant use with benzodiazepines or other CNS depressants.
Life-threatening respiratory depression; monitor closely (esp. during initiation). Accidental exposure may cause fatal overdose (esp. in children). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. Abuse potential (monitor). COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression; monitor and consider non-opioid analgesics. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. CNS depression. Impaired consciousness, coma, shock; avoid. Seizure disorders. Biliary tract disease. Acute pancreatitis. Bradyarrhythmias. Drug abusers. Hepatic or severe renal impairment. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery: not recommended. Nursing mothers: monitor infants.
Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and/or precipitate withdrawal symptoms. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors); monitor. Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin); monitor. May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.
Nausea, headache, vomiting, dizziness, hypotension; respiratory depression, syncope.