DILAUDID ORAL SOLUTION CII
Generic Name and Formulations:
Hydromorphone HCl 5mg/5mL; contains sulfites.
Indications for DILAUDID ORAL SOLUTION:
Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations Of use:
Reserve for use in patients for whom alternative treatment options have not been tolerated or not provided adequate analgesia.
Use lowest effective dose for shortest duration. Avoid dosing errors. Obtain a calibrated measuring cup/syringe. Individualize. Initially 2.5–10mg (2.5–10mL) every 3–6 hours as needed. Elderly: start at lower dose. Renal or hepatic impairment: initially ¼ to ½ the usual dose. Conversion from other opioids: see full labeling. Withdraw gradually by 25–50% every 2–4 days.
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.
Risk of medication errors. Addiction, abuse, and misuse. Risk evaluation and mitigation strategy (REMS). Life-threatening respiratory depression. Accidental ingestion. Neonatal opioid withdrawal syndrome. Risks from concomitant use with benzodiazepines or other CNS depressants.
Risk of accidental overdose and death due to medication errors; ensure accuracy when prescribing, dispensing, and administering (oral soln). Abuse potential (monitor). Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Drug abusers. Renal or hepatic 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, 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 precipitate withdrawal symptoms. May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.
Lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, pruritus; respiratory depression, severe hypotension, syncope.
Tabs: 2mg, 4mg—100; 8mg—100, 500; Oral soln—473mL
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