DILAUDID CII

Indications for DILAUDID:

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.

Adult:

Use lowest effective dose for shortest duration. Individualize. Initially 2–4mg every 4–6 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.

Children:

Not established.

Contraindications:

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.

Boxed Warning:

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.

Warnings/Precautions:

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.

See Also:

DILAUDID ORAL SOLUTION

Pharmacological Class:

Opioid agonist.

Interactions:

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.

Adverse Reactions:

Lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, pruritus; respiratory depression, severe hypotension, syncope.

REMS:

YES

How Supplied:

Tabs: 2mg, 4mg—100; 8mg—100, 500; Oral soln—473mL