Drug Name:
DILAUDID-HP INJECTION CII

Generic Name and Formulations:
Hydromorphone HCl 10mg/mL; soln for IV, IM or SC inj; preservative-free; contains sulfites.
Company:
Fresenius Kabi USA
Therapeutic Use:
Indications for DILAUDID-HP INJECTION:
Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in opioid-tolerant patients who require higher doses.
Limitations Of use:
Reserve for use in patients for whom alternative treatment options have not been tolerated or not provided adequate analgesia.
Adult:
Use in opioid-tolerant patients only. Individualize; base starting dose on prior Dilaudid inj or prior dose of alternate opioid: see full labeling.
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. Dilaudid-HP: opioid non-tolerant.
Boxed Warning:
Addiction, abuse, and misuse. Life-threatening respiratory depression. Accidental ingestion. Neonatal opioid withdrawal syndrome. Risks from concomitant use with benzodiazepines and other CNS depressants. Risk of medication errors.
Warnings/Precautions:
Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Abuse potential (monitor). 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:
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.
How Supplied:
Prefilled syringes—24
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