DILAUDID-HP INJECTION CII
Generic Name and Formulations:
Hydromorphone HCl 10mg/mL; soln for IV, IM or SC inj; preservative-free; contains sulfites.
Fresenius Kabi USA
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.
Use in opioid-tolerant patients only. Individualize; base starting dose on prior Dilaudid inj or prior dose of alternate opioid: see full labeling.
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.
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.
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.
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.
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