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• DILAUDID INJECTION is an opioid analgesic indicated for the management of pain where an opioid analgesic is appropriate.
• DILAUDID-HP INJECTION is indicated for the management of moderate-to-severe pain in opioid-tolerant patients who require higher doses of opioids.
- Most common adverse reactions are lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus.
• Concurrent use of other CNS depressants may cause respiratory depression, hypotension, and profound sedation or coma.
• Mixed agonist/antagonist analgesics may reduce the analgesic effect of hydromorphone and may precipitate withdrawal symptoms in these patients.
• DILAUDID-HP INJECTION is a concentrated formulation of
hydromorphone. Do NOT confuse DILAUDID-HP INJECTION with
DILAUDID INJECTION. Overdose and death could result.
• May cause respiratory depression, use with extreme caution in patients
at risk of respiratory depression, elderly and debilitated patients.
• Abuse of DILAUDID INJECTION and DILAUDID-HP INJECTION,
poses a hazard of overdose and death.
• Risk of medication errors: Morphine does not convert to hydromorphone
on a milligram per milligram basis. Use Table 1 to convert.
• Alcohol, other opioids and central nervous system depressants potentiate
the respiratory depressant effects of hydromorphone.
• Infants born to mothers physically dependent on DILAUDID
INJECTION or DILAUDID-HP INJECTION will also be physically
dependent and may exhibit respiratory difficulties and withdrawal
symptoms.
• Respiratory depression may be markedly increased in patients with head
injury, other intracranial lesions, or preexisting increase in intracranial
pressure.
• May cause hypotension, use with caution in patients at increased risk of
hypotension and in patients in circulatory shock.
• DILAUDID INJECTION and DILAUDID-HP INJECTION contain
sodium metabisulfite. There is a risk of anaphylactic symptoms and lifethreatening asthmatic episodes in susceptible people.
• Use with caution in patients with biliary tract disease including
pancreatitis.
• Use with caution and in reduced initial doses in the elderly, debilitated,
or other patient populations with increased risk of adverse reactions
from opioids.
• Use with caution in patients with alcoholism or other drug dependencies.
• May impair the mental and physical abilities needed to perform
potentially hazardous activities such as driving a car or operating
machinery.
