The major hazards of DILAUDID ORAL LIQUID and DILAUDID 8 mg TABLETS include respiratory depression and apnea. To a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest have occurred.

The most frequently observed adverse effects are light-headedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus. These effects seem to be more prominent in ambulatory patients and in those not experiencing severe pain.

General and CNS: Weakness, headache, agitation, tremor, uncoordinated muscle movements, alterations of mood (nervousness, apprehension, depression, floating feelings, dreams), muscle rigidity, paresthesia, muscle tremor, blurred vision, nystagmus, diplopia and miosis, transient hallucinations and disorientation, visual disturbances, insomnia, increased intracranial pressure

Cardiovascular: Flushing of the face, chills, tachycardia, bradycardia, palpitation, faintness, syncope, hypotension, hypertension.

Respiratory: Bronchospasm and laryngospasm

Gastrointestinal: Constipation, biliary tract spasm, ileus, anorexia, diarrhea, cramps, taste alteration

Genitourinary: Urinary retention or hesitancy, antidiuretic effects

Dermatologic: Urticaria, other skin rashes, diaphoresis.

Drug Interactions with Other CNS Depressants: The concomitant use of other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers and alcohol may produce additive depressant effects. Respiratory depression, hypotension and profound sedation or coma may occur. When such combined therapy is contemplated, the dose of one or both agents should be reduced. DILAUDID should not be taken with alcohol. Opioid analgesics, including DILAUDID ORAL LIQUID and DILAUDID 8 mg TABLETS, may enhance the action of neuromuscular blocking agents and produce an excessive degree of respiratory depression.

Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol, and buprenorphine) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as hydromorphone. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of hydromorphone and/or may precipitate withdrawal symptoms in these patients.

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