Usual Adult Dose for Pain

Initial dose: 1.5 mg intravenously
Supplemental dose: 0.75 mg intravenously every hour as needed, starting 1 hour after initial dose
Maximum single dose: 3 mg
Maximum daily dose: 27 mg

Patient Controlled Analgesia (PCA):
Recommended demand dose: 0.35 mg with a 6-minute lock out; may consider a demand dose of 0.5 mg
Maximum dose: 27 mg per day

Comments:

• Use the lowest effective dose for the shortest duration consistent with treatment goals.
• Individualize dose based on pain severity, patient response and prior analgesic experience, and addiction, abuse, and misuse risk.
• Use beyond 48 hours has not been studied in trials.
• Onset of analgesia is expected within 2 to 5 minutes of initial dose.
• An initial 1 mg dose of this drug is approximately equipotent to 5 mg morphine; as patients differ in their response to opioids, use this comparison only as a guide.

• Have not been tolerated or toleration is not expected
• Have not provided adequate analgesia or adequate analgesia is not expected

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild to moderate liver dysfunction: No adjustment of initial dose recommended; less frequent dosing may be required.

Severe liver dysfunction: Consider reducing initial dose, administer subsequent doses only after careful review of pain severity and clinical status.

Dose Adjustments

Poor CYP 450 2D6 Metabolizers: Less frequent dosing may be required.

• Base on genotype or previous experience with other CYP 450 2D6 substrates.
• Monitor closely, administer subsequent doses only after careful review of pain severity and response to treatment.

• Titrate to a dose adequate for analgesia and minimization of adverse reactions; continually assess for efficacy, adverse events, and development of addiction, abuse, or misuse.
• Frequent communication among the healthcare providers, patient, and family is important during changing analgesic requirements, including initial dose titration.
• If pain increases after dose stabilization, try to identify the pain source before increasing the dose of this drug.
• Consider dose reduction for unacceptable adverse reactions.

• Patients taking opioids regularly who may be physically dependent should have their dose tapered gradually while monitoring for withdrawal.
• Taper more slowly if withdrawal symptoms appear; either by increasing the interval between decreases, reducing the amount of dose change, or both.
• Do not abruptly discontinue in an opioid-dependent patient.

Precautions

US BOXED WARNING(S): ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS

• This drug carries a risk of opioid addiction, abuse, and misuse, potentially leading to overdose and death; assess patient risk before prescribing and regularly monitor for symptom development.
• Serious, life-threatening, or fatal respiratory depression may occur; monitor for respiratory depression, especially at treatment initiation or dose increases.
• Neonatal opioid withdrawal syndrome may occur with prolonged use during pregnancy, which if unrecognized and untreated can be life-threatening; if prolonged use during pregnancy is required, advise the patient of the risk of neonatal opioid withdrawal syndrome and have appropriate treatment available.
• Profound sedation, respiratory depression, coma, and death may occur with concomitant use of benzodiazepines or other CNS depressants (including alcohol); reserve concomitant use to those for whom other treatments are inadequate, limit dose and duration to the minimum needed, monitor for respiratory depression and sedation.

• Significant respiratory depression
• Acute or severe bronchial asthma if unmonitored or in the absence of resuscitative equipment.
• Known or suspected gastrointestinal obstruction, including paralytic ileus
• Hypersensitivity to the active ingredient (e.g. anaphylaxis)

Dialysis

Data not available

Other Comments

Administration advice:

• For intravenous administration only.

• Store at controlled room temperature; excursions permitted to 15 to 30C.
• Protect from freezing.
• Protect from light.

• Draw drug directly from vial into the PCA syringe or IV bag without diluting.
• The solution is clear, colorless, and preservative free; discard if discolored, cloudy, or particles are seen.

• Monitor closely for respiratory depression, especially within 24 to 48 hours of initiation and after dose increases; adjust dose accordingly.