Medically reviewed by Drugs.com. Last updated on Feb 5, 2021.
Applies to the following strengths: 1 mg/mL
Usual Adult Dose for:
Additional dosage information:
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
-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.
Use: Management of acute pain severe enough to require an intravenous opioid analgesic and for whom other treatments are inadequate.
Because of the risk of addiction, abuse, and misuse, even at recommended doses, reserve use for those in whom alternative treatments (e.g. non-opioid analgesics or opioid combination products):
-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.
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.
Titration and Maintenance Therapy:
-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.
Safe Reduction or Discontinuation:
-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.
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)
Safety and efficacy have not been established in patients younger than 18 years.
This drug is not recommended for use in children.
Consult WARNINGS section for additional precautions.
US Controlled Substance: Schedule II
Data not available
-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.
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