Usual Adult Dose for Pain

Major Orthopedic Surgery of the Lower Extremity: 15 mg via lumbar epidural administration once prior to surgery

Lower Abdominal or Pelvic Surgery: 10 to 15 mg via lumbar epidural administration once prior to surgery

Maximum dose: 20 mg

Caesarian Section: 10 mg via lumbar epidural administration once after clamping of the umbilical cord

Comments:

• Like all opioids, dosing requirements will vary and it is necessary to individualize dose taking into account patient's age, body mass, physical status, prior opioid experience, risk factors for respiratory depression, and concomitant medications.
• This drug should not be administered to women for vaginal labor and delivery.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

Elderly and Debilitated Patients:

• Carefully evaluate benefits and risks
• Dose should generally be at the low end of the dosing range
• May require monitoring for periods longer than 48 hours

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to active substance or any component of the product
• Respiratory depression
• Acute or severe bronchial asthma
• Upper airway obstruction
• Any contraindication that precludes an epidural injection
• Paralytic ileus
• Known head injury
• Increased intracranial pressure
• Circulatory shock

Dialysis

Data not available

Other Comments

Administration advice:

• For lumbar epidural administration only; not intended for intrathecal, intravenous, or intramuscular administration
• Do not use an in-line filter during administration
• Proper needle or catheter placement into epidural space must be verified prior to injection; administration at the thoracic level or higher is not recommended because it has not been studied.
• Once administered, no other medication should be administered into the epidural space for at least 48 hours

• Protect from freezing; each vial has a freeze indicator that should be checked prior to administration. If the bulb of the freeze indicator changes from clear to pink or purple, the vial may have frozen and should not be used.
• Store refrigerated (36F to 46F [2C to 8C]) in carton
• Unopened intact vials may be held at room temperature for up to 30 days, after 30 days they should be discarded; these vials should not be returned to the refrigerator.

• May be administered undiluted or may be diluted to a total volume of up to 5 mL (dilute with preservative-free 0.9% normal saline)
• Gently invert vials to re-suspend the particles immediately prior to withdrawal from the vial; avoid aggressive agitation.
• Following withdrawal from the vial, may keep at room temperature (59F to 86F) for up to 4 hours prior to administration; do not heat-sterilize or gas-sterilize

• Do not mix with any other medication

• This drug should be administered under the direct supervision of a physician experienced in the technique of epidural administration; it should be administered in a setting with staff and equipment to manage severe respiratory depression; patients should be monitored for a minimum of 48 hours after dosing.

• Monitor for respiratory depression for a minimum of 48 hours after administration in a facility with staff and equipment to manage significant respiratory depression
• Monitor for orthostatic hypotension during post-surgical ambulation, especially in patients with reduced circulating blood volume, impaired myocardial function, and those receiving concomitant sympatholytic drugs