Brief Summary (For full Prescribing Information including Dosage and
Administration, and Patient Information, refer to package insert.)
WARNING: ABUSE POTENTIAL, LIFE-THREATENING
RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and
INTERACTION WITH ALCOHOL
Abuse Potential
OPANA ER contains oxymorphone, an opioid agonist and Schedule II
controlled substance with an abuse liability similar to other opioid
agonists, legal or illicit (see Warnings and Precautions). Assess each
patient’s risk for opioid abuse or addiction prior to prescribing
OPANA ER. The risk for opioid abuse is increased in patients with
a personal or family history of substance abuse (including drug or
alcohol abuse or addiction) or mental illness (e.g., major depressive
disorder). Routinely monitor all patients receiving OPANA ER for signs
of misuse, abuse, and addiction during treatment (see Drug Abuse
and Dependence).
Life-threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use
of OPANA ER, even when the drug has been used as recommended
and not misused or abused (see Warnings and Precautions). Proper
dosing and titration are essential and OPANA ER should only be
prescribed by healthcare professionals who are knowledgeable
in the use of potent opioids for the management of chronic pain.
Monitor for respiratory depression, especially during initiation of
OPANA ER or following a dose increase. Instruct patients to swallow
OPANA ER tablets whole. Crushing, dissolving, or chewing OPANA ER
can cause rapid release and absorption of a potentially fatal dose
of oxymorphone.
Accidental Exposure
Accidental ingestion of OPANA ER, especially in children, can result in a
fatal overdose of oxymorphone (see Warnings and Precautions).
Interaction with Alcohol
The co-ingestion of alcohol with OPANA ER may result in an increase
of plasma levels and potentially fatal overdose of oxymorphone (see
Warnings and Precautions). Instruct patients not to consume alcoholic
beverages or use prescription or non-prescription products that contain
alcohol while on OPANA ER.
INDICATIONS AND USAGE
OPANA ER is indicated for the relief of moderate to severe pain in patients requiring
continuous, around-the-clock opioid treatment for an extended period of time.
Limitations of Usage
OPANA ER is not intended for use:
• As an as-needed (prn) analgesic
• For pain that is mild or not expected to persist for an extended period of time
• For acute pain
• For postoperative pain unless the patient is already receiving chronic opioid
therapy prior to surgery or if the postoperative pain is expected to be moderate
to severe and persist for an extended period of time.
CONTRAINDICATIONS
OPANA ER is contraindicated in patients with:
• Significant respiratory depression
• Acute or severe bronchial asthma or hypercarbia
• Known or suspected paralytic ileus
• Moderate and severe hepatic impairment (see Clinical Pharmacology, Warnings
and Precautions).
• Hypersensitivity (e.g. anaphylaxis) to oxymorphone, any other ingredients in
OPANA ER, or to morphine analogs such as codeine (see Adverse Reactions).
WARNINGS AND PRECAUTIONS
Abuse Potential
OPANA ER contains oxymorphone, an opioid agonist and a Schedule II controlled
substance. Oxymorphone can be abused in a manner similar to other opioid
agonists, legal or illicit. Opioid agonists are sought by drug abusers and people
with addiction disorders and are subject to criminal diversion. Consider these risks
when prescribing or dispensing OPANA ER in situations where there is concern about
increased risks of misuse, abuse, or diversion. Concerns about abuse, addiction, and
diversion should not, however, prevent the proper management of pain.
Assess each patient’s risk for opioid abuse or addiction prior to prescribing
OPANA ER. The risk for opioid abuse is increased in patients with a personal or family
history of substance abuse (including drug or alcohol abuse or addiction) or mental
illness (e.g., major depression). Patients at increased risk may still be appropriately
treated with modified-release opioid formulations; however these patients will
require intensive monitoring for signs of misuse, abuse, or addiction. Routinely
monitor all patients receiving opioids for signs of misuse, abuse, and addiction
because these drugs carry a risk for addiction even under appropriate medical use.
Misuse or abuse of OPANA ER by crushing, chewing, snorting, or injecting the
dissolved product will result in the uncontrolled delivery of the opioid and pose
a significant risk that could result in overdose and death (see Overdosage).
Contact local state professional licensing board or state controlled substances authority
for information on how to prevent and detect abuse or diversion of this product.
Life Threatening Respiratory Depression
Respiratory depression is the primary risk of OPANA ER. Respiratory depression, if
not immediately recognized and treated, may lead to respiratory arrest and death.
Respiratory depression from opioids is manifested by a reduced urge to breathe and
a decreased rate of respiration, often associated with a “sighing