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Name
Oxymorphone

Generic Name
Oxymorphone

Dosage Form
Pills

Strengths
7.5 mg, 10 mg

Packaging
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Description

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Description

Oxymorphone, sold under the brand names Numorphan among others, is a powerful semi-synthetic opioid analgesic (painkiller) developed in Germany in 1914. Pain relief after injection begins after about 5–10 minutes and 15–30 minutes after rectal administration, and lasts about 3–4 hours for immediate-release tablets and 12 hours for extended-release tablets.

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Indications

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.

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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
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” pattern of breathing (deep breaths separated by abnormally long pauses). Carbon
dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. Management of
respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s
clinical status
While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of OPANA ER, the risk is greatest
during the initiation of therapy or following a dose increase. Closely monitor patients for respiratory depression when initiating
therapy with OPANA ER and following dose increases. Instruct patients against use by individuals other than the patient for whom
OPANA ER was prescribed and to keep OPANA ER out of the reach of children, as such inappropriate use may result in fatal
respiratory depression.
To reduce the risk of respiratory depression, proper dosing and titration of OPANA ER are essential
(2.1, 2.2)]. Overestimating the OPANA ER dose when converting patients from another opioid product can result in fatal overdose
with the first dose. Respiratory depression has also been reported with use of modified-release opioids when used as recommended
and not misused or abused.
To further reduce the risk of respiratory depression, consider the following:
• 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.
• Instruct patients to swallow OPANA ER tablets intact. The tablets are not to be crushed, dissolved, or chewed. The resulting
oxymorphone dose may be fatal, particularly in opioid-naïve individuals.
• OPANA ER is contraindicated in patients with respiratory depression and in patients with conditions that increase the risk of lifethreatening
respiratory depression.

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Side Effects

The following serious adverse reactions are discussed elsewhere in the labeling
Respiratory Depression
Chronic Pulmonary Disease
Head Injuries and Increased Intracranial Pressure
Interactions with Other CNS Depressants
Hypotensive Effect
Gastrointestinal Effects
Seizures.

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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
? Hypersensitivity (e.g. anaphylaxis) to oxymorphone, any other ingredients in OPANA ER, or to morphine analogs such as
codeine.

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Additional information

Quantity

120 Pills, 150 Pills, 180 Pills, 90 Pills

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