What is Opana?

Opana is an opioid pain medication. An opioid is sometimes called a narcotic.

Opana is used to treat moderate to severe pain.

Opana ER, the extended-release form of oxymorphone, is for around-the-clock treatment of pain and should not be used on an as-needed basis for pain.

The brands Opana and Opana ER have been discontinued, but generic oxymorphone tablets and extended-release tablets are still available. This information is retained for educational purposes only and may not be up to date.

Warnings

You should not use Opana if you have severe asthma or breathing problems, a blockage in your stomach or intestines, or moderate to severe liver disease.

Oxymorphone can slow or stop your breathing, and may be habit-forming. MISUSE OF OPANA CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Taking Opana during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use Opana with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not take Opana if you are allergic to oxymorphone, or if you have:

• severe asthma or breathing problems;
• severe liver disease; or
• a stomach or bowel obstruction (including paralytic ileus).

To make sure Opana is safe for you, tell your doctor if you have ever had:

• breathing problems, sleep apnea (breathing that stops during sleep);
• a head injury or seizures;
• drug or alcohol addiction, or mental illness;
• urination problems;
• liver or kidney problems; or
• problems with your gallbladder, pancreas, or thyroid.

If you use Opana while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Ask a doctor before using Opana if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

How should I use Opana?

Take Opana exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Never use Opana in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine.

Never share Opana with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Stop using all other around-the-clock opioid pain medications when you start taking Opana.

Take Opana on an empty stomach, at least 1 hour before or 2 hours after a meal.

Take the medicine at the same times each day.

Swallow the tablet whole to avoid exposure to a potentially fatal overdose. Do not crush, chew, break, or dissolve.

Take only one Opana ER extended-release tablet at a time. To avoid choking, do not lick or wet the tablet before placing it in your mouth.

Never crush or break an Opana pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This can cause in death.

Dosing information

Usual Adult Dose of Opana for Pain:

The following dosing recommendations can only be considered suggested approaches to what is actually a series of clinical decisions over time; each patient should be managed individually.

ORAL:
Use as first Opioid Analgesic:
-Initial dose: 10 to 20 mg orally every 4 to 6 hours as needed for pain
Maximum initial dose: 20 mg

Conversion from Other Oral Opioids to Oral Oxymorphone:
-Determine equipotent dose using published potency tables; it is safest to start therapy by administering one-half the calculated total daily oxymorphone requirement in 4 to 6 equally divided oral doses every 4 to 6 hours and gradually adjust dose as needed.

Comments:
-Dose conversion should be done carefully and with close monitoring due to large patient variability in regards to opioid analgesic response.
-Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
-Monitor closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and with each dose increase.
-Due to risks of addiction, abuse, and misuse, even at recommended doses, reserve use for patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products) have not been tolerated, or are not expected to be tolerated, or have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Use as the First Opioid Analgesic or for those who are NOT Opioid Tolerant:
Initial dose: Extended-release tablets: 5 mg orally every 12 hours

CONVERSION DOSES:
Immediate-Release Oxymorphone to Extended-Release Oxymorphone Tablets: Administer same total daily dose
-Initial dose: One-half total daily immediate-release requirement as extended-release tablet orally every 12 hours

From Other Oral Opioids to Oxymorphone Extended-Release Tablets:
-Discontinue all other around-the-clock opioid drugs when oxymorphone extended-release therapy is initiated.
-Published potency tables can be used to estimate a patient’s 24-hour oral oxymorphone requirement; however, due to substantial inter-patient variability, the conversion should then underestimate a patient’s 24-hour requirement and provide rescue medication as the dose is titrated.
-Alternatively, the following conversion factors (CF) may be used to convert selected oral opioids to the extended-release oxymorphone tablet: Oxymorphone, CF=1; Hydrocodone, CF=0.5; Oxycodone, CF=0.5; Methadone, CF= 0.5, Morphine, CF=0.333
-As an example: Sum the total daily dose of prior oral opioid; multiply that sum by the CF to obtain 24-hour oral oxymorphone requirement; divide by 2 to calculate approximate starting dose to be given every 12 hours, round down, if necessary.
-These CFs cannot be used to convert from oxymorphone extended-release tablets to the selected oral opioid as doing so will result in overestimation of the oral opioid dose and may result in fatal respiratory depression

TITRATION AND MAINTENANCE:
Maintenance Dose: Individually titrate to a dose that provides adequate analgesia and minimizes adverse reactions; dose adjustments may be made in 5 to 10 mg increments every 12 hours, every 3 to 7 days.
Breakthrough Pain: If the level of pain increases after dose stabilization, attempt to identify the source before increasing dose; rescue medication with appropriate immediate-release analgesia may be helpful