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.

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.

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.

Do not stop using Opana suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using Opana.

Store at room temperature away from moisture, heat, and light. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

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.

Usual Adult Dose of Opana ER for Chronic Pain:

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

Comments:
-An opioid tolerant patient is one who has been receiving for 1-week or longer at least: oral morphine 60 mg/day, fentanyl transdermal patch 25 mcg per hour, oral oxycodone 30 mg/day, oral hydromorphone 8 mg/day, oral oxymorphone 25 mg/day, or an equianalgesic dose of another opioid
-When converting from methadone, close monitoring is of particular importance due to methadone's long half-life.
-Dose conversion should be done carefully and with close monitoring due to large patient variability in regards to opioid analgesic response.
-Upon cessation of therapy in the physically dependent patient, individually taper reassessing frequently to manage pain and withdrawal symptoms.

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.

Since Opana is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An oxymorphone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction to Opana: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• weak or shallow breathing, breathing that stops;

• a light-headed feeling, like you might pass out;

• seizure (convulsions);

• chest pain, wheezing, cough with yellow or green mucus;

• severe vomiting;

• high levels of serotonin in the body - agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea; or

• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common Opana side effects may include:

• dizziness, drowsiness;

• headache, tiredness; or

• stomach pain, nausea, vomiting, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other opioids - opioid pain medicine or prescription cough medicine;

• a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Ativan, and others;

• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

• drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may interact with oxymorphone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.