Oxymorphone

Oxymorphone is a semi-synthetic opioid analgesic that is used primarily for the treatment of moderate to severe pain. It is a potent opioid derived from thebaine, an alkaloid found in the opium poppy, and is structurally similar to morphine and oxycodone.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Brain tumor
• Drug abuse or addiction
• Head injury
• Heart disease
• If you often drink alcohol
• Kidney disease
• Liver disease
• Lung disease, asthma, or breathing problems
• Problems urinating
• Seizures
• Stomach or intestine problems
• Taken an MAOI like Marplan, Nardil, or Parnate in the last 14 days
• An unusual or allergic reaction to oxymorphone, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Take this medication on an empty stomach, at least 1 hour before or 2 hours after food. Do not take with food. Take your medication at regular intervals. Do not take it more often than directed. Do not stop taking except on your care team’s advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

Forms of Oxymorphone Used in Treatment:

1. Immediate-Release (IR) Tablets:
   • Used for acute pain or breakthrough pain.
   • Typically taken every 4 to 6 hours as needed.
2. Extended-Release (ER) Tablets:
   • Designed for long-term, around-the-clock management of chronic pain.
   • These tablets are taken once or twice a day and should not be crushed, chewed, or dissolved, as this can lead to a dangerous release of too much medication.
3. Injectable Form:
   • Used in clinical settings for rapid pain relief, often after surgery or in emergency situations.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

This medication may interact with the following:

• Alcohol
• Antihistamines for allergy, cough and cold
• Atropine
• Certain medications for anxiety or sleep
• Certain medications for bladder problems like oxybutynin, tolterodine
• Certain medications for depression like amitriptyline, fluoxetine, sertraline
• Certain medications for Parkinson disease like benztropine, trihexyphenidyl
• Certain medications for seizures like phenobarbital, primidone
• Certain medications for stomach problems like dicyclomine, hyoscyamine
• Certain medications for travel sickness like scopolamine
• General anesthetics like halothane, isoflurane, methoxyflurane, propofol
• Ipratropium
• Local anesthetics like lidocaine, pramoxine, tetracaine
• Medications that relax muscles for surgery
• Other narcotic medications for pain or cough
• Phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to this medication. Tolerance means that you will need a higher dose of the medication for pain relief. Tolerance is normal and is expected if you take this medication for a long time.

There are different types of narcotic medications (opioids) for pain. If you take more than one type at the same time, you may have more side effects. Give your care team a list of all medications you use. They will tell you how much medication to take. Do not take more medication than directed. Get emergency help right away if you have problems breathing.

Do not suddenly stop taking your medication because you may develop a severe reaction. Your body becomes used to the medication. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a medication for a nonmedical reason. If you have pain, you have a medical reason to take pain medication. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose will be slowly lowered over time to avoid any side effects.

Talk to your care team about naloxone and how to get it. Naloxone is an emergency medication used for an opioid overdose. An overdose can happen if you take too much opioid. It can also happen if an opioid is taken with some other medications or substances, like alcohol. Know the symptoms of an overdose, like trouble breathing, unusually tired or sleepy, or not being able to respond or wake up. Make sure to tell caregivers and close contacts where it is stored. Make sure they know how to use it. After naloxone is given, you must get emergency help right away. Naloxone is a temporary treatment. Repeat doses may be needed.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medication. Avoid alcoholic drinks.

This medication will cause constipation. If you do not have a bowel movement for 3 days, call your care team.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Dizziness
• Drowsiness
• Dry mouth
• Headache
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Managing Oxymorphone Treatment:

Proper management is essential to prevent adverse effects, addiction, and overdose. Below are key components of managing oxymorphone treatment effectively:

1. Assessment and Individualized Treatment Plans:

• Patient Evaluation: Before prescribing oxymorphone, a healthcare provider assesses the patient’s medical history, pain levels, opioid tolerance, and risk factors for opioid abuse or addiction.
• Tailored Dosages: The dosage is tailored to each patient’s needs. It often starts low and is gradually adjusted based on pain relief and side effects.
• Monitoring: Regular follow-ups are necessary to monitor the patient’s response to treatment, effectiveness, side effects, and any signs of misuse.

2. Adjusting for Opioid Tolerance:

• Oxymorphone is usually prescribed for patients who are opioid-tolerant, meaning they are already on a stable opioid regimen. Opioid-naïve patients (those who haven’t used opioids before) require careful dosing to avoid overdose or severe respiratory depression.

3. Managing Side Effects:

• Common side effects such as nausea, constipation, drowsiness, and dizziness should be addressed by the healthcare provider.
• Respiratory depression is a serious risk, especially in high doses or when combined with other sedatives. Patients should be monitored for any signs of difficulty breathing.
• Preventing Constipation: Patients are often advised to take laxatives or stool softeners, as opioids, including oxymorphone, commonly cause constipation.

4. Avoiding Abuse and Overdose:

• Abuse Deterrent Formulations (ADFs): Some forms of oxymorphone are formulated to prevent abuse by making it harder to crush or inject the drug.
• Limiting Access: Healthcare providers may prescribe limited quantities of oxymorphone to reduce the risk of abuse or overdose.
• Patient Education: Patients should be made aware of the dangers of combining oxymorphone with other substances like alcohol, benzodiazepines, or other central nervous system depressants, which can lead to fatal respiratory depression.

Key Information about Oxymorphone:

1. Brand Names:

• Opana (discontinued in some markets due to abuse concerns)
• Numorphan (less common)

2. Indications:

• Severe Acute Pain: Oxymorphone is often used for managing severe pain, such as pain following surgery, trauma, or in cases of severe injury.
• Chronic Pain: It is prescribed for patients dealing with long-term, chronic pain, such as cancer-related pain or pain associated with terminal illnesses.
• Preoperative Medication: Oxymorphone can also be used as a preoperative sedative and to alleviate anxiety before surgery.

3. Formulations:

• Immediate-release (IR) tablets: For managing acute, breakthrough pain.
• Extended-release (ER) tablets: For around-the-clock pain management in chronic conditions.
• Injection: Occasionally used in hospitals or clinical settings for severe pain or surgical sedation.

4. Mechanism of Action:

Oxymorphone works by binding to mu-opioid receptors in the central nervous system (CNS), leading to a change in the perception of pain and the emotional response to pain. Like other opioids, it mimics the action of endogenous pain-relieving chemicals (endorphins) by activating these receptors.

5. Usage and Dosage:

• The dosage of oxymorphone varies depending on the patient’s pain level, previous exposure to opioids, and specific condition.
• For opioid-tolerant patients, extended-release oxymorphone may be prescribed for continuous pain management.
• Immediate-release forms are used to treat acute pain or breakthrough pain episodes in individuals already on long-term opioid therapy.

6. Side Effects:

Common side effects include:

• Drowsiness
• Nausea and vomiting
• Constipation
• Dizziness
• Respiratory depression (potentially life-threatening at high doses)

Serious side effects may include:

• Addiction, tolerance, and dependence: Like all opioids, oxymorphone has a high potential for misuse, abuse, and addiction.
• Respiratory depression: Especially at higher doses or when combined with other CNS depressants (such as alcohol, benzodiazepines).

7. Warnings and Precautions:

• Potential for Abuse: Oxymorphone is classified as a Schedule II controlled substance under the Controlled Substances Act due to its high potential for addiction and abuse.
• Risk of Overdose: Patients who are opioid-naïve or those who misuse the drug (e.g., by crushing and injecting extended-release formulations) face a significant risk of overdose.
• Interactions: Oxymorphone should not be taken with alcohol, sedatives, or other central nervous system depressants, as this can increase the risk of severe respiratory depression.
• Pregnancy: Use during pregnancy can result in neonatal opioid withdrawal syndrome, a serious condition in newborns.

Discontinuation of Opana ER:

Due to the rising abuse of Opana ER, particularly when people crushed the tablets and injected them, leading to outbreaks of disease and overdose, the FDA requested the discontinuation of this formulation in 2017. However, oxymorphone remains available in other formulations.

Why Should You Use Oxymorphone ?

Oxymorphone treatment refers to the medical use of oxymorphone for managing pain, particularly in individuals with moderate to severe pain that is not well controlled by other pain relievers. It is also used in specific cases for pain management in cancer patients or individuals with chronic pain conditions. Oxymorphone is a potent opioid analgesic and must be carefully managed to avoid the risk of addiction, misuse, and overdose.

Uses of Oxymorphone in Treatment:

1. Acute Pain Management:
   • Oxymorphone is used to treat acute, severe pain, such as post-surgical pain, injury, or trauma.
   • In such cases, immediate-release formulations are often used for fast pain relief.
2. Chronic Pain Management:
   • For patients with long-term conditions such as cancer, severe arthritis, or back pain, extended-release (ER) oxymorphone is prescribed to provide round-the-clock pain control.
   • It is particularly helpful for patients who need continuous opioid therapy and are opioid-tolerant (already taking opioids regularly).
3. Preoperative and Postoperative Pain:
   • Oxymorphone is sometimes used as a preoperative medication to alleviate anxiety and pain before surgery.
   • It may also be used postoperatively to manage significant pain following surgery.
4. Palliative Care:
   • In palliative care, oxymorphone is used to improve the quality of life for patients with terminal illnesses by effectively controlling severe pain, especially for cancer patients.

How to Prevent Oxymorphone Abuse ?

Oxymorphone abuse is a significant concern due to the drug’s potency as an opioid analgesic, its high potential for addiction, and the serious risks of overdose and fatal respiratory depression. Like other opioids, oxymorphone can be misused by taking higher doses than prescribed, using it in ways other than intended (e.g., crushing and injecting tablets), or by individuals without a legitimate prescription.

Preventing Oxymorphone Abuse:

Preventing the abuse of oxymorphone requires a combination of responsible prescribing practices, patient education, proper medication storage, and broader systemic interventions. Below are key strategies to prevent oxymorphone abuse:

1. Patient Education and Awareness

• Understanding Addiction Risks: Patients prescribed oxymorphone should be thoroughly informed about the potential for addiction, overdose, and the dangers of misuse. They need to understand that even when used as prescribed, oxymorphone carries risks, and misuse greatly increases those risks.
• Proper Use: Patients should be taught to take the medication exactly as prescribed—no altering the dose, frequency, or method of administration (such as crushing extended-release tablets, which is dangerous).
• Avoid Sharing Medication: Patients should never share oxymorphone with anyone, as it is tailored to individual pain management needs, and misuse by others can be fatal.

2. Safe Prescribing Practices

• Follow Prescribing Guidelines: Healthcare providers should adhere to the latest opioid prescribing guidelines, which emphasize using the lowest effective dose for the shortest duration necessary.
• Prescribe Non-Opioid Alternatives First: If possible, providers should prioritize non-opioid analgesics or less potent opioids. Oxymorphone should be reserved for cases where other treatments are insufficient.
• Monitor for Abuse Risk: Providers should screen patients for a history of substance abuse, mental health conditions, or other risk factors that may increase the likelihood of opioid misuse. High-risk patients should be closely monitored or prescribed alternative treatments.

3. Prescription Drug Monitoring Programs (PDMPs)

• Monitor Prescriptions: Healthcare providers should use Prescription Drug Monitoring Programs (PDMPs) to track a patient’s history with controlled substances. This can help identify patterns of misuse, such as “doctor shopping” (visiting multiple providers to obtain opioids).
• Limit Refills: Prescriptions should be written for limited quantities, especially for opioid-naïve patients, and regular follow-up should be conducted to assess pain management and the potential for misuse.

4. Abuse-Deterrent Formulations (ADFs)

• Use Abuse-Deterrent Formulations (ADFs): When available, prescribing oxymorphone in abuse-deterrent formulations can reduce the potential for misuse. These formulations are designed to make it difficult to crush, snort, or inject the medication, which are common methods of abuse.
  • Example: Some abuse-deterrent technologies make the tablet turn into a gel when crushed or dissolve more slowly, making it difficult to manipulate for non-oral use.

5. Proper Storage and Disposal

• Safe Storage: Patients should store oxymorphone in a secure, locked location, away from children, family members, or visitors who could potentially misuse the medication. This helps prevent theft and unauthorized access.
• Proper Disposal: Unused oxymorphone should be disposed of safely, either by returning it to a drug take-back program or following FDA guidelines for medication disposal. This prevents leftover pills from being abused.

6. Early Detection and Intervention

• Identify Early Signs of Misuse: Healthcare providers and family members should be aware of early warning signs of oxymorphone misuse, such as requesting early refills, mood swings, withdrawal symptoms between doses, or using the medication in higher doses than prescribed.
• Regular Monitoring: Patients prescribed oxymorphone for long-term use should be regularly monitored through follow-up appointments. Healthcare providers can assess the effectiveness of the medication, detect any signs of misuse, and adjust the treatment plan as needed.

7. Access to Naloxone

• Prescribe Naloxone: For patients at high risk of overdose (e.g., those on high doses of oxymorphone or combining it with other sedatives), naloxone (Narcan) should be co-prescribed. Naloxone is an opioid antagonist that can reverse the effects of an overdose.
• Educate on Naloxone Use: Patients, family members, and caregivers should be educated on how to administer naloxone in case of an emergency, as this can save lives in overdose situations.

8. Addressing Underlying Mental Health Issues

• Mental Health Support: People with mental health disorders are more vulnerable to opioid misuse. Ensuring comprehensive mental health care, including treatment for conditions like depression and anxiety, can reduce the risk of turning to opioids for relief.
• Integrated Care: Healthcare providers should screen for mental health conditions and provide or refer patients to psychological or psychiatric support, as addressing these issues may reduce the need for opioids.

9. Opioid Treatment Programs (OTPs) and Medication-Assisted Treatment (MAT)

• Treat Opioid Use Disorder (OUD): For patients who have developed an opioid use disorder, referral to treatment programs is essential. Opioid Treatment Programs (OTPs) offer Medication-Assisted Treatment (MAT) using drugs such as methadone, buprenorphine, or naltrexone, which help manage withdrawal symptoms and cravings.
• Counseling and Behavioral Therapy: Alongside MAT, counseling and behavioral therapies (such as Cognitive Behavioral Therapy) are critical to addressing the root causes of addiction and helping individuals manage their opioid use disorder.

10. Public Awareness Campaigns

• Community Education: Public health campaigns that raise awareness about the dangers of opioid misuse, the importance of safe medication storage and disposal, and the availability of treatment resources can help reduce oxymorphone abuse at the community level.