Opana ER

What is Oxymorphone (marketed as Opana ER) in USA?

Opana ER (oxymorphone) is a semi-synthetic opioid used as a substitute for morphine in USA, known for its potent analgesic properties. Opioid analgesics primarily affect the central nervous system and the gastrointestinal tract. Their main therapeutic effects include providing pain relief and inducing sedation. Opioids can result in reduced respiration by directly impacting the respiratory centers in the brain stem. This respiratory depression is caused by decreased responsiveness of these centers to elevated carbon dioxide levels and electrical stimulation.

Opana ER, also known as oxymorphone hydrochloride extended-release tablets, was initially approved in 2006 for managing moderate to severe pain when continuous, around-the-clock opioid analgesia is necessary for an extended duration. Marketed by Endo Pharmaceuticals, the current formulation of the product was developed with specific physicochemical properties to deter physical and chemical abuse methods such as snorting and injecting.

However, despite being approved in 2011, the FDA deemed that the reformulated drug did not meet the agency’s standards for being classified as abuse-deterrent. Consequently, Endo’s request to include a description of abuse-deterrent properties in the product labeling was declined by the FDA.

Replacement medication for Opana ER in USA

When considering a replacement medication for Opana ER in USA, it’s important to recognize the wide range of options available to clinicians. There are numerous branded, proprietary products on the market, as well as generic alternatives that may be suitable. Additionally, it’s inevitable that other pharmaceutical companies will seek to take advantage of the discontinuation of Oxymorphone by encouraging patients to switch to their own products. These companies will likely provide compelling reasons for clinicians to consider their offerings.

It’s essential to acknowledge the unique characteristics of various opioids and the variability in patient response. No single product will be suitable for all patients who were previously taking Opana ER.

In our experience, most pharmaceutical companies operate ethically. They are likely to understand that their extended-release opioid (ERO) may not be the perfect fit for every patient who was previously using Opana ER. While they may want patients to switch to their product, they also recognize that for some prescribers, the transition away from Oxymorphone presents an opportunity for their ERO to be considered as a replacement.

Prevention:

It’s reasonable to assume that reputable companies aim to avoid scenarios where their product is associated with treatment failure after just one use. Therefore, they would likely prefer that only patients with the highest likelihood of tolerating and responding well to their product make the switch.

To initiate the selection process, clinicians should revisit the reasons why the patient was originally prescribed Opana ER in USA. Market analyses have indicated that Oxymorphone was the second-most commonly prescribed branded long-acting opioid for many years. Patients often started on Opana ER after trying other long-acting opioids, such as morphine ER or fentanyl patches, in combination with or without OxyContin. Due to Oxymorphone’s high therapy persistence in comparison to other long-acting opioid products, clinicians may need to review the patient’s medical records to understand the initial decision to prescribe Opana ER.

Selecting a replacement product requires careful consideration to mitigate the risk of over- or under dosing and to assess the likelihood of tolerability based on the patient’s history. When all these factors are taken into account, the selection of a suitable pharmacotherapeutic option should fall into place effectively.

In case of emergency/overdose when using Opana ER in USA:

When using Opana ER, it is crucial to have a discussion with your doctor regarding the availability of naloxone in USA, a rescue medication that can be used in case of emergency or overdose situations. Naloxone is a medication that works by blocking the effects of opiates, thus counteracting the life-threatening effects of an overdose and relieving dangerous symptoms caused by high levels of opiates in the blood. Your doctor may also prescribe naloxone if you live in a household with young children or individuals with a history of drug abuse.

It’s important to inquire with your doctor about how to obtain Opana ER, whether it’s directly from a pharmacy or through a community-based program. Additionally, it’s essential for you, your family members, caregivers, and anyone who spends time with you to be knowledgeable about recognizing an overdose, administering naloxone, and understanding the necessary steps to take until emergency medical help arrives.

Your pharmacist or doctor can provide detailed instructions on how to use Opana ER in USA. Alternatively, you can visit the manufacturer’s website for guidance. In the event of overdose symptoms, a friend or family member should administer the first dose of naloxone, call 911 immediately, and stay with you until medical help arrives. It’s important to note that symptoms may reoccur within a few minutes after administering naloxone. In such cases, additional doses can be given every 2 to 3 minutes before medical help arrives.