WHAT IS OPAND AND WHAT IS IT USED FOR?
Opana (Oxymorphone Hydrochloride) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve OPANA for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Opana (Oxymorphone Hydrochloride) is not indicated as an as-needed (prn) analgesic.
Opana is supplied as follow: 5mg, 10mg, 15mg, 20mg, 30mg, 40mg
DOSAGE AND ADMINISTRATION
To avoid medication errors, prescribers and pharmacists must be aware that oxymorphone is available as both immediate-release 5 mg and 10 mg tablets and extended-release 5 mg and 10 mg tablets.
OPANA should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
Initiate the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience and risk factors for addiction, abuse, and misuse. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with Opana (Oxymorphone Hydrochloride)
OPANA tablets must be taken whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth. Crushing, chewing, or dissolving OPANA ER tablets will result in uncontrolled delivery of oxymorphone and can lead to overdose or death
OPANA is administered at a frequency of twice daily (every 12 hours). Administer on an empty stomach, at least 1 hour prior to or 2 hours after eating.
Use of OPANA as the First Opioid Analgesic
Initiate treatment with OPANA ER with the 5 mg tablet orally every 12-hours.
Use of Opana (Oxymorphone Hydrochloride) in Patients who are not Opioid Tolerant
The starting dose for patients who are not opioid tolerant is OPANA 5 mg orally every 12 hours. Patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, or an equianalgesic dose of another opioid.
Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.
Conversion from OPANA to Opana (Oxymorphone Hydrochloride)
Patients receiving OPANA may be converted to OPANA by administering half the patient’s total daily oral OPANA dose as OPANA, every 12 hours.
Conversion from Parenteral Oxymorphone to Opana (Oxymorphone Hydrochloride)
The absolute oral bioavailability of OPANA is approximately 10%. Convert patients receiving parenteral oxymorphone to OPANA by administering 10 times the patient’s total daily parenteral oxymorphone dose as OPANA in two equally divided doses (e.g., [IV dose x 10] divided by 2). Due to patient variability with regards to opioid analgesic response, upon conversion monitor patients closely to evaluate for adequate analgesia and side effects.
Conversion from Other Oral Opioids to Opana (Oxymorphone Hydrochloride)
Discontinue all other around-the-clock opioid drugs when OPANA therapy is initiated.
While there are useful tables of opioid equivalents readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products. As such, it is preferable to underestimate a patient’s 24-hour oral oxymorphone requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral oxymorphone requirements which could result in adverse reactions.
SIDE EFFECTS OF OXYMORPHONE (OPANA, OPANA ER)?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Like other narcotic medicines, oxymorphone can slow your breathing. Death may occur if breathing becomes too weak.
weak or shallow breathing;
a light-headed feeling, like you might pass out;
chest pain, wheezing, cough with yellow or green mucus;
severe vomiting; or
low cortisol levels–nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Serious side effects may be more likely in older adults and those who are malnourished or debilitated
Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.
Common side effects may include:
stomach pain, nausea, vomiting, constipation, diarrhea;
dizziness, drowsiness, headache, tired feeling;
dry mouth, increased sweating;
sleep problems (insomnia); or
mild rash or itching.
IMPORTANT INFORMATION TO KNOW
You should not use this medicine 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 THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.
Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.
Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.