OXYMORPHONE HYDROCHLORIDE ER 15mg
Oxymorphone is a semi-synthetic opioid substitute for morphine. It is a potent analgesic. Opioid analgesics exert their principal pharmacologic effects on the CNS and the gastrointestinal tract. The principal actions of therapeutic value are analgesia and sedation. Opioids produce respiratory depression by direct action on brain stem respiratory centers. The mechanism of respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to increases in carbon dioxide tension and to electrical stimulation.
Mechanism of action :
Oxymorphone interacts predominantly with the opioid mu-receptor. These mu-binding sites are discretely distributed in the human brain, with high densities in the posterior amygdala, hypothalamus, thalamus, nucleus caudatus, putamen, and certain cortical areas. They are also found on the terminal axons of primary afferents within laminae I and II (substantia gelatinosa) of the spinal cord and in the spinal nucleus of the trigeminal nerve. Also, it has been shown that oxymorphone binds to and inhibits GABA inhibitory interneurons via mu-receptors. These interneurons normally inhibit the descending pain inhibition pathway. So, without the inhibitory signals, pain modulation can proceed downstream.
Patients should never confuse the Dilaudid-HP Injection with other types of injections because an overdose and even death could occur.
When dispensing, administering, or prescribing, patients and doctors should avoid confusing between ml and mg. Such errors can result in overdose and even death.
Hydromorphone HCI can expose users to misuse, abuse and addiction risks that can cause overdose and death.
Doctors should monitor their patients closely because severe, fatal, or life-threatening respiratory depression may occur.
Prolonged use of hydromorphone HCL during pregnancy can cause neonatal opioid withdrawal syndrome that can be life-threatening if not recognized and treated. A pregnant woman or one planning to be pregnant should know and be advised of the risk of the withdrawal syndrome. The appropriate treatment is available too.
Combining hydromorphone HCL with alcohol, benzodiazepines or other depressants of the central nervous system can cause severe respiratory depression, acute sedation, coma, and death.
Side effects :
See also Warning section.Nausea, vomiting, headache, constipation, dry mouth, mild itching, lightheadedness, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Sometimes a soft mass that looks like the tablet may appear in your stool. This effect is harmless because your body has already absorbed the medication.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as agitation, confusion, hallucinations), stomach/abdominal pain, vision changes, slow/fast heartbeat, difficulty urinating, difficulty swallowing this medication (such as choking, gagging), signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, fainting, seizure, severe drowsiness/difficulty waking up.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
DOSAGE AND ADMINISTRATION :
To avoid medication errors, prescribers and pharmacists must be aware that oxymorphone is available as both immediate-release 5 mg and 15 mg tablets and extended-release 5 mg and 15 mg tablets
OPANA ER 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 ER.
OPANA ER 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 ER 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 ER as the First Opioid Analgesic
Initiate treatment with OPANA ER with the 5 mg tablet orally every 12-hours.
Use of OPANA ER in Patients who are not Opioid Tolerant
The starting dose for patients who are not opioid tolerant is OPANA ER 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 ER
Patients receiving OPANA may be converted to OPANA ER by administering half the patient’s total daily oral OPANA dose as OPANA ER, every 12 hours.
Conversion from Parenteral Oxymorphone to OPANA ER
The absolute oral bioavailability of OPANA ER is approximately 15%. Convert patients receiving parenteral oxymorphone to OPANA ER by administering 10 times the patient’s total daily parenteral oxymorphone dose as OPANA ER 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 ER
Discontinue all other around-the-clock opioid drugs when OPANA ER 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. In an OPANA ER clinical trial with an open-label titration period, patients were converted from their prior opioid to OPANA ER using Table 1 as a guide for the initial OPANA ER dose.