Opana ER Dosage
Generic name: oxymorphone hydrochloride
Dosage form: tablet, extended release
This dosage information does not include all the information needed to use Opana ER safely and effectively. See full prescribing information for Opana ER.
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
2.1 Initial Dosing
â€‹Initiate the dosing regimen for each patient individually, taking into account the patient"s prior analgesic treatment experience. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with OPANA ER â€‹â€‹[see Warnings and Precautions (5.2)].
â€‹Consider the following factors when selecting an initial dose of OPANA ER:
- â€‹Total daily dose, potency, and any prior opioid the patient has been taking previously;
- â€‹Reliability of the relative potency estimate used to calculate the equivalent dose of oxymorphone needed (Note: potency estimates may vary with the route of administration);
- â€‹Patient"s degree of opioid experience and opioid tolerance;
- â€‹General condition and medical status of the patient;
- â€‹Concurrent medication;
- â€‹Type and severity of the patient"s pain.
â€‹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 [see Patient Counseling Information (17)].
â€‹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.
â€‹Use of OPANA ER as the First Opioid Analgesic
â€‹Initiate Opana ER therapy with the 5 mg tablet twice daily (at 12-hour intervals). Adjust the dose of OPANA ER in increments of 5-10 mg every 12 hours every 3 to 7 days.
â€‹Conversion from OPANA to OPANA ER
â€‹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.
â€‹Conversion from Parenteral Oxymorphone to OPANA ER
â€‹The absolute oral bioavailability of OPANA ER is approximately 10%. 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.
â€‹Conversion from Other Oral Opioids to OPANA ER
â€‹While there are useful tables of oral and parenteral equivalents, there is substantial inter-patient variability in the relative potency of different opioid drugs and formulations. As such, it is safer to underestimate a patient’s 24-hour oral oxymorphone dose and provide rescue medication (e.g. immediate-release oxymorphone) than to overestimate the 24-hour oral oxymorphone dose and manage an adverse reaction. Consider the following general points:
â€‹In a Phase 3 clinical trial with an open-label titration period, patients were converted from their prior opioid to OPANA ER using the following table as a guide for the initial OPANA ER dose.
- â€‹The table is not a table of equianalgesic doses.
- â€‹The conversion ratios in this table are only to be used for the conversion from oral therapy with one of the listed opioid analgesics to OPANA ER.
- â€‹Do not use this table to convert from OPANA ER to another opioid. Doing so will result in an over-estimation of the dose of the new opioid and may result in fatal overdose.
â€‹For example, a patient receiving oxycodone at a total daily dose of 40 mg would then be converted to a total daily dose of 20 mg of oxymorphone (40 mg x 0.5), dosed as OPANA ER 10 mg twice daily.
|â€‹ CONVERSION RATIOS TO OPANA ER|
|â€‹ Opioids||â€‹ Total Daily Oral Dose||â€‹ Oral Conversion Ratio|
|â€‹ Oxymorphone||â€‹ 10 mg||â€‹ 1|
|â€‹ Hydrocodone||â€‹ 20 mg||â€‹ 0.5|
|â€‹ Oxycodone||â€‹ 20 mg||â€‹ 0.5|
|â€‹ Methadone||â€‹ 20 mg||â€‹ 0.5|
|â€‹ Morphine||â€‹ 30 mg||â€‹ 0.333|
2.2 Titration and Maintenance of Therapy
â€‹Individually titrate OPANA ER to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving OPANA ER to assess the maintenance of pain control and the relative incidence of adverse reactions. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.
â€‹If the level of pain increases, attempt to identify the source of increased pain, while adjusting the OPANA ER dose to decrease the level of pain. Because steady-state plasma concentrations are approximated within 3 days, OPANA ER dosage adjustments, preferably at increments of 5-10 mg every 12 hours, may be done every 3 to 7 days. Patients who experience breakthrough pain may require dosage adjustment or rescue medication with a small dose of an immediate-release medication (e.g. immediate-release oxymorphone).
â€‹During chronic, around-the-clock opioid therapy, especially for non-cancer pain syndromes, reassess the continued need for around-the-clock opioid therapy periodically (e.g., every 6 to 12 months) as appropriate.
â€‹If signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
2.3 Discontinuation of OPANA ER
â€‹When a patient no longer requires therapy with OPANA ER, use a gradual downward titration of the dose every two to four days, to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue OPANA ER.
2.4 Administration of OPANA ER
â€‹Instruct patients to swallow OPANA ER tablets intact. The tablets are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of oxymorphone [see Warnings and Precautions (5.2)]. Administer on an empty stomach, at least 1 hour prior to or 2 hours after eating.
2.5 Patients with Hepatic Impairment
â€‹OPANA ER is contraindicated in patients with moderate or severe hepatic impairment.
â€‹In opioid-naïve patients with mild hepatic impairment, initiate treatment with the 5 mg dose. For patients on prior opioid therapy, start OPANA ER at 50% lower than the starting dose for a patient with normal hepatic function on prior opioids and titrate slowly. Monitor patients closely for signs of respiratory or central nervous system depression [see Warnings and Precautions (5.2), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
2.6 Patients with Renal Impairment
â€‹In patients with creatinine clearance rates less than 50 mL/min, start OPANA ER in the opioid-naïve patient with the 5 mg dose. For patients on prior opioid therapy, start OPANA ER at 50% lower than the starting dose for a patient with normal renal function on prior opioids and titrate slowly. Monitor patients closely for signs of respiratory or central nervous system depression [see Warnings and Precautions (5.2), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
2.7 Geriatric Patients
â€‹The steady-state plasma concentrations of oxymorphone are approximately 40% higher in elderly subjects than in young subjects. Initiate dosing with OPANA ER in patients 65 years of age and over using the 5 mg dose and monitor closely for signs of respiratory and central nervous system depression when initiating and titrating OPANA ER to adequate analgesia [see Warnings and Precautions (5.2), Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)]. For patients on prior opioid therapy, start OPANA ER at 50% lower than the starting dose for a younger patient on prior opioids and titrate slowly.
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