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Painkillers: Analgesics and Muscle Relaxants

Oxymorphone Hydrochloride, Page 1

Oxymorphone hydrochloride extended-release tablets are a semi-synthetic opioid analgesic indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.

OXYMORPHONE HYDROCHLORIDE — oxymorphone hydrochloride tablet, extended release
Actavis Elizabeth LLC

WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE

Potential for Abuse

Oxymorphone hydrochloride extended-release tablets contain oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. ( 9 )

Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing oxymorphone hydrochloride extended-release tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. ( 9.2 )

Proper Patient Selection

Oxymorphone hydrochloride extended-release tablets are an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. ( 1 )

Limitations of Use

Oxymorphone hydrochloride extended-release tablets are NOT intended for use as an as needed analgesic. ( 1 )

Oxymorphone hydrochloride extended-release tablets are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed oxymorphone hydrochloride extended-release tablets leads to rapid release and absorption of a potentially fatal dose of oxymorphone. ( 2 )

Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while on oxymorphone hydrochloride extended-release tablet therapy. The co-ingestion of alcohol with oxymorphone hydrochloride extended-release tablets may result in increased plasma levels and a potentially fatal overdose of oxymorphone. ( 2 )

1 INDICATIONS & USAGE

Oxymorphone hydrochloride extended-release tablets are indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.

Limitations of Usage

Oxymorphone hydrochloride extended-release tablets are not intended for use as an as needed analgesic.

Oxymorphone hydrochloride extended-release tablets are not indicated for pain in the immediate post-operative period if the pain is mild, or not expected to persist for an extended period of time.

Oxymorphone hydrochloride extended-release tablets are only indicated for post-operative use if the patient is already receiving the drug prior to surgery or if the post-operative pain is expected to be moderate or severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines).

2 DOSAGE & ADMINISTRATION

2.1 Safe Administration Instructions

Oxymorphone hydrochloride extended-release tablets are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed oxymorphone hydrochloride extended-release tablets leads to rapid release and absorption of a potentially fatal dose of oxymorphone.

Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while on oxymorphone hydrochloride extended-release tablet therapy. The co-ingestion of alcohol with oxymorphone hydrochloride extended-release tablets may result in increased plasma levels and a potentially fatal overdose of oxymorphone.

While symmetric (same dose AM and PM), around-the-clock, every 12 hours dosing is appropriate for the majority of patients, some patients may benefit from asymmetric (different dose given in AM than in PM) dosing, tailored to their pain pattern. It is usually appropriate to treat a patient with only one extended-release opioid for around-the-clock therapy.

Selection of patients for treatment with oxymorphone hydrochloride extended-release tablets should be governed by the same principles that apply to the use of other extended-release opioid analgesics [see Indications and Usage (1)]. Physicians should individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis, combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society and the Federation of State Medical Boards Model Guidelines. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring [see Boxed Warning].

2.2 Initiating Therapy with Oxymorphone Hydrochloride Extended-Release Tablets

It is necessary to adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. In the selection of the initial dose of oxymorphone hydrochloride extended-release tablets, attention should be given to the following:

  • total daily dose, potency and specific characteristics of the opioid the patient has been taking previously;
  • relative potency estimate used to calculate the equivalent oxymorphone dose needed;
  • patient’s degree of opioid tolerance;
  • age, general condition, and medical status of the patient;
  • concurrent non-opioid analgesics and other medications;
  • type and severity of the patient’s pain;
  • balance between pain control and adverse experiences;
  • risk factors for abuse or addiction, including a prior history of abuse or addiction.

Once therapy is initiated, frequently assess pain relief and other opioid effects. Base the titration of the total daily oxymorphone hydrochloride extended-release tablet dose upon the amount of supplemental opioid utilization, severity of the patient’s pain, and the patient’s ability to tolerate the opioid. Titrate dose to generally mild or no pain with the regular use of no more than two doses of supplemental analgesia, i.e. “rescue,” per 24 hours. Patients who experience breakthrough pain may require dosage adjustment.

If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. If this adjustment leads to inadequate analgesia, a supplemental dose of an immediate-release opioid, or a non-opioid analgesic may be administered. Adjust dosing to obtain an appropriate balance between pain relief and opioid-related adverse experiences. If significant adverse events occur before the therapeutic goal of mild or no pain is achieved, the events should be treated aggressively. Once adverse events are adequately managed, continue upward titration to an acceptable level of pain control.

During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient and the caregiver/family. Advise patients and caregivers/family members of the potential adverse reactions.

The dosing recommendations below, therefore, can only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Titrate dose to adequate pain relief (generally mild or no pain).

Administer oxymorphone hydrochloride extended-release tablets on an empty stomach, at least one hour prior to or two hours after eating [see Clinical Pharmacology (12.3)].

Opioid-Naïve Patients

The initial dose for patients who are not opioid-experienced and who are being initiated on chronic around-the-clock opioid therapy with oxymorphone hydrochloride extended-release tablets is 5 mg every 12 hours. Thereafter, titrate the dose individually at increments of 5 to 10 mg every 12 hours every 3 to 7 days, to a level that provides adequate analgesia and minimizes side effects under the close supervision of the prescribing physician.

Opioid-Experienced Patients

Conversion from Oxymorphone Hydrochloride Tablets to Oxymorphone Hydrochloride Extended-Release Tablets

Patients receiving oxymorphone hydrochloride tablets may be converted to oxymorphone hydrochloride extended-release tablets by administering half the patient’s total daily oral oxymorphone hydrochloride tablets dose as oxymorphone hydrochloride extended-release tablets, every 12 hours.

Conversion from Parenteral Oxymorphone to Oxymorphone Hydrochloride Extended-Release Tablets

Given oxymorphone hydrochloride extended-release tablet’s absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to oxymorphone hydrochloride extended-release tablets by administering 10 times the patient’s total daily parenteral oxymorphone dose as oxymorphone hydrochloride extended-release tablets 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 Oxymorphone Hydrochloride Extended-Release Tablets

For conversion from other opioids to oxymorphone hydrochloride extended-release tablets, physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate. In general, it is safest to start the oxymorphone hydrochloride extended-release tablets therapy by administering half of the calculated total daily dose of oxymorphone hydrochloride extended-release tablets (see conversion ratio table below) in 2 divided doses, every 12 hours. Gradually adjust the initial dose of oxymorphone hydrochloride extended-release tablets until adequate pain relief and acceptable side effects have been achieved.

The following table provides approximate equivalent doses, which may be used as a guideline for conversion. The conversion ratios and approximate equivalent doses in this conversion table areonly to be used for the conversion from current opioid therapy to oxymorphone hydrochloride extended-release tablets. In a Phase 3 clinical trial with an open-label titration period, patients were converted from their current opioid to oxymorphone hydrochloride extended-release tablets using the following table as a guide. There is substantial patient variation in the relative potency of different opioid drugs and formulations.

CONVERSION RATIOS TO OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS
Approximate Equivalent Dose Oral
Opioid Oral Conversion Ratioa
a Ratio for conversion of oral opioid dose to approximate oxymorphone equivalent dose. Select opioid and multiply the dose by the conversion ratio to calculate the approximate oral oxymorphone equivalent.
The conversion ratios and approximate equivalent doses in this conversion table are only to be used for the conversion from current opioid therapy to oxymorphone hydrochloride extended-release tablets.
● Sum the total daily dose for the opioid and multiply by the conversion ratio to calculate the oxymorphone total daily dose.
● For patients on a regimen of mixed opioids, calculate the approximate oral oxymorphone dose for each opioid and sum the totals to estimate the total daily oxymorphone dose.
● The dose of oxymorphone hydrochloride extended-release tablets can be gradually adjusted, preferably at increments of 10 mg every 12 hours every 3 to 7 days, until adequate pain relief and acceptable side effects have been achieved [see Dosage and Administration (2.1)].
bIt is extremely important to monitor all patients closely when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and tends to accumulate in the plasma.
Oxymorphone 10 mg 1
Hydrocodone 20 mg 0.5
Oxycodone 20 mg 0.5
Methadone b 20 mg 0.5
Morphine 30 mg 0.333

No dose adjustment for CYP 3A4-or 2C9-mediated drug-drug interactions is required [see Clinical Pharmacology (12.3)].

2.3 Patients with Hepatic Impairment

Start patients with mild hepatic impairment with the lowest dose and titrate slowly while carefully monitoring side effects. Oxymorphone hydrochloride extended-release tablets are contraindicated in patients with moderate or severe hepatic impairment [see Warnings and Precautions (5.7) and Clinical Pharmacology (12.3)].

2.4 Patients with Renal Impairment

There are 57% and 65% increases in oxymorphone bioavailability in patients with moderate and severe renal impairment, respectively [see Clinical Pharmacology (12.3)]. Accordingly, in patients with creatinine clearance rates less than 50 mL/min, start oxymorphone hydrochloride extended-release tablets with the lowest dose and titrate slowly while carefully monitoring side effects.

2.5 Use with Central Nervous System Depressants

In patients who are concurrently receiving other central nervous system (CNS) depressants including sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, and alcohol, start oxymorphone hydrochloride extended-release tablets at 1/3 to 1/2 of the usual dose because respiratory depression, hypotension, and profound sedation, coma or death may result [see Warnings and Precautions (5.4) and Drug Interactions (7.2)].

Although no specific interaction between oxymorphone and monoamine oxidase inhibitors has been observed, oxymorphone hydrochloride extended-release tablets are not recommended for use in patients who have received MAO inhibitors within 14 days [see Drug Interactions (7.6)].

2.6 Geriatrics Patients

The steady-state plasma concentrations of oxymorphone are approximately 40% higher in elderly subjects than in young subjects. Exercise caution in the selection of the starting dose of oxymorphone hydrochloride extended-release tablets for an elderly patient by starting at the low end of the dosing range and slowly titrating to adequate analgesia [see Clinical Pharmacology (12.3) and Use in Specific Populations (8.5)].

2.7 Maintenance of Therapy

During chronic therapy with oxymorphone hydrochloride extended-release tablets, periodically reassess the continued need for around-the-clock opioid therapy. Continue to assess patients for their clinical risks for opioid abuse, addiction, or diversion particularly with high-dose formulations. If patients need to titrate while on maintenance therapy, follow the same method outlined in Initiating Therapy with Oxymorphone Hydrochloride Extended-Release Tablets.

2.8 Cessation of Therapy

When the patient no longer requires therapy with oxymorphone hydrochloride extended-release tablets, gradually taper doses to prevent signs and symptoms of withdrawal in the physically dependent patient.

3 DOSAGE FORMS & STRENGTHS

  • The 7.5 mg dosage form are gray, round tablets, debossed with “a7770a0f-figure-01” on one side and “261” on the other side.

    The 15 mg dosage form are white to off-white, round tablets, debossed with “a7770a0f-figure-02” on one side and “262” on the other side.