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Opana ER

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Opana ER

Opana ER

INDICATIONS

OPANA ER is 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

OPANA ER is not intended for use:

  • As an as-needed (prn) analgesic
  • For pain that is mild or not expected to persist for an extended period of time
  • For acute pain
  • For postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time.

DOSAGE AND ADMINISTRATION

Initial Dosing

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 [see WARNINGS AND PRECAUTIONS].

Consider the following factors when selecting an initial dose of OPANA ER:

  • Total daily dose, potency, and any prior opioid the patient has been taking previously;
  • 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);
  • Patient's degree of opioid experience and opioid tolerance;
  • General condition and medical status of the patient;
  • Concurrent medication;
  • Type and severity of the patient's pain.

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 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.

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 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.

Conversion from Other Oral Opioids to OPANA ER

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:

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.

  • The table is not a table of equianalgesic doses.
  • 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.
  • Do not use this table to convert from OPANA ER to another opioid. Doing so will result in an overestimation of the dose of the new opioid and may result in fatal overdose.

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.

CONVERSION RATIOS TO OPANA ER

Opioid Total Daily Oral Dose Oral Conversion Ratio
Oxymorphone 10 mg 1
Hydrocodone 20 mg 0.5
Oxycodone 20 mg 0.5
Methadone 20 mg 0.5
Morphine 30 mg 0.333

Titration and Maintenance of Therapy

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. 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).

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.

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.

Discontinuation of OPANA ER

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.

Administration of OPANA ER

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]. Administer on an empty stomach, at least 1 hour prior to or 2 hours after eating.

Patients with Hepatic Impairment

OPANA ER is contraindicated in patients with moderate or severe hepatic impairment.

In opioid-na´ve 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, Use In Specific Populations and CLINICAL PHARMACOLOGY].

Patients with Renal Impairment

In patients with creatinine clearance rates less than 50 mL/min, start OPANA ER in the opioid-na´ve 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, Use in Specific Populations and CLINICAL PHARMACOLOGY].

Geriatric Patients

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, Use In Specific Populations and CLINICAL PHARMACOLOGY]. 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.

HOW SUPPLIED

Dosage Forms And Strengths

The 5 mg dosage form is a pink, octagon shape, film coated, convex extended-release tablets debossed with “5” on one side and plain on the other.

The 7.5 mg dosage form is a gray, octagon shape, film coated, convex extended-release tablets debossed with “7 ½” on one side and plain on the other.

The 10 mg dosage form is a light orange, octagon shape, film coated, convex extended-release tablets debossed with “10” on one side and plain on the other.

The 15 mg dosage form is a white, octagon shape, film coated, convex extended-release tablets debossed with “15” on one side and plain on the other.

The 20 mg dosage form is a light green, octagon shape, film coated, convex extended-release tablets debossed with “20” on one side and plain on the other.

The 30 mg dosage form is a red, octagon shape, film coated, convex extended-release tablets debossed with “30” on one side and plain on the other.

The 40 mg dosage form is a yellow, octagon shape, film coated, convex extended-release tablets debossed with “40” on one side and plain on the other.

Storage And Handling

OPANA ER tablets are supplied as follows:

5 mg

Pink, octagon shape, film coated, convex extended-release tablets debossed with “5” on one side and plain on the other.

Bottles of 100 with child-resistant closure NDC 63481-907-70
Unit-Dose package of 100 tablets (5 blister cards of 20 tablets, not child-resistant, for hospital use only) NDC 63481-907-75

7.5 mg

Gray, octagon shape, film coated, convex extended-release tablets debossed with “7 ½” on one side and plain on the other.

Bottles of 100 with child-resistant closure NDC 63481-522-70
Unit-Dose package of 100 tablets (5 blister cards of 20 tablets, not child-resistant, for hospital use only) NDC 63481-522-75

10 mg

Light orange, octagon shape, film coated, convex extended-release tablets debossed with “10” on one side and plain on the other.

Bottles of 100 with child-resistant closure NDC 63481-674-70
Unit-Dose package of 100 tablets (5 blister cards of 20 tablets, not child-resistant, for hospital use only) NDC 63481-674-75

15 mg

White, octagon shape, film coated, convex extended-release tablets debossed with “15” on one side and plain on the other.

Bottles of 100 with child-resistant closure NDC 63481-553-70
Unit-Dose package of 100 tablets (5 blister cards of 20 tablets, not child-resistant, for hospital use only) NDC 63481-553-75

20 mg

Light green, octagon shape, film coated, convex extended-release tablets debossed with “20” on one side and plain on the other.

Bottles of 100 with child-resistant closure NDC 63481-617-70
Unit-Dose package of 100 tablets (5 blister cards of 20 tablets, not child-resistant, for hospital use only) NDC 63481-617-75

30 mg

Red, octagon shape, film coated, convex extended-release tablets debossed with “30” on one side and plain on the other.

Bottles of 100 with child-resistant closure NDC 63481-571-70
Unit-Dose package of 100 tablets (5 blister cards of 20 tablets, not child-resistant, for hospital use only) NDC 63481-571-75

40 mg

Yellow, octagon shape, film coated, convex extended-release tablets debossed with “40” on one side and plain on the other.

Bottles of 100 with child-resistant closure NDC 63481-693-70
Unit-Dose package of 100 tablets (5 blister cards of 20 tablets, not child-resistant, for hospital use only) NDC 63481-693-75

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in tight container as defined in the USP, with a child-resistant closure (as required).

Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, PA 19317. Manufactured by: Novartis Consumer Health Inc. Lincoln, NE 68517. Revised: July 2012

Last reviewed on RxList: 7/27/2012
This monograph has been modified to include the generic and brand name in many instances.

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Opana ER - User Reviews

Opana ER User Reviews

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