Recommended Topic Related To:

Opana ER

"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...

Opana ER

Indications
Dosage
How Supplied

INDICATIONS

OPANA ER 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 ER 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 ER is not indicated as an as-needed (prn) analgesic.

DOSAGE AND ADMINISTRATION

Initial Dosing

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 [see Dosage Forms and Strengths].

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 [see WARNINGS AND PRECAUTIONS]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with OPANA ER [see WARNINGS AND PRECAUTIONS].

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 INFORMATION]. Crushing, chewing, or dissolving OPANA ER tablets will result in uncontrolled delivery of oxymorphone and can lead to overdose or death [see WARNINGS AND PRECAUTIONS].

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 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

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.

Consider the following when using the information in Table 1:

  • This is not a table of equianalgesic doses.
  • The conversion factors in this table are only for the conversion from one of the listed oral opioid analgesics to OPANA ER.
  • This table cannot be used 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.

CONVERSION FACTORS TO OPANA ER

Prior Oral Opioid Approximate Oral Conversion Factor
Oxymorphone 1
Hydrocodone 0.5
Oxycodone 0.5
Methadone 0.5
Morphine 0.333

To calculate the estimated OPANA ER dose using Table 1:

  • For patients on a single opioid, sum the current total daily dose of the opioid and then multiply the total daily dose by the conversion factor to calculate the approximate oral (active opioid) daily dose.
  • For patients on a regimen of more than one opioid, calculate the approximate oral (active opioid) dose for each opioid and sum the totals to obtain the approximate total (active opioid) daily dose.
  • For patients on a regimen of fixed-ratio opioid/non-opioid analgesic products, use only the opioid component of these products in the conversion

Always round the dose down, if necessary, to the appropriate OPANA ER strength(s) available.

Example conversion from a single opioid to OPANA ER:

Step 1: Sum the total daily dose of the opioid oxycodone 20 mg BID 20 mg former opioid 2 times daily = 40 mg total daily dose of former opioid

Step 2: Calculate the approximate equivalent dose of oral (active opioid) based on the total daily dose of the current opioid using Table 1 40 mg total daily dose of former opioid x 0.5 mg Conversion Factor = 20 mg of oral (active opioid) daily

Step 3: Calculate the approximate starting dose of OPANA ER to be given every 12 hours. Round down, if necessary, to the appropriate OPANA ER TABLETS strengths available. 10 mg OPANA ER every 12 hours

Conversion from Methadone to OPANA ER

Close monitoring is of particular importance 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 can accumulate in the plasma.

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, as well as monitoring for the development of addiction, abuse, and misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, 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 a dose increase of OPANA ER, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing OPANA ER dose.

If unacceptable opioid-related adverse reactions are observed, the subsequent 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.

Manufactured for: Endo Pharmaceuticals Inc., Malvern, PA 19355, www.endo.com or call 1-800-462-3636 OPANA® is a registered trademark of Endo Pharmaceuticals Inc. Revised: April 2014

HOW SUPPLIED

Dosage Forms And Strengths

The 5 mg dosage form is a pink, round, film-coated, biconcave extended-release tablet debossed with an “E” on one side and a “5” on the other side.

The 7.5 mg dosage form is a gray, round, film-coated, biconcave extended-release tablet debossed with an “E” on one side and a “7 ½” on the other side.

The 10 mg dosage form is a light orange, round, film-coated, biconcave extended-release tablet debossed with an “E” on one side and a “10” on the other side.

The 15 mg dosage form is a white, round, film-coated, biconcave extended-release tablet debossed with an “E” on one side and a “15” on the other side.

The 20 mg dosage form is a light green, round, film-coated, biconcave extended-release tablet debossed with an “E” on one side and a “20” on the other side.

The 30 mg dosage form is a red, round, film-coated, biconcave extended-release tablet debossed with an “E” on one side and a “30” on the other side.

The 40 mg dosage form is a light yellow to pale yellow, round, film-coated, biconcave extended-release tablet debossed with an “E” on one side and a “40” on the other side.

Storage And Handling

OPANA ER extended-release tablets are supplied as follows:

5 mg

Pink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.

Bottles of 60 with child-resistant closure NDC 63481-812-60
Bottles of 100 with child-resistant closure NDC 63481-812-70
Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only) NDC 63481-812-20

7.5 mg

Gray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.

Bottles of 60 with child-resistant closure NDC 63481-813-60
Bottles of 100 with child-resistant closure NDC 63481-813-70
Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only) NDC 63481-813-20

10 mg

Light orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.

Bottles of 60 with child-resistant closure NDC 63481-814-60
Bottles of 100 with child-resistant closure NDC 63481-814-70
Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only) NDC 63481-814-20

15 mg

White, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.

Bottles of 60 with child-resistant closure NDC 63481-815-60
Bottles of 100 with child-resistant closure NDC 63481-815-70
Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only) NDC 63481-815-20

20 mg

Light green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.

Bottles of 60 with child-resistant closure NDC 63481-816-60
Bottles of 100 with child-resistant closure NDC 63481-816-70
Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only) NDC 63481-816-20

30 mg

Red, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.

Bottles of 60 with child-resistant closure NDC 63481-817-60
Bottles of 100 with child-resistant closure NDC 63481-817-70
Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only) NDC 63481-817-20

40 mg

Light yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.

Bottles of 60 with child-resistant closure NDC 63481-818-60
Bottles of 100 with child-resistant closure NDC 63481-818-70
Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only) NDC 63481-818-20

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).

Last reviewed on RxList: 4/30/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Opana ER - User Reviews

Opana ER User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Opana ER sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Chronic Pain/Back Pain

Find tips and advances in treatment.