Opana ER

Name: Opana ER

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

US Brand Name

  1. Opana
  2. Opana ER

Pregnancy & Lactation

Pregnancy

Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome; there are no available data in pregnant women to inform a drug associated risk for major birth defects and miscarriage; published studies with morphine use during pregnancy have not reported a clear association with morphine and major birth defects

Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth; the onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of drug by newborn; observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly

Observe newborns for symptoms of neonatal opioid withdrawal syndrome (eg, poor feeding, diarrhea, irritability, tremor, rigidity, and seizures), and manage accordingly

Labor or delivery

  • Opioids cross placenta and may produce respiratory depression and psycho-physiologic effects in neonates; an opioid antagonist, such as naloxone, must be available for reversal of opioid induced respiratory depression in neonate; drug is not recommended for use in women during and immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate; opioid analgesics can prolong labor through actions that temporarily reduce strength, duration, and frequency of uterine contractions; however, this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor; monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression

Infertility

  • Due to effects of androgen deficiency, chronic use of opioids may cause reduced fertility in females and males of reproductive potential; it is not known whether effects on fertility are reversible

Lactation

Unknown if excreted in breast milk; many drugs, including some opioids, are excreted in human milk

If opioid must be used; monitor infant closely for excess sedation and respiratory depression; withdrawal symptoms can occur when breastfeeding or maternal opioid is stopped

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

What is the most important information i should know about oxymorphone (opana, opana er)?

Oxymorphone may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

Do not drink alcohol while you are taking oxymorphone. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol.

Never take oxymorphone in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how oxymorphone will affect you.

Do not stop using oxymorphone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using oxymorphone.

Manufacturer

  • Endo Pharmaceuticals, Inc.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of oxymorphone in the pediatric population. Safety and efficacy have not been established.

Pregnancy

Information about this oxymorphone-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Opana ER Dosage and Administration

2.1  Important Dosage and Administration Instructions

Opana ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5.1)].
  • Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)].
  • Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with Opana ER and adjust the dosage accordingly [see Warnings and Precautions (5.2)].

Instruct patients to swallow Opana ER tablets whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17)].  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 (5.2)].

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

Opana ER is administered orally every 12 hours.

2.2  Initial Dosing

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 considered opioid tolerant are those taking, 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, 60 mg oral hydrocodone 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 oxymorphone daily dose.
  • For patients on a regimen of more than one opioid, calculate the approximate oral oxymorphone dose for each opioid and sum the totals to obtain the approximate total oxymorphone 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 oxymorphone 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 oxymorphone 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.

2.3  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.

2.4  Discontinuation of Opana ER

When a patient no longer requires therapy with Opana ER, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both.  Do not abruptly discontinue Opana ER [see Warnings and Precautions (5.14), Drug Abuse and Dependence (9.3)].

2.5  Dosage Modifications in Patients with Hepatic Impairment

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

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  Dosage Modifications in Patients with Renal Impairment

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  Dosage Modifications in Geriatric Patients

The steady-state plasma concentrations of oxymorphone are 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.

How Supplied/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).

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