40 (Opana ER 40 mg)

Pill imprint 40 has been identified as Opana ER 40 mg.

Opana ER is used in the treatment of pain and belongs to the drug class narcotic analgesics. Risk cannot be ruled out during pregnancy. Opana ER 40 mg is classified as a Schedule 2 controlled substance under the Controlled Substance Act (CSA).

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 (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with OPANA ER [see Warnings and Precautions (5.2)].

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)].  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)].

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 .

 

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