Zohydro ER 40mg (hydrocodone bitartrate)
Zohydro ER 40mg (hydrocodone bitartrate) is a pain reliever. It is used to treat constant pain that lasts for more than a few days.
INDICATIONS AND USAGE
ZOHYDRO ER is an opioid agonist 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 ZOHYDRO 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.
• ZOHYDRO ER is not indicated as an as-needed (prn) analgesic.
DOSAGE AND ADMINISTRATION
• To be prescribed only by healthcare providers knowledgeable in use of potent opioids for management of chronic pain.
• Daily doses of ZOHYDRO ER, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established.
• 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 the lowest effective dosage for the shortest duration consistent with
individual patient treatment goals.