Xtampza ER 9mg is indicated for the management of pain severe enough to require daily, around-the-clock, longterm 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 XTAMPZA 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.
Xtampza ER 9mg is not indicated as an as-needed (prn) analgesic.
DOSAGE AND ADMINISTRATION
Important Dosage And Administration Instructions
Xtampza ER 9mg should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
Xtampza ER 9mg single doses greater than 36 mg (equivalent to 40 mg oxycodone hydrochloride [HCl]) or a total daily dose greater than 72 mg (equivalent to 80 mg oxycodone HCl) are to be administered only to patients in whom tolerance to an opioid of comparable potency has been established. Patients considered 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 HCl 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.
XTAMPZA ER is administered, twice daily, every 12 hours, and must be taken with food. Instruct patients to take Xtampza ER 9mg capsules with approximately the same amount of food for every dose in order to ensure consistent plasma levels are achieved.
Patients who are unable to swallow XTAMPZA ER should be instructed to sprinkle the capsule contents on soft foods or into a cup and then administer directly into the mouth and immediately swallow. XTAMPZA ER may also be administered through a gastrostomy or nasogastric feeding tube.
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals
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
Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with XTAMPZA ER and adjust the dosage accordingly The maximum daily dose of XTAMPZA ER is 288 mg per day (eight 36 mg capsules, equivalent to 320 mg oxycodone HCl per day) as the safety of the excipients in XTAMPZA ER for doses over 288 mg/day has not been established.
XTAMPZA ER is formulated with oxycodone base. The following table describes the equivalent amount of oxycodone HCl present in other oxycodone products.
Use Of XTAMPZA ER As The First Opioid Analgesic (Opioid-Naïve Patients)
Initiate treatment with XTAMPZA ER with one 9 mg capsule orally every 12 hours with food.
Use Of XTAMPZA ER In Patients Who Are Not Opioid Tolerant
The starting dose for patients who are not opioid tolerant is XTAMPZA ER 9 mg orally every 12 hours with food.
Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression
Patients receiving other oral oxycodone formulations, may be converted to XTAMPZA ER, using the same total daily dose of oxycodone, by administering one-half of the patient’s total daily oral oxycodone dose as Xtampza ER 9mg every 12 hours with food. Because XTAMPZA ER is not bioequivalent to other oxycodone extended-release products, monitor patients for possible dosage adjustmen
The following serious adverse reactions are described elsewhere in the labeling:
Addiction, Abuse, and Misuse
Life-Threatening Respiratory Depression
Neonatal Opioid Withdrawal Syndrome
Interactions with Benzodiazepines or Other CNS Depressants
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