Xtampza ER (Oxycodone)
$260.00 – $1,630.00
What is Xtampza ER (Oxycodone)
Xtampza ER (Oxycodone) extended-release capsules are an opioid agonist for oral use. The capsules contain microspheres formulated with oxycodone base and are supplied in strengths of 9 mg (equivalent to 10 mg oxycodone HCl), 13.5 mg (equivalent to 15 mg oxycodone HCl), 18 mg (equivalent to 20 mg oxycodone HCl), 27 mg (equivalent to 30 mg oxycodone HCl), and 36 mg (equivalent to 40 mg oxycodone HCl) capsules. The capsule strengths describe the amount of oxycodone base per capsule.
Xtampza ER (Oxycodone) 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 immediaterelease opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
- XTAMPZA ER is not indicated as an as-needed (prn) analgesic.
DOSAGE AND ADMINISTRATION
Important Dosage And Administration Instructions
Xtampza ER (Oxycodone) should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
XTAMPZA ER 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 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.
SIDE EFFECTS of Xtampza ER (Oxycodone)
- 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
- Adrenal Insufficiency
- Severe Hypotension
- Gastrointestinal Adverse Reactions
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