Xtampza ER Dosage
Generic name: OXYCODONE 9mg
Dosage form: capsule, extended release
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Important Dosage and Administration Instructions
XTAMPZA ER 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. [see Clinical Pharmacology (12.3)].
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 [see Dosage and Administration 2.6].
- Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].
- 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 XTAMPZA ER and adjust the dosage accordingly [see Warnings and Precautions (5.2)].
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.
|Oxycodone Hydrochloride||Oxycodone base (XTAMPZA ER)|
|10 mg||9 mg|
|15 mg||13.5 mg|
|20 mg||18 mg|
|30 mg||27 mg|
|40 mg||36 mg|
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 [see Warnings and Precautions (5.2)].
Conversion from other Oral Oxycodone Formulations to XTAMPZA ER
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 every 12 hours with food. Because XTAMPZA ER is not bioequivalent to other oxycodone extended-release products, monitor patients for possible dosage adjustment [see Dosage and Administration (2.1) and Patient Counseling Information (17)].
Conversion from other Opioids to XTAMPZA ER
Discontinue all other around-the-clock opioid drugs when XTAMPZA ER therapy is initiated.
There are no established conversion ratios for conversion from other opioids to XTAMPZA ER defined by clinical trials. Initiate dosing using XTAMPZA ER 9 mg orally every 12 hours with food.
It is safer to underestimate a patient's 24-hour oral oxycodone dosage and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral oxycodone dosage and manage adverse reactions due to an overdose. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products.
Conversion from Methadone to XTAMPZA 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.
Conversion from Transdermal Fentanyl to XTAMPZA ER
Eighteen hours following the removal of the transdermal fentanyl patch, XTAMPZA ER treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 9 mg (equivalent to 10 mg oxycodone HCl) every 12 hours of XTAMPZA ER, should be initially substituted for each 25 mcg/hr fentanyl transdermal patch. Follow the patient closely during conversion from transdermal fentanyl to XTAMPZA ER, as there is limited documented experience with this conversion.
Dosage Modifications in Patients with Hepatic Impairment
For patients with hepatic impairment, start dosing patients at 1/3 to 1/2 the usual starting dose followed by careful dose titration. Monitor closely for adverse events such as respiratory depression. Use of alternate analgesics is recommended for patients who require an XTAMPZA ER dose of less than 9 mg. [see Use in Specific Populations (8.5), Clinical Pharmacology (12.3)].
Titration and Maintenance of Therapy
Individually titrate XTAMPZA ER to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving XTAMPZA 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.
Patients who experience breakthrough pain may require a dose increase of XTAMPZA 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 the XTAMPZA ER dose. Because steady-state plasma concentrations are approximated in 1 to 2 days, XTAMPZA ER dosage may be adjusted every 1 to 2 days. 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.
There are no well-controlled clinical studies evaluating the safety and efficacy with dosing more frequently than every 12 hours. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose, each time an increase is clinically indicated.
If unacceptable opioid-related adverse reactions are observed, the subsequent dosages may be reduced. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
Discontinuation of XTAMPZA ER
When the patient no longer requires therapy with XTAMPZA ER capsules, use a gradual downward titration of the dosage to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue XTAMPZA ER [see Warnings and Precautions (5.12), Drug Abuse and Dependence (9.2, 9.3)].
Administration of XTAMPZA ER
Instruct patients to always take XTAMPZA ER capsules with food and with approximately the same amount of food in order to ensure consistent plasma levels are achieved [see Dosage and Administration (2.1), Clinical Pharmacology (12.3)].
For patients who have difficulty swallowing, XTAMPZA ER can also be taken by sprinkling the capsule contents on soft foods or sprinkling the contents into a cup and then administering directly into the mouth or through a gastrostomy or nasogastric feeding tube. Patients who are unable to swallow a capsule should be instructed to:
- Open the capsule.
- Sprinkle the capsule contents (microspheres) onto a small amount of soft food (e.g., applesauce, pudding, yogurt, ice cream, or jam) or into a cup and then administer directly into the mouth and swallow immediately.
- Rinse the mouth to ensure all capsule contents (microspheres) have been swallowed.
- Discard the XTAMPZA ER capsule shells after the contents have been sprinkled on soft food or into a cup and then administered directly into the mouth.
The contents of the XTAMPZA ER capsules (microspheres) may be administered through a nasogastric tube or gastrostomy tube. When administering XTAMPZA ER through a nasogastric or gastrostomy tube:
- Flush the tube with water.
- Open an XTAMPZA ER capsule and carefully pour the microspheres directly into the tube. Do not pre-mix the capsule contents with the liquid that you will be usingto flush them through the tube.
- Draw up 15 mL of water into a syringe, insert the syringe into the tube, and flush the microspheres through the tube.
- Repeat the flushing two more times, each with 10 mL of water, to ensure no microspheres remain in the tube.
Alternatively, milk or liquid nutritional supplement may be used as vehicles for flush and administration through feeding tubes.