Drugplain

XTAMPZA ER 9 mg/1

OXYCODONE · CAPSULE, EXTENDED RELEASE · Collegium Pharmaceutical, Inc.

No Recall HistoryCurrently in Shortage
Plain English

Xtampza ER is an extended-release oral opioid medication containing oxycodone, used to treat moderate to severe pain that requires around-the-clock pain relief. As an opioid agonist, it works by binding to opioid receptors in the body to reduce pain signals.

Key Facts

Brand Name
XTAMPZA ER
Generic Name
OXYCODONE
NDC Code (Product)
24510-110
Manufacturer
Collegium Pharmaceutical, Inc.
Strength
9 mg/1
Dosage Form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing Status
DEA Schedule
Schedule II (Controlled)
Application #
NDA208090
Drug Class
Opioid Agonist [EPC]
Marketing Start
05/10/2016

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pain10,968 reports
fatigue9,628 reports
drug ineffective9,036 reports
nausea8,180 reports
off label use6,667 reports
diarrhoea6,646 reports
death6,587 reports
dyspnoea6,285 reports
rash6,006 reports
arthralgia5,928 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE XTAMPZA ER is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. XTAMPZA ER is an opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death,which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including XTAMPZA ER, for use in patients for whom alternative treatment optionsare ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 , 5.1 ) XTAMPZA ER is not indicated as an as-needed (prn) analgesic. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1) ], reserve opioid analgesics, including XTAMPZA ER, for use in pa…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION XTAMPZA ER should be prescribed only by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. ( 2.1 ) XTAMPZA ER at a total daily dose greater than 72 mg (equivalent to 80 mg oxycodone hydrochloride [HCl]) or a single dose greater than 36 mg (equivalent to 40 mg oxycodone HCl) is only for use in patients in whom tolerance to an opioid of comparable potency has been established. ( 2.1 ) 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. ( 2.1 ) Use the lowest effective dose for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of XTAMPZA ER for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2 , 5 ) Initiate the d…

Contraindications

4 CONTRAINDICATIONS XTAMPZA ER is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2) ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.8) ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12) ] Hypersensitivity (e.g., anaphylaxis) to oxycodone. Significant respiratory depression ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus ( 4 ) Hypersensitivity to oxycodone ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table includes clinically significant drug interactions with XTAMPZA ER. Table 3: Clinically Significant Drug Interactions with XTAMPZA ER Inhibitors of CYP3A4 and CYP2D6 Clinical Impact: The concomitant use of XTAMPZA ER and CYP3A4 inhibitors can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of XTAMPZA ER and CYP2D6 and CYP3A4 inhibitors , particularly when an inhibitor is added after a stable dose of XTAMPZA ER is achieved [see Warnings and Precautions (5.6) ]. After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see Clinical Pharmacology (12.3) ] , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to oxycodone. Intervention: If concomitant use is necessary, consider dosage reduction of XTAMPZA ER until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation. If a CYP3A4 inhibitor is discontinued, consider increasing the XTAMPZA ER dosage until stable drug …

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7) ] Adrenal Insufficiency [see Warnings and Precautions (5.9) ] Severe Hypotension [see Warnings and Precautions (5.10) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12) ] Seizures [see Warnings and Precautions (5.13) ] Withdrawal [see Warnings and Precautions (5.14) ] Most common adverse reactions (>5%) were nausea, headache, constipation, somnolence, pruritus, vomiting, and dizziness. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Collegium Pharmaceutical, Inc. at 1-855-331-5615 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in th…

Frequently Asked Questions

What is XTAMPZA ER used for?

Xtampza ER is an extended-release oral opioid medication containing oxycodone, used to treat moderate to severe pain that requires around-the-clock pain relief. As an opioid agonist, it works by binding to opioid receptors in the body to reduce pain signals.

Is XTAMPZA ER a controlled substance?

Yes, XTAMPZA ER is classified as CII under the DEA Controlled Substances Act.

What is the generic name for XTAMPZA ER?

The generic name for XTAMPZA ER is OXYCODONE. There are 12 other brand versions of OXYCODONE.

What is the NDC code for XTAMPZA ER 9 mg/1?

The NDC (National Drug Code) for XTAMPZA ER 9 mg/1 is 24510-110, listed by Collegium Pharmaceutical, Inc..

Product NDC

24510-110

Package NDC

24510-110-10

Other Oxycodone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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