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XTAMPZA ER
Narcotic analgesics
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Drug Name:

XTAMPZA ER CII

Generic Name and Formulations:
Oxycodone 9mg, 13.5mg, 18mg, 27mg, 36mg; ext-rel caps.

Company:
Collegium Pharmaceutical, Inc.

Therapeutic Use:

Indications for XTAMPZA ER:

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:

Not for use as an as-needed (prn) analgesic. Use only if alternative treatment options (eg, non-opioid analgesics, immediate-release opioids) are ineffective, not tolerated, or otherwise inadequate to provide sufficient management of pain.

Adult:

Use lowest effective dose for shortest duration. Take with food. Swallow whole or may sprinkle capsule contents on soft foods or into a cup. May also give through gastrostomy or NG feeding tube. Individualize. Usually given on a 12-hour schedule. ≥18yrs: Opioid-naive or opioid non-tolerant: initially 9mg every 12hrs. May adjust dose at 1–2 day intervals. Max dose 288mg/day. Hepatic impairment: initiate at ⅓ to ½ the usual starting dose and titrate slowly; use alternative analgesic if <9mg required. Use a single dose >36mg, or a total daily dose >72mg in opioid-tolerant patients only. Conversion from other opioids: see full labeling. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling).

Children:

<18yrs: not established.

Contraindications:

Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.

Warnings/Precautions:

Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Abuse potential (monitor). Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Drug abusers. Renal or hepatic impairment. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.

Interactions:

Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and precipitate withdrawal symptoms. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. May increase serum amylase.

Pharmacological Class:

Opioid agonist.

Adverse Reactions:

Nausea, headache, constipation, somnolence, pruritus, vomiting, dizziness; respiratory depression, severe hypotension, syncope.

REMS:

YES

Generic Availability:

NO

How Supplied:

ER caps—100

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