XTAMPZA ER CII
Generic Name and Formulations:
Oxycodone 9mg, 13.5mg, 18mg, 27mg, 36mg; ext-rel caps.
Collegium Pharmaceutical, Inc.
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.
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).
<18yrs: not established.
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.
Addiction, abuse, and misuse. Life-threatening respiratory depression. Accidental ingestion. Neonatal opioid withdrawal syndrome. Cytochrome P450 3A4 interaction. Hepatotoxicity. Risks from concomitant use with benzodiazepines or other CNS depressants.
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.
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.
Nausea, headache, constipation, somnolence, pruritus, vomiting, dizziness; respiratory depression, severe hypotension, syncope.
Neurology Advisor Articles
- OCD in Duchenne Muscular Dystrophy Features Distinct Phenotype, Associated Symptoms
- History of Migraine Associated With Higher Risk for Cochlear Disorders
- Patent Foramen Ovale Closure for Stroke Prevention: Key Principles for Clinical Practice
- Vagus Nerve Stimulation in Pediatric Epilepsy: Weighing the Risks and Benefits
- A Model for Predicting Quality of Life Improvements After Deep Brain Stimulation
- Some Statins May Be Associated With Cognition, Memory Deficits
- Neuropathic Pain Treatments
- Cannabis for Multiple Sclerosis: Prescriber's Perspective
- New Monoclonal Antibody BAN2401 Reduces Amyloid Plaques, Improves Cognition in Alzheimer's
- Nonpharmacologic Interventions for Alzheimer's Have Greater Impact on Outcomes Than Currently Available Medications
- Population-Based Incidence of Acute Idiopathic Optic Neuritis Estimated
- First-in-Class Therapy Approved for Polyneuropathy Caused by hATTR
- High Anxiety Symptoms Prevalent in Epilepsy, Mesial Temporal Sclerosis
- Advance Care Planning Doesn't Aid Quality of Life
- Variation in Specialty Drug Coverage Across Health Plans