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Oxycodone ER

Class
Narcotic analgesics
Subclass
Semisynthetic opioids
Generic name
oxyCODONE hydrochloride ER
Brand names
Oxycontin®, Xtampza ER®
Common formulations
Film-coated tablet, Capsule
See also
Oxycodone (Roxybond®, Oxaydo®)
Dosage and administration
Adults patients
Treatment
Chronic pain • Severe, opioid-tolerant • Off-label
•
10 mg PO BID
Symptomatic relief
Symptomatic relief of pain • Severe, requiring opioids
•
10 mg PO BID
A single dose of 60 mg or a total daily dose greater than 80mg are only used in opioid tolerant patients. Titrate dosing regimen individually and use the lowest effective dose.
Indications for use
Labeled indications
Adults
•
Symptomatic relief of pain (severe, requiring opioids)
Off-label indications
Adults
•
Treatment of chronic pain (severe, opioid-tolerant)
Safety risks
Boxed warnings
Drug abuse, drug misuse, opioid use disorder
•
Use extreme caution in all patients, especially with a personal or family history of substance abuse or mental illness.
Drug overdose, death
•
Use extreme caution especially in children, if accidentally ingested my lead to fatal overdose.
Increased serum oxycodone levels
•
Use extreme caution Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers).
Neonatal abstinence syndrome
•
Use extreme caution in pregnant patients.
Respiratory depression
•
Use extreme caution in all patients, especially those with concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose.
Respiratory depression, coma
•
Use extreme caution in all patients, especially in elderly, children, malnourished, or frail patients or patients with significant pulmonary disease, accidental ingestion, and exposure to a potentially fatal dose of oxycodone.
Contraindications
Hypersensitivity to oxycodone or its components
Acute or severe asthma
Gastrointestinal obstruction
On an as needed basis for analgesia.
Significant respiratory depression
Warnings and precautions
Achalasia, opioid-induced hyperalgesia
•
Maintain a high level of suspicion for paradoxical increase in pain, or an increase in sensitivity to pain caused by continued use of a n opioid analgesic.
Adrenal insufficiency
•
Use caution in patients taking the drug for a prolonged period (> 1 month).
Increased ICP, respiratory depression, oversedation
•
Use extreme caution in patients with increased ICP, brain tumors, head injury, or impaired consciousness.
•
Use extreme caution in patients with increased ICP, brain tumors, head injury, or impaired consciousness.
Opioid withdrawal syndrome
•
Do not discontinue abruptly in patients physically dependent on opioids.
Seizure
•
Use caution in patients with seizure disorder.
Serotonin syndrome
•
Use caution concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system.
Severe hypotension
•
Use extreme caution in patients with circulatory shock.
Somnolence
•
Use caution in patients performing activities requiring mental alertness, such as driving or operating machinery.
Sphincter of Oddi dysfunction
•
Use caution in patients with biliary tract disease and acute pancreatitis.
Specific populations
Renal impairment
eGFR > 50 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required. Monitor serum concentrations. Monitor for signs of respiratory depression and excessive sedation.
eGFR 10-50 mL/min/1.73 m²
•
Use with caution. Reduce dose by 25%. Monitor serum concentrations. Monitor for signs of respiratory depression and excessive sedation.
eGFR < 10 mL/min/1.73 m²
•
Reduce dose by 50%. Titrate to response. Monitor serum concentrations. Monitor for signs of respiratory depression and sedation.
Renal replacement therapy
Any modality
•
Use with caution. Reduce starting dose. Reduce dose by 33-50%. Titrate to response. Monitor serum concentrations. Monitor for excessive sedation and respiratory depression.
Hepatic impairment
Substantial chronic alcohol consumption
•
Use with caution.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: C
•
Avoid use. Evidence of fetal harm in humans. Monitor for neonatal opioid withdrawal syndrome. Monitor neonates for respiratory depression. Use of oxycodone hydrochloride extended release tablets for an extended period of time during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated. Chronic use of opioids may cause reduced fertility; it is unknown whether these effects are reversible.
Breastfeeding
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Very low levels in breastfed infants (< 5%).
May potentially cause adverse effects in breastfed infants.
No overt adverse effects on lactation reported.
Adverse reactions
Very common > 10%
•
Constipation, nausea, somnolence, vomiting
Common 1-10%
•
Agitation, amblyopia, anemia, apnea, ataxia, bleeding, bone fracture, ↓ WBC count, ↓ blood neutrophil count, ↓ platelet count, ↓ serum chloride, ↓ serum sodium, dehydration, diaphoresis, dysgeusia, dysphonia, exfoliative dermatitis, gastroesophageal reflux disease, gastritis, gingivitis, glossitis, gout, heart failure, hyperesthesia, hyperhidrosis, hyperkinesia, hypertension, hypertonia, hypotension, ↑ blood glucose, laryngospasm, lethargy, lymphadenopathy, migraine, miosis, orthostatic hypotension, peripheral edema, peripheral vasodilation, pharyngitis, photosensitivity of skin, abdominal pain, amnesia, anxiety, arthralgia, asthenia, back pain, blurred vision, bone pain, chest pain, chills, confusion, cough, depression, diarrhea, dizziness, dry mouth, dyspepsia, dysphagia, dyspnea, dysuria, emotional lability, erectile dysfunction, euphoria, fatigue, fever, flatulence, hallucinations, headache, hematuria, hiccups, hypoesthesia, ↑ appetite, insomnia, irritability, itching, loss of appetite, malaise, musculoskeletal pain, myalgia, night sweats, nosebleed, palpitations, paresthesia, polyuria, restlessness, seizure, skin flushing, skin rash, syncope, tinnitus, urinary retention, vertigo, rhinitis, sinus tachycardia, sinusitis, skin dryness, stomatitis, thrombosis, tremor
Unknown frequency
•
Acute pancreatitis, adrenocortical insufficiency, anaphylaxis, bradycardia, bradycardia, cardiac arrest, cholestasis, cognitive impairment, dental caries, ileus, ↑ liver enzymes, mydriasis, myoclonus, psychological dependence, amenorrhea, ↓ libido, infertility, suicidal ideation, respiratory arrest, respiratory depression, syndrome of inappropriate antidiuretic hormone secretion, serotonin syndrome, urticaria
Interactions
Drug(s)
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