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Oxycodone

    DEA Class; Rx

    Common Brand Names; OxyContin, Xtampza ER, Roxicodone, Oxaydo, RoxyBond

    • Opioid Analgesics

    Phenanthrene opioid agonist
    Used for moderate to severe pain
    Some products formulated to deter abuse by inhalation or injection

    Indicated for the treatment of severe pain.

    For the treatment of refractory restless legs syndrome (RLS).
    For the treatment of painful diabetic neuropathy.

    Known or suspected GI obstruction, including paralytic ileus

    Hypersensitivity (eg, anaphylaxis) to oxycodone

    Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment

    • Agitation
    • Angina pectoris
    • Anticholinergic effects (dry mouth, palpitation, tachycardia)
    • Bradycardia
    • Cardiac arrest
    • Coma
    • Constipation
    • Dizziness
    • Dysphoria
    • Euphoria
    • Faintness
    • Mental clouding/depression
    • Myocardial infarction
    • Nausea
    • Nervousness
    • Pruritus, urticaria
    • QT-interval prolongation
    • Respiratory arrest
    • Respiratory/circulatory depression
    • Restlessness
    • Sedation
    • Seizures
    • Severe cardiac arrhythmias
    • Shock
    • ST-segment elevation
    • Sweating, flushing, warmness of face/neck/upper thorax
    • Syncope
    • Urinary retention, oliguria
    • Ventricular tachycardia
    • Visual disturbances
    • Vomiting
    • Weakness

    Use caution in patients with anemia, cardiac arrhythmias, drug abuse or dependence, emotional lability, gallbladder disease, gout, head injury, renal/hepatic disease or impairment, hypoprothrombinemia, toxic psychosis, hypothyroidism, increased intracranial pressure, prostatic hypertrophy, renal impairment, seizures with epilepsy, thyrotoxicosis, urethral stricture, urinary tract surgery, vitamin K deficiency, anoxia, central nervous system (CNS) depression, hypercapmia, respiratory depression or disease, hypersensitivity to phenantrene-derivative opioid agonists, morbid obesity, untreated myxedema, adrenocrotical insufficiency including Addison disease

    If crushed, extended-release preparation (OxyContin) can deliver large opiate dose with potential for abuse or overdose; OxyContin reformulated in April 2010 to prevent tablet from being cut, broken, crushed, or dissolved to release more medication; inability to tamper with product reduces potential for abuse

    Caution with OxyContin in patients who have difficulty swallowing or have underlying GI disorders that may predispose to obstruction

    May obscure diagnosis of acute abdominal conditions

    Avoid use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic; mixed agonist/antagonist and partial agonist analgesics may reduce analgesic effect and/or precipitate withdrawal symptoms; when discontinuing therapy in physically-dependent patient, gradually taper dosage; do not abruptly discontinue therapy in these patients

    Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome

    Drug is present in breast milk; published lactation studies report variable concentrations of drug in breast milk with administration of immediate-release formulation to nursing mothers in early postpartum period

    Adults

    Immediate-release dosage forms, extended-release tablets: There is no maximum dose of oxycodone; however, careful titration of oxycodone, especially in opiate-naive patients, is required until tolerance develops to some of the side effects (i.e., drowsiness and respiratory depression). Individualize dosage carefully.
    Extended-release capsules (Xtampza ER): 288 mg/day PO (equivalent to 320 mg/day oxycodone hydrochloride).

    Geriatric

    Immediate-release dosage forms, extended-release tablets: There is no maximum dose of oxycodone; however, careful titration of oxycodone, especially in opiate-naive patients, is required until tolerance develops to some of the side effects (i.e., drowsiness and respiratory depression). Individualize dosage carefully.
    Extended-release capsules (Xtampza ER): 288 mg/day PO (equivalent to 320 mg/day oxycodone hydrochloride).

    Adolescents

    Extended-release tablets: With appropriate dosage titration, there is no maximum dose of extended-release oxycodone in opioid-tolerant pediatric patients; however, careful titration is required until tolerance develops to some of the side effects (i.e., drowsiness and respiratory depression). Individualize dosage carefully.
    Immediate-release dosage forms and extended-release capsules (Xtampza ER): Safety and efficacy have not been established.

    Children

    Extended-release tablets in Children 11 years or older: With appropriate dosage titration, there is no maximum dose of extended-release oxycodone in opioid-tolerant pediatric patients; however, careful titration is required until tolerance develops to some of the side effects (i.e., drowsiness and respiratory depression). Individualize dosage carefully.
    Extended-release tablets in Children younger than 11 years, immediate-release dosage forms, and extended-release capsules (Xtampza ER): Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Oxycodone hydrochloride

    capsule, immediate-release: Schedule II

    • 5mg

    tablet, immediate-release: Schedule II

    • 5mg
    • 10mg
    • 15mg
    • 20mg
    • 30mg

    abuse deterrent tablet, immediate-release (Oxaydo): Schedule II

    • 5mg
    • 7.5mg
    • Discourages intranasal abuse

    abuse deterrent tablet, immediate-release (RoxyBond): Schedule II

    • 5mg
    • 7.5mg
    • Creates viscous material if mixed with liquid that does not pass through a needle

    abuse deterrent tablet, controlled-release (OxyContin): Schedule II

    • 10mg
    • 15mg
    • 20mg
    • 30mg
    • 40mg
    • 60mg
    • 80mg

    abuse deterrent capsule, controlled-release (Xtampza ER): Schedule II

    • 9mg (equivalent to 10 mg oxycodone HCl)
    • 13.5mg (equivalent to 15 mg oxycodone HCl)
    • 18mg (equivalent to 20 mg oxycodone HCl)
    • 27mg (equivalent to 30 mg oxycodone HCl)
    • 36mg (equivalent to 40 mg oxycodone HCl)
    • Abuse-deterrent capsule utilizing DETERx technology platform to maintain its extended-release profile after being subjected to common methods of tampering

    oral concentrate: Schedule II

    • 20mg/mL

    oral solution: Schedule II

    • 5mg/5mL