Classes
DEA Class; Rx
Common Brand Names; OxyContin, Xtampza ER, Roxicodone, Oxaydo, RoxyBond
- Opioid Analgesics
Description
Phenanthrene opioid agonist
Used for moderate to severe pain
Some products formulated to deter abuse by inhalation or injection
Indications
Indicated for the treatment of severe pain.
Contraindications
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
Adverse Effects
- 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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
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).
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).
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.
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.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
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