Oxycodone Hydrochloride (28 brand names, 5 dosage forms, 1 route)
Available dosage forms: TABLET, CAPSULE, SOLUTION, TABLET, EXTENDED RELEASE, CAPSULE, EXTENDED RELEASE.
Routes of administration: ORAL.
Brand Names
- ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- CODOXY
- COMBUNOX
- OXAYDO
- OXYCET
- OXYCODONE 2.5/APAP 500
- OXYCODONE 5/APAP 500
- OXYCODONE AND ACETAMINOPHEN
- OXYCODONE AND ASPIRIN
- OXYCODONE AND ASPIRIN (HALF-STRENGTH)
- OXYCODONE HYDROCHLORIDE
- OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
- OXYCODONE HYDROCHLORIDE AND IBUPROFEN
- OXYCONTIN
- PERCOCET
- PERCODAN
- PERCODAN-DEMI
- ROXICET
- ROXICET 5/500
- ROXICODONE …and 8 more
Indications and Usage
Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Contraindications
Oxycodone hydrochloride tablets are contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2)]. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment or hypercarbia [see Warnings and Precautions (5.8)]. Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12)]. Known hypersensitivity (e.g., anaphylaxis) to oxycodone [see Adverse Reactions (6.2)].
Adverse Reactions
The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3)] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4)] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7)] Adrenal Insufficiency [see Warnings and Precautions (5.9)] Severe Hypotension [see Warnings and Precautions (5.10)] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12)] Seizures [see Warnings and Precautions (5.13)] Withdrawal [see Warnings and Precautions (5.14)]
Drug Interactions
Table 1 includes clinically significant drug interactions with oxycodone hydrochloride tablets. Table 1: Clinically Significant Drug Interactions with Oxycodone Hydrochloride Tablets Inhibitors of CYP3A4 and CYP2D6 Clinical Impact: The concomitant use of oxycodone hydrochloride tablets and CYP3A4 inhibitors can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of oxycodone hydrochloride tablets and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of oxycodone hydrochloride tablets is achieved [see Warnings and Precautions (5.3)]. After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see Clinical Pharmacology (12.3)], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to oxycodone. Intervention: If concomitant use is necessary, consider dosage reduction of oxycodone hydrochloride tablets until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation. If a CYP3A4 inhibitor is discontinued, consider increasing the oxycodone hydrochloride tablets dosage until stable drug effects are achieved. Evaluate for signs of opioid withdrawal. Examples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir). CYP3A4 Inducers Clinical Impact: The concomitant use of oxycodone hydrochloride tablets and CYP3A4 inducers can decrease the plasma concentration of oxycodone [see Clinical Pharmacology (12.3)], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to oxycodone [see Warnings and Precautions (5.6)]. After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone plasma concentration wil
Mechanism of Action
Oxycodone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxycodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.