FDA drug label 72260dc5: US FDA label indications

Indications and usage (label excerpt)

1 INDICATIONS AND USAGE Oxycodone Hydrochloride Oral Solution USP is an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe acute and chronic pain where the use of an opioid analgesic is appropriate. Oxycodone Hydrochloride Oral Solution USP is an opioid agonist indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. (1)

Warnings (label excerpt)

5 WARNINGS AND PRECAUTIONS • Use caution when prescribing, dispensing, and administering oxycodone hydrochloride oral solution to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. (5.1) • Increased risk or respiratory depression in elderly, debilitated patients, those suffering from conditions accompanied by hypoxia, hypercapnea, or upper airway obstruction (5.2) • Oxycodone hydrochloride is a Schedule II controlled substance with an abuse liability similar to other opioids. (5.3) • Assess patients for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. (5.3) • Additive CNS depressive effects when used in conjunction with alcohol, other opioids, or illicit drugs. (5.4) • Increased risk of respiratory depression and of elevation of cerebrospinal fluid pressure in patients with head injury, intracranial lesions or preexisting increase in intracranial pressure.…

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