FDA drug label fb100a73: US FDA label indications

Indications and usage (label excerpt)

1 INDICATIONS & USAGE Oxycodone hydrochloride oral solution USP, 100 mg per 5 mL (20 mg per mL) an opioid agonist is indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. Oxycodone hydrochloride oral solution USP, 100 mg per 5 mL (20 mg per mL) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. Patients considered to be opioid tolerant are those who are taking at least 30 mg of oral oxycodone per day, or at least 60 mg oral morphine per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. Oxycodone Hydrochloride 100 mg per 5 mL (20 mg per mL) solution is indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. ( 1 )

Warnings (label excerpt)

5 WARNINGS AND PRECAUTIONS Risk of Medication Errors: Use caution when prescribing, dispensing, and administering 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 ) Respiratory depression: Increased risk in elderly, debilitated patients, those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction. ( 5.2 ) Misuse, Abuse and Diversion: Oxycodone hydrochloride is a Schedule II controlled substance with an abuse liability similar to other opioids. ( 5.3 ) CNS effects: Additive CNS depressive effects when used in conjunction with alcohol, other opioids, or illicit drugs. ( 5.4 ) Elevation of intracranial pressure: May be markedly exaggerated in the presence of head injury, other intracranial lesions. ( 5.5 ) Hypotensive effect: Increased risk with compromised ability to maintain blood pressure. ( 5.6 ) Prolonged gastric obstruction: In patients with …

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