OXYMORPHONE HCL ER

Oxymorphone Hydrochloride 10mg, Oral tablet, extended release

Alcohol

· Severity: Major

· Notes for Consumers: Do not drink alcohol while taking Oxymorphone. In addition to not drinking alcohol drinks while taking oxymorphone, do not take any medicines that contain alcohol. Serious side effects such as excessive sedation, confusion, trouble breathing, or death may result if alcohol is taken with Oxymorphone. Some medicines that do not require a prescription contain alcohol. Ask your doctor or pharmacist for help. Do not drive or operate machinery while taking Oxymorphone until the effects of the drug are known.

· Notes for Professionals: Patients who receive oxymorphone should be advised to avoid drinking ethanol (alcohol) or taking prescription or nonprescription medications containing alcohol. Concomitant use of oxymorphone with other central nervous system (CNS) depressants, such as ethanol, can potentiate the effects of oxymorphone and may lead to additive CNS or respiratory depression. This may cause respiratory depression, hypotension, profound sedation, and death. In addition, ingestion of extended-release oral oxymorphone with ethanol results in significantly higher peak plasma oxymorphone concentrations; the extended-release mechanism can be compromised. A potentially fatal overdose of oxymorphone may occur. The Cmax of oxymorphone increased on average by 70% and up to 270% in individual patients when taken with 240 mL of 40% ethanol. Increased exposure was also seen if the medicine was taken with 20% alcohol; the Cmax increased on average by 31% and up to 260% in individual patients. Following the concomitant administration of 240 mL of 4% ethanol, the Cmax increased 7% on average and by as much as 110% for individual subjects. The effect on Cmax was highly variable. The oxymorphone mean AUC was 13% higher after coadministration of 240 mL of 40% alcohol but was essentially unaffected in subjects following the coadministration of 240 mL of 20% or 4% ethanol.

Oxymorphone Hydrochloride 10mg, Oral tablet, extended release

Food

· Severity: Major

· Notes for Consumers: Do not take Oxymorphone immediate-release or extended-release tablets with food. If you take this drug with food, you may get too much medicine at once, which can be very dangerous. You may have difficulty breathing. Take Oxymorphone either 1 hour before or 2 hours after eating. No interaction with food occurs with Oxymorphone that you get by injection.

· Notes for Professionals: Food can increase the systemic exposure of oxymorphone. The Cmax and AUC of oxymorphone were increased by approximately 38% in fed subjects relative to fasted subjects after receipt of a 40 mg immediate-release tablet. Administer oxymorphone at least 1 hour before or 2 hours after eating.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>