NUCYNTA

Tapentadol 50mg, Oral tablet

Alcohol

· Severity: Major

· Notes for Consumers: Do not drink Alcohol while you are taking Tapentadol. Do not take prescription or OTC medicines that have Alcohol in them if you are taking long-acting Tapentadol. You may get too much medicine. This can be a medical emergency. Get medical help right away if you get slurred speech, confusion, severe weakness, or difficulty breathing.

· Notes for Professionals: Consumption of ethanol with tapentadol will result in additive CNS deppressant effects and use with extended-release tapentadol will result in increased drug exposure. Advise patients to avoid alcohol during therapy with this medication. Patients taking tapentadol extended-release tablets must not consume alcoholic beverages or take prescription or non-prescription medications that contain alcohol. In vivo pharmacokinetic study results have demonstrated concurrent administration of alcohol (240 ml of 40%) with 100 mg of extended-release tapentadol increased tapentadol Cmax by 48% and increased drug exposure by 17%. Study patients administered 250 mg of tapentadol extended-release with alcohol had a 28% increase in Cmax and a 16% increase in drug exposure as compared to patients who did not consume alcohol.

<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>