Posted from: Wednesday, June 03, 2015 - 10:47 AM - Present

Treximet Approved for Use in Children

May 8, 2015 – The U.S. Food and Drug Administration’s (FDA) approved Treximet (sumatriptan/naproxen) to be used by Children.  Pernix Therapeutics manufactures Treximet tablets for the acute treatment of migraine attacks with or without aura.  In 2008 Treximet was originally approved for the acute treatment of migraine attacks with or without aura in adults.  Now Treximat is also approved for use in children 12 years of age and older. The recommended dose for children 12 years of age and older is Treximet 10/60mg (10mg sumatriptan / 60mg naproxen) per 24-hour period, with a maximum dose of 85/500mg per 24-hour period. The recommended dose for adults is 85/500mg per 24-hour period.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Friday, October 18, 2019 - 02:17 AM.