Formulary Drug Reviews - Sumatriptan Succinate/Naproxen Sodium

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650 Volume 43, August 2008 Sumatriptan Succinate/Naproxen Sodium Dennis J. Cada, PharmD, FASHP, FASCP (Editor)*; Terri L. Levien, PharmD ; and Danial E. Baker, PharmD, FASHP, FASCP INDICATIONS The combination sumatriptan succinate and naproxen sodium tablet is indicated for the acute treatment of migraine attacks with or without aura in adults. 1 CLINICAL PHARMACOLOGY Sumatriptan succinate 85 mg and naproxen sodium 500 mg have been formulated in a single, fast-disintegrating tablet formula- tion using RT Technology. RT Technology is designed to enhance dispersion and dissolution of sumatriptan, even in the presence of gastric stasis, allowing the drug to be absorbed more quickly. 2,3 Naproxen sodium is a non- steroidal anti-inflammatory drug (NSAID); the sodium salt is a more rapidly absorbed salt used primar- ily as an analgesic. 4 Sumatriptan is a vascular 5-hydroxytryptamine 1 (5-HT1) receptor agonist that pro- duces vasoconstriction and, there- by, migraine relief. 4 PHARMACOKINETICS With the combination tablet using RT Technology, the suma- triptan component disintegrates rapidly and empties from the stom- ach faster, allowing the sumatrip- tan to be absorbed more quickly than the naproxen, following oral administration. 5 Peak sumatriptan concentrations occur approxi- mately 1 hour after oral Treximet administration compared with a 1.5-hour time to peak for suma- triptan 100 mg tablets (Imitrex). 1 Peak naproxen concentrations are reached approximately 5 hours after Treximet administration, a 4- hour delay compared with naprox- en sodium 550 mg tablets (Anaprox DS). 1 Administration with food has no effect on the bioavailability of either compo- nent but can delay the absorption of the sumatriptan component by 40 minutes. 6 With the combination tablet, sumatriptan peak concentrations are reached a median of 53 min- utes faster than a similar, fast- dissolving formulation of suma- triptan that does not contain the naproxen component. 7 The suma- triptan peak concentration and overall exposure did not differ between the 2 formulations despite the more rapid time-to-peak con- Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Thera- peutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing inservices. A comprehensive target drug utilization evaluation (DUE) is also provided each month. With a subscription, the monographs are sent to you in print and are also available online. Monographs can be customized to meet the needs of your facility. Subscribers to the The Formulary Mono- graph Service also receive access to a pharmacy bulletin board, The For- mulary Information Exchange (The F.I.X.). All topics pertinent to clinical and hospital pharmacy are discussed on The F.I.X. Through the cooperation of The Formulary, Hospital Pharmacy pub- lishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800-322-4349. The August 2008 monograph topics are on alvimopan, tolvaptan, liraglutide, iclaprim injection, and alogliptin. The DUE is on alvimopan. *Executive Editor, The Formulary; Clinical Associate Professor of Pharmacotherapy, Drug Information Center, Washington State University Spokane, WA; Director, Drug Information Center and Professor of Pharmacy Practice; College of Pharmacy, Wash- ington State University Spokane, PO Box 1495, Spokane, WA 99210-1495. Generic Name: SUMATRIPTAN SUCCINATE/NAPROXEN SODIUM Proprietary Name: Treximet (Pozen, GlaxoSmithKline) Approval Rating: 4S Therapeutic Class: Serotonin 5-Hydroxytryptamine 1 (5-HT1) Receptor Agonists, Migraine Combinations Similar Drugs: Sumatriptan, Naproxen Sound- or Look-Alike Names: Torecan, Tricon, Trisenox Hospital Pharmacy Volume 43, Number 8, pp 650-660 2008 Wolters Kluwer Health, Inc. FORMULARY DRUG REVIEWS

Transcript of Formulary Drug Reviews - Sumatriptan Succinate/Naproxen Sodium

Page 1: Formulary Drug Reviews - Sumatriptan Succinate/Naproxen Sodium

FORMULARY DRUG REVIEWS

650 Volume 43, August 2008

Sumatriptan Succinate/Naproxen SodiumDennis J. Cada, PharmD, FASHP, FASCP (Editor)*; Terri L. Levien, PharmD†;

and Danial E. Baker, PharmD, FASHP, FASCP‡

INDICATIONSThe combination sumatriptan

succinate and naproxen sodium

tablet is indicated for the acutetreatment of migraine attacks withor without aura in adults.1

CLINICAL PHARMACOLOGYSumatriptan succinate 85 mg

and naproxen sodium 500 mghave been formulated in a single,fast-disintegrating tablet formula-tion using RT Technology. RTTechnology is designed to enhancedispersion and dissolution ofsumatriptan, even in the presenceof gastric stasis, allowing the drugto be absorbed more quickly.2,3

Naproxen sodium is a non-steroidal anti-inflammatory drug(NSAID); the sodium salt is a morerapidly absorbed salt used primar-ily as an analgesic.4 Sumatriptan isa vascular 5-hydroxytryptamine 1

(5-HT1) receptor agonist that pro-duces vasoconstriction and, there-by, migraine relief.4

PHARMACOKINETICSWith the combination tablet

using RT Technology, the suma-triptan component disintegratesrapidly and empties from the stom-ach faster, allowing the sumatrip-tan to be absorbed more quicklythan the naproxen, following oraladministration.5 Peak sumatriptanconcentrations occur approxi-mately 1 hour after oral Treximetadministration compared with a1.5-hour time to peak for suma-triptan 100 mg tablets (Imitrex).1

Peak naproxen concentrations arereached approximately 5 hoursafter Treximet administration, a 4-hour delay compared with naprox-en sodium 550 mg tablets(Anaprox DS).1 Administrationwith food has no effect on thebioavailability of either compo-nent but can delay the absorptionof the sumatriptan component by40 minutes.6

With the combination tablet,sumatriptan peak concentrationsare reached a median of 53 min-utes faster than a similar, fast-dissolving formulation of suma-triptan that does not contain thenaproxen component.7 The suma-triptan peak concentration andoverall exposure did not differbetween the 2 formulations despitethe more rapid time-to-peak con-

Each month, subscribers to The Formulary Monograph Service receive 5 to6 well-documented monographs on drugs that are newly released or are inlate phase 3 trials. The monographs are targeted to Pharmacy & Thera-peutics Committees. Subscribers also receive monthly 1-page summarymonographs on agents that are useful for agendas and pharmacy/nursinginservices. A comprehensive target drug utilization evaluation (DUE) is alsoprovided each month. With a subscription, the monographs are sent to youin print and are also available online. Monographs can be customized tomeet the needs of your facility. Subscribers to the The Formulary Mono-graph Service also receive access to a pharmacy bulletin board, The For-mulary Information Exchange (The F.I.X.). All topics pertinent to clinicaland hospital pharmacy are discussed on The F.I.X.

Through the cooperation of The Formulary, Hospital Pharmacy pub-lishes selected reviews in this column. If you would like information aboutThe Formulary Monograph Service or The F.I.X., call The Formulary at800-322-4349. The August 2008 monograph topics are on alvimopan,tolvaptan, liraglutide, iclaprim injection, and alogliptin. The DUE is onalvimopan.

*Executive Editor, The Formulary; †Clinical Associate Professor of Pharmacotherapy, Drug Information Center, Washington StateUniversity Spokane, WA; ‡Director, Drug Information Center and Professor of Pharmacy Practice; College of Pharmacy, Wash-ington State University Spokane, PO Box 1495, Spokane, WA 99210-1495.

Generic Name: SUMATRIPTANSUCCINATE/NAPROXENSODIUMProprietary Name: Treximet(Pozen, GlaxoSmithKline)Approval Rating: 4STherapeutic Class: Serotonin 5-Hydroxytryptamine 1 (5-HT1)Receptor Agonists, MigraineCombinationsSimilar Drugs: Sumatriptan,NaproxenSound- or Look-Alike Names:Torecan, Tricon, Trisenox

Hospital PharmacyVolume 43, Number 8, pp 650-6602008 Wolters Kluwer Health, Inc.

FORMULARY DRUG REVIEWS