Vimovo

Product manufactured by Horizon Pharma Inc.

Application Nr Approved Date Route Status External Links
NDA022511 2010-04-30 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Vimovo, A Combination Of Naproxen And Esomeprazole Magnesium, Is Indicated In Adult And Adolescent Patients 12 Years Of Age And Older Weighing At Least 38 Kg, Requiring Naproxen For Symptomatic Relief Of Arthritis And Esomeprazole Magnesium To Decrease The Risk For Developing Naproxen-Associated Gastric Ulcers. The Naproxen Component Of Vimovo Is Indicated For Relief Of Signs And Symptoms Of: Osteoarthritis, Rheumatoid Arthritis And Ankylosing Spondylitis In Adults. Juvenile Idiopathic Arthritis (jia) In Adolescent Patients. The Esomeprazole Magnesium Component Of Vimovo Is Indicated To Decrease The Risk Of Developing Naproxen-Associated Gastric Ulcers. Vimovo Is A Combination Of Naproxen, A Non-Steroidal Anti-Inflammatory Drug (nsaid), And Esomeprazole Magnesium, A Proton Pump Inhibitor (ppi) Indicated In Adult And Adolescent Patients 12 Years Of Age And Older Weighing At Least 38 Kg, Requiring Naproxen For Symptomatic Relief Of Arthritis And Esomeprazole Magnesium To Decrease The Risk Of Developing Naproxen-Associated Gastric Ulcers. The Naproxen Component Of Vimovo Is Indicated For Relief Of Signs And Symptoms Of: Osteoarthritis, Rheumatoid Arthritis And Ankylosing Spondylitis In Adults. Juvenile Idiopathic Arthritis (jia) In Adolescent Patients. The Esomeprazole Magnesium Component Of Vimovo Is Indicated To Decrease The Risk Of Developing Naproxen-Associated Gastric Ulcers. (1) Limitations Of Use: Do Not Substitute Vimovo With The Single-Ingredient Products Of Naproxen And Esomeprazole Magnesium. (1) Vimovo Is Not Recommended For Initial Treatment Of Acute Pain Because The Absorption Of Naproxen Is Delayed Compared To Absorption From Other Naproxen-Containing Products. (1) Controlled Studies Do Not Extend Beyond 6 Months. (1) Limitations Of Use: Do Not Substitute Vimovo With The Single-Ingredient Products Of Naproxen And Esomeprazole Magnesium. Vimovo Is Not Recommended For Initial Treatment Of Acute Pain Because The Absorption Of Naproxen Is Delayed Compared To Absorption From Other Naproxen-Containing Products. Controlled Studies Do Not Extend Beyond 6 Months [see Use In Specific Populations (8.4), Clinical Studies (14)].

All Formulated Excipients (15 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
4. Glyceryl Monostearate GLYCERYL MONOSTEARATE Molecular
5. Hypromelloses HYPROMELLOSES Unresolved
6. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
7. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
9. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
10. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
11. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
12. Povidones POVIDONES Unresolved
13. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
14. Propylparaben PROPYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
15. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 2 Total)

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