Aciphex

Product manufactured by Cardinal Health

Application Nr Approved Date Route Status External Links
NDA020973 2002-05-29 Oral DISCN Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Aciphex Is A Proton-Pump Inhibitor (ppi) Indicated In Adults For: Healing Of Erosive Or Ulcerative Gastroesophageal Reflux Disease (gerd) (1.1) Maintenance Of Healing Of Erosive Or Ulcerative Gerd (1.2) Treatment Of Symptomatic Gerd (1.3) Healing Of Duodenal Ulcers (1.4) Helicobacter Pylori Eradication To Reduce The Risk Of Duodenal Ulcer Recurrence (1.5) Treatment Of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome (1.6) Aciphex Is A Proton-Pump Inhibitor Indicated For Adolescent Patients 12 Years Of Age And Above For: Short-Term Treatment Of Symptomatic Gerd (1.3) 1.1 Healing Of Erosive Or Ulcerative Gerd Aciphex Is Indicated For Short-Term (4 To 8 Weeks) Treatment In The Healing And Symptomatic Relief Of Erosive Or Ulcerative Gastroesophageal Reflux Disease (gerd). For Those Patients Who Have Not Healed After 8 Weeks Of Treatment, An Additional 8-Week Course Of Aciphex May Be Considered. 1.2 Maintenance Of Healing Of Erosive Or Ulcerative Gerd Aciphex Is Indicated For Maintaining Healing And Reduction In Relapse Rates Of Heartburn Symptoms In Patients With Erosive Or Ulcerative Gastroesophageal Reflux Disease (gerd Maintenance). Controlled Studies Do Not Extend Beyond 12 Months. 1.3 Treatment Of Symptomatic Gerd Aciphex Is Indicated For The Treatment Of Daytime And Nighttime Heartburn And Other Symptoms Associated With Gerd In Adults And Adolescents 12 Years Of Age And Above. 1.4 Healing Of Duodenal Ulcers Aciphex Is Indicated For Short-Term (up To Four Weeks) Treatment In The Healing And Symptomatic Relief Of Duodenal Ulcers. Most Patients Heal Within Four Weeks. 1.5 Helicobacter Pylori Eradication To Reduce The Risk Of Duodenal Ulcer Recurrence Aciphex In Combination With Amoxicillin And Clarithromycin As A Three Drug Regimen, Is Indicated For The Treatment Of Patients With H. Pylori Infection And Duodenal Ulcer Disease (active Or History Within The Past 5 Years) To Eradicate H. Pylori. Eradication Of H. Pylori Has Been Shown To Reduce The Risk Of Duodenal Ulcer Recurrence. {see Clinical Studies (14.5) And Dosage And Administration (2.5)}. In Patients Who Fail Therapy, Susceptibility Testing Should Be Done. If Resistance To Clarithromycin Is Demonstrated Or Susceptibility Testing Is Not Possible, Alternative Antimicrobial Therapy Should Be Instituted. {see Clinical Pharmacology, Microbiology (12.2) And The Clarithromycin Package Insert, Clinical Pharmacology, Microbiology.} 1.6 Treatment Of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome Aciphex Is Indicated For The Long-Term Treatment Of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome.

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Diacetylated Monoglycerides DIACETYLATED MONOGLYCERIDES Unresolved
2. Ethylcelluloses ETHYLCELLULOSES Unresolved
3. Hypromellose Phthalate HYPROMELLOSE PHTHALATE Unresolved
4. 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.
5. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
6. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Sodium Hydroxide SODIUM HYDROXIDE Unresolved BC-Boiler compound , B&N-Buffer & neutralizing agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. Sodium Stearyl Fumarate SODIUM STEARYL FUMARATE Molecular MISC-Miscellaneous , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.
9. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Rabeprazole Sodium RABEPRAZOLE SODIUM ZINC1530935

Comments