Aciphex (Rabeprazole Sodium) - Summary

ACIPHEX SUMMARY

The active ingredient in ACIPHEX® Delayed-Release Tablets is rabeprazole sodium, a substituted benzimidazole that inhibits gastric acid secretion.

HEALING OF EROSIVE OR ULCERATIVE GASTROESOPHAGEAL REFLUX DISEASE (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.

MAINTENANCE OF HEALING OF EROSIVE OR ULCERATIVE GASTROESOPHAGEAL REFLUX DISEASE (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.

TREATMENT OF SYMPTOMATIC GASTROESOPHAGEAL REFLUX DISEASE (GERD)

ACIPHEX® is indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD.

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.

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 and DOSAGE AND ADMINISTRATION.)

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 and the clarithromycin package insert, CLINICAL PHARMACOLOGY, Microbiology.) ACIPHEX® is indicated for the following:

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.

See all Aciphex indications & dosage >>

ACIPHEX NEWS HIGHLIGHTS

Published Studies Related to Aciphex (Rabeprazole)

Immediate acid-suppressing effects of ranitidine hydrochloride and rabeprazole sodium following initial administration and reintroduction: A randomized, cross-over study using wireless pH monitoring capsules. [2008.11.20]
Abstract Background and Aim: Histamine 2 receptor antagonists and proton-pump inhibitors, drugs that are widely used for the treatment of acid-related diseases, have different clinical characteristics. The objective of this study was to compare the acid-suppressing effects of ranitidine hydrochloride and those of rabeprazole [generic for Aciphex] sodium at the first administration and re-administration after withdrawal...

Endoscopic analysis of gastric ulcer after one week's treatment with omeprazole and rabeprazole in relation to CYP2C19 genotype. [2008.04]
In Japanese healthy CYP2C19 extensive metabolizers, rabeprazole [generic for Aciphex] 10 mg shows a faster onset of action and stronger inhibition of acid secretion than does omeprazole 20 mg on the first 3 days of administration. We evaluated gastric ulcer improvement after 1 week's treatment with rabeprazole or omeprazole in relation to CYP2C19 polymorphism... The improvement ratios with rabeprazole in homoEMs and heteroEMs were significantly greater than that with omeprazole in homoEMs.

Maintenance treatment of gastroesophageal reflux disease: An evaluation of continuous and on-demand therapy with rabeprazole 20 mg. [2007.12]
OBJECTIVE: To evaluate continuous therapy (COT) and on-demand therapy (ODT) with rabeprazole [generic for Aciphex] 20 mg for maintenance in uninvestigated gastroesophageal reflux disease (GERD)... CONCLUSION: Results based on symptom assessments favour COT with rabeprazole 20 mg for maintenance therapy in patients with uninvestigated GERD; however, both therapy types are safe and acceptable treatment options for selected patients.

Influence of cytochrome P450 2C19 genetic polymorphism and dosage of rabeprazole on accuracy of proton-pump inhibitor testing in Chinese patients with gastroesophageal reflux disease. [2007.08]
BACKGROUND AND AIM: To evaluate the optimal dosage of rabeprazole [generic for Aciphex] for proton-pump inhibitor (PPI) testing of gastroesophageal reflux disease (GERD) and to test the influence of cytochrome P450 (CYP) 2C19 polymorphism in a population with a high prevalence of people who metabolize PPI poorly... CONCLUSIONS: Both dose levels of rabeprazole proved efficacious in the diagnosis of GERD. Various measures of test accuracy were unrelated to the status of the CYP2C19 genotype.

Rabeprazole test for the diagnosis of gastro-oesophageal reflux disease: results of a study in a primary care setting. [2006.04.28]
AIM: To determine the diagnostic value of the rabeprazole [generic for Aciphex] test in patients seen by general practitioners... CONCLUSION: The poor specificity of the proton-pump inhibitor (PPI) test does not support such an approach to establish a diagnosis of GERD in a primary care setting.

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Clinical Trials Related to Aciphex (Rabeprazole)

Fed Study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium 20 mg tablets to Eisai's Aciphex® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fed conditions.

Food Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Tablets 20 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium delayed-release 20 mg tablets relative to Eisai's Aciphex® delayed-release 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fed conditions.

Fasting Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Delayed-Release Tablets 20 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium delayed-release 20 mg tablets to Eisai's Aciphex® delayed-release 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fasting conditions.

A Study of Rabeprazole and Pantoprazole on Stomach Acid and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease (GERD) and a History of Nighttime Heartburn [Completed]
The purpose of the study is to compare the pharmacodynamics (the way a drug works in the body) of rabeprazole and pantoprazole on intragastric acidity and esophageal acid exposure in gastroesophageal reflux disease (GERD) patients with nighttime heartburn. Patients will be given one dose of each medication with a washout period of 6 to 13 days between doses ("washout period" means they will receive no further proton pump inhibitor medication for 6-13 days, allowing the 1st dose to completely leave their bodies). Rabeprazole is approved in the United States for the short-term treatment (4-8 weeks) in the healing and symptomatic relief of erosive or ulcerative GERD with symptoms of daytime or nighttime heartburn, maintenance of healing of erosive or ulcerative GERD, and treatment of symptomatic GERD. The dosage regimen for all GERD indications is 20 mg once a day. Other indications include healing of duodenal ulcers, Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence, and treatment of pathological hypersecretory conditions including Zollinger-Ellison Syndrome. The most common side effect of rabeprazole is headache. In clinical trials headache was assessed as possibly related to rabeprazole in 2. 4% of subjects vs. 1. 6% for placebo. Pantoprazole at a dose of 40 mg once a day is indicated for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis, and the maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in patients with GERD. Other indications include pathological hypersecretory conditions including Zollinger-Ellison Syndrome. The most common side effects are headache and diarrhea.

Double-Blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis [Recruiting]
The purpose of this study is to evaluate the efficacy and safety of E3810 (Aciphex) tablets in patients with Proton Pump Inhibitor-resistant reflux esophagitis.

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ACIPHEX PATIENT REVIEWS / RATINGS / COMMENTS

Aciphex review by 45 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		acid reflux
Dosage & duration:		20mg taken 1x aday for the period of 60 days
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		stomach did not hurt any more. no more reflux in the middle of the night.I did not have to take it with any regard to food. the once a day dose mad it easy,did not have to take doses with me to work.
Side effects:		none noted
Comments:		take 1 tab a day for 60 days.

Aciphex review by 37 year old male patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		gerd
Dosage & duration:		20mg taken 2 times a day for the period of 2 years
Other conditions:		n/a
Other drugs taken:		n/a
		Reported Results
Benefits:		My heartburn greatly reduced and I could sleep at night so the GERD was successfully addressed.
Side effects:		Very frequent and bad dysentery. Stomach Cramps were also an issue and if those side effects could be eliminated this would then be the perfect GERD relief drug.
Comments:		1 pill twice a day with meals with lots of liquids.

Aciphex review by 37 year old male patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		gerd
Dosage & duration:		20mg taken 2 times a day for the period of 2 years
Other conditions:		n/a
Other drugs taken:		n/a
		Reported Results
Benefits:		My heartburn greatly reduced and I could sleep at night so the GERD was successfully addressed.
Side effects:		Very frequent and bad dysentery. Stomach Cramps were also an issue and if those side effects could be eliminated this would then be the perfect GERD relief drug.
Comments:		1 pill twice a day with meals with lots of liquids.