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 indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Aciphex (Rabeprazole)

Clinical trial: the treatment of gastro-oesophageal reflux disease in primary care--prospective randomized comparison of rabeprazole 20 mg with esomeprazole 20 and 40 mg. [2009.05.01]
BACKGROUND: A trial of empirical PPI therapy is usual practice for most patients with symptoms of gastro-oesophageal reflux disease (GERD) in primary care. AIM: To determine if the 4-week efficacy of rabeprazole 20 mg for resolving heartburn and regurgitation symptoms is non-inferior to esomeprazole 40 mg or 20 mg... CONCLUSIONS: In uninvestigated GERD patients, rabeprazole 20 mg was non-inferior to esomeprazole 40 mg for complete and satisfactory relief of regurgitation and satisfactory relief of heartburn, and not different for complete resolution of heartburn.

Pharmacokinetic- pharmacodynamic analysis of the role of CYP2C19 genotypes in short-term rabeprazole-based triple therapy against Helicobacter pylori. [2009.05]
AIMS: The aim was to explore the role of CYP2C19 polymorphism in short-term rabeprazole-based triple therapy against Helicobacter pylori infection... CONCLUSIONS: CYP2C19 genotypes play a role in H. pylori eradication therapy. Rabeprazole-based short-term triple therapy may be applicable in CYP2C19 PMs for H. pylori eradication.

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. [2009.04]
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 sodium at the first administration and re-administration after withdrawal... CONCLUSION: In view of our observations, we expect symptoms associated with gastric acidity to be more adequately controlled with rabeprazole sodium in the short term when compared to ranitidine hydrochloride.

Furazolidone, amoxicillin, bismuth and rabeprazole quadruple rescue therapy for the eradication of Helicobacter pylori. [2009.02.21]
AIM: To compare the efficacy and side effect profiles of three furazolidone and amoxicillin-based quadruple rescue therapies for the eradication of Helicobacter pylori (H pylori)... CONCLUSION: One- or two-week furazolidone and amoxicillin-based quadruple rescue therapy with a low dose furazolidone (100 mg bid) for the eradication of H pylori is effective. Extending the antibiotic course to 14 d could improve the eradication rates.

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 sodium at the first administration and re-administration after withdrawal...

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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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PATIENT REVIEWS / RATINGS / COMMENTS

Aciphex review by 49 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Stomach nervousness
Dosage & duration:		20 mg taken everyday for the period of 3 years
Other conditions:		Eating while not hungry to calm my stomach
Other drugs taken:		Synthroid
		Reported Results
Benefits:		This medicine was very effective. It calms my stomach and I do not feel constant contraction and nervousness in my stomach.
Side effects:		No side effects for me.
Comments:		Doctor performed a colonscopy to role out cancer then he prescribed this medicne. I have been taking it for the last three years, one a day. Once I ran out and did not take it for a few days and all of my previous symptems came back.

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 57 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		GERD
Dosage & duration:		20 mg taken 1 pd for the period of 3 wks
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Aciphex was extremely effective in the treatment of GERD. It reduced reflux and burning sensation immediately. Unfortunately, due to severe side-effects, medication had to be discontinued.
Side effects:		Severe muscle pain and weakness
Comments:		20 mg. taken daily. Highly effective for treatment of GERD. Unfortunately, resulting severe pain and weakness forced me to discontinue medication.