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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 >>

NEWS HIGHLIGHTS

Media Articles Related to Aciphex (Rabeprazole)

Generic Aciphex Approved to Treat Chronic Heartburn
Source: MedicineNet Proton-Pump Inhibitors Specialty [2013.11.11]
Title: Generic Aciphex Approved to Treat Chronic Heartburn
Category: Health News
Created: 11/8/2013 4:35:00 PM
Last Editorial Review: 11/11/2013 12:00:00 AM

more news >>

Published Studies Related to Aciphex (Rabeprazole)

Acid-suppressive effect of rabeprazole 5 mg and 10 mg once daily by 24-hour esophageal pH monitoring in patients with non-erosive reflux disease in Japan: a multicenter, randomized, parallel-group, double-blind pharmacodynamic study. [2011.08]
BACKGROUND: Acid suppression induced by rabeprazole 5 mg in patients with NERD has not been reported in the literature. AIMS: The objective of this study was to investigate gastroesophageal acid suppression in NERD patients by rabeprazole 5 mg and 10 mg/day... CONCLUSIONS: Administration of 5 mg and 10 mg rabeprazole sufficiently inhibited pathological gastroesophageal acid reflux and relieved heartburn episodes in NERD patients who did not respond to an antacid. Further investigation would be necessary to determine proper usage of the two doses.

Prospective, observational study using rabeprazole in 455 patients with laryngopharyngeal reflux disease. [2011.06]
The role of proton pump inhibitor in the treatment of laryngopharygneal reflux disease (LPRD) has been advocated, but there has been few reports dealing with large population based on time-related efficacy of rabeprazole. It was designed to assess the efficacy of rabeprazole and to evaluate which symptoms or findings varied significantly as medication sustained...

A randomized controlled trial of rebamipide plus rabeprazole for the healing of artificial ulcers after endoscopic submucosal dissection. [2011.05]
BACKGROUND: Endoscopic submucosal dissection (ESD) is an increasingly common technique for the resection of early gastric cancers. Although 8 weeks of treatment with a proton pump inhibitor (PPI) reportedly heals most patients with ESD-derived artificial ulcers, it does not heal those with severe atrophic gastritis, for whom there is little data. This study examined whether healing rates of the latter especially were improved by the addition of the non-PPI mucosal healing agent rebamipide after ESD... CONCLUSION: Treatment with a PPI plus rebamipide improved healing rates at 8 weeks for patients with ESD-derived artificial ulcer, and appeared to be particularly effective for patients with severe atrophic gastritis.

An open-label, parallel, multiple-dose study comparing the pharmacokinetics and gastric acid suppression of rabeprazole extended-release with esomeprazole 40 mg and rabeprazole delayed-release 20 mg in healthy volunteers. [2011.04]
BACKGROUND: Novel rabeprazole extended-release (ER) formulations were developed to provide prolonged gastric acid suppression and potentially improved clinical outcomes in GERD patients. AIM: To evaluate the pharmacodynamics and pharmacokinetics of six rabeprazole-ER formulations vs. esomeprazole 40 mg and rabeprazole delayed-release (DR) 20 mg... CONCLUSION: Rabeprazole-ER once daily for 5 days demonstrated a significantly longer duration of gastric acid suppression in 24 h vs. esomeprazole 40 mg and rabeprazole-DR 20 mg. The increase in acid suppression was predominantly due to prolonged acid suppression during the night-time; this was supported by the extended-release pharmacokinetic characteristics. (c) 2011 Blackwell Publishing Ltd.

Randomised clinical trial: a novel rabeprazole extended release 50 mg formulation vs. esomeprazole 40 mg in healing of moderate-to-severe erosive oesophagitis - the results of two double-blind studies. [2011.01]
BACKGROUND: Current PPIs may not achieve desired outcomes in some GERD patients due to limited duration of acid inhibition. AIM: To evaluate a novel rabeprazole extended release (ER), which provides longer duration of drug exposure and acid suppression, in healing and symptomatic resolution of moderate-severe erosive oesophagitis... CONCLUSIONS: Rabeprazole-ER is as effective as esomeprazole in healing moderate-severe oesophagitis and achieves similar rates of heartburn resolution. Subgroup analysis suggests the possibility of benefit in severe oesophagitis, but this requires further evaluation (ClinicalTrials.gov: NCT00658528 and NCT00658775). (c) 2010 Blackwell Publishing Ltd.

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Clinical Trials Related to Aciphex (Rabeprazole)

A Relative Bioavailability Study of Rabeprazole Sodium Administered With Different Dosing Vehicles (Food, Other) in Healthy Adult Volunteers [Recruiting]
The purpose of the study is to investigate the bioavailability (rate and extent of absorption) of rabeprazole sodium when a sprinkle capsule granule formulation of rabeprazole sodium is mixed with different dosing vehicles (food, others) and is administered to healthy adult volunteers. Rabeprazole sodium is a drug used to treat patients with Gastro Esophageal Reflux Disease (GERD). GERD is a condition in which the esophagus (tube from throat to stomach) becomes irritated or inflamed because of acid backing up from the stomach.

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.

A Study to Evaluate the Effect on 24-hour, Intragastric pH of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40 mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets [Not yet recruiting]
This will be a randomized, open-label, single-center, 3-way crossover study in healthy subjects who are confirmed to be Helicobacter pylori (H. pylori)-negative. The study will consist of 3 study periods separated by a washout period of at least 7 days. Subjects will receive study drugs once daily for 5 days. Barring any safety concerns, subjects will be discharged from the study on Day 6 of Period 3 after completion of discharge procedures.

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.

more trials >>

Reports of Suspected Aciphex (Rabeprazole) Side Effects

Drug Ineffective (10)Fatigue (9)Weight Decreased (7)Pain (7)Malaise (7)Dyspnoea (7)Hypertension (7)Flatulence (6)Pruritus (5)Constipation (5)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 6 ratings/reviews, Aciphex has an overall score of 8.83. The effectiveness score is 9.33 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

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.

See all Aciphex reviews / ratings >>

Page last updated: 2013-11-11

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