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 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 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 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.

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 (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.}

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

Published Studies Related to Aciphex (Rabeprazole)

Randomised clinical trial: rabeprazole improves symptoms in patients with functional dyspepsia in Japan. [2013]
multicentre, double-blinded, randomised, placebo-controlled trial... CONCLUSIONS: Rabeprazole 20 mg once daily but not 10 or 40 mg significantly

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.

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Clinical Trials Related to Aciphex (Rabeprazole)

Comparison of Oral Rabeprazole vs. iv Omeprazole in Mild to Moderate Nonvariceal Upper Gastrointestinal Bleeding [Recruiting]
Introduction: Proton pump inhibitor (PPI) is the drug of choice used in patients with non-variceal upper gastrointestinal tract bleeding (UGIB). Intravenous (IV) PPI is more commonly used than oral form when overt bleeding occurs. Previous study has revealed that oral rabeprazole and IV omeprazole achieved similar intragastric pH elevation. It's probable that oral form and IV PPI provide equal efficacy in treating mild to moderate UGIB patients. Aim: This study aims to compare the effect of three-day oral rabeprazole and iv omeprazole on bleeding control in patients with mild to moderate non-variceal UGIB. Patients and methods: All patients presented with black to tarry stool passage or hematemesis and visited our ER will be evaluated to recruit into this study. They will receive regular vital sign monitoring, laboratory study and nasogastric tube insertion with gastric fluid aspiration. Esophagogastroendoscopy and hemostatic procedure if need will be performed within 12 hours. Those confirmed to have non-variceal UGIB, stable vital signs and agree to participate into this study will be randomized into two groups receiving either oral rabeprazole (20mg bid) or iv omeprazole (40mg qd) for three days. The presence of recurrent bleeding within three days, in-hospital complication and duration of hospital stay will be recorded and analyzed. Expected results: At the end of this study, we will be able to determine whether patients treated with oral rabeprazole and iv omeprazole have similar re-bleeding or complication rates and hospitalization days.

Effect of High-dose Oral Rabeprazole on Recurrent Bleeding After the Endoscopic Treatment of Bleeding Peptic Ulcers [Terminated]

E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers [Completed]

A Study of Rabeprazole for Prevention of Non Steroidal Anti-inflammatory Drug -Associated Gastroduodenal Injury [Active, not recruiting]
The aim of this study is to determine whether rabeprazole is superior to placebo in preventing dyspepsia and gastroduodenal injury in subjects with osteoarthritis (OA) and/or rheumatoid arthritis (RA) and/or bone pain.

E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers [Completed]

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

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.