14.5 Helicobacter pylori Eradication in Patien ts with Peptic Ulcer Disease or Symptomatic Non-Ulcer Disease in Adults
The U.S. multicenter study was a double-blind, parallel-group comparison of ACIPHEX delayed-release tablets, amoxicillin, and clarithromycin for 3, 7, or 10 days vs. omeprazole, amoxicillin, and clarithromycin for 10 days. Therapy consisted of rabeprazole 20 mg twice daily, amoxicillin 1000 mg twice daily, and clarithromycin 500 mg twice daily (RAC) or omeprazole 20 mg twice daily, amoxicillin 1000 mg twice daily, and clarithromycin 500 mg twice daily (OAC). Patients with H. pylori infection were stratified in a 1:1 ratio for those with peptic ulcer disease (active or a history of ulcer in the past five years) [PUD] and those who were symptomatic but without peptic ulcer disease [NPUD], as determined by upper gastrointestinal endoscopy. The overall H. pylori eradication rates, defined as negative 13 C-UBT for H. pylori ≥6 weeks from the end of the treatment are shown in the following table. The eradication rates in the 7-day and 10-day RAC regimens were found to be similar to 10-day OAC regimen using either the Intent-to-Treat (ITT) or Per-Protocol (PP) populations. Eradication rates in the RAC 3-day regimen were inferior to the other regimens.
Table 13: Helicobacter pylori Eradication at ≥ 6 Weeks After the End of Treatment
|Treatment GroupPercent (%) of Patients Cured(Number of Patients)||Difference(RAC – OAC)[95% Confidence Interval]|
|7-day RAC*||10-day OAC|
|Per Protocola||84.3%(N=166)||81.6%(N=179)||2.8[- 5.2, 10.7]|
|Intent-to-Treatb||77.3%(N=194)||73.3%(N=206)||4.0[- 4.4, 12.5]|
|10-day RAC*||10-day OAC|
|Per Protocola||86.0%(N=171)||81.6%(N=179)||4.4[- 3.3, 12.1]|
|Intent-to-Treatb||78.1%(N=196)||73.3%(N=206)||4.8[- 3.6, 13.2]|
|3-day RAC||10-day OAC|
|Per Protocola||29.9%(N=167)||81.6%(N=179)||- 51.6[- 60.6, -- 42.6]|
|Intent-to-Treatb||27.3%(N=187)||73.3%(N=206)||- 46.0[- 54.8, -- 37.2]|
a Patients were included in the analysis if they had H. pylori infection documented at baseline, defined as a positive 13 C-UBT plus rapid urease test or culture and were not protocol violators. Patients who dropped out of the study due to an adverse event related to the study drug were included in the evaluable analysis as failures of therapy.
b Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and took at least one dose of study medication. All dropouts were included as failures of therapy.
* The 95% confidence intervals for the difference in eradication rates for 7-day RAC minus 10-day RAC are (- 9.3, 6.0) in the PP population and (-9.0, 7.5) in the ITT population.
The recommended dosage of ACIPHEX delayed-release tablets is 20 mg twice daily with amoxicillin and clarithromycin for 7 days.
Twelve patients with idiopathic gastric hypersecretion or Zollinger-Ellison syndrome have been treated successfully with ACIPHEX delayed-release tablets at doses from 20 to 120 mg for up to 12 months. ACIPHEX produced satisfactory inhibition of gastric acid secretion in all patients and complete resolution of signs and symptoms of acid-peptic disease where present. ACIPHEX also prevented recurrence of gastric hypersecretion and manifestations of acid-peptic disease in all patients. The high doses of ACIPHEX used to treat this small cohort of patients with gastric hypersecretion were well tolerated.
The recommended starting dosage of ACIPHEX delayed-release tablets is 60 mg once daily.
1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically ; Approved Standard —Tenth Edition. CLSI Document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania, 19087, USA 2015.
ACIPHEX 20 mg is supplied as delayed-release light yellow enteric-coated tablets. The name and strength, in mg, (ACIPHEX 20) is imprinted on one side.
Bottles of 30 (NDC 62856-243-30)
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [ see USP Controlled Room Temperature ]. Protect from moisture.
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Acute Interstitial Nephritis
Advise the patient or caregiver to call the patient’s healthcare provider immediately if they experience signs and/or symptoms associated with acute interstitial nephritis [see Warnings and Precautions ( 5.3)].
Clostridium difficile -Associated Diarrhea
Advise the patient or caregiver to immediately call the patient’s healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions ( 5.4)].
Advise the patient or caregiver to report any fractures, especially of the hip, wrist or spine, to the patient’s healthcare provider [see Warnings and Precautions ( 5.5)].
Cutaneous and Systemic Lupus Erythematosus
Advise the patient or caregiver to immediately call the patient’s healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus [see Warnings and Precautions ( 5.6)].
Cyanocobalamin (Vitamin B-12) Deficiency
Advise the patient or caregiver to report any clinical symptoms that may be associated with cyanocobalamin deficiency to the patient’s healthcare provider if they have been receiving ACIPHEX for longer than 3 years [see Warnings and Precautions ( 5.7)].
Advise the patient or caregiver to report any clinical symptoms that may be associated with hypomagnesemia to the patient’s healthcare provider, if they have been receiving ACIPHEX for at least 3 months [see Warnings and Precautions ( 5.8)].
Advise patients to report to their healthcare provider if they are taking rilpivirine-containing products [see Contraindications ( 4)] , warfarin, digoxin or high-dose methotrexate [see Warnings and Precautions ( 5.2, 5.8, 5.9)].
- Swallow ACIPHEX delayed-release tablets whole. Do not chew, crush or split the tablets.
- For the treatment of duodenal ulcers take ACIPHEX delayed-release tablets after a meal.
- For Helicobacter pylori eradication take ACIPHEX delayed-release tablets with food.
- For all other indications ACIPHEX delayed-release tablets can be taken with or without food.
- Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to the normal schedule. Do not take two doses at the same time.
Distributed by Eisai Inc., Woodcliff Lake, NJ 07677
All brand names are the trademarks of their respective owners.
|MEDICATION GUIDE ACIPHEX ® (a-se-feks) (rabeprazole sodium) delayed-release tablets|
|What is the most important information I should know about ACIPHEX? You should take ACIPHEX exactly as prescribed, at the lowest dose possible and for the shortest time needed. ACIPHEX may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.ACIPHEX can cause serious side effects, including: |
|What is ACIPHEX? ACIPHEX is a prescription medicine called a proton pump inhibitor (PPI).ACIPHEX reduces the amount of acid in your stomach. In adults , ACIPHEX is used for: |
| Do not take ACIPHEX if you are : |
|Before you take ACIPHEX , tell your doctor about all of your medical conditions, including if you: |
| How should I take ACIPHEX? |
| What are the possible side effects of ACIPHEX? ACIPHEX can cause serious side effects, including: |
|○ pain, swelling or discomfort||○ menstrual bleeding that is heavier than normal|
|○ headaches, dizziness, or weakness||○ pink or brown urine|
|○ unusual bruising (bruises that happen without known cause or that grow in size)||○ red or black stools|
|○ nosebleeds||○ coughing up blood|
|○ bleeding gums||○ vomiting blood or vomit that looks like coffee grounds|
|○ bleeding from cuts take a long time to stop|
|How should I store ACIPHEX? Store ACIPHEX tablets in a dry place at room temperature between 68ºF to 77ºF (20ºC to 25ºC).Keep ACIPHEX and all medicines out of the reach of children.|
|General Information about the safe and effective use of ACIPHEX . Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ACIPHEX for a condition for which it was not prescribed. Do not give ACIPHEX to other people, even if they have the same symptoms that you have. It may harm them.You can ask your doctor or pharmacist for information about ACIPHEX that is written for health professionals.|
|What are the ingredients in ACIPHEX? Active ingredient: rabeprazole sodiumInactive ingredients: carnauba wax, crospovidone, diacetylated monoglycerides, ethylcellulose, hydroxypropyl cellulose, hypromellose phthalate, magnesium stearate, mannitol, sodium hydroxide, sodium stearyl fumarate, talc, and titanium dioxide. Iron oxide yellow is the coloring agent for the tablet coating. Iron oxide red is the ink pigment.Distributed by Eisai Inc., Woodcliff Lake, NJ 07677All brand names are the trademarks of their respective owners.For more information, go to www.aciphex.com or call 1-888-274-2378.|
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: September 2019
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