RABEPRAZOLE SODIUM (Page 10 of 10)

14.5 Helicobacter pylori Eradication in Patients with Peptic Ulcer Disease or Symptomatic Non-Ulcer Disease in Adults

The U.S. multicenter study was a double-blind, parallel-group comparison of Rabeprazole Sodium 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.

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.

Table 13: Helicobacter pylori Eradication at ≥6 Weeks After the End of Treatment

Treatment Group Percent (%) of Patients Cured (Number of Patients)

Difference (RAC — OAC) [95% Confidence Interval]

7-day RAC *

10-day OAC

Per Protocol a

84.3% (N=166)

81.6% (N=179)

2.8 [- 5.2, 10.7]

Intent-to-Treat b

77.3% (N=194)

73.3% (N=206)

4.0 [- 4.4, 12.5]

10-day RAC *

10-day OAC

Per Protocol a

86.0% (N=171)

81.6% (N=179)

4.4 [- 3.3, 12.1]

Intent-to-Treat b

78.1% (N=196)

73.3% (N=206)

4.8 [- 3.6, 13.2]

3-day RAC

10-day OAC

Per Protocol a

29.9% (N=167)

81.6% (N=179)

— 51.6 [- 60.6, — 42.6]

Intent-to-Treat b

27.3% (N=187)

73.3% (N=206)

— 46.0 [- 54.8, — 37.2]

The recommended dosage of Rabeprazole Sodium Delayed-Release Tablets is 20 mg twice daily with amoxicillin and clarithromycin for 7 days.

14.6 Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults

Twelve patients with idiopathic gastric hypersecretion or Zollinger-Ellison syndrome have been treated successfully with Rabeprazole Sodium delayed-release tablets at doses from 20 to 120 mg for up to 12 months. Rabeprazole Sodium delayed-release tablets produced satisfactory inhibition of gastric acid secretion in all patients and complete resolution of signs and symptoms of acid-peptic disease where present. Rabeprazole Sodium delayed-release tablets also prevented recurrence of gastric hypersecretion and manifestations of acid-peptic disease in all patients. The high doses of Rabeprazole Sodium delayed-release tablets used to treat this small cohort of patients with gastric hypersecretion were well tolerated.

The recommended starting dosage of Rabeprazole Sodium delayed-release tablets is 60 mg once daily.

15 REFERENCES

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.

16 HOW SUPPLIED/STORAGE AND HANDLING

Rabeprazole Sodium delayed-release tablets 20 mg are supplied as light yellow colored round, biconvex tablets with beveled edges and B683 printed on one side with black ink and plain on the other side.

Bottles of 30 NDC# 71205-603-30

Bottles of 60 NDC# 71205-603-60

Bottles of 90 NDC# 71205-603-90

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [see USP Controlled Room Temperature]. Protect from moisture.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Acute Tubulointerstitial Nephritis

Advise patients or caregiver to call the patient’s healthcare provider immediately if they experience any signs and/or symptoms associated with acute tubulointerstitial 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 Error! Hyperlink reference not valid. ] .

Bone Fracture

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 Rabeprazole Sodium delayed-release tablets for longer than 3 years [see Warnings and Precautions (5.7)].

Hypomagnesemia

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 Rabeprazole Sodium delayed-release tablets for at least 3 months [see Warnings and Precautions (5.8)].

Drug Interactions

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)] .

Administration

•
Swallow Rabeprazole Sodium delayed-release tablets whole. Do not chew, crush or split the tablets.
•
For the treatment of duodenal ulcers take Rabeprazole Sodium delayed-release tablets after a meal.
•
For Helicobacter pylori eradication take Rabeprazole Sodium delayed-release tablets with food.
•
For all other indications Rabeprazole Sodium 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:
Advagen Pharma Ltd.,
666 Plainsboro Road,
Suite 605
Plainsboro, NJ, 08536, USA.
Manufactured by:
Rubicon Research Private Limited
Ambernath, Dist: Thane, 421506 India.

Repackaged by:
Proficient Rx LP Thousand Oaks, CA 91320

Rev. 12/2020

All brand names are the trademarks of their respective owners.

MEDICATION GUIDE Rabeprazole Sodium (ra-bep-ra-zole soe-dee-um) delayed-release tablets

What is the most important information I should know about Rabeprazole Sodium delayed-release tablets? You should take Rabeprazole Sodium delayed-release tablets exactly as prescribed, at the lowest dose possible and for the shortest time needed. Rabeprazole Sodium delayed-release tablets may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Rabeprazole Sodium delayed-release tablets can cause serious side effects, including:

•
A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including Rabeprazole Sodium delayed-release tablets, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with Rabeprazole Sodium delayed-release tablets. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.
•
Diarrhea caused by an infection ( Clostridium difficile) in your intestines. Call your doctor right away if you have watery stool or stomach pain that does not go away. You may or may not have a fever.
•
Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine.
•
Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including Rabeprazole Sodium delayed-release tablets, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun.
Talk to your doctor about your risk of these serious side effects. Rabeprazole Sodium delayed-release tablets can have other serious side effects. See “What are the possible side effects of Rabeprazole Sodium delayed-release tablets?”
What are Rabeprazole Sodium delayed-release tablets? Rabeprazole Sodium delayed-release tablets are a prescription medicine called a proton pump inhibitor (PPI). Rabeprazole Sodium delayed-release tablets reduces the amount of acid in your stomach. In adults, Rabeprazole Sodium delayed-release tablets are used for:
•
8 weeks up to 16 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE) and to relieve symptoms, such as heartburn pain.
•
maintaining the healing of the esophagus and relief of symptoms related to EE. It is not known if Rabeprazole Sodium delayed-release tablets are safe and effective if used longer than 12 months (1 year).
•
up to 4 weeks to treat daytime and nighttime heartburn and other symptoms that happen with Gastroesophageal Reflux Disease (GERD).
•
up to 4 weeks for the healing and relief of duodenal ulcers.
•
7 days with certain antibiotic medicines to treat an infection and stomach (duodenal) ulcers caused by bacteria called H. pylori.
•
the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison syndrome.
In adolescents 12 years of age and older, Rabeprazole Sodium delayed-release tablets is used up to 8 weeks to treat symptoms of GERD. It is not known if Rabeprazole Sodium delayed-release tablets are safe and effective in children less than 12 years of age. Rabeprazole Sodium delayed-release tablets should not be used in children under 12 years of age.

Do not take Rabeprazole Sodium delayed-release tablets if you are:

•
allergic to rabeprazole, any other PPI medicine, or any of the ingredients in Rabeprazole Sodium delayed-release tablets. See the end of this Medication Guide for a complete list of ingredients.
•
taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY) used to treat HIV-1 (Human Immunodeficiency Virus)

Before you take Rabeprazole Sodium delayed-release tablets, tell your doctor about all of your medical conditions, including if you:

•
have low magnesium levels in your blood
•
have liver problems
•
are pregnant or plan to become pregnant. It is not known if Rabeprazole Sodium delayed-release tablets can harm your unborn baby.
•
are breastfeeding or plan to breastfeed. It is not known if rabeprazole passes into your breast milk.

Talk to your doctor about the best way to feed your baby if you take Rabeprazole Sodium delayed-release tablets. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take an antibiotic that contains clarithromycin or amoxicillin or if you take warfarin (COUMADIN, JANTOVEN) or methotrexate (OTREXUP, RASUVO, TREXALL, XATMEP), digoxin (LANOXIN), or a water pill (diuretic).

How should I take Rabeprazole Sodium delayed-release tablets?

•
Take Rabeprazole Sodium delayed-release tablets exactly as prescribed.
•
Rabeprazole Sodium delayed-release tablets is usually taken 1 time each day. Your doctor will tell you the time of day to take Rabeprazole Sodium delayed-release tablets, based on your medical condition.
•
Rabeprazole Sodium delayed-release tablets can be taken with or without food. Your doctor will tell you whether to take this medicine with or without food based on your medical condition.
•
Swallow each Rabeprazole Sodium delayed-release tablets whole. Do not chew, crush, or split Rabeprazole Sodium delayed-release tablets. Tell your doctor if you cannot swallow tablets whole.
•
If you miss a dose of Rabeprazole Sodium delayed-release tablets, take it as soon as possible. If it is almost time for your next dose, you should not take the missed dose. You should take your next dose at your regular time. Do not take 2 doses at the same time.
•
If you take too much Rabeprazole Sodium delayed-release tablets, call your doctor or your poison control center at 1-800-222-1222 right away, or go to the nearest emergency room.
•
If your doctor prescribes antibiotic medicines with Rabeprazole Sodium delayed-release tablets, read the patient information that comes with the antibiotic medicines before you take them.

What are the possible side effects of Rabeprazole Sodium delayed-release tablets? Rabeprazole Sodium delayed-release tablets may cause serious side effects, including:

•
See “What is the most important information I should know about Rabeprazole Sodium delayed-release tablets?”
•
Interaction with warfarin. Taking warfarin with a PPI medicine may lead to an increased risk of bleeding and death. If you take warfarin, your doctor may check your blood to see if you have an increased risk of bleeding. If you take warfarin during treatment with Rabeprazole Sodium delayed-release tablets, tell your doctor right away if you have any signs or symptoms of bleeding, including:
○ pain, swelling or discomfort ○ headaches, dizziness, or weakness ○ unusual bruising (bruises that happen without known cause or that grow in size) ○ nosebleeds ○ bleeding gums ○ bleeding from cuts take a long time to stop
○ menstrual bleeding that is heavier than normal ○ pink or brown urine ○ red or black stools ○ coughing up blood ○ vomiting blood or vomit that looks like coffee grounds
•
Low vitamin B-12 levels in the body can happen in people who have taken Rabeprazole Sodium delayed-release tablets for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B-12 levels, including shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms and legs.
•
Low magnesium levels in your body can happen in people who have taken Rabeprazole Sodium delayed-release tablets for at least 3 months. Tell your doctor if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.
•
Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an increased risk of developing a certain type of stomach growths called fundic gland polyps, especially after taking PPI medicines for more than 1 year.

The most common side effects of Rabeprazole Sodium delayed-release tablets in adults include: pain, sore throat, gas, infection, and constipation.

The most common side effects of Rabeprazole Sodium delayed-release tablets in adolescents 12 years of age and older include: headache, diarrhea, nausea, vomiting, and stomach-area (abdomen) pain. These are not all of the possible side effects of Rabeprazole Sodium delayed- release tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Rabeprazole Sodium delayed-release tablets? Store Rabeprazole Sodium delayed-release tablets in a dry place at room temperature between 68°F to 77°F (20°C to 25°C). Keep Rabeprazole Sodium delayed-release tablets and all medicines out of the reach of children.
General Information about the safe and effective use of Rabeprazole Sodium delayed-release tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Rabeprazole Sodium delayed-release tablets for a condition for which it was not prescribed. Do not give Rabeprazole Sodium delayed-release tablets 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 Rabeprazole Sodium delayed-release tablets that is written for health professionals.
What are the ingredients in Rabeprazole Sodium delayed-release tablets? Active ingredient: rabeprazole sodium Inactive ingredients: diacetylated monoglycerides, ethylcellulose, hydroxypropyl cellulose, hypromellose phthalate, light magnesium oxide, low substituted hydroxypropyl cellulose, magnesium stearate, mannitol, talc, and titanium dioxide. Iron oxide yellow is the coloring agent for the tablet coating. The ink pigment contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac glaze (modified) in SD-45. This Medication Guide has been approved by the U.S. Food and Drug Administration. All the registered trademarks used herein are the property of their respective owners. Distributed by: Advagen Pharma Ltd., 666 Plainsboro Road, Suite 605 Plainsboro, NJ, 08536, USA. Manufactured by: Rubicon Research Private Limited Ambernath, Dist: Thane, 421506 India.

Revised: 12/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — Rabeprazole DR tablets — NDC# 71205-603-60 — 60 Counts Label

71205-603-60
(click image for full-size original)
RABEPRAZOLE SODIUM rabeprazole sodium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-603(NDC:72888-059)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABEPRAZOLE SODIUM (RABEPRAZOLE) RABEPRAZOLE SODIUM 20 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
DIACETYLATED MONOGLYCERIDES
ETHYLCELLULOSE, UNSPECIFIED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
MAGNESIUM OXIDE
MAGNESIUM STEARATE
MANNITOL
PROPYLENE GLYCOL
SHELLAC
TALC
TITANIUM DIOXIDE
Product Characteristics
Color yellow (light yellow) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code B683
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-603-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE None
2 NDC:71205-603-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE None
3 NDC:71205-603-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204237 06/01/2017
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (71205-603), RELABEL (71205-603)

Revised: 04/2022 Proficient Rx LP

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