Aciphex (Page 2 of 2)

Dosage and Administration Section

2 DOSAGE & ADMINISTRATION

Table 1 shows the recommended dosage of rabeprazole sodium delayed-release tablets in adults and adolescent patients 12 years of age and older. The use of rabeprazole sodium delayed-release tablets is not recommended for use in pediatric patients 1 year to less than 12 years of age because the lowest available tablet strength (20 mg) exceeds the recommended dose for these patients. Use another rabeprazole formulation for pediatric patients 1 year to less than 12 years of age.

Table 1: Recommended Dosage and Duration of Rabeprazole sodium delayed-release tablets in Adults and Adolescents 12 Years of Age and Older

Indication
Dosage of Rabeprazole sodium delayed-release tablets
Treatment Duration
Adults
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD)
20 mg once daily
4 to 8 weeks*
Maintenance of Healing of Erosive or Ulcerative GERD
20 mg once daily
Controlled studies do not extend beyond 12 months
Symptomatic GERD in Adults
20 mg once daily
Up to 4 weeks**
Healing of Duodenal Ulcers
20 mg once daily after the morning meal
Up to 4 weeks***
Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Rabeprazole sodium delayed-release tablets 20 mg Amoxicillin 1000 mg Clarithromycin 500 mg Take all three medications twice daily with morning and evening meals; it is important that patients comply with the full 7-day regimen [see Clinical Studies (14.5)]
7 days
Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome
Starting dose 60 mg once daily then adjust to patient needs; some patients require divided doses Dosages of 100 mg once daily and 60 mg twice daily have been administered
As long as clinically indicated Some patients with Zollinger-Ellison syndrome have been treated continuously for up to one year
Adolescents 12 Years of Age and Older
Symptomatic GERD
20 mg once daily Up to 8 weeks

* For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole sodium delayed-release tablets may be considered.

** If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered.

*** Most patients heal within 4 weeks; some patients may require additional therapy to achieve healing.

Administration Instructions

• Swallow rabeprazole sodium delayed-release tablets whole. Do not chew, crush, or split 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.

Indications and Usage Section

1 INDICATIONS & USAGE

1.1 Healing of Erosive or Ulcerative GERD in Adults

Rabeprazole sodium delayed-release tablets are 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 rabeprazole sodium delayed-release tablets may be considered.

1.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults

Rabeprazole sodium delayed-release tablets are 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.

1.3 Treatment of Symptomatic GERD in Adults

Rabeprazole sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks.

1.4 Healing of Duodenal Ulcers in Adults

Rabeprazole sodium delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.

1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults

Rabeprazole sodium delayed-release tablets, in combination with amoxicillin and clarithromycin as a three drug regimen, are 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.

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 (12.2)and the full prescribing information for clarithromycin].

1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults

Rabeprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

1.7 Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older

Rabeprazole sodium delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.

Principal Display Panel

Rabeprazole 20mg
(click image for full-size original)

ACIPHEX rabeprazole 20mg tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80425-0134(NDC:67877-443)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABEPRAZOLE SODIUM (RABEPRAZOLE) RABEPRAZOLE SODIUM 20 mg
Product Characteristics
Color yellow Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80425-0134-2 60 TABLET, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208644 04/27/2018
Labeler — Advanced Rx Pharmacy of Tennessee, LLC (117023142)
Establishment
Name Address ID/FEI Operations
Advanced Rx Pharmacy of Tennessee, LLC 117023142 repack (80425-0134)

Revised: 03/2021 Advanced Rx Pharmacy of Tennessee, LLC

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