Rabeprazole Sodium

RABEPRAZOLE SODIUM- rabeprazole sodium tablet, delayed release
Amneal Pharmaceuticals LLC

1 INDICATIONS AND 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 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.

2 DOSAGE AND 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 1,000 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.

3 DOSAGE FORMS AND STRENGTHS

Rabeprazole sodium delayed-release tablets are provided in one strength of 20 mg and are light yellow to yellow color, round shaped, biconvex enteric-coated delayed release tablets imprinted “AR” with black ink on one side and plain on other side.

4 CONTRAINDICATIONS

  • Rabeprazole sodium is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles, or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [see Adverse Reactions (6)].
  • PPIs, including rabeprazole sodium, are contraindicated with rilpivirine-containing products [see Drug Interactions (7)].
  • For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with rabeprazole sodium delayed-release tablets, refer to the Contraindications section of their package inserts.

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