Prescription Drug Information: RABEPRAZOLE SODIUM

RABEPRAZOLE SODIUM- rabeprazole sodium tablet, delayed release
REMEDYREPACK INC.

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 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.

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

*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.

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

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, 20 mg. The tablets are light yellow colored round, biconvex with beveled edges. “B683” is printed on one side with black ink and plain on other side.

4 CONTRAINDICATIONS

  • Rabeprazole Sodium delayed-release tablets are 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 tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.3), Adverse Reactions (6)] .
  • PPIs, including Rabeprazole Sodium delayed-release tablets, 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.

5 WARNINGS AND PRECAUTIONS

5.1 Presence of Gastric Malignancy

In adults, symptomatic response to therapy with Rabeprazole Sodium delayed-release tablets does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI.

5.2 Interaction with Warfarin

Steady state interactions of rabeprazole and warfarin have not been adequately evaluated in patients. There have been reports of increased INR and prothrombin time in patients receiving a proton pump inhibitor and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with Rabeprazole Sodium delayed-release tablets and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time [see Drug Interactions (7)] .

5.3 Acute Tubulointerstitial Nephritis

Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia). Discontinue Rabeprazole Sodium delayed-release tablets and evaluate patients with suspected acute TIN [see Contraindications (4)] .

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