RABEPRAZOLE SODIUM- rabeprazole sodium tablet, delayed release
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
|Indication||Dosage of Rabeprazole sodium delayed-release tablets||Treatment Duration|
|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.
• 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 yellow, round , biconvex, bevelled, coated tablets imprinted ‘20’ in black on one side.
- Rabeprazole 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 tubulointerstitial nephritis, and urticaria [ see Warnings and Precautions (5.3), Adverse Reactions (6) ].
- PPIs, including rabeprazole, 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.
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