RABEPRAZOLE SODIUM — rabeprazole sodium tablet, delayed release
Lupin Pharmaceuticals, Inc.
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.
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.
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
Table 1 shows the recommended dosage of rabeprazole delayed-release tablets in adults and adolescent patients 12 years of age and older. The use of rabeprazole 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.
* For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole 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 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 extendbeyond 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 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 indicatedSome patients with Zollinger-Ellison syndrome have been treatedcontinuously for up to one year|
|Adolescents 12 Years of Age and Older|
|Symptomatic GERD||20 mg once daily||Up to 8 weeks|
- Swallow rabeprazole sodium delayed-release tablets whole. Do not chew, crush, or split tablets.
- For the treatment of duodenal ulcers take rabeprazole delayed-release tablets after a meal.
- For Helicobacter pylori eradication take rabeprazole 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.
- 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.
In adults, symptomatic response to therapy with rabeprazole 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.
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) ].
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 and evaluate patients with suspected acute TIN [see Contraindication (4)].
Published observational studies suggest that PPI therapy like rabeprazole sodium may be associated with an increased risk of Clostridium difficile -associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions (6.2) ].
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with rabeprazole sodium, refer to Warnings and Precautions sections of the corresponding prescribing information.
Several published observational studies in adults suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration (2) , Adverse Reactions (6.2) ].
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