Rabec Tablet

Rabeprazole sodium delayed-release tablets are a proton pump inhibitor (PPI) indicated in adults for: Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD). ( 1.1 ) Maintenance of Healing of Erosive or Ulcerative GERD. ( 1.2 ) Treatment of Symptomatic GERD. ( 1.3 ) Healing of Duodenal Ulcers. ( 1.4 ) Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence. ( 1.5 ) Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome. ( 1.6 ) In adolescent patients 12 years of age and older for: Short-term Treatment of Symptomatic GERD. …

• 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 sodiumdelayed-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 ] 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 D …

Rabeprazole sodium delayed-release tablets are provided in one strength, 20 mg. The tablets 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. Delayed-Release Tablets: 20 mg. (3)

• Advise the patient to read the FDA-approved patient labeling (Medication Guide)
• Acute Tubulointerstitial Nephritis Advise the patient or caregiver to call the patient’s healthcare provider immediately if they experience signs and/or symptoms associated with -acute tubulointerstitial nephritis [see Warnings and Precautions ]
• Clostridium difficile -Associated Diarrhea Advise the patient or caregiver to immediately call the patient’s healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions ] . …

• Rabeprazole delayed-release sodium 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 , Adverse Reactions ]. …

Table 2 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with rabeprazole sodium delayed-release tablets and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 2: Clinically Relevant Interactions Affecting Drugs Co-Administered with Rabeprazole Sodium Delayed-Release Tablets and Interactions with Diagnostics Antiretrovirals Clinical Impact: The effect of PPI on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. …

Gastric Malignancy: In adults, symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 ) Use with Warfarin: Monitor for increases in INR and prothrombin time. ( 5.2 , 7 ) Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. ( 5.3 ) Clostridium difficile- Associated Diarrhea: PPI therapy may be associated with increased risk of Clostridium difficile- Associated Diarrhea. ( 5.4 ) Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. …

The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.3) ]. Clostridium difficile -Associated Diarrhea [see Warnings and Precautions (5.4) ]. Bone Fracture [see Warnings and Precautions (5.5) ]. Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.7) ]. Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (5.8) ]. Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.9) ]. Fundic Gland Polyps [see Warnings and Precautions (5.11) ]. …

IN SPECIFIC POPULATIONS Pediatric Use : Dosage strength not appropriate for patients less than 12 years. ( 2 , 8.4 ) 8.1 Pregnancy Risk Summary There are no available human data on rabeprazole sodium use in pregnant women to inform the drug associated risk. The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. …

Seven reports of accidental overdosage with rabeprazole have been received. The maximum reported overdose was 80 mg. There were no clinical signs or symptoms associated with any reported overdose. Patients with Zollinger-Ellison syndrome have been treated with up to 120 mg rabeprazole once daily. No specific antidote for rabeprazole is known. Rabeprazole is extensively protein bound and is not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive. …

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