Rabeprazole Sodium
Generic Name: rabeprazole sodium
Brand Names:
Rabeprazole Sodium
11 DESCRIPTION The active ingredient in rabeprazole sodium delayed-release tablets is rabeprazole sodium, which is a proton pump inhibitor. It is a substituted benzimidazole known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfinyl]-1 H– benzimidazole sodium salt. It has an empirical formula of C 18 H 20 N 3 NaO 3 S and a molecular weight of 381.42. Rabeprazole sodium is a white to slightly yellowish-white solid.
Overview
11 DESCRIPTION The active ingredient in rabeprazole sodium delayed-release tablets is rabeprazole sodium, which is a proton pump inhibitor. It is a substituted benzimidazole known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfinyl]-1 H– benzimidazole sodium salt. It has an empirical formula of C 18 H 20 N 3 NaO 3 S and a molecular weight of 381.42. Rabeprazole sodium is a white to slightly yellowish-white solid.
Uses
1 INDICATIONS AND USAGE Rabeprazole sodium delayed-release tablets is 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 ).
Dosage
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.
Side Effects
6 ADVERSE REACTIONS 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 )] Most common adverse reactions in adults (>2%) are pain, pharyngitis, flatulence, infection, and constipation ( 6.1 ).
Interactions
7 DRUG INTERACTIONS 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.
Warnings
5 WARNINGS AND PRECAUTIONS 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 (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 (5.5 ). 4 CONTRAINDICATIONS 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) ].
Pregnancy
8.1 Pregnancy Risk Summary There are no available human data on rabeprazole sodium delayed-release tablets 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. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Rabeprazole Sodium Delayed-Release Tablets 20 mg is supplied as yellow, round , biconvex, beveled, coated tablets imprinted ‘20’ in black on one side.
Frequently Asked Questions
What is Rabeprazole Sodium used for?▼
1 INDICATIONS AND USAGE Rabeprazole sodium delayed-release tablets is 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 ).
What are the side effects of Rabeprazole Sodium?▼
6 ADVERSE REACTIONS 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 )] Most common adverse reactions in adults (>2%) are pain, pharyngitis, flatulence, infection, and constipation ( 6.1 ).
Can I take Rabeprazole Sodium during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available human data on rabeprazole sodium delayed-release tablets 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. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.
What are the important warnings for Rabeprazole Sodium?▼
5 WARNINGS AND PRECAUTIONS 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 (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 (5.5 ). 4 CONTRAINDICATIONS 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) ].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.