Rabeprazole
Generic Name: rabeprazole
Brand Names:
Rabeprazole Sodium
11 DESCRIPTION The active ingredient in rabeprazole sodium delayed-release tablets is rabeprazole sodium, USP 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, USP is a white to slightly yellowish-white solid.
Overview
11 DESCRIPTION The active ingredient in rabeprazole sodium delayed-release tablets is rabeprazole sodium, USP 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, USP is a white to slightly yellowish-white solid.
Uses
1 INDICATIONS AND USAGE 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.
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.
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 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. 4 CONTRAINDICATIONS Rabeprazole delayed-release sodium tablets are contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles, or to any component of the formulation.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Rabeprazole sodium delayed-release tablets, 20 mg are supplied as light yellow to yellow color, round shaped, biconvex enteric-coated tablets imprinted “AR” with black ink on one side and plain on the other side.
Frequently Asked Questions
What is Rabeprazole used for?▼
1 INDICATIONS AND USAGE 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.
What are the side effects of Rabeprazole?▼
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.
What are the important warnings for Rabeprazole?▼
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 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. 4 CONTRAINDICATIONS Rabeprazole delayed-release sodium tablets are contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles, or to any component of the formulation.
Related Medications
Virox
virox
Non-Standardized Food Allergenic Extract [EPC]
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Antimonium Tartaricum, Arsenicum Album, Bryonia (alba), Echinacea (angustifolia), Gelsemium Sempervirens, Hepar Suis, Histaminum Hydrochloricum, Hyoscyamus Niger, Influenzinum, Lac Felinum, Ledum Palustre, Mercurius Solubilis, Mezereum, Nicotinamidum, Rna, Senega Officinalis, Silicea, Spigelia Anthelmia, Sulphur, Thuja Occidentalis, Zincum Metallicum.
antimonium tartaricum, arsenicum album, bryonia (alba), echinacea (angustifolia), gelsemium sempervirens, hepar suis, histaminum hydrochloricum, hyoscyamus niger, influenzinum, lac felinum, ledum palustre, mercurius solubilis, mezereum, nicotinamidum, rna, senega officinalis, silicea, spigelia anthelmia, sulphur, thuja occidentalis, zincum metallicum.
PURPOSE: Antimonium Tartaricum - Headache, Arsenicum Album - Tiredness, Bryonia (Alba) – Sore Muscles, Echinacea (Angustifolia) – Headache, Gelsemium Sempervirens - Tiredness, Hepar Suis Tiredness, Histaminum Hydrochloricum - Tiredness, Hyoscyamus Niger – Sore Muscles, Influenzinum - Tiredness, Lac Felinum – Headache, Ledum Palustre – Sore Muscles, Mercurius Solubilis - Tiredness, Mezereum - Headache, Nicotinamidum - Tiredness, RNA – Sore Muscles, Senega Officinalis - Tiredness, Silicea - Tiredn
Ciprofloxacin
ciprofloxacin
Ciprofloxacin is a fluoroquinolone antibacterial agent indicated for treating various infections caused by susceptible bacteria.
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.