Drugplain

Rabeprazole Sodium DR 20 mg/1

Rabeprazole Sodium · TABLET, DELAYED RELEASE · Advanced Rx of Tennessee, LLC

No Recall History
Plain English

Rabeprazole sodium is a proton pump inhibitor used to treat conditions caused by excess stomach acid, such as heartburn, gastroesophageal reflux disease (GERD), and ulcers. This delayed-release tablet is taken by mouth and requires a prescription.

Key Facts

Brand Name
Rabeprazole Sodium DR
Generic Name
Rabeprazole Sodium
NDC Code (Product)
80425-0094
Manufacturer
Advanced Rx of Tennessee, LLC
Strength
20 mg/1
Dosage Form
TABLET, DELAYED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA208644
Marketing Start
04/27/2018

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1. Indications and Usage Section 1 INDICATIONS & 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 sympto…

Dosage & Administration

2. Dosage and Administration Section 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 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 Rabepr…

Contraindications

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 interstitial nephritis, and urticaria [see 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.

Drug Interactions

7. Drug Interaction 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. • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with rabeprazole may reduce antiviral effect and promote the development of drug resistance. • Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with rabeprazole may increase toxicity. • There are other antiretroviral drugs which do not result in clinically relevant interactions with rabeprazole. Intervention: Rilpivirine-containing product…

Adverse Reactions

6. Adverse Reactions The following serious adverse reactions are described below and elsewhere in labeling: Acute Interstitial 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 (5.6)] Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (5.7)] Hypomagnesemia [see Warnings and Precautions (5.8)] Fundic Gland Polyps [see WARNINGS AND PRECAUTIONS (5.10)] 6.1 Clinical Studies Experience Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults The data described below reflect exposure to rabeprazole sodium delayed-release tablets in 1064 adult patients exposed for up to 8 weeks. The studies were primarily placebo-and active-controlled trials in adult patients with Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD), Duodenal Ulcers and Gastric Ulcers. The popul…

Frequently Asked Questions

What is Rabeprazole Sodium DR used for?

Rabeprazole sodium is a proton pump inhibitor used to treat conditions caused by excess stomach acid, such as heartburn, gastroesophageal reflux disease (GERD), and ulcers. This delayed-release tablet is taken by mouth and requires a prescription.

Is Rabeprazole Sodium DR a controlled substance?

Rabeprazole Sodium DR is not classified as a controlled substance by the DEA.

What is the generic name for Rabeprazole Sodium DR?

The generic name for Rabeprazole Sodium DR is Rabeprazole Sodium. There are 12 other brand versions of Rabeprazole Sodium.

What is the NDC code for Rabeprazole Sodium DR 20 mg/1?

The NDC (National Drug Code) for Rabeprazole Sodium DR 20 mg/1 is 80425-0094, listed by Advanced Rx of Tennessee, LLC.

Product NDC

80425-0094

Package NDC

80425-0094-1

Other Rabeprazole Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)