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Rabeprazole sodium 20 mg Tablet, Delayed Release, 90-count — NDC 63187-0555-90 package photo

Rabeprazole sodium 20 mg Tablet, Delayed Release, 90-count

by Proficient Rx LP · 90 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-555-90)
NDC 63187-0555-90
🏷️ FDA NDC (as labeled) 63187-555-90 billing pads the product segment with a zero
This package
Contains90-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.3379/unit — full pricing hub ↓
Also comes in: 30 tablets 63187-0555-30 60 tablets 63187-0555-60
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 63187-555-90
Product NDC 63187-555
11-digit billing NDC 63187055590
RxCUI 854868
UNII 3L36P16U4R
Application # ANDA202376
SPL Set ID d1444508-fe40-4f68-8350-52f13399e38a
Established class (EPC) Proton Pump Inhibitor
Mechanism of action Proton Pump Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-11-08
Route ORAL
Dosage form TABLET, DELAYED RELEASE
Substance RABEPRAZOLE SODIUM
GPI-14 49270076100620
GPI class RABEprazole Sodium
GCN Seq No 040941
GCN 94639
HICL code 018847
Ingredient (HICL) Rabeprazole Sodium
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D4
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract
HIC3 code D4J
Therapeutic class — specific (HIC3) Proton-Pump Inhibitors
AHFS code 56:28.36.00
AHFS class Proton-Pump Inhibitors
FDB label name RABEPRAZOLE SOD DR 20 MG TAB
FDB brand name Rabeprazole Sodium
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 63187-555-90 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63187-0555-90. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Proton Pump Inhibitor class.

Pharmacologic class Proton Pump Inhibitor
Drug family (ATC) Proton pump inhibitors
How it works Proton Pump Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerProficient Rx LP
Application holderTORRENT PHARMACEUTICALS LTD
FDA applicationANDA202376 (ANDA)
Labeler code63187
First marketedNov 2013
Product typeHuman Prescription Drug
Portfolio1,723 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name RABEPRAZOLE SOD DR 20 MG TAB Ingredient Rabeprazole Sodium
📗 Our plain-language guide HelloPharmacist
  • Rabeprazole cuts down the amount of acid your stomach produces — significantly. That lower acid level gives your esophagus or stomach lining time to heal if it's been damaged by ac...
  • What exactly is rabeprazole supposed to do for me?
  • For most uses, you can take rabeprazole with or without food — it's flexible. The main exceptions are duodenal ulcers, where you should take it after your morning meal, and the H....
  • Does it matter when I take my tablet — with food or on an empty stomach?
📖 Read our full Rabeprazole guide →
9
Nutrient depletion considerations

Rabeprazole Sodium may be associated with lower levels of 9 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Rabeprazole Sodium nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Yellow
ShapeRound
Imprint107
Size7 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII UF064M00AF
    Diethyl phthalate is a clear, colorless liquid made from phthalic acid. It's used in medicines as a plasticizer to make tablet coatings flexible and as a solvent to help dissolve and distribute active ingredients evenly throughout the product.
  • UNII 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII G4U024CQK6
    Hypromellose phthalate is a plant-derived polymer coating material. It's used to coat tablets or capsules so the medicine dissolves in the intestines rather than the stomach, protecting it from stomach acid or reducing stomach irritation.
  • UNII 3A3U0GI71G
    Magnesium oxide is a mineral compound that acts as a buffer and filler in medications. It helps neutralize stomach acid and adds bulk to the tablet or capsule formulation.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.3379 $30.41 / 90 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rabeprazole Sodium 20 mg 62135-0503-30 Chartwell 30 tablets $0.209 AB Availability likely —
Rabeprazole Sodium 20 mg 62175-0302-32 Lannett 30 tablets $0.209 AB Availability likely —
Rabeprazole Sodium 20 mg 65862-0721-30 Aurobindo 30 tablets $0.209 — Availability likely —
Rabeprazole Sodium 20 mg 67877-0443-30 Ascend 30 tablets $0.209 AB Availability likely —
Rabeprazole Sodium 20 mg 72888-0059-30 Advagen 30 tablets $0.209 AB Availability likely —
Rabeprazole sodium 20 mg 13668-0107-05 Torrent 500 tablets $0.279 AB FDA listed —
Rabeprazole Sodium 20 mg 50090-4751-00 A-S 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 50090-6887-00 A-S 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 51407-0184-05 Golden 500 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 60760-0560-30 St. 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 60760-0972-30 St. 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 63187-0259-30 Proficient 30 tablets — AB FDA listed —
Rabeprazole sodium 20 mgthis 63187-0555-90 Proficient 90 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 65162-0724-03 Amneal 30 tablets — AB FDA listed —
Rabeprazole sodium 20 mg 68788-4060-03 Preferred 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 68788-7459-03 Preferred 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 68788-8536-03 Preferred 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 70518-2590-00 REMEDYREPACK 60 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 70518-3209-00 REMEDYREPACK 60 tablets — AB Discontinued —
Rabeprazole Sodium 20 mg 71205-0292-30 Proficient 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 71205-0603-30 Proficient 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 71335-0244-02 Bryant 90 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 71335-1100-02 Bryant 90 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 71335-1558-02 Bryant 90 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 71335-2304-02 Bryant 90 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 72162-2367-05 Bryant 500 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 72162-2503-03 Bryant 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 72189-0142-90 DIRECT 90 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 72189-0169-30 DIRECT 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 76420-0107-30 Asclemed 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 76420-0223-30 Asclemed 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 76420-0818-30 Asclemed 30 tablets — AB FDA listed —
Rabeprazole Sodium DR 20 mg 80425-0094-01 Advanced 30 tablets — AB FDA listed —
Rabeprazole Sodium DR 20 mg 80425-0134-01 Advanced 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 80425-0363-01 Advanced 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 80425-0449-01 Advanced 30 tablets — AB FDA listed —
Aciphex 20 mg 80725-0243-30 Waylis 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 85509-1443-03 PHOENIX 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2013
On the market since
Nov 2013
📍
2026
Currently FDA-listed
13 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Rabeprazole Sodium — the program that covers self-administered drugs. 5 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Rabeprazole Sodium. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.14M
Claims incl. refills
88.3K
Beneficiaries
67.1K
Spend / beneficiary
$46.86
Spend / claim
$35.61
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63187-0555-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-555-30) 2018-12-01 Active
63187-0555-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-555-60) 2018-12-01 Active
63187-0555-90 You're viewing this 90 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-555-90) 2018-12-01 Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 63187-0555-90?
NDC 63187-0555-90 is a 90-count package — 90 tablet, delayed release in 1 bottle.
What is the difference between NDC 63187-0555-90 and NDC 63187-0555-30?
Both are Rabeprazole sodium 20 mg Tablet, Delayed Release — the drug itself is identical. NDC 63187-0555-90 is the 90-count package, while NDC 63187-0555-30 is the 30 tablets package.
What NDC number is used to bill for this package of Rabeprazole sodium 20 mg Tablet, Delayed Release?
Bill NDC 63187-0555-90 — the 11-digit billing format is 63187055590. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 63187-555-90, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 63187-0555-90, written without dashes as 63187055590. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 63187-0555-90, the first segment (63187) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0555) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (90) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 30 tablets (63187-0555-30), 60 tablets (63187-0555-60). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage ~2 min read ▾

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 the 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 (1.7)

1.1Healing 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.

1.2Maintenance 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.

1.3Treatment 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.

1.4Healing of Duodenal Ulcers in Adults Rabeprazole sodium delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.

1.5Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults Rabeprazole sodium delayed-release tablets in combination with amoxicillin and clarithromycin as a three drug regimen, is 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 [ see Clinical Studies (14.5) and Dosage and Administration (2.5) ].

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 clarithromycin package insert, Clinical Pharmacology (12.2) ].

1.6Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults Rabeprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

1.7Short-term Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older Rabeprazole sodium delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.

⏱️ Dosage and Administration ~3 min read ▾

2. DOSAGE AND ADMINISTRATION Rabeprazole sodium delayed-release tablets should be swallowed whole. The tablets should not be chewed, crushed or split (2.10).

Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) (2.1) 20 mg once daily Maintenance of Healing of Erosive or Ulcerative GERD (2.2) 20 mg once daily Treatment of Symptomatic GERD in Adults (2.3) 20 mg once daily Healing of Duodenal Ulcers (2.4) 20 mg once daily after morning meal Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (2.5) Three Drug Regimen: Rabeprazole sodium delayed-release tablets 20 mg Amoxicillin 1000 mg Clarithromycin 500 mg All three medications should be taken twice daily with morning and evening meals for 7 days Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome (2.6) Starting dose 60 mg once daily then adjust to patient needs Treatment of Symptomatic GERD in Adolescents 12 Years of Age and Older (2.7) 20 mg once daily

2.1Healing of Erosive or Ulcerative GERD in Adults The recommended adult oral dose is one rabeprazole sodium 20 mg delayed-release tablet to be taken once daily for four to eight weeks [ see Indications and Usage (1.1) ]. 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.

2.2Maintenance of Healing of Erosive or Ulcerative GERD in Adults The recommended adult oral dose is one rabeprazole sodium 20 mg delayed-release tablet to be taken once daily [ see Indications and Usage (1.2) ].

2.3Treatment of Symptomatic GERD in Adults The recommended adult oral dose is one rabeprazole sodium 20 mg delayed-release tablet to be taken once daily for 4 weeks [ see Indications and Usage (1.3) ]. If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered. The recommended adolescent dosing is one rabeprazole sodium 20 mg delayed-release tablet to be taken once daily for 8 weeks.

2.4Healing of Duodenal Ulcers in Adults The recommended adult oral dose is one rabeprazole sodium 20 mg delayed-release tablet to be taken once daily after the morning meal for a period up to four weeks [ see Indications and Usage (1.5) ]. Most patients with duodenal ulcer heal within four weeks. A few patients may require additional therapy to achieve healing.

2.5Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults TABLE 1 THREE DRUG REGIMEN a All three medications should be taken twice daily with the morning and evening meals. a It is important that patients comply with the full 7-day regimen [ see Clinical Studies (14.5 )]. Rabeprazole sodium delayed-release tablet 20 mg Twice Daily for 7 Days Amoxicillin 1000 mg Twice Daily for 7 Days Clarithromycin 500 mg Twice Daily for 7 Days

2.6Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults The dosage of rabeprazole sodium delayed-release tablets in patients with pathologic hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated.

Some patients may require divided doses. Doses up to 100 mg QD and 60 mg BID have been administered. Some patients with Zollinger-Ellison syndrome have been treated continuously with rabeprazole sodium delayed-release tablets for up to one year.

2.7Short-term Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older The recommended oral dose for adolescents 12 years of age and older is one 20 mg delayed-release tablet once daily for up to 8 weeks [ see Use in Specific Populations (8.4) and Clinical Studies (14.7) ].

2.9Elderly, Renal and Hepatic Impaired Patients No dosage adjustment is necessary in elderly patients, in patients with renal disease or in patients with mild to modera…

💊 Dosage Forms and Strengths 22 words ▾

3. DOSAGE FORMS AND STRENGTHS • Delayed-release tablets: 20 mg (3) Rabeprazole sodium delayed-release tablets are provided in strength of 20 mg.

⛔ Contraindications 53 words ▾

4. CONTRAINDICATIONS • History of hypersensitivity to rabeprazole (4) Rabeprazole is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles or to any component of the formulation. For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with rabeprazole sodium, refer to the Contraindications section of their package inserts.

⚠️ Warnings and Cautions ~3 min read ▾

5. WARNINGS AND PRECAUTIONS • Symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy (5.1) • Use with warfarin: monitor for increases in INR and prothombin time (5.2) • PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea (5.3) • 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 (5.4) • Hypomagnesemia has been reported rarely with prolonged treatment with PPIs (5.5)

5.1Presence of Gastric Malignancy Symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy. Patients with healed GERD were treated for up to 40 months with rabeprazole and monitored with serial gastric biopsies. Patients without H. pylori infection (221 of 326 patients) had no clinically important pathologic changes in the gastric mucosa.

Patients with H. pylori infection at baseline (105 of 326 patients) had mild or moderate inflammation in the gastric body or mild inflammation in the gastric antrum. Patients with mild grades of infection or inflammation in the gastric body tended to change to moderate, whereas those graded moderate at baseline tended to remain stable. Patients with mild grades of infection or inflammation in the gastric antrum tended to remain stable.

At baseline 8% of patients had atrophy of glands in the gastric body and 15% had atrophy in the gastric antrum. At endpoint, 15% of patients had atrophy of glands in the gastric body and 11% had atrophy in the gastric antrum. Approximately 4% of patients had intestinal metaplasia at some point during follow-up, but no consistent changes were seen.

5.2Concomitant Use with Warfarin 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 a proton pump inhibitor and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.

5.3Clostridium difficile Associated Diarrhea 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 Reaction (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 those package inserts.

5.4Bone Fracture 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) and Adverse Reactions (6.2) ].

5.5Hypomagnesemia Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required m…

🤒 Adverse Reactions ~3 min read ▾

6. ADVERSE REACTIONS • In the adult studies (4 to 8 weeks), adverse reactions that occurred at a rate greater than 2% and greater than placebo included pain, pharyngitis, flatulence, infection and constipation (6.1). • In studies of adolescent patients (ages 12 to 16 years, and up to 36 weeks exposure) adverse reactions that occurred at a rate of ≥5% of patients included abdominal pain, diarrhea and headache (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-269-544-2299 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Worldwide, over 2900 patients have been treated with rabeprazole in Phase II-III clinical trials involving various dosages and durations of treatment.

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.

6.1Clinical Studies Experience Adults The data described below reflect exposure to rabeprazole sodium 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 population had a mean age of 53 years (range 18-89 years) and had a ratio of approximately 60% male: 40% female.

The racial distribution was 86% Caucasian, 8% African American, 2% Asian and 5% other. Most patients received either 10 mg, 20 mg or 40 mg/day of rabeprazole sodium. An analysis of adverse reactions appearing in ≥ 2% of rabeprazole sodium patients (n=1064) and with a greater frequency than placebo (n=89) in controlled North American and European acute treatment trials, revealed the following adverse reactions: pain (3% vs.

1%), pharyngitis (3% vs. 2%), flatulence (3% vs. 1%), infection (2% vs.

1%), and constipation (2% vs. 1%). Three long-term maintenance studies consisted of a total of 740 adult patients; at least 54% of adult patients were exposed to rabeprazole for 6 months and at least 33% were exposed for 12 months.

Of the 740 adult patients, 247 (33%) and 241 (33%) patients received 10 mg and 20 mg of rabeprazole sodium, respectively, while 169 (23%) patients received placebo and 83 (11%) received omeprazole. The safety profile of rabeprazole in the maintenance studies in adults was consistent with what was observed in the acute studies. Other adverse reactions seen in controlled clinical trials, which do not meet the above criteria (≥ 2% of rabeprazole sodium treated patients and greater than placebo) and for which there is a possibility of a causal relationship to rabeprazole, include the following: headache, abdominal pain, diarrhea, dry mouth, dizziness, peripheral edema, hepatic enzyme increase, hepatitis, hepatic encephalopathy, myalgia, and arthralgia.

Combination Treatment with Amoxicillin and Clarithromycin: In clinical trials using combination therapy with rabeprazole plus amoxicillin and clarithromycin (RAC), no adverse reactions unique to this drug combination were observed. In the U.S. multicenter study, the most frequently reported drug related adverse reactions for patients who received RAC therapy for 7 or 10 days were diarrhea (8% and 7%) and taste perversion (6% and 10%), respectively. No clinically significant laboratory abnormalities particular to the drug combinations were observed.

For more information on adverse reactions or laboratory changes with amoxicillin or clarithromycin, refer to their respective package prescribing information, Adverse Reactions section. Pediatric In a multicenter, open-label study of adolescent patients 12 to 16 years of age with a clinical diagnosis of symptomatic GERD or endoscopically proven GERD, the adverse event profile was similar to that of adults. The adverse reactions reported without regard to relationship to rabeprazole sodium that occurred in ≥ 2% of 111 patients were h…

🔄 Drug Interactions ~3 min read ▾

7. DRUG INTERACTIONS • Increased INR and prothrombin times have been reported with concomitant use with warfarin. Patients need to be monitored (7.2) • Rabeprazole has been shown to inhibit cyclosporine metabolism in vitro (7.3) • Rabeprazole sodium inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin) (7.4) • Rabeprazole sodium may reduce the plasma levels of atazanavir (7.4) • Methotrexate: Rabeprazole sodium may increase serum level of methotrexate (7.7)

7.1Drugs Metabolized by CYP450 Rabeprazole is metabolized by the cytochrome P450 (CYP450) drug metabolizing enzyme system. Studies in healthy subjects have shown that rabeprazole does not have clinically significant interactions with other drugs metabolized by the CYP450 system, such as warfarin and theophylline given as single oral doses, diazepam as a single intravenous dose, and phenytoin given as a single intravenous dose (with supplemental oral dosing). Steady state interactions of rabeprazole and other drugs metabolized by this enzyme system have not been studied in patients.

7.2Warfarin There have been reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including rabeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death [ see Warnings and Precautions (5.2) ].

7.3Cyclosporine In vitro incubations employing human liver microsomes indicated that rabeprazole inhibited cyclosporine metabolism with an IC 50 of 62 micromolar, a concentration that is over 50 times higher than the C max in healthy volunteers following 14 days of dosing with 20 mg of rabeprazole. This degree of inhibition is similar to that by omeprazole at equivalent concentrations.

7.4Compounds Dependent on Gastric pH for Absorption Rabeprazole produces sustained inhibition of gastric acid secretion. An interaction with compounds which are dependent on gastric pH for absorption may occur due to the magnitude of acid suppression observed with rabeprazole. For example, in normal subjects, co-administration of rabeprazole 20 mg QD resulted in an approximately 30% decrease in the bioavailability of ketoconazole and increases in the AUC and C max for digoxin of 19% and 29%, respectively.

Therefore, patients may need to be monitored when such drugs are taken concomitantly with rabeprazole. Co-administration of rabeprazole and antacids produced no clinically relevant changes in plasma rabeprazole concentrations. Concomitant use of atazanavir and proton pump inhibitors is not recommended.

Co-administration of atazanavir with proton pump inhibitors is expected to substantially decrease atazanavir plasma concentrations and thereby reduce its therapeutic effect.

7.5Drugs Metabolized by CYP2C19 In a clinical study in Japan evaluating rabeprazole in adult patients categorized by CYP2C19 genotype (n=6 per genotype category), gastric acid suppression was higher in poor metabolizers as compared to extensive metabolizers. This could be due to higher rabeprazole plasma levels in poor metabolizers. Whether or not interactions of rabeprazole sodium with other drugs metabolized by CYP2C19 would be different between extensive metabolizers and poor metabolizers has not been studied.

7.6Combined Administration with Clarithromycin Combined administration consisting of rabeprazole, amoxicillin, and clarithromycin resulted in increases in plasma concentrations of rabeprazole and 14-hydroxyclarithromycin [ see Clinical Pharmacology (12.3) ]. Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions due to drug interactions [ see Warnings and Precautions in prescribing information for clarithromycin] . Because of these drug interactions, clarithromycin is contraindicated for co-administration with certain drugs [ see Contraindications in prescribing info…

👥 Use in Specific Populations ~2 min read ▾

8. USE IN SPECIFIC POPULATIONS • The safety and efficacy of rabeprazole sodium delayed-release tablets for GERD have not been established for pediatric patients less than 12 years of age. • The safety and efficacy of rabeprazole sodium for the other adult indications have not been established for pediatric patients (8.4).

8.1Pregnancy Pregnancy Category B Risk Summary There are no adequate and well-controlled studies with rabeprazole sodium in pregnant women. No evidence of teratogenicity was seen in animal reproduction studies with rabeprazole at 13 and 8 times the human exposure at the recommended dose for GERD, in rats and rabbits, respectively. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Animal Data Embryo-fetal developmental studies have been performed in rats at intravenous doses of rabeprazole up to 50 mg/kg/day (plasma AUC of 11.8 μg•hr/mL, about 13 times the human exposure at the recommended oral dose for GERD) and rabbits at intravenous doses up to 30 mg/kg/day (plasma AUC of 7.3 μg•hr/mL, about 8 times the human exposure at the recommended oral dose for GERD) and have revealed no evidence of harm to the fetus due to rabeprazole. Administration of rabeprazole to rats in late gestation and during lactation at an oral dose of 400 mg/kg/day (about 195-times the human oral dose based on mg/m 2 ) resulted in decreases in body weight gain of the pups.

8.3Nursing Mothers It is not known if rabeprazole sodium is excreted in human milk; however, rabeprazole is present in rat milk. Because many drugs are excreted in milk, caution should be exercised when rabeprazole sodium is administered to a nursing woman.

8.4Pediatric Use Symptomatic GERD in Adolescent Patients Greater or Equal to 12 Years of Age In a multicenter, randomized, open-label, parallel-group study, 111 adolescent patients 12 to 16 years of age with a clinical diagnosis of symptomatic GERD or suspected or endoscopically proven GERD were randomized and treated with either rabeprazole sodium 10 mg or rabeprazole sodium 20 mg once daily for up to 8 weeks for the evaluation of safety and efficacy. The adverse event profile in adolescent patients was similar to that of adults.

The related reported adverse reactions that occurred in ≥ 2% of patients were headache (5.4%) and nausea (1.8%). There were no adverse reactions reported in these studies that were not previously observed in adults.

8.5Geriatric Use Of the total number of subjects in clinical studies of rabeprazole sodium, 19% were 65 years and over, while 4% were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

8.6Gender Duodenal ulcer and erosive esophagitis healing rates in women are similar to those in men. Adverse reactions and laboratory test abnormalities in women occurred at rates similar to those in men.

🤰 Pregnancy 189 words ▾

8.1Pregnancy Pregnancy Category B Risk Summary There are no adequate and well-controlled studies with rabeprazole sodium in pregnant women. No evidence of teratogenicity was seen in animal reproduction studies with rabeprazole at 13 and 8 times the human exposure at the recommended dose for GERD, in rats and rabbits, respectively. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Animal Data Embryo-fetal developmental studies have been performed in rats at intravenous doses of rabeprazole up to 50 mg/kg/day (plasma AUC of 11.8 μg•hr/mL, about 13 times the human exposure at the recommended oral dose for GERD) and rabbits at intravenous doses up to 30 mg/kg/day (plasma AUC of 7.3 μg•hr/mL, about 8 times the human exposure at the recommended oral dose for GERD) and have revealed no evidence of harm to the fetus due to rabeprazole. Administration of rabeprazole to rats in late gestation and during lactation at an oral dose of 400 mg/kg/day (about 195-times the human oral dose based on mg/m 2 ) resulted in decreases in body weight gain of the pups.

🧒 Pediatric Use 121 words ▾

8.4Pediatric Use Symptomatic GERD in Adolescent Patients Greater or Equal to 12 Years of Age In a multicenter, randomized, open-label, parallel-group study, 111 adolescent patients 12 to 16 years of age with a clinical diagnosis of symptomatic GERD or suspected or endoscopically proven GERD were randomized and treated with either rabeprazole sodium 10 mg or rabeprazole sodium 20 mg once daily for up to 8 weeks for the evaluation of safety and efficacy. The adverse event profile in adolescent patients was similar to that of adults.

The related reported adverse reactions that occurred in ≥ 2% of patients were headache (5.4%) and nausea (1.8%). There were no adverse reactions reported in these studies that were not previously observed in adults.

🧓 Geriatric Use 71 words ▾

8.5Geriatric Use Of the total number of subjects in clinical studies of rabeprazole sodium, 19% were 65 years and over, while 4% were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 175 words ▾

10. OVERDOSAGE Because strategies for the management of overdose are continually evolving, it is advisable to contact a Poison Control Center to determine the latest recommendations for the management of an overdose of any drug. There has been no experience with large overdoses with rabeprazole.

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 QD. 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. Single oral doses of rabeprazole at 786 mg/kg and 1024 mg/kg were lethal to mice and rats, respectively. The single oral dose of 2000 mg/kg was not lethal to dogs.

The major symptoms of acute toxicity were hypoactivity, labored respiration, lateral or prone position and convulsion in mice and rats and watery diarrhea, tremor, convulsion and coma in dogs.

🧬 Clinical Pharmacology ~3 min read ▾

12. CLINICAL PHARMACOLOGY

12.1Mechanism of Action Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H 2 -receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H + , K + ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, rabeprazole has been characterized as a gastric proton-pump inhibitor. Rabeprazole blocks the final step of gastric acid secretion.

In gastric parietal cells, rabeprazole is protonated, accumulates, and is transformed to an active sulfenamide. When studied in vitro , rabeprazole is chemically activated at pH 1.2 with a half-life of 78 seconds. It inhibits acid transport in porcine gastric vesicles with a half-life of 90 seconds.

12.2Pharmacodynamics Antisecretory Activity The antisecretory effect begins within one hour after oral administration of 20 mg rabeprazole sodium. The median inhibitory effect of rabeprazole sodium on 24 hour gastric acidity is 88% of maximal after the first dose. Rabeprazole sodium 20 mg inhibits basal and peptone meal-stimulated acid secretion versus placebo by 86% and 95%, respectively, and increases the percent of a 24-hour period that the gastric pH>3 from 10% to 65% (see table below).

This relatively prolonged pharmacodynamic action compared to the short pharmacokinetic half-life (1-2 hours) reflects the sustained inactivation of the H + , K + ATPase. TABLE 3 GASTRIC ACID PARAMETERS RABEPRAZOLE SODIUM VERSUS PLACEBO AFTER 7 DAYS OF ONCE DAILY DOSING *(p<0.01 versus placebo) Parameter Rabeprazole sodium (20 mg QD) Placebo Basal Acid Output 0.4* 2.8 (mmol/hr) Stimulated Acid Output 0.6* 13.3 (mmol/hr) % Time Gastric pH>3 65* 10 Compared to placebo, rabeprazole sodium, 10 mg, 20 mg, and 40 mg, administered once daily for 7 days significantly decreased intragastric acidity with all doses for each of four meal-related intervals and the 24-hour time period overall.

In this study, there were no statistically significant differences between doses; however, there was a significant dose-related decrease in intragastric acidity. The ability of rabeprazole to cause a dose-related decrease in mean intragastric acidity is illustrated below. TABLE 4 AUC ACIDITY (MMOLHR/L) RABEPRAZOLE SODIUM VERSUS PLACEBO ON DAY 7 OF ONCE DAILY DOSING (MEAN±SD) *(p<0.001 versus placebo) Treatment AUC 10 mg 20 mg 40 mg Placebo interval RBP RBP RBP (N=24) (hrs) (N=24) (N=24) (N=24) 08:00 – 13:00 19.6±21.5* 12.9±23* 7.6±14.7* 91.1±39.7 13:00 – 19:00 5.6±9.7* 8.3±29.8* 1.3±5.2* 95.5±48.7 19:00 – 22:00 0.1±0.1* 0.1±0.06* 0.0±0.02* 11.9±12.5 22:00 – 08:00 129.2±84* 109.6±67.2* 76.9±58.4* 479.9±165 AUC 0-24 155.5±90.6* 130.9±81* 85.8±64.3* 678.5±216 hours After administration of 20 mg rabeprazole sodium tablets once daily for eight days, the mean percent of time that gastric pH>3 or gastric pH>4 after a single dose (Day 1) and multiple doses (Day 8) was significantly greater than placebo (see table below).

The decrease in gastric acidity and the increase in gastric pH observed with 20 mg rabeprazole sodium tablets administered once daily for eight days were compared to the same parameters for placebo, as illustrated below: TABLE 5 GASTRIC ACID PARAMETERS RABEPRAZOLE SODIUM ONCE DAILY DOSING VERSUS PLACEBO ON DAY 1 AND DAY 8 a No inferential statistics conducted for this parameter. * (p<0.001 versus placebo) b Gastric pH was measured every hour over a 24-hour period. Parameter Rabeprazole sodium 20 mg QD Placebo Day 1 Day 8 Day 1 Day 8 Mean AUC 0-24 Acidity 340.8* 176.9* 925.5 862.4 Median trough pH (23-hr) a 3.77 3.51 1.27 1.38 % Time Gastric pH>3 b 54.6* 68.7* 19.1 21.7 % Time Gastric pH>4 b 44.1* 60.3* 7.6

11.0Effects on Esophageal Acid Exposure In patients with gastroesophageal reflux disease (GERD) and moderate to severe esophageal acid exposure, rabeprazole sodium 20 mg an…

🧬 Mechanism of Action 131 words ▾

12.1Mechanism of Action Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H 2 -receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H + , K + ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, rabeprazole has been characterized as a gastric proton-pump inhibitor. Rabeprazole blocks the final step of gastric acid secretion.

In gastric parietal cells, rabeprazole is protonated, accumulates, and is transformed to an active sulfenamide. When studied in vitro , rabeprazole is chemically activated at pH 1.2 with a half-life of 78 seconds. It inhibits acid transport in porcine gastric vesicles with a half-life of 90 seconds.

📦 How Supplied / Storage and Handling 64 words ▾

16. HOW SUPPLIED/STORAGE AND HANDLING Rabeprazole sodium 20 mg is supplied as yellow colored, round biconvex, delayed-release tablets imprinted with '107' on one side in black ink and plain on other side. Bottles of 30 NDC 63187-555-30 Bottles of 60 NDC 63187-555-60 Bottles of 90 NDC 63187-555-90 Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from moisture.

📋 Description 168 words ▾

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. It is very soluble in water and methanol, freely soluble in ethanol, chloroform and ethyl acetate and insoluble in ether and n-hexane.

The stability of rabeprazole sodium is a function of pH; it is rapidly degraded in acid media, and is more stable under alkaline conditions. The structural figure is: Rabeprazole sodium is available for oral administration as delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium. Inactive ingredients of the 20 mg tablet are diethyl phthalate, ethyl cellulose, hypromellose phthalate, magnesium oxide, magnesium stearate, mannitol, povidone, sodium starch glycolate, talc, and titanium dioxide.

Ferric oxide yellow is the coloring agent for the tablet coating. structure

💬 Information for Patients ~3 min read ▾

17. PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Medication Guide). How to Take Rabeprazole Sodium Delayed-Release Tablets Patients should be cautioned that rabeprazole sodium delayed-release tablets should be swallowed whole.

The tablets should not be chewed, crushed, or split. Rabeprazole sodium delayed-release tablets can be taken with or without food. Advise patient to immediately report and seek care for diarrhea that does not improve.

This may be a sign of Clostridium difficile associated diarrhea [ see Warnings and Precautions (5.3) ]. Manufactured by: TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA.

For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. Repackaged by: PROFICIENT RX LP, Thousand Oaks, CA 91320 8046433 Revised March 2014 MEDICATION GUIDE Rabeprazole Sodium Delayed-Release Tablets Read the Medication Guide that comes with rabeprazole sodium delayed-release tablets before you start taking them and each time you get a refill. There may be new information.

This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. What is the most important information I should know about rabeprazole sodium delayed-release tablets? Rabeprazole sodium delayed-release tablets may help your acid-related symptoms, but you could still have serious stomach problems.

Talk with your doctor. Rabeprazole sodium delayed-release tablets can cause serious side effects, including: • Diarrhea. Rabeprazole sodium delayed-release tablets may increase your risk of getting severe diarrhea.

This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away. • Bone fractures. People who take multiple daily doses of Proton Pump Inhibitor medicines for a long period of time (1 year or longer) may have an increased risk of fractures of the hip, wrist, or spine.

You should take rabeprazole sodium delayed-release tablets exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take rabeprazole sodium delayed-release tablets Rabeprazole sodium delayed-release tablets can have other serious side effects. See "What are the possible side effects of rabeprazole sodium delayed-release tablets?" What are rabeprazole sodium delayed-release tablets?

Rabeprazole sodium delayed-release tablets are a prescription medicine called a proton pump inhibitor (PPI). Rabeprazole sodium delayed-release tablets reduce the amount of acid in your stomach. Rabeprazole sodium delayed-release tablets are used in adults: • for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE) and to relieve symptoms, such as heartburn pain.

If needed, your doctor may decide prescribe another 8 weeks of rabeprazole sodium delayed-release tablets. • to maintain the healing of the esophagus and relief of symptoms related to EE. It is not known if rabeprazole sodium delayed-release tablets are safe and effective if used longer than 12 months (1 year). • for 4 weeks to treat daytime and nighttime heartburn and other symptoms that happen with Gastroesophageal Reflux Disease (GERD). GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach.

This may cause a burning feeling in your chest or throat, sour taste, or burping. • for up to 4 weeks for the healing and relief of duodenal ulcers. The duodenal area is the area where food passes when it leaves the stomach. • for 7 days with certain antibiotic medicines to treat an infection caused by bacteria called H. pylori . Sometimes H. pylori bacteria can cause duodenal ulcers.

The infection needs to be treated to prevent the ulcers from coming back. • for the long-term treatment of conditions where your…

💬 Medication Guide ~3 min read ▾

Medication Guide MEDICATION GUIDE Rabeprazole sodium (ra-BEP-ra-zole SOE-dee-um) delayed-release tablets What is the most important information I should know about r abeprazole sodium delayed-release tablets? You should take rabeprazole sodium delayed-release tablets exactly as prescribed, at the lowest dose possible and for the shortest time needed. Rabeprazole sodium delayed-release tablets may help your acid-related symptoms, but you could still have serious stomach problems.

Talk with your doctor. Rabeprazole sodium delayed-release tablets can cause serious side effects, including: • A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including rabeprazole sodium delayed-release tablets, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with rabeprazole sodium delayed-release tablets.

Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. • Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever. • Bone fractures (hip, wrist, or spine).

Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine. • Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body's immune cells attack other cells or organs in the body).

Some people who take PPI medicines, including rabeprazole sodium delayed-release tablets, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun. Talk to your doctor about your risk of these serious side effects.

Rabeprazole sodium delayed-release tablets can have other serious side effects. See "What are the possible side effects of r abeprazole sodium delayed-release tablets?" What are rabeprazole sodium delayed-release tablets? Rabeprazole sodium delayed-release tablets are a prescription medicine called a proton pump inhibitor (PPI).

Rabeprazole sodium delayed-release tablets reduces the amount of acid in your stomach. In adults, rabeprazole sodium delayed-release tablets are used for: • 8 weeks up to 16 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE) and to relieve symptoms, such as heartburn pain. • maintaining healing of the esophagus and relief of symptoms related to EE. It is not known if rabeprazole sodium delayed-release tablets are safe and effective if used longer than 12 months (1 year). • up to 4 weeks to treat daytime and nighttime heartburn and other symptoms that happen with Gastroesophageal Reflux Disease (GERD). • up to 4 weeks for the healing and relief of symptoms of duodenal ulcers. • 7 days with certain antibiotic medicines to treat an infection and stomach (duodenal) ulcers caused by bacteria called H. pylori . • the long-term treatment of conditions where your stomach makes too much acid.

This includes a rare condition called Zollinger-Ellison syndrome. In adolescents 12 years of age and older, rabeprazole sodium delayed-release tablets are used for up to 8 weeks to treat symptoms of GERD. It is not known if rabeprazole sodium delayed-release tablets are safe and effective in children less than 12 years of age for other uses. rabeprazole sodium delayed-release tablets should not be used in children under 12 years of age.

Do not take rabeprazole sodium delayed-release tablets if you are: • allergic to rabeprazole, any other PPI medicine, or any of the ingredients in rabeprazole sodium delayed-release tablets. See the end of th…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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