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PANTOPRAZOLE SODIUM 40 mg Tablet, Delayed Release, 30-count

by Proficient Rx LP · 30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-654-30)
NDC 63187-0654-30
🏷️ FDA NDC (as labeled) 63187-654-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.1131/unit — full pricing hub ↓
Also comes in: 60 tablets 63187-0654-60 90 tablets 63187-0654-90
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

⚠️
Other active recalls for Pantoprazole (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 26, 2026 — Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots." (Hetero Labs Limited (Unit V)) · FDA recall D-0484-2026
Class II · Mar 14, 2023 — CGMP Deviations: Discoloration (Hetero USA Inc) · FDA recall D-0530-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 63187-654-30
Product NDC 63187-654
11-digit billing NDC 63187065430
NCPDP billing unit EA — each (per item)
RxCUI 314200
UNII 6871619Q5X
UPC 0363187654306
Application # ANDA202882
SPL Set ID 50a278de-bd16-417c-a741-81bfe0d745f2
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 2014-09-10
Route ORAL
Dosage form TABLET, DELAYED RELEASE
Substance PANTOPRAZOLE SODIUM
GPI-14 49270070100620
GPI class Pantoprazole Sodium
GCN Seq No 027462
GCN 40120
HICL code 022008
Ingredient (HICL) Pantoprazole 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 PANTOPRAZOLE SOD DR 40 MG TAB
FDB brand name Pantoprazole 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 63187-654-30 — 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 → 63187-0654-30. 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 holderHETERO LABS LTD UNIT V
FDA applicationANDA202882 (ANDA)
Labeler code63187
First marketedSep 2014
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 PANTOPRAZOLE SOD DR 40 MG TAB Ingredient Pantoprazole Sodium
📗 Our plain-language guide HelloPharmacist
  • Pantoprazole shuts down the pumps in your stomach that produce acid. Most people notice relief from heartburn and related symptoms within a few days of starting it, but the full he...
  • What exactly does pantoprazole do, and how quickly will I feel better?
  • It depends on the form you're taking. If you're on the delayed-release tablet, you can take it with or without food — meals just delay it a bit but don't affect how much gets absor...
  • Does it matter when I take pantoprazole — with food or without?
📖 Read our full Pantoprazole guide →
9
Nutrient depletion considerations

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

🧪 Full Pantoprazole 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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 $0.1131 $3.39 / 30 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
Pantoprazole Sodium 40 mg 00378-6689-10 Mylan 1000 tablets $0.035 AB Availability likely —
Pantoprazole Sodium 40 mg 00904-6870-45 Major 1 tablet $0.035 AB Availability likely —
Pantoprazole Sodium 40 mg 13668-0429-05 Torrent 500 tablets $0.035 AB Availability likely —
Pantoprazole Sodium 40 mg 31722-0713-10 Camber 1000 tablets $0.035 AB Availability likely —
Pantoprazole Sodium 40 mg 35573-0428-80 Burel 10 tablets $0.035 AB Availability likely —
Pantoprazole Sodium 40 mg 50268-0639-15 AvPAK 1 tablet $0.035 AB Availability likely —
Pantoprazole Sodium 40 mg 51079-0051-20 Mylan 1 tablet $0.035 AB Availability likely —
Pantoprazole Sodium 40 mg 60687-0736-01 American 1 tablet $0.035 AB Availability likely —
Pantoprazole Sodium 40 mg 62135-0534-08 Chartwell 450 tablets $0.035 AB Availability likely —
Pantoprazole Sodium 40 mg 62175-0617-43 Lannett 1000 tablets $0.035 AB Availability likely —
Pantoprazole Sodium 40 mg 64980-0677-09 Rising 90 tablets $0.035 AB Availability likely —
pantoprazole sodium 40 mg 70010-0191-09 Granules 90 tablets $0.035 AB Availability likely —
Pantoprazole sodium delayed-release 40 mg 70756-0019-12 Lifestar 1000 tablets $0.035 — Availability likely —
Pantoprazole 40 mg 72603-0178-01 NorthStar 90 tablets $0.035 AB Availability likely —
Pantoprazole Sodium 40 mg 72603-0746-01 NorthStar 500 tablets $0.035 AB Availability likely —
Pantoprazole Sodium 40 mg 82009-0011-90 Quallent 90 tablets $0.035 AB Availability likely —
Protonix Delayed-Release 40 mg 00008-0841-81 Wyeth 90 tablets $14.215 AB Availability likely —
Pantoprazole Sodium 40 mg 00615-7629-05 NCS 15 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 00904-6474-45 Major 1 tablet — AB Discontinued —
Pantoprazole Sodium 40 mg 42708-0104-30 QPharma 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 42708-0180-30 QPharma 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 42708-0185-30 QPharma 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 43353-0027-30 Aphena 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 48433-0081-20 Safecor 1 tablet — AB FDA listed —
Pantoprazole Sodium 40 mg 50090-5378-00 A-S 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 50090-5379-00 A-S 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 50090-5794-00 A-S 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 50090-7512-00 A-S 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 51407-0613-10 Golden 1000 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 51655-0797-52 Northwind 30 tablets — AB FDA listed —
Pantoprazole 40 mg 55111-0333-01 Dr. 100 tablets — — FDA listed —
Pantoprazole Sodium 40 mg 55154-4165-00 Cardinal 1 tablet — AB FDA listed —
Pantoprazole Sodium 40 mg 55154-4382-00 Cardinal 1 tablet — AB FDA listed —
Pantoprazole Sodium 40 mg 55154-7634-00 Cardinal 1 tablet — AB FDA listed —
Pantoprazole Sodium 40 mg 60760-0679-30 St. 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mgthis 63187-0654-30 Proficient 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 63187-0938-30 Proficient 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 63187-0974-30 Proficient 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 65162-0637-03 Amneal 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 65862-0560-10 Aurobindo 10 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 67046-0536-03 Coupler 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 68071-1963-03 NuCare 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 68071-2215-03 NuCare 30 tablets — AB FDA listed —
Pantoprazole 40 mg 68071-3524-03 NuCare 30 tablets — AB FDA listed —
Pantoprazole 40 mg 68071-3995-09 NuCare 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 68071-4864-09 NuCare 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 68071-4895-09 NuCare 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 68071-4917-04 NuCare 14 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 68788-8644-01 Preferred 100 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 70518-0860-00 REMEDYREPACK 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 70518-1298-01 REMEDYREPACK 1 tablet — AB FDA listed —
Pantoprazole Sodium 40 mg 71335-0310-01 Bryant 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 71335-0551-01 Bryant 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 71335-1429-01 Bryant 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 71610-0653-30 Aphena 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 72162-1746-03 Bryant 30 tablets — AB FDA listed —
Pantoprazole Sodium DR 40 mg 72189-0514-90 Direct_Rx 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 72789-0086-30 PD-Rx 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 72789-0268-30 PD-Rx 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 72865-0230-10 XLCare 1000 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 76420-0669-10 Asclemed 10 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 76420-0674-01 Asclemed 100 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 76420-0806-10 Asclemed 10 tablets — AB FDA listed —
Pantoprazole Sodium DR 40 mg 80425-0133-01 Advanced 30 tablets — AB FDA listed —
Pantoprazole Sodium DR 40 mg 80425-0162-01 Advanced 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 85534-0028-00 HAWAII 10 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 85766-0225-01 Sportpharm 100 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 50268-0727-10 AvPAK 1 tablet — 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

🏛️
2014
On the market since
Sep 2014
📍
2026
Currently FDA-listed
12 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 Pantoprazole Sodium — the program that covers self-administered drugs. 30 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 Pantoprazole 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
$79.44M
Claims incl. refills
6.9M
Beneficiaries
4.9M
Spend / beneficiary
$16.30
Spend / claim
$11.55
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
63187-0654-30 You're viewing this 30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-654-30) 2018-12-01 Active
63187-0654-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-654-60) 2018-12-01 Active
63187-0654-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-654-90) 2018-12-01 Active

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

Pack size FAQ

What quantity is in NDC 63187-0654-30?
NDC 63187-0654-30 is a 30-count package — 30 tablet, delayed release in 1 bottle.
What is the difference between NDC 63187-0654-30 and NDC 63187-0654-60?
Both are PANTOPRAZOLE SODIUM 40 mg Tablet, Delayed Release — the drug itself is identical. NDC 63187-0654-30 is the 30-count package, while NDC 63187-0654-60 is the 60 tablets package.
What NDC number is used to bill for this package of PANTOPRAZOLE SODIUM 40 mg Tablet, Delayed Release?
Bill NDC 63187-0654-30 — the 11-digit billing format is 63187065430. 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 63187-654-30, 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: 63187-0654-30, written without dashes as 63187065430. 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 63187-0654-30, the first segment (63187) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0654) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 60 tablets (63187-0654-60), 90 tablets (63187-0654-90). 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 214 words ▾

1 INDICATIONS & USAGE Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for: Pantoprazole sodium delayed-release tablet, USP is a proton pump inhibitor indicated for the following: • Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1 ) • Maintenance of Healing of Erosive Esophagitis ( 1.2 ) • Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome ( 1.3 )

1.1Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole Sodium Delayed-Release Tablet, USP is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.

1.2Maintenance of Healing of Erosive Esophagitis Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.

1.3Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Pantoprazole Sodium Delayed-Release Tablets USP are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE & ADMINISTRATION Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD ( 2.1 ) Adults 40 mg Once Daily for up to 8 wks Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once Daily for up to 8 wks ≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis ( 2.1 ) Adults 40 mg Once Daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome ( 2.1 ) Adults 40 mg Twice Daily *Controlled studies did not extend beyond 12 months See full prescribing information for administration instructions

2.1Recommended Dosing Schedule Pantoprazole Sodium is supplied as Delayed-Release Tablets. The recommended dosages are outlined in Table 1. Table 1: Recommended Dosing Schedule for Pantoprazole SodiumDelayed-Release Tablets Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD Adults 40 mg Once daily for up to 8 weeks* Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once daily for up to 8 weeks ≥ 40 kg 40 mg Maintenanceof Healing of Erosive Esophagitis Adults 40 mg Once daily PathologicalHypersecretory Conditions Including Zollinger-Ellison Syndrome Adults 40 mg Twice daily ** * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. ** Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated.

Doses up to 240 mg daily have been administered. *** Controlled studies did not extend beyond 12 months

2.2Administration Instructions Directions for method of administration for each dosage form are presented in Table 2. Table 2: Administration Instructions Formulation Route Instructions* Delayed-Release Tablets Oral Swallowed whole, with or without food * Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed, or crushed. Pantoprazole Sodium Delayed-Release Tablets should be swallowed whole, with or without food in the stomach.

If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of Pantoprazole Sodium Delayed-Release Tablets.

💊 Dosage Forms and Strengths 66 words ▾

3 DOSAGE FORMS & STRENGTHS • 20 mg, yellow to pale yellow, oval, biconvex, delayed-release tablets imprinted "H125" on one side with black ink and plain on the other side. • 40 mg, yellow to pale yellow, oval, biconvex, delayed-release tablets imprinted "H126" on one side with black ink and plain on the other side. • Delayed-Release Tablets, 20 mg and 40 mg ( 3 )

⛔ Contraindications 60 words ▾

4 CONTRAINDICATIONS Pantoprazole Sodium Delayed-Release Tablets are contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole . Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticarial [see Adverse Reactions ( 6 )] . Known hypersensitivity to any component of the formulation or to substituted benzimidazoles ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Symptomatic response does not preclude presence of gastric malignancy ( 5.1 ) • Atrophic gastritis has been noted with long-term therapy ( 5.2 ) • Acute gastritis has been observed in patients taking PPIs. ( 5.3 ) • Cyanocobalamin (vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin.( 5.4 ) • PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea. ( 5.5 ) • 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.

( 5.6 ) • Hypomagnesemia has been reported rarely with prolonged treatment with PPIs ( 5.7 )

5.1Concurrent Gastric Malignancy Symptomatic response to therapy with pantoprazole sodium does not preclude the presence of gastric malignancy.

5.2Atrophic Gastritis Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with pantoprazole sodium, particularly in patients who were H. pylori positive.

5.3Acute Interstitial Nephritis Acute interstitial nephritis has been observed in patients taking PPIs including pantoprazole sodium delayed-release tablets. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue pantoprazole sodium delayed-release tablets if acute interstitial nephritis develops [see Contraindications ( 4 )] .

5.4Cyanocobalamin (Vitamin B-12) Deficiency Generally, daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (Vitamin B-12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.

5.5Clostridium difficile associated diarrhea Published observational studies suggest that PPI therapy like pantoprazole 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 Reactions ( 6.2 )]. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

5.6Bone Fracture Several published observational studies suggest that proton pump inhibitor (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 )] .

5.7Hypomagnesemia 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 magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically [see Adverse Reactions ( 6.2 )].

5.8Tumorigenicity Due to the chronic nature of GERD, there may be a potential for prolonged administration of pantoprazole sodium. In long-term…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most frequently occurring adverse reactions are as follows: • For adult use (>2%) are headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. ( 6 ) • For pediatric use (>4%) are URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trial Experience Because clinical trials are conducted under widely 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 clinical practice. Adults Safety in nine randomized comparative US clinical trials in patients with GERD included 1,473 patients on oral pantoprazole sodium (20 mg or 40 mg), 299 patients on an H 2 -receptor antagonist, 46 patients on another proton pump inhibitor, and 82 patients on placebo.

The most frequently occurring adverse reactions are listed in Table 3. Table 3: Adverse Reactions Reported in Clinical Trials of Adult Patients with GERD at a Frequency of > 2% Pantoprazole sodium (n=1473) % Comparators (n=345) % Placebo (n=82) % Headache 12.2 12.8

8.5Diarrhea 8.8 9.6

4.9Nausea 7 5.2

9.8Abdominal pain 6.2 4.1

6.1Vomiting Flatulence 4.3 3.9 3.5 2.9 2.4

3.7Dizziness 3 2.9

1.2Arthralgia 2.8 1.4

1.2Additional adverse reactions that were reported for pantoprazole sodium in clinical trials with a frequency of ≤ 2% are listed below by body system: Body as a Whole : allergic reaction, pyrexia, photosensitivity reaction, facial edema Gastrointestinal : constipation, dry mouth, hepatitis Hematologic : leukopenia, thrombocytopenia Metabolic/Nutritional : elevated CK (creatine kinase), generalized edema, elevated triglycerides, liver enzymes elevated Musculoskeletal : myalgia Nervous : depression, vertigo Skin and Appendages : urticaria, rash, pruritus Special Senses : blurred vision Pediatric Patients Safety of pantoprazole sodium in the treatment of Erosive Esophagitis (EE) associated with GERD was evaluated in pediatric patients ages 1 year through 16 years in three clinical trials.

Safety trials involved pediatric patients with EE; however, as EE is uncommon in the pediatric population, 249 pediatric patients with endoscopically-proven or symptomatic GERD were also evaluated. All adult adverse reactions to pantoprazole sodium is considered relevant to pediatric patients. In patients ages 1 year through 16 years, the most commonly reported (> 4%) adverse reactions include: URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain.

For safety information in patients less than 1 year of age see Use in Specific Populations ( 8.4 ) . Additional adverse reactions that were reported for pantoprazole sodium in pediatric patients in clinical trials with a frequency of ≤ 4% are listed below by body system: Body as a Whole : allergic reaction, facial edema Gastrointestinal : constipation, flatulence, nausea Metabolic/Nutritional : elevated triglycerides, elevated liver enzymes, elevated CK (creatine kinase) Musculoskeletal : arthralgia, myalgia Nervous : dizziness, vertigo Skin and Appendages : urticaria The following adverse reactions seen in adults in clinical trials were not reported in pediatric patients in clinical trials, but are considered relevant to pediatric patients: photosensitivity reaction, dry mouth, hepatitis, thrombocytopenia, generalized edema, depression, pruritus, leukopenia, and blurred vision.

Zollinger-Ellison Syndrome In clinical studies of Zollinger-Ellison Syndrome, adverse reactions reported in 35 patients taking pantoprazole sodium 80 mg/day to 240 mg/day for up to 2 years were similar to those reported in adult patients with GERD.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of pantoprazole sodium. Because these reactio…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS • Do not co-administer with atazanavir or nelfinavir ( 7.1 ) • Concomitant warfarin use may require monitoring ( 7.2 ) • May interfere with the absorption of drugs where gastric pH is important for bioavailability (e.g. ketoconazole, ampicillin esters, atazanavir, iron salts, erlotinib and mycophenolate mofetil) ( 7.4 ) • May produce false-positive urine screen for THC ( 7.5 ) • Methotrexate: Pantoprazole sodium may increase serum level of methotrexate ( 7.6 )

7.1Interference with Antiretroviral Therapy Concomitant use of atazanavir or nelfinavir with proton pump inhibitors is not recommended. Coadministration of atazanavir or nelfinavir with proton pump inhibitors is expected to substantially decrease atazanavir or nelfinavir plasma concentrations and may result in a loss of therapeutic effect and development of drug resistance.

7.2Coumarin Anticoagulants There have been postmarketing reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including pantoprazole sodium, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with proton pump inhibitors and warfarin concomitantly should be monitored for increases in INR and prothrombin time.

7.3Clopidogrel Concomitant administration of pantoprazole and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition [see Clinical Pharmacology ( 12.3 )]. No dose adjustment of clopidogrel is necessary when administered with an approved dose of pantoprazole sodium.

7.4Drugs for Which Gastric pH Can Affect Bioavailability Due to its effects on gastric acid secretion, pantoprazole can reduce the absorption of drugs where gastric pH is an important determinant of their bioavailability. Like with other drugs that decrease the intragastric acidity, the absorption of drugs such as ketoconazole, ampicillin esters, atazanavir, iron salts, erlotinib, and mycophenolate mofetil (MMF) can decrease. Co-administration of pantoprazole in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH.

The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving pantoprazole sodium delayed-release tablets and MMF. Use pantoprazole sodium delayed-release tablets with caution in transplant patients receiving MMF [see Clinical Pharmacology ( 12.3 )] .

7.5False Positive Urine Tests for THC There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving proton pump inhibitors. An alternative confirmatory method should be considered to verify positive results.

7.6Methotrexate Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted [see Warnings and Precautions (5 .10 )].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in rats at oral doses up to 88 times the recommended human dose and in rabbits at oral doses up to 16 times the recommended human dose and have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed [see Nonclinical Toxicology ( 13.2 )].

8.3Nursing Mothers Pantoprazole and its metabolites are excreted in the milk of rats. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose. The clinical relevance of this finding is not known.

Many drugs which are excreted in human milk have a potential for serious adverse reactions in nursing infants. Based on the potential for tumorigenicity shown for pantoprazole in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

8.4Pediatric Use The safety and effectiveness of pantoprazole sodium for short-term treatment (up to eight weeks) of erosive esophagitis (EE) associated with GERD have been established in pediatric patients 1 year through 16 years of age. Effectiveness for EE has not been demonstrated in patients less than 1 year of age. In addition, for patients less than 5 years of age, there is no appropriate dosage strength in an age-appropriate formulation available.

Therefore, pantoprazole sodium is indicated for the short-term treatment of EE associated with GERD for patients 5 years and older. The safety and effectiveness of pantoprazole sodium for pediatric uses other than EE have not been established. 1 year through 16 years of age Use of pantoprazole sodium in pediatric patients 1 year through 16 years of age for short-term treatment (up to eight weeks) of EE associated with GERD is supported by: a) extrapolation of results from adequate and well-controlled studies that supported the approval of pantoprazole sodium for treatment of EE associated with GERD in adults, and b) safety, effectiveness, and pharmacokinetic studies performed in pediatric patients [see Clinical Studies ( 14.1 ), and Clinical Pharmacology ( 12.3) ] .

Safety of pantoprazole sodium in the treatment of EE associated with GERD in pediatric patients 1 through 16 years of age was evaluated in three multicenter, randomized, double-blind, parallel - treatment studies, involving 249 pediatric patients, including 8 with EE (4 patients ages 1 year to 5 years and 4 patients 5 years to 11 years). The children ages 1 year to 5 years with endoscopically diagnosed EE (defined as an endoscopic Hetzel-Dent score ≥ 2) were treated once daily for 8 weeks with one of two dose levels of pantoprazole sodium (approximating 0.6 mg/kg or 1.2 mg/kg).

All 4 of these patients with EE were healed (Hetzel-Dent score of 0 or 1) at 8 weeks. Because EE is uncommon in the pediatric population, predominantly pediatric patients with endoscopically-proven or symptomatic GERD were also included in these studies. Patients were treated with a range of doses of pantoprazole sodium once daily for 8 weeks.

For safety findings see Adverse Reactions (6.1) . Because these pediatric trials had no placebo, active comparator, or evidence of a dose response, the trials were inconclusive regarding the clinical benefit of pantoprazole sodium for symptomatic GERD in the pediatric population. The effectiveness of pantoprazole sodium for treating symptomatic GERD in pediatric patients has not been established.

Although the data from the clinical trials support use of pantoprazole sodium for the short-term treatment of EE associated with GERD in pediatric patients 1 year through 5 years, there is no…

🤰 Pregnancy 94 words ▾

8.1Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in rats at oral doses up to 88 times the recommended human dose and in rabbits at oral doses up to 16 times the recommended human dose and have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed [see Nonclinical Toxicology ( 13.2 )].

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use The safety and effectiveness of pantoprazole sodium for short-term treatment (up to eight weeks) of erosive esophagitis (EE) associated with GERD have been established in pediatric patients 1 year through 16 years of age. Effectiveness for EE has not been demonstrated in patients less than 1 year of age. In addition, for patients less than 5 years of age, there is no appropriate dosage strength in an age-appropriate formulation available.

Therefore, pantoprazole sodium is indicated for the short-term treatment of EE associated with GERD for patients 5 years and older. The safety and effectiveness of pantoprazole sodium for pediatric uses other than EE have not been established. 1 year through 16 years of age Use of pantoprazole sodium in pediatric patients 1 year through 16 years of age for short-term treatment (up to eight weeks) of EE associated with GERD is supported by: a) extrapolation of results from adequate and well-controlled studies that supported the approval of pantoprazole sodium for treatment of EE associated with GERD in adults, and b) safety, effectiveness, and pharmacokinetic studies performed in pediatric patients [see Clinical Studies ( 14.1 ), and Clinical Pharmacology ( 12.3) ] .

Safety of pantoprazole sodium in the treatment of EE associated with GERD in pediatric patients 1 through 16 years of age was evaluated in three multicenter, randomized, double-blind, parallel - treatment studies, involving 249 pediatric patients, including 8 with EE (4 patients ages 1 year to 5 years and 4 patients 5 years to 11 years). The children ages 1 year to 5 years with endoscopically diagnosed EE (defined as an endoscopic Hetzel-Dent score ≥ 2) were treated once daily for 8 weeks with one of two dose levels of pantoprazole sodium (approximating 0.6 mg/kg or 1.2 mg/kg).

All 4 of these patients with EE were healed (Hetzel-Dent score of 0 or 1) at 8 weeks. Because EE is uncommon in the pediatric population, predominantly pediatric patients with endoscopically-proven or symptomatic GERD were also included in these studies. Patients were treated with a range of doses of pantoprazole sodium once daily for 8 weeks.

For safety findings see Adverse Reactions (6.1) . Because these pediatric trials had no placebo, active comparator, or evidence of a dose response, the trials were inconclusive regarding the clinical benefit of pantoprazole sodium for symptomatic GERD in the pediatric population. The effectiveness of pantoprazole sodium for treating symptomatic GERD in pediatric patients has not been established.

Although the data from the clinical trials support use of pantoprazole sodium for the short-term treatment of EE associated with GERD in pediatric patients 1 year through 5 years, there is no commercially available dosage formulation appropriate for patients less than 5 years of age [see Dosage and Administration ( 2 )] . In a population pharmacokinetic analysis, clearance values in the children 1 to 5 years old with endoscopically proven GERD had a median value of

2.4L/h. Following a 1.2 mg/kg equivalent dose (15 mg for ≤ 12.5 kg and 20 mg for > 12.5 to < 25 kg), the plasma concentrations of pantoprazole were highly variable and the median time to peak plasma concentration was 3 to 6 hours. The estimated AUC for patients 1 to 5 years old was 37% higher than for adults receiving a single 40 mg tablet, with a geometric mean AUC value of 6.8 mcg•hr/mL.

Neonates to less than one year of age Pantoprazole sodium was not found to be effective in a multicenter, randomized, double-blind, placebo- controlled, treatment-withdrawal study of 129 pediatric patients 1 through 11 months of age. Patients were enrolled if they had symptomatic GERD based on medical history and had not responded to non-pharmacologic interventions for GERD for two weeks. Patients received pantoprazole sodium daily for four weeks in an open-label phase, then patients were randomized in equal proportion to receive pantoprazole sodium treatment o…

🧓 Geriatric Use 66 words ▾

8.5Geriatric Use In short-term US clinical trials, erosive esophagitis healing rates in the 107 elderly patients (≥ 65 years old) treated with pantoprazole sodium were similar to those found in patients under the age of 65. The incidence rates of adverse reactions and laboratory abnormalities in patients aged 65 years and older were similar to those associated with patients younger than 65 years of age.

🆘 Overdosage 88 words ▾

10 OVERDOSAGE Experience in patients taking very high doses pantoprazole sodium (> 240 mg) is limited. Spontaneous post-marketing reports of overdose are generally within the known safety profile of pantoprazole sodium. Pantoprazole is not removed by hemodialysis.

In case of overdosage, treatment should be symptomatic and supportive. Single oral doses of pantoprazole at 709 mg/kg, 798 mg/kg, and 887 mg/kg were lethal to mice, rats, and dogs, respectively. The symptoms of acute toxicity were hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex, and tremor.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Pantoprazole is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production by covalently binding to the (H + , K + )-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. The binding to the (H + , K + )-ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested (20 mg to 120 mg).

12.2Pharmacodynamics Antisecretory Activity Under maximal acid stimulatory conditions using pentagastrin, a dose-dependent decrease in gastric acid output occurs after a single dose of oral (20 to 80 mg) or a single dose of intravenous (20 to 120 mg) pantoprazole in healthy volunteers. Pantoprazole given once daily results in increasing inhibition of gastric acid secretion. Following the initial oral dose of 40 mg pantoprazole, a 51% mean inhibition was achieved by 2.5 hours.

With once-a-day dosing for 7 days, the mean inhibition was increased to 85%. Pantoprazole suppressed acid secretion in excess of 95% in half of the subjects. Acid secretion had returned to normal within a week after the last dose of pantoprazole; there was no evidence of rebound hypersecretion.

In a series of dose-response studies, pantoprazole, at oral doses ranging from 20 to 120 mg, caused dose-related increases in median basal gastric pH and in the percent of time gastric pH was > 3 and > 4. Treatment with 40 mg of pantoprazole produced significantly greater increases in gastric pH than the 20 mg dose. Doses higher than 40 mg (60, 80, 120 mg) did not result in further significant increases in median gastric pH.

The effects of pantoprazole on median pH from one double-blind crossover study are shown in Table 4. Table 4: Effect of Single Daily Doses of Oral Pantoprazole on Intragastric pH ——————— Median pH on day 7 ——————— Time Placebo 20 mg 40 mg 80 mg 8 a.m. - 8 a.m. (24 hours) 1.3 2.9* 3.8*# 3.9*# 8 a.m. - 10 p.m.

(Daytime) 1.6 3.2* 4.4*# 4.8*# 10 p.m. - 8 a.m. (Nighttime) 1.2 2.1* 3* 2.6* * Significantly different from placebo # Significantly different from 20 mg Serum Gastrin Effects Fasting serum gastrin levels were assessed in two double-blind studies of the acute healing of erosive esophagitis (EE) in which 682 patients with gastroesophageal reflux disease (GERD) received 10, 20, or 40 mg of pantoprazole sodium for up to 8 weeks. At 4 weeks of treatment there was an increase in mean gastrin levels of 7%, 35%, and 72% over pretreatment values in the 10, 20, and 40 mg treatment groups, respectively.

A similar increase in serum gastrin levels was noted at the 8-week visit with mean increases of 3%, 26%, and 84% for the three pantoprazole dose groups. Median serum gastrin levels remained within normal limits during maintenance therapy with Pantoprazole Sodium Delayed-Release Tablets. In long-term international studies involving over 800 patients, a 2- to 3-fold mean increase from the pretreatment fasting serum gastrin level was observed in the initial months of treatment with pantoprazole at doses of 40 mg per day during GERD maintenance studies and 40 mg or higher per day in patients with refractory GERD.

Fasting serum gastrin levels generally remained at approximately 2 to 3 times baseline for up to 4 years of periodic follow-up in clinical trials. Following short-term treatment with pantoprazole sodium, elevated gastrin levels return to normal by at least 3 months. Enterochromaffin-Like (ECL) Cell Effects In 39 patients treated with oral pantoprazole 40 mg to 240 mg daily (majority receiving 40 mg to 80 mg) for up to 5 years, there was a moderate increase in ECL-cell density, starting after the first year of use, which appeared to plateau after 4 years.

In a nonclinical study in Sprague-Dawley rats, lifetime exposure (24 months) to pantoprazole at doses of 0.5 to 200 mg/kg/day resulted in dose-related increas…

🧬 Mechanism of Action 91 words ▾

12.1Mechanism of Action Pantoprazole is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production by covalently binding to the (H + , K + )-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. The binding to the (H + , K + )-ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested (20 mg to 120 mg).

📦 How Supplied / Storage and Handling 75 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 40 mg yellow to pale yellow, oval, biconvex, delayed-release tablets imprinted “H126” on one side with black ink and plain on the other side. They are supplied as follows: Bottles of 30 tablets NDC 63187-654-30 Bottles of 90 tablets NDC 63187-654-90 Storage Store pantoprazole sodium delayed-release tablets, USP at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].

📋 Description ~1 min read ▾

11 DESCRIPTION The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP is a substituted benzimidazole, 5-(Difluoromethoxy) -2- [[(3,4 dimethoxy-2- pyridyl)methyl] sulfinyl]benzimidazole, sodium salt, sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C 16 H 14 F 2 N 3 NaO 4 S .

1.5H 2 O, with a molecular weight of 432.4. The structural formula is: Pantoprazole sodium sesquihydrate, USP is a white to off-white powder. Pantoprazole sodium sesquihydrate, USP is freely soluble in water, in methanol, in dehydrated alcohol, practically insoluble in hexane and dichloromethane.

The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8.

Pantoprazole Sodium is supplied as a Delayed-Release Tablet, available in two strengths (20 mg and 40 mg). Each Pantoprazole Sodium Delayed-Release Tablet, USP contains 45.11 mg or 22.55 mg of pantoprazole sodium sesquihydrate, USP (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium stearate, ferric oxide yellow, hydroxy propyl cellulose, hypromellose, lactose monohydrate, methacrylic acid copolymer, polysorbate 80, propylene glycol, sodium carbonate anhydrous, sodium lauryl sulfate, titanium dioxide and triethyl citrate.

The tablets are imprinted with opacode black containing ammonium hydroxide, iron oxide black, propylene glycol and shellac. Pantoprazole Sodium Delayed-Release Tablets, (40 mg and 20 mg) complies with USP dissolution test 2. structure.jpg

💬 Information for Patients 169 words ▾

17 PATIENT COUNSELING INFORMATION See FDA-Approved Medication Guide . • Caution Patients that pantoprazole sodium delayed-release tablets should not be split, crushed, or chewed. • Tell patients that pantoprazole sodium delayed-release tablets should be swallowed whole, with or without food in the stomach. • Let patients know that concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed-release tablets. • Advise patients to immediately report and seek care for any cardiovascular or neurological symptoms including palpitation, dizziness, seizures, and tetany as these may be signs of hypomagnesemia. [See Warnings and Precautions ( 5.7 )] • Advise patients 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 ( 5.5 )]. Manufactured for: Camber Pharmaceuticals Inc. Piscataway, NJ 08854 By: HETERO TM 2028011 Hetero Labs Limited Unit V, Polepally, Jadcherla, Mahaboob Nagar – 509 301, India.

Repackaged and Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: February 2015 address2.jpg

💬 Medication Guide ~3 min read ▾

Medication Guide Pantoprazole Sodium Delayed-Release Tablets, USP pan toe’ pra zole soe’ dee um Read this Medication Guide before you start taking pantoprazole sodium delayed-release tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about pantoprazole sodium delayed-release tablets? Pantoprazole sodiumdelayed-release tablets may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

Pantoprazole sodiumdelayed-release tablets can cause serious side effects, including: • Diarrhea. Pantoprazole 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 (a year or longer) may have an increased risk offractures of the hip, wrist or spine. You should take pantoprazole 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 pantoprazole sodium delayed-release tablet.

Pantoprazole sodium delayed-release tablets can have other serious side effects. See “What are the possible side effects of pantoprazole sodium delayed-release tablets?” What are pantoprazole sodium delayed-release tablets? Pantoprazole sodium delayed-release tablets are a prescription medicine called a proton pump inhibitor (PPI).

Pantoprazole sodium delayed-release tablet reduces the amount of acid in your stomach. Pantoprazole sodium delayed-release tablets are used in adults: • for up to 8 weeks to heal acid-related damage to the lining of the esophagus (erosive esophagitis or EE) and to relieve symptoms caused by gastroesophageal reflux disease (GERD). If needed, your doctor may decide to prescribe another 8 weeks of pantoprazole sodium delayed-release tablet. • to maintain the healing of acid-related damage to the lining of the esophagus and help prevent return of heartburn symptoms caused by GERD.

It is not known if pantoprazole sodium delayed-release tablet is safe and effective if used longer than 12 months (1 year). 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 the long-term treatment of conditions where your stomach makes too much acid.

This includes a rare condition called Zollinger-Ellison syndrome. Pantoprazole sodium delayed-release tablets are used in children 5 years of age and older for up to 8 weeks to heal acid-related damage to the lining of the esophagus (erosive esophagitis or EE) caused by GERD. It is not known if pantoprazole sodium delayed-release tablets are safe if used longer than 8 weeks in children.

Pantoprazole sodium delayed-release tablets are not for use in children under 5 years of age. Who should not take pantoprazole sodiumdelayed-release tablets? Do not take pantoprazole sodium delayed-release tablets if you are: • allergic to pantoprazole sodium or any of the other ingredients in pantoprazole sodium delayed-release tablets.

See the end of this Medication Guide for a complete list of ingredients in pantoprazole sodium delayed-release tablets. • allergic to any proton pump inhibitor (PPI) medicine. What should I tell my doctor before taking pantoprazole sodium delayed-release tablets ? Before taking pantoprazole sodiumdelayed-release tablets, tell your doctor if you: • have been told that you have low magnesium levels in your blood. • have liver problems • have any other medica…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63187-0653-30 · Proficient 63187-0655-30 · Proficient →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.