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Omeclamox-Pak omeprazole, clarithromycin, amoxicillin Kit, 1 kit

by Cumberland Pharmaceuticals Inc. · 1 KIT in 1 BLISTER PACK (66220-422-01)

NDC 66220-0422-01

🏷️ FDA NDC (as labeled) 66220-422-01 billing pads the product segment with a zero

This package

Contains1 kit Pack sizes2 compare ↓

Also comes in: 1 kit 66220-0422-02

Rx only Brand Discontinued Non-controlled ⚠ Inactivated by FDA

🗂️ Data synced Aug 2, 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 Dr. Brian Staiger, PharmD

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

⚠️

Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 66220-422-01

Product NDC 66220-422

11-digit billing NDC 66220042201

NCPDP billing unit EA — each (per item)

Application # NDA050824

SPL Set ID 9e52c29a-fdbe-4a4d-b280-d700eba5b94f

DEA schedule Non-controlled

Marketing category NDA

Marketing status Discontinued

FDA listing status Inactivated by FDA (certified through Dec 2024)

Dosage form KIT

GCN Seq No 069169

GCN 32137

HICL code 019017

Ingredient (HICL) Omeprazole/Clarith/Amoxicillin

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 D4F

Therapeutic class — specific (HIC3) Anti-Ulcer-H.pylori Agents

AHFS code 08:12.12.08

AHFS class Other Macrolide Antibiotics

FDB label name OMECLAMOX-PAK DAILY CARD

FDB brand name Omeclamox-Pak

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 66220-422-01 — 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 → 66220-0422-01. 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.

🏭 Manufacturer & labeler

LabelerCumberland Pharmaceuticals Inc.

Application holderCUMBERLAND PHARMACEUTICALS INC

FDA applicationNDA050824 (NDA)

Labeler code66220

Product typeHuman Prescription Drug

Portfolio7 products on file

🔎 All NDCs from Cumberland Pharmaceuticals Inc.

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 OMECLAMOX-PAK DAILY CARD Ingredient Omeprazole/Clarith/Amoxicillin

📖 What it is MedlinePlus · NLM

Amoxicillin is used to treat certain infections caused by bacteria, such as pneumonia, skin, and urinary tract infections eliminate H. pylori, a bacteria that causes ulcers in combination with other medications Amoxicillin is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of bacteria. Antibiotics such as amoxicillin will not work for colds, flu, and other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

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 Gray / White / Orange

ShapeCapsule

ImprintWC;731

Size22 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.

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 system	Per each	Per 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 · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 1 kit

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Omeclamox-Pakthis 66220-0422-01	Cumberland	1 kit	—	—	Discontinued	—

About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.

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

📍

2026

Currently FDA-listed

listed with the FDA

🔒

No generic listed yet

brand only

ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
66220-0422-01 You're viewing this	1 KIT in 1 BLISTER PACK (66220-422-01)	2012-04-27	Inactivated by FDA
66220-0422-02	10 BLISTER PACK in 1 CARTON (66220-422-02) / 1 KIT in 1 BLISTER PACK	2012-04-27	Inactivated by FDA

Pack size FAQ

What quantity is in NDC 66220-0422-01?

NDC 66220-0422-01 contains 1 kit — 1 kit in 1 blister pack.

What NDC number is used to bill for this package of Omeclamox-Pak omeprazole, clarithromycin, amoxicillin Kit?

Bill NDC 66220-0422-01 — the 11-digit billing format is 66220042201. 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 Kit / multi-component package No longer marketed (per FDA listing data)

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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)	— 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	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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.

What does the discontinued status mean for this NDC?

The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.

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 66220-422-01, 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: 66220-0422-01, written without dashes as 66220042201. 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 66220-0422-01, the first segment (66220) is the labeler code FDA assigned to Cumberland Pharmaceuticals Inc.; the middle segment (0422) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 1 kit (66220-0422-02). 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?

Cumberland Pharmaceuticals Inc. 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 🔄 Drug / Laboratory Test 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

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE OMECLAMOX-PAK, a co-packaged product containing omeprazole, a proton pump inhibitor, clarithromycin, a macrolide antimicrobial, and amoxicillin, a penicillin class antibacterial, is indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or up to one-year history) to eradicate H. pylori . ( 1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of OMECLAMOX-PAK and other antibacterial drugs, OMECLAMOX-PAK should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

( 1.2 )

1.1Eradication of Helicobacter pylori in Patients with Active Duodenal Ulcer or History of Duodenal Ulcer Disease OMECLAMOX-PAK (Omeprazole delayed-release capsules, clarithromycin tablets, and amoxicillin capsules taken together) are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or one-year history) to eradicate H. pylori in adults. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [ see Clinical Studies ( 14.1 ) ].

1.2Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of OMECLAMOX-PAK and other antibacterial drugs OMECLAMOX-PAK should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

⏱️ Dosage and Administration 159 words ▾

2 DOSAGE AND ADMINISTRATION The recommended adult oral dose and regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg, each given twice daily, for 10 days, in the morning and evening before eating a meal. Inform patients that omeprazole, clarithromycin, and amoxicillin should not be crushed or chewed, and should be swallowed whole. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Adult regimen: omeprazole 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg, each given twice daily for 10 days in the morning and evening before eating a meal. ( 2 ) Advise patients to swallow all tablets and capsules whole. ( 2 ) In patients with an ulcer present at initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended.

( 2 )

💊 Dosage Forms and Strengths 128 words ▾

3 DOSAGE FORMS AND STRENGTHS OMECLAMOX-PAK is supplied in a carton containing ten individual daily administration cards. Each card contains: Omeprazole Delayed-Release Capsules, USP, 20 mg Two opaque, hard gelatin lavender and grey capsules, with ‘R 158’ and ‘OMEPRAZOLE 20 mg’ imprinted on the capsules in black ink, containing off-white to pale-yellow, elliptical spherical pellets. Clarithromycin Tablets, USP, 500 mg Two white, biconvex beveled-edge capsule-shaped coated tablets debossed with ‘54 312’ on one side and plain on the other side.

Amoxicillin Capsules, USP, 500 mg Four opaque hard gelatin yellow capsules, marked ‘GG849’. Pack of 10 daily administration cards for morning and evening dosing, each containing ( 3 ): Two omeprazole delayed-release capsules, USP, 20 mg. Two clarithromycin tablets, USP, 500 mg.

Four amoxicillin capsules, USP, 500 mg.

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS Known hypersensitivity to omeprazole, any macrolide antibiotic, any penicillin, or any component of the formulations. ( 4.1 ) Coadministration with pimozide, lurasidone, ergotamine or dihydroergotamine. ( 4.2 , 7.2 , 7.3 )

4.1Hypersensitivity OMECLAMOX-PAK is contraindicated in the following patients: Known history of hypersensitivity to omeprazole or benzimidazoles, any macrolide antibacterial drug, or any penicillin. Hypersensitivity reactions to omeprazole may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria. Hypersensitivity reactions to clarithromycin may include anaphylaxis, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Hypersensitivity reactions to amoxicillin may include serum sickness like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria [ see Warnings and Precautions ( 5.7 ), Adverse Reactions ( 6.3 ) ]. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins.

These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with amoxicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens.

4.2Serious Drug Interactions OMECLAMOX-PAK is contraindicated in patients taking ergotamine or dihydroergotamine and pimozide. Cardiac arrhythmias, some fatal, have been reported with the use of clarithromycin and/or erythromycin and pimozide. Arrhythmias have included QT prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes, and are most likely due to inhibition of metabolism of these drugs by clarithromycin and/or erythromycin [ see Drug Interactions ( 7.2 , 7.3 ) ].

Coadministration of OMECLAMOX-PAK with lurasidone is contraindicated since it may result in an increase in lurasidone expose and the potential for serious adverse reactions [see Drug Interactions ( 7 )] .

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity: Based on animal findings for omeprazole and clarithromycin, OMECLAMOX-PAK may cause fetal harm. OMECLAMOX-PAK is not recommended for use in pregnant women except in clinical circumstances when there is no appropriate alternative therapy. ( 5.1 ) Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.

( 5.2 ) Colchicine interaction: Concomitant use of clarithromycin and colchicine has resulted in deaths, especially in the elderly with renal insufficiency. Monitor patients for clinical symptoms of colchicine toxicity. ( 5.3 , 7.1 ) Myasthenia gravis: Exacerbation of symptoms and new onset of symptoms reported with clarithromycin.

Monitor patients for symptoms. ( 5.4 ) Clostridioides difficile -associated diarrhea: Reported with use of clarithromycin and amoxicillin; evaluate if diarrhea occurs. ( 5.5 ) Risk of gastric malignancy: Symptomatic response does not preclude concomitant underlying malignancy.

( 5.6 ) Acute Tubulointerstitial Nephritis: has been observed in patients taking proton pump inhibitors (PPIs), including omeprazole. Discontinue OMECLAMOX-PAK and evaluate patients ( 5.7 ) Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue OMECLAMOX- PAK and evaluate ( 5.8 )

5.1Embryo-Fetal Toxicity Clarithromycin, a component of OMECLAMOX-PAK, has demonstrated adverse effects on pregnancy outcomes and/or embryo-fetal development in monkeys, rats, mice, and rabbits at doses that produced plasma concentrations 2 to 17 times the serum concentrations achieved in humans at the maximum recommended human dose. Based on findings in animal studies, OMECLAMOX-PAK is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate. If OMECLAMOX-PAK is used during pregnancy, or if pregnancy occurs while the patient is taking this drug, the patient should be apprised of the potential hazard to the fetus [ see Use in Specific Populations ( 8.1 ) ].

5.2Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCAR), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the components of OMECLAMOX-PAK: omeprazole, clarithromycin, and amoxicillin [see Adverse Reactions ( 6.3 )] . Discontinue OMECLAMOX-PAK at the first signs or symptoms of SCAR or other signs of hypersensitivity and consider further evaluation.

5.3Colchicine Toxicity with Clarithromycin There have been postmarketing reports of colchicine toxicity, some fatal, with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Monitor patients for clinical symptoms of colchicine toxicity [ see Drug Interactions ( 7.1 ) ].

5.4Myasthenia Gravis Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome have been reported in patients receiving clarithromycin therapy. Monitor patients for symptoms.

5.5Clostridioides difficile-associated diarrhea Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of clarithromycin and amoxicillin, and may range in severity from mild diarrhea to fatal colitis [ see Adverse Reactions ( 6.3 ) ]. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibioti…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [ see Contraindications ( 4.1 ) ] Myasthenia Gravis [ see Warnings and Precautions ( 5.4 ) ] Clostridioides difficile -associated diarrhea [ see Warnings and Precautions ( 5.5 ) ] Acute Tubulointerstitial Nephritis [ see Warnings and Precautions ( 5.7 ) ] Most frequent adverse reactions (> 7%) with triple therapy were diarrhea, taste perversion, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cumberland Pharmaceuticals Inc. at 1-877-484-2700 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials 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 practice. In clinical trials using triple therapy with omeprazole, clarithromycin, and amoxicillin, no adverse reactions unique to triple therapy were observed. Adverse reactions observed were limited to those previously reported with omeprazole, clarithromycin, or amoxicillin alone.

The most frequent adverse reactions observed in clinical trials using combination therapy with omeprazole, clarithromycin, and amoxicillin (n = 274) were diarrhea (14%), taste perversion (10%), and headache (7%). None of these occurred at a higher frequency than that reported by patients taking antimicrobial agents alone.

6.2Adverse Reactions from Labeling for the Individual Components of OMECLAMOX-PAK The safety data below reflect exposure to omeprazole delayed-release capsules and clarithromycin worldwide in clinical trials for various indications using doses and durations of therapy that may differ from how they are used as a component of OMECLAMOX-PAK. For complete information on these reactions, see the full prescribing information for omeprazole delayed-release capsules and clarithromycin. Omeprazole : The most common adverse reactions reported (i.e., with an incidence rate ≥ 2%) in 3096 patients from omeprazole delayed-release capsules-treated patients enrolled in clinical trials included headache (6.9%), abdominal pain (5.2%), nausea (4.0%), diarrhea (3.7%), vomiting (3.2%), and flatulence (2.7%).

Additional adverse reactions that were reported with an incidence rate ≥ 1% included acid regurgitation (1.9%), upper respiratory infection (1.9%), constipation (1.5%), dizziness (1.5%), rash (1.5%), asthenia (1.3%), back pain (1.1%), and cough (1.1%). The clinical trial safety profile in patients greater than 65 years of age was similar to that in patients 65 years of age or less. Clarithromycin : The most frequently reported events in adults were diarrhea (3%), nausea (3%), abnormal taste (3%), dyspepsia (2%), abdominal pain/discomfort (2%), and headache (2%).

Most of these events were described as mild or moderate in severity. Of the reported adverse events, only 1% were described as severe. Fewer than 3% of adult patients without mycobacterial infections discontinued therapy because of drug-related side effects.

6.3Post-Marketing Experience with the Individual Components of OMECLAMOX-PAK Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their actual frequency or establish a causal relationship to drug exposure. Omeprazole : Body As a Whole: Hypersensitivity reactions including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, urticaria, (see also Skin below); fever; pain; fatigue; malaise. Cardiovascular: Chest pain or angina, tachycardia, bradycardia, palpitations, elevated blood pressure, peripheral edema.

Endocrine: Gynecomastia. Gastrointestinal: Pancreatitis (some fatal), anorexia, irritable colon, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, stomatitis, abdominal swelling, dry mouth. Duri…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Antiarrhythmics: Risk of torsades de pointes and other arrhythmias with concurrent use of clarithromycin and quinidine, disopyramide, and digoxin. Monitor ECGs and serum digoxin concentrations. ( 7.4 ) Oral anticoagulants: Concomitant administration of omeprazole or clarithromycin may potentiate the anticoagulant effects of warfarin and other oral anticoagulants.

Monitor prothrombin times and INR. ( 7.5 ) Atazanavir and nelfinavir: Omeprazole reduces plasma concentrations of atazanavir and nelfinavir. Concomitant use is not recommended.

( 7.6 ) Saquinavir: Omeprazole increases plasma concentrations of saquinavir. Monitor for toxicity and consider dose reduction of saquinavir. ( 7.6 ) Cilostazol: Omeprazole increases systemic exposure of cilostazol and one of its active metabolites.

Consider dose reduction of cilostazol. ( 7.7 ) Tacrolimus: Omeprazole may increase serum concentrations of tacrolimus. Frequently monitor whole blood trough concentrations of tacrolimus.

( 7.8 ) Theophylline: Clarithromycin may increase serum concentrations of theophylline. Monitor serum theophylline concentrations. ( 7.9 ) Carbamazepine: Clarithromycin may increase plasma concentrations of carbamazepine.

Monitor blood concentrations of carbamazepine. ( 7.10 ) Sildenafil: Clarithromycin may increase systemic exposure of sildenafil. Consider dose reduction of sildenafil.

( 7.11 ) HMG-CoA reductase inhibitors (statins): Clarithromycin may alter the effect of HMG-CoA reductase inhibitors (statins). ( 7.12 ) Drugs metabolized by cytochrome P450 (e.g., diazepam, warfarin, phenytoin, cyclosporine, disulfiram, benzodiazepines): Omeprazole can prolong their elimination. Monitor and determine need for dose adjustments.

( 7 , 7.13 ) Probenecid: Probenecid may increase blood concentrations of the amoxicillin. ( 7.14 ) Omeprazole may interfere with drugs for which gastric pH affects bioavailability (e.g., ketoconazole, iron salts, ampicillin esters, digoxin, and mycophenolate mofetil). ( 7.15 ) Effect of Omeprazole Omeprazole is a substrate and an inhibitor of CYP2C19 in vivo, a substrate of CYP3A4 in vivo, and an inhibitor of CYP2C19 in vitro.

Therefore, omeprazole may affect the metabolism and plasma concentrations of drugs that are metabolized by these CYP enzymes. Although in healthy subjects no interaction with theophylline or propranolol was reported, there have been reports of an interaction with other drugs metabolized via the CYP enzyme system (e.g., cyclosporine, disulfiram, benzodiazepines). Carefully monitor patients taking these drugs to determine if dosage adjustments of these drugs are necessary when taken concomitantly with omeprazole.

Effect of Clarithromycin Clarithromycin is a substrate and inhibitor of CYP3A enzymes. Coadministration of clarithromycin with drugs metabolized by CYP3A may be associated with elevations in drug concentrations that could increase the therapeutic and adverse effects of the concomitant drug. There have been reports of CYP3A-based interactions of erythromycin and/or clarithromycin with cyclosporine, tacrolimus, alfentanil, rifabutin, methylprednisolone, cilostazol, bromocriptine and lurasidone.

OMECLAMOX_PAK is contraindicated in patients receiving lurasidone [see Contraindications ( 4.2 )] . In addition, there have been reports of interactions of erythromycin or clarithromycin with drugs not thought to be metabolized by CYP3A, including: hexobarbital, phenytoin, and valproate.

7.1Colchicine Concurrent use of colchicine and OMECLAMOX-PAK may increase plasma colchicine concentrations. Colchicine is a substrate for both CYP3A and the efflux transporter, P-glycoprotein (Pgp). The clarithromycin component of OMECLAMOX-PAK is known to inhibit CYP3A and Pgp.

When clarithromycin and colchicine are administered together, inhibition of Pgp and/or CYP3A by clarithromycin may lead to increased plasma exposure to colchicine. Monitor patients for clinical symptoms of colchicine toxicity [ see Warnings and Pr…

🔄 Drug / Laboratory Test Interactions 98 words ▾

7.16Drug-Laboratory Test Interactions High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using glucose tests based on the Benedict's copper reduction reaction that determines the amount of reducing substances like glucose in urine. Since this effect may also occur with amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions be used. Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estradiol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.

This effect may also occur with amoxicillin.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Hepatic Impairment: Avoid use ( 8.7 ) Asian Patients: Avoid use unless it is deemed that the benefits outweigh the risks. ( 8.8 )

8.1Pregnancy Risk Summary Based on findings in animal studies for omeprazole and clarithromycin (components of OMECLAMOX-PAK), use of OMECLAMOX-PAK during pregnancy may cause fetal harm. OMECLAMOX-PAK is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate. If OMECLAMOX-PAK is used during pregnancy, or if pregnancy occurs while taking OMECLAMOX-PAK, the patient should be apprised of the potential hazard to the fetus [ see Warnings and Precautions ( 5.1 ) ].

There are no adequate and well controlled studies of omeprazole, clarithromycin, or amoxicillin (used separately or together) in pregnant women. Clarithromycin demonstrated adverse developmental effects in four animal species at clinically relevant doses. Omeprazole increased embryo-fetal loss in rabbits, but animal studies and multiple human studies do not show an increased risk for major malformations.

There was no evidence of harm to the fetus in mice and rats due to amoxicillin. Omeprazole There are no adequate and well-controlled studies with omeprazole in pregnant women. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use.

Reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg. No fetal malformations were observed in animal reproduction studies with administration of oral esomeprazole (an enantiomer of omeprazole) magnesium in rats and rabbits during organogenesis with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg esomeprazole or 40 mg omeprazole. Changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times the clinical dose of omeprazole.

When maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age [see Data ]. Clarithromycin Limited data from a small number of published human studies with clarithromycin use during pregnancy are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, administration of oral clarithromycin to pregnant mice, rats, rabbits, and monkeys during the period of organogenesis produced malformations in rats (cardio-vascular anomalies) and mice (cleft palate) at clinically relevant doses based on body surface area comparison.

Fetal effects in mice, rats, and monkeys (e.g., reduced fetal survival, body weight, body weight gain) and implantation losses in rabbits were generally considered to be secondary to maternal toxicity (see Animal Data ). Amoxicillin Available data from published epidemiologic studies and pharmacovigilance case reports over several decades with amoxicillin use have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ). No adverse developmental effects were observed in animal reproduction studies with administration of amoxicillin to pregnant mice and rats at doses up to 3 and 6 times the recommended human dose (see Data ).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data Omeprazole Reproductive studies conducted with omeprazole in rats at oral doses up to 1…

🤰 Pregnancy ~3 min read ▾

Data Animal Data Omeprazole Reproductive studies conducted with omeprazole in rats at oral doses up to 138 mg/kg/day (about 34 times an oral human dose of 40 mg based on body surface area comparison) and in rabbits at doses up to 69.1 mg/kg/day (about 34 times an…

🧒 Pediatric Use 19 words ▾

8.4Pediatric Use The safety and effectiveness of OMECLAMOX-PAK for pediatric patients with H. pylori have not been established.

🧓 Geriatric Use ~2 min read ▾

8.5Geriatric Use Omeprazole Omeprazole was administered to over 2000 elderly individuals (≥ 65 years of age) in clinical trials in the U.S. and Europe. There were no differences in safety and effectiveness between the elderly and younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

Pharmacokinetic studies have shown the elimination rate was somewhat decreased in the elderly and bioavailability was increased. The plasma clearance of omeprazole was 250 mL/min (about half that of young volunteers) and its plasma half-life averaged one hour, about twice that of young healthy volunteers. However, no dosage adjustment is necessary in the elderly [ see Clinical Pharmacology ( 12.3 ) ].

Clarithromycin In a steady-state study in which healthy elderly subjects (age 65 to 81 years old) were given 500 mg every 12 hours, the maximum serum concentrations and area under the curves of clarithromycin and 14-OH clarithromycin were increased compared to those achieved in healthy young adults. These changes in pharmacokinetics parallel known age-related decreases in renal function. In clinical trials, elderly patients did not have an increased incidence of adverse events when compared to younger patients.

Amoxicillin An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. Of the 1811 subjects treated with amoxicillin, 85% were < 60 years old, 15% were ≥ 61 years old and 7% were ≥ 71 years old. This analysis and other reported clinical experience have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🆘 Overdosage ~2 min read ▾

10 OVERDOSAGE In case of an overdose, patients should contact a physician, poison control center, or emergency room. There is neither a pharmacologic basis nor data suggesting an increased toxicity of the combination compared to individual components. As with the management of any overdose, the possibility of multiple drug ingestion should be considered.

For current information on treatment of any drug overdose, contact your local Poison Control Center at 1-800-222-1222. Omeprazole : Reports have been received of overdosage with omeprazole in humans. Doses ranged up to 2400 mg (120 times the usual recommended clinical dose).

Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience [ see Adverse Reactions ( 6.3 ) ]. Symptoms were transient, and no serious clinical outcome has been reported when omeprazole was taken alone. No specific antidote for omeprazole overdosage is known.

Omeprazole is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive. Single oral doses of omeprazole at 1350, 1339, and 1200 mg/kg were lethal to mice, rats, and dogs, respectively.

Animals given these doses showed sedation, ptosis, tremors, convulsions, and decreased activity, body temperature, and respiratory rate and increased depth of respiration. Clarithromycin : Overdosage of clarithromycin can cause gastrointestinal symptoms such as abdominal pain, vomiting, nausea, and diarrhea. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures.

As with other macrolides, clarithromycin serum concentrations are not expected to be appreciably affected by hemodialysis or peritoneal dialysis. Amoxicillin : In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed.

A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying 1 . Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin. Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients.

In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria. Renal impairment appears to be reversible with cessation of drug administration. High blood concentrations may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin.

Amoxicillin can be removed from circulation by hemodialysis.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Omeprazole is an antisecretory drug whereas clarithromycin and amoxicillin are antibacterial drugs [ see Clinical Pharmacology ( 12.4 ) ].

12.3Pharmacokinetics Pharmacokinetics when all three of the OMECLAMOX-PAK components were coadministered has not been studied. Studies have shown the low risk of clinically significant interactions of omeprazole and amoxicillin or omeprazole and clarithromycin when administered together. There is no information about the gastric mucosal concentrations of omeprazole, clarithromycin and amoxicillin after administration of these drugs concomitantly.

The systemic pharmacokinetic information presented below is based on studies in which each product was administered alone, or in combination of two components. Omeprazole Delayed-Release Capsules, USP Absorption and Distribution Omeprazole delayed-release capsules contain an enteric-coated granule formulation of omeprazole (because omeprazole is acid- labile), so that absorption of omeprazole begins only after the granules leave the stomach. Absorption is rapid, with peak plasma concentrations of omeprazole occurring within 0.5 to 3.5 hours.

Peak plasma concentrations of omeprazole and AUC are approximately proportional to doses up to 40 mg, but because of a saturable first-pass effect, a greater than linear response in peak plasma concentration and AUC occurs with doses greater than 40 mg. Absolute bioavailability (compared with intravenous administration) is about 30-40% at doses of 20-40 mg, due in large part to presystemic metabolism. In healthy subjects the plasma half-life is 0.5 to 1 hour, and the total body clearance is 500-600 mL/min.

The bioavailability of omeprazole increases slightly upon repeated administration of omeprazole delayed-release capsules. Omeprazole delayed-release capsules 40 mg was bioequivalent when administered with and without applesauce. However, omeprazole delayed-release capsules 20 mg was not bioequivalent when administered with and without applesauce.

When administered with applesauce, a mean 25% reduction in Cmax was observed without a significant change in AUC for omeprazole delayed-release capsules 20 mg. The clinical relevance of this finding is unknown. Protein binding is approximately 95%.

Metabolism and Excretion Among those females aged 18 to 44 years of age, 22.4% were diagnosed with skin infections and 7.6% had pneumonia. Geriatric Patients The elimination rate of omeprazole was somewhat decreased in the elderly, and bioavailability was increased. Omeprazole was 76% bioavailable when a single 40 mg oral dose of omeprazole (buffered solution) was administered to healthy elderly volunteers, versus 58% in young volunteers given the same dose.

Nearly 70% of the dose was recovered in urine as metabolites of omeprazole and no unchanged drug was detected. The plasma clearance of omeprazole was 250 mL/min (about half that of young volunteers) and its plasma half-life averaged one hour, about twice that of young healthy volunteers. Hepatic Impairment In patients with chronic hepatic disease, the bioavailability of omeprazole increased to approximately 100% compared with an IV dose, reflecting decreased first-pass effect, and the plasma half-life of the drug increased to nearly 3 hours compared with the half-life in normals of 0.5-1 hour.

Plasma clearance averaged 70 mL/min, compared with a value of 500-600 mL/min in normal subjects. It is recommended to avoid the use of OMECLAMOX-PAK in patients with hepatic impairment. Renal Impairment In patients with chronic renal impairment, whose creatinine clearance ranged between 10 and 62 mL/min/1.73m 2 , the disposition of omeprazole was very similar to that in healthy volunteers, although there was a slight increase in bioavailability.

Because urinary excretion is a primary route of excretion of omeprazole metabolites, their elimination slowed in proportion to the decreased creatinine clearance. No dose reduction is nec…

🧬 Mechanism of Action 24 words ▾

12.1Mechanism of Action Omeprazole is an antisecretory drug whereas clarithromycin and amoxicillin are antibacterial drugs [ see Clinical Pharmacology ( 12.4 ) ].

📦 How Supplied / Storage and Handling 145 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING OMECLAMOX-PAK is supplied in a carton containing ten individual daily administration cards. Each card contains the morning dose and the evening dose of the following three drugs: Omeprazole Delayed-Release Capsules, USP, 20 mg Two opaque hard gelatin lavender and grey capsules, with ‘R 158’ and ‘OMEPRAZOLE 20 mg’ imprinted on the capsules in black ink, containing off-white to pale-yellow, elliptical spherical pellets. Clarithromycin Tablets, USP, 500 mg Two white, biconvex beveled-edge capsule-shaped coated tablets debossed with ‘54 312’ on one side and plain on the other side.

Amoxicillin Capsules, USP, 500 mg Four opaque hard gelatin yellow capsules, marked ’GG849’. Each capsule contains amoxicillin trihydrate equivalent to 500 mg amoxicillin. NDC 66220-422-02 Carton containing 10 daily administration cards NDC 66220-422-01 Daily administration card Store at controlled room temperature between 20°C and 25°C (68°F and 77°F).

Protect from light and moisture.

📋 Description ~2 min read ▾

11 DESCRIPTION OMECLAMOX-PAK consists of a pack of ten individual daily administration cards, each card containing two omeprazole delayed-release 20 mg capsules, USP, two clarithromycin 500 mg tablets, USP, and four amoxicillin 500 mg capsules, USP, for oral administration. Omeprazole Delayed-Release Capsules, USP The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl- 2-pyridinyl) methyl] sulfinyl]1H-benzimidazole, a proton pump inhibitor that inhibits gastric acid secretion.

Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is: Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol, and very slightly soluble in water.

The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Each omeprazole delayed-release capsule contains 20 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, lactose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl acetate. The capsule shells contain: D&C Red #28, FD&C Blue No.

1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide.

Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No.

2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide. Structural Formula Clarithromycin Tablets, USP Clarithromycin is a semi-synthetic macrolide antimicrobial.

Chemically, it is 6- 0 -methylerythromycin. The molecular formula is C 38 H 69 NO 13 , and the molecular weight is 747.96. Clarithromycin has the following structural formula: Clarithromycin is a white to off-white crystalline powder.

It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Each tablet for oral administration contains 500 mg of clarithromycin and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry II (White), povidone, stearic acid, and talc. Opadry II (White) contains hypromellose, polyethylene glycol, polydextrose, titanium dioxide and triacetin.

Structural Formula Amoxicillin Capsules, USP : Amoxicillin, a semisynthetic penicillin class antibacterial, is an analogue of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (2S, 5R, 6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]- 3,3-dimethyl-7-oxo-4-thia-1-aza-bicyclo[3.2.0] heptane-2-carboxylic acid trihydrate. Its empirical formula is C16H19N3O5S •3H2O with a molecular weight of 419.45.

Amoxicillin has the following structural formula: Amoxicillin capsules contain amoxicillin trihydrate equivalent to 500 mg of amoxicillin. Amoxicillin capsules USP also contain magnesium stearate and sodium lauryl sulfate. The capsule shell contains D&C Red No.

33, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No.

6, gelatin, sodium lauryl sulfate and titanium dioxide. Each 500 mg capsule contains up to 0.0052 mEq (0.119 mg) of sodium. Structural Formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Administration Inform patients that each dose of OMECLAMOX-PAK contains four pills: one opaque lavender/grey capsule (omeprazole), one white tablet (clarithromycin) and two opaque yellow capsules (amoxicillin). Take each dose of four pills in the morning and four pills in the evening before eating a meal, for 10 days. Capsules and tablets should not be crushed or chewed, and should be swallowed whole [ see Dosage and Administration ( 2 ) ].

Embryo-Fetal Toxicity Advise females of reproductive potential that that if pregnancy occurs while taking this OMECLAMOX-PAK, there is a potential hazard to the fetus [ see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 ) ]. Drug Interactions Patients should be advised to report to their doctor the use of any other medications while taking OMECLAMOX-PAK [ see Drug Interactions ( 7 ) ]. The simultaneous administration of any of the following drugs with OMECLAMOX-PAK may result in clinically significant adverse reactions or even death: Colchicine Ergotamine/dihydroergotamine Pimozide Lurasidone Antiarrhythmic drugs (e.g., quinidine, disopyramide) Digoxin Anticoagulants (e.g., warfarin) Atazanavir Nelfinavir Saquinavir Cilostazol Tacrolimus Theophylline Carbamazepine Sildenafil HMG-CoA reductase inhibitors (also known as statins) Triazolobenzodiazepines (e.g., triazolam and alprazolam) and related benzodiazepines (e.g., midazolam) Probenecid Drugs for which gastric pH can affect bioavailability Diarrhea Advise patients that diarrhea is a common problem caused by omeprazole and antibiotics that usually ends when the drug is discontinued.

Sometimes after starting treatment, patients can develop severe diarrhea with watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the drug. If this occurs, patients should contact a physician as soon as possible [ see Warnings and Precautions ( 5.4 ) ]. Acute Tubulointerstitial Nephritis Advise the patient or caregiver to call the patient's healthcare provider immediately if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis [ see Warnings and Precautions ( 5.7 ) ].

Cutaneous or Systemic Lupus Advise patients to report any symptoms associated with cutaneous or systemic lupus erythematosus [ see Warnings and Precautions ( 5.8 ) ]. Antibacterial Resistance Patients should be counseled that antibacterial drugs including OMECLAMOX-PAK should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).

When OMECLAMOX-PAK is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by OMECLAMOX-PAK or other antibacterial drugs in the future. Severe Cutaneous Adverse Reactions Advise patients about the signs and symptoms of serious skin manifestations.

Instruct patients to stop taking OMECLAMOX-PAK immediately and promptly report the first signs or symptoms of skin rash, mucosal lesions, or any other sign of hypersensitivity [see WARNINGS AND PRECAUTIONS ( 5.2 )] . OMECLAMOX-PAK is manufactured for CUMBERLAND PHARMACEUTICALS INC., Nashville, TN 37203.

Glossary — plain-language definitions of medical terms used in this label:

anticoagulant: A medicine that slows down blood clotting; often called a blood thinner.

contraindicated: Should not be used in that situation, because the risk is considered too high.

contraindication: A situation in which a medicine should not be used because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

systemic lupus erythematosus: A long-term autoimmune disease in which the immune system attacks the body's own tissues, affecting joints, skin, kidneys, and other organs.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Active ingredient: The part of a medicine that produces its intended effect on the body.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

asthenia: Unusual weakness or lack of physical strength and energy.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

bactericidal: Describes a medicine that kills bacteria outright.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

candidiasis: An infection caused by a yeast called Candida, which can affect the mouth, throat, skin, or other areas.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Clostridioides difficile: A type of gut germ that can overgrow and cause severe, watery diarrhea, often after antibiotic use.

Cmax: The highest level a medicine reaches in the blood after a dose is taken.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

CYP2C19: A liver enzyme that breaks down certain medicines, such as some stomach-acid drugs and drugs that help prevent blood clots.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

delayed-release: A pill coated so it does not release its medicine until after it has passed through the stomach.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

diaphoresis: Heavy or excessive sweating.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efflux transporter: A protein pump that pushes drugs out of cells, lowering how much stays inside.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

embryo-fetal toxicity: Harm to a developing baby in the womb, such as birth defects, slowed growth, or loss of the pregnancy.

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

enteric-coated: A special coating that keeps a pill from dissolving in the stomach, so it opens up further along in the intestine.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

erythema multiforme: A skin reaction with red, target-shaped spots, usually on the hands, arms, or face.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

exfoliative dermatitis: Widespread redness with heavy scaling or peeling of the skin over most of the body.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

gynecomastia: Swelling or enlargement of breast tissue in males.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

INR: A blood test result that shows how quickly blood clots, often used to monitor blood-thinning medicines.

interstitial nephritis: Inflammation of the tissue between the kidney's tiny filtering tubes, sometimes triggered by a medicine, that can reduce kidney function.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

lactation: The making and release of milk from a mother's breasts after giving birth.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

myasthenia gravis: A long-term condition where muscles tire and grow weak easily, often affecting the eyes, face, and swallowing.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

P-glycoprotein: A tiny pump in cells that pushes certain medicines back out, affecting how much of a medicine is absorbed or stays in the body.

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

peripheral edema: Swelling, usually in the feet, ankles, or legs, caused by extra fluid building up in the tissues.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

QT prolongation: A longer-than-normal electrical recovery time between heartbeats, seen on a heart tracing (ECG), which can raise the chance of a dangerous heart rhythm.

refractory: Describing a disease that does not respond to, or improve with, treatment.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

sedation: A calm, sleepy, slowed-down state caused by a medicine that relaxes the brain and body.

serum sickness: A delayed reaction, usually one to two weeks after exposure, causing fever, rash, and joint pain as the body reacts to a foreign substance.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

stomatitis: Soreness, swelling, or sores on the lining inside the mouth.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

torsades de pointes: A rare but dangerous fast heart rhythm that can cause fainting and, in the worst cases, become life-threatening.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

transporter: A protein that moves drugs across cell membranes, carrying them either into or out of cells.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

trough: The lowest level a medicine reaches in the blood, just before the next dose is due.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

ventricular fibrillation: A life-threatening, chaotic rhythm in the heart's lower chambers that stops the heart from pumping blood effectively.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 66220-0315-11 · Cumberland 66220-0637-31 · Cumberland →

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.

Omeclamox-Pak omeprazole, clarithromycin, amoxicillin Kit, 1 kit

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