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Amoxicillin and Clavulanate Potassium 500 mg; 125 mg Tablet, Film Coated, 20-count — NDC 72189-0281-20 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Amoxicillin and Clavulanate Potassium 500 mg; 125 mg Tablet, Film Coated, 20-count — NDC 72189-281-20 (Billing 72189-0281-20)

by DirectRx · 20 TABLET, FILM COATED in 1 BOTTLE

This is a package of 20 tablets of Amoxicillin and Clavulanate Potassium 500 mg; 125 mg Tablet, Film Coated from DirectRx, marketed since Oct 2021 and currently FDA-listed.

NDC 72189-0281-20
🏷️ FDA NDC (as labeled) 72189-281-20 billing pads the product segment with a zero
This package
Contains20-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.0932/unit — full pricing hub ↓
Product page 72189-0281-14 Also comes in: 14 tablets 72189-281-14
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72189-281-20
Product NDC 72189-281
11-digit billing NDC 72189028120
NCPDP billing unit EA — each (per item)
RxCUI 617296
UNII 804826J2HU, Q42OMW3AT8
Application # ANDA065064
SPL Set ID cdc6d30a-754e-6672-e053-2a95a90afa7f
Established class (EPC) Penicillin-class Antibacterial; beta Lactamase Inhibitor
Mechanism of action beta Lactamase Inhibitors
Chemical class Penicillins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-10-07
Route ORAL
Dosage form TABLET, FILM COATED
Substance AMOXICILLIN; CLAVULANATE POTASSIUM
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 01990002200320
GPI class Amoxicillin-Pot Clavulanate
GCN Seq No 008992
GCN 67071
HICL code 003962
Ingredient (HICL) Amoxicillin/Potassium Clav
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1A
Therapeutic class — specific (HIC3) Penicillin Antibiotics
AHFS code 08:12.16.08
AHFS class Aminopenicillin Antibiotics
FDB label name AMOX-CLAV 500-125 MG TABLET
FDB brand name Amoxicillin-Clavulanate Potass
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 008992
  • GCN: 67071
  • GPI-14 (Medi-Span): 01990002200320
  • HICL (First Databank): 003962
  • AHFS class code: 08:12.16.08
  • RxCUI (RxNorm): 617296
Why two NDCs? The FDA registers this code as 72189-281-20 — 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 → 72189-0281-20. 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 beta Lactamase Inhibitor class.

Pharmacologic class beta Lactamase Inhibitor
How it works beta Lactamase 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.

Clinical

Label name AMOX-CLAV 500-125 MG TABLET Ingredient Amoxicillin/Potassium Clav
📗 Our plain-language guide HelloPharmacist
  • It treats bacterial infections such as those of the lungs, sinuses, ears, skin and urinary tract. Some forms are for specific infections, like middle ear infections in young childr...
  • You can take it with or without food. But taking it at the start of a meal helps you absorb the clavulanate and often eases stomach upset. Follow your prescriber's directions for y...
  • Diarrhea, loose stools, nausea and mild rash are the most common. Vomiting and vaginal yeast infections can also happen. Call us if symptoms are severe or don't settle.
  • Get urgent help for trouble breathing, swelling, hives or a spreading or blistering rash. Call your doctor if you have yellow skin or eyes, or watery or bloody diarrhea, even weeks...
📖 Read our full Amoxicillin / Clavulanate guide →

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.

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 $0.0932 $1.86 / 20 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72189-0281-14 72189-281-14 Main listing 14 TABLET, FILM COATED in 1 BOTTLE 2021-10-07 — Active
72189-0281-20 You're viewing this 20 TABLET, FILM COATED in 1 BOTTLE 2021-10-07 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 20-count package — 20 tablet, film coated in 1 bottle.
How does this package differ from NDC 72189-0281-14?
Both are Amoxicillin and Clavulanate Potassium 500 mg; 125 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 20-count one, while NDC 72189-0281-14 is the 14 tablets package.
What NDC number is used to bill for this package of Amoxicillin and Clavulanate Potassium 500 mg; 125 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 00093-2274-34 Teva 20 tablets $0.253 AB Availability likely —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 00781-1831-01 Sandoz 100 tablets $0.253 AB Availability likely —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 16714-0296-01 NorthStar 20 tablets $0.253 AB Availability likely —
Amoxicillin And Clavulanate Potassium 500 mg/1; 125 mg 42571-0161-01 Micro 100 tablets $0.253 AB Availability likely —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 60687-0792-01 American 1 tablet $0.253 AB Availability likely —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 16714-0477-01 Northstar 20 tablets $0.304 AB Discontinued —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 45865-0230-20 Medsource 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 50090-0820-00 A-S 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 50090-6997-00 A-S 14 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 55289-0845-06 PD-Rx 6 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 63187-0032-06 Proficient 6 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 63187-0803-20 Proficient 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 65862-0502-05 Aurobindo 500 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 500 mg/1; 125 mg 67046-0366-03 Coupler 30 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 68071-2896-02 NuCare 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 68071-2933-03 NuCare 3 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 68071-3947-03 NuCare 30 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 500 mg/1; 125 mg 68071-4275-02 NuCare 20 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 500 mg/1; 125 mg 68071-4284-03 NuCare 3 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 500 mg/1; 125 mg 68071-4300-01 NuCare 21 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 500 mg/1; 125 mg 68788-7998-02 Preferred 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 68788-8317-02 Preferred 20 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 500 mg/1; 125 mg 70518-2625-00 REMEDYREPACK 30 tablets — AB Discontinued —
Amoxicillin And Clavulanate Potassium 500 mg/1; 125 mg 71205-0014-06 Proficient 6 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 71335-2735-01 Bryant 20 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 500 mg/1; 125 mg 71335-2824-01 Bryant 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 71335-2999-01 Bryant 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 72162-2210-02 Bryant 20 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 500 mg/1; 125 mg 72162-2433-01 Bryant 100 tablets — AB FDA listed —
Amoxicillin And Clavulanate Potassium 500 mg/1; 125 mgthis 72189-0281-20 DirectRx 20 tablets — AB FDA listed —
Amoxicillin/Clav Pot 125 mg/1; 500 mg 72189-0638-14 Direct_Rx 14 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 72789-0418-14 PD-Rx 14 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 72789-0533-21 PD-Rx 21 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 73043-0007-20 Devatis, 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 76420-0507-20 Asclemed 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 76420-0608-20 Asclemed 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 85766-0022-20 Sportpharm 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 85766-0079-20 Sportpharm 20 tablets — AB FDA listed —
Amoxicillin and Clavulanate Potassium 500 mg/1; 125 mg 68071-2630-02 NuCare 20 tablets — AB Discontinued —
amoxicillin and clavulanate potassium 500 mg/1; 125 mg 62135-0091-20 Chartwell 20 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2021
On the market since
Oct 2021
📍
2026
Currently FDA-listed
5 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.

What it looks like

Color white
ShapeOval
ImprintGGN6
Size21 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.

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.

Manufacturer & labeler

LabelerDirectRx
Application holderSANDOZ INC
FDA applicationANDA065064 (ANDA)
Labeler code72189
First marketedOct 2021
Product typeHuman Prescription Drug
Portfolio49 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 Storage and Handling 📋 Description 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 213 words ▾

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat 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.

Amoxicillin and clavulanate potassium tablets, oral suspension and chewable tablets are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below:

1.1Lower Respiratory Tract Infections Caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis.

1.2Acute Bacterial Otitis Media Caused by beta-lactamase–producing isolates of H.influenzae and M.catarrhalis.

1.3Sinusitis Caused by beta-lactamase–producing isolates of H.influenzae and M.catarrhalis.

1.4Skin and Skin Structure Infections Caused by beta-lactamase producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.

1.5Urinary Tract Infections Caused by beta-lactamase producing isolates of E.coli, Klebsiella species, and Enterobacter species.

1.6Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium should not be used.

⏱️ Dosage and Administration ~3 min read ▾

Amoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal.

2.1Adults The usual adult dose is one 500 mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 250 mg tablet of amoxicillin and clavulanate potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875 mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 500 mg tablet of amoxicillin and clavulanate potassium every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500 mg tablet.

The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875 mg tablet. Two 250 mg tablets of amoxicillin and clavulanate potassium should not be substituted for one 500 mg tablet of amoxicillin and clavulanate potassium. Since both the 250 mg and 500 mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg tablets are not equivalent to one 500 mg tablet of amoxicillin and clavulanate potassium.

The 250 mg tablet of amoxicillin and clavulanate potassium and the 250 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250 mg tablet of amoxicillin and clavulanate potassium and the 250 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250 mg chewable tablet contains 62.5 mg of clavulanic acid.

2.2Pediatric Patients Based on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows: Neonates and Infants Aged <12 weeks (<3 months) The recommended dose of Amoxicillin and clavulanate potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended. Patients Aged 12 weeks (3 months) and Older See dosing regimens provided in Table 1.

The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)]. However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics [see Warnings and Precautions (5.6)]. Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older DOSING REGIMEN Every 12 hours Every 8 hours INFECTION 200 mg/5 mL or 400 mg/5 mL oral suspension* 125 mg/5 mL or 250 mg/5 mL oral suspension Otitis media†, sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day every 12 hours 40 mg/kg/day every 8 hours Less severe infections 25 mg/kg/day every 12 hours 20 mg/kg/day every 8 hours * Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children. † Duration of therapy studied and recommended for acute otitis media is 10 days.

Patients Weighing 40 kg or More Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations. The 250 mg tablet of amoxicillin and clavulanate potassium should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250 mg tablet of amoxicillin and clavulanate potassium (250 mg/125 mg) versus the 250 mg chewable tablet of amoxicillin and clavulanate potassium (250 mg/62.5 mg).

2.3Patients with Renal Impairment Patients with impaired renal function do not generally require a reduction in… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths ~2 min read ▾

Tablets Amoxicillin and Clavulanate Potassium Tablets, USP, 250 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule shaped, debossed GGN5 on one side and plain on the reverse side, and contains 250 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg: Each film coated tablet, for oral administration, is white, oval-shaped, debossed GGN6 on one side and plain on the reverse side, and contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.

Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule-shaped, scored and debossed GGN7 on one side and scored on the reverse side, and contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. For Oral Suspension Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 200 mg/28.5 mg per 5 mL: as a dry, white powder. Each 5 mL of reconstituted orange-flavored suspension contains 200 mg amoxicillin as the trihydrate and 28.5 mg clavulanic acid as the potassium salt.

Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 400 mg/57 mg per 5 mL: as a dry, white powder. Each 5 mL of reconstituted orange-flavored suspension contains 400 mg amoxicillin as the trihydrate and 57 mg clavulanic acid as the potassium salt. Chewable Tablets Amoxicillin and Clavulanate Potassium Tablets, USP, (Chewable) 200 mg/28.5 mg: Each chewable tablet is round, pink, cherry-banana flavored, embossed GGN2 on one side and plain on the reverse side, and contains 200 mg amoxicillin as the trihydrate and 28.5 mg clavulanic acid as the potassium salt.

Amoxicillin and Clavulanate Potassium Tablets, USP, (Chewable) 400 mg/57 mg: Each chewable tablet is round, pink, cherry-banana flavored, embossed GGN4 on one side and plain on the reverse side, and contains 400 mg amoxicillin as the trihydrate and 57 mg clavulanic acid as the potassium salt. The 250 mg tablet of amoxicillin and clavulanate potassium and the 250 mg chewable tablet should NOT be substituted for each other, as they are not interchangeable and the 250 mg tablet should not be used in children weighing less than 40 kg.

The 250 mg tablet of amoxicillin and clavulanate potassium and the 250 mg chewable tablet do not contain the same amount of clavulanic acid. The 250 mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid whereas the 250 mg chewable tablet contains 62.5 mg of clavulanic acid. Two 250 mg tablets of amoxicillin and clavulanate potassium should NOT be substituted for one 500 mg tablet of amoxicillin and clavulanate potassium.

Since both the 250 mg and 500 mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg tablets of amoxicillin and clavulanate potassium are not equivalent to one 500 mg tablet of amoxicillin and clavulanate potassium.

⛔ Contraindications 63 words ▾

4.1Serious Hypersensitivity Reactions Amoxicillin and clavulanate potassium is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins).

4.2Cholestatic Jaundice/Hepatic Dysfunction Amoxicillin and clavulanate potassium is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium.

⚠️ Warnings and Cautions ~2 min read ▾

5.1Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials, including amoxicillin and clavulanate potassium. 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 and clavulanate potassium, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.

If an allergic reaction occurs, amoxicillin and clavulanate potassium should be discontinued and appropriate therapy instituted.

5.2Hepatic Dysfunction Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of amoxicillin and clavulanate potassium. Hepatic toxicity is usually reversible; however, deaths have been reported. Hepatic function should be monitored at regular intervals in patients with hepatic impairment.

5.3Clostridium difficile Associated Diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin and clavulanate potassium, and may range in severity from mild diarrhea to fatal colitis. 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 antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C.difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C.difficile, and surgical evaluation should be instituted as clinically indicated.

5.4Skin Rash in Patients with Mononucleosis A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus, amoxicillin and clavulanate potassium should not be administered to patients with mononucleosis.

5.5Potential for Microbial Overgrowth The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. If superinfection occurs, amoxicillin/clavulanate potassium should be discontinued and appropriate therapy instituted.

5.6Phenylketonurics Amoxicillin and clavulanate potassium chewable tablets and amoxicillin and clavulanate potassium for oral suspension contain aspartame which contains phenylalanine. Each 200 mg chewable tablet of amoxicillin and clavulanate potassium contains 2 mg phenylalanine; each 400 mg chewable tablet contains 4 mg phenylalanine; each 5 mL of either the 200 mg/5 mL or 400 mg/5 mL oral suspension contains 7 mg phenylalanine. The other formulations of amoxicillin and clavulanate potassium do not contain phenylalanine.

5.7Development of Drug-Resistant Bacteria Prescribing amoxicillin and clavulanate potassium in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient, and increases the risk of the development of drug-resistant bacteria.

🤒 Adverse Reactions ~2 min read ▾

The following are discussed in more detail in other sections of the labeling: • Anaphylactic reactions [see Warnings and Precautions (5.1)] • Hepatic Dysfunction [see Warnings and Precautions (5.2)] • CDAD [see Warnings and Precautions (5.3)]

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. The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). Less than 3% of patients discontinued therapy because of drug-related adverse reactions.

The overall incidence of adverse reactions, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported adverse reactions (<1%) include: Abdominal discomfort, flatulence, and headache. In pediatric patients (aged 2 months to 12 years), 1 US/Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of amoxicillin and clavulanate potassium for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of amoxicillin and clavulanate potassium for 10 days in the treatment of acute otitis media.

A total of 575 patients were enrolled, and only the suspension formulations were used in this trial. Overall, the adverse reactions seen were comparable to that noted above; however, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area rashes [see Clinical Studies (14.2)].

6.2Post-Marketing Experience In addition to adverse reactions reported from clinical trials, the following have been identified during post-marketing use of amoxicillin and clavulanate potassium. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to amoxicillin and clavulanate potassium.

Gastrointestinal: Indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment [see Warnings and Precautions (5.3)]. Hypersensitivity Reactions: Pruritus, angioedema, serum sickness–like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and cases of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported [see Warnings and Precautions (5.1)].

Liver: Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with amoxicillin and clavulanate potassium. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic-hepatocellular changes.

The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic dysfunction, which may be severe, is usually reversible. Deaths have been reported [see Contraindications (4.2), Warnings and Precautions (5.2)].

Renal: Interstitial nephritis, hematuria, and crystalluria have been reported [see Overdosage (10)]. Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported. These reactions are usually reversible on discontinuation of therapy and are bel… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7.1Probenecid Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid. Concurrent use with amoxicillin and clavulanate potassium may result in increased and prolonged blood concentrations of amoxicillin. Co-administration of probenecid is not recommended.

7.2Oral Anticoagulants Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently with amoxicillin and clavulanate potassium. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.

7.3Allopurinol The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients.

7.4Oral Contraceptives Amoxicillin and clavulanate potassium may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

7.5Effects on Laboratory Tests High urine concentrations of amoxicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST®, Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with amoxicillin and clavulanate potassium, it is recommended that glucose tests based on enzymatic glucose oxidase reactions be used. Following administration of amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.

👥 Use in Specific Populations ~2 min read ▾

8.1Pregnancy Teratogenic Effects Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate potassium. The amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours). For clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours).

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.

8.2Labor and Delivery Oral ampicillin-class antibiotics are poorly absorbed during labor. It is not known whether use of amoxicillin/clavulanate potassium in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention.

8.3Nursing Mothers Amoxicillin has been shown to be excreted in human milk. Amoxicillin/clavulanate potassium use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin/clavulanate potassium is administered to a nursing woman.

8.4Pediatric Use The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension and chewable tablets have been established in pediatric patients. Use of amoxicillin and clavulanate potassium in pediatric patients is supported by evidence from studies of amoxicillin and clavulanate potassium tablets in adults with additional data from a study of amoxicillin and clavulanate potassium for oral suspension in pediatric patients aged 2 months to 12 years with acute otitis media [see Clinical Studies (14.2)].

Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed; clavulanate elimination is unaltered in this age group. Dosing of amoxicillin and clavulanate potassium should be modified in pediatric patients aged <12 weeks (<3 months) [see Dosage and Administration (2.2)].

8.5Geriatric Use Of the 3,119 patients in an analysis of clinical studies of amoxicillin and clavulanate potassium, 32% were ≥65 years old, and 14% were ≥75 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of adverse 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.

8.6Dosing in Renal Impairment Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR <30 mL/min). See Patients with Renal Impairment (2.3) for specific recommendations in patients with renal impairment.

🆘 Overdosage 146 words ▾

In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. 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 symptoms1. Interstitial nephritis resulting in oliguric renal failure has been reported in patients after overdosage with amoxicillin/clavulanate potassium.

Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin/clavulanate potassium overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin/clavulanate potassium crystalluria. Renal impairment appears to be reversible with cessation of drug administration.

High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin/clavulanate potassium. Amoxicillin/clavulanate potassium may be removed from circulation by hemodialysis [see Dosage and Administration (2.3)].

🧬 Clinical Pharmacology ~3 min read ▾

12.1Mechanism of Action Amoxicillin and clavulanate potassium is an antibacterial drug [see Microbiology 12.4].

12.3Pharmacokinetics Mean amoxicillin and clavulanate potassium pharmacokinetic parameters in normal adults following administration of amoxicillin and clavulanate potassium tablets are shown in Table 3 and following administration of amoxicillin and clavulanate potassium for oral suspension and chewable tablets are shown in Table 4. Table 3: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters*, † with Amoxicillin and Clavulanate Potassium Tablets Dose and Regimen Cmax (mcg/mL) AUC0-24 (mcg•h/mL) Amoxicillin/Clavulanate potassium Amoxicillin Clavulanate potassium Amoxicillin Clavulanate potassium 250 mg/125 mg every 8 hours 3.3 ± 1.12 1.5 ± 0.70 26.7 ± 4.56 12.6 ± 3.25 500 mg/125 mg every 12 hours 6.5 ± 1.41 1.8 ± 0.61 33.4 ± 6.76 8.6 ± 1.95 500 mg/125 mg every 8 hours 7.2 ± 2.26 2.4 ± 0.83 53.4 ± 8.87 15.7 ± 3.86 875 mg/125 mg every 12 hours 11.6 ± 2.78 2.2 ± 0.99 53.5 ± 12.31 10.2 ± 3.04 * Mean (± standard deviation) values of 14 normal adults (N=15 for clavulanate potassium in the low-dose regimens).

Peak concentrations occurred approximately 1.5 hours after the dose. † Amoxicillin/clavulanate potassium administered at the start of a light meal. Table 4: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters*, † with Amoxicillin and Clavulanate Potassium for Oral Suspension and Chewable Tablets Dose Cmax (mcg/mL) AUC0-24 (mcg•h/mL) Amoxicillin/Clavulanate potassium Amoxicillin Clavulanate potassium Amoxicillin Clavulanate potassium 400 mg/57 mg (5 mL of suspension) 6.94 ± 1.24 1.10 ± 0.42 17.29 ± 2.28 2.34 ± 0.94 400 mg/57 mg (1 chewable tablet) 6.67 ± 1.37 1.03 ± 0.33 17.24 ± 2.64 2.17 ± 0.73 * Mean (± standard deviation) values of 28 normal adults.

Peak concentrations occurred approximately 1 hour after the dose. † Amoxicillin/clavulanate potassium administered at the start of a light meal. Oral administration of 5 mL of 250 mg/5 mL suspension of amoxicillin and clavulanate potassium or the equivalent dose of 10 mL of 125 mg/5 mL suspension of amoxicillin and clavulanate potassium provides average peak serum concentrations approximately 1 hour after dosing of 6.9 mcg/mL for amoxicillin and 1.6 mcg/mL for clavulanic acid. The areas under the serum concentration curves obtained during the first 4 hours after dosing were 12.6 mcg•h/mL for amoxicillin and 2.9 mcg•h/mL for clavulanic acid when 5 mL of 250 mg/5 mL suspension of amoxicillin and clavulanate potassium or equivalent dose of 10 mL of 125 mg/5 mL suspension of amoxicillin and clavulanate potassium were administered to normal adults.

One 250 mg chewable tablet of amoxicillin and clavulanate potassium or two 125 mg chewable tablets of amoxicillin and clavulanate potassium are equivalent to 5 mL of 250 mg/5 mL suspension of amoxicillin and clavulanate potassium and provide similar serum concentrations of amoxicillin and clavulanic acid. Amoxicillin serum concentrations achieved with amoxicillin and clavulanate potassium are similar to those produced by the oral administration of equivalent doses of amoxicillin alone. Time above the minimum inhibitory concentration of 1 mcg/mL for amoxicillin has been shown to be similar after corresponding every 12 hour and every 8 hour dosing regimens of amoxicillin and clavulanate potassium in adults and children.

Absorption Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. While amoxicillin and clavulanate potassium can be given without regard to meals, absorption of clavulanate potassium when taken with food is greater relative to the fasted state. In one study, the relative bioavailability of clavulanate was reduced when amoxicillin and clavulanate potassium was dosed at 30 and 150 minutes after the start of a high-fat breakfast.

Distribution Neither component in amoxicillin and clavulanate potassium is highly protein-bound; clav… [Excerpted — this section continues on DailyMed.]

📦 Storage and Handling ~2 min read ▾

Tablets Amoxicillin and Clavulanate Potassium Tablets, USP, 250 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule shaped, debossed GGN5 on one side and plain on the reverse side, and contains 250 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 0781-1874-31 bottles of 30 Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg: Each film coated tablet, for oral administration, is white, oval-shaped, debossed GGN6 on one side and plain on the reverse side, and contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.

NDC 0781-1831-20 bottles of 20 NDC 0781-1831-13 Unit Dose (10 x 10) 100 film coated tablets Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule-shaped, scored and debossed GGN7 on one side and scored on the reverse side, and contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 0781-1852-20 bottles of 20 NDC 0781-1852-13 Unit Dose (4 x 25) 100 film coated tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in original container; advise patient to keep in closed container. For Oral Suspension Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 200 mg/28.5 mg per 5 mL: as a dry, white powder. Each 5 mL of reconstituted orange-flavored suspension contains 200 mg amoxicillin as the trihydrate and 28.5 mg clavulanic acid as the potassium salt.

NDC 0781-6102-46 100 mL bottle Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 400 mg/57 mg per 5 mL: as a dry, white powder. Each 5 mL of reconstituted orange-flavored suspension contains 400 mg amoxicillin as the trihydrate and 57 mg clavulanic acid as the potassium salt. NDC 0781-6104-46 100 mL bottle Store dry powder at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in original container; Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Chewable Tablets Amoxicillin and Clavulanate Potassium 200 mg/28.5 mg tablets, USP (chewable): Each chewable tablet is round, pink, cherry-banana flavored, embossed GGN2 on one side and plain on the reverse side, and contains 200 mg amoxicillin as the trihydrate and 28.5 mg clavulanic acid as the potassium salt.

NDC 0781-1619-66 Carton of 20 (4 x 5) tablets Amoxicillin and Clavulanate Potassium 400 mg/57 mg tablets, USP (chewable): Each chewable tablet is round, pink, cherry-banana flavored, embossed GGN4 on one side and plain on the reverse side, and contains 400 mg amoxicillin as the trihydrate and 57 mg clavulanic acid as the potassium salt. NDC 0781-1643-66 Carton of 20 (4 x 5) tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in original container.

KEEP OUT OF REACH OF CHILDREN.

📋 Description ~1 min read ▾

Amoxicillin and clavulanate potassium tablets, USP; for oral suspension, USP; and chewable tablets, USP are oral antibacterial combinations consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S•3H2O, and the molecular weight is 419.46.

Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(phydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as: amoxicillin-chemical-structure Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25.

Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as: clavulanate-chemical-structure Inactive Ingredients • Tablets – Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide, triethyl citrate, ethylcellulose, cetyl alcohol and sodium lauryl sulfate. In addition, the 875 mg/125 mg tablet contains crospovidone. Each tablet of amoxicillin and clavulanate potassium contains 0.63 mEq potassium. • For Oral Suspension – Aspartame, colloidal silicon dioxide, hydroxypropyl methylcellulose, mannitol, orange flavoring, precipitated silicon dioxide, succinic acid, xanthan gum, and golden syrup flavoring (caramel). • Chewable Tablets – Aspartame, banana flavoring, cherry flavoring, colloidal silicon dioxide, FD&C Red No.

40, magnesium stearate, mannitol, and sodium starch glycolate [see Warnings and Precautions (5.6)]. ∘ Each 200 mg chewable tablet and each 5 mL of reconstituted 200 mg/5 mL oral suspension of amoxicillin and clavulanate potassium contains 0.14 mEq potassium ∘ Each 400 mg chewable tablet and each 5 mL of reconstituted 400 mg/5 mL oral suspension of amoxicillin and clavulanate potassium contains 0.29 mEq potassium

🔬 Clinical Studies ~3 min read ▾

14.1Lower Respiratory Tract and Complicated Urinary Tract Infections Data from 2 pivotal trials in 1,191 patients treated for either lower respiratory tract infections or complicated urinary tract infections compared a regimen of 875 mg tablets of amoxicillin and clavulanate potassium every 12 hours to 500 mg tablets of amoxicillin and clavulanate potassium dosed every 8 hours (584 and 607 patients, respectively). Comparable efficacy was demonstrated between the every 12 hours and every 8 hours dosing regimens. There was no significant difference in the percentage of adverse events in each group.

The most frequently reported adverse event was diarrhea; incidence rates were similar for the 875 mg every 12 hours and 500 mg every 8 hours dosing regimens (15% and 14%, respectively); however, there was a statistically significant difference (p < 0.05) in rates of severe diarrhea or withdrawals with diarrhea between the regimens: 1% for 875 mg every 12 hours regimen versus 2% for the 500 mg every 8 hours regimen. In one of these pivotal trials, patients with either pyelonephritis (n = 361) or a complicated urinary tract infection (i.e., patients with abnormalities of the urinary tract that predispose to relapse of bacteriuria following eradication, n = 268) were randomized (1:1) to receive either 875 mg tablets of amoxicillin and clavulanate potassium every 12 hours (n=308) or 500 mg tablets of amoxicillin and clavulanate potassium every 8 hours (n=321).

The number of bacteriologically evaluable patients was comparable between the two dosing regimens. Amoxicillin and clavulanate potassium produced comparable bacteriological success rates in patients assessed 2 to 4 days immediately following end of therapy. The bacteriologic efficacy rates were comparable at one of the follow-up visits (5 to 9 days post-therapy) and at a late post-therapy visit (in the majority of cases, this was 2 to 4 weeks post-therapy), as seen in Table 5.

Table 5: Bacteriologic efficacy rates for amoxicillin and clavulanate potassium Time Post Therapy 875 mg every 12 hours % (n) 500 mg every 8 hours % (n) 2 to 4 days 81% (58) 80% (54) 5 to 9 days 58% (41) 52% (52) 2 to 4 weeks 52% (101) 55% (104) As noted before, though there was no significant difference in the percentage of adverse events in each group, there was a statistically significant difference in rates of severe diarrhea or withdrawals with diarrhea between the regimens.

14.2Acute Bacterial Otitis Media and Diarrhea in Pediatric Patients One US/Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of amoxicillin and clavulanate potassium for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of amoxicillin and clavulanate potassium for 10 days in the treatment of acute otitis media. Only the suspension formulations were used in this trial. A total of 575 pediatric patients (aged 2 months to 12 years) were enrolled, with an even distribution among the 2 treatment groups and a comparable number of patients were evaluable (i.e., ≥ 84%) per treatment group.

Otitis media-specific criteria were required for eligibility and a strong correlation was found at the end of therapy and follow-up between these criteria and physician assessment of clinical response. The clinical efficacy rates at the end of therapy visit (defined as 2 to 4 days after the completion of therapy) and at the follow-up visit (defined as 22 to 28 days post-completion of therapy) were comparable for the 2 treatment groups, with the following cure rates obtained for the evaluable patients: At end of therapy, 87% (n = 265) and 82% (n = 260) for 45 mg/kg/day every 12 hours and 40 mg/kg/day every 8 hours, respectively.

At follow-up, 67% (n = 249) and 69% (n = 243) for 45 mg/kg/day every 12 hours and 40 mg/kg/day every 8 hours, respectively. Diarrhea was defined as either: (a) 3 or more watery or 4 or more loose/watery stools in 1 day; OR (b) 2 watery stools per day or 3 loose/watery stools per day… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 202 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. Amoxicillin and clavulanate potassium (4:1 ratio formulation of amoxicillin:clavulanate) was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. Amoxicillin and clavulanate potassium was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival.

Amoxicillin and clavulanate potassium was negative in the mouse micronucleus test, and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test, and was negative in each of these assays. Amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses of up to 1,200 mg/kg/day was found to have no effect on fertility and reproductive performance in rats.

Based on body surface area, this dose of amoxicillin is approximately 4 times the maximum recommended adult human oral dose (875 mg every 12 hours). For clavulanate, the dose multiple is approximately 9 times higher than the maximum recommended adult human oral dose (125 mg every 8 hours), also based on body surface area.

📚 References 29 words ▾

Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol. 1988; 30: 66-67.

📄 Package Label / Principal Display Panel 2 words ▾

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72189-281-14

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