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Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL Powder, For Suspension, 125 mL — NDC 82804-017-12 (Billing 82804-0017-12)

by Proficient Rx LP · 125 mL in 1 BOTTLE

This is a package of 125 mL of Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL Powder, For Suspension from Proficient Rx LP, marketed since Dec 2011 and currently FDA-listed. It is this product's only package size.

NDC 82804-0017-12
🏷️ FDA NDC (as labeled) 82804-017-12 billing pads the product segment with a zero
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 →

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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) 82804-017-12
Product NDC 82804-017
11-digit billing NDC 82804001712
NCPDP billing unit ML — per mL (volume)
RxCUI 617993
UNII 804826J2HU, Q42OMW3AT8
UPC 0382804017126
Application # ANDA201091
SPL Set ID e05caabb-b95c-4e54-890e-bbc371a20fc3
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 2011-12-20
Route ORAL
Dosage form POWDER, FOR SUSPENSION
Substance AMOXICILLIN; CLAVULANATE POTASSIUM
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 048449
GCN 28020
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 600-42.9 MG/5 ML SUS
FDB brand name Amoxicillin-Clavulanate Potass
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 048449
  • GCN: 28020
  • HICL (First Databank): 003962
  • AHFS class code: 08:12.16.08
  • RxCUI (RxNorm): 617993
Why two NDCs? The FDA registers this code as 82804-017-12 — 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 → 82804-0017-12. 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 600-42.9 MG/5 ML SUS Ingredient Amoxicillin/Potassium Clav
📖 What it is MedlinePlus · NLM

Amoxicillin and clavulanic acid is used to treat certain infections caused by bacteria, including infections of the ears, lungs, sinus, skin, and urinary tract. Amoxicillin is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of bacteria. Clavulanic acid is in a class of medications called beta-lactamase inhibitors. It works by stopping bacteria from breaking down amoxicillin. Antibiotics will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists a...

Read the full MedlinePlus article ↗
📗 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 mLPer 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 $0.1176 $14.70 / 125 ml
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
82804-0017-12 You're viewing this Main listing 125 mL in 1 BOTTLE 2023-10-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 00143-9853-16 Hikma 125 ml $0.063 AB Availability likely —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 00093-8675-74 Teva 200 ml $0.069 AB Availability likely —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 00781-6139-48 Sandoz 200 ml $0.069 AB Availability likely —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 65862-0535-02 Aurobindo 200 ml $0.069 AB Availability likely —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 16714-0294-01 NorthStar 75 ml $0.077 AB Availability likely —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 73043-0008-01 Devatis 75 ml $0.077 AB Availability likely —
Amoxicillin And Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 81964-0203-51 USAntibiotics, 75 ml $0.077 AB Availability likely —
Amoxicillin and clavulanate potassium 600 mg/5mL; 42.9 mg/5mL 42571-0395-46 Micro 75 ml — — Discontinued —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 50090-1857-00 A-S 125 ml — AB FDA listed —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 50090-2219-00 A-S 125 ml — AB FDA listed —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 63187-0857-12 Proficient 125 ml — AB FDA listed —
Amoxicillin And Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 67296-1921-07 Redpharm 75 ml — AB FDA listed —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 67296-2234-01 Redpharm 75 ml — AB FDA listed —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 68071-2355-05 NuCare 75 ml — AB FDA listed —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 68071-2852-05 NuCare 125 ml — AB FDA listed —
Amoxicillin And Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 68071-3774-05 NuCare 125 ml — AB FDA listed —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 68071-5144-05 NuCare 75 ml — AB FDA listed —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 68071-5207-05 NuCare 125 ml — AB FDA listed —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 68788-0483-01 Preferred 125 ml — AB FDA listed —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 68788-8157-01 Preferred 125 ml — AB FDA listed —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 68788-8299-01 Preferred 125 ml — AB FDA listed —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 68788-8770-01 Preferred 125 ml — AB FDA listed —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 71205-0036-12 Proficient 125 ml — AB FDA listed —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL 71205-0620-75 Proficient 75 ml — AB FDA listed —
Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mLthis 82804-0017-12 Proficient 125 ml — AB FDA listed —
Augmentin Es-600 600 mg/5mL; 42.9 mg/5mL 81964-0003-51 USAntibiotics, 75 ml — AB FDA listed —
amoxicillin and clavulanate potassium 600 mg/5mL; 42.9 mg/5mL 62135-0095-13 Chartwell 125 ml — 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

🏛️
2011
On the market since
Dec 2011
📍
2026
Currently FDA-listed
15 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.

Inactive Ingredients / Excipients

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

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

  • UNII Z0H242BBR1
    Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
  • UNII 1IVH67816N
    Hypromellose 2910 is a plant-derived cellulose compound used as a thickener and film-former in medicines. It helps control how quickly the medication dissolves and creates protective coatings on tablets or capsules.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 4J2TY8Y81V
    A natural flavoring derived from strawberries that gives the medicine its strawberry taste and smell. It helps make the medicine more pleasant to take, especially for children.
  • UNII AB6MNQ6J6L
    Succinic acid is an organic acid derived from natural sources or chemical synthesis. In medications, it functions as a buffer to help maintain the proper pH level and may also serve as a preservative or flavor enhancer in formulations.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerProficient Rx LP
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA201091 (ANDA)
Labeler code82804
First marketedDec 2011
Product typeHuman Prescription Drug
Portfolio1,729 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 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of pediatric patients with • Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains) characterized by the following risk factors: - Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology (12.4)] .

Limitations of Use Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and clavulanate potassium for oral suspension is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC greater than or equal to 4 mcg/mL. Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC less than or equal to 2 mcg/mL) and the β-lactamase-producing organisms listed above.

Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension 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.

Amoxicillin and clavulanate potassium for oral suspension is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor, indicated for the treatment of pediatric patients with • Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-lactamase-‑producing strains) characterized by the following risk factors ( 1 ) : - Antibacterial exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) daycare attendance Limitations of Use Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin.

Amoxicillin and clavulanate potassium for oral suspension is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC greater than or equal to 4 mcg/mL. Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC less than or equal to 2 mcg/mL) and the β-lactamase-producing organisms listed above. ( 1 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, Amoxicillin and clavulanate potassium for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Pediatric Patients less than 40 kg: 90 mg/kg/day divided every 12 hours, administered for 10 days. ( 2 )

2.1Important Administration Instructions To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal.

2.2Dosage in Pediatric Patients Pediatric patients 3 months and older: Based on the amoxicillin component (600 mg/5 mL), the recommended dose of amoxicillin and clavulanate potassium for oral suspension is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below). This dose provides 6.4 mg/kg/day of the clavulanic acid component. Body Weight (kg) Volume of Amoxicillin and Clavulanate Potassium for Oral Suspension providing 90 mg/kg/day 8 3 mL twice daily 12 4.5 mL twice daily 16 6 mL twice daily 20 7.5 mL twice daily 24 9 mL twice daily 28 10.5 mL twice daily 32 12 mL twice daily 36 13.5 mL twice daily Pediatric patients weighing 40 kg and more: Experience with amoxicillin and clavulanate potassium for oral suspension in this group is not available.

2.3Dosage in Adult Patients Experience with amoxicillin and clavulanate potassium for oral suspension in adults is not available and adults who have difficulty swallowing should not be given amoxicillin and clavulanate potassium for oral suspension in place of the 500 mg or 875 mg tablet of amoxicillin and clavulanate potassium.

2.4Dosage in Patients with Hepatic Impairment Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals [see Warnings and Precautions (5) ].

2.5Preparation of the Oral Suspension Directions for Mixing Oral Suspension: Prepare a suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Measure the total amount of water (see chart below) to be added in two parts. Add approximately 2/3 of the total amount of water for reconstitution, replace cap and shake vigorously to suspend powder.

Add remainder of the water (that had been measured), replace cap and again shake vigorously. Amoxicillin and Clavulanate Potassium for Oral Suspension Bottle Size Amount of Water Required for Reconstitution 75 mL 71 mL 125 mL 112 mL 200 mL 176 mL Each teaspoonful (5 mL) will contain 600 mg of amoxicillin as the trihydrate, and 42.9 mg of clavulanic acid as the potassium salt. Shake oral suspension well before each use.

Suspension must be refrigerated. Discard after 10 days. Suspension is white to off-white at time of reconstitution; some color change is normal during the dosing period.

Flavoring Information : For patients who wish to alter the taste of amoxicillin and clavulanate potassium for oral suspension, immediately after reconstitution 1 drop of FLAVORx™ (apple, banana cream, bubble gum, cherry, or watermelon flavor) may be added for every 5 mL of amoxicillin and clavulanate potassium for oral suspension. The resulting suspension is stable for 10 days under refrigeration. Stability of amoxicillin and clavulanate potassium for oral suspension when mixed with other flavors distributed by FLAVORx has not been evaluated for flavors other than the 5 flavors listed above.

2.6Switching between Dosage Forms and between Strengths Amoxicillin and clavulanate potassium for oral suspension does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of amoxicillin and clavulanate potassium. Amoxicillin and clavulanate potassium for oral suspension contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/28.5 mg per 5 mL suspension of amoxicillin and clavulanate potassium contains 28.5 mg clavulanic acid per 5 mL and the 400 mg/57 mg per 5 mL suspension of amoxicillin and clavulanate potassium contains 57 mg clavulanic acid per 5 mL.

Therefore,… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 62 words ▾

3 DOSAGE FORMS AND STRENGTHS Amoxicillin and Clavulanate Potassium for Oral Suspension, USP: • 600 mg/42.9 mg per 5 mL: Strawberry-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 600 mg of amoxicillin USP as the trihydrate, and 42.9 mg of clavulanic acid as the potassium salt). For oral suspension: 600 mg/42.9 mg per 5 mL. ( 3 )

⛔ Contraindications 122 words ▾

4 CONTRAINDICATIONS • History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin and clavulanate potassium for oral suspension or any other beta-lactams (e.g., penicillins or cephalosporins). ( 4.1 ) • History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium for oral suspension. ( 4.2 )

4.1Serious Hypersensitivity Reactions Amoxicillin and clavulanate potassium for oral suspension are 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 for oral suspension is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with treatment with amoxicillin and clavulanate potassium.

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Serious (including fatal) hypersensitivity reactions: Discontinue amoxicillin and clavulanate potassium for oral suspension if a reaction occurs. ( 5.1 ) • Severe Cutaneous Adverse Reactions (SCAR): Monitor closely. Discontinue if rash progresses.

( 5.2 ) • Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment ( 5.3 ) • Clostridioides difficile- associated diarrhea (CDAD) (ranging from mild diarrhea to fatal colitis): Evaluate patients if diarrhea occurs. ( 5.4 ) • Patients with mononucleosis who receive amoxicillin and clavulanate potassium for oral suspension develop skin rash.

Avoid amoxicillin and clavulanate potassium for oral suspension use in these patients. ( 5.5 )

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

If an allergic reaction occurs, discontinue amoxicillin and clavulanate potassium for oral suspension and institute appropriate therapy.

5.2Severe Cutaneous Adverse Reactions Amoxicillin and clavulanate potassium for oral suspension may cause severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If patients develop a skin rash, they should be monitored closely, and amoxicillin and clavulanate potassium for oral suspension discontinued if lesions progress.

5.3Hepatic Dysfunction Use amoxicillin and clavulanate potassium for oral suspension with caution in patients with evidence of hepatic dysfunction. Hepatic toxicity associated with the use of amoxicillin clavulanate potassium for oral suspension is usually reversible. Deaths have been reported (fewer than one death reported per estimated four million prescriptions worldwide).

These have generally been cases associated with serious underlying diseases or concomitant medications [see Contraindications (4.2) and Adverse Reactions (6.2) ].

5.4Clostridioides difficile -Associated Diarrhea (CDAD) Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin and clavulanate potassium for oral suspension, 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 drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial drug 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.

5.5Skin Rash in Patients with Mononucleosis A high percentage of patients with mononucleosis who receive amoxicillin develop… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling [see Warnings and Precautions (5) ] : • Anaphylactic reactions [see Warnings and Precautions (5.1) ] • Severe Cutaneous Adverse Reactions (SCAR) [see Warnings and Precautions (5.2) ] • Hepatic Dysfunction [see Warnings and Precautions (5.3) ] • Clostridioides difficile- Associated Diarrhea (CDAD) [see Warnings and Precautions (5.4) ] The most frequently reported adverse reactions were diaper rash (4%), diarrhea (3%), vomiting (2%), candidiasis (1%), and rash (1%).

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Two clinical trials evaluated the safety of a 10-day treatment course of amoxicillin and clavulanate potassium for oral suspension 90/6.4 mg/kg/day, divided every 12 hours, in pediatric patients with acute otitis media [see Clinical Studies (14)] .

The first trial involved 521 pediatric patients (3 months to 50 months) and the second trial involved 450 pediatric patients (3 months to 12 years). In the intent-to-treat population of the first trial of 521 patients, the most frequently reported adverse events were vomiting (7%), fever (6%), contact dermatitis (i.e., diaper rash) (6%), upper respiratory tract infection (4%), and diarrhea (4%). Protocol-defined diarrhea (i.e., 3 or more watery stools in one day or 2 watery stools per day for 2 consecutive days as recorded on diary cards) occurred in 13% of patients.

The primary objective of the second study was to compare the safety of amoxicillin and clavulanate potassium for oral suspension (90/6.4 mg/kg/day, divided every 12 hours) to amoxicillin and clavulanate potassium (45/6.4 mg/kg/day, divided every 12 hours) for ten days. There was no statistically significant difference between treatments in the proportion of patients with 1 or more adverse events. The most frequently reported adverse reactions for amoxicillin and clavulanate potassium for oral suspension and the comparator of amoxicillin and clavulanate potassium were coughing (12% versus 7%), vomiting (7% versus 8%), contact dermatitis (i.e., diaper rash, 6% versus 5%), fever (6% versus 4%), and upper respiratory infection (3% versus 9%), respectively.

The frequencies of protocol-defined diarrhea with amoxicillin and clavulanate potassium for oral suspension (11%) and amoxicillin and clavulanate potassium (9%) were not statistically different. Two patients in the group treated with amoxicillin and clavulanate potassium for oral suspension and one patient in the group treated with amoxicillin and clavulanate potassium were withdrawn due to diarrhea.

6.2Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing use of amoxicillin and clavulanate potassium products, including amoxicillin and clavulanate potassium for oral suspension. 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: Diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions (5) ]. Immune: Hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock), angioedema, serum si… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS • Co-administration with probenecid is not recommended. ( 7.1 ) • Concomitant use of amoxicillin and clavulanate potassium for oral suspension with oral anticoagulants may increase the prolongation of prothrombin time. ( 7.2 ) • Co-administration with allopurinol increases the risk of rash. ( 7.3 ) • Amoxicillin and clavulanate potassium for oral suspension may reduce efficacy of oral contraceptives. ( 7.4 )

7.1Probenecid Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin and clavulanate potassium for oral suspension may result in increased and prolonged blood levels 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. 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 substantially 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. There are no data with amoxicillin and clavulanate potassium for oral suspension and allopurinol administered concurrently.

7.4Oral Contraceptives Amoxicillin and clavulanate potassium for oral suspension 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 for oral suspension, 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 USE IN SPECIFIC POPULATIONS • Pediatric 3 months to 12 years old: Modify dose according to weight. ( 2.2 , 8.4 ) • Adults and pediatric patients weighing more than 40 kg: The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension has not been established. ( 8 )

8.1Pregnancy Pregnancy Category B. There are 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.

Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral dosages up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate potassium. The amoxicillin doses in rodents (based on body surface area and assuming a 20 kg child) were approximately 2 times (rats) or equal to (mice) the recommended clinical amoxicillin and clavulanate potassium for oral suspension dose of 90/6.4 mg/kg/day.

For clavulanate, these dose multiples were approximately 15 times and 7.5 times the recommended daily dose of amoxicillin and clavulanate potassium for oral suspension.

8.2Labor and Delivery Oral ampicillin-class antibacterial drugs are generally poorly absorbed during labor. Studies in guinea pigs have shown that intravenous administration of ampicillin decreased the uterine tone, frequency of contractions, height of contractions, and duration of contractions. However, it is not known whether the use of amoxicillin and 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 that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.

In a single study in women with premature rupture of fetal membranes, it was reported that prophylactic treatment with amoxicillin and clavulanate potassium may be associated with an increased risk of necrotizing enterocolitis in neonates.

8.3Nursing Mothers Ampicillin-class antibacterial drugs are excreted in human milk; therefore, caution should be exercised when amoxicillin and clavulanate potassium is administered to a nursing woman.

8.4Pediatric Use Safety and efficacy of amoxicillin and clavulanate potassium for oral suspension in infants younger than 3 months have not been established. Safety and efficacy of amoxicillin and clavulanate potassium for oral suspension have been demonstrated for treatment of acute otitis media in infants and children 3 months to 12 years [see Clinical Studies (14) ]. The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension have been established for the treatment of pediatric patients (3 months to 12 years) with acute bacterial sinusitis.

This use is supported by evidence from adequate and well-controlled studies of amoxicillin and clavulanate potassium extended-release tablets in adults with acute bacterial sinusitis, studies of amoxicillin and clavulanate potassium for oral suspension in pediatric patients with acute otitis media, and by similar pharmacokinetics of amoxicillin and clavulanate in pediatric patients taking amoxicillin and clavulanate potassium for oral suspension [see Clinical Pharmacology (12) ] and adults taking amoxicillin and clavulanate potassium extended-release tablets.

🤰 Pregnancy 139 words ▾

8.1Pregnancy Pregnancy Category B. There are 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.

Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral dosages up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate potassium. The amoxicillin doses in rodents (based on body surface area and assuming a 20 kg child) were approximately 2 times (rats) or equal to (mice) the recommended clinical amoxicillin and clavulanate potassium for oral suspension dose of 90/6.4 mg/kg/day.

For clavulanate, these dose multiples were approximately 15 times and 7.5 times the recommended daily dose of amoxicillin and clavulanate potassium for oral suspension.

🧒 Pediatric Use 161 words ▾

8.4Pediatric Use Safety and efficacy of amoxicillin and clavulanate potassium for oral suspension in infants younger than 3 months have not been established. Safety and efficacy of amoxicillin and clavulanate potassium for oral suspension have been demonstrated for treatment of acute otitis media in infants and children 3 months to 12 years [see Clinical Studies (14) ]. The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension have been established for the treatment of pediatric patients (3 months to 12 years) with acute bacterial sinusitis.

This use is supported by evidence from adequate and well-controlled studies of amoxicillin and clavulanate potassium extended-release tablets in adults with acute bacterial sinusitis, studies of amoxicillin and clavulanate potassium for oral suspension in pediatric patients with acute otitis media, and by similar pharmacokinetics of amoxicillin and clavulanate in pediatric patients taking amoxicillin and clavulanate potassium for oral suspension [see Clinical Pharmacology (12) ] and adults taking amoxicillin and clavulanate potassium extended-release tablets.

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE Following overdosage, patients have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness have also been observed in a small number of patients. In case of overdosage, discontinue amoxicillin and clavulanate potassium for oral suspension, 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 levels may occur more readily in patients with impaired renal function because of decreased renal clearance of both amoxicillin and clavulanate. Both amoxicillin and clavulanate are removed from the circulation by hemodialysis [see Dosage and Administration (2) ].

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Amoxicillin and clavulanate potassium for oral suspension is an antibacterial drug [see Microbiology (12.4) ].

12.3Pharmacokinetics The pharmacokinetics of amoxicillin and clavulanate were determined in a study of 19 pediatric patients, 8 months to 11 years, given amoxicillin and clavulanate potassium for oral suspension at an amoxicillin dose of 45 mg/kg q12h with a snack or meal. The mean plasma amoxicillin and clavulanate pharmacokinetic parameter values are listed in the following table. Table 1.

Mean (±SD) Plasma Amoxicillin and Clavulanate Pharmacokinetic Parameter Values Following Administration of 45 mg/kg of Amoxicillin and Clavulanate Potassium for Oral Suspension Every 12 Hours to Pediatric Patients PARAMETER AMOXICILLIN CLAVULANATE C max (mcg/mL) 15.7 ± 7.7 1.7 ±

0.9T max (hr) 2 (1 to 4) 1.1 (1 to 4) AUC 0-T (mcg*hr/mL) 59.8 ± 20 4 ±

1.9T½(hr) 1.4 ± 0.3 1.1 ±

0.3CL/F (L/hr/kg) 0.9 ± 0.4 1.1 ± 1.1 * Arithmetic mean ± standard deviation, except T max values which are medians (ranges). The effect of food on the oral absorption of amoxicillin and clavulanate potassium for oral suspension has not been studied. Approximately 50% to 70% of the amoxicillin and approximately 25% to 40% of the clavulanic acid are excreted unchanged in urine during the first 6 hours after administration of 10 mL of 250 mg/5 mL suspension of amoxicillin and clavulanate potassium.

Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid. Neither component in amoxicillin and clavulanate potassium for oral suspension is highly protein-bound; clavulanic acid has been found to be approximately 25% bound to human serum and amoxicillin approximately 18% bound. Oral administration of a single dose of amoxicillin and clavulanate potassium for oral suspension at 45 mg/kg (based on the amoxicillin component) to pediatric patients, 9 months to 8 years, yielded the following pharmacokinetic data for amoxicillin in plasma and middle ear fluid (MEF): Table 2.

Amoxicillin Concentrations in Plasma and Middle Ear Fluid Following Administration of 45 mg/kg of Amoxicillin and Clavulanate Potassium for Oral Suspension to Pediatric Patients Timepoint Amoxicillin concentration in plasma (mcg/mL) Amoxicillin concentration in MEF (mcg/mL) 1 hour mean median range 7.7 9.3 1.5 to 14 (n equals 5) 3.2 3.5 0.2 to 5.5 (n equals 4) 2 hour mean median range 15.7 13 11 to 25 (n equals 7) 3.3 2.4 1.9 to 6 (n equals 5) 3 hour mean median range 13 12 5.5 to 21 (n equals 5) 5.8 6.5 3.9 to 7.4 (n equals 5) Dose administered immediately prior to eating.

Amoxicillin diffuses readily into most body tissues and fluids, with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, like amoxicillin, is well distributed in body tissues.

12.4Microbiology Amoxicillin is a semisynthetic antibacterial with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Amoxicillin is, however, susceptible to degradation by β-lactamases, and therefore, its spectrum of activity does not include organisms which produce these enzymes. Clavulanic acid is a β-lactam, structurally related to penicillin, which possesses the ability to inactivate a wide range of β-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins.

In particular, it has good activity against the clinically important plasmid-mediated β-lactamases frequently found responsible for transferred drug resistance. The clavulanic acid component of amoxicillin and clavulanate potassium for oral suspension protects amoxicillin from degradation by β-lactamase enzymes and effectively extends the antibacterial spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and other β-lactam antibacterials. Thus, amoxicillin and… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 19 words ▾

12.1Mechanism of Action Amoxicillin and clavulanate potassium for oral suspension is an antibacterial drug [see Microbiology (12.4) ].

📦 How Supplied / Storage and Handling 100 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Amoxicillin and Clavulanate Potassium for Oral Suspension, USP: 600 mg/42.9 mg per 5 mL: Strawberry-flavored powder for oral suspension. Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin USP as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt (equivalent to 51.1 mg of clavulanate potassium). Bottles of 125 mL NDC 82804-017-12 Storage Store dry powder for oral suspension 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.

📋 Description ~1 min read ▾

11 DESCRIPTION Amoxicillin and clavulanate potassium for oral suspension, USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the β-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 C 16 H 19 N 3 O 5 S•3H 2 O, and the molecular weight is 419.46.

Chemically, amoxicillin is (2 S ,5 R ,6 R )-6-[ (R )-(-)-2-Amino-2-( p ‑-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as: Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus . It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β - lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins.

The clavulanate potassium molecular formula is C 8 H 8 KNO 5 and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z )-(2 R ,5 R )-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2‑carboxylate and may be represented structurally as: Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin USP as the trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Amoxicillin and clavulanate potassium for oral suspension, USP is white to off-white granular powder and becomes white to pale yellow suspension with strawberry flavor after reconstitution.

Inactive Ingredients: —Aspartame, colloidal silicon dioxide, hypromellose, silicon dioxide, strawberry cream permaseal, succinic acid, and xanthan gum [see Warnings and Precautions (5.7) ]. Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg per 5 mL contains 0.21 mEq potassium. Amoxicillin chemical structure clavulanate potassium chemical structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Administration Instructions Inform patients to take amoxicillin and clavulanate potassium for oral suspension every 12 hours with a meal or snack to reduce the possibility of gastrointestinal upset. If diarrhea develops and is severe or lasts more than 2 or 3 days, call your doctor. Allergic Reactions Counsel patients that amoxicillin and clavulanate potassium for oral suspension contains a penicillin class drug product that can cause allergic reactions in some individuals.

Severe Cutaneous Adverse Reactions (SCAR ) Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking amoxicillin and clavulanate potassium for oral suspension 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)]. Diarrhea Counsel patients that diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial is discontinued.

Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible. Antibacterial Resistance Patients should be counseled that antibacterial drugs, including amoxicillin and clavulanate potassium for oral suspension, should only be used to treat bacterial infections.

Antibacterial drugs do not treat viral infections (e.g., the common cold). When amoxicillin and clavulanate potassium for oral suspension 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 amoxicillin and clavulanate potassium for oral suspension or other antibacterial drugs in the future.

Storage Instructions Keep suspension refrigerated. Shake well before using. When dosing a child with the suspension (liquid) of amoxicillin and clavulanate potassium for oral suspension, use a dosing spoon or medicine dropper.

Be sure to rinse the spoon or dropper after each use. Bottles of suspension of amoxicillin and clavulanate potassium for oral suspension may contain more liquid than required. Follow your doctor’s instructions about the amount to use and the days of treatment your child requires.

Discard any unused medicine. Phenylketonuria Counsel patients with phenylketonuria: Each 5 mL of suspension of amoxicillin and clavulanate potassium contains 7.02 mg phenylalanine. The brands listed are trademarks of their respective owners and are not trademarks of the Aurobindo Pharma Limited.

Manufactured for: Northstar Rx LLC Memphis, TN 38141. Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India. Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 M.L.No.: 57/RR/AP/2003/F/R Revised: 12/2022

🍼 Nursing Mothers 27 words ▾

8.3Nursing Mothers Ampicillin-class antibacterial drugs are excreted in human milk; therefore, caution should be exercised when amoxicillin and clavulanate potassium is administered to a nursing woman.

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics The pharmacokinetics of amoxicillin and clavulanate were determined in a study of 19 pediatric patients, 8 months to 11 years, given amoxicillin and clavulanate potassium for oral suspension at an amoxicillin dose of 45 mg/kg q12h with a snack or meal. The mean plasma amoxicillin and clavulanate pharmacokinetic parameter values are listed in the following table. Table 1.

Mean (±SD) Plasma Amoxicillin and Clavulanate Pharmacokinetic Parameter Values Following Administration of 45 mg/kg of Amoxicillin and Clavulanate Potassium for Oral Suspension Every 12 Hours to Pediatric Patients PARAMETER AMOXICILLIN CLAVULANATE C max (mcg/mL) 15.7 ± 7.7 1.7 ±

0.9T max (hr) 2 (1 to 4) 1.1 (1 to 4) AUC 0-T (mcg*hr/mL) 59.8 ± 20 4 ±

1.9T½(hr) 1.4 ± 0.3 1.1 ±

0.3CL/F (L/hr/kg) 0.9 ± 0.4 1.1 ± 1.1 * Arithmetic mean ± standard deviation, except T max values which are medians (ranges). The effect of food on the oral absorption of amoxicillin and clavulanate potassium for oral suspension has not been studied. Approximately 50% to 70% of the amoxicillin and approximately 25% to 40% of the clavulanic acid are excreted unchanged in urine during the first 6 hours after administration of 10 mL of 250 mg/5 mL suspension of amoxicillin and clavulanate potassium.

Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid. Neither component in amoxicillin and clavulanate potassium for oral suspension is highly protein-bound; clavulanic acid has been found to be approximately 25% bound to human serum and amoxicillin approximately 18% bound. Oral administration of a single dose of amoxicillin and clavulanate potassium for oral suspension at 45 mg/kg (based on the amoxicillin component) to pediatric patients, 9 months to 8 years, yielded the following pharmacokinetic data for amoxicillin in plasma and middle ear fluid (MEF): Table 2.

Amoxicillin Concentrations in Plasma and Middle Ear Fluid Following Administration of 45 mg/kg of Amoxicillin and Clavulanate Potassium for Oral Suspension to Pediatric Patients Timepoint Amoxicillin concentration in plasma (mcg/mL) Amoxicillin concentration in MEF (mcg/mL) 1 hour mean median range 7.7 9.3 1.5 to 14 (n equals 5) 3.2 3.5 0.2 to 5.5 (n equals 4) 2 hour mean median range 15.7 13 11 to 25 (n equals 7) 3.3 2.4 1.9 to 6 (n equals 5) 3 hour mean median range 13 12 5.5 to 21 (n equals 5) 5.8 6.5 3.9 to 7.4 (n equals 5) Dose administered immediately prior to eating.

Amoxicillin diffuses readily into most body tissues and fluids, with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, like amoxicillin, is well distributed in body tissues.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Two clinical studies were conducted in pediatric patients with acute otitis media. A non-comparative, open-label study assessed the bacteriologic and clinical efficacy of amoxicillin and clavulanate potassium for oral suspension (90/6.4 mg/kg/day, divided every 12 hours) for 10 days in 521 pediatric patients (3 to 50 months) with acute otitis media. The primary objective was to assess bacteriological response in children with acute otitis media due to S. pneumoniae with amoxicillin/clavulanic acid MICs of 4 mcg/mL.

The study sought the enrollment of patients with the following risk factors: Failure of antibacterial therapy for acute otitis media in the previous 3 months, history of recurrent episodes of acute otitis media, 2 years or younger, or daycare attendance. Prior to receiving amoxicillin and clavulanate potassium for oral suspension, all patients had tympanocentesis to obtain middle ear fluid for bacteriological evaluation. Patients from whom S. pneumoniae (alone or in combination with other bacteria) was isolated had a second tympanocentesis 4 to 6 days after the start of therapy.

Clinical assessments were planned for all patients during treatment (4 to 6 days after starting therapy), as well as 2 to 4 days post-treatment and 15 to 18 days post-treatment. Bacteriological success was defined as the absence of the pretreatment pathogen from the on-therapy tympanocentesis specimen. Clinical success was defined as improvement or resolution of signs and symptoms.

Clinical failure was defined as lack of improvement or worsening of signs and/or symptoms at any time following at least 72 hours of amoxicillin and clavulanate potassium for oral suspension; patients who received an additional systemic antibacterial drug for otitis media after 3 days of therapy were considered clinical failures. Bacteriological eradication on therapy (day 4 to 6 visit) in the per protocol population is summarized in the following table: Table 1. Bacteriologic Eradication Rates in the Per Protocol Population * CI equals confidence intervals; 95% CIs are not adjusted for multiple comparisons.

Pathogen Bacteriologic Eradication on Therapy n/N % 95% CI* All S. pneumoniae 121/123 98 (94.3, 99.8) S. pneumoniae with penicillin MIC equal to 2 mcg/mL 19/19 100 (82.4, 100) S. pneumoniae with penicillin MIC equal to 4 mcg/mL 12/14 86 (57.2, 98.2) H. influenzae 75/81 93 (84.6, 97.2) M. catarrhalis 11/11 100 (71.5, 100) Clinical assessments were made in the per protocol population 2 to 4 days post-therapy and 15 to 18 days post-therapy. Patients who responded to therapy 2 to 4 days post-therapy were followed for 15 to 18 days post-therapy to assess them for acute otitis media.

Non-responders at 2 to 4 days post-therapy were considered failures at the latter timepoint. Table 4. Clinical Assessments in the Per Protocol Population (Includes S. pneumoniae Patients with Penicillin MICs equal to 2 or 4 mcg/mL*) Pathogen 2 to 4 Days Post-Therapy (Primary Endpoint) 95% CI† n/N % All S. pneumoniae 122/137 89 (82.6, 93.7) S. pneumoniae with penicillin MIC equal to 2 mcg/mL 17/20 85 (62.1, 96.8) S. pneumoniae with penicillin MIC equal to 4 mcg/mL 11/14 79 (49.2, 95.3) H. influenzae 141/162 87 (80.9, 91.8) M. catarrhalis 22/26 85 (65.1, 95.6) Pathogen 15 to 18 Days Post-Therapy ‡ (Secondary Endpoint) 95% CI† n/N % All S. pneumoniae 95/136 70 (61.4, 77.4) S. pneumoniae with penicillin MIC equal to 2 mcg/mL 11/20 55 (31.5, 76.9) S. pneumoniae with penicillin MIC equal to 4 mcg/mL 5/14 36 (12.8, 64.9) H. influenzae 106/156 68 (60, 75.2) M . catarrhalis 14/25 56 (34.9, 75.6) * S. pneumoniae strains with penicillin MICs of 2 or 4 mcg/mL are considered resistant to penicillin. † CI equals confidence intervals; 95% CIs are not adjusted for multiple comparisons. ‡ Clinical assessments at 15 to 18 days post-therapy may have been confounded by viral infections and new episodes of acute otitis media with time elapsed post-treatment.

In the intent-to-treat analys… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 205 words ▾

13 NONCLINICAL TOXICOLOGY

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 concentrations 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 (assuming a 20 kg child), this dose of amoxicillin is approximately 2 times the recommended clinical amoxicillin and clavulanate potassium for oral suspension dose of 90/6.4 mg/kg/day. For clavulanate, the dose multiple is approximately 15 times higher than the recommended clinical daily dose, also based on body surface area.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 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 concentrations 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 (assuming a 20 kg child), this dose of amoxicillin is approximately 2 times the recommended clinical amoxicillin and clavulanate potassium for oral suspension dose of 90/6.4 mg/kg/day. For clavulanate, the dose multiple is approximately 15 times higher than the recommended clinical daily dose, also based on body surface area.

📚 References 30 words ▾

15 REFERENCES 1. 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.

📄 Recent Major Changes 7 words ▾

Warnings and Precautions ( 5 ) 6/2022

📄 Package Label / Principal Display Panel 37 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/42.9 mg per 5 mL (125 mL Bottle) Rx only NDC 82804-017-12 Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 600 mg/42.9 mg* per 5 mL 125 mL when reconstituted 82804-017-12

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

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 82804-0015-30 · Proficient 82804-0018-10 · Proficient →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.