Amoxicillin and Clavulanate Potassium 875 mg; 125 mg Tablet, Film Coated, 100-count
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
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 ↗- This antibiotic is used for a range of common bacterial infections — ear infections, sinus infections, lower respiratory tract infections, skin infections, and urinary tract infect...
- What infections does amoxicillin/clavulanate actually treat?
- Taking it at the start of a meal is the best approach. Food doesn't affect amoxicillin much, but it does meaningfully improve how much clavulanate your body absorbs. More important...
- Should I take this with food or on an empty stomach?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 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 68401960MK
Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
-
UNII 7Z8S9VYZ4B
Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
-
UNII 288VBX44JC
Hypromellose is a plant-based cellulose derivative that acts as a binder and film-coating agent in medications. It helps hold tablet ingredients together and creates a smooth, protective coating on pills.
-
UNII R75537T0T4
Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII 4R4HFI6D95
Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
-
UNII 30IQX730WE
Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
-
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 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
-
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
11 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.286 | $28.56 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.8416 | $84.16 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.0932 | $9.32 / 100 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 00093-2275-34 | Teva | 20 tablets | $0.286 | AB | Availability likely | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 00143-9249-20 | Hikma | 20 tablets | $0.286 | AB | Availability likely | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 00781-1852-01 | Sandoz | 100 tablets | $0.286 | AB | Availability likely | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 16714-0297-01 | NorthStar | 20 tablets | $0.286 | AB | Availability likely | — |
| Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 42571-0162-01 | Micro | 100 tablets | $0.286 | AB | Availability likely | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 60687-0803-01 | American | 1 tablet | $0.286 | AB | Availability likely | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mgthis 65862-0503-01 | Aurobindo | 100 tablets | $0.286 | AB | Availability likely | — |
| Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 81964-0221-14 | USAntibiotics, | 20 tablets | $0.286 | AB | Availability likely | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 16714-0014-01 | Northstar | 20 tablets | $0.340 | AB | Discontinued | +19% |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 43063-0077-03 | PD-Rx | 3 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 43063-0377-02 | PD-Rx | 2 tablets | — | AB | FDA listed | — |
| Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 45865-0227-20 | Medsource | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 50090-0822-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 50090-1809-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 50090-3179-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 50090-4413-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 50090-6324-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 50090-7003-00 | A-S | 14 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 50090-7415-00 | A-S | 14 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 55289-0767-10 | PD-Rx | 10 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 63187-0014-14 | Proficient | 14 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 63187-0327-20 | Proficient | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 63187-0488-14 | Proficient | 14 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 63629-4541-01 | Bryant | 14 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 63629-5847-01 | Bryant | 6 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 67046-0955-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-2982-02 | NuCare | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 68071-3402-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-3822-03 | NuCare | 3 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-3842-02 | NuCare | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-3860-02 | NuCare | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-3864-04 | NuCare | 14 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-3866-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 68071-4224-02 | NuCare | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 68071-4549-03 | NuCare | 3 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-4586-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-4967-02 | NuCare | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-5026-04 | NuCare | 14 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-5057-03 | NuCare | 3 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-5065-03 | NuCare | 3 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-5295-03 | NuCare | 3 tablets | — | AB | FDA listed | — |
| Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 68788-7531-02 | Preferred | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 68788-8307-02 | Preferred | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68788-8836-02 | Preferred | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 70518-2225-00 | REMEDYREPACK | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 70518-2263-03 | REMEDYREPACK | 1 tablet | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 70518-3604-00 | REMEDYREPACK | 1 tablet | — | AB | Discontinued | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 70518-3624-00 | REMEDYREPACK | 1 tablet | — | AB | Discontinued | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 70518-3676-00 | REMEDYREPACK | 1 tablet | — | AB | Discontinued | — |
| Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 70518-3967-00 | REMEDYREPACK | 28 tablets | — | AB | Discontinued | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 70518-4148-00 | REMEDYREPACK | 100 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 70518-4424-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 71205-0331-14 | Proficient | 14 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 71205-0651-10 | Proficient | 10 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 71205-0712-10 | Proficient | 10 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 71335-2787-01 | Bryant | 10 tablets | — | AB | FDA listed | — |
| Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 71335-2917-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 71335-3138-01 | Bryant | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 72162-2211-02 | Bryant | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 72162-2434-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 72789-0147-03 | PD-Rx | 3 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 72789-0253-20 | PD-Rx | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 72789-0421-14 | PD-Rx | 14 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 72789-0456-14 | PD-Rx | 14 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 72789-0459-14 | PD-Rx | 14 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 73043-0006-20 | Devatis, | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 76420-0005-20 | Asclemed | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 76420-0501-20 | Asclemed | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 76420-0529-20 | Asclemed | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 76420-0607-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 125 mg/1; 875 mg 80425-0180-01 | Advanced | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 80425-0279-01 | Advanced | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 81964-0575-83 | USAntibiotics, | 180 tablets | — | AB | FDA listed | — |
| Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 82804-0060-20 | Proficient | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 82804-0177-14 | Proficient | 14 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 82804-0201-20 | Proficient | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 82868-0002-10 | Northwind | 10 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 82868-0067-14 | Northwind | 14 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 85766-0019-01 | Sportpharm | 100 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 85766-0078-01 | Sportpharm | 100 tablets | — | AB | FDA listed | — |
| Amoxicillin And Clavulanate Potassium 875 mg/1; 125 mg 85766-0171-14 | Sportpharm | 14 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68071-2751-02 | NuCare | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 68788-4158-02 | Preferred | 20 tablets | — | AB | FDA listed | — |
| amoxicillin and clavulanate potassium 875 mg/1; 125 mg 62135-0092-20 | Chartwell | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 72789-0585-28 | PD-Rx | 28 tablets | — | AB | FDA listed | — |
| Amoxicillin and Clavulanate Potassium 875 mg/1; 125 mg 85766-0268-01 | Sportpharm | 1 tablet | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 65862-0503-01 You're viewing this | 100 TABLET, FILM COATED in 1 BOTTLE (65862-503-01) | $0.2856 / ea | $28.56 | 2012-01-20 | Active |
| 65862-0503-20 | 20 TABLET, FILM COATED in 1 BOTTLE (65862-503-20) | $0.2856 / ea | $5.71 | 2012-01-20 | Active |
| 65862-0503-82 | 800 TABLET, FILM COATED in 1 BAG (65862-503-82) | — | — | — | Active |
You're viewing one of 3 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.2856 NADAC).
This pack accounts for about 11% of this product's recent Medicaid fills; most go to the 20 tablets pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 65862-0503-01?
What is the difference between NDC 65862-0503-01 and NDC 65862-0503-20?
What NDC number is used to bill for this package of Amoxicillin and Clavulanate Potassium 875 mg; 125 mg Tablet, Film Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Amoxicillin and clavulanate potassium tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: Lower Respiratory Tract Infections - caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis . Acute Bacterial Otitis Media - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis . Sinusitis - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis .
Skin and Skin Structure Infections - caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species . Urinary Tract Infections - caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species , and Enterobacter species. Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used.
Usage To reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets 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 tablets are a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: ( 1 ) Lower respiratory tract infections Acute bacterial otitis media Sinusitis Skin and skin structure infections Urinary tract infections Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used.
( 1 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Adults and Pediatric Patients greater than 40 kg: 500 mg/125 mg or 875 mg/125 mg every 12 hours or 250 mg/125 mg or 500 mg/125 mg every 8 hours, based on amoxicillin component. ( 2.2 , 2.3 ) Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose. ( 2.3 ) Neonates and infants less than 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component.
Use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended. ( 2.3 )
2.1Important Administration Instructions Amoxicillin and clavulanate potassium tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets should be taken at the start of a meal.
2.2Adult Patients See dosing regimens of amoxicillin and clavulanate potassium tablets (based on the amoxicillin component) provided in Table 1 below. Table 1. Dosing Regimens of Amoxicillin and Clavulanate Potassium Tablets in Adult Patients TYPE OF INFECTION DOSING REGIMEN OF AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS Severe infections and infections of the respiratory tract one 875 mg/125 mg tablet a of amoxicillin and clavulanate potassium tablets every 12 hours or one 500 mg/125 mg tablet b,c of amoxicillin and clavulanate potassium tablets every 8 hours Less severe infections one 500 mg/125 mg tablet b,c of amoxicillin and clavulanate potassium tablets every 12 hours or one 250 mg/125 mg tablet d of amoxicillin and clavulanate potassium tablets every 8 hours a Adults who have difficulty swallowing may be given the amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL suspension or the amoxicillin and clavulanate potassium 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet. b Adults who have difficulty swallowing may be given the amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL or amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. c Two amoxicillin and clavulanate potassium 250 mg/125 mg tablets are NOT substitutable with one 500 mg/125 mg amoxicillin and clavulanate potassium tablet [see Dosage and Administration (2.6) ] . d Amoxicillin and clavulanate potassium 250 mg/125 mg tablet is NOT substitutable with amoxicillin and clavulanate potassium 250 mg/62.5 mg chewable tablet [see Dosage and Administration (2.6) ] .
2.3Pediatric Patients Based on the amoxicillin component, amoxicillin and clavulanate potassium tablets should be dosed as follows: Neonates and Infants Aged less than 12 weeks (less than 3 months) : See dosing regimens of amoxicillin and clavulanate potassium tablets provided in Table 2 below. Table 2: Dosing Regimens of Amoxicillin and Clavulanate Potassium Tablets in Neonates and Infants Aged Less than 12 Weeks (Less than 3 Months) PATIENT POPULATION DOSING REGIMEN Amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL for oral suspension a Neonates and Infants aged less than 12 weeks (less than 3 months) 30 mg/kg/day every 12 hours a Experience with the amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL for oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older and Weighing Less than 40 kg : See dosing regimens provided in Table 3 below. The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2) ] . Table 3: Dosing in Patients Aged 12 Weeks (3 Months) and Older and Weighing Less than 40 kg INFECTION DOSING REGIMEN Every 12 hours Every 8 hours Amoxicillin and clavulanate potassium 200 mg/28.…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 250 mg/125 mg : White to off-white, oval shaped, film-coated tablets, debossed with ‘A’ on one side and ‘63’ on the other side, contains 250 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic acid as the potassium salt. 500 mg/125 mg: White to off-white, oval shaped, film-coated tablets, debossed with ‘X’ on one side and ‘33’ on the other side, contains 500 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic acid as the potassium salt. 875 mg/125 mg: White to off-white, capsule shaped, film-coated tablets, debossed with ‘X’ on one side and score line in between 3 and 2 on the other side, contains 875 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic acid as the potassium salt.
Tablets: 250 mg/125 mg, 500 mg/125 mg, 875 mg/125 mg; 875 mg/125 mg tablets are scored. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin and clavulanate potassium tablets or to other beta-lactams (e.g., penicillins or cephalosporins). ( 4.1 ) History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium tablets. ( 4.2 )
4.1Serious Hypersensitivity Reactions Amoxicillin and clavulanate potassium tablets 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 tablets are contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium tablets.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Serious (including fatal) hypersensitivity reactions: Discontinue amoxicillin and clavulanate potassium if a reaction occurs. ( 5.1 ) Severe Cutaneous Adverse Reactions (SCAR): Monitor closely. Discontinue if rash progresses.
( 5.2 ) Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of amoxicillin and clavulanate potassium tablets. If this occurs, discontinue amoxicillin and clavulanate potassium and institute appropriate therapy. ( 5.3 ) Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur.
Monitor liver function tests in patients with hepatic impairment. ( 5.4 ) Clostridioides difficile -associated diarrhea (CDAD): Evaluate patients if diarrhea occurs. ( 5.5 ) Patients with mononucleosis who receive amoxicillin and clavulanate potassium develop skin rash.
Avoid amoxicillin and clavulanate potassium use in these patients. ( 5.6 ) Overgrowth: The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. ( 5.7 )
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.
5.2Severe Cutaneous Adverse Reactions Amoxicillin and clavulanate potassium 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 discontinued if lesions progress.
5.3Drug-Induced Enterocolitis Syndrome (DIES) Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of amoxicillin and clavulanate potassium tablets [see Adverse Reactions (6.2) ] , with most cases occurring in pediatric patients ≤ 18 years of age. DIES is a non-IgE mediated hypersensitivity reaction characterized by protracted vomiting occurring 1 to 4 hours after drug ingestion in the absence of skin or respiratory symptoms. DIES may be associated with pallor, lethargy, hypotension, shock, diarrhea within 24 hours of ingesting amoxicillin, and leukocytosis with neutrophilia.
If DIES occurs, discontinue amoxicillin and clavulanate potassium and institute appropriate therapy.
5.4Hepatic 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.
5.5Clostridioides difficile Associated Diarrhea (CDAD) Clostridioides 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 consider…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2) ] Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions (5.3) ] Hepatic Dysfunction [see Warnings and Precautions (5.4) ] Clostridioides difficile Associated Diarrhea (CDAD) [see Warnings and Precautions (5.5) ] The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%).
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 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. 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 (less than 1%) include: Abdominal discomfort, flatulence, and headache. In pediatric patients (aged 2 months to 12 years), 1 U.S./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) ] .
6.2Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing 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: Drug-induced enterocolitis syndrome (DIES), 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 (5.5) ] . Immune: Hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock), angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), hypersensitivity vasculitis [see Warnings and Precautions (5.1 )].
Skin and Appendages: Rashes, pruritus, urticaria, erythema multiforme, SJS, TEN, DRESS, AGEP, exfoliative dermatitis, and linear IgA bullous dermatosis. 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 o…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Co-administration with probenecid is not recommended. (7.1) Concomitant use of amoxicillin and clavulanate potassium and 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 may reduce efficacy of oral contraceptives. (7.4)
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 ▾
8 USE IN SPECIFIC POPULATIONS Pediatric Use: Modify dose in patients 12 weeks or younger. (8.4) Renal Impairment: Dosage adjustment is recommended for severe renal impairment (GFR less than 30 mL/min). (2.4, 8.6)
8.1Pregnancy Teratogenic Effects: Pregnancy Category B. 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 antibacterials are poorly absorbed during labor. It is not known whether 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 of the necessity for an obstetrical intervention.
8.3Nursing Mothers Amoxicillin has been shown to be excreted in human milk. Amoxicillin and clavulanate potassium use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin and 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 tablets 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 less than 12 weeks (less than 3 months) [see Dosage and Administration (2.3) ] .
8.5Geriatric Use Of the 3,119 patients in an analysis of clinical studies of amoxicillin and clavulanate potassium, 32% were greater than or equal to 65 years old, and 14% were greater than or equal to 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.
8.6Renal Impairment Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR less than 30 mL/min). See Patients with Renal Impairment [see Dosage and Administration (2.4) ] for specific recommendations in patients with renal impairment.
🤰 Pregnancy ▾
8.1Pregnancy Teratogenic Effects: Pregnancy Category B. 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.
🧒 Pediatric Use ▾
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 tablets 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 less than 12 weeks (less than 3 months) [see Dosage and Administration (2.3) ] .
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 3,119 patients in an analysis of clinical studies of amoxicillin and clavulanate potassium, 32% were greater than or equal to 65 years old, and 14% were greater than or equal to 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.
🆘 Overdosage ▾
10 OVERDOSAGE 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 symptoms 1 . Interstitial nephritis resulting in oliguric renal failure has been reported in patients after overdosage with amoxicillin and clavulanate potassium.
Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin and 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 and 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 and clavulanate potassium. Amoxicillin and clavulanate potassium may be removed from circulation by hemodialysis [see Dosage and Administration (2.4) ] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
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 6 and following administration of amoxicillin and clavulanate potassium for oral suspension and chewable tablets are shown in Table 7. Table 6: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters a,b with Amoxicillin and Clavulanate Potassium Tablets a Mean (± standard deviation) values of 14 normal adults (N equals 15 for clavulanate potassium in the low-dose regimens).
Peak concentrations occurred approximately 1.5 hours after the dose. b Amoxicillin and clavulanate potassium administered at the start of a light meal. Dose and Regimen of Amoxicillin and Clavulanate Potassium C max (mcg/mL) AUC 0-24 (mcg*h/mL) Amoxicillin and Clavulanate Potassium Amoxicillin Clavulanate Potassium Amoxicillin Clavulanate Potassium 250 mg/125 mg every 8 hours 3.3 ± 1.12 1.5 ± 0.7 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 ±
3.04Table 7: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters a,b with Amoxicillin and Clavulanate Potassium for Oral Suspension and Chewable Tablets a Mean (± standard deviation) values of 28 normal adults. Peak concentrations occurred approximately 1 hour after the dose. b Amoxicillin and clavulanate potassium administered at the start of a light meal. Dose of Amoxicillin and Clavulanate Potassium C max (mcg/mL) AUC 0-24 (mcg*h/mL) Amoxicillin and Clavulanate Potassium Amoxicillin Clavulanate Potassium Amoxicillin Clavulanate Potassium 400 mg/57 mg (5 mL of suspension) 6.94 ± 1.24 1.1 ± 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 ±
0.73Oral administration of 5 mL of the 250 mg/62.5 mg suspension of amoxicillin and clavulanate potassium or the equivalent dose of 10 mL of the 125 mg/31.25 mg 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 the 250 mg/62.5 mg suspension of amoxicillin and clavulanate potassium or equivalent dose of 10 mL of the 125 mg/31.25 mg suspension of amoxicillin and clavulanate potassium were administered to normal adults.
One 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium or two 125 mg/31.25 mg chewable tablets of amoxicillin and clavulanate potassium are equivalent to 5 mL of the 250 mg/62.5 mg 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 clavu…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Amoxicillin and clavulanate potassium is an antibacterial drug [see Microbiology (12.4) ] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING A moxicillin and Clavulanate Potassium Tablets USP, 250 mg/125 mg are white to off-white, oval shaped, film-coated tablets, debossed with ‘A’ on one side and ‘63’ on the other side, contains 250 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic acid as the potassium salt (equivalent to 149 mg of clavulanate potassium). Bottles of 30 NDC 65862-501-30 Bottles of 500 NDC 65862-501-05 Amoxicillin and Clavulanate Potassium Tablets USP, 500 mg/125 mg are white to off-white, oval shaped, film-coated tablets, debossed with ‘X’ on one side and ‘33’ on the other side, contains 500 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic acid as the potassium salt (equivalent to 149 mg of clavulanate potassium).
Bottles of 20 NDC 65862-502-20 Bottles of 500 NDC 65862-502-05 Amoxicillin and Clavulanate Potassium Tablets USP, 875 mg/125 mg are white to off-white, capsule shaped, film-coated tablets, debossed with ‘X’ on one side and score line in between 3 and 2 on the other side, contains 875 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic acid as the potassium salt (equivalent to 149 mg of clavulanate potassium). Bottles of 20 NDC 65862-503-20 Bottles of 100 NDC 65862-503-01 Dispense in a tight container [see USP].
Advise patients to keep in a closed container. Use only if inner seal is intact. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Keep out of the reach of children.
📋 Description ▾
11 DESCRIPTION Amoxicillin and clavulanate potassium tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin USP 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 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 C 8 H 8 KNO 5 , 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: • 250 mg/125 mg: Each tablet contains 250 mg of amoxicillin USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). • 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). • 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium).
Inactive Ingredients: Colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, surelease clear (aqueous ethyl cellulose dispersion), and titanium dioxide. Each tablet of amoxicillin and clavulanate contains 0.63 mEq potassium. Chemical Structure1 chemical structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Administration Instructions Inform patients that amoxicillin and clavulanate potassium tablets may be taken every 8 hours or every 12 hours, depending on the dose prescribed. Each dose should be taken with a meal or snack to reduce the possibility of gastrointestinal upset. Allergic Reactions Counsel patients that amoxicillin and clavulanate potassium tablets 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 tablets 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 antibacterials, and it usually ends when the antibacterial is discontinued.
Sometimes after starting treatment with antibacterials, 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 their last dose of the antibacterial. If diarrhea is severe or lasts more than 2 or 3 days, patients should contact their physician as soon as possible. Antibacterial Resistance Patients should be counseled that antibacterial drugs, including amoxicillin and clavulanate potassium tablets, should only be used to treat bacterial infections.
They do not treat viral infections (e.g., the common cold). When amoxicillin and clavulanate potassium tablet 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 tablets or other antibacterial drugs in the future.
CLINITEST is a registered trademark of Miles, Inc. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 06/2024