Amoxicillin 875 mg Tablet, Film Coated, 100-count — NDC 65862-015-01 (Billing 65862-0015-01)
This is a package of 100 tablets of Amoxicillin 875 mg Tablet, Film Coated from Aurobindo Pharma Limited, marketed since Nov 2005 and currently FDA-listed; retail pharmacies pay about $0.1536 per tablet (NADAC). It is the main listing for this product, which comes in 5 package sizes.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 040292
- GCN: 39632
- GPI-14 (Medi-Span): 01200010100315
- HICL (First Databank): 003963
- AHFS class code: 08:12.16.08
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Amoxicillin is used to treat certain infections caused by bacteria, such as pneumonia, skin, and urinary tract infections eliminate H. pylori, a bacteria that causes ulcers in combination with other medications Amoxicillin is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of bacteria. Antibiotics such as amoxicillin will not work for colds, flu, and other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Read the full MedlinePlus article ↗- It is an antibiotic for infections caused by susceptible bacteria. These include ear, nose and throat, chest, urinary tract and skin infections. In adults it is also used with othe...
- Take it by mouth at the start of a meal, which helps limit stomach upset. Follow the schedule your prescriber gave you. Finish the full course even if you feel better, because stop...
- Diarrhea, nausea, vomiting and mild rash are the most common. Call your doctor if a rash spreads, if you have severe or bloody diarrhea, or if your child has repeated vomiting an h...
- What side effects are normal, and when should I call?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Amoxicillin — tap one for details:
Amoxicillin may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $0.154 | $15.36 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.5278 | $52.78 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.2990 | $29.90 / 100 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 65862-0015-01 You're viewing this Main listing | 100 TABLET, FILM COATED in 1 BOTTLE | $0.1536 / ea | $15.36 | 2005-11-09 | — | Active |
| 65862-0015-05 65862-015-05 | 500 TABLET, FILM COATED in 1 BOTTLE | — | — | 2005-11-09 | — | Active |
| 65862-0015-20 65862-015-20 | 20 TABLET, FILM COATED in 1 BOTTLE | — | — | 2005-11-09 | — | Active |
| 65862-0015-89 65862-015-89 | 900 TABLET, FILM COATED in 1 BAG | — | — | — | — | Active |
| 65862-0015-99 65862-015-99 | 1000 TABLET, FILM COATED in 1 BAG | — | — | — | — | Active |
You're viewing one of 5 pack sizes for this product.
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 65862-0015-20?
What NDC number is used to bill for this package of Amoxicillin 875 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.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Amoxicillin 875 mg 00093-2264-01 | Teva | 100 tablets | $0.154 | AB | Discontinued | — |
| Amoxicillin 875 mg 00143-9285-01 | Hikma | 100 tablets | $0.154 | AB | Availability likely | — |
| Amoxicillin 875 mg 00781-5061-01 | Sandoz | 100 tablets | $0.154 | AB | Availability likely | — |
| Amoxicillin 875 mg 57237-0029-01 | Rising | 100 tablets | $0.154 | AB | Availability likely | — |
| Amoxicillin 875 mg 60687-0809-28 | American | 1 tablet | $0.154 | AB | Availability likely | — |
| Amoxicillin 875 mgthis 65862-0015-01 | Aurobindo | 100 tablets | $0.154 | — | Availability likely | — |
| Amoxicillin 875 mg 42708-0078-20 | QPharma, | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 42708-0112-20 | QPharma, | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 43063-0885-20 | PD-Rx | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 50090-0713-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 50090-0714-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 50090-1595-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 50090-1596-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 50090-5863-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 50090-5880-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 63187-0325-14 | Proficient | 14 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 63187-0729-14 | Proficient | 14 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 63629-4777-01 | Bryant | 14 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 67046-0015-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 68071-3716-02 | NuCare | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 68071-4982-02 | NuCare | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 68071-5096-02 | NuCare | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 68788-4062-02 | Preferred | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 68788-7414-02 | Preferred | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 70518-2191-00 | REMEDYREPACK | 20 tablets | — | AB | Discontinued | — |
| Amoxicillin 875 mg 70518-2333-00 | REMEDYREPACK | 14 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 71205-0035-14 | Proficient | 14 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 72189-0463-20 | Direct_Rx | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 72789-0224-01 | PD-Rx | 100 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 76420-0003-20 | Asclemed | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 76420-0138-20 | Asclemed | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 82804-0200-20 | Proficient | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 68788-4152-02 | Preferred | 20 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 62135-0085-01 | Chartwell | 100 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 67046-0734-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Amoxicillin 875 mg 67296-2328-02 | Redpharm | 20 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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.
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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.
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UNII 2S42T2808B
A synthetic red dye used as a colorant to give the medicine its red color. It helps make pills or liquids visually distinct and easier to identify.
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UNII 36SFW2JZ0W
Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
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UNII 0WZ8WG20P6
Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
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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.
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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.
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UNII G2M7P15E5P
Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
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UNII Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
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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.
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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.
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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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full FDA label FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . Infections of the Genitourinary Tract: Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis .
Infections of the Skin and Skin Structure: Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli . Infections of the Lower Respiratory Tract: Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp.
(α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae . Adult Patients only Helicobacter pylori Infection and Duodenal Ulcer Disease: Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole: Amoxicillin tablets, in combination with clarithromycin plus lansoprazole as triple therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Dual therapy for H. pylori with lansoprazole : Amoxicillin tablets, in combination with lansoprazole delayed-release capsules as dual therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected . (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets and other antibacterial drugs, amoxicillin tablets should be used only to treat infections that are proven or strongly suspected to be caused by 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 tablets are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. ( 1 ) Adults and Pediatric Patients ( 1 ) Upper Respiratory Tract Infections of the Ear, Nose, and Throat Infections of the Genitourinary Tract Infections of the Skin and Skin Structure Infections of the Lower Respiratory Tract Adult Patients only ( 1 ) Helicobacter pylori Infection and Duodenal Ulcer Disease Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets and other antibacterial drugs, amoxicillin 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 In Adults, 750 to 1750 mg/day in divided doses every 8 to 12 hours. In Pediatric Patients over 3 Months of Age, 20 to 45 mg/kg/day in divided doses every 8 to 12 hours. Refer to full prescribing information for specific dosing regimens.
( 2.2 , 2.3 ) The upper dose for neonates and infants aged 3 months or younger is 30 mg/kg/day divided every 12 hours. ( 2.3 ) Dosing for H. pylori Infection (in Adults): Triple therapy: 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.
( 2.4 ) Reduce the dose in patients with severe renal impairment (GFR greater than 30 mL/min). ( 2.5 )
2.1Important Administration Instructions To minimize the potential for gastrointestinal intolerance, amoxicillin tablets should be taken at the start of a meal.
2.2Dosage for Adults and Pediatric Patients Aged 3 Months (12 weeks) and Older Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic, or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks.
It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Table 1. Dosage Recommendations for Adult and Pediatric Patients Aged 3 Months (12 weeks) and Older Infection Severity a Recommended Dosage for Adults and Pediatric Patients Aged 3 Months and Older and Weight Greater than 40 kg Recommended Dosage for Pediatric Patients Aged 3 Months and Older and Weight Less than 40 kg Ear/Nose/Throat Skin/Skin Structure Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours a Dosage for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
2.3Dosage in Pediatric Patients Aged Less than 12 Weeks (3 months) It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin tablets is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.
Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic, or evidence of bacterial eradication has been obtained.
2.4Dosage for H. pylori Infection in Adults Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. Please refer to clarithromycin and lansoprazole full prescribing information.
2.5Dosage in Renal Impairment for Adults and Pediatric Patients Aged 3 Months and Older and Weight Greater than 40 kg Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration r… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 500 mg Tablets are pink colored, capsule shaped, film coated tablets debossed with “A” on one side and “66” on the other side. 875 mg Tablets are pink colored, capsule shaped, film coated tablets debossed with “A” on one side and with a score line in between “6” and “7” on the other side. Tablets: 500 mg and 875 mg (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Amoxicillin tablets are contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin tablets or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins). History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin tablets or to other beta-lactams (e.g., penicillins or cephalosporins). (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Anaphylactic reactions: Serious and occasionally fatal anaphylactic reactions have been reported in patients on penicillin therapy, including amoxicillin. Discontinue amoxicillin 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 amoxicillin use. If this occurs, discontinue amoxicillin and institute appropriate therapy.
( 5.3 ) Clostridioides difficile -associated diarrhea (CDAD) (ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs. ( 5.4 )
5.1Anaphylactic Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy including amoxicillin. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens.
There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with amoxicillin, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, amoxicillin should be discontinued, and appropriate therapy instituted.
5.2Severe Cutaneous Adverse Reactions Amoxicillin 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 skin rash they should be monitored closely, and amoxicillin discontinued if lesions progress.
5.3Drug-Induced Enterocolitis Syndrome (DIES) Drug-induced enterocolitis syndrome (DIES) has been reported with amoxicillin use [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 after ingesting amoxicillin, and leukocytosis with neutrophilia.
If DIES occurs, discontinue amoxicillin and institute appropriate therapy.
5.4Clostridioides difficile -Associated Diarrhea (CDAD) Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
5.5Development of Drug-Resistant Bacteria Prescribing amoxicillin in the absence of a proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of d… [Excerpted — this section continues on DailyMed.]
🤒 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) ] Clostridioides difficile- Associated Diarrhea (CDAD) [see Warnings and Precautions (5.4) ] The most common adverse reactions (greater than 1%) observed in clinical trials of amoxicillin tablets or for oral suspension were diarrhea, rash, vomiting, and nausea.
(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 Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (greater than 1%) observed in clinical trials of amoxicillin tablets or oral suspension were diarrhea, rash, vomiting, and nausea. Triple therapy: The most frequently reported adverse events for patients who received triple therapy (amoxicillin/clarithromycin/lansoprazole) were diarrhea (7%), headache (6%), and taste perversion (5%).
Dual therapy: The most frequently reported adverse events for patients who received double therapy amoxicillin/lansoprazole were diarrhea (8%) and headache (7%). For more information on adverse reactions with clarithromycin or lansoprazole, refer to the Adverse Reactions section of their package inserts.
6.2Postmarketing Experience In addition to adverse events reported from clinical trials, the following events have been identified during postmarketing use of penicillins. 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.
Infections and Infestations: Mucocutaneous candidiasis. Gastrointestinal: Drug-induced enterocolitis syndrome (DIES), black hairy tongue, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions (5.4) ] .
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: A moderate rise in AST and/or ALT has been noted, but the significance of this finding is unknown.
Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported. Renal: Crystalluria has been reported [see Overdosage (10) ] . Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported.
These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, aseptic meningitis, and/or dizziness have been reported. Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been reported.
Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Co-administration with probenicid is not recommended. (7.1) Concomitant use of amoxicillin and oral anticoagulants may increase the prolongation of prothrombin time. (7.2) Co-administration with allopurinol increases the risk of rash. (7.3) Amoxicillin may reduce the efficacy of oral contraceptives. (7.4)
7.1Probenecid Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.
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 the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of rashes is due to allopurinol or the hyperuricemia present in these patients.
7.4Oral Contraceptives Amoxicillin may affect the intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
7.5Other Antibacterials Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro ; however, the clinical significance of this interaction is not well documented.
7.6Effects on Laboratory Tests High urine concentrations of ampicillin 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, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX ® ) be used. Following administration of ampicillin or 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
8.1Pregnancy Teratogenic Effects : Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). There was no evidence of harm to the fetus due to amoxicillin.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, amoxicillin should be used during pregnancy only if clearly needed.
8.2Labor and Delivery Oral ampicillin is poorly absorbed during labor. It is not known whether use of amoxicillin 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 Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman.
8.4Pediatric Use The safety and effectiveness of amoxicillin for the treatment of upper respiratory tract infections, and infections of the genitourinary tract, skin and skin structure and lower respiratory tract have been established in pediatric patients. The safety and effectiveness of amoxicillin for the treatment of H.Pylori infection have not been established in pediatric patients. Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed.
Dosing of amoxicillin should be modified in pediatric patients 12 weeks or younger (3 months or younger) [see Dosage and Administration (2.3) ].
8.5Geriatric Use An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. These analyses have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
8.6Dosing in Renal Impairment Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR less than 30 mL/min). See Dosing in Renal Impairment (2.5) for specific recommendations in patients with renal impairment.
🤰 Pregnancy ▾
8.1Pregnancy Teratogenic Effects : Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). There was no evidence of harm to the fetus due to amoxicillin.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, amoxicillin should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of amoxicillin for the treatment of upper respiratory tract infections, and infections of the genitourinary tract, skin and skin structure and lower respiratory tract have been established in pediatric patients. The safety and effectiveness of amoxicillin for the treatment of H.Pylori infection have not been established in pediatric patients. Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed.
Dosing of amoxicillin should be modified in pediatric patients 12 weeks or younger (3 months or younger) [see Dosage and Administration (2.3) ].
🧓 Geriatric Use ▾
8.5Geriatric Use An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. These analyses have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
🆘 Overdosage ▾
10 OVERDOSAGE In case of overdosage, discontinue amoxicillin, 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. Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin 1 .
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 amoxicillin. Amoxicillin may be removed from circulation by hemodialysis.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Amoxicillin is an antibacterial drug [see Microbiology (12.4) ].
12.3Pharmacokinetics Absorption: Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. The effect of food on the absorption of amoxicillin from the tablets and suspension of amoxicillin has been partially investigated; 400 mg and 875 mg formulations have been studied only when administered at the start of a light meal. Orally administered doses of 250 mg and 500 mg amoxicillin capsules result in average peak blood levels 1 to 2 hours after administration in the range of 3.5 mcg/mL to 5 mcg/mL and 5.5 mcg/mL to 7.5 mcg/mL, respectively.
Mean amoxicillin pharmacokinetic parameters from an open, two-part , single-dose crossover bioequivalence study in 27 adults comparing 875 mg of amoxicillin with 875 mg of amoxicillin/clavulanate potassium showed that the 875 mg tablet of amoxicillin produces an AUC 0-∞ of 35.4 ± 8.1 mcg • hr/mL and a C max of 13.8 ± 4.1 mcg/mL. Dosing was at the start of a light meal following an overnight fast. Orally administered doses of amoxicillin suspension, 125 mg/5 mL and 250 mg/5 mL, result in average peak blood levels 1 to 2 hours after administration in the range of 1.5 mcg/mL to 3 mcg/mL and 3.5 mcg/mL to 5 mcg/mL, respectively.
Oral administration of single doses of 400 mg chewable tablets and 400 mg/5 mL suspension of amoxicillin to 24 adult volunteers yielded comparable pharmacokinetic data: Table 4. Mean Pharmacokinetic Parameters of Amoxicillin (400 mg chewable tablets and 400 mg/5 mL suspension) in Healthy Adults Dose * AUC 0-∞ (mcg ● hr/mL) C max (mcg/mL) † * Administered at the start of a light meal. † Mean values of 24 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose.
Amoxicillin Amoxicillin (±S.D.) Amoxicillin (±S.D.) 400 mg (5 mL of suspension) 17.1 (3.1) 5.92 (1.62) 400 mg (1 chewable tablet) 17.9 (2.4) 5.18 (1.64) Distribution: Amoxicillin diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed. In blood serum, amoxicillin is approximately 20% protein-bound. Following a 1 gram dose, and utilizing a special skin window technique to determine levels of the antibiotic, it was noted that therapeutic levels were found in the interstitial fluid.
Metabolism and Excretion: The half-life of amoxicillin is 61.3 minutes. Approximately 60% of an orally administered dose of amoxicillin is excreted in the urine within 6 to 8 hours. Detectable serum levels are observed up to 8 hours after an orally administered dose of amoxicillin.
Since most of the amoxicillin is excreted unchanged in the urine, its excretion can be delayed by concurrent administration of probenecid [see Drug Interactions (7.1) ] .
12.4Microbiology Mechanism of Action Amoxicillin is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria. Resistance Resistance to amoxicillin is mediated primarily through enzymes called beta-lactamases that cleave the beta-lactam ring of amoxicillin, rendering it inactive.
Antimicrobial Activity Amoxicillin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections [see Indications and Usage (1) ] . Gram-Positive Bacteria Enterococcus faecalis Staphylococcus spp. Streptococcus pneumoniae Streptococcus spp.
(alpha and beta-hemolytic) Gram-Negative Bacteria Escherichia coli Haemophilus influenzae Helicobacter pylori Proteus mirabilis Susceptibility Testing: For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Amoxicillin is an antibacterial drug [see Microbiology (12.4) ].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Amoxicillin Tablets, USP contains 500 mg or 875 mg amoxicillin as the trihydrate. 500 mg Tablet Pink colored, capsule shaped, film coated tablets debossed with “A” on one side and “66” on the other side. Bottles of 20 NDC 65862-014-20 Bottles of 100 NDC 65862-014-01 Bottles of 500 NDC 65862-014-05 875 mg Tablet Pink colored, capsule shaped, film coated tablets debossed with “A” on one side and with a score line in between “6” and “7” on the other side.
Bottles of 20 NDC 65862-015-20 Bottles of 100 NDC 65862-015-01 Bottles of 500 NDC 65862-015-05 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container.
📋 Description ▾
11 DESCRIPTION Amoxicillin tablets, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it 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. It may be represented structurally as: The amoxicillin molecular formula is C 16 H 19 N 3 O 5 S • 3H 2 O, and the molecular weight is 419.45.
Each film coated tablet contains 500 mg or 875 mg amoxicillin USP as the trihydrate. The 500 mg pink colored, capsule shaped, film coated tablets debossed with “A” on one side and “66” on the other side. The 875 mg pink colored, capsule shaped, film coated tablets debossed with “A” on one side and with a score line in between “6” and “7” on the other side.
Inactive ingredients: Colloidal silicon dioxide, crospovidone, D&C Red No. 30 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Administration Instructions Advise patients that amoxicillin tablets may be taken every 8 hours or every 12 hours, depending on the dose prescribed. Allergic Reactions Counsel patients that amoxicillin 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 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 antibacterial drugs which usually ends when the antibacterial drug 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 their 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 tablets, should only be used to treat or prevent bacterial infections. Antibacterial drugs do not treat viral infections (e.g., the common cold).
When amoxicillin tablets are 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 tablets or other antibacterial drugs in the future. CLINITEST is a registered trademark of Miles, Inc.
CLINISTIX is a registered trademark of Bayer Corporation. CLOtest is a registered trademark of Kimberly-Clark Corporation. 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
🍼 Nursing Mothers ▾
8.3Nursing Mothers Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption: Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. The effect of food on the absorption of amoxicillin from the tablets and suspension of amoxicillin has been partially investigated; 400 mg and 875 mg formulations have been studied only when administered at the start of a light meal. Orally administered doses of 250 mg and 500 mg amoxicillin capsules result in average peak blood levels 1 to 2 hours after administration in the range of 3.5 mcg/mL to 5 mcg/mL and 5.5 mcg/mL to 7.5 mcg/mL, respectively.
Mean amoxicillin pharmacokinetic parameters from an open, two-part , single-dose crossover bioequivalence study in 27 adults comparing 875 mg of amoxicillin with 875 mg of amoxicillin/clavulanate potassium showed that the 875 mg tablet of amoxicillin produces an AUC 0-∞ of 35.4 ± 8.1 mcg • hr/mL and a C max of 13.8 ± 4.1 mcg/mL. Dosing was at the start of a light meal following an overnight fast. Orally administered doses of amoxicillin suspension, 125 mg/5 mL and 250 mg/5 mL, result in average peak blood levels 1 to 2 hours after administration in the range of 1.5 mcg/mL to 3 mcg/mL and 3.5 mcg/mL to 5 mcg/mL, respectively.
Oral administration of single doses of 400 mg chewable tablets and 400 mg/5 mL suspension of amoxicillin to 24 adult volunteers yielded comparable pharmacokinetic data: Table 4. Mean Pharmacokinetic Parameters of Amoxicillin (400 mg chewable tablets and 400 mg/5 mL suspension) in Healthy Adults Dose * AUC 0-∞ (mcg ● hr/mL) C max (mcg/mL) † * Administered at the start of a light meal. † Mean values of 24 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose.
Amoxicillin Amoxicillin (±S.D.) Amoxicillin (±S.D.) 400 mg (5 mL of suspension) 17.1 (3.1) 5.92 (1.62) 400 mg (1 chewable tablet) 17.9 (2.4) 5.18 (1.64) Distribution: Amoxicillin diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed. In blood serum, amoxicillin is approximately 20% protein-bound. Following a 1 gram dose, and utilizing a special skin window technique to determine levels of the antibiotic, it was noted that therapeutic levels were found in the interstitial fluid.
Metabolism and Excretion: The half-life of amoxicillin is 61.3 minutes. Approximately 60% of an orally administered dose of amoxicillin is excreted in the urine within 6 to 8 hours. Detectable serum levels are observed up to 8 hours after an orally administered dose of amoxicillin.
Since most of the amoxicillin is excreted unchanged in the urine, its excretion can be delayed by concurrent administration of probenecid [see Drug Interactions (7.1) ] .
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Randomized, double-blind clinical studies performed in the United States in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within 1 year) evaluated the efficacy of lansoprazole in combination with amoxicillin capsules and clarithromycin tablets as triple 14-day therapy, or in combination with amoxicillin capsules as dual 14-day therapy, for the eradication of H. pylori . Based on the results of these studies, the safety and efficacy of 2 different eradication regimens were established: Triple therapy: Amoxicillin 1 gram twice daily/clarithromycin 500 mg twice daily/lansoprazole 30 mg twice daily (see Table 5).
Dual therapy: Amoxicillin 1 gram three times daily/lansoprazole 30 mg three times daily (see Table 6). All treatments were for 14 days. H. pylori eradication was defined as 2 negative tests (culture and histology) at 4 to 6 weeks following the end of treatment.
Triple therapy was shown to be more effective than all possible dual therapy combinations. Dual therapy was shown to be more effective than both monotherapies. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Table 5. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Triple Therapy Regimen Study Triple Therapy Triple Therapy Evaluable Analysis a [95% Confidence Interval] (number of patients) Intent-to-Treat Analysis b [95% Confidence Interval] (number of patients) Study 1 92 [80 to 97.7] (n equals 48) 86 [73.3 to 93.5] (n equals 55) Study 2 86 [75.7 to 93.6] (n equals 66) 83 [72 to 90.8] (n equals 70) a This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest ® , histology, and/or culture.
Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. b Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy.
Table 6. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Dual Therapy Regimen Study Dual Therapy Dual Therapy Evaluable Analysis a [95% Confidence Interval] (number of patients) Intent-to-Treat Analysis b [95% Confidence Interval] (number of patients) Study 1 77 [62.5 to 87.2] (n equals 51) 70 [56.8 to 81.2] (n equals 60) Study 2 66 [51.9 to 77.5] (n equals 58) 61 [48.5 to 72.9] (n equals 67) a This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest ® , histology, and/or culture.
Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. b Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of amoxicillin and potassium clavulanate. Amoxicillin and potassium clavulanate was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay.
Amoxicillin and potassium clavulanate was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival. Amoxicillin and potassium clavulanate 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.
In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 2 times the 3 g human dose based on body surface area).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of amoxicillin and potassium clavulanate. Amoxicillin and potassium clavulanate was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay.
Amoxicillin and potassium clavulanate was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival. Amoxicillin and potassium clavulanate 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.
In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 2 times the 3 g human dose based on body surface area).
📚 References ▾
15 REFERENCES 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 ▾
Warnings and Precautions, Drug-Induced Enterocolitis Syndrome (DIES) ( 5.3 ) 5/2024
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg (100 Tablets Bottle) NDC 65862-014-01 Rx only Amoxicillin Tablets, USP 500 mg AMOXICILLIN, 500 mg as the trihydrate AUROBINDO 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg (100 Tablets Bottle)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 875 mg (100 Tablets Bottle) NDC 65862-015-01 Rx only Amoxicillin Tablets, USP 875 mg AMOXICILLIN, 875 mg as the trihydrate AUROBINDO 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 875 mg (100 Tablets Bottle)
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FDA lists this package under the "drug for further processing" marketing category: Aurobindo Pharma Limited supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.
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