Cefuroxime Axetil 250 mg Tablet, 20-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Cephalosporin Antibacterial class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Cefuroxime is used to treat certain infections caused by bacteriaand Lyme disease (an infection spead by ticks). It is also used to treat gonorrhea (a sexually transmitted disease).. Cefuroxime is in a class of medications called cephalosporin antibiotics. It works by stopping the growth of bacteria. Antibiotics such as cefuroxime 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 antibiotic treatment.
Read the full MedlinePlus article ↗- Cefuroxime treats a wide range of bacterial infections. In tablet form — sold as Cefuroxime Axetil — it's used for things like strep throat, sinus infections, ear infections in kid...
- What kinds of infections does cefuroxime treat?
- You can take Cefuroxime Axetil tablets with or without food — both work. That said, taking it with food does improve how much your body absorbs, so if your stomach tolerates it, a...
- Should I take the tablet with food or on an empty stomach?
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🧪 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.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII Z82Y2C65EA
Hydrogenated cottonseed oil is a solid fat made by adding hydrogen to cottonseed oil. It's used in medicines as a binder and lubricant to help hold ingredients together and make tablets easier to compress and release.
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Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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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 B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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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 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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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.
8 inactive ingredients listed in the exact product block matched to this NDC.
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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
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.5304 | $10.61 / 20 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cefuroxime axetil 250 mg 00904-7542-10 | Major | 10 tablets | $0.292 | AB | Availability likely | — |
| Cefuroxime Axetil 250 mg 16714-0400-01 | NorthStar | 20 tablets | $0.292 | AB | Availability likely | — |
| Cefuroxime Axetil 250 mg 57237-0058-20 | Rising | 20 tablets | $0.292 | AB | Availability likely | — |
| Cefuroxime axetil 250 mg 60687-0272-94 | American | 1 tablet | $0.292 | AB | Availability likely | — |
| Cefuroxime Axetil 250 mg 65862-0699-20 | Aurobindo | 20 tablets | $0.292 | — | Availability likely | — |
| Cefuroxime Axetil 250 mg 43063-0623-20 | PD-Rx | 20 tablets | — | AB | FDA listed | — |
| Cefuroxime axetil 250 mg 43063-0656-20 | PD-Rx | 20 tablets | — | AB | FDA listed | — |
| Cefuroxime axetil 250 mg 43063-0657-20 | PD-Rx | 20 tablets | — | AB | FDA listed | — |
| Cefuroxime Axetil 250 mgthis 50090-0781-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Cefuroxime Axetil 250 mg 50090-0782-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Cefuroxime axetil 250 mg 50090-2158-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Cefuroxime axetil 250 mg 50090-2159-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Cefuroxime Axetil 250 mg 50090-6999-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Cefuroxime Axetil 250 mg 50090-7095-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Cefuroxime Axetil 250 mg 50090-7667-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Cefuroxime axetil 250 mg 51407-0333-20 | Golden | 20 tablets | — | AB | FDA listed | — |
| Cefuroxime axetil 250 mg 63187-0991-20 | Proficient | 20 tablets | — | AB | FDA listed | — |
| Cefuroxime Axetil 250 mg 67046-1307-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Cefuroxime axetil 250 mg 67877-0215-01 | Ascend | 100 tablets | — | AB | FDA listed | — |
| Cefuroxime axetil 250 mg 68071-4947-02 | NuCare | 2 tablets | — | AB | FDA listed | — |
| Cefuroxime Axetil 250 mg 67296-2265-04 | Redpharm | 14 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 50090-0781-00 You're viewing this | 20 TABLET in 1 BOTTLE (50090-0781-0) | 2014-11-28 | Active |
| 50090-0781-03 | 14 TABLET in 1 BOTTLE (50090-0781-3) | 2025-10-07 | Active |
You're viewing the largest of 2 pack sizes for this product.
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Cefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: ( 1 ) Pharyngitis/tonsillitis (adults and pediatric patients) ( 1.1 ) Acute bacterial otitis media (pediatric patients) ( 1.2 ) Acute bacterial maxillary sinusitis (adults and pediatric patients) ( 1.3 ) Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) ( 1.4 ) Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) ( 1.5 ) Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) ( 1.6 ) Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) ( 1.7 ) Early Lyme disease (adults and pediatric patients 13 years and older) ( 1.8 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil tablets and other antibacterial drugs, cefuroxime axetil tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
1.1Pharyngitis/Tonsillitis Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (13 years and older) with mild-to-moderate pharyngitis/tonsillitis caused by susceptible strains of Streptococcus pyogenes . Limitations of Use The efficacy of cefuroxime axetil tablets in the prevention of rheumatic fever was not established in clinical trials. The efficacy of cefuroxime axetil tablets in the treatment of penicillin-resistant strains of Streptococcus pyogenes has not been demonstrated in clinical trials.
1.2Acute Bacterial Otitis Media Cefuroxime axetil tablets are indicated for the treatment of pediatric patients (who can swallow tablets whole) with acute bacterial otitis media caused by susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase–producing strains), Moraxella catarrhalis (including β-lactamase–producing strains), or Streptococcus pyogenes .
1.3Acute Bacterial Maxillary Sinusitis Cefuroxime axetil tablets are indicated for the treatment of adult and pediatric patients (13 years and older) with mild-to-moderate acute bacterial maxillary sinusitis caused by susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae (non - β-lactamase–producing strains only). Limitations of Use The effectiveness of cefuroxime axetil tablets for sinus infections caused by β-lactamase–producing Haemophilus influenzae or Moraxella catarrhalis in patients with acute bacterial maxillary sinusitis was not established due to insufficient numbers of these isolates in the clinical trials [see Clinical Studies (14.1) ] .
1.4Acute Bacterial Exacerbations of Chronic Bronchitis Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with mild-to-moderate acute bacterial exacerbations of chronic bronchitis caused by susceptible strains of Streptococcus pneumoniae , Haemophilus influenzae (β-lactamase–negative strains), or Haemophilus parainfluenzae (β-lactamase–negative strains).
1.5Uncomplicated Skin and Skin-Structure Infections Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated skin and skin-structure infections caused by susceptible strains of Staphylococcus aureus (including β - lactamase–producing strains) or Streptococcus pyogenes.
1.6Uncomplicated Urinary Tract Infections Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated urinary tract infections caused by susceptible strains of Escherichia coli or Klebsiella pneumoniae .
1.7Uncomplicated Gonorrhea Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated gon…
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Tablets and oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis. ( 2.1 ) Administer tablets with or without food. ( 2.2 ) Administer cefuroxime axetil tablets as described in the dosage guidelines.
( 2.2 ) Dosage adjustment is required for patients with impaired renal function. ( 2.5 ) Adult Patients and Pediatric Patients Dosage Guidelines for Cefuroxime Axetil Tablets Infection Dosage Duration (Days) Adults and Adolescents (13 years and older) Pharyngitis/tonsillitis (mild to moderate) 250 mg every 12 hours 10 Acute bacterial maxillary sinusitis (mild to moderate) 250 mg every 12 hours 10 Acute bacterial exacerbations of chronic bronchitis (mild to moderate) 250 mg or 500 mg every 12 hours 10 Uncomplicated skin and skin-structure infections 250 mg or 500 mg every 12 hours 10 Uncomplicated urinary tract infections 250 mg every 12 hours 7 to 10 Uncomplicated gonorrhea 1,000 mg single dose Early Lyme disease 500 mg every 12 hours 20 Pediatric Patients younger than 13 years (who can swallow tablets whole) Acute bacterial otitis media 250 mg every 12 hours 10 Acute bacterial maxillary sinusitis 250 mg every 12 hours 10
2.1Important Administration Instructions Cefuroxime axetil tablets and cefuroxime axetil for oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis [see Clinical Pharmacology (12.3)] . Administer cefuroxime axetil tablets as described in the appropriate dosage guidelines [see Dosage and Administration (2.2) ]. Administer cefuroxime axetil tablets with or without food.
Pediatric patients (aged 13 years and older) who cannot swallow the cefuroxime axetil tablets whole should receive cefuroxime axetil for oral suspension because the tablet has a strong, persistent bitter taste when crushed [see Dosage and Administration (2.2) ].
2.2Dosage for Cefuroxime Axetil Tablets Administer cefuroxime axetil tablets as described in the dosage guidelines table below with or without food. Table 1. Adult Patients and Pediatric Patients Dosage Guidelines for Cefuroxime Axetil Tablets Infection Dosage Duration (Days) Adults and Adolescents (13 years and older) Pharyngitis/tonsillitis (mild to moderate) 250 mg every 12 hours 10 Acute bacterial maxillary sinusitis (mild to moderate) 250 mg every 12 hours 10 Acute bacterial exacerbations of chronic bronchitis (mild to moderate) 250 mg or 500 mg every 12 hours 10 a Uncomplicated skin and skin-structure infections 250 mg or 500 mg every 12 hours 10 Uncomplicated urinary tract infections 250 mg every 12 hours 7 to 10 Uncomplicated gonorrhea 1,000 mg single dose Early Lyme disease 500 mg every 12 hours 20 Pediatric Patients younger than 13 years (who can swallow tablets whole) b Acute bacterial otitis media 250 mg every 12 hours 10 Acute bacterial maxillary sinusitis 250 mg every 12 hours 10 a The safety and effectiveness of cefuroxime axetil tablets administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established. b When crushed, the tablet has a strong, persistent bitter taste.
Therefore, patients who cannot swallow the tablet whole should receive the oral suspension.
2.5Dosage in Patients with Impaired Renal Function A dosage interval adjustment is required for patients whose creatinine clearance is less than 30 mL/min, as listed in Table 4 below, because cefuroxime is eliminated primarily by the kidney [see Clinical Pharmacology (12.3) ]. Table 4. Dosing in Adults with Renal Impairment Creatinine Clearance (mL/min) Recommended Dosage ≥30 No dosage adjustment 10 to <30 Standard individual dose given every 24 hours <10 (without hemodialysis) Standard individual dose given every 48 hours Hemodialysis A single additional standard dose should be given at the end of each dialysis
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Cefuroxime Axetil Tablets USP, 125 mg of cefuroxime (as cefuroxime axetil), are white to off-white, film-coated, capsule shaped tablets with ‘A32’ debossed on one side and plain on the other side. Cefuroxime Axetil Tablets USP, 250 mg of cefuroxime (as cefuroxime axetil), are white to off-white, film-coated, capsule shaped tablets with ‘A33’ debossed on one side and plain on the other side. Cefuroxime Axetil Tablets USP, 500 mg of cefuroxime (as cefuroxime axetil), are white to off-white, film-coated, capsule shaped tablets with ‘A34’ debossed on one side and plain on the other side.
Tablets: 125 mg, 250 mg and 500 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Cefuroxime axetil tablets are contraindicated in patients with a known hypersensitivity (e.g., anaphylaxis) to cefuroxime axetil tablets or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins). Known hypersensitivity (e.g., anaphylaxis) to cefuroxime axetil tablets or to other β-lactams (e.g., penicillins and cephalosporins). ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Serious hypersensitivity (anaphylactic) reactions: In the event of a serious reaction, discontinue cefuroxime axetil and institute appropriate therapy. ( 5.1 ) Clostridioides difficile- associated diarrhea (CDAD): If diarrhea occurs, evaluate patients for CDAD. ( 5.2 )
5.1Anaphylactic Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on β-lactam antibacterials, including cefuroxime axetil [see Adverse Reactions (6.2) ] . These reactions are more likely to occur in individuals with a history of β-lactam 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.
Cefuroxime axetil is contraindicated in patients with a known hypersensitivity to cefuroxime axetil or other β-lactam antibacterial drugs [see Contraindications (4) ] . Before initiating therapy with cefuroxime axetil, inquire about previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, discontinue cefuroxime axetil and institute appropriate therapy.
5.2Clostridioides difficile -Associated Diarrhea Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefuroxime axetil, 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 antibiotic 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 antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
5.3Potential for Microbial Overgrowth The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy.
5.4Development of Drug-Resistant Bacteria Prescribing cefuroxime axetil either in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
5.6Interference with Glucose Tests A false-positive result for glucose in the urine may occur with copper reduction tests, and a false-negative result for blood/plasma glucose may occur with ferricyanide tests in subjects receiving cefuroxime axetil [see Drug Interactions (7.3) ] .
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious and otherwise important adverse reaction is described in greater detail in the Warnings and Precautions section of the label: Anaphylactic Reactions [see Warnings and Precautions (5.1)] . The most common adverse reactions (≥3%) for cefuroxime axetil tablets are diarrhea, nausea/vomiting, Jarisch-Herxheimer reaction, and vaginitis (early Lyme disease). ( 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Tablets Multiple-Dose Dosing Regimens with 7 to 10 Days’ Duration : In multiple-dose clinical trials, 912 subjects were treated with cefuroxime axetil (125 to 500 mg twice daily). It is noted that 125 mg twice daily is not an approved dosage.
Twenty (2.2%) subjects discontinued medication due to adverse reactions. Seventeen (85%) of the 20 subjects who discontinued therapy did so because of gastrointestinal disturbances, including diarrhea, nausea, vomiting, and abdominal pain. The percentage of subjects treated with cefuroxime axetil who discontinued study drug because of adverse reactions was similar at daily doses of 1,000, 500, and 250 mg (2.3%, 2.1%, and 2.2%, respectively).
However, the incidence of gastrointestinal adverse reactions increased with the higher recommended doses. The adverse reactions in Table 5 are for subjects (n = 912) treated with cefuroxime axetil in multiple-dose clinical trials. Table 5.
Adverse Reactions (≥1%) after Multiple-Dose Regimens with Cefuroxime Axetil Tablets Adverse Reaction Cefuroxime Axetil (n = 912) Blood and lymphatic system disorders Eosinophilia 1% Gastrointestinal disorders Diarrhea 4% Nausea/Vomiting 3% Investigations Transient elevation in AST 2% Transient elevation in ALT 2% Transient elevation in LDH 1% The following adverse reactions occurred in less than 1% but greater than 0.1% of subjects (n = 912) treated with cefuroxime axetil in multiple-dose clinical trials. Immune System Disorders: Hives, swollen tongue.
Metabolism and Nutrition Disorders: Anorexia. Nervous System Disorders: Headache. Cardiac Disorders: Chest pain.
Respiratory Disorders: Shortness of breath. Gastrointestinal Disorders: Abdominal pain, abdominal cramps, flatulence, indigestion, mouth ulcers. Skin and Subcutaneous Tissue Disorders: Rash, itch.
Renal and Urinary Disorders: Dysuria. Reproductive System and Breast Disorders: Vaginitis, vulvar itch. General Disorders and Administration Site Conditions: Chills, sleepiness, thirst.
Investigations: Positive Coombs’ test. Early Lyme Disease with 20-Day Regimen: Two multicenter trials assessed cefuroxime axetil 500 mg twice daily for 20 days. The most common drug-related adverse experiences were diarrhea (10.6%), Jarisch-Herxheimer reaction (5.6%), and vaginitis (5.4%).
Other adverse experiences occurred with frequencies comparable to those reported with 7 to 10 days’ dosing. Single-Dose Regimen for Uncomplicated Gonorrhea: In clinical trials using a single 1,000 mg dose of cefuroxime axetil, 1,061 subjects were treated for uncomplicated gonorrhea. The adverse reactions in Table 6 were for subjects treated with a single dose of 1,000 mg cefuroxime axetil in U.S. clinical trials.
Table 6. Adverse Reactions (≥1%) after Single-Dose Regimen with 1,000 mg Cefuroxime Axetil Tablets for Uncomplicated Gonorrhea Adverse Reaction Cefuroxime Axetil (n = 1,061) Gastrointestinal disorders Nausea/Vomiting 7% Diarrhea 4% The following adverse reactions occurred in less than 1% but greater than 0.1% of subjects (n = 1,061) treated with a single dose of cefuroxime axetil 1,000 mg for uncomplicated gonorrhea in U.S. clinical trials. Infections and Infe…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Drugs that reduce gastric acidity may lower the bioavailability of cefuroxime axetil. ( 7.1 ) Coadministration with probenecid increases systemic exposure to cefuroxime axetil and is therefore not recommended. ( 7.2 )
7.1Drugs that Reduce Gastric Acidity Drugs that reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil compared with administration in the fasting state. Administration of drugs that reduce gastric acidity may negate the food effect of increased absorption of cefuroxime axetil when administered in the postprandial state. Administer cefuroxime axetil at least 1 hour before or 2 hours after administration of short-acting antacids.
Histamine-2 (H 2 ) antagonists and proton pump inhibitors should be avoided.
7.2Probenecid Concomitant administration of probenecid with cefuroxime axetil tablets increases serum concentrations of cefuroxime [see Clinical Pharmacology (12.3) ]. Coadministration of probenecid with cefuroxime axetil is not recommended.
7.3Drug/Laboratory Test Interactions A false-positive reaction for glucose in the urine may occur with copper reduction tests (e.g., Benedict's or Fehling's solution), but not with enzyme-based tests for glycosuria. As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood/plasma glucose levels in patients receiving cefuroxime axetil. The presence of cefuroxime does not interfere with the assay of serum and urine creatinine by the alkaline picrate method.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available data from published epidemiologic studies, case series, and case reports over several decades with cephalosporin use, including cefuroxime axetil, in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . In studies in pregnant mice and rats administered oral cefuroxime axetil during organogenesis at 14 and 9 times the maximum recommended human dose (MRHD) based on body surface area, respectively, there were no adverse developmental outcomes (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Maternal gonorrhea may be associated with preterm birth, low neonatal birth weight, chorioamnionitis, intrauterine growth restriction, small for gestational age, and premature rupture of membranes. Perinatal transmission of gonorrhea to the offspring can result in infant blindness, joint infections, and bloodstream infections. Data Human Data: While available studies cannot definitively establish the absence of risk, published data from epidemiologic studies, case series, and case reports over several decades have not identified an association with cephalosporin use (including cefuroxime axetil) during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. Animal Data: Studies performed with oral cefuroxime axetil administered to pregnant mice during organogenesis (Gestation Days 7 through 16) at doses up to 3,200 mg/kg/day (14 times the MRHD based on body surface area); and in rats dosed during organogenesis and lactation (Gestation Days 7 through 16 and Gestation Days 17 through Lactation Day 21, respectively) at doses up to 1,000 mg/kg/day (9 times the MRHD based on body surface area) have revealed no adverse developmental outcomes.
8.2Lactation Risk Summary Based on several published case reports describing multiple lactating women who received cefuroxime via intravenous, intramuscular, and oral routes, cefuroxime is present in human milk. The highest maternal milk concentration described occurred in lactating women 8 hours after an intramuscular administration of cefuroxime 750 mg. Allowing for an infant milk consumption of 150 mL/kg/day, the estimated breastfed infant dose would be less than 1% of the adult dose .
No data are available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cefuroxime and any potential adverse effects on the breastfed infant from cefuroxime or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of cefuroxime axetil have been established for pediatric patients aged 3 months to 12 years for acute bacterial maxillary sinusitis based upon its approval in adults. Use of cefuroxime axetil in pediatric patients is supported by pharmacokinetic and safety data in adults and pediatric patients, and by clinical and microbiological data from adequate and well-controlled trials of the treatment of acute bacterial maxillary sinusitis in adults and of acute otitis media with effusion in pediatric patients.
It is also supported by postmarketing adverse events surveillance [see Indications and Usage (1) , Dosage and Administration (2) , Adverse Reactions (6) , Clinical Pharmaco…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from published epidemiologic studies, case series, and case reports over several decades with cephalosporin use, including cefuroxime axetil, in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . In studies in pregnant mice and rats administered oral cefuroxime axetil during organogenesis at 14 and 9 times the maximum recommended human dose (MRHD) based on body surface area, respectively, there were no adverse developmental outcomes (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Maternal gonorrhea may be associated with preterm birth, low neonatal birth weight, chorioamnionitis, intrauterine growth restriction, small for gestational age, and premature rupture of membranes. Perinatal transmission of gonorrhea to the offspring can result in infant blindness, joint infections, and bloodstream infections. Data Human Data: While available studies cannot definitively establish the absence of risk, published data from epidemiologic studies, case series, and case reports over several decades have not identified an association with cephalosporin use (including cefuroxime axetil) during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. Animal Data: Studies performed with oral cefuroxime axetil administered to pregnant mice during organogenesis (Gestation Days 7 through 16) at doses up to 3,200 mg/kg/day (14 times the MRHD based on body surface area); and in rats dosed during organogenesis and lactation (Gestation Days 7 through 16 and Gestation Days 17 through Lactation Day 21, respectively) at doses up to 1,000 mg/kg/day (9 times the MRHD based on body surface area) have revealed no adverse developmental outcomes.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of cefuroxime axetil have been established for pediatric patients aged 3 months to 12 years for acute bacterial maxillary sinusitis based upon its approval in adults. Use of cefuroxime axetil in pediatric patients is supported by pharmacokinetic and safety data in adults and pediatric patients, and by clinical and microbiological data from adequate and well-controlled trials of the treatment of acute bacterial maxillary sinusitis in adults and of acute otitis media with effusion in pediatric patients.
It is also supported by postmarketing adverse events surveillance [see Indications and Usage (1) , Dosage and Administration (2) , Adverse Reactions (6) , Clinical Pharmacology (12.3) ].
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of subjects who received cefuroxime axetil in 20 clinical trials, 375 were aged 65 and older while 151 were aged 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger adult subjects. Reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out.
Cefuroxime is substantially excreted by the kidney, and the risk of adverse reactions 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 Overdosage of cephalosporins can cause cerebral irritation leading to convulsions or encephalopathy. Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Cefuroxime axetil is an antibacterial drug [see Microbiology (12.4) ].
12.3Pharmacokinetics Absorption After oral administration, cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolyzed by nonspecific esterases in the intestinal mucosa and blood to cefuroxime. Serum pharmacokinetic parameters for cefuroxime following administration of cefuroxime axetil tablets to adults are shown in Table 8. Table 8.
Pharmacokinetics of Cefuroxime Administered in the Postprandial State as Cefuroxime Axetil Tablets to Adults a a Mean values of 12 healthy adult volunteers. b Drug administered immediately after a meal. Dose b (Cefuroxime Equivalent) Peak Plasma Concentration (mcg/mL) Time of Peak Plasma Concentration (h) Mean Elimination Half-life (h) AUC (mcg·h/mL) 125 mg 2.1 2.2 1.2 6.7 250 mg 4.1 2.5 1.2 12.9 500 mg 7 3 1.2 27.4 1,000 mg 13.6 2.5 1.3 50 Effect of Food: Absorption of the tablet is greater when taken after food (absolute bioavailability increases from 37% to 52%).
Despite this difference in absorption, the clinical and bacteriologic responses of subjects were independent of food intake at the time of tablet administration in 2 trials where this was assessed. Lack of Bioequivalence: Oral suspension was not bioequivalent to tablets when tested in healthy adults. The tablet and oral suspension formulations are NOT substitutable on a milligram-per-milligram basis.
The area under the curve for the suspension averaged 91% of that for the tablet, and the peak plasma concentration for the suspension averaged 71% of the peak plasma concentration of the tablets. Therefore, the safety and effectiveness of both the tablet and oral suspension formulations were established in separate clinical trials. Distribution Cefuroxime is distributed throughout the extracellular fluids.
Approximately 50% of serum cefuroxime is bound to protein. Metabolism The axetil moiety is metabolized to acetaldehyde and acetic acid. Excretion Cefuroxime is excreted unchanged in the urine; in adults, approximately 50% of the administered dose is recovered in the urine within 12 hours.
The pharmacokinetics of cefuroxime in pediatric subjects have not been studied. Until further data are available, the renal elimination of cefuroxime axetil established in adults should not be extrapolated to pediatric subjects. Specific Populations Patients with Renal Impairment: In a trial of 28 adults with normal renal function or severe renal impairment (creatinine clearance <30 mL/min), the elimination half-life was prolonged in relation to severity of renal impairment.
Prolongation of the dosage interval is recommended in adult patients with creatinine clearance <30 mL/min [see Dosage and Administration (2.5) ] . Geriatric Patients: In a trial of 20 elderly subjects (mean age = 83.9 years) having a mean creatinine clearance of 34.9 mL/min, the mean serum elimination half-life was prolonged to 3.5 hours; however, despite the lower elimination of cefuroxime in geriatric patients, dosage adjustment based on age is not necessary [see Use in Specific Populations (8.5) ] . Drug Interaction Studies Concomitant administration of probenecid with cefuroxime axetil tablets increases the cefuroxime area under the serum concentration versus time curve and maximum serum concentration by 50% and 21%, respectively [see Drug Interactions (7.2) ] .
12.4Microbiology Mechanism of Action Cefuroxime axetil is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Cefuroxime axetil has activity in the presence of some β-lactamases, both penicillinases and cephalosporinases, of gram-negative and gram-positive bacteria. Resistance Resistance to cefuroxime axetil is primarily through hydrolysis by β-lactamase, alteration of penicillin-binding proteins (PBPs), decreased permeability, and the presence of bacterial efflux pumps.
Susceptibility to cefuroxime axetil will vary with geography and time; local s…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Cefuroxime axetil is an antibacterial drug [see Microbiology (12.4) ].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-0781 NDC: 50090-0781-0 20 TABLET in a BOTTLE NDC: 50090-0781-3 14 TABLET in a BOTTLE
📋 Description ▾
11 DESCRIPTION Cefuroxime axetil tablets, USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, cephalosporin antibacterial drug for oral administration. The chemical name of cefuroxime axetil (1-(acetyloxy) ethyl ester of cefuroxime) is ( RS )-1-hydroxyethyl (6 R ,7 R )-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 7 2 -( Z )-( O -methyl-oxime), 1-acetate 3-carbamate.
Its molecular formula is C 20 H 22 N 4 O 10 S, and it has a molecular weight of 510.48. Cefuroxime axetil is in the amorphous form and has the following structural formula: Tablets are film-coated and contain the equivalent of 125 mg, 250 mg or 500 mg of cefuroxime as cefuroxime axetil USP. Tablets contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide.
Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Allergic Reactions Inform patients that cefuroxime axetil is a cephalosporin that can cause allergic reactions in some individuals [see Warnings and Precautions (5.1) ] . Clostridioides difficile -Associated Diarrhea Inform 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 this occurs, advise patients to contact their physician as soon as possible. Crushing Tablets Instruct patients to swallow the tablet whole, without crushing the tablet. Patients who cannot swallow the tablet whole should receive the oral suspension.
Drug Resistance Inform patients that antibacterial drugs, including cefuroxime axetil, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefuroxime axetil is prescribed to treat a bacterial infection, inform patients 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 cefuroxime axetil or other antibacterial drugs in the future. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 10/2021