Cefuroxime axetil 250 mg/1
Cefuroxime axetil · TABLET, FILM COATED · Major Pharmaceuticals
Cefuroxime axetil is a tablet, film coated containing cefuroxime axetil at 250 mg/1, taken oral. Manufactured by Major Pharmaceuticals.
Key Facts
- Brand Name
- Cefuroxime axetil
- Generic Name
- Cefuroxime axetil
- NDC Code (Product)
0904-7542- Manufacturer
- Major Pharmaceuticals
- Strength
- 250 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA065496
- Marketing Start
- 08/25/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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. 1.1 Pharyngitis/Tonsillitis Cefuroxime axetil tablets are i…
Dosage & 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…
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 )
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 ) 7.1 Drugs 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. 7.2 Probenecid 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. 7.3 Drug/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…
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 . 6.1 Clinical 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 d…
Frequently Asked Questions
What is Cefuroxime axetil used for?
Cefuroxime axetil contains Cefuroxime axetil. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Cefuroxime axetil a controlled substance?
Cefuroxime axetil is not classified as a controlled substance by the DEA.
What is the generic name for Cefuroxime axetil?
The generic name for Cefuroxime axetil is Cefuroxime axetil. There are 7 other brand versions of Cefuroxime axetil.
What is the NDC code for Cefuroxime axetil 250 mg/1?
The NDC (National Drug Code) for Cefuroxime axetil 250 mg/1 is 0904-7542, listed by Major Pharmaceuticals.