Finished product reference · In the Hanpars portfolio

Cefuroxime

Injection, Powder, for Solution · Parenteral · 1.5 g

List code
2421
Salt form
Sodium

What it is and how it works

Mechanism of Action Cefuroxime axetil is an antibacterial drug .

Indications

Cefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: Pharyngitis/tonsillitis (adults and pediatric patients) Acute bacterial otitis media (pediatric patients) Acute bacterial maxillary sinusitis (adults and pediatric patients) Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) Early Lyme disease (adults and pediatric patients 13 years and older) 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.

Dosage and administration (summary)

Tablets and oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis. Administer tablets with or without food. Administer cefuroxime axetil tablets as described in the dosage guidelines. Dosage adjustment is required for patients with impaired renal function. 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…

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).

Warnings and precautions

Serious hypersensitivity (anaphylactic) reactions: In the event of a serious reaction, discontinue cefuroxime axetil and institute appropriate therapy. Clostridioides difficile- associated diarrhea (CDAD): If diarrhea occurs, evaluate patients for CDAD. Anaphylactic Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on β-lactam antibacterials, including cefuroxime axetil . 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.

Pregnancy

Pregnancy 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) .

Storage and supply

Product: 50090-0781 NDC: 50090-0781-0 20 TABLET in a BOTTLE NDC: 50090-0781-3 14 TABLET in a BOTTLE

Source: Cefuroxime Axetil (Cefuroxime Axetil) — US FDA prescribing information, 2025-10-08, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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