Finished product reference
Cefixime
Powder, for Suspension · Oral · 200 mg/5 mL · 50 mL
- List code
- 51971
What it is and how it works
Mechanism of Action Cefixime is a semisynthetic cephalosporin antibacterial drug .
Indications
Cefixime is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months and older with the following infections: Uncomplicated Urinary Tract Infections Otitis Media Pharyngitis and Tonsillitis Acute Exacerbations of Chronic Bronchitis Uncomplicated Gonorrhea (cervical/urethral) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefixime and other antibacterial drugs, cefixime for oral suspension and cefixime capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. Uncomplicated Urinary Tract Infections Cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli and Proteus mirabilis .
Dosage and administration (summary)
Adults: 400 mg daily Pediatric patients (6 months and older): 8 mg/kg/day Adults The recommended dose of cefixime is 400 mg daily. This may be given as a 400 mg capsule daily. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended. The capsule may be administered without regard to food. In the treatment of infections due to Streptococcus pyogenes , a therapeutic dosage of cefixime should be administered for at least 10 days. Pediatric Patients (6 months or older) The recommended dose is 8 mg/kg/day of the cefixime for suspension.
Contraindications
Contraindicated in patients with known allergy to cefixime or other cephalosporins. Cefixime is contraindicated in patients with known allergy to cefixime or other cephalosporins.
Warnings and precautions
Hypersensitivity reactions including shock and fatalities have been reported with cefixime. Discontinue use if a reaction occurs. Clostridiodes difficile- Associated Diarrhea: Evaluate if diarrhea occurs. Hypersensitivity Reactions Anaphylactic/anaphylactoid reactions (including shock and fatalities) have been reported with the use of cefixime. Before therapy with cefixime is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.
Pregnancy
Pregnancy Risk Summary Available data from published observational studies, case series, and case reports over several decades with cephalosporin use, including cefixime, 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
Cefixime capsules, 400 mg is size "0" capsule with pink opaque cap and pink opaque body, imprinted with "LU" on cap and "U43" on body in black ink, containing white to yellowish white granular powder containing 400 mg of cefixime as the trihydrate and is supplied as follows: NDC: 70518-3221-00 NDC: 70518-3221-01 NDC: 70518-3221-02 NDC: 70518-3221-0…
Source: Cefixime (Cefixime) — US FDA prescribing information, 2026-08-05, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
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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