Cefotaxime

Indications

INDICATIONS AND USAGE Treatment Cefotaxime for Injection, USP is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae ), Streptococcus pyogenes* (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis ), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli , Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae , Proteus mirabilis , Serratia marcescens* , Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa ). Genitourinary infections .

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION The intent of this Pharmacy Bulk Package is for the preparation of solutions for intravenous infusion only. Adults Dosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient (see table for dosage guideline). Cefotaxime may be administered IV after reconstitution. The maximum daily dosage should not exceed 12 grams.

Contraindications

CONTRAINDICATIONS Cefotaxime is contraindicated in patients who have shown hypersensitivity to cefotaxime sodium, or the cephalosporin group of antibiotics.

Warnings and precautions

WARNINGS BEFORE THERAPY WITH CEFOTAXIME IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFOTAXIME SODIUM, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN WITH CAUTION TO PATIENTS WITH TYPE I HYPERSENSITIVITY REACTIONS TO PENICILLIN. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS. IF AN ALLERGIC REACTION TO CEFOTAXIME OCCURS, DISCONTINUE TREATMENT WITH THE DRUG.

Pregnancy

Pregnancy: Teratogenic Effects Reproduction studies have been performed in pregnant mice given cefotaxime intravenously at doses up to 1200 mg/kg/day (0.4 times the recommended human dose based on mg/m 2 ) or in pregnant rats when administered intravenously at doses up to 1200 mg/kg/day (0.8 times the recommended human dose based on mg/m 2 ).

Storage and supply

HOW SUPPLIED Sterile Cefotaxime for Injection, USP, in Pharmacy Bulk Packages, is a dry off-white to pale yellow crystalline powder containing cefotaxime sodium as follows: 10 g cefotaxime (free acid equivalent) in bottles, packages of 1 (NDC 0143-9935-01); NOT FOR DIRECT ADMINISTRATION.

Source: Cefotaxime (Cefotaxime) — US FDA prescribing information, 2024-04-11, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.