Cefotaxim Medochemie 1 g powder for solution for injection/infusion – a third-generation cephalosporin antibiotic

Cefotaxim Medochemie is a third-generation cephalosporin antibiotic containing the active substance cefotaxime (as cefotaxime sodium). It kills bacteria by preventing them from building their cell wall and is used to treat serious bacterial infections in newborns, children and adults, and to prevent infections in some operations.

The medicine is a powder for solution for injection/infusion (1 g cefotaxime per vial) and may be used only in an inpatient healthcare facility – it is prepared and given by a doctor or nurse, into a muscle or a vein.

What is Cefotaxim Medochemie (cefotaxime) used for and how is it given?

Key facts about the medicine

What is Cefotaxim Medochemie used for?

Cefotaxim Medochemie is used in newborns, children and adults to treat infections caused by bacteria that are confirmed or likely to be susceptible to cefotaxime:

• blood infections (septicaemia)
• respiratory tract infections – acute and chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess, postoperative chest infections
• kidney and urinary tract infections – acute and chronic pyelonephritis, cystitis, asymptomatic bacteriuria
• soft tissue infections – cellulitis, peritonitis, wound infections
• bone and joint infections – osteomyelitis, septic arthritis
• gynaecological and obstetric infections, such as pelvic inflammatory disease
• gonorrhoea
• other bacterial infections, such as meningitis

The medicine may also be given before some surgical procedures to prevent infection (prophylaxis); administration is usually stopped within 24 hours.

How is it given and dosed?

The dose and dosing interval depend on the type and severity of the infection, the susceptibility of the pathogen, body weight and other illnesses, particularly kidney disease.

The medicine is prepared and given by a healthcare professional – as an injection into a muscle, an injection into a vein over 3–5 minutes or an infusion into a vein over 20–60 minutes. This is general dosing from the package leaflet – the doctor determines the dose for each patient.

Special patient groups

• Impaired kidney function: with creatinine clearance below 10 mL/min, after the usual initial dose the maintenance doses are reduced by half without changing the dosing interval.
• Haemodialysis: 1–2 g daily depending on the severity of infection; on dialysis days the medicine is given after dialysis. Peritoneal dialysis: 1–2 g daily (cefotaxime is not removed by peritoneal dialysis).
• Newborns and children: the dose is calculated according to body weight (see table).
• People on a sodium-controlled diet: 1 g of the medicine contains approximately 48 mg (2.09 mmol) of sodium.

Contraindications – when the medicine must not be given

• allergy (hypersensitivity) to cephalosporins
• previous hypersensitivity to cefotaxime (rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue)

Warnings and precautions

• Tell the doctor if you are allergic to any antibiotic, especially penicillins – cross-allergic reactions are possible.
• Caution in kidney disease (dose adjustment may be needed) and in patients with previous severe diarrhoea during or after antibiotics (pseudomembranous colitis).
• Antibiotics, including cefotaxime, may cause encephalopathy (convulsions, confusion, impaired consciousness, abnormal movements), especially at high doses or with impaired kidney function.
• Prolonged use may lead to overgrowth of resistant organisms (superinfection).
• The medicine may affect the Coombs test and urine glucose tests – tell the staff that you are receiving Cefotaxim Medochemie.

Interactions with other medicines

• aminoglycoside antibiotics (gentamicin, streptomycin, neomycin, kanamycin, amikacin, tobramycin) – possible increased harmful effect on the kidneys; not mixed in the same syringe or infusion
• diuretics such as furosemide and etacrynic acid – kidney function should be monitored
• probenecid (a medicine for gout) – reduces excretion and increases blood levels of cefotaxime

Tell your doctor about all medicines you are taking, including non-prescription and herbal medicines.

Pregnancy and breast-feeding

If you are pregnant, breast-feeding or planning a pregnancy, ask your doctor before treatment. Safety in pregnant women has not been established and cefotaxime crosses the placenta, so in pregnancy it is used only when the expected benefit outweighs the possible risks.

Cefotaxime passes into breast milk and may affect the infant’s gut flora (diarrhoea, fungal colonisation, sensitisation); the doctor decides whether to stop breast-feeding or treatment.

Driving and using machines

Abnormal movements, sudden involuntary muscle contractions, dizziness or slowed reactions may occur. If this happens, do not drive or use machines.

Possible side effects

• Very common: pain at the injection site with intramuscular use.
• Uncommon: eosinophilia, reduced neutrophil and platelet counts, Jarisch-Herxheimer reaction (when treating borreliosis), convulsions, diarrhoea, increased liver enzymes and bilirubin, rash, itching, hives, reduced kidney function (especially with aminoglycosides), fever, inflammatory reactions at the injection site including phlebitis.
• Frequency not known: superinfection, severe blood disorders (leukopenia, agranulocytosis, haemolytic anaemia), anaphylaxis, angioedema, bronchospasm, headache, dizziness, encephalopathy, heart rhythm disturbance after rapid injection through a central venous catheter, nausea, vomiting, abdominal pain, pseudomembranous colitis, hepatitis (sometimes with jaundice), severe skin reactions (erythema multiforme, SJS, TEN, AGEP), acute kidney failure and interstitial nephritis.

Report any suspected side effects to your doctor, nurse or ALIMS.

Overdose, missed dose and stopping treatment

• The medicine is given by a healthcare professional, so overdose is unlikely. Symptoms of overdose correspond to the side effects, with a risk of encephalopathy; treatment is then stopped and supportive care given (cefotaxime can be removed by haemodialysis).
• If you think a dose has been missed, tell the doctor; a double dose is not given.
• Treatment should continue as long as the doctor has prescribed – stopping early may lead to a return of the illness and bacterial resistance.

Related information

For additional care and support with restoring the gut flora during and after antibiotic treatment, see also the Probiotics category – products in this category do not replace the medicine you have been prescribed.

Composition, packaging and manufacturer

• Active substance: cefotaxime 1 g (as cefotaxime sodium) per vial; approximately 48 mg (2.09 mmol) of sodium per gram.
• The medicine contains no excipients.
• Appearance and pack: white or slightly yellow hygroscopic powder in a 10 mL clear glass vial with a grey rubber stopper and aluminium cap; pack of 10 or 100 vials.
• Marketing authorisation holder: FARMALOGIST D.O.O. BEOGRAD, Mirijevski bulevar 3, Belgrade. Manufacturer: Medochemie Ltd (Factory C), Agios Athanassios, Limassol, Cyprus.

Storage

• Store below 25 °C, protected from light and moisture; shelf life of the unopened medicine 2 years.
• Use immediately after reconstitution; the solution is physically and chemically stable for 20 hours at 2–8 °C (in water for injections, saline, 5% glucose, their mixture or Ringer lactate).
• Do not use a cloudy solution or one with visible particles. Keep out of the sight and reach of children.

Frequently asked questions

Can Cefotaxim Medochemie be bought in a pharmacy?

No. The medicine may be used only in an inpatient healthcare facility and is given by a doctor or nurse.

How is cefotaxime given?

As an injection into a muscle, a slow injection into a vein over 3–5 minutes or an infusion into a vein over 20–60 minutes. The medicine is dissolved in a suitable solvent before use.

Can I receive cefotaxime if I am allergic to penicillin?

Cross-allergic reactions between penicillins and cephalosporins are possible. Tell the doctor about any allergy – if you are allergic to cephalosporins, you must not receive this medicine.

Is cefotaxime also given to babies?

Yes, it is used in newborns and children, with a dose the doctor calculates according to body weight (e.g. in newborns 50 mg/kg daily for mild to moderate infections).

What if I get diarrhoea?

Diarrhoea is an uncommon side effect. Severe, watery diarrhoea with blood or mucus may be a sign of pseudomembranous colitis and requires urgent medical help.

Sources

• ALIMS – Summary of Product Characteristics, Cefotaxim Medochemie 1 g powder for solution for injection/infusion (10 x 1 g, Serbian)
• ALIMS – Package leaflet, Cefotaxim Medochemie 1 g (September 2021; 10 x 1 g, Serbian)
• ALIMS – Package leaflet, Cefotaxim Medochemie 1 g (100 x 1 g, Serbian)

Sources checked on: 24 October 2026.