Source: Υπουργείο Υγείας (CY) Revision Year: 2018 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Cefotaxime is a broad-spectrum bactericidal cephalosporin antibiotic. Cefotaxime is exceptionally active in vitro against Gram-negative organisms sensitive or resistant to first or second-generation cephalosporins. It is similar to other cephalosporins in activity against Gram-positive organisms.
Valoran is indicated in the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity:
The administration of cefotaxime prophylactically may reduce the incidence of certain post-operative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated or in clean operations where infections would have serious effects.
Protection is best ensured by achieving adequate local tissue concentrations at the time contamination is likely to occur.
Cefotaxime should therefore be administered immediately prior to surgery and if necessary continued in the immediate post-operative period.
Administration should usually be stopped within 24 hours since continuing use of any antibiotic in the majority of surgical procedures does not reduce the incidence of subsequent infection.
Cefotaxime may also be used prophylactically along with orally administered non-absorbable antibiotics to reduce the incidence of infection among selected patients undergoing intensive therapy, whose duration of stay in Intensive Care Unit is anticipated to exceed 48 hours.
Cefotaxime may be administered intravenously or by slow injection or infusion or intramuscularly. The dosage, route and frequency of administration should be determined by the severity of infection, the sensitivity of causative organism and condition of the patient. Therapy may be initiated before the results of sensitivity tests are known.
The recommended dosage for mild to moderate infections is 1g 12 hourly. However, dosage may be varied according to the severity of the infection, sensitivity of causative organisms and condition of the patient. Therapy may be initiated before the results of sensitivity tests are known.
In severe infections dosage may be increased up to 12g daily given in 3 or 4 divided doses. For infections caused by sensitive Psuedomonas spp. daily doses of greater than 6 g will usually be required.
Dosage in Gonorrhea: A single injection of 1g may be administered intramuscularly or intravenously.
The usual dosage range is 100-150mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200mg/kg/day may be required.
The recommended dosage is 50mg/kg/day in 2 to 4 divided doses. In severe infections 150-200mg/kg/day, in divided doses, have been given.
Dosage in Renal Impairment: In patients with a creatinine clearance less than 10 ml/minute, after an initial normal dose, the maintenance doses have to be reduced to one-half of the normal dose, without change of the dose interval.
In haemodialysed or peritoneal dialysis patients: 1 to 2 g daily, depending on the severity of the infection; on the day of haemodialysis, cefotaxime must be administered after the dialysis session.
Reconstitute cefotaxime with Water for Injection as given in the Dilution Table.
Shake well until dissolved and then withdraw the entire contents of the vial into the syringe and use immediately.
| Vial Size | Diluent to be added | Approximate volume |
|---|---|---|
| 500 mg | 2 ml | 2.2 ml |
| 1 g | 4 ml | 4.5 ml |
Cefotaxime may be administered by intravenous infusion:
The prepared infusion may be administered over 20-60 minutes. To produce an infusion using vials with an infusion connector, remove the safety cap and directly connect the infusion bag. The needle in the closure will automatically pierce the vial stopper. Pressing the infusion bag will transfer solvent into the vial. Reconstitute by shaking the vial and finally, transfer the reconstituted solution back to the infusion bag ready for use.
For intermittent I.V. injections, the solution must be injected over a period of 3 to 5 minutes. During post-marketing surveillance, potentially life-threatening arrhythmia has been reported in a very few patients who received rapid intravenous administration of cefotaxime through a central venous catheter.
Cefotaxime and aminoglycosides should not be mixed in the same syringe or infusion fluid.
In case of intramuscular administration, re-constitute cefotaxime with Water for Injection or 1% lidocaine solution as per the Dilution Table below. When using lidocaine solution as diluent, intravascular injection must be strictly avoided.
| Vial Size | Volume of diluent | Nature of diluent |
|---|---|---|
| 500 mg | 2 ml | Water for injection or 1% lidocaine solution |
| 1 g | 4 ml |
For instructions on dilution of the medicinal product before administration, see section 6.6.
Symptoms of overdose may largely correspond to the profile of side effects.
There is a risk of reversible encephalopathy in cases of administration of high doses of b-lactam antibiotics including cefotaxime.
In case of overdose, cefotaxime must be discontinued, and supportive treatment initiated, which includes measures to accelerate elimination, and symptomatic treatment of adverse reactions (e.g. convulsions).
No specific antidote exists. Serum levels of cefotaxime can be reduced by haemodialysis or peritoneal dialysis.
Unopened: 2 years.
Reconstituted solution: twenty four (24) hours.
Satisfactory potency is maintained for twenty four (24) hours when stored refrigerated with the following intravenous infusion fluids:
Any unused solution remaining must be discarded at twenty four hours.
Unopened: Store below 25°C, in the original package in order to protect from light and moisture.
Reconstituted solutions should preferably be used immediately upon reconstitution.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
Cefotaxime is also compatible with Lignocaine 1% injection, but freshly prepared solutions only must be used.
Cefotaxime is also compatible with metronidazole infusion (500 mg/100 ml) and both will maintain potency when refrigerated for up to 24 hours.
Clear type I glass vials, sealed with a grey bromobutyl rubber stopper and aluminium cap. Vials are cartonned in packs of 10, 50 or 100 with an instruction leaflet. Valoran 1g is also available in packs of 1 vial.
Not all pack sizes may be marketed.
Reconstitution of the vials should be done with suitable aseptic precautions. From a microbiological point of view, reconstituted solution for intramuscular or intravenous administration should be used immediately.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution/dilution (etc) has taken place in controlled and validated aseptic conditions.
Infusion solutions, as specified in section 6.3, should not be stored for more than twenty hours. Any unused solution should be discarded. Before use, examine solutions for evidence of particles, any such solutions should not be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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