Posology : מינונים

4.2.      Posology and method of administration

Posology
Cefotaxime Medo 1 gr 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 organisms and condition of the patient. Therapy may be initiated before the results of sensitivity tests are known.


Adults:
The recommended dosage for mild to moderate infections is 1 g 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 12 g 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 1 g may be administered intramuscularly or intravenously.


Children:
The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.


Neonates:
The recommended dosage is 50 mg/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:
Because of extra-renal elimination, it is only necessary to reduce the dosage of Cefotaxime Medo 1 gr in severe renal failure (GFR <5 ml/min = serum creatinine approximately 751 micromol/l). After an initial loading dose of 1 g, daily dose should be halved without change in the frequency of dosing, i.e., 

1 g in 12 hourly becomes 0.5 g 12 hourly, 1 g 8 hourly becomes 0.5 g 8 hourly, 2 g 8 hourly becomes 1 g 8 hourly, etc. As in all other patients, dosage may require further adjustment according to the course of the infection and the general condition of the patient.


Method of administration:
Intravenous and Intramuscular
Intravenous administration (Injection or infusion):
For Intravenous injection, reconstitute cefotaxime Medo 1 gr 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.


Dilution Table:
Vial Size                           Diluent to be added                    Approximate volume 1g                                  4 ml                                   4.5 ml 
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.


Intravenous infusion: Cefotaxime Medo 1 gr may be administered by intravenous infusion: -   1-2 g are dissolved in 40-100 ml of Water for Injection or in the infusion fluids listed under section 6.6.


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.



Cefotaxime and aminoglycosides should not be mixed in the same syringe or infusion fluid.

Intramuscular administration:
For intramascular injection Cefotaxime Medo 1gr should be dissolved in 4 ml Water for Injections and then administered by deep intragluteal injection. Pain on I.M. injection can be avoided by dissolving Cefotaxime Medo 1gr in 4 ml lidocaine solution 1%. An intravascular injection should be avoided because lidocaine can cause restlessness, tachycardia, conduction disturbances, vomiting and convulsions following intravascular administration. (See 4.3 contraindications) It is advisable not to inject a volume greater than 4 ml on one side. If the daily dose exceeds 2 g, or more than two daily injections are required, the dose should be administered intravenously.


For instructions on dilution of the medicinal product before administration, see section 6.6.