STOPAREN Powder and solvent for solution for injection Ref.[4799] Active ingredients: Cefotaxime

Cefotaxime may be administered intravenously, by bolus injection or by infusion, or by intramuscular injection. 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 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 three or four divided doses. For infections caused by sensitive Pseudomonas species daily doses of greater than 6g will usually be required.

Children: The usual dosage range is 100-150mg/kg/day in two to four divided doses. However, in very severe infection doses of up to 200mg/kg/day may be required. Neonates: The recommended dosage is 50mg/kg/day in two to four 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 in severe renal failure (GFR <5ml/min = serum creatinine approximately 751 micromol/litre). After an initial loading dose of 1g, daily dose should be halved without change in the frequency of dosing, i.e. 1g twelve hourly becomes 0.5g twelve hourly, 1g eight hourly becomes 0.5g eight hourly, 2g eight hourly becomes 1g eight 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.

Dosage in hepatic impairment: No dosage adjustment is required. Intravenous and Intramuscular Administration: Reconstitute cefotaxime with Water for Injection (IV) or 1% lidocaine Hcl solution as directed in Section 5.6 (Instructions for use/handling). Shake well until dissolved and then withdraw the entire contents of the vial into the syringe.

Intravenous Infusion: Cefotaxime may be administered by intravenous infusion using the fluids stated in Section 5.6 (Instructions for use/handling). The prepared infusion may be administered over 20-60 minutes.

Serum levels of cefotaxime may be reduced by peritoneal dialysis or haemodialysis. In the case of overdosage, particularly in renal insufficiency, there is a risk of reversible encephalopathy.

Unopened: 2 years.

From a microbiological point of view, once opened, the product 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 2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Unopened: Do not store above 25°C.

Keep the vials in the outer carton. For storage times following reconstitution, see section 5.3.

Cefotaxime is supplied in Type III glass vials, closed with a rubber stopper.

STOPAREN 500mg (IM+IV): BTx1 vial + 1 ampoule solvent (2ml).

STOPAREN 1g (IV): BTx 1 vial + 1 ampoule solvent (4ml).

STOPAREN 1g (IM): BTx 1 vial + 1 ampoule solvent (4ml).

For single use only. Discard any unused contents.

When dissolved in Water for Injection, cefotaxime forms a straw-coloured solution suitable for intravenous and intramuscular injection. Variations in the intensity of colour of the freshly prepared solutions do not indicate a change in potency or safety. Dilution table (Intramuscular and Intravenous administration):

Reconstituted solution

Whilst it is preferable to use only freshly prepared solutions for both intravenous and intramuscular injection, cefotaxime is compatible with several commonly used intravenous infusion fluids and will retain satisfactory potency for up to 24 hours refrigerated (2°C-8°C) in the following:

• Water for Injections
• Sodium Chloride Intravenous Infusion
• 5% Glucose Intravenous Infusion
• Compound Sodium Lactate Intravenous Infusion (Ringer-lactate solution for injection)
• Haemaccel
• Macrodex 6%
• Rheomacrodex 10%

Intravenous Infusion

1-2g cefotaxime are dissolved in 40-100ml of infusion fluid. After 24 hours any unused solution should be discarded.

Cefotaxime is compatible with 1% lidocaine; however freshly prepared solutions should be used.