Source: Υπουργείο Υγείας (CY) Revision Year: 2018 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Axetine is indicated for the treatment of the infections listed below in adults and children, including neonates (from birth) (see sections 4.4 and 5.1).
In the treatment and prevention of infections in which it is very likely that anaerobic organisms will be encountered, cefuroxime should be administered with additional appropriate antibacterial agents.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Table 1. Adults and children ≥40 kg:
| Indication | Dosage |
|---|---|
| Community acquired pneumonia and acute exacerbations of chronic bronchitis | 750 mg every 8 hours (intravenously or intramuscularly) |
| Soft-tissue infections: cellulitis, erysipelas and wound infections | |
| Intra-abdominal infections | |
| Complicated urinary tract infections, including pyelonephritis | 1.5 g every 8 hours (intravenously or intramuscularly) |
| Severe infections | 750 mg every 6 hours (intravenously) 1.5 g every 8 hours (intravenously) |
| Surgical prophylaxis for gastrointestinal, gynaecological surgery (including caesarean section) and orthopaedic operations | 1.5 g with the induction of anaesthesia. This may be supplemented with two 750 mg doses (intramuscularly) after 8 hours and 16 hours. |
| Surgical prophylaxis for cardiovascular and oesophageal operations | 1.5 g with induction of anaesthesia followed by 750 mg (intramuscularly) every 8 hours for a further 24 hours. |
Table 2. Children <40kg:
| Infants and toddlers >3 weeks and children <40 kg | Infants (birth to 3 weeks) | |
|---|---|---|
| Community acquired pneumonia | 30 to 100 mg/kg/day (intravenously) given as 3 or 4 divided doses; a dose of 60 mg/kg/day is appropriate for most infections | 30 to 100 mg/kg/day (intravenously) given as 2 or 3 divided doses (see section 5.2) |
| Complicated urinary tract infections, including pyelonephritis | ||
| Soft-tissue infections: cellulitis, erysipelas and wound infections | ||
| Intra-abdominal infections |
Cefuroxime is primarily excreted by the kidneys. Therefore, as with all such antibiotics, in patients with markedly impaired renal function it is recommended that the dosage of Axetine should be reduced to compensate for its slower excretion.
Table 3. Recommended doses for Axetine in renal impairment:
| Creatinine clearance | T1/2 (hrs) | Dose mg |
|---|---|---|
| >20 mL/min/1.73 m² | 1.7–2.6 | It is not necessary to reduce the standard dose (750 mg to 1.5 g three times daily). |
| 10-20 mL/min/1.73 m² | 4.3–6.5 | 750 mg twice daily |
| <10 mL/min/1.73 m² | 14.8–22.3 | 750 mg once daily |
| Patients on haemodialysis | 3.75 | A further 750 mg dose should be given intravenously or intramuscularly at the end of each dialysis; in addition to parenteral use, cefuroxime sodium can be incorporated into the peritoneal dialysis fluid (usually 250 mg for every 2 litres of dialysis fluid). |
| Patients in renal failure on continuous arteriovenous haemodialysis (CAVH) or high-flux haemofiltration (HF) in intensive therapy units | 7.9–12.6 (CAVH) 1.6 (HF) | 750 mg twice daily; for low-flux haemofiltration follow the dosage recommended under impaired renal function. |
Cefuroxime is primarily eliminated by the kidney. In patients with hepatic dysfunction this is not expected to affect the pharmacokinetics of cefuroxime.
Axetine should be administered by intravenous injection over a period of 3 to 5 minutes directly into a vein or via a drip tube or infusion over 30 to 60 minutes, or by deep intramuscular injection. For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Overdose can lead to neurological sequelae including encephalopathy, convulsions and coma. Symptoms of overdose can occur if the dose is not reduced appropriately in patients with renal impairment (see sections 4.2 and 4.4).
Serum levels of cefuroxime can be reduced by haemodialysis or peritoneal dialysis.
2 years.
Reconstituted Solution: Immediate use of the reconstituted solution is recommended.
Chemical and physical stability has been demonstrated:
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally be no longer than 24 hours at 2°C–8 °C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Store below 25ºC, in the original package.
For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Axetine 250mg powder for solution for injection or infusion:
Type I clear glass vials having a nominal capacity of 10ml that are sealed with a 20mm bromobutyl rubber stopper and an aluminium cap.
Axetine 750mg powder for solution for injection or infusion:
Type I clear glass vials having a nominal capacity of 15ml that are sealed with a 20mm bromobutyl rubber stopper and an aluminium cap.
Axetine 1.5g powder for solution for injection or infusion:
Type I clear glass vials having a nominal capacity of 15ml that are sealed with a 20mm bromobutyl rubber stopper and an aluminium cap.
Boxes of 1, 10, 50 or 100 vials.
Table 4. Addition volumes and solution concentrations, which may be useful when fractional doses are required.
| Addition volumes and solution concentrations, which may be useful when fractional doses are required | |||
| Vial size | Amount of water to be added (ml) | Approximate cefuroxime concentration (mg/mL)** | |
| 250 mg | intramuscular intravenous | 1 mL at least 2 mL | 216 116 |
| 750 mg | intramuscular intravenous bolus intravenous infusion | 3 mL at least 6 mL at least 6 mL | 216 116 116 |
| 1.5 g | intramuscular intravenous bolus intravenous infusion | 6 mL at least 15mL 15 mL* | 216 94 94 |
* Reconstituted solution to be added to 50 or 100 ml of compatible infusion fluid (see information on compatibility, below)
** The resulting volume of the solution of cefuroxime in reconstitution medium is increased due the displacement factor of the drug substance resulting in the listed concentrations in mg/ml.
Cefuroxime sodium is compatible with the following infusion fluids. It will retain potency for up to 6 hours at 25°C and 24 hours at 2°C-8°C (in refrigerator) in:
Freshly prepared solution for IV administration is yellowish, while suspension for IM administration is almost white.
Solution can turn darker when standing but change of intensity of color of diluted solution does not affect safety of administration and effectiveness of medicinal product.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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