Source: Υπουργείο Υγείας (CY) Revision Year: 2018 Publisher: Medochemie Ltd, 1–10 Constantinoupoleus Street 3011 Limassol, Cyprus
Zepilen is indicated for the treatment of serious infections caused by cefazolin-susceptible micro-organism:
The dosage, the route of administration and the dosing interval depends on the severity of the infection, the susceptibility of the detected pathogen and the patient’s condition (e.g. kidney function).
The recommended daily dose for mild to moderate infections is 2 to 6 g, distributed in 2-3 doses; if necessary, the dose may be increased to up to 12 g in severe and life-threatening infections.
| Infection | Dose | Dosing interval |
|---|---|---|
| Pneumococcal pneumonia | 500 mg | 12 h |
| Mild infections caused by susceptible gram-positive cocci | 250 mg to 500 mg | 8h |
| Acute uncomplicated urinary tract infections | 1 g | 12h |
| Moderate to severe infections | 500 mg to 1 g | 6h to 8h |
| Severe to life-threatening infections (eg endocarditis, septicemia)* | 1 g to 1.5 g | 6h |
* In rare instances, up to 12 g/day (septicemia).
For perioperative prophylaxis, the following dosages are recommended for adults:
It is important that the pre-operative dose is administered in time (30 minutes to 1 hour) prior to the surgery, so the appropriate antibiotics to be present in serum and tissue; also, in case of risk of infection, cefazolin should be administered at appropriate intervals during the operation, so that sufficient antibiotic doses are provided.
In renal impairment, a suitable dose should be given. The dose should be determined based on the degree of renal impairment, the severity of the infection and the sensitivity of the pathogen.
Dosage limitation:
| CrCl = >55 ml/min Serum creatinine = <1,5 mg % | Full daily dose |
| CrCl = 35-54 ml/min Serum creatinine = 1,6-3mg % | Full daily dose with dosing interval of min. 8 h |
| CrCl = 11–34 ml/min Serum creatinine = 3,1-4,5 | Half the full daily dose at 12 h intervals |
| CrCl = <10 ml/min Serum creatinine = >4,6 mg % | Half the full daily dose at 18-24 h intervals |
Cr.Cl. = Creatinine Clearance
Paediatric dosing:
| Weight | 25 mg/kg/day 3 single doses | 25 mg/kg/day 4 single doses | ||
| Single dose approximately every 8 hours. | Volume at a conc. of 125 mg/ml | Single dose approximately every 6 hours. | Volume at a conc. of 125 mg/ml | |
| 4,5 kg | 40 mg | 0,35 ml | 30 mg | 0,25 ml |
| 9,0 kg | 75 mg | 0,6 ml | 55 mg | 0,45 ml |
| 13,5 kg | 115 mg | 0,9 ml | 85 mg | 0,7 ml |
| 18.0 kg | 150 mg | 1,2 ml | 115 mg | 0,9 m |
| 22,5 kg | 190 mg | 1,5 ml | 140 mg | 1,1 ml |
| Weight | 50 mg/kg/day 3 single doses | 50 mg/kg/day 4 single doses | ||
| Single dose approximately every 8 hours. | Volume at a conc. of 225 mg/ml | Single dose approximately every 6 hours. | Volume at a conc. of 225 mg/ml | |
| 4 kg | 75 mg | 0,35 ml | 55 mg | 0,25 ml |
| 9 kg | 150 mg | 0,7 ml | 110 mg | 0,5 ml |
| 13,5 kg | 225 mg | 1 ml | 170 mg | 0,75 ml |
| 18 kg | 300 mg | 1,35 ml | 225 mg | 1,0 ml |
| 22,5 kg | 375 mg | 1,7 ml | 285 mg | 1,25 ml |
A total daily dose of 25-50 mg/kg body weight, 3-4 evenly divided doses, is effective against most mild to moderate infections.
In severe infections, the total daily dose may be increased to 100 mg/kg body weight.
In renal impairment, a suitable dose should be given. The dose should be determined based on the degree of renal impairment, the severity of the infection and the sensitivity of the pathogen.
Dosage limitation:
| CrCl = 70-40 ml/min | 60% of the usual daily dose in 2 same doses |
| CrCl = 40-20 ml/min | 20% of the usual daily dose in 2 same doses |
| CrCl = 20-5 ml/min | 10% of the usual daily dose in 2 same doses |
Cr. Cl. = Creatinine Clearance
The safety of cefazolin in premature infants and infants less than one month was not investigated.
Zepilen may be administered intramuscularly or intravenously. Not for intrathecal use.
The total daily dose for administration is the same for both routes.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Following reconstitution, the solution should be injected deeply into a muscle.
Following reconstitution, the solution should be injected slowly over a period of three to five minutes. The period of injection must not be less than three minutes. Injection may be made directly into a vein, or if the patient is receiving one of the infusion fluids listed in section 6.6 under intravenous infusion, into the tubing.
Pain, inflammation and phlebitis at the injection site may occur following overdose. Very high doses of parenteral cephalosporins may cause dizziness, paresthesia and headache.
Seizures can occur following overdose with some cephalosporins, particularly in patients with kidney disease.
The following abnormal laboratory results may occur: increase in creatinine, BUN, liver enzymes and bilirubin, a positive Coombs' test, thrombocytosis, thrombocytopenia, eosinophilia, leucopenia and prolongation of prothrombin time. The drug should be discontinued immediately if spasms occur.
A treatment with an anticonvulsant may be appropriate. Close monitoring of vital physiological processes, as well as appropriate laboratory tests should be performed.
In case of large overdose, especially in patients with kidney damage, a combination of hemodialysis and hemoperfusion can be useful, if other therapies fail to respond, although no data is available on such use.
Powder for solution for injection/infusion: 36 months.
Reconstituted solution: The reconstituted solution is preferably to be used immediately.
Chemical and physical in-use stability after reconstitution for all types of administration has been demonstrated for 24 hours at 2°C–8°C. From a microbiological point of view, 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°C–8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Store below 25°C in the original package.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Clear, colourless type I glass vials, sealed with a grey bromobutyl stopper and an aluminium overcap.
Each vial contains either 500 mg, or 1 g of cefazolin as cefazolin sodium. Cartons containing 1, 10, 50 or 100 vials are available.
Not all pack sizes may be marketed.
Intramuscular administration: The vial is reconstituted with 2.0ml water for injection. Shake well to completely dissolve. The administration is deeply i.m.
Intravenous injection: The vials is first reconstituted with 2.0ml water for injection and then is diluted with water for injection to a volume of 10ml water for injection, until it is completely dissolved and slowly, (never less than 3 minutes) injected for 5 min directly into a vein or into the intravenous infusion line.
Intravenous Infusion: The vial is reconstituted with 2.0ml water for injection until it is completely dissolved and diluted in 100ml in the one of the following diluents:
Intramuscular administration: The vial is reconstituted with 2.5ml water for injection. Shake well to completely dissolve. The administration is deeply i.m.
Intravenous injection: The vial is first reconstituted with 2.5ml water for injection and then is diluted with water for injection to a volume of 10ml water for injection, until it is completely dissolved and slowly, (never less than 3 minutes) injected for 5 min directly into a vein or into the intravenous infusion line.
Intravenous infusion: The vial is reconstituted with 2.5ml water for injection until it is completely dissolved and diluted in 100ml in the one of the following diluents:
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