Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: MIP Pharma GmbH, Kirkeler Str. 41, 66440, Blieskastel, Germany
Cefazolin is indicated for the treatment of the following infections caused by cefazolin-susceptible micro-organisms:
Perioperative prophylaxis. For surgical operations with increased risk of infections with anaerobic pathogens, e.g. colorectal surgery, a combination with an appropriate drug with activity against anaerobes is recommended.
The use of cefazolin should be limited to cases where parenteral treatment is needed.
Susceptibility of causative organism to the treatment should be tested (if possible), although therapy may be initiated before the results are available.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The dosage as well as the method of administration are dependent on the location and severity of the infection and on the clinical and bacteriological progress.
In severe infections, doses of up to 6 g per day can be administered in three or four equal doses (one dose every 6 or 8 hours).
Peri-operative prophylaxis:
It is important that (1) the preoperative dose be given just (30 min to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.
Adults with renal impairment may need a lower dose to avoid overlapping.
This lower dose may be guided by determining blood levels. If not possible the dosage of creatinine clearance can be established.
Cefazolin maintenance therapy in patients with renal impairment:
| Creatinine clearance [ml/min] | Serum creatinine [mg/dl] | Dosage |
|---|---|---|
| ≥55 | ≤1.5 | Normal dose and normal dosage interval |
| 33-54 | 1.6-3.0 | Normal dose, every 8 hours |
| 11-34 | 3.1-4.5 | Half of the normal dose every 12 hours |
| ≤10 | ≥4.6 | Half of the normal dose every 18-24 hours |
In haemodialysis patients, the treatment schedule depends on the dialysis conditions.
Infections caused by sensitive microorganisms: A dose of 25-50 mg/kg body weight divided into two to four equal doses per day is recommended (one dose every 6, 8 or 12 hours).
Infections caused by moderately sensitive microorganisms: A dose of up to 100 mg/kg body weight divided in three or four equal doses is recommended (one dose every 6 or 8 hours).
Since safety of use in prematures and infants below the age of one month has not been determined, the use of Cefazolin in these patients is not recommended. See also section 4.4.
The content of 1 vial (2000 mg cefazolin) is dissolved in 10 ml of a compatible solvent (i.e. concentration approx. 200 mg/ml). The respective volume of this solution to be used is indicated in the following table in addition to the dose in mg.
Alternatively, the dosage can be given as intravenous infusion, using the diluted solution (10 mg/ml) described in section 6.6.
| Body weight | 5 kg | 10 kg | 15 kg | 20 kg | 25 kg |
|---|---|---|---|---|---|
| Divided dose every 12 hours at 25 mg/kg body weight per day | 63 mg; 0.3 ml | 125 mg; 0.65 ml | 188 mg; 0.95 ml | 250 mg; 1.3 ml | 313 mg; 1.55 ml |
| Divided dose every 8 hours at 25 mg/kg body weight per day | 42 mg; 0.2 ml | 85 mg; 0.4 ml | 125 mg; 0.65 ml | 167 mg; 0.85 ml | 208 mg; 1.05 ml |
| Divided dose every 6 hours at 25 mg/kg body weight per day | 31 mg; 0.15 ml | 62 mg; 0.3 ml | 94 mg; 0.45 ml | 125 mg; 0.65 ml | 156 mg; 0.8 ml |
| Divided dose every 12 hours at 50 mg/kg body weight per day | 125 mg; 0.65 ml | 250 mg; 1.3 ml | 375 mg; 1.9 ml | 500 mg; 2.5 ml | 625 mg; 3.15 ml |
| Divided dose every 8 hours at 50 mg/kg body weight per day | 83 mg; 0.4 ml | 166 mg; 0.85 ml | 250 mg; 1.3 ml | 333 mg; 1.65 ml | 417 mg; 2.1 ml |
| Divided dose every 6 hours at 50 mg/kg body weight per day | 63 mg; 0.3 ml | 125 mg; 0.65 ml | 188 mg; 0.95 ml | 250 mg; 1.3 ml | 313 mg; 1.55 ml |
| Divided dose every 8 hours at 100 mg/kg body weight per day | 167 mg; 0.85 ml | 333 mg; 1.7 ml | 500 mg; 2.5 ml | 667 mg; 3.5 ml | 833 mg; 4.15 ml |
| Divided dose every 6 hours at 100 mg/kg body weight per day | 125 mg; 0.65 ml | 250 mg; 1.3 ml | 375 mg; 1.9 ml | 500 mg; 2.5 ml | 625 mg; 3.15 ml |
Children with renal impairment (like adults) may need a lower dose to avoid overlapping.
This lower dose may be guided by determining blood levels. If not possible, the dosage of creatinine clearance may be determined according to the following guidelines.
In children with moderate impairment (creatinine clearance 40-20 ml/min), 25% of the normal daily dose, divided into doses every 12 hours are sufficient.
In children with severe impairment (creatinine 20-5 ml/min) will be 10% of normal daily dose, given every 24 hours are sufficient.
All these guidelines are valid after an initial starting dose.
See also section 4.4.
In elderly patients with normal renal function no dosage adjustment is necessary.
Cefazolin 2 g may be administered by slow intravenous injection or by intravenous infusion after dilution.
The volume of diluent to be used for the reconstitution is dependent upon the method of administration.
For instructions on the reconstitution of the medicinal product before administration, please see section 6.6.
The duration of the treatment depends on the severity of the infection as well as on the clinical and bacteriological progress.
Symptoms of an overdose are headache, vertigo, paraesthesia, central nervous states of agitation, myoclonia and convulsions.
In case of poisoning, elimination accelerating measures are indicated. A specific antidote does not exist. Cefazolin can be haemodialysed.
Shelf life: 3 years.
Shelf-life of the reconstituted solution for injection/infusion The chemical and physical stability of the prepared solution is 12 hours at 25°C and 24 hours at 2-8°C. From a microbiological point of view, the prepared solution should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Do not store above 30°C. Keep the vial in the outer carton in order to protect from light.
For storage conditions after reconstitution, see section 6.3.
The product is supplied in 15 ml (type I) and 100 ml colourless glass vials (type II) closed with a chlorobutyl rubber stopper which is sealed with an aluminium flip-off cap, containing a white or almost white powder.
Packages with 1, 5 and 10 vials.
Not all pack sizes may be marketed.
For each route of administration see the table for addition volumes and solution concentrations, which may be useful when fractional doses are required.
The dry powder is dissolved in at least 10 ml water for injections, physiological sodium chloride solution (0.9%) or 5% glucose solution.
Reconstitution table for intravenous injection:
| Content per vial | Minimum amount of diluent to be added | Approximate concentration |
|---|---|---|
| 2 g | 10 ml | 200 mg/ml |
Cefazolin is to be injected slowly over three to five minutes. In no case should the solution be injected in less than 3 minutes. This should be done directly into the vein or into the tube from which the patient receives intravenous solution.
Single doses exceeding 1 g should be given as intravenous infusion over 30 to 60 minutes.
The dry powder is dissolved in 8 ml water for injections and diluted to 50-100 ml with a compatible diluent. For infusion, the powder can be reconstituted with the solvent directly in the vial.
Dilution table for intravenous infusion:
| Content per vial | Reconstitution | Dilution | Approximate concentration |
|---|---|---|---|
| Minimum amount of diluent to be added | Amount of diluent to be added | ||
| 2 g | 8 ml | 50 ml-100 ml | 34 mg/ml-19 mg/ml |
If smaller doses are needed, it is recommended to use half of the reconstituted solution (about 4 ml with 1 g cefazolin; i.e. half of the vial content) and to add a compatible diluent to a final volume of 100 ml (resulting concentration about 10 mg/ml). The required amount of this diluted solution can then be administered to the patient over the prescribed time.
The following solvents are suitable for the preparation of the solution:
The reconstituted solution is clear, pale yellow and should be protected from light.
As for all parenteral medicinal products, inspect the reconstituted solution visually for particulate matter and discoloration prior to administration. The solution should only be used if the solution is clear and practically free from particles.
The reconstituted product is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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