Cefazolin-Trima

/ Trima

The dosage depends on the susceptibility of the pathogens, and the severity of the disease.
See prescribing information for full details.

Treatment of serious infections caused by susceptible organisms and also perioperatively for prophylaxis.
Treatment Respiratory tract: Respiratory tract infections due to streptococcus pneumoniae (formerly diplococcus pneumoniae), klebsiella species, haemophilus influenzae, staphylococcus aureus (penicillin-sensitive and penicillin-resistant) and group A beta-hemolytic streptococci.
Cefazolin is effective in the eradication of streptococci from the nasopharynx. However, data establishing the efficacy of cefazolin in the subsequent
prevention of rheumatic fever is not available at present.
Urinary tract: Infections due to escherichia coli, klebsiella species, proteus mirabilis and some strains of Enterobacter and enterococci.
Skin and skin structure: Hemolytic beta Infections due to staphylococcus aureus (penicillin-sensitive and penicillin- resistant), group A streptococci and other strains of streptococci.
Biliary tract: Infections due to escherichia coli, various strains of streptococci, proteus mirabilis, klebsiella species and staphylococcus aureus.
Bone and joint: Infections due to staphylococcus aureus.
Genital infections: (i.e. prostatitis epididymitis) due to escherichia coli, proteus mirabilis, klebsiella species and some strains of enterococci.
Septicemia due to streptococcus pneumoniae: (formerly diplococcus pneumoniae), staphylococcus aureus (penicillin-sensitive and penicillin-resistant), proteus mirabilis,
escherichia coli and klebsiella species.
Endocarditis: caused by staphylococcus aureus (penicillin-sensitive and penicillin-resistant) and group A beta-hemolytic streptococci.
Appropriate culture and susceptibility studies should be performed to determine the susceptibility of the causative organism to cefazolin.
Perioperative prophylaxis:
The prophylactic administration of cefazolin perioperatively (preoperatively, intraoperatively and postoperatively) may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures (e.g. hysterectomy, gastrointestinal surgery and transurethral prostatectomy) that are classified as contaminated or potentially contaminated.
The perioperative use of cefazolin may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g. open-heart surgery and prosthetic arthroplasty).

* Hypersensitivity to the active substance, other cephalosporins or to any of the excipients.
* History of previous immediate and/or severe hypersensitivity reaction to a penicillin or to any other type of beta-lactam drug.
* Cefazolin must not be used together with antibiotics which have a bacteriostatic mode of action (e.g. tetracyclines, sulfonamides, erythromycin, chloramphenicol) since antagonistic effects were observed in in-vitro tests.

* Special precaution should be exercised in patients with an allergic diathesis, with bronchial asthma or hay fever. Before the administration of cefazolin previous hypersensitivity reactions to other beta-lactams (penicillins or cephalosporins) should be investigated.
* In patients developing allergic reactions the drug should be discontinued and appropriate symptomatic treatment should be instituted. Cross allergies with other
cephalosporins and occasionally occurring cross allergies with penicillins should be considered. In cases of known hypersensitivity to penicillins, a cross-allergy to other
beta-lactams such as cephalosporins should be taken into account. Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients treated with beta-lactam antibiotics. These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity.
* In the case of severely impaired renal function with a glomerular filtration rate below 55 ml/min, accumulation of cefazolin can be expected; therefore the dose should be reduced accordingly or the dosing interval extended. Although  Cefazolin seldom causes renal impairment, it is recommended to monitor the renal function, especially in severely ill patients, who are administered maximum doses and in patients who receive other potentially nephrotoxic drugs concomitantly, such as aminoglycosides or potent diuretics (e.g. furosemide).
* In rare cases, coagulation disorders may occur during cefazolin treatment. Patients at risk are those with risk factors causing vitamin K deficiency or affecting other
coagulation mechanisms (parenteral nutrition, dietary deficiencies, impaired hepatic and renal function, thrombocytopenia). Blood clotting may also be disrupted in
case of associated diseases (e.g. haemophilia, gastric and duodenal ulcers) causing or aggravating haemorrhages. Prothrombin time should, therefore, be monitored
in patients presenting with these diseases. If these values are reduced, vitamin K (10 mg/week) should be supplemented.
* Antibiotic-related pseudomembranous colitis
Cases of antibiotic-associated colitis have been reported in almost all antibiotics, the severity of which can range from mild to life threatening (see section 4.8). Therefore
it is important to be mindful of this diagnosis in patients who experience diarrhoea during or after using an antibiotic. In the event of antibiotic-associated colitis, cefazolin should be discontinued immediately, and appropriate treatment initiated. Anti-peristaltic medicinal products are contraindicated in this situation.
* With long-term use of cefazolin, non-sensitive pathogens can get out of control. Close monitoring of the patient is therefore essential. If a superinfection occurs
during treatment, appropriate measures must be taken.
* Long-term or high-dose therapy: Regular check of organ system functions, including renal, hepatic and hematopoietic function, is advisable during long-term or high-dose treatment. Elevated liver enzymes and changes in blood cells have been reported.
* In patients with hypertension or heart failure the sodium content of the solutions for injection should be taken into account (48 mg per 1 g cefazolin)
* Paediatric population
Cefazolin should not be administered to premature and newborn infants of less than 1 month of age as no data is available and the safety of use has not been established.
* Intrathecal administration: Not for intrathecal administration. Severe central nervous system intoxications (including convulsions) were reported following intrathecal administration of cefazolin.
See prescribing information for full details

Common: Allergic skin reactions such as, erythema, urticaria and pruritus, diarrhoea, nausea, vomiting, loss of appetite, rash.
See prescribing information for full details

Simultaneous administration is Contraindicated
Antibiotics
Cefazolin must not be used together with antibiotics which have a bacteriostatic mode of action (e.g. tetracyclines, sulfonamides, erythromycin, chloramphenicol) since
antagonistic effects were observed in in-vitro tests.
Concomitant administration is not recommended
Probenecid
The renal clearance of cefazolin is reduced when probenecid is co-administered.
Precautions
Vitamin K1
Some cephalosporins such as cefamandol, cefazolin and cefotetan may interfere with the metabolism of vitamin K1, especially in cases of vitamin K1 deficiency. This
may require vitamin K1 supplementation.
Anticoagulants
Cephalosporins may very rarely lead to blood coagulation disorders. If oral anticoagulants or high dosage heparin are concomitantly used, coagulation
parameters should be monitored.
Nephrotoxic agents
An increase in nephrotoxic effects of antibiotics (e.g. aminoglycosides, colistin, polymyxin B) and diuretics (e.g. furosemide) cannot be ruled out. Renal values should
be carefully monitored when these medicinal products are co-administered with cefazolin.
Laboratory tests
Laboratory tests for urinary glucose concentrations may give false positive readings if based on Benedict’s solution, Fehling’s solution or Clinitest® tablets. However,
cefazolin does not affect enzyme-based tests.
Both the indirect and the direct Coombs test may also give false positive readings, e.g. in newborns whose mothers received cephalosporins.
Please refer to the license holder for further details.

Pregnancy: To date there is insufficient experience on use of cefazolin during pregnancy in humans, therefore it should only be used during pregnancy, especially during the first trimester, after careful benefit-risk evaluation.
Lactation: Cefazolin is excreted into human milk at low concentration. Cefazolin can cause sensitization and change in the intestinal flora, as well as candida infections in breast-fed infants. In these cases, breast-feeding should be stopped during treatment.

Symptoms of overdose:
Overdosing may cause pain, inflammatory reactions and phlebitis at the injection site. If administered in very high parenteral doses, cephalosporins may cause vertigo, paresthesias and headache. Particularly in patients with renal disease, overdosing of cephalosporins may induce convulsions.
Overdose may be associated with the following abnormal laboratory tests results: Elevated creatinine, BUN, liver enzymes and bilirubin; positive Coombs test; thrombocytosis and thrombocytopenia, eosinophilia, leukopenia as well as prolonged prothrombin time.
Treatment of overdose:
In case of seizures, administration of the medicinal product should be discontinued immediately. Antiepileptic medicinal products may be appropriate. Vital body functions and parameters should be monitored closely. In the event of severe overdose, especially in patients with renal impairment, a combination of haemodialysis and haemoperfusion may be useful if the patient fails to respond to other treatments. However, no corresponding supporting data are available. Peritoneal dialysis is not effective.