Cefazolin Other names: Cephazolin

Cephalosporins may very rarely cause bleeding disorders. During concomitant use with oral anticoagulants (for e.g. warfarin or heparin) in high doses, the coagulation parameters should be monitored.

Some cefalosporins such as cefamandol, cefazolin and cefotetan can cause interference in the metabolism of vitamin K₁, especially in cases of vitamin K₁ deficiency. This may require vitamin K₁ supplementation.

It cannot be excluded that cefazolin intensifies the nephrotoxic effect of aminoglycosides and quick-acting diuretics (e.g. Furosemide). Therefore, the renal function should be controlled during a concomitant therapy with these drugs.

Due to its inhibitory effect on the renal diuresis, the administration of probenicid induces a higher concentration and a longer retention time of cefazolin in the blood.

Antibacterial agent-associated pseudomembranous colitis has been reported with use of cefazolin and may range in severity from mild to life threatening. This diagnosis should be considered in patients with diarrhoea during or subsequent to the administration of cefazolin. Discontinuation of therapy with cefazolin and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.

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.

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:

In haemodialysis patients, the treatment schedule depends on the dialysis conditions.

Cefazolin reaches the embryo/fetus via the placenta. There is not sufficient experience in the human use of cefazolin. As a precautionary measure, cefazolin should only be used during pregnancy after careful benefit/risk assessment, especially during the first trimester of pregnancy.

Cefazolin is excreted in maternal milk at low concentrations and therefore it should only be used after careful benefit/risk assessment. Diarrhoea and fungus infection of the mucous membranes could occur in the breast-fed infant, so that nursing might have to be discontinued. The possibility of sensitisation should be borne in mind.

Cefazolin has no or negligible influence on the ability to drive and use machines.

Dependent on the dose and duration of the treatment, patients are expected to experience one or several of the adverse reactions mentioned below.

Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)

Infections and infestations

Uncommon: Oral candidiasis (prolonged use).

Rare: Genital candidiasis (monoliasis), vaginitis.

Blood and lymphatic system disorder

Rare: Increase or decrease in blood glucose concentration (hyperglycemia or hypoglycemia). Leukopenia, granulocytopenia, neutropenia, thrombocytopenia, leukocytosis, granulocytosis, monocytosis, lymphocytopenia, basophilia and eosinophilia were observed in blood counts. These effects are rare and reversible.

Very rare: Coagulation (blood clotting) disorders and bleeding as a consequence. At risk for these side effects are patients with a deficiency of vitamin K or other blood clotting factors, or patients on artificial nutrition, inadequate diet, impaired liver and renal function, thrombocytopenia and patients with disorders or diseases that cause bleeding (e.g. haemophilia, stomach and duodenal ulcers). Decreased haemoglobin and/or hematocrit, anaemia, agranulocytosis, aplastic anaemia, pancytopenia and hemolytic anaemia.

Immune system disorders

Uncommon: Erythema, erythema multiforme, exanthema, urticaria, reversible local permeability of the blood vessels, joints, or mucous membranes (angioedema), drug-induced fever and interstitial pneumonia or pneumonitis.

Rare: Toxic epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome.

Very rare: Anaphylactic shock, swelling of the larynx with narrowing of the airways, increased heart rate, shortness of breath, falling blood pressure, swollen tongue, anal pruritus, genital pruritus, face edema.

Nervous system disorders

Uncommon: Seizures (in patients with renal dysfunction, with inappropriate high treated doses).

Rare: Dizziness, malaise, fatigue. Nightmares, vertigo, hyperactivity, nervousness or anxiety, insomnia, drowsiness, weakness, hot flushes, disturbed colour vision, confusion and epileptogenic activity.

Respiratory, thoracic and mediastinal disorders

Rare: Pleural effusion, chest pain, dyspnoea or respiratory distress, cough, rhinitis.

Gastrointestinal disorders

Common: Loss of appetite, diarrhoea, nausea and vomiting. These symptoms are usually moderate and often disappear during or after treatment.

Very rare: Pseudomembranous colitis

Hepatobiliary disorders

Rare: Temporary increase in serum concentrations of AST, ALT, gamma GT, bilirubin and/or LDH and alkaline phosphatase, transient hepatitis, transient cholestatic jaundice.

Renal and urinary disorders

Rare: Nephrotoxicity, interstitial nephritis, undefined nephropathy, proteinuria, temporary increase in blood urea nitrogen (BUN) usually in patients treated concomitantly with other potential nephrotoxic medicines.

General disorders and administration site conditions

Common: Pain at the site of intramuscular injection, sometimes with induration.

Uncommon: Intravenous administration may cause thrombophlebitis.