Consumer medicine information

Hospira Cefazolin Sodium Powder for Injection

Cefazolin

BRAND INFORMATION

Brand name

Hospira Cefazolin Sodium Powder for Injection

Active ingredient

Cefazolin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Hospira Cefazolin Sodium Powder for Injection.

What is in this leaflet

This leaflet answers some common questions about Hospira™ Cefazolin Sodium Powder for Injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given cefazolin against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

Keep this leaflet.

You may need to read it again.

What Hospira™ Cefazolin Sodium Powder for Injection is used for

Cefazolin is an antibiotic used to treat infections in different parts of the body caused by bacteria.

Cefazolin will not work against infections caused by viruses such as colds or the flu.

This medicine belongs to a group of antibiotics called cephalosporins (ke-fä-lö-spör-ins).

It works by killing the bacteria causing your infection or by stopping its growth.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

This medicine is not addictive.

It is available only with a doctor’s prescription.

Before you are given Hospira™ Cefazolin Sodium Powder for Injection

When you must not be given it

You must not be given Hospira™ Cefazolin Sodium Powder for Injection if you have an allergy to:

  • any medicine containing cefazolin
  • any other cephalosporin antibiotics.

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

You must not be given this medicine if you have had a serious allergic reaction to penicillin antibiotics.

If you are not sure whether you should be given this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have any types of allergies to penicillin antibiotics or any other medicines, foods, preservatives or dyes.

You may have an increased chance of being allergic to cefazolin if you are allergic to penicillins.

Tell your doctor if you have any types of allergies to lignocaine.

Tell your doctor if you have:

  • kidney problems
  • stomach or intestinal problems

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.

Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you are given cefazolin.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and cefazolin may interfere with each other. These include:

  • probenicid, a medicine used to treat gout
  • aminoglycoside antibiotics (such as amikacin, gentamicin, tobramycin)
  • live typhoid vaccine
  • warfarin.

These medicines may be affected by cefazolin or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while being treated with this medicine.

How Hospira™ Cefazolin Sodium Powder for Injection is given

How much is given

Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight.

For most infections, Hospira™ Cefazolin Sodium for Powder Injection is given in divided doses throughout the day.

How it is given

Hospira™ Cefazolin Sodium Powder for Injection is given as a deep injection into a muscle, or a slow injection into a vein. It must only be given by a nurse or doctor.

If you receive too much (overdose)

As Hospira™ Cefazolin Sodium Powder for Injection is given to you under the supervision of your doctor, it is very unlikely that you will receive an overdose. However if you experience severe side effects tell your doctor immediately.

Symptoms following an overdose may include pain and inflammation of the veins near the injection site, dizziness, tingling in the fingers or toes, headache, and seizures (fits).

Ask your doctor or pharmacist if you have any concerns.

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26 in Australia, or call 0800 764 766 in New Zealand) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much cefazolin. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

While you are being given Hospira™ Cefazolin Sodium Powder for Injection

Things you must do

If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.

If you get severe diarrhoea tell your doctor immediately. Do this even if it occurs several weeks after cefazolin has been stopped.

Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care.

Do not take any diarrhoea medicine without first checking with your doctor.

If you get a sore, white mouth or tongue while you are being treated with, or soon after stopping trea ent with cefazolin, tell your doctor. Also tell your doctor if you get vaginal itching or discharge.

This may mean you have fungal infection called thrush. Sometimes the use of this medicine allows fungi to grow and the above symptoms to occur. This medicine does not work against fungi.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being treated with cefazolin.

Tell any other doctors, dentists, and pharmacists who treat you that you are being treated with this medicine.

If you become pregnant while you are being treated with this medicine, tell your doctor immediately.

If you are about to have any blood or urine tests, tell your doctor that you are being treated with this medicine.

It may interfere with the results of some tests.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being treated with cefazolin.

This medicine helps most people with infections, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects.

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor, nurse or pharmacist if you notice any of the following and they worry you:

  • oral thrush - white, furry, sore tongue and mouth
  • vaginal thrush - sore and itchy vagina and/or discharge
  • nausea, vomiting or mild diarrhoea
  • pain or a change in the appearance of the vein at the site of the injection.

The above list includes side effects which are usually mild and/or short-lived.

If any of the following happen, tell your doctor or nurse immediately, or go to Accident and Emergency at your nearest hospital:

  • severe abdominal cramps or stomach cramps
  • watery and severe diarrhoea, which may be bloody
  • swelling of the face, lips or tongue which may cause difficulty swallowing or breathing,
  • wheezing or shortness of breath
  • skin rash, itching or hives,
  • blisters and bleeding in the lips, eyes, mouth nose and genitals
  • frequent infections, fever, severe chills, sore throat or mouth ulcers
  • bleeding or bruising more easily than normal
  • seizures (fits), muscle spasms, lethargy, disorientation, memory loss, tremor.

The above list includes very serious side effects. You may need urgent medical attention. These side effects are rare.

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping trea ent with cefazolin:

  • severe abdominal cramps or stomach cramps
  • watery and severe diarrhoea, which may also be bloody
  • fever, in combination with one or both of the above.

These are rare but serious side effects. You may have a serious condition affecting your bowel. Cefazolin can cause bacteria, which is normally present in the bowel and normally harmless, to multiply and therefore cause the above symptoms. You may need urgent medical attention. However, this side effect is rare.

Do not take any diarrhoea medicine without first checking with your doctor.

Tell your doctor, nurse or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

Some of these side effects can only be found when your doctor does tests from time to time to check your progress.

After using Hospira™ Cefazolin Sodium Powder for Injection

Storage

Hospira™ Cefazolin Sodium Powder for Injection will generally be stored in the pharmacy or on the ward. The injection is kept in a cool dry place, protected from light and moisture where the temperature stays below 25°C.

If storing this medicine at home, keep the vials in their original packs until it is time for them to be used.

If you take the vials out of the pack they may not keep well.

Do not store cefazolin or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Product description

What it looks like

Hospira™ Cefazolin Sodium Powder for Injection is a white or almost white powder in a glass vial. It is available in packs of 5 vials.

Ingredients

Hospira™ Cefazolin Sodium Powder for Injection contains cefazolin sodium, equivalent to 1 g of cefazolin, as the active ingredient.

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

Australian Sponsor:
Hospira Pty Ltd
ABN 13 107 058 328
Level 3,
500 Collins Street,
Melbourne, VIC 3000,
Australia

New Zealand Sponsor:
Hospira NZ Limited
23 Haining Street
Te Aro
Wellington
New Zealand

This leaflet was updated in February 2012 .

AUST R number(s):
175817 (1 g vial)

BRAND INFORMATION

Brand name

Hospira Cefazolin Sodium Powder for Injection

Active ingredient

Cefazolin

Schedule

S4

 

Name of the medicine

Cefazolin sodium.

Excipients.

Sodium content is 48.3 mg/g of cefazolin sodium.

Description

Chemical name: sodium (6R, 7R)-3-[[(5-methyl-1, 3, 4-thiadiazol-2-yl) sulphanyl]methyl]-8-oxo-7-[(1H-tetrazol-1-ylacetyl) amino] -5-thia-1-azabicyclo[4.2.0] oct-2-ene-2-carboxylate. Molecular formula: C14H13N8NaO4S3. MW: 476.5. CAS: 27164-46-1.
Cefazolin sodium is a white to off white crystalline powder with a solubility in water of greater than or equal to 100 mg/mL. Hospira Cefazolin Sodium Powder for Injection contains cefazolin sodium as a single ingredient.
Hospira Cefazolin Sodium Powder for Injection is a powder for parenteral administration following reconstitution. Each vial contains 1.05 g of cefazolin sodium which is approximately equivalent to 1 g of cefazolin.

Pharmacology

Microbiology.

In vitro tests demonstrate that the bactericidal action of cephalosporins results from inhibition of cell wall synthesis. Cefazolin sodium is active against the following organisms in vitro: Staphylococcus aureus (penicillin sensitive and penicillin resistant); group A β-haemolytic Streptococci and other strains of Streptococci (many strains of enterococci are resistant); Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella sp., Enterobacter aerogenes, Haemophilus influenzae.
Most strains of Enterobacter cloacae and indole positive Proteus (Pr. vulgaris, Pr. morganii, Pr. rettgeri) are resistant. Methicillin resistant Staphylococci, Serratia, Pseudomonas, Acinetobacter calcoaceticus (formerly Mima and Herellea sp.) are almost uniformly resistant to cefazolin.

Disc susceptibility tests.

Quantitative methods that require measurements of zone diameters give the most precise estimates of antibiotic susceptibility. One such procedure has been recommended for use with discs for testing susceptibility to cephalosporin class antibiotics. Interpretations correlate diameters of the disc test with minimum inhibitory concentration (MIC) values for cefazolin. With this procedure, a report from the laboratory of ‘susceptible’ indicates that the infecting organism is likely to respond to therapy. A report of ‘resistant’ indicates that the infecting organism is not likely to respond to therapy. A report of ‘intermediate susceptibility’ suggests that the organism would be susceptible if high dosage is used, or if the infection is confined to tissues and fluids (e.g. urine) in which high antibiotic levels are attained.

Pharmacokinetics.

Table 1 demonstrates the blood levels of cefazolin following intramuscular administration.
Clinical pharmacology studies in patients hospitalised with infections indicate that cefazolin produces mean peak serum levels approximately equivalent to those seen in normal volunteers.
In a study (using normal volunteers) of constant intravenous (IV) infusion with dosages of 3.5 mg/kg for one hour (approximately 250 mg) and 1.5 mg/kg for the next two hours (approximately 100 mg) cefazolin produced a steady serum level at the third hour of approximately 28 microgram/mL.
Table 2 shows the average serum concentration after IV injection of a single 1 g dose; average half-life was 1.4 hours.
Controlled studies on adult normal volunteers receiving 1 g four times daily for ten days, monitoring CBC, SGOT, SGPT, bilirubin, alkaline phosphatase, serum urea, creatinine and urinalysis, indicated no clinically significant changes attributed to cefazolin.
Cefazolin is excreted unchanged in the urine. Following intramuscular injection of 500 mg, 56 to 89% of the administered dose was recovered within six hours and 80 to nearly 100% was recovered in 24 hours.
Cefazolin achieved peak urine concentrations greater than 1,000 microgram/mL and 4,000 microgram/mL respectively following 500 mg and 1 g IM doses.
When cefazolin is administered to patients with unobstructed biliary tracts, high concentrations, well over serum levels, occur in the gall bladder tissue and bile. In the presence of obstruction, however, concentration of the antibiotic in bile is considerably lower than the serum level.
Cefazolin readily crosses an inflamed synovial membrane and the concentration of the antibiotic achieved in the joint space is comparable to levels measured in serum.
Cefazolin readily crosses the placental barrier into the cord blood and amniotic fluid. Cefazolin is present in very low concentrations in the milk of breastfeeding mothers.

Indications

Hospira Cefazolin Sodium Powder for Injection is indicated in the treatment of the following serious infections due to susceptible organisms.
Respiratory tract infections due to Strep. pneumoniae, Klebsiella sp., H. influenzae, Staph. aureus (penicillin sensitive and penicillin resistant) and group A β-haemolytic Streptococci. Injectable benzathine penicillin is considered to be the drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. 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 are not available at present.
Genitourinary tract infections due to E. coli, P. mirabilis, Klebsiella sp. and some strains of Enterobacter and Enterococci.
Skin and soft tissue infections due to Staph. aureus (penicillin sensitive and penicillin resistant) and group A β-haemolytic Streptococci and other strains of Streptococci.
Bone and joint infections due to Staph. aureus.
Septicaemia due to Strep. pneumoniae, Staph. aureus (penicillin sensitive and penicillin resistant), P. mirabilis, E. coli and Klebsiella sp.
Endocarditis due to Staph. aureus (penicillin sensitive and penicillin resistant) and group A β-haemolytic Streptococci.
Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefazolin.

Contraindications

Hospira Cefazolin Sodium Powder for Injection is contraindicated in patients with known allergy to the cephalosporin group of antibiotics or previous experience of a major allergy to penicillin (see Precautions).
Lignocaine should not be used as a diluent for intramuscular injection in patients who are hypersensitive to lignocaine.

Precautions

Before cefazolin therapy is instituted, careful inquiry should be made concerning previous hypersensitivity reactions to cephalosporins and penicillins. Cephalosporin C derivatives should be given cautiously in penicillin sensitive patients. Serious acute hypersensitivity reactions may require adrenaline and other emergency measures. There is some clinical and laboratory evidence of partial cross allergenicity of the penicillins and the cephalosporins. Patients have been reported to have had severe reactions (including anaphylaxis) to both drugs. Antibiotics, including cefazolin, should be administered cautiously to any patient who has demonstrated some form of allergy, particularly to drugs. If an allergic reaction to Hospira Cefazolin Sodium Powder for Injection occurs, the drug should be discontinued and the patient treated with the usual agents (e.g. adrenaline or other pressor amines, antihistamines or corticosteroids).
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including cefazolin. A toxin produced with Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases, appropriate therapy such as oral antibacterial agents effective against Cl. difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated.
Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not be used.
Prolonged use of cefazolin sodium may result in the overgrowth of nonsusceptible organisms. Careful clinical observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
The intrathecal administration of Hospira Cefazolin Sodium Powder for Injection is not an approved route of administration for this antibiotic; in fact, there have been reports of severe central nervous system (CNS) toxicity including seizures when cefazolin was administered in this manner.
The intraventricular administration of Hospira Cefazolin Sodium Powder for Injection is not an approved route of administration for this antibiotic; in fact, there have been reports of tremulousness, headache, agitation, lightheadedness and sensations of seeing flashing lights when cefazolin was administered in this manner for the treatment of infected ventricular shunts.

History of gastrointestinal disease.

Cefazolin, as with all cephalosporins, should be prescribed with caution in individuals with a history of gastrointestinal disease.

Impaired renal function.

As with other beta-lactam antibiotics, seizures may occur if inappropriately high doses are administered to patients with impaired renal function. When cefazolin is administered to patients with low urinary output because of impaired renal function, lower daily dosage is required (see Dosage and Administration).
Encephalopathy has been reported with the use of cefazolin in patients with renal failure. The symptoms have included tonic-clonic seizures, lethargy, disorientation, memory loss, asterixis and multifocal myoclonus. Toxicity has been attributed to increased cefazolin serum levels and increased permeability of the blood brain barrier caused by uraemia. When cefazolin is administered to patients with low urinary output because of impaired renal function, lower daily dosage is required (see Dosage and Administration).

Use in pregnancy.

(Category B1)
Safety of this product for use during pregnancy has not been established in human clinical trials. Studies in animals are inadequate or lacking, but available data shows no evidence of an increased occurrence of foetal damage. Studies of cord blood show prompt transfer of cefazolin across the placenta. Drug levels in cord blood were approximately one quarter and one third maternal drug levels.

Use in lactation.

Cefazolin is present in very low concentrations in the milk of breastfeeding mothers. Safety for use in breastfeeding women has not been established.

Use in infants.

Safety for use in premature infants and infants under 1 month of age has not been established.

Carcinogenicity.

Long-term studies in animals to determine the carcinogenic potential of cefazolin have not been performed.

Genotoxicity.

Mutagenicity studies have not been performed.

Interactions

Probenecid.

Probenecid may decrease renal tubular secetion of cephalosporins when used concurrently, resulting in increased and more prolonged cephalosporin blood levels.

Aminoglycoside antibiotics.

Coadministration of aminoglycoside antibiotics with cephalosporins could produce additive nephrotoxic effects. Use of these agents should be avoided in patients with prior renal insufficiency. If coadministration of these two antibiotic classes is necessary, patients should be monitored for evidence of nephrotoxicity.

Live typhoid vaccine.

Antibiotics that possess bactericidal activity against Salmonella typhi organisms may interfere with the immunological response to the live typhoid vaccine. At least 24 hours should elapse between the last dose of the antibiotic and the administration of oral live typhoid vaccine.

Warfarin.

Cefazolin may produce hypoprothrombinaemic and may enhance the anticoagulant effect of warfarin. Patients receiving oral anticoagulant therapy with warfarin should be closely monitored using the prothrombin time ratio or internationally normalized ratio (INR) during concurrent therapy with cefazolin. Adjustment of the warfarin dosage to maintain the desired anticoagulant effect may be necessary. An alternative would be to use a cephalosporin which does not possess hypoprothrombinaemic properties.

Effects on laboratory tests.

A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solution or with Clinitest tablets, but not with enzyme based tests, such as Clinistix and Tes-Tape. Positive direct and indirect antiglobulin (Coombs') tests have occurred following cefazolin therapy; these may also occur in neonates whose mothers received cephalosporins before delivery.

Adverse Effects

The following reactions have been reported.

Hypersensitivity.

Drug fever, skin rash, vulvar pruritus, eosinophilia, itching and Stevens-Johnson syndrome have occurred.

Haematological.

The most common blood disorder with cefazolin has been eosinophilia, neutropenia, leucopenia, thrombocythaemia, thrombocytopenia and positive direct and indirect Coombs' tests have occurred.

Hepatic and renal.

Isolated transient rise in AST, ALT, serum urea and alkaline phosphatase levels has been observed without evidence of renal or hepatic impairment.

Gastrointestinal.

Nausea, anorexia, vomiting, diarrhoea and oral candidiasis (oral thrush) have been reported. As with other broad spectrum antibiotics, colitis, including rare instances of pseudomembranous colitis, has been reported in conjunction with therapy with cefazolin (see Precautions).

Other.

Pain at the site of injection after IM administration has occurred, sometimes with induration. Phlebitis at the site of injection has been noted. Other reactions have included genital and anal pruritus, genital candidiasis and vaginitis.

Dosage and Administration

Hospira Cefazolin Sodium Powder for Injection may be administered intramuscularly or intravenously after reconstitution. The intrathecal administration of cefazolin is not an approved route of administration for this antibiotic; in fact, there have been reports of severe CNS toxicity including seizures when cefazolin was administered in this manner.

Intramuscular administration.

Reconstitute with water for injections, 0.9% sodium chloride injection or lignocaine 0.5% injection according to the dilution table (Table 3). Shake well until dissolved. To facilitate putting the product into solution, the vial should be warmed in the hands while shaking. Do not use the reconstituted injection solution if there is any sign of turbidity. Hospira Cefazolin Sodium Powder for Injection should be injected into a large muscle mass.

Intravenous administration.

Hospira Cefazolin Sodium Powder for Injection may be administered by direct IV injection or by intermittent or continuous infusion. Total daily dosages are the same as with intramuscular injection.

Direct intravenous injection.

Dilute the reconstituted 1 g Hospira Cefazolin Sodium Powder for Injection in 5 mL of water for injections and then dilute to 10 mL. Inject solution slowly over three to five minutes. It may be administered directly into a vein or via the giving line for a patient receiving a compatible IV solution. Cefazolin sodium has been reported to be compatible with the following IV fluids: 0.9% sodium chloride injection, 5% or 10% glucose injection, 5% glucose and 0.9% sodium chloride injection, lactated Ringer's injection.

Intermittent intravenous infusion.

Hospira Cefazolin Sodium Powder for Injection can be administered along with primary IV fluid management programs in a volume control set or in a separate, secondary IV infusion bag. Reconstituted cefazolin (1 g Hospira Cefazolin Sodium Powder for Injection) may be diluted in 50 to 100 mL of water for injections or one of the previously listed compatible parenteral fluids, and infused over a period of 3 to 5 minutes. If a Y-type administration set is used, it is desirable to discontinue the other solution during the infusion of the solution containing cefazolin sodium.

Continuous intravenous infusion.

The total daily dose of cefazolin sodium, diluted and well mixed with at least 50 mL of water for injections, may be added to an IV infusion bag containing one of the above parenteral fluids. The choice of saline or glucose solution and the volume to be employed are dictated by fluid and electrolyte management.

Adults.

Usual dosage for mild Gram positive infections is cefazolin 250 to 500 mg of cefazolin every eight hours.
In mild to moderate infections of the respiratory tract caused by S. pneumoniae, or mild to moderate infections of the genitourinary tract caused by susceptible organisms, a dosage of 500 mg to 1 g every twelve hours may be used.
In moderate or severe infections, the usual adult dosage is cefazolin 500 mg to 1 g every six to eight hours. Cefazolin has been administered in dosages of 6 g/day in serious infections such as endocarditis.
In patients with renal impairment, cefazolin is not readily excreted. After a loading dose of 500 mg, the recommendations in Table 4 for maintenance dosage may be used as a guide.

Children.

A total daily dosage of 25 to 50 mg/kg bodyweight, divided into three or four equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg/kg bodyweight for severe infections. (See Table 5.)
In children with mild to moderate impairment of renal function (creatinine clearance of 70 to 40 mL/minute), 60% of the normal daily dose given in divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/minute), 25% of the normal daily dose given in divided doses every 12 hours should be sufficient.
In children with marked impairment (creatinine clearance of 20 to 5 mL/minute), 10% of the normal daily dose given every 24 hours should be adequate. All dosage recommendations apply after an initial loading dose.
Since safety for use in premature infants and in infants aged under 1 month has not been established, the use of cefazolin in these patients is not recommended.

Overdosage

Signs and symptoms.

Toxic signs and symptoms following an overdose of cefazolin may include pain, inflammation and phlebitis at the injection site.
The administration of inappropriately large doses of parenteral cephalosporins may cause dizziness, paraesthesiae and headaches. Seizures may occur following overdosage with some cephalosporins, particularly in patients with renal impairment, in whom accumulation is likely to occur.
Laboratory abnormalities that may occur after an overdose may include elevations in creatinine, serum urea, liver enzymes and bilirubin, a positive Coombs' test, thrombocytosis, thrombocytopenia, eosinophilia, leucopenia and prolongation of the prothrombin time.

Treatment.

In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs and unusual drug kinetics in your patient.
If seizures occur, the drug should be discontinued promptly; anticonvulsant therapy may be administered if clinically indicated. Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc.
In cases of severe overdosage, especially in a patient with renal failure, combined haemodialysis and haemoperfusion may be considered if response to more conservative therapy fails. However, no data supporting such therapy are available.
In case of overdose, immediately contact the Poisons Information Centre for advice. (In Australia, call 131 126; in New Zealand call 0800 764 766).

Presentation

Powder for injection (white to off white), cefazolin sodium 1.05 g ≡ cefazolin 1 g: 5's (10 mL clear glass moulded type 1 vials, sealed with bromobutyl rubber stopper, flip-off seal, AUST R 175817).

Storage

Powder for injection: store below 25°C. Protect from light and moisture.
Reconstituted solution: to reduce microbiological hazard, use as soon as practicable after dilution. If storage is necessary, hold at 2-8°C for not more than 24 hours.
Product is for single use in one patient only.

Poison Schedule

S4.