ZINACEF Powder for injection / infusion Ref.[6607] Active ingredients: Cefuroxime

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Glaxo Operations UK Limited, 980 Great West Road,Brentford,TW8 9GS Trading as: GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT

Therapeutic indications

Zinacef is indicated for the treatment of the infections listed below in adults and children, including neonates (from birth) (see sections 4.4 and 5.1).

  • Community acquired pneumonia.
  • Acute exacerbations of chronic bronchitis.
  • Complicated urinary tract infections, including pyelonephritis.
  • Soft-tissue infections: cellulitis, erysipelas and wound infections.
  • Intra-abdominal infections (see section 4.4).
  • Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic, cardiovascular, and gynaecological surgery (including caesarean section).

In the treatment and prevention of infections in which it is very likely that anaerobic organisms will be encountered, cefuroxime should be administered with additional appropriate antibacterial agents.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Posology and method of administration

Posology

Table 1. Adults and children ≥40 kg:

IndicationDosage
Community acquired pneumonia and acute exacerbations of chronic bronchitis750 mg every 8 hours (intravenously or intramuscularly)
Soft-tissue infections: cellulitis, erysipelas and wound infections.
Intra-abdominal infections
Complicated urinary tract infections, including pyelonephritis1.5 g every 8 hours (intravenously or intramuscularly)
Severe infections750 mg every 6 hours (intravenously). 1.5 g every 8 hours (intravenously)
Surgical prophylaxis for gastrointestinal, gynaecological surgery (including caesarean section) and orthopaedic operations1.5 g with the induction of anaesthesia. This may be supplemented with two 750 mg doses (intramuscularly) after 8 hours and 16 hours
Surgical prophylaxis for cardiovascular and oesophageal operations1.5 g with induction of anaesthesia followed by 750 mg (intramuscularly) every 8 hours for a further 24 hours

Table 2. Children <40 kg:

 Infants and toddlers >3 weeks and children <40 kgInfants (birth to 3 weeks)
Community acquired pneumonia30 to 100 mg/kg/day (intravenously) given as 3 or 4 divided doses; a dose of 60 mg/kg/day is appropriate for most infectionsto 100 mg/kg/day (intravenously) given as 2 or 3 divided doses (see section 5.2)
Complicated urinary tract infections, including pyelonephritis
Soft-tissue infections: cellulitis, erysipelas and wound infections
Intra-abdominal infections

Renal impairment

Cefuroxime is primarily excreted by the kidneys. Therefore, as with all such antibiotics, in patients with markedly impaired renal function it is recommended that the dosage of Zinacef should be reduced to compensate for its slower excretion.

Table 3. Recommended doses for Zinacef in renal impairment:

Creatinine clearanceT1/2(hrs) Dose (mg)
>20 mL/min/1.73 m²1.7–2.6It is not necessary to reduce the standard dose (750 mg to 1.5 g three times daily).
10-20 mL/min/1.73 m²4.3–6.5750 mg twice daily
<10 mL/min/1.73 m²14.8–22.3750 mg once daily
Patients on haemodialysis3.75A further 750 mg dose should be given intravenously or intramuscularly at the end of each dialysis; in addition to parenteral use, cefuroxime sodium can be incorporated into the peritoneal dialysis fluid (usually 250 mg for every 2 litres of dialysis fluid).
Patients in renal failure on continuous arteriovenous haemodialysis (CAVH) or high-flux haemofiltration (HF) in intensive therapy units7.9–12.6 (CAVH). 1.6 (HF) 750 mg twice daily; for low-flux haemofiltration follow the dosage recommended under impaired renal function.

Hepatic impairment

Cefuroxime is primarily eliminated by the kidney. In patients with hepatic dysfunction this is not expected to affect the pharmacokinetics of cefuroxime.

Method of administration

Zinacef should be administered by intravenous injection over a period of 3 to 5 minutes directly into a vein or via a drip tube or infusion over 30 to 60 minutes, or by deep intramuscular injection.

Intramuscular injections should be injected well within the bulk of a relatively large muscle and not more than 750 mg should be injected at one site. For doses greater than 1.5 g intravenous administration should be used. For instructions on reconstitution of the medicinal product before administration, see section 6.6.

750 mg, 1.5 g powder for solution for infusion (Monovial presentation).

For instructions on preparation of the medicinal product before administration, see section 6.6.

Overdose

Overdose can lead to neurological sequelae including encephalopathy, convulsions and coma. Symptoms of overdose can occur if the dose is not reduced appropriately in patients with renal impairment (see sections 4.2 and 4.4).

Serum levels of cefuroxime can be reduced by haemodialysis or peritoneal dialysis.

Shelf life

Shelf life: Three years when stored below 25°C and protected from light.

Special precautions for storage

Store below 25°C and protect from light.

After constitution, Zinacef should be stored at 2-8°C for no longer than 24 hours.

Nature and contents of container

  1. Moulded glass (type 1 or III) vials with bromobutyl or fluoro-resin laminated butyl rubber plug, overseal and flip-off cap containing either 250mg, 750mg or 1.5g Zinacef.
  2. A bulk pack of 100 vials.
  3. Monovial containing either 750mg or 1.5g Zinacef with transfer needle.

* Only the 1.5g injection pack is marketed (the infusion pack is not)

Special precautions for disposal and other handling

Instructions for constitution

Table 4. Additional volumes and concentrations which may be useful when fractional doses are required:

 Additional volumes and concentrations, which may be useful when fractional doses are required
Vial sizeRoutes of administrationPhysical StateAmount of water to be added (mL) Approximate cefuroxime concentration (mg/mL)**
 250 mg powder for solution for injection
250 mgintramuscularsuspension1 mL216
intravenous bolussolutionat least 2 mL116
intravenous infusionsolutionat least 2 mL* 116
 750 mg powder for solution for injection or infusion
750 mgintramuscularsuspension3 mL216
intravenous bolussolutionat least 6 mL116
intravenous infusionsolutionat least 6 mL116
 1.5 g powder for solution for injection or infusion
1.5 gintramuscularsuspension6 ml216
intravenous bolussolutionat least 15 mL94
intravenous infusionsolution15 ml* 94

* Reconstituted solution to be added to 50 or 100 mL of compatible infusion fluid (see information on compatibility, below)
** The resulting volume of the solution of cefuroxime in reconstitution medium is increased due the displacement factor of the drug substance resulting in the listed concentrations in mg/mL.

Zinacef 750 mg and 1.5 g powder for solution for infusion (Monovial presentation)

Preparation of solution for intravenous infusion

The contents of the Monovial are added to small volume infusion bags containing 0.9% w/v Sodium Chloride Injection BP, or 5% Dextrose Injection, or another compatible fluid.

  1. Peel off the removable top part of the label and remove the cap.
  2. Insert the needle of the Monovial into the additive port of the infusion bag.
  3. To activate, push the plastic needle holder of the Monovial down onto the vial shoulder until a “click” is heard.
  4. Holding it upright, fill the vial to approximately two-thirds capacity by squeezing the bag several times.
  5. Shake the vial to reconstitute the cefuroxime sodium.
  6. With the vial uppermost, transfer the reconstituted cefuroxime sodium into the infusion bag by squeezing and releasing the bag.
  7. Repeat steps 4 to 6 to rinse the inside of the vial. Dispose of the empty Monovial safely. Check that the powder has dissolved, and that the bag has no leaks.

Compatibility

1.5 g cefuroxime sodium constituted with 15 mL Water for Injection may be added to metronidazole injection (500 mg/100 mL) and both retain their activity for up to 24 hours below 25°C.

1.5 g cefuroxime sodium is compatible with azlocillin 1 g (in 15 mL) or 5 g (in 50 mL) for up to 24 hours at 4°C or 6 hours below 25°C.

Cefuroxime sodium (5 mg/mL) in 5% w/v or 10% w/v xylitol injection may be stored for up to 24 hours at 25°C.

Cefuroxime sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.

Cefuroxime sodium is compatible with the following infusion fluids. It will retain potency for up to 24 hours at room temperature in:

0.9% w/v Sodium Chloride Injection BP
5% Dextrose Injection BP
0.18% w/v Sodium Chloride plus 4% Dextrose Injection BP
5% Dextrose and 0.9% w/v Sodium Chloride Injection BP
5% Dextrose and 0.45% Sodium Chloride Injection
5% Dextrose and 0.225% Sodium Chloride Injection
10% Dextrose Injection
10% Invert Sugar in Water for Injection
Ringer’s Injection USP
Lactated Ringer’s Injection USP
M/6 Sodium Lactate Injection
Compound Sodium Lactate Injection BP (Hartmann’s Solution).

The stability of cefuroxime sodium in 0.9% w/v Sodium Chloride Injection BP and in 5% Dextrose Injection is not affected by the presence of hydrocortisone sodium phosphate.

Cefuroxime sodium has also been found compatible for 24 hours at room temperature when admixed in IV infusion with:

Heparin (10 and 50 units/mL) in 0.9% w/v Sodium Chloride Injection BP; Potassium Chloride (10 and 40 mEqL) in 0.9% w/v Sodium Chloride Injection BP.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.