Cefuroxime: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Malaysia prescribing information.

Generic Medicine Info

Indications and Dosage

Intramuscular, Intravenous
Acute exacerbations of chronic bronchitis, Community-acquired pneumonia, Intra-abdominal infections, Soft tissue infections

Adult: 750 mg 8 hourly via deep IM inj or IV inj over 3-5 minutes or infused over 30-60 minutes.
Child: ≤3 weeks 30-100 mg/kg daily via IV in 2-3 divided doses. >3 weeks weighing <40 kg: 30-100 mg/kg daily via IV in 3-4 divided doses. Usual dose: 60 mg/kg daily. ≥40 kg: Same as adult dose.

Intramuscular, Intravenous
Prophylaxis of surgical infections

Adult: For CV and oesophageal operations: 1.5 g via IV with induction of anaesthesia followed by 750 mg via IM 8 hourly for a further 24 hours. For gastrointestinal, gynaecological, and orthopaedic operations: 1.5 g via IV with the induction of anaesthesia; supplemented with two 750 mg doses via IM after 8 hours and 16 hours.
Child: ≥40 kg: Same as adult dose

Intramuscular, Intravenous
Complicated urinary tract infections, Pyelonephritis

Adult: 1.5 g 8 hourly via deep IM inj or IV inj over 3-5 minutes or infused over 30-60 minutes.
Child: ≤3 weeks 30-100 mg/kg daily via IV in 2-3 divided doses. >3 weeks weighing <40 kg: 30-100 mg/kg daily via IV in 3-4 divided doses. Usual dose: 60 mg/kg daily. ≥40 kg: Same as adult dose.

Intramuscular, Intravenous
Bone and joint infections

Adult: 1.5 g 8 hourly.
Child: >3 months 50 mg/kg/dose 8 hourly. Max: 1,500 mg/dose.

Intramuscular
Uncomplicated gonorrhoea

Adult: 1.5 g as a single dose divided between 2 inj sites. May be given with oral probenecid 1 g.

Intravenous
Severe infections

Adult: 750 mg 6 hourly or 1,500 mg 8 hourly.
Child: ≥40 kg: Same as adult dose.

Intravenous
Bacterial meningitis

Adult: 3 g 8 hourly.

Oral
Cystitis, Uncomplicated skin and skin structure infections

Adult: 250 mg bid for 5-10 days. Usual treatment duration: 7 days.
Child: ≥3 months weighing <40 kg: 15 mg/kg bid for 5-10 days. Usual treatment duration: 7 days. Max: 250 mg bid. ≥40 kg: Same as adult dose.

Oral
Uncomplicated urinary tract infections

Adult: 250 mg bid for 5-10 days. Usual treatment duration: 7 days.
Child: 3 months to 12 years 15 mg/kg bid for 5-10 days. Usual treatment duration: 7 days. Max: 1,000 mg daily. ≥13 years Same as adult dose.

Oral
Uncomplicated gonorrhoea

Adult: 1,000 mg as single dose.

Oral
Acute bacterial sinusitis, Pharyngitis, Tonsillitis

Adult: 250 mg bid for 5-10 days. Usual treatment duration: 7 days.
Child: ≥3 months weighing <40 kg: 10 mg/kg bid for 5-10 days. Usual treatment duration: 7 days. Max: 125 mg bid. ≥40 kg: Same as adult dose.

Oral
Acute otitis media

Adult: 500 mg bid for 5- 10 days. Usual treatment duration: 7 days.
Child: 3 months to 18 years weighing <40 kg: 15 mg/kg bid for 5-10 days. Usual treatment duration: 7 days. Max: 250 mg bid. ≥40 kg: Same as adult dose.

Oral
Pyelonephritis

Adult: 250 mg bid for 5-10 days. Usual treatment duration: 7 days.
Child: ≥3 months weighing <40 kg: 15 mg/kg bid for 10-14 days. Max: 250 mg bid. ≥40 kg Same as adult dose.

Oral
Lyme disease

Adult: 500 mg bid for 14 days. Usual treatment range: 10-21 days.
Child: ≥3 months weighing <40 kg: 15 mg/kg bid for 14 days. Usual treatment range: 10-21 days. Max: 250 mg bid. ≥40 kg: Same as adult dose.

Oral
Acute exacerbations of chronic bronchitis

Adult: 250 or 500 mg bid for 5-10 days. Usual treatment duration: 7 days.
Child: ≥40 kg Same as adult dose.

Renal Impairment

Oral:
Patient on haemodialysis: Give additional single usual dose at the end of each dialysis.

CrCl (mL/min)	Dosage
<10	Usual dose given 48 hourly.
10-29	Usual dose given 24 hourly.

IV:
Patient on continuous arteriovenous haemodialysis (CAVH) or high-flux haemofiltration (HF) in intensive therapy units: 750 mg bid. Patient on haemodialysis: Give additional 750 mg dose after each dialysis.

CrCl (mL/min)	Dosage
<10	750 mg once daily.
10-20	750 mg bid.

Administration

oral susp: Should be taken with food.
tab: May be taken with or without food.

Reconstitution

Powder for oral susp: Add the appropriate amount of water as specified on the label. Shake well until suspended. IM: Add 3 mL or 16 mL sterile water for injection to a vial labelled as containing 750 mg or 1,500 mg, respectively, to provide a solution containing approx 225 mg/mL or 90 mg/mL. IV infusion: Reconstitute a vial labelled as 0.75 g or 1.5 g with 3 mL or 16 mL of sterile water for injection, respectively; further dilute to a suitable container with 50 mL or 100 mL of compatible infusion fluid. IV: Add 8 mL or 16 mL of sterile water for injection to a vial labelled as containing 750 mg or 1,500 mg, respectively, to provide a solution containing approx 90 mg/mL.

Incompatibility

Aminoglycosides.

Contraindications

Hypersensitivity to cefuroxime or any other cephalosporins.

Special Precautions

Patient with a penicillin or other beta-lactam allergy; history of colitis, history of seizure disorder. Patient taking potent diuretics (e.g. furosemide) and aminoglycosides. Renal impairment. Children and elderly. Pregnancy and lactation. Cefuroxime axetil tab and granules for oral susp are not bioequivalent and are not substitutable on a mg-per-mg basis.

Adverse Reactions

Significant: Elevated INR (in nutritionally deficient patients; renal or hepatic disease, prolonged use), bacterial or fungal superinfection with prolonged use, including Clostridium difficile-associated diarrhoea and pseudomembranous colitis; Jarisch-Herxheimer reaction (following treatment of Lyme disease).
Blood and lymphatic system disorders: Neutropenia, eosinophilia, decreased Hb, leucopenia, thrombocytopenia.
Gastrointestinal disorders: Diarrhoea, nausea, vomiting, abdominal pain.
General disorders and administration site conditions: Inj site reaction (e.g. pain, thrombophlebitis).
Investigations: Transient increase of hepatic enzyme levels.
Nervous system disorders: Headache, dizziness.
Skin and subcutaneous tissue disorders: Skin rash, urticaria, pruritus.
Potentially Fatal: Severe hypersensitivity (anaphylactic) reactions.

Pregnancy Category (US FDA)

IM/IV/Parenteral/PO: B

Patient Counseling Information

This drug may cause dizziness, if affected, do not drive or operate machinery.

Monitoring Parameters

Monitor renal, hepatic and haematologic function periodically during prolonged treatment. Monitor prothrombin time in patients at risk of prolongation (e.g. nutritionally-deficit, prolonged therapy, renal or hepatic impairment). Observe for signs and symptoms of anaphylaxis during 1st dose. Perform culture and sensitivity tests and consult local recommendations before treatment initiation due to antibiotic resistance risks.

Overdosage

Symptoms: Neurological sequelae including encephalopathy, cerebral irritation leading to convulsions, and coma. Management: May perform haemo- or peritoneal dialysis.

Drug Interactions

Increased serum concentration with probenecid. May reduce the efficacy of estrogen/progesterone oral contraceptives.

Food Interaction

Increased bioavailability with food.

Lab Interference

May cause false-positive urinary glucose test using copper reduction methods (e.g. Benedict's or Fehling's solution, Clinitest^®). False-negative result for blood/plasma glucose with ferricyanide tests. May result to positive Coomb’s test.

Action

Description:
Mechanism of Action: Cefuroxime is a 2nd generation cephalosporin which binds to 1 or more of the penicillin-binding proteins (PBPs) thereby inhibiting the final transpeptidation step of peptidoglycan synthesis in the bacterial cell wall, thus interrupting cell wall biosynthesis, and arresting cell wall assembly resulting in bacterial cell lysis and death.
Pharmacokinetics:
Absorption: Absorbed from the gastrointestinal tract. Increased absorption with food. Bioavailability: Tab: 37% (fasting); 52% (following food); oral susp is less bioavailable than the tab. Time to peak plasma concentration: Approx 15-60 minutes (IM); 2-3 minutes (IV); approx 2-3 hours (oral).
Distribution: Widely distributed to body tissues and fluids including bronchial secretions, synovial and pericardial fluid, heart, liver, kidneys, bone, and bile. Crosses the placenta, and blood-brain barrier; enters breast milk. Volume of distribution: 50 ± 28 L. Plasma protein binding: 33-50%.
Metabolism: Hydrolysed in the intestinal mucosa and blood to cefuroxime.
Excretion: Via urine (66-100% as unchanged drug); bile (small amounts). Elimination half-life: Approx 1-2 hours.

Chemical Structure

Storage

Tab: Store between 15-30°C. Powder for oral susp: Store below 30°C. Reconstituted susp: Store between 2-8°C up to 10 days. Powder for inj: Store between 15-30°C. Protect from light. Reconstituted solution: Store between 2-8°C up to 72 hours.

MIMS Class

Cephalosporins

ATC Classification

J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
S01AA27 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the treatment of eye infections.

References

Anon. Cefuroxime. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 25/01/2023.

Buckingham R (ed). Cefuroxime. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 25/01/2023.

Cefuroxime 250 mg Tablets (Sandoz Limited). MHRA. https://products.mhra.gov.uk. Accessed 26/01/2022.

Cefuroxime Axetil (Ascend Laboratories, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 26/01/2022.

Cefuroxime Axetil For Oral Suspension (Ranbaxy Pharmaceuticals Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 26/01/2022.

Cefuroxime Sodium (Sagent Pharmaceuticals). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 26/01/2022.

Devatis Limited. Cefuroxime Devatis 250 mg, 750 mg & 1.5 g Powder for Injection/Infusion data sheet June 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 26/01/2022.

Joint Formulary Committee. Cefuroxime. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 26/01/2023.

Zinacef (ACS Dobfar S.p.A). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 26/01/2022.

Zinacef 750 mg Powder for Solution for Injection or Infusion (Sandoz Pharmaceuticals d.d.). MHRA. https://products.mhra.gov.uk. Accessed 26/01/2022.

Zinnat 125 mg/5 mL Granules for Oral Suspension (Sandoz Pharmaceuticals d.d.). MHRA. https://products.mhra.gov.uk. Accessed 26/01/2022.

Zinnat Suspension (Glaxo Wellcome Operations). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 26/01/2022.

Zinnat Tablet (Glaxo Wellcome Operations). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 26/01/2022.

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