Cefixime

Registered South African indications:

• Upper respiratory tract infections (infections of the ear, nose and throat)
  - Bacterial pharyngitis
  - Tonsillitis
  - Otitis media
  - Sinusitis
  - Laryngitis
• Lower respiratory tract infections
• Urinary tract infections
• Uncomplicated gonorrhoea

Contraindications 

• Hypersensitivity to the active ingredient or any of its excipients

Cautions 

• History of cutaneous hypersensitivity to other medications
• History of hypersensitivity to penicillin
• Pregnancy
• Breastfeeding
• Severe renal impairment (CrCl <20ml/min, chronic ambulatory peritoneal dialysis, haemodialysis)
• Re-administration of cefixime in patients with a history of cephalosporin-associated haemolytic anaemia
• Premature or newborn infants
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: tab

Infections caused by:
- Upper respiratory tract infections e.g. otitis media; and other upper respiratory tract infections where the causative organism is known or suspected to be resistant to other commonly used antibiotics, or where treatment failure may carry significant risk
- Lower respiratory tract infection e.g. bronchitis
- Urinary tract infections e.g. cystitis, cystourethritis, uncomplicated pyelonephritis
Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Branhamella catarrhalis (beta-lactamase positive and negative) and Enterobacter species

International manufacturer's recommendations

General dosing range 

• Oral (tab): 200-400mg, dly as a single dose or in 2 divided doses; Treatment duration: 7-14 days

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African manufacturer's recommendations

Lower respiratory tract infection

• Oral (tab): 400mg, dly

Upper respiratory tract infection

• Oral (tab): 200mg, dly

Uncomplicated urinary tract infection

• Oral (tab): 200-400mg, dly as a single dose or in 2 divided doses; Treatment duration: 1-3 days

Sinusitis

• Oral (tab): 200-400mg, dly as a single dose or in 2 divided doses; Treatment duration: 10-14 days

Most strains of enterococci (Streptococcus faecalis, group D Streptococci) and Staphylococci (including coagulase-positive and negative strains and methicillin-resistant strains) are resistant to Suprax. In addition, most strains of Pseudomonas, Bacteroides fragalis, Listeria monocytogenes and Clostridia are resistant to cefixime

Uncomplicated gonorrhoea

• Oral (tab): 400mg, as a single dose

Paed. forms avail. in SA and covered in this monograph: tab

Infections caused by:
- Upper respiratory tract infections e.g. otitis media; and other upper respiratory tract infections where the causative organism is known or suspected to be resistant to other commonly used antibiotics, or where treatment failure may carry significant risk
- Lower respiratory tract infection e.g. bronchitis
- Urinary tract infections e.g. cystitis, cystourethritis, uncomplicated pyelonephritis
Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Branhamella catarrhalis (beta-lactamase positive and negative) and Enterobacter species

Younger than 6 months

• Not established for use

Between 6 months-10 years

• Oral (tab): 8mg/kg/day, as single dose or 2 divided doses (4mg/kg/12hrly)

Older than 10 years, >50kg

• See adult dosage

Manufacturer does not recommend 200mg tablets for use in children <10 years

Dose is based on body weight and must be determined by your doctor

Pregnancy

• Caution; not recommended
• Reproduction studies have been performed in mice and rats at doses up to 400 times the human dose and have revealed no evidence of impaired fertility or harm to the foetus due to cefixime. In the rabbit, at doses up to 4 times the human dose, there was no evidence of a teratogenic effect; there was a high incidence of abortion and maternal death which is an expected consequence of the known sensitivity of rabbits to antibiotic-induced changes in the population of the microflora of the intestine. There are no adequate and well-controlled studies in pregnant women. Cefixime should therefore not be used in pregnancy unless considered essential by the physician

Breastfeeding

• Caution; not recommended
• It is not known if cefixime is excreted in breast milk. Cefixime should not be used in breastfeeding mothers unless considered essential by the physician

Renal Impairment

• CrCl ≥20ml/min: No dose adjustment recommended
• CrCl <20ml/min, chronic ambulatory peritoneal dialysis, haemodialysis: Caution; dose adjustment recommended
  Max dose: 200mg/24hrs

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended
  Renal function should be assessed and dosage should be adjusted in severe renal impairment

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dizziness
• Headache
• Seizures
• Risk of encephalopathy
  - Seizures
  - Confusion
  - Impairment of consciousness
  - Movement disorders

Respiratory Disorders

• Dyspnoea

Gastrointestinal Disorders

• Abdominal pain
• Diarrhoea
• Dyspepsia
• Nausea and vomiting
• Flatulance
• Pseudomembranous colitis

Hepatobiliary Disorders

• Jaundice
• Increased aspartate aminotransferase
• Increased alanine aminotransferase
• Increased blood bilirubin

Genitourinary Disorders

• Acute renal failure
• Tubulointerstitial nephritis as un underlying pathological condition
• Increased blood urea
• Increased blood creatinine
• Genital pruritus
• Vaginitis

Musculoskeletal Disorders

• Arthralgia

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Rash
• Urticaria
• Erythema multiforme
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis

Immune, Blood and Lymphatic System Disorders

• Eosinophilia
• Hypereosinophilia
• Agranulocytosis
• Leucopenia
• Neutropenia
• Granulocytopenia
• Haemolytic anaemia
• Thrombocytopenia
• Thrombocytosis
• Anaphylactic reaction
• Serum sickness-like reaction
• Drug rash with eosinophilia and systemic symptoms (DRESS)
• Drug fever
• Fever
• Face oedema
• Angioedema

• Anticoagulants
• Warfarin potassium

None routine. Specific cases may require

• Renal function
• Hepatic function

Additional observations

• Signs and symptoms of anaphylaxis during first dose

Interaction with laboratory tests

• A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets, but not with tests based on enzymatic glucose oxidase reactions
• A false positive direct Coombs test has been reported during treatment with cephalosporin antibiotics, therefore it should be recognised that a positive Coombs test may be due to the drug

Cefixime is an orally active third generation cephalosporin antibiotic which has in vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms. The mechanism of action of cefixime is based on inhibition of bacterial cell wall synthesis. It is highly stable in the presence of beta-lactamase enzymes.

Spectrum of activity: Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Branhamella catarrhalis (beta-lactamase positive and negative) and Enterobacter species

Tablet 400mg

• Exsef 400 (Innovata Pharmaceuticals)
• Fixime (Merck) originator