CFTRIAX

What it is

CFTRIAX is a ceftriaxone sodium powder for injection available in 1 g and 2 g vial strengths. The 1000 mg strength is indicated for intramuscular injection, intravenous injection and intravenous infusion, while the 2000 mg strength is for intravenous infusion only. Each vial contains ceftriaxone sodium equivalent to either 1000 mg or 2000 mg of ceftriaxone as a single ingredient.

Approved indications

— Lower respiratory tract infections caused by susceptible organisms including *Streptococcus pneumoniae*, *Haemophilus influenzae*, *Klebsiella* species, *Escherichia coli* and other gram-negative and gram-positive aerobic bacteria. — Skin and skin structure infections caused by susceptible aerobic organisms. — Complicated and uncomplicated urinary tract infections caused by susceptible organisms. — Uncomplicated gonorrhoea (cervical, urethral and rectal) caused by *Neisseria gonorrhoeae*. — Bacterial septicaemia caused by *Streptococcus pneumoniae*, *Escherichia coli* and *Haemophilus influenzae*. — Bone infections caused by susceptible aerobic organisms. — Joint infections caused by susceptible aerobic organisms. — Meningitis in children and immunocompetent adults when presumed or proven to be caused by *Haemophilus influenzae* type b, *Neisseria meningitidis*, *Streptococcus pneumoniae* or Enterobacteriaceae. — Surgical prophylaxis to reduce post-operative infections in patients undergoing vaginal or abdominal hysterectomy, cholecystectomy in high risk patients, contaminated or potentially contaminated procedures, and coronary artery bypass surgery.

Dosing overview

The recommended adult daily dose is 1000 to 2000 mg given once a day or in equally divided doses twice a day depending on the type and severity of the infection. For uncomplicated gonococcal infections, a single intramuscular dose of 250 mg is recommended. For surgical prophylaxis, a single dose of 1000 mg administered ½ to 2 hours before surgery is recommended. For serious miscellaneous infections in children, the recommended total daily dose is 50–75 mg/kg (not to exceed 2000 mg), given once per day or in divided doses every 12 hours, with meningitis doses divided and administered every twelve hours.

Key safety warnings

Careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins or other drugs, as anaphylactic reactions with fatal outcome have been reported even in patients not known to be allergic. Serious acute hypersensitivity reactions may require subcutaneous adrenaline and other emergency measures. Hypersensitivity reactions progressing to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction) have been reported. Severe cutaneous adverse reactions including Stevens–Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalised exanthematous pustulosis have been reported in patients taking beta-lactam antibiotics. When suspected, ceftriaxone should be discontinued immediately and alternative treatment considered. Clostridium difficile associated diarrhoea has been reported with use of ceftriaxone and may range in severity from mild diarrhoea to fatal colitis. It must be considered in all patients presenting with diarrhoea following antibiotic use. Immune-mediated haemolytic anaemia has been observed in patients receiving ceftriaxone, with severe cases including fatalities reported. If a patient develops anaemia while on ceftriaxone, the diagnosis of cephalosporin-associated anaemia should be considered and ceftriaxone discontinued until the aetiology is determined. Ceftriaxone may precipitate in the gallbladder and kidneys and be detectable as shadows on ultrasound, more likely in infants and small children. In children, doses greater than 80 mg/kg body weight should be avoided—except for meningitis—because of the increased risk of biliary precipitates.

Contraindications

Ceftriaxone is contraindicated in patients with known hypersensitivity to beta-lactam antibiotics. In patients hypersensitive to penicillin, the possibility of allergic cross-reactions should be borne in mind. Hyperbilirubinaemic neonates, especially premature, should not be treated with ceftriaxone. In vitro studies have shown that ceftriaxone can displace bilirubin from its binding to serum albumin and bilirubin encephalopathy can possibly develop in these patients. Ceftriaxone is contraindicated in premature newborns up to a corrected age of 41 weeks and full-term newborns up to 28 days of age with jaundice, hypoalbuminaemia or acidosis, and in those requiring or expected to require intravenous calcium treatment or calcium-containing infusions because of the risk of precipitation of ceftriaxone-calcium. Lidocaine should not be used as a diluent for intramuscular injection in patients who are hypersensitive to lidocaine.

PBS listing

Information regarding PBS listing, including strength, item count, restriction type, and ex-manufacturer price, is not provided in the source documents.

Regulatory history

CFTRIAX ceftriaxone sodium 1 g and 2 g powder for injection vials were first listed on the Australian Register of Therapeutic Goods on 8 December 2017.