Ceftriaxone (as sodium hemiheptahydrate) 2,000 mg/vial

A third-generation cephalosporin antibiotic whose methoxyimino side chain on the cephem ring broadens gram-negative activity and confers stability against many beta-lactamases. The reference product is ceftriaxone sodium for injection (1 g/vial) given intravenously or intramuscularly. **A prescription medicine subject to antibiotic stewardship**

Broad-spectrum treatment: central nervous system infection (meningitis), respiratory tract infection, urinary tract infection, skin and soft-tissue infection, intra-abdominal and pelvic infection, bone and joint infection, sepsis; prophylaxis (surgical, trauma); Neisseria gonorrhoeae infection (single dose). Indications, doses and durations follow the locally approved label and guidelines

Binds bacterial penicillin-binding proteins (PBPs) to inhibit peptidoglycan synthesis; strong activity against gram-negative organisms (including Neisseria meningitidis) and some gram-positive organisms; a long half-life (about 8 hours) permits once-daily or q12h dosing; eliminated by **both renal and biliary routes**, so it can be used in hepatic impairment (predominantly biliary) without adjustment; penetrates the blood-brain barrier

Intravenous or deep intramuscular administration away from nerves and vessels; monitor temperature, local signs of infection, full blood count, hepatic and renal function (ALT/AST/bilirubin) and serum calcium. **Monitor for bleeding and coagulation abnormalities** — risk rises with vitamin-K antagonists, hepatic impairment, renal impairment and older age. Monitor for rash and for Clostridioides difficile-associated diarrhoea. Confirm penicillin/cephalosporin allergy history before use

Prescription medicine. Verify allergy history before administration; cross-reactivity risk is low but not zero, and anaphylaxis can occur. Risk of cholestasis and biliary sludge/pseudolithiasis. Intravenous administration of ceftriaxone together with calcium-containing solutions can precipitate ceftriaxone calcium and has caused deaths — this must be avoided. Prolonged or high-dose use can cause hypocalcaemia, splenic atrophy or haemolytic anaemia (rare, especially in children). Neurotoxicity (encephalopathy, seizures) is mainly seen at high doses in renal impairment. Administration requires professional technique, and intravenous infusion must be slow

**Neonates and infants**: contraindicated for intravenous calcium-ceftriaxone formulations (risk of kernicterus and calcium deposition); pregnancy: may be used for appropriate indications; lactation: usable, noting low breast-milk exposure; older adults: adjust dose to creatinine clearance; renal impairment: extend the dosing interval and monitor (halve the dose in severe impairment); hepatic impairment alone usually requires no adjustment; bleeding-risk monitoring is especially important above 65 years; sickle-cell disease (e.g. in cystic fibrosis) requires monitoring for haemolysis and renal stones

**Prescription medicine subject to antibiotic stewardship**: prescribe-only, strictly for the approved indication, dose and duration, and not for common colds or viral infections. **Must not be mixed with other beta-lactams in the same infusion**, and must not share a venous access with calcium-containing products. Avoid combination with NSAIDs and large amounts of alcohol (increased bleeding risk). Administer intravenously slowly with site monitoring; not suitable for unsupervised self-administration at home

**Ceftriaxone is not on the WADA Prohibited List** (it is neither a stimulant, a hormone, nor a substance prohibited as a doping agent, nor a priority Monitoring Program substance), so its use does not constitute an anti-doping violation. It should still be used for a legitimate prescription indication, and any use must be proactively declared when relevant to anti-doping testing so that it is not confused with a prohibited substance

Identification (FTIR/HPLC-MS), assay (HPLC; typically required within 90.0–115.0% of label claim), water content, pH, clarity and colour of solution, related substances/impurity profile (including ceftriaxone isomers), pyrogen/bacterial endotoxin, sterility, fill and weight variation, reconstitution time and in-use stability, residual solvents, stability; COA and lot-to-lot consistency