Generic Medicine Info
Hypersensitivity to ceftriaxone, other cephalosporins, or history of severe hypersensitivity reaction to any other type of β-lactam antibiotic (e.g. penicillins, monobactams, carbapenems). Premature neonates up to a postmenstrual age of 41 weeks (gestational age and chronological age); full-term neonates (up to 28 days of age) with hyperbilirubinaemia, jaundice, hypoalbuminaemia, or acidosis, and if they require IV Ca treatment or Ca-containing infusions. IV administration of ceftriaxone solutions containing lidocaine.
Special Precautions
Patient with history of non-severe hypersensitivity to other β-lactam agents, history of gastrointestinal disease (particularly colitis) or renal lithiasis; hypercalciuria, impaired vitamin K synthesis or low vitamin K stores (e.g. malnutrition, chronic hepatic disease); risk factors for biliary stasis and sludge (e.g. preceding major therapy, severe illness and TPN). Severe renal and hepatic impairment. Neonates and children. Pregnancy and lactation. Monitoring Parameters Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Monitor prothrombin time/INR, renal function tests, and LFTs; CBC regularly during prolonged use. Assess for signs and symptoms of hypersensitivity reactions (especially anaphylaxis) during the 1st dose, haemolytic anaemia, and pancreatitis.
Adverse Reactions
Significant: Biliary lithiasis, gallbladder sludge, pseudolithiasis, pancreatitis (possibly secondary to biliary obstruction), renal lithiasis (reversible), urolithiasis, acute renal failure; Jarisch-Herxheimer reaction, encephalopathy, kernicterus in neonates; fungal or bacterial superinfection (prolonged use). Rarely, increased INR (particularly during prolonged use, or in patients with nutritional deficiency, renal and hepatic impairment). Blood and lymphatic system disorders: Eosinophilia, leucopenia, thrombocytopenia, granulocytopenia, neutropenia, anaemia, coagulopathy. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, loose stools, dysgeusia. General disorders and administration site conditions: Inj site pain or tenderness (IV/IM); inj site induration, warm sensation, and skin tightness (IM); chills, pyrexia. Infections and infestations: Candidiasis. Investigations: Increased ALT, AST, alkaline phosphatase, serum bilirubin, BUN, and serum creatinine. Nervous system disorders: Dizziness, headache. Reproductive system and breast disorders: Vaginitis. Skin and subcutaneous tissue disorders: Rash, pruritus, diaphoresis. Vascular disorders: Flushing; phlebitis (IV).
Potentially Fatal: Hypersensitivity reactions, including anaphylaxis and anaphylactic shock; severe cutaneous adverse reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms [DRESS], acute generalised exanthematous pustulosis), severe haemolytic anaemia; Clostridioides difficile-associated diarrhoea, pseudomembranous colitis; ceftriaxone-Ca precipitation in the lungs and kidneys (particularly in premature and term neonates).
Drug Interactions
May increase the risk of bleeding with vitamin K antagonists (e.g. warfarin). May increase the nephrotoxicity of aminoglycosides. May diminish the therapeutic effects of BCG, typhoid vaccine, and Na picosulfate.
CIMS Class
ATC Classification
J01DD04 - ceftriaxone ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
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