Pan-Ceftriaxone 1 g

/ Pharmalogic

Adults and Children over twelve years old:
The usual dosage is 1-2 gm of ceftriaxone administered once daily (every 24 hours). In severe cases or in infections caused by moderately sensitive organisms, the dosage may be raised to 4 gm, administered once daily.
Elderly patients: The dosages recommended for adults require no modification in the case of geriatric patients.
Neonates, Infants and Children up to twelve years old: The following dosage schedules are recommended for once daily administration:
Neonates (up to 14 days): A daily dose of 20-50 mg/kg bodyweight, not to exceed 50 mg/kg, on account of the immaturity of the infant’s enzyme systems. It is not necessary to differentiate between premature and infants born at term.
Hyperbilirubinemic neonates, especially prematures, should not be treated with ceftriaxone.
Infants and children (15 days to twelve years): A daily dose of 20-80 mg/kg.
NOTE: For children with bodyweights of 50 kg or more, the usual adult dosage should be used.
Intravenous doses of 50 mg or more per kg should be given by infusion over at least 30 minutes.
See prescribing information for full details.

Infections caused by pathogens sensitive to ceftriaxone e.g.: sepsis; meningitis; abdominal infections (peritonitis, infections of the biliary and gastrointestinal tracts); infections of the bones, joints, soft tissue, skin and of wounds; infections in patients with impaired defense mechanisms; renal and urinary tract infections; respiratory tract infections, particularly pneumonia; ear, nose and throat infections; genital infections, including gonorrhoea. Perioperative prophylaxis of infections.

Hypersensitivity. Pregnancy.
See prescribing information for full details.

See prescribing information for full details.

Ceftriaxone is generally well tolerated. During the use of ceftriaxone, the following side effects, which were reversible either spontaneously or after withdrawal of the medicine, have been observed:
Systemic side effects
Gastrointestinal complaints (about 2% of cases): loose stools or diarrhoea, nausea, vomiting, stomatitis and glossitis.
Haematological changes (about 2%): eosinophilia, leukopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia.
Skin reactions (about 1%): exanthema, allergic dermatitis, pruritus, urticaria, oedema, a few cases of severe mucocutaneous reactions (erythema multiforme, Stevens-Johnson syndrome, Lyell’s syndrome).
See prescribing information for full details.

Amsacrine, vancomycin, fluconazole, aminoglycosides.

Pregnancy: Safety in human pregnancy has not been established. Reproductive toxicity studies have been performed in mice and rats at doses up to 20 times the human dose of 2 gm/d (586 mg/kg/d in rats), and have not shown evidence of embryotoxicity, foetotoxicity, teratogenicity or adverse effects on male or female fertility, birth or peri- and postnatal development. In primates, no embryotoxicity or teratogenicity was demonstrated at a dose approximately 3 times the human dose (84 mg/kg/d in monkeys).
Lactation: As ceftriaxone is secreted in the breast milk at low concentrations, caution is advised in nursing mothers.

In the case of overdosage, drug concentration would not be reduced by haemodialysis or peritoneal dialysis. There is no specific antidote. Treatment of overdosage should be symptomatic.