Composition
IM Inj 250 mg/500 mg/1 gm: Ceftriaxone 250 mg/500 mg/1 gm (as sodium); powder in vial. IV Inj 250 mg/500 mg/1 gm/2 gm: Ceftriaxone 250 mg/500 mg/1 gm/2 gm (as sodium); powder in vial.
Indications & Dosage
Pneumonia, Intra-abdominal infections, Complicated Genitourinary tract infections, Severe infection of respiratory tract, Acute exacerbations of chronic obstructive pulmonary disease: BY IV INF, OR IV INJ, OR DEEP IM INJ: Adult: 1-2 g once daily, 2 g dose to be used for hospital-acquired pneumonia and severe cases. Complicated skin and soft tissue infections, Infections of bones and joints: BY IV INF, OR IV INJ, OR DEEP IM INJ: Adult: 2 g once daily. Suspected bacterial infection in neutropenic patients: BY IV INF, OR IV INJ, OR DEEP IM INJ: Adult: 2-4 g once daily, higher doses used in severe cases. Bacterial meningitis, Bacterial endocarditis: BY IV INF, OR IV INJ, OR DEEP IM INJ: Adult: 2-4 g once daily, higher doses used in severe cases. BY IV INF OR DEEP IM INJ: Children 1 month-11 years (body-weight up to50 kg): 80-100 mg/kg once daily, 100 mg/kg once daily; max. 4 g per day; 9-17 years (body-weight 50 kg and above): 2-4 gonce daily, higher doses used in severe cases BY IV INJ: Children 9-17 years (body-weight 50 kg and above): 2-4 gonce daily, higher doses used in severe cases. Surgical prophylaxis: BY IV INF, OR IV INJ, OR DEEP IM INJ: Adult: 2 g for 1 dose, administered 30-90 minutes before procedure. Uncomplicated gonorrhea, Pelvic inflammatory disease: BY DEEP IM INJ: Adult: 500 mg for 1 dose. Syphilis: BY IV INF, OR IV INJ, OR DEEP IM INJ: Adult: 0.5-1 g once daily for 10-14 days, dose increased to 2 g once daily for neurosyphilis. Disseminated Lyme borreliosis (Stage II & III): BY IV INF, OR IV INJ, OR DEEP IM INJ: Adult: 2 g once daily for 14-21 days. Prevention of secondary case of meningococcal meningitis: BY IM INJ: Adult: 250 mg for 1 dose. Prevention of secondary case of Haemophilus influenza type b disease: BY IM INJ, ORIV INJ, OR IV INF: Adult: 1 g daily for 2 days. Acute otitis media: BY DEEP IM INJ: Adult: 1-2 g for 1 dose, dose can be given for 3 days ifseverely ill or previous therapy failed; Children: 50 mg/kg single dose. Max: 1 gm/dose.
Administration
Administer IV intermittent infusion over 10-30 min; final concentration for IV administration should not exceed 40 mg/ml. By direct IV push over 2-4 min. Inject deep IM into large muscle mass, 250 mg/500 mg/1000 mg VIAL: To make concentration of 250 mg/ml add Water for Injection 0.9 ml in 250 mg vial; 1.8 ml in 500 mg vial; 3.6 ml in 1000 mg vial. IV: 250 mg/500 mg/1000 mg VIAL: To make concentration of 100 mg/ml add Water for Injection 2.4 ml in 250 mg vial; 4.8 ml in 500 mg vial; 9.6 ml in 1000 mg vial.
Compatibility
Stable in D5W with KCI 10 mEq, D5W, D1OW, NS, mannitol 5%, mannitol 10%, sodium bicarbonate 5%, bacteriostatic water, SWFI.
Stability
For IV infusion in NS or D5W, solution is stable for 24 hours at room temperature or 3 days when refrigerated.
Contraindications
Beta-lactam hypersensitivity. Premature newborns having less than 41 weeks postmenstrual age; neonates over 41 weeks postmenstrual age with jaundice, hypoalbuminaemia or acidosis; concomitant treatment with IV calcium (including total parenteral nutrition containing calcium) in neonates over 41 weeks postmenstrual age -risk of precipitation in urine and lung. Do not use in hyper-bilirubinaemia neonates.
Precautions
Severe renal and hepatic impairment. Do not use in pregnancy unless absolutely indicted.
Interactions
Oral contraceptives, calcium containing IV solns.
Pregnancy
No evidence of harm
Side Effects
Abdominal discomfort, agranulocytosis, allergic reactions, anaphylaxis, aplastic anaemia, blood disorders, confusion, disturbances in liver enzymes, dizziness, eosinophilia, haemolytic anaemia, hallucinations, headache, hypertonia, leucopenia, nervousness, pruritus, rashes, fever and arthralgia, sleep disturbances, urticaria, GI disturbances, Rare: Stevens-Johnsonsyndrome, thrombocytopenia, toxic epidermal necrolysis, transient cholestatic jaundice, transient hepatitis