Cefone 2 g IV Injection: Each vial contains 2 g of Ceftriaxone as sterile Ceftriaxone Sodium USP.

Lidocaine Solution: Each ampoule contains 2 ml of Lidocaine Hydrochloride BP 1% Injection for reconstitution. Water for Injection: Each ampoule contains 10 ml sterile Water for Injection BP for reconstitution. PHARMACOLOGY Ceftriaxone (Cefone) is a third generation parenteral cephalosporin antibiotic which has potent bactericidal activity against a wide range of gram-positive and especially gram-negative organisms. Ceftriaxone (Cefone), like other cephalosporins and penicillins, kills bacteria by interfering bacterial cell wall synthesis. The spectrum of activity includes both aerobic and some anaerobic species. It has considerable stability against degradation by most bacterial betalactamases particularly those produced by gram-negative organisms. Ceftriaxone (Cefone) has relatively long plasma elimination half-life of approximately 8 hours, which offers single or once-daily dose of the drug. INDICATIONS Ceftriaxone (Cefone) is indicated for the treatment of the following infections when caused by susceptible organisms: . Lower Respiratory Tract Infections . Acute Bacterial Otitis Media . Skin & Skin Structure Infections . Urinary Tract Infections . Intra-abdominal Infections . Meningitis . Bone and Joint Infections . Septicemia . Uncomplicated Gonorrhoea . Pelvic Inflammatory Disease . Surgical Prophylaxis DOSAGE AND ADMINISTRATION Adults: The usual adult daily dose is 1 to 2 g given once a day (or in equally divided doses twice a day) depending on the type and severity of infection. The total daily dose should not exceed 4 g. . Severe Infections: 2-4 g daily, normally as a single dose every 24 hours. . Uncomplicated Gonorrhoea:A single dose of 250 mg intramuscularly should be administered. . Surgical Prophylaxis: A single dose of 1 g administered intravenously ½ to 2 hours before surgery is recommended. Neonates: By intravenous infusion over 60 minutes, 20-50 mg/kg daily (max. 50 mg/kg daily). Children: 20-50 mg/kg daily as a single dose, maximum up to 80 mg/kg as a single dose in severe infections; doses over 50 mg/kg should be given through intravenous infusion only. . Skin and Skin Structure Infections: The recommended total daily dose is 50 to 75 mg/kg given once a day (or in equally divided doses twice a day). The total daily dose should not exceed 2 g. . Acute Bacterial Otitis Media: A single intramuscular dose of 50 mg/kg (not to exceed 1 g) is recommended. .

Serious Miscellaneous Infections other than Meningitis: The recommended total daily dose is 50 to 75 mg/kg, given in divided doses every 12 hours. The total daily dose should not exceed 2 g. .

Meningitis: It is recommended that, the initial therapeutic dose is 100 mg/kg (not to exceed 4 g). Thereafter, a total daily dose of 100 mg/kg/day (not to exceed 4 g daily) is recommended. The daily dose may be administered once a day (or in equally divided doses every 12 hours). The usual duration of therapy is 7 to 14 days. USE INTHE ELDERLY The recommended dosage for adults do not require modification in the case of elderly patients provided that renal and hepatic functions are satisfactory. RENAL AND HEPATIC IMPAIRMENT In patients with impaired renal function, there is no need to reduce the dosage of Ceftriaxone provided liver function is intact. Only in cases of pre-terminal renal failure (creatinine clearance