Ceftriaxone injection is used for the treatment of the following serious infections:

• Lower respiratory tract infections
• Acute bacterial otitis media
• Skin and soft tissue infections
• Urinary tract infections
• Gonorrhea
• Bacterial septicemia
• Bone and joint infections
• Meningitis
• Prevention of postoperative infections
• Perioperative prophylaxis associated with surgical procedures

Ceftriaxone is a third-generation, broad-spectrum parenteral cephalosporin antibiotic with strong bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria. It acts by inhibiting the synthesis of the bacterial cell wall, leading to bacterial cell death. Ceftriaxone is highly stable in the presence of beta-lactamase enzymes. It has a relatively long plasma elimination half-life of approximately 6 to 9 hours, allowing convenient once-daily dosing for most patients. The drug is not metabolized in the body. Approximately 40–65% of the administered dose is excreted unchanged in the urine, while the remaining portion is eliminated through bile and excreted in feces as unchanged drug and inactive metabolites. Ceftriaxone is highly protein bound (about 95%).

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
• Uncomplicated gonococcal infections: 250 mg IM as a single dose
• Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
• Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
• Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

Administration

Preparation of Solutions for Intramuscular / Intravenous Injections:

• For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCl 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCl 1% injection.
• For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C.)

No clinically significant drug interactions have been reported with Ceftriaxone.

Ceftriaxone should not be administered to patients with known hypersensitivity to cephalosporin antibiotics.

Ceftriaxone is generally well tolerated. However, some adverse effects may occur, including gastrointestinal disturbances such as diarrhea, nausea, vomiting, stomatitis and glossitis; skin reactions like rash, itching, urticaria, edema and erythema multiforme; hematological changes including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic effects such as elevated SGOT or SGPT and hyperbilirubinemia; and CNS-related symptoms including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsions, hypertonia and dizziness. Local phlebitis may rarely occur after intravenous administration, which can be minimized by slow injection over 2–4 minutes.

The safety of Ceftriaxone during human pregnancy has not been fully established. Therefore, it should be used during pregnancy only when clearly necessary. Small amounts of Ceftriaxone are excreted in human breast milk, so caution should be exercised when administered to breastfeeding mothers.

As with other cephalosporins, the possibility of anaphylactic shock cannot be completely excluded, even with careful patient history. Immediate treatment, including intravenous epinephrine followed by a glucocorticoid, is required in such cases. Rarely, ultrasound findings may indicate gallbladder sludge formation during therapy, which is reversible after discontinuation or completion of treatment. If this condition is associated with pain, conservative non-surgical management is recommended. During prolonged therapy, regular monitoring of blood parameters is advised.

Ceftriaxone should not be administered to premature neonates and newborns up to 28 days of age.

There is no specific antidote for Ceftriaxone overdose. Management should be supportive and based on symptoms.

Third generation Cephalosporins

Store the vial in a cool, dry place below 30°C, protected from light and moisture. Keep out of reach of children.