Softcef 500mg Injection (Each vial contains Ceftriaxone Sodium 500mg)

Indications

• Bacterial meningitis
• Community-acquired pneumonia
• Skin and soft tissue infections
• Urinary tract infections
• Sepsis
• Intra-abdominal infections
• Pelvic inflammatory disease

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations based on the child's age, weight, and clinical condition.

Adults: Refer to the BNF for specific dosing guidelines based on the infection being treated and patient factors.

Mechanism of action

Ceftriaxone exerts its antibacterial effect by inhibiting bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) within the bacterial cell wall, disrupting the transpeptidation process necessary for cell wall integrity. This leads to cell lysis and death in susceptible bacteria, making it effective against a wide range of pathogens.

Pharmacodynamics

The pharmacodynamic properties of ceftriaxone include a time-dependent killing effect, where the duration of time that plasma concentrations remain above the minimum inhibitory concentration (MIC) is crucial for its efficacy. Ceftriaxone demonstrates a prolonged half-life, allowing for once-daily dosing in many cases, which can improve patient compliance and ease of administration.

Pharmacokinetics

Ceftriaxone is well absorbed when administered intravenously or intramuscularly, achieving high plasma concentrations. It has a volume of distribution of approximately 7-12 L/kg and is approximately 85% bound to plasma proteins. Ceftriaxone is eliminated primarily via the kidneys, with around 50-60% excreted unchanged in the urine. The elimination half-life is approximately 6-8 hours, which can be extended in patients with renal impairment.

Contra-indications

• Hypersensitivity to ceftriaxone or other cephalosporins
• Severe allergic reactions to penicillin
• Neonates with hyperbilirubinemia
• Concurrent use with calcium-containing solutions in neonates

Adverse effects

• Diarrhea
• Nausea
• Vomiting
• Rash
• Allergic reactions
• Elevated liver enzymes
• Thrombocytopenia
• Nephrotoxicity
• Superinfection with prolonged use

Interactions

• Increased risk of nephrotoxicity when combined with other nephrotoxic agents
• Probenecid may increase ceftriaxone levels
• Calcium-containing solutions should not be mixed or simultaneously infused

Precautions

• Use with caution in patients with a history of gastrointestinal disease, particularly colitis
• Monitor renal function in patients with renal impairment
• Caution in patients with a history of hypersensitivity reactions

Pregnancy

Ceftriaxone is categorized as pregnancy category B. It is generally considered safe for use during pregnancy, but should be used only if clearly needed.

Breast-feeding

Ceftriaxone is excreted in breast milk in small amounts. Caution is advised when administering to nursing mothers, as it may affect the infant.

Storage

Store at room temperature away from light, in a dry place. Reconstituted solutions should be stored in the refrigerator and used within a short period.

Formulations

• Injection: 1 g, 2 g vials (lyophilized powder for reconstitution)