Chloramphenicol Sod. Succinate Injection

Description

Product Description: Chloramphenicol Sodium Succinate Injection is a sterile solution containing chloramphenicol, a broad-spectrum antibiotic. It is indicated for the treatment of various bacterial infections caused by susceptible organisms.

Indications and Usage: Chloramphenicol Sodium Succinate Injection is indicated for the treatment of serious infections caused by susceptible strains of gram-positive and gram-negative bacteria. These infections may include meningitis, septicemia, respiratory tract infections, urinary tract infections, and others.

Dosage and Administration: Dosage and administration of Chloramphenicol Sodium Succinate Injection should be based on the severity of the infection, the patient's weight, and renal function. It is typically administered intravenously at a dose of 50 mg/kg/day divided into 4 equal doses for adults and children.

Dosage Forms and Strengths: Chloramphenicol Sodium Succinate Injection is available as a sterile solution in vials containing 500 mg or 1 gram of chloramphenicol per vial.

Contraindications: Chloramphenicol Sodium Succinate Injection is contraindicated in patients with a known hypersensitivity to chloramphenicol or any component of the formulation. It should not be used in patients with a history of bone marrow suppression or blood dyscrasias.

Warnings and Precautions:

• Serious and fatal blood dyscrasias, including aplastic anemia, have been reported with the use of chloramphenicol. Monitor patients closely for signs of bone marrow suppression during therapy.
• Use caution in patients with hepatic or renal impairment, as dosage adjustment may be necessary.
• Avoid prolonged use of chloramphenicol, as it may increase the risk of developing resistance and superinfections.

Adverse Reactions/Side Effects: Common adverse reactions associated with Chloramphenicol Sodium Succinate Injection include nausea, vomiting, diarrhea, and reversible bone marrow suppression. Less commonly, it may cause hypersensitivity reactions, including rash, urticaria, and angioedema.

Drug Interactions: Chloramphenicol Sodium Succinate Injection may interact with other medications, including anticoagulants, phenobarbital, and rifampin. Use caution when administering concomitant medications and monitor for potential drug interactions.

Use In Specific Populations Description: Safety and efficacy of Chloramphenicol Sodium Succinate Injection in pediatric patients, pregnant women, and nursing mothers have not been established. Use in these populations should be carefully considered, and the potential risks and benefits should be weighed.

Clinical Pharmacology: Chloramphenicol inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit. It exhibits broad-spectrum activity against gram-positive and gram-negative bacteria, including some anaerobes.

Nonclinical Toxicology: Animal studies have shown evidence of dose-related bone marrow suppression and toxicity. However, these effects are typically not observed at therapeutic doses in humans.

Clinical Studies: Clinical studies have demonstrated the efficacy of Chloramphenicol Sodium Succinate Injection in the treatment of various bacterial infections, including meningitis, septicemia, and respiratory tract infections.

References:

1. Chloramphenicol Sodium Succinate Injection Prescribing Information.
2. Clinical Pharmacology of Chloramphenicol Sodium Succinate Injection.
3. Clinical Studies on the Efficacy of Chloramphenicol Sodium Succinate Injection.

How Supplied/Storage and Handling: Chloramphenicol Sodium Succinate Injection is supplied as a sterile solution in single-dose vials. It should be stored at controlled room temperature (20°C to 25°C) and protected from light. Reconstituted solutions should be used within the recommended time frame and stored according to instructions.

Patient Counseling Information: Patients should be counseled on the importance of completing the full course of treatment as prescribed by their healthcare provider, even if symptoms improve before the medication is finished. They should also be advised to report any signs of adverse reactions or side effects to their healthcare provider promptly. Additionally, patients should be educated on the importance of proper hydration during treatment.