Ceftriaxone + Sulbactam Injection.
- Packing: Vial
- Available Strength : 3 Gm, 4.5 Gm
Description
Product Description: Ceftriaxone + Sulbactam Injection is a combination antibiotic formulation that synergistically combines the broad-spectrum cephalosporin antibiotic ceftriaxone with the beta-lactamase inhibitor sulbactam. This combination provides enhanced antimicrobial activity against a wide range of bacterial infections, particularly those caused by beta-lactamase-producing organisms.
Indications and Usage: Ceftriaxone + Sulbactam Injection is indicated for the treatment of the following infections caused by susceptible organisms:
- Lower respiratory tract infections
- Urinary tract infections
- Skin and soft tissue infections
- Intra-abdominal infections
- Bone and joint infections
- Bacterial meningitis
- Gonorrhea
Dosage and Administration: Dosage and administration of Ceftriaxone + Sulbactam Injection should be determined by a qualified healthcare professional based on the severity of the infection, the patient's age and weight, renal function, and the susceptibility of the causative bacteria. It is typically administered intravenously or intramuscularly.
Dosage Forms and Strengths: Ceftriaxone + Sulbactam Injection is available as a sterile powder for reconstitution in vials containing various strengths, typically combining ceftriaxone with sulbactam in fixed ratios.
Contraindications: Ceftriaxone + Sulbactam Injection is contraindicated in patients with a known hypersensitivity to cephalosporin antibiotics, sulbactam, or any component of the formulation. It should not be used in patients with a history of severe allergic reactions to penicillin or other beta-lactam antibiotics.
Warnings and Precautions:
- Serious hypersensitivity reactions, including anaphylaxis, may occur with the use of cephalosporin antibiotics. Discontinue the medication if a severe allergic reaction occurs.
- Ceftriaxone + Sulbactam Injection may cause Clostridium difficile-associated diarrhea. Consider discontinuation and appropriate supportive therapy if diarrhea occurs.
- Use caution in patients with renal impairment or those at risk of gallbladder disease.
Adverse Reactions/Side Effects: Common adverse reactions associated with Ceftriaxone + Sulbactam Injection include diarrhea, nausea, vomiting, rash, and injection site reactions. Less commonly, it may cause allergic reactions, including severe skin reactions and anaphylaxis.
Drug Interactions: Ceftriaxone + Sulbactam Injection may interact with other medications, including anticoagulants, probenecid, and loop diuretics. Monitor patients closely for potential drug interactions.
Use In Specific Populations Description: Safety and efficacy of Ceftriaxone + Sulbactam Injection in pediatric patients, pregnant women, and nursing mothers have been established through clinical studies and extensive post-marketing surveillance. However, caution should be exercised when administering to these populations, and the potential risks and benefits should be carefully considered.
Clinical Pharmacology: The combination of ceftriaxone and sulbactam provides enhanced antimicrobial activity by inhibiting bacterial cell wall synthesis and inactivating beta-lactamase enzymes, respectively.
Nonclinical Toxicology: Animal studies have demonstrated the potential for renal toxicity and hepatotoxicity at high doses. However, these effects are typically not observed at therapeutic doses in humans.
Clinical Studies: Clinical studies have demonstrated the efficacy of Ceftriaxone + Sulbactam Injection in the treatment of various bacterial infections, including respiratory tract infections, urinary tract infections, and bacterial meningitis.
References:
- Ceftriaxone + Sulbactam Injection Prescribing Information.
- Clinical Pharmacology of Ceftriaxone + Sulbactam Injection.
- Clinical Studies on the Efficacy of Ceftriaxone + Sulbactam Injection.
How Supplied/Storage and Handling: Ceftriaxone + Sulbactam Injection is supplied as a sterile powder for reconstitution 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.
