Ampicillin + Sulbactam Injection

Description

Product Description: Ampicillin + Sulbactam Injection is a combination antibiotic that consists of ampicillin, a broad-spectrum penicillin, and sulbactam, a beta-lactamase inhibitor. This combination provides enhanced efficacy against a wide range of bacterial infections, particularly those caused by beta-lactamase-producing organisms. Ampicillin + Sulbactam Injection is an essential therapeutic option for treating various infections effectively.

Indications and Usage: Ampicillin + Sulbactam Injection is indicated for the treatment of moderate to severe infections caused by susceptible bacteria, including intra-abdominal infections, skin and soft tissue infections, respiratory tract infections, urinary tract infections, and gynecological infections.

Dosage and Administration: Dosage and administration should be determined by a qualified healthcare professional based on factors such as the severity of the infection, the patient's age and weight, renal function, and the susceptibility of the causative bacteria. Ampicillin + Sulbactam is typically administered intravenously over a period of 15 to 30 minutes.

Dosage Forms and Strengths: Ampicillin + Sulbactam Injection is available as a sterile powder for reconstitution in various strengths, typically ranging from 1.5 grams to 3 grams per vial.

Contraindications: Ampicillin + Sulbactam Injection is contraindicated in patients with a known hypersensitivity to penicillins, cephalosporins, or any component of the formulation. It should not be used in patients with a history of severe allergic reactions to beta-lactam antibiotics.

Warnings and Precautions: Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of ampicillin + sulbactam. It should be used with caution in patients with a history of allergies, asthma, or other allergic conditions. Prolonged use may result in the overgrowth of non-susceptible organisms, including fungi. Clostridium difficile-associated diarrhea has been reported with the use of nearly all antibacterial agents, including ampicillin + sulbactam.

Adverse Reactions/Side Effects: Common adverse reactions associated with ampicillin + sulbactam include diarrhea, nausea, vomiting, rash, and injection site reactions. Serious adverse reactions may include severe allergic reactions, nephrotoxicity, and hepatotoxicity.

Drug Interactions: Ampicillin + Sulbactam may interact with other medications, including oral contraceptives, which may reduce their effectiveness. Concurrent use with probenecid may increase ampicillin plasma concentrations. Caution should be exercised when co-administering with other drugs that may affect renal function.

Use In Specific Populations Description: Use of Ampicillin + Sulbactam Injection in pregnant women should be weighed against the potential risks to the fetus. It is excreted in breast milk; caution should be exercised when administering to nursing mothers. Safety and efficacy in pediatric patients have been established for certain indications and age groups.

How Supplied/Storage and Handling: Ampicillin + Sulbactam Injection is supplied as a sterile powder 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 immediately or stored under refrigeration for up to 24 hours.