Imipenem + Cilastatin Injection

Description

Product Description: Imipenem + Cilastatin Injection is a potent combination antibiotic composed of imipenem, a broad-spectrum carbapenem antibiotic, and cilastatin, a renal dehydropeptidase inhibitor. This combination therapy offers enhanced efficacy against a wide range of bacterial infections, making it a valuable treatment option for serious infections where resistance is a concern.

Indications and Usage: Imipenem + Cilastatin Injection is indicated for the treatment of moderate to severe infections caused by susceptible organisms, including intra-abdominal infections, skin and soft tissue infections, pneumonia, urinary tract infections, and bacterial septicemia.

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. Imipenem + Cilastatin is typically administered intravenously over a period of 30 minutes.

Dosage Forms and Strengths: Imipenem + Cilastatin Injection is available as a sterile powder for reconstitution in various strengths, typically ranging from 500 mg/500 mg to 1 gram/1 gram per vial.

Contraindications: Imipenem + Cilastatin Injection is contraindicated in patients with known hypersensitivity to carbapenems, 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 imipenem + cilastatin. 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 imipenem + cilastatin.

Adverse Reactions/Side Effects: Common adverse reactions associated with imipenem + cilastatin include diarrhea, nausea, vomiting, rash, and injection site reactions. Serious adverse reactions may include severe allergic reactions, Clostridium difficile-associated diarrhea, and hepatic dysfunction.

Drug Interactions: Imipenem + Cilastatin may interact with other medications, including valproic acid, which may reduce valproic acid levels. Concurrent use with probenecid may increase imipenem plasma concentrations. Caution should be exercised when co-administering with other drugs that may affect renal function.

Use In Specific Populations Description: Use of imipenem + cilastatin 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.

Clinical Pharmacology: Imipenem exerts its bactericidal effects by inhibiting bacterial cell wall synthesis, leading to cell death. Cilastatin inhibits the renal metabolism of imipenem, thereby extending its half-life and enhancing its efficacy.

How Supplied/Storage and Handling: Imipenem + Cilastatin 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.