Finished product reference
Imipenem / Cilastatin
Injection, Powder, for Solution · Parenteral · 500 mg/500 mg
- List code
- 1876
What it is and how it works
Mechanism of Action Imipenem and Cilastatin for Injection (I.V.) is a combination of imipenem and cilastatin. Imipenem is a penem antibacterial drug . Cilastatin is a renal dehydropeptidase inhibitor that limits the renal metabolism of imipenem.
Indications
Imipenem and Cilastatin for Injection, USP for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: Lower respiratory tract infections. Urinary tract infections. Intra-abdominal infections. Gynecologic infections. Bacterial septicemia. Bone and joint infections. Skin and skin structure infections. Endocarditis. Limitations of Use : Imipenem and Cilastatin for Injection, USP (I.V.) is not indicated in patients with meningitis because safety and efficacy have not been established . Imipenem and Cilastatin for Injection, USP (I.V.) is not recommended in pediatric patients with CNS infections because of the risk of seizures . Imipenem and Cilastatin for Injection, USP (I.V.) is not recommended in pediatric patients weighing less than 30 kg with impaired renal function .
Dosage and administration (summary)
The dosage of Imipenem and Cilastatin for Injection (I.V.) in adult patients should be based on suspected or confirmed pathogen susceptibility . For adult patients with normal renal function (creatinine clearance of greater than or equal to 90 mL/min), the recommended dosage regimens are: 500 mg every 6 hours OR 1,000 mg every 8 hours OR 1,000 mg every 6 hours . See full prescribing information for dosage recommendations in pediatric patients . A reduction in dose must be made for a patient with a creatinine clearance of less than 90 mL/min .
Contraindications
Imipenem and Cilastatin for Injection (I.V.) is contraindicated in patients who have shown hypersensitivity to any component of this product. Known hypersensitivity to any component of Imipenem and Cilastatin for Injection (I.V.)
Warnings and precautions
Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. If an allergic reaction to Imipenem and Cilastatin for Injection (I.V.) occurs, discontinue the drug immediately . Seizure Potential: Seizures and other CNS adverse reactions, such as confusional states and myoclonic activity, have been reported during treatment with Imipenem and Cilastatin for Injection (I.V.).
Pregnancy
Pregnancy Risk Summary Available data from a small number of postmarketing cases with Imipenem and Cilastatin for Injection (I.V.) use in pregnancy are not sufficient to identify any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Storage and supply
Storage and Handling Before Reconstitution: Imipenem and Cilastatin for Injection, USP (I.V.) sterile powder should be stored at 20° to 25°C (68° to 77°F) .
Source: Imipenem And Cilastatin Sodium (Imipenem And Cilastatin) — US FDA prescribing information, 2022-10-10, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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