GNH USA

Europe — EMA

Imipenem/Cilastatine Fresenius Kabi

GNH USA supplies Imipenem/Cilastatin Fresenius Kabi (Imipenem/Cilastatin), a carbapenem antibiotic for severe intra‑abdominal, urinary and respiratory

Cilastatin Sodium, Imipenem Monohydrate

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What is Cilastatin Sodium, Imipenem Monohydrate?

Imipenem/Cilastatin, the active ingredient in Imipenem/Cilastatin Fresenius Kabi, is a carbapenem antibiotic presented as an injection solution for intravenous use. It treats severe bacterial infections in hospitalized patients, including intra‑abdominal, urinary, respiratory and central nervous system infections.

GNH USA supplies Imipenem/Cilastatin Fresenius Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide.

What is Cilastatin Sodium, Imipenem Monohydrate used for?

Imipenem/Cilastatin is a broad‑spectrum carbapenem used for serious bacterial infections affecting various organ systems.

- Complicated intra‑abdominal infections: provides rapid bacterial clearance in severe abdominal sepsis. - Complicated urinary tract infections: eradicates resistant uropathogens causing pyelonephritis. - Skin and soft‑tissue infections: treats deep tissue infections caused by Gram‑negative and Gram‑positive bacteria. - Hospital‑acquired and ventilator‑associated pneumonia: covers multidrug‑resistant respiratory pathogens. - Meningitis: achieves therapeutic concentrations in cerebrospinal fluid for bacterial meningitis. - Febrile neutropenia: offers empiric coverage for high‑risk neutropenic patients.

What are the side effects of Cilastatin Sodium, Imipenem Monohydrate?

Adverse reactions may occur with any antimicrobial therapy and should be monitored.

Common Side Effects: - Nausea: mild to moderate gastrointestinal upset. - Vomiting: occasional emesis following infusion. - Diarrhea: may range from loose stools to mild colitis. - Rash: skin erythema or pruritus. - Headache: transient headache during or after infusion. - Elevated liver enzymes: mild transaminase increase.

Serious or Rare Side Effects: - Seizures: especially in patients with renal impairment or CNS disorders. - Anaphylaxis: severe hypersensitivity reaction requiring immediate intervention. - Clostridioides difficile infection: antibiotic‑associated colitis. - Severe neutropenia or thrombocytopenia: hematologic suppression. - Renal toxicity: worsening renal function in susceptible individuals. - Stevens‑Johnson syndrome: rare severe cutaneous adverse reaction.

What precautions apply to Cilastatin Sodium, Imipenem Monohydrate?

Careful assessment and monitoring are required when using this injectable antibiotic. - Renal function assessment: evaluate creatinine clearance before initiation and adjust dosing as needed. - Monitor for seizures: observe patients with a history of CNS disease or electrolyte imbalance. - Dose adjustment in renal impairment: reduce dose or extend interval based on renal function. - Caution with concomitant nephrotoxic agents: avoid or closely monitor when used with other kidney‑toxic drugs. - Avoid valproic acid co‑administration: imipenem reduces valproate levels, risking seizure breakthrough. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

What does Cilastatin Sodium, Imipenem Monohydrate interact with?

Imipenem/Cilastatin may interact with several drug classes, requiring vigilance.

Major Interactions (Avoid): - Valproic acid: reduces serum valproate concentrations, increasing seizure risk. - Other carbapenems: concurrent use may increase neurotoxicity. - High‑dose aminoglycosides: additive nephrotoxicity.

Moderate Interactions (Monitor Closely): - Diuretics: may potentiate electrolyte disturbances that lower seizure threshold. - Warfarin: monitor INR as antibiotics can alter anticoagulant effect. - Oral contraceptives: possible reduction in efficacy; advise alternative contraception.

Frequently asked questions

What infections is Imipenem/Cilastatin used for?+
Imipenem/Cilastatin is indicated for severe bacterial infections such as complicated intra‑abdominal infections, complicated urinary tract infections, skin and soft‑tissue infections, hospital‑acquired or ventilator‑associated pneumonia, bacterial meningitis, and febrile neutropenia. It is typically reserved for hospitalized patients where broad‑spectrum coverage is required.
How does Imipenem/Cilastatin work?+
Imipenem inhibits bacterial cell‑wall synthesis by binding to penicillin‑binding proteins, leading to cell lysis. Cilastatin, co‑formulated, blocks renal dehydropeptidase I, preventing enzymatic breakdown of imipenem and thereby maintaining higher plasma concentrations for effective antibacterial activity.
What is the usual dose of Imipenem/Cilastatin?+
The dosage of Imipenem/Cilastatin is determined by the prescribing clinician based on the type and severity of infection, renal function, and patient weight. The prescriber will select the appropriate dose, infusion rate, and treatment duration according to clinical guidelines.
Is Imipenem/Cilastatin safe during pregnancy or breastfeeding?+
Safety data for Imipenem/Cilastatin in pregnancy and lactation are limited. It should only be used if the potential benefit justifies any potential risk to the fetus or infant. Clinicians should evaluate the risk‑benefit profile and consider alternative therapies when possible.
How do I order Imipenem/Cilastatin from GNH USA?+
To place an order, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain if needed), and necessary import documentation.
How does Imipenem/Cilastatin compare with other carbapenems?+
Imipenem/Cilastatin offers a broad spectrum of activity against many Gram‑negative, Gram‑positive, and anaerobic bacteria, similar to meropenem or ertapenem. Its unique combination with cilastatin protects the drug from renal degradation, allowing higher plasma levels. Choice among carbapenems depends on local resistance patterns, pharmacokinetic considerations, and patient-specific factors.
What are the storage and handling requirements for Imipenem/Cilastatin?+
The product must be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. Before use, the solution should be inspected for particulate matter and discoloration. Once reconstituted, follow the manufacturer’s guidance on stability and discard any unused portion after the recommended time.
How is Imipenem/Cilastatin administered?+
Imipenem/Cilastatin is given as an intravenous infusion. The infusion rate and duration are determined by the prescriber, typically over 30 minutes to 1 hour, depending on the dose and patient tolerance. Administration should be performed by qualified healthcare personnel in a clinical setting.
What are the most serious risks associated with Imipenem/Cilastatin?+
Serious adverse events include seizures, especially in patients with renal impairment or pre‑existing CNS disorders, severe allergic reactions such as anaphylaxis, Clostridioides difficile‑associated colitis, and significant hematologic abnormalities like neutropenia or thrombocytopenia. Prompt recognition and medical intervention are essential if these occur.
Who should not receive Imipenem/Cilastatin?+
Patients with a known hypersensitivity to imipenem, cilastatin, or any component of the formulation should avoid this medication. Caution is also advised for individuals with a history of seizures, severe renal impairment, or those receiving valproic acid, as the drug can lower valproate levels and increase seizure risk.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Cilastatin Sodium, Imipenem Monohydrate
Route
Intravenous Use
Manufacturer
Fresenius Kabi Nederland B.V.
Origin
EU

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