GNH USA

Europe — EMA

Imipenem/Cilastatina Kabi

GNH USA supplies Imipenem/Cilastatin Kabi (Imipenem/Cilastatin), a carbapenem antibiotic for complicated intra‑abdominal infections, urinary tract

Cilastatin Sodium, Imipenem Monohydrate

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What is Cilastatin Sodium, Imipenem Monohydrate?

Imipenem/Cilastatin, the active ingredient in Imipenem/Cilastatin Kabi, is a carbapenem antibiotic presented as a sterile powder for reconstitution for intravenous use. It treats severe bacterial infections, including intra‑abdominal, urinary, skin, and respiratory infections, in hospitalized adult patients. GNH USA supplies Imipenem/Cilastatin 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 eradication in the peritoneal cavity. - Complicated urinary tract infections: eliminates resistant uropathogens causing pyelonephritis and cystitis. - Complicated skin and soft tissue infections: clears mixed Gram‑positive and Gram‑negative organisms. - Hospital‑acquired and ventilator‑associated pneumonia: penetrates lung tissue to treat resistant pneumonia pathogens. - Severe sepsis: offers bactericidal activity against a wide range of pathogens in systemic infection.

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

Adverse reactions may occur with any antimicrobial therapy.

Common Side Effects: - Nausea: mild to moderate gastrointestinal upset. - Diarrhea: may be watery and self‑limiting. - Vomiting: occasional emesis after infusion. - Headache: transient cranial discomfort. - Rash: erythematous skin eruption. - Elevated liver enzymes: transient increase in ALT/AST.

Serious or Rare Side Effects: - Seizures: especially in patients with renal impairment or CNS disorders. - Anaphylaxis: severe allergic reaction requiring immediate medical attention. - Clostridioides difficile‑associated diarrhea: colitis due to disruption of normal flora. - Neutropenia: marked reduction in neutrophil count. - Thrombocytopenia: decreased platelet levels. - Renal impairment: worsening kidney function in susceptible individuals.

What precautions apply to Cilastatin Sodium, Imipenem Monohydrate?

Careful assessment and monitoring are required when using this intravenous carbapenem. - Assess renal function: dose adjustment may be needed in renal insufficiency. - Monitor for seizures: avoid in patients with a history of CNS disorders. - Evaluate hypersensitivity: discontinue if signs of an allergic reaction appear. - Use caution with concomitant nephrotoxic agents: increased risk of kidney injury. - Adjust dose in severe renal impairment: follow prescriber guidance. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

What does Cilastatin Sodium, Imipenem Monohydrate interact with?

Imipenem/Cilastatin can alter the pharmacokinetics of several co‑administered drugs.

Major Interactions (Avoid): - Valproic acid: carbapenems reduce serum valproate levels, risking seizure breakthrough. - Other carbapenems: concurrent use may increase toxicity without added benefit. - High‑dose aminoglycosides: combined nephrotoxic potential.

Moderate Interactions (Monitor Closely): - Diuretics: may enhance renal electrolyte loss; monitor electrolytes. - Warfarin: possible alteration of INR; check coagulation status regularly. - Oral contraceptives: reduced efficacy; advise alternative contraception.

Frequently asked questions

What infections is Imipenem/Cilastatin Kabi used to treat?+
Imipenem/Cilastatin Kabi is indicated for severe bacterial infections such as complicated intra‑abdominal infections, complicated urinary tract infections, complicated skin and soft tissue infections, hospital‑acquired or ventilator‑associated pneumonia, and severe sepsis. It is reserved for patients who need broad‑spectrum coverage against resistant Gram‑negative and Gram‑positive organisms.
How does Imipenem/Cilastatin work against bacteria?+
The drug combines imipenem, which binds to penicillin‑binding proteins and blocks the final step of bacterial cell‑wall synthesis, with cilastatin, an inhibitor of renal dehydropeptidase‑I. Cilastatin prevents rapid degradation of imipenem in the kidneys, maintaining therapeutic drug levels and ensuring potent bactericidal activity.
What is the usual dose of Imipenem/Cilastatin Kabi?+
Dosing is individualized by the prescribing clinician based on the type and severity of infection, patient weight, and renal function. The prescriber determines the exact amount, infusion rate, and duration of therapy to achieve optimal efficacy while minimizing toxicity.
Is Imipenem/Cilastatin safe to use during pregnancy or breastfeeding?+
The pregnancy safety category for Imipenem/Cilastatin is not definitively established. It should be used only when the potential benefit justifies any potential risk to the fetus. Breastfeeding mothers should consult their healthcare provider, as the drug may be excreted in breast milk.
How do I order Imipenem/Cilastatin Kabi 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 any cold‑chain requirements), and necessary import documentation.
How does Imipenem/Cilastatin compare with other carbapenems like meropenem?+
Both imipenem/cilastatin and meropenem belong to the carbapenem class and offer broad‑spectrum activity. Imipenem is often combined with cilastatin to protect it from renal degradation, whereas meropenem is administered without an inhibitor. Clinical choice depends on local resistance patterns, patient renal function, and specific infection site.
What are the storage and handling requirements for Imipenem/Cilastatin Kabi?+
The product should be stored at 2‑8 °C, protected from light, and kept in its original packaging. Do not freeze or shake the reconstituted solution. Once prepared, the solution should be used within the time frame recommended by the manufacturer to maintain potency.
How is Imipenem/Cilastatin administered to patients?+
Imipenem/Cilastatin is supplied as a sterile powder for intravenous infusion. After reconstitution with the appropriate diluent, the solution is administered by slow IV infusion over 30‑60 minutes, following the dosing schedule prescribed by the treating physician.
What are the most serious risks associated with Imipenem/Cilastatin therapy?+
The most critical adverse events include seizures, especially in patients with renal impairment or pre‑existing CNS disorders; severe allergic reactions such as anaphylaxis; and Clostridioides difficile‑associated colitis, which can lead to life‑threatening diarrhea. Prompt medical attention is required if any of these occur.
Who should not receive Imipenem/Cilastatin?+
Patients with a known hypersensitivity to imipenem, cilastatin, or any other carbapenem should avoid this medication. Caution is also advised for individuals with severe renal impairment, as dose adjustments are necessary, and for those with a history of seizures or central nervous system disorders.
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 Pharma Portugal, Lda.
Origin
EU

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