GNH USA

Europe — EMA

Imipenem/Cilastatine Hikma (Cilastatin Sodium, Imipenem Monohydrate)

GNH USA supplies Imipenem/Cilastatine Hikma (Imipenem/cilastatin), a carbapenem antibiotic for complicated intra‑abdominal, urinary tract, and nosocomial

Cilastatin Sodium, Imipenem Monohydrate

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What is Cilastatin Sodium, Imipenem Monohydrate?

Imipenem/cilastatin, the active ingredient in Imipenem/Cilastatine Hikma, is a carbapenem antibiotic presented as an injectable solution for intravenous use. It treats a range of serious bacterial infections, including intra‑abdominal, urinary tract, respiratory, skin and soft‑tissue, and bloodstream infections, primarily in hospitalized adult patients.

GNH USA supplies Imipenem/Cilastatine Hikma as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals worldwide.

What is Cilastatin Sodium, Imipenem Monohydrate used for?

Imipenem/cilastatin is used for severe bacterial infections that require broad‑spectrum intravenous therapy.

- Complicated intra‑abdominal infections: provides rapid bacterial eradication and clinical cure. - Complicated urinary tract infections: eliminates resistant Gram‑negative and Gram‑positive pathogens. - Nosocomial pneumonia: offers coverage against multidrug‑resistant organisms in ventilated patients. - Skin and soft tissue infections: treats deep or extensive infections caused by susceptible bacteria. - Septicemia: delivers bactericidal activity in systemic bloodstream infections.

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

Adverse reactions may occur with any intravenous antibiotic and should be monitored.

Common Side Effects: - Nausea: mild to moderate gastrointestinal upset. - Diarrhea: may be watery and self‑limiting. - Rash: erythematous skin eruption. - Injection site pain: local discomfort at the infusion site.

Serious or Rare Side Effects: - Seizures: especially in patients with renal impairment or CNS disorders. - Clostridioides difficile colitis: severe diarrhea with pseudomembranous colitis. - Anaphylaxis: acute, potentially life‑threatening hypersensitivity. - Stevens‑Johnson syndrome: severe mucocutaneous reaction.

What precautions apply to Cilastatin Sodium, Imipenem Monohydrate?

Use of Imipenem/Cilastatine Hikma requires careful clinical assessment and monitoring.

- Assess renal function: adjust dosing in patients with impaired clearance. - Monitor for seizures: avoid in patients with a history of epilepsy. - Evaluate for hypersensitivity: discontinue if an allergic reaction occurs. - Use caution in CNS disorders: increased risk of neurotoxicity. - Adjust dose in renal impairment: follow renal dosing guidelines. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

What does Cilastatin Sodium, Imipenem Monohydrate interact with?

Imipenem/cilastatin can interact with several concomitant medicines, influencing efficacy or safety.

Major Interactions (Avoid): - Valproic acid: reduces valproate levels, risking seizure breakthrough. - Probenecid: decreases renal clearance, increasing imipenem exposure. - Cyclosporine: heightened nephrotoxicity risk.

Moderate Interactions (Monitor Closely): - Diuretics: may potentiate neurotoxic effects. - Aminoglycosides: combined renal toxicity requires renal function monitoring.

Frequently asked questions

What infections is Imipenem/Cilastatine Hikma used to treat?+
Imipenem/Cilastatine Hikma is indicated for severe bacterial infections such as complicated intra‑abdominal infections, complicated urinary tract infections, hospital‑acquired (nosocomial) pneumonia, skin and soft‑tissue infections, and septicemia. It is administered intravenously in hospitalized patients who need broad‑spectrum coverage against Gram‑positive, Gram‑negative, and anaerobic organisms.
How does imipenem/cilastatin work against bacteria?+
Imipenem inhibits bacterial cell‑wall synthesis by binding to penicillin‑binding proteins, preventing the cross‑linking of peptidoglycan strands, which leads to cell lysis. Cilastatin, co‑formulated with imipenem, blocks renal dehydropeptidase I, an enzyme that would otherwise degrade imipenem, thereby preserving its antibacterial activity in the bloodstream.
What is the usual dose of Imipenem/Cilastatine Hikma?+
The dosage of Imipenem/Cilastatine Hikma is individualized by the prescribing clinician based on the type and severity of infection, patient weight, renal function, and local susceptibility patterns. Healthcare professionals determine the appropriate infusion rate, frequency, and duration according to established clinical guidelines.
Is Imipenem/Cilastatine Hikma safe during pregnancy or breastfeeding?+
Imipenem/cilastatin is classified as Pregnancy Category B, indicating that animal studies have not shown fetal risk, but there are no adequate controlled studies in pregnant women. It should be used during pregnancy only if clearly needed. Caution is advised during breastfeeding, as the drug may be excreted in milk; a risk‑benefit assessment should be performed by the prescriber.
How do I order Imipenem/Cilastatine Hikma from GNH USA?+
To place an order, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies, and procurement teams worldwide. After the request, the sales team will verify trade or institutional credentials, then provide pricing, availability, shipping details (including cold‑chain logistics if needed), and assist with import documentation.
How does Imipenem/Cilastatine Hikma compare with other carbapenems?+
Imipenem/cilastatin offers a broad spectrum of activity similar to other carbapenems such as meropenem or ertapenem, but it is distinguished by its co‑administration with cilastatin, which protects the drug from renal degradation, allowing higher plasma concentrations. Choice among carbapenems often depends on local resistance patterns, dosing convenience, and specific infection sites.
What are the storage and handling requirements for Imipenem/Cilastatine Hikma?+
The product must be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. Prior to use, the solution should be inspected for particulate matter and discoloration. If the product is removed from refrigeration, it should be used within the time frame specified in the product label.
How is Imipenem/Cilastatine Hikma administered to patients?+
Imipenem/Cilastatine Hikma is given as an intravenous infusion. The recommended infusion time varies with the dose and patient condition, typically ranging from 15 to 60 minutes. Administration should be performed by qualified healthcare personnel in a clinical setting, with appropriate monitoring for infusion‑related reactions.
What are the most serious risks associated with Imipenem/Cilastatine Hikma?+
Serious adverse events include seizures, especially in patients with renal impairment or pre‑existing CNS disorders, Clostridioides difficile‑associated colitis, severe hypersensitivity reactions such as anaphylaxis, and rare but life‑threatening skin reactions like Stevens‑Johnson syndrome. Prompt recognition and discontinuation of therapy are essential if any of these events occur.
Who should not receive Imipenem/Cilastatine Hikma?+
Patients with a known hypersensitivity to imipenem, cilastatin, or any component of the formulation should not receive the drug. Caution is also advised for individuals with a history of seizures, severe renal impairment without dose adjustment, or those receiving concomitant medications that lower the seizure threshold.
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.
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Product details

Drug
Cilastatin Sodium, Imipenem Monohydrate
Route
Intravenous Use
Manufacturer
Hikma Farmacêutica (Portugal), S.A.
Origin
EU

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