GNH USA

Europe — EMA

Imipenem/Cilastatina Hikma

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

Cilastatin Sodium, Imipenem Monohydrate

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What is Cilastatin Sodium, Imipenem Monohydrate?

Imipenem, the active ingredient in Imipenem/Cilastatin 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, pulmonary, skin and soft‑tissue infections, as well as severe sepsis, in hospitalized adult patients.

GNH USA supplies Imipenem/Cilastatin Hikma as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide, with a focus on quality assurance and regulatory compliance, and reliable delivery across global markets.

What is Cilastatin Sodium, Imipenem Monohydrate used for?

Imipenem/Cilastatin is a carbapenem antibiotic indicated for severe bacterial infections affecting various organ systems.

- Complicated intra‑abdominal infections: provides rapid bacterial eradication to resolve intra‑abdominal sepsis. - Complicated urinary tract infections: offers broad‑spectrum activity to treat resistant uropathogens. - Nosocomial pneumonia (including ventilator‑associated pneumonia): delivers effective coverage against Gram‑negative and Gram‑positive pathogens in hospital‑acquired lung infections. - Skin and soft‑tissue infections: offers potent activity for serious cellulitis and wound infections. - Severe sepsis and septic shock: supplies critical antimicrobial support to improve outcomes in systemic infection.

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

The safety profile of Imipenem/Cilastatin includes both frequent and infrequent adverse reactions that clinicians monitor during therapy.

Common Side Effects: - Nausea: mild to moderate gastrointestinal upset. - Diarrhea: may be watery and self‑limiting. - Rash: skin erythema or pruritus. - Elevated liver enzymes: transient increase in transaminases. - Injection site pain: discomfort at the IV site.

Serious or Rare Side Effects: - Seizures: especially in patients with renal impairment or high doses. - Anaphylaxis: severe allergic reaction requiring immediate intervention. - Clostridioides difficile colitis: antibiotic‑associated intestinal infection. - Neutropenia: marked reduction in white blood cell count. - Renal dysfunction: worsening kidney function in susceptible individuals.

What precautions apply to Cilastatin Sodium, Imipenem Monohydrate?

Prior to initiating Imipenem/Cilastatin therapy, healthcare providers should consider several precautionary measures to minimize risk.

- Renal function assessment: adjust dose in patients with impaired clearance. - Seizure risk evaluation: avoid high doses in individuals with a history of seizures or CNS disorders. - Allergy screening: confirm no known hypersensitivity to β‑lactam antibiotics or cilastatin. - Concomitant nephrotoxic drugs: monitor closely when used with aminoglycosides or vancomycin. - Electrolyte monitoring: watch for hypokalemia during prolonged therapy. - 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 other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid): - Valproic acid: concomitant use can reduce valproate levels, risking seizure breakthrough. - Carbapenem‑inducing agents: may increase risk of seizures when combined with high‑dose carbapenems.

Moderate Interactions (Monitor Closely): - Aminoglycosides: additive nephrotoxicity; monitor renal function. - Vancomycin: potential for increased nephrotoxic effect; assess kidney markers. - Diuretics: may exacerbate electrolyte disturbances; check serum potassium. - Oral contraceptives: possible reduction in hormonal efficacy; advise alternative contraception.

Frequently asked questions

What conditions is Imipenem/Cilastatin Hikma used to treat?+
Imipenem/Cilastatin Hikma is indicated for a range of serious bacterial infections, including complicated intra‑abdominal infections, complicated urinary tract infections, hospital‑acquired (nosocomial) pneumonia such as ventilator‑associated pneumonia, severe skin and soft‑tissue infections, and for patients with severe sepsis or septic shock requiring broad‑spectrum antimicrobial coverage.
How does Imipenem work and what role does Cilastatin play?+
Imipenem kills bacteria by binding to penicillin‑binding proteins, which blocks the final steps of cell‑wall synthesis and leads to bacterial lysis. Cilastatin is co‑administered to inhibit the renal enzyme dehydropeptidase I, preventing the breakdown of imipenem in the kidneys and thereby maintaining higher active drug concentrations in the urine and bloodstream.
How is the dosage of Imipenem/Cilastatin determined?+
The specific dose of Imipenem/Cilastatin is set by the prescribing clinician based on the type and severity of the infection, the patient’s renal function, body weight, and any concomitant medications. Dosing regimens are individualized and should follow the latest clinical guidelines and the product’s prescribing information.
Is Imipenem/Cilastatin safe during pregnancy or breastfeeding?+
The pregnancy category for Imipenem/Cilastatin is listed as unknown. It should only be used during pregnancy or lactation when the potential benefits to the mother outweigh any possible risk to the fetus or infant. Clinicians should discuss the risk‑benefit profile with the patient and consider alternative therapies when appropriate.
How do I order Imipenem/Cilastatin 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 handling if needed), and assist with any import documentation.
How does Imipenem/Cilastatin compare with other carbapenems such as meropenem?+
Both imipenem/cilastatin and meropenem belong to the carbapenem class and offer broad‑spectrum activity against many Gram‑negative and Gram‑positive bacteria. Imipenem is often combined with cilastatin to protect it from renal degradation, whereas meropenem does not require this inhibitor. Clinical choice may depend on local resistance patterns, patient renal function, and specific safety considerations such as seizure risk.
What are the recommended storage conditions for Imipenem/Cilastatin Hikma?+
Imipenem/Cilastatin should be stored at 2‑8 °C (refrigerated). Keep the vials in their original packaging, protect them from light, and do not freeze or shake the solution. Maintaining the cold‑chain ensures drug stability and potency until the point of reconstitution and administration.
How is Imipenem/Cilastatin administered to patients?+
The product is supplied as a sterile powder for injection. It must be reconstituted with the appropriate diluent and administered intravenously, typically as a short infusion over 15‑30 minutes. The exact infusion rate and duration are determined by the prescriber based on the infection type, patient condition, and renal function.
What are the most serious risks associated with Imipenem/Cilastatin therapy?+
Serious adverse events include seizures, especially in patients with renal impairment or when high doses are used, severe allergic reactions such as anaphylaxis, Clostridioides difficile‑associated colitis, neutropenia, and worsening renal function. Prompt recognition and management of these events are essential, and patients should be monitored closely during treatment.
Who should not receive Imipenem/Cilastatin?+
Imipenem/Cilastatin is contraindicated in individuals with a known hypersensitivity to imipenem, cilastatin, or any other β‑lactam antibiotics. Patients with a history of severe allergic reactions to carbapenems should also avoid this medication. Caution is advised for patients with pre‑existing seizure disorders, significant renal impairment, or those receiving interacting drugs.
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
Hikma Farmacêutica (Portugal), S.A.
Origin
EU

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