prepenem imipenem and cilastatin sodium injection 1g0

Description

Indication & Scope

Prepenem® is a prescription carbapenem antibacterial combination indicated for the treatment of susceptible moderate to severe bacterial infections caused by aerobic and anaerobic bacteria in adults and children. It is also used as empirical therapy for febrile neutropenia.

Mechanism: Imipenem inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), while cilastatin inhibits renal dehydropeptidase I, preventing imipenem degradation and increasing urinary concentrations without possessing antibacterial activity.
Drug class: Carbapenem antibiotic combined with a dehydropeptidase inhibitor.
Clinical use: Treatment of severe lower respiratory tract, urinary tract, intra-abdominal, gynecological, skin and soft tissue, bone and joint infections, septicemia, and empirical treatment of febrile neutropenia.

Specification

Generic Name	Imipenem and Cilastatin Sodium for Injection
Brand Name	Prepenem®
Ingredient	Imipenem and Cilastatin Sodium
Dosage Form	Powder for Injection
Package	1 g/vial, 10 vials/carton
Conditions Treated	Severe bacterial infections
Taboos	Hypersensitivity to imipenem, cilastatin, carbapenems or other β-lactam antibiotics; concomitant use with valproic acid/divalproex sodium should be avoided
Place of origin	Korea
Prescription type	Prescription Drug (Rx)
Storage Conditions	Store below 25°C in a dry place and protect from light. Use reconstituted solution within the recommended stability period.
Manufacturer	JW PHARMACEUTICAL CORPORATION
Registration Authority	National Medical Products Administration (NMPA), China
Approval Number	HJ20160502
Approval Date	July 13, 2021
Shelf Life	24 months

How to use ?

Recommended Dose: Adults: 500 mg every 6 hours or 1 g every 6–8 hours by intravenous infusion depending on infection severity. Adjust dosage in patients with renal impairment.

Time: Administer by intravenous infusion over 20–60 minutes, depending on the dose.

Instructions for use: For intravenous infusion only. Reconstitute and dilute before administration. Do not mix with lactate-containing solutions. Complete the prescribed treatment course.

Interaction: Avoid concomitant use with valproic acid/divalproex sodium. Probenecid may increase imipenem exposure. Monitor INR when used with warfarin.

Side effects: Common adverse reactions include nausea, vomiting, diarrhea, rash, infusion-site reactions, and elevated liver enzymes. Serious adverse reactions include hypersensitivity reactions, seizures, Clostridioides difficile-associated diarrhea, and severe skin reactions.

Important Notice

This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

What is Prepenem® (Imipenem and Cilastatin Sodium for Injection) used for?

Prepenem® (Imipenem and Cilastatin Sodium for Injection) is used to treat severe bacterial infections caused by susceptible aerobic and anaerobic bacteria.

Can it be used for meningitis?

No. Imipenem/cilastatin is generally not recommended for bacterial meningitis because of an increased risk of seizures and limited clinical use for this indication.

Can children receive Prepenem® (Imipenem and Cilastatin Sodium for Injection)?

Yes. It can be used in children 3 months of age and older, with dosage adjusted according to body weight.

Why should valproic acid be avoided?

Imipenem/cilastatin can markedly reduce serum valproic acid concentrations, increasing the risk of seizures.