Imipenem & Cilastatin Injection

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Imipenem and Cilastatin injection (brand name Primaxin) is a combination antibiotic therapy supplied as a sterile powder for reconstitution. It is used to treat severe or complicated bacterial infections.

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Description

Imipenem & Cilastatin Injection

Healthy Inc is a specialized global supplier and exporter of ultra-broad-spectrum carbapenem antibiotics. We provide high-purity Imipenem & Cilastatin Injection (500 mg + 500 mg), sourced from WHO–GMP certified sterile injectable facilities. This “ICU Heavyweight” is a top export to critical care units, burn centers, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the empiric drug of choice for polymicrobial “catastrophe” infections where narrower antibiotics fail.


Product Overview

This formulation combines Imipenem, the first thienamycin carbapenem, with Cilastatin Sodium, a specific enzyme inhibitor.

The “Dynamic Duo” Specialist:

  • Imipenem (The Killer): A potent cell-wall inhibitor with the broadest spectrum of any beta-lactam. It kills Gram-positives (Staph/Strep), Gram-negatives (Pseudomonas/E. coli), and Anaerobes (Bacteroides) simultaneously.
  • Cilastatin (The Bodyguard): Imipenem alone is rapidly destroyed by an enzyme in the human kidney called Dehydropeptidase-I (DHP-I). Cilastatin inhibits this enzyme, preventing the breakdown of Imipenem.
    • Result 1: Increases the half-life and concentration of Imipenem in the urine.
    • Result 2: Prevents the formation of toxic metabolites that damage the kidneys.
  • “Gorilla” Coverage: It is often called the “Gorilla” because it covers almost everything, making it ideal for septic shock where the causative organism is unknown.

Product Composition & Strength

We supply this product as a Sterile Buffered Lyophilized Powder for Injection in glass vials.

Active Ingredient Strength Role
Imipenem USP/BP 500 mg Antibiotic (Carbapenem)
Cilastatin Sodium USP/BP Equivalent to 500 mg Cilastatin DHP-I Inhibitor
Buffer Sodium Bicarbonate pH Stabilizer

*Pack Sizes: Tray of 1 Vial, 10 Vials, or Box of 1/10 Vials.


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

HS Code 3004.20.19 (Medicaments containing other antibiotics)
Dosage Form Lyophilized Powder (Reconstitute & Dilute)
Packaging Type I Glass Vial (Sterile) with Flip-off Seal
Storage Store below 25°C. Protect from Light. Reconstituted solution is stable for 4 hours at room temp.
Certificates WHO-GMP, COPP, Free Sale Certificate

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

  • Sterile Crystallization: Imipenem is thermally unstable. We use a proprietary cold sterile crystallization process to ensure the molecule remains intact. If heat-dried improperly, Imipenem degrades into polymers that cause allergic reactions and loss of potency.
  • Sodium Control: The formulation contains Sodium Bicarbonate as a buffer. We strictly control the sodium content (approx. 37.5 mg per vial) to ensure compatibility with heart failure patients who are sodium-restricted.

Therapeutic Indications (Human Use)

Indicated for severe, life-threatening polymicrobial infections:

  • Ventilator-Associated Pneumonia (VAP): Especially Acinetobacter or Pseudomonas.
  • Complicated Intra-Abdominal Infections: Ruptured appendix, peritonitis (Mixed Aerobic/Anaerobic flora).
  • Gynecological Infections: Post-partum sepsis.
  • Bone & Joint Infections: Osteomyelitis.
  • Febrile Neutropenia: Empiric therapy in cancer patients.

Dosage & Administration

Recommended Dosage (Strictly as per Critical Care Specialist):

  • Route: Intravenous (IV) Infusion ONLY. (IM formulation is different and rarely used).
  • Standard Dose: 500 mg/500 mg every 6 hours (Total 2g/day).
  • Severe Infections (Pseudomonas): 1 g/1 g every 8 hours (Total 3g/day).
  • Renal Impairment: Dose reduction is MANDATORY. Accumulation of Cilastatin causes seizures.
    • CrCl 20-40 ml/min: 250 mg every 6 hours.
    • CrCl < 20 ml/min: 250 mg every 12 hours.
  • Administration: Reconstitute with 10ml Saline. Dilute in 100ml Saline. Infuse over 20-60 minutes. (Slow infusion reduces nausea).

Safety Warnings (CRITICAL):

  • Seizure Risk: HIGHEST among Carbapenems. Imipenem lowers the seizure threshold. Contraindicated in patients with history of epilepsy or brain lesions (stroke/tumor), and in renal failure if dose is not adjusted. (Use Meropenem instead).
  • Valproic Acid Interaction: Rapidly lowers Valproic Acid levels, causing breakthrough seizures. Avoid combination.
  • Ganciclovir Interaction: Concurrent use causes generalized seizures. Avoid.
  • Beta-Lactam Allergy: Cross-reactivity with Penicillin/Cephalosporin.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Sterile Injectables, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.

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