Imipenem

SLC is capable of supplying high quality API and Drug Product:
  API FDF
Imipenem/Cilastatin
Imipenem (Sterile)
Cilastatin Sodium (Sterile)
Imipenem and Cilastatin Sodium (Sterile Bulk)
Imipenem / Cilastatin Inj.
500/500 mg
Imipenem / Cilastatin Inj.
250/250 mg

 
Imipenem and Cilastatin sodium (Sterile Bulk) is a potent broad-spectrum antibacterial agent for intravenous infusion.

Savior Lifetec provides this sterile premix of Imipenem and Cilastatin sodium (in bulk) from our isolator-based aseptic manufacturing facility. The specification of the sterile compound in bulk complies with all major pharmacopoeia monographs (EP, JP, & USP).
Imipenem/ Cilastatin Injection is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
  • Lower respiratory tract infections.
  • Urinary tract infections (complicated and uncomplicated).
  • Intra-abdominal infections. Enterococcus faecalis.
  • Gynecologic infections.
  • Bacterial septicemia.
  • Bone and joint infections.
  • Skin and skin structure infections.
  • Endocarditis.
  • Polymicrobic infections.
Adults
The dosage recommendations for Imipenem/ Cilastatin Injection represent the quantity of Imipenem to be administered. An equivalent amount of Cilastatin is also present in the solution. Each 125 mg, 250 mg, or 500 mg dose should be given by intravenous administration over 20 to 30 minutes. Each 750 mg or 1000 mg dose should be infused over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed.

The total daily dosage for Imipenem/ Cilastatin Injection should be based on the type or severity of infection and given in equally divided doses based on consideration of degree of susceptibility of the pathogen(s), renal function, and body weight. Adult patients with impaired renal function, as judged by creatinine clearance ≤70 mL/min/1.73 m2, require adjustment of dosage as described in the succeeding section of these guidelines.

Intravenous Dosage Schedule for Adults with Normal Renal Function and Body Weight ≥70 kg


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