(Imipenem and Cilastain for Injection USP)
Each Vials Contains:
Sterile mixture of Imipenem USP
Equivalent to anhydrous Imipenum 500mg
Cilastatin Sodium USP Equivalent to
and Sodium Bicarbonate
ZIMILAST I.V.(Imipenem and Cilastatin for injection) is a sterile formulation of Imipenemand Cilastatin sodium (the inhibitor of the renal dipeptidase, dehydropeptidase I), with sodium bicarbonate added as a buffer. ZIMILAST I.V is a potent broad spectrum antibacterial agent for intravenous administration.
INDICATIONS AND USAGE
ZIMILAST I.V. is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the condition listed below:
(1) Lower respiratory tract infections.Staphylococcus aureus (penicillinase-producing strains),
Acinetobacterspeices, Enterobacter species, Escherichia coli, Haemophilusinfluenzae, Haemophilusparainfluenzae*, Klebsiella species, Serratiamarcescens
(2) Urinary tract Infections (complicated and uncomplicated). Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains)*, Enterobacter species, Escherichia coli, Klebsiella species, Morganellamorganii*, Proteus vulgaris*, Providenciarettgeri*, Pseudomonasaeruginosa
(3) Intra-abdominal infections.Enterococcus faecalis, Staphylococcus aureus(penicillinaseproducing strains)*, Staphylococcus epidermidis, Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Morganellamorganii*, Proteus species, Pseudomonas aeruginosa,
Bifidobacterium species, Clostridium species, Eubacterium species, Peptococcus species, Peptostreptococcusspeices, Propionibacterium species*, Bacteroides species including B.Fragilis, Fusobacterium species
(4) Gyencologic infections. Enterococcus faecalis, Staphylococcus aureus(penicillinase-producing strains)* , Staphtlococcus epidermis, Streptococcus agalactiae (Group B strepcocci), Enterobacterspeicies*, Escherichia coli, Gardnerellavaginalis, Klebsiella species*, Proteus species, Bifidobacterium species*, Peptococcus species*, Peptostreptococcus species, Propionibacterium species*, Bacteroides species including B.fragilis*
(5) Bacterial septicemia.Enterococcus faecalis, Staphylococcus aureus(penicillinase-producing strains),Enterobacterspeicies, Escherichia coli, Klebsiella species, Pseudomonas aeruginosa, Serratia species*, Bacteroides species including B.fragilis*
(6) Bone and joint infections.Enterococcus faecalis, Staphylococcus aureus(penicillinase-producing strains),Staphylococcus epidermis,Enterobacter species, Pseudomonas aeruginosa
(7) Skin and skin structure infections.Enterococcus faecalis, Staphylococcus aureus(penicillinase-producing strains),Staphylococcus epidermis,Acinetobacter species, Citrobacter species, Enterobacter species, Escherichia coli, Klebsiellaspeices, Morganellamorganii, Proteus vulgaris, Providenciarettgeri*,
*Efficacy for this organism in this organ system was studied in fewer than 10 infections.
PRIMAXIN?I.V.(Imipenem and Cilastatin for Injection)78821316
Pseudomonas aeruginosa, Serratia species, Peptococcus species, Peptostreptococcus species,
Bacteroides species including B. fragilis, Fusobacterium species*
(8) Endocarditis. Staphylococcus aureus (penicillinase-producing strains)
(9) Polymicrobic infections. ZIMILAST I.V. is indicated for polymicorbic infections including those in which S.pneumoniae (pneumonia,septicemia), S.pyogenes (skin and skin structure), or nonpenicillinase-producing S. aureus is one of the causative organisms. However,monobacterial infections due to these organisms are usually treated with narrower spectrum antibiotics, such as penicillin G.
ZIMILASTI.V. is not indicated in patients with meningitis because safety and efficacy have not been established.
ZIMILASTI.V. is contraindicated in patients who have shown hypersensitivity to any component of this product.
Dosage and administration;
The dosage recommendations for ZIMILAST I.V. represent the quantity of imipenem to be administered.
The total daily dosage for ZIMILAST I.V. 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), renalfunction, and body weight. Adult patients with impaired renal function, as judged by creatinine clearance=70ml/min/1.73m2, require adjustment of dosage.
|Type or Severity of Infection||Fully susceptibleOrganisms includingGram positive and Gram negative aerobes and anaerobes||Moderately susceptible organisms, primarily some strains of P.Aeruginosa|
|Mild||250mg q 6h(Total Daily Dose=1.0g)||500mg q 6h(Total Daily Dose=2.0g)|
|Moderate||500mg q 8h(Total Daily Dose=1.5g)Or500mg q 6h(Total Daily Dose=2.0g)||500mg q 6h(Total Daily Dose=2.0g)Or1g q 8h(Total Daily Dose=3.0g)|
|Severe Life threatening Only||500mg q 6 h(Total Daily Dose=2.0g)||1g q 8 h(Total Daily Dose=3.0g)Or1g q 6 h(Total Daily Dose=4.0g)|
|Uncomplicated urinary tract Infection||250mg q 6 h(Total Daily Dose=1.0g)||250mg q 6 h(Total Daily Dose=1.0g)|
|Complicated urinary tract Infection||500mg q 6 h(Total Daily Dose=2.0g)||500mg q 6 h(Total Daily Dose=2.0g)|
Due to the high antimicrobial activity of ZIMILASTI.V., it is recommended that the maximum total daily dosage not exceed 50mg/kg/day or 4.0 g/day, whichever is lower.
For pediatric patients = 3 months of age, the recommended dose for non-CNS infections is 15-25mg/kg every sixed hours. Based on studies in adults, the maximum daily dose for treatment of infections with fully susceptible organisms is 2.0g per day, and of infections with moderately suscetpibleorganisms(primarily some strains of P. aeruginosa) is 4.0g/day. Higher doses (up to 90mg/kg/day in older children)have been used in patients with cystic fibrosis.
For pediatric patient= 3 months of age (weighing=1500 gms), the following dosage schedule is recommended for non.CNS infections: <1 wk of age: 25mg/kg every 12 hrs, 1-4 wks of age: 25mg/kg every 8 hrs, 4wks-3mos. of age: 25mg/kg every 6 hrs.
Doses less than or equal to 500mg should be given by intravenous infusion over 15 to 30 minutes.
Doses greater than 500 mg should be given by intravenous infusion over 40 to 60 minutes.
ZIMILAST I.V. is not recommended in pediatric patients with CNS infections because of the risk of seizures. is not recommended in pediatric patients <30 kg with impaired renal function.,
Generalized seizures have been reported in patients who received ganciclovir and ZIMILAST.
Pregnancy and Lactation:
Pregnancy Category C:
ZIMILAST I.V. should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
Caution should be exercised when ZIMILAST I.V. is administered to anursing woman.