Imitatin

IMITATIN®

 

Composition :

Each vial IMITATIN® contain powder injection which contain Imipenem and Cilastatin sodium equivalent with Imipenem 500 mg and Cilastatin 500 mg

 

Pharmacology :

Combination Imipenem and Cilastatin sodium is a broad-spectrum β-lactam antibiotic. IMITATIN® consists of two components: (1) Imipenem, first β-lactam antibiotic new class, thienamycin, and (2) Cilastatin sodium, a specific enzyme inhibitor that inhibits Imipenem metabolism in the kidney, and substantially increases intact Immune concentrations in the urinary tract. Thienamycin antibiotic group, Imipenem has a broader spectrum characteristic of bactericidal activity than any other known antibiotic.

Combination Imipenem and Cilastatin sodium inhibits bacterial cell wall synthesis and strong bactericidal against pathogen with broad spectrum (gram positive and gram negative, aerob and anaerob).

The combination of Imipenem and Cilastatin sodium is the latest cephalosporin and penicillin with broad spectrum activity against the gram-negative species, but is specific in maintaining a high potential for gram-positive species, previously only associated with narrow-spectrum β-lactam antibiotics previously known. Spectrum activity The combinations of Imipenem and Cilastatin sodium include Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus faecalis and Bacteroides fragilis, distinct groups of common pathogens, which are resistant to other antibiotics.

Combination Imipenem and Cilastatin sodium is resistant to degradation by the β-lactamase bacteria, which makes the drug active against highly concentrated organisms such as Pseudomonas aeruginosa, Serratia spp and Enterobacter spp, which are resistant to most β-lactam antibiotics.

The antibacterial spectrum of the combination of Imipenem and Cilastatin sodium is wider than any other known antibiotic, and almost all pathogens are clinically significant. In vitro, a combination of Imipenem and Cilastatin sodium is active against the following organisms:

Aerob Negative Gram

Achromobacter spp., Acinetobacter spp. (formerly Mima-Herellea), Aeromonas hydrophila, Bordetella bronchicanis, Bordetella bronchiseptica, Brucella melitensis, Campylobacter spp., Citrobacter spp., Citrobacter freundii, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae, Escherichia coli, Gardnerella vaginalis Haemophilus influenzae Haemophilus parainfluenzae Hafnia spp. Hafnia alvei Klebsiella spp. Klebsiella oxytoca Klebsiella ozaenae Klebsiella pneumoniae Moraxella spp. Morganella morganii (formerly Proteus morganii), Neisseria gonorrhoeae (including penicillinase-producing strains), Neisseria meningitidis, Pasteurella spp., Pasteurella multoacida, Proteus spp., Proteus mirabilis, Proteus vulgaris, Providencia spp., Providencia alcalifaciens, Providencia rettgeri, Providencia stuartii, Pseudomonas spp. * *, Pseudomonas aeruginosa, Pseudomonas fluorescens, Salmon ella spp., Salmonella thypi, Serratia spp., Serratia marcescens, Serratia liquifaciens, Shigella spp., Yersinia spp. (formerly Pasteurella), Yersinia enterocolitica, Yersinia pseudotuberculosis, ** Xanthomonas maltophilia (formerly named Pseudomonas maltophilia) and several earlier strains named Pseudomonas cepacia which are generally insensitive to the combination of Imipenem and Cilastatin sodium.

Aerob Positive Gram

Erysipelothrix rhusiopathiae, Staphylococcus aureus, Staphylococcus aureus, Staphylococcus epidermidis (including penicillinase-producing strains), Staphylococcus saprophyticus, Streptococcus Group A (S. pyogenes), Streptococcus Group B (S. agalactiae), Streptococcus Group C, Streptococcus Group D (Including Enterococci), Streptococcus Group G (including Streptococcus faecalis and non Enterococci), Streptococcus pneumoniae, Streptococcus pyogenes, Viridans groupstreptococc (including alpha and gamma hemolytic strains) Several Staphylococci-resistant methicillin and some Streptococci group D is not sensitive to the combination of Imipenem and Cilastatin sodium.

Anaerob Negative Gram

Bacteroides asaccharolyticus, Bacteroides spp., Bacteroides distasonis, Bacteroides fragilis, Bacteroides melaninogenicus, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus, Fusobacterium spp., Fusobacterium necrophorum, Fusobacterium nucleatum, Veillnolle spp.

Anaerob Positive Gram

Microaerophilic streptococcus, Peptococcus spp., Peptostreptococcus spp., Propionibacterium spp. (including P. acnes).

In vitro showed synergistic Imipenem activity with aminoglycoside antibiotics against some Pseudomonas aeruginosa isolates.

 

Indication :

Treatment

IMITATIN® activity against unusual wide-spectrum pathogens causes IMITATIN® to be used specifically in polymorbic and aerobic / anaerobic treatments, similar to those of initial therapy prior to identification of the causative organism. IMITATIN® is indicated for the treatment of infections caused by the following sensitive organisms:

  • Intra-abdominal infection
  • Lower respiratory tract infection
  • Gynecological infection
  • Septikemia
  • Genitourinary tract infection
  • Joints and bone infection
  • Skin structure and skin infection
  • Endokarditis

IMITATIN® is indicated for the treatment of mixed infections caused by sensitive aerobic and anaerobic strains of bacteria. Most of these mixed infections are associated with contamination of stool flora or flora derived from the vagina, skin and mouth. In this mixed infection, Bacteroides fragilis is usually sensitive to IMITATIN®,

IMITATIN® efficacy is demonstrated against several infections caused by aerobic and gram-positive and gram-negative gram-negative bacteria resistant to cephalosporins, including cefazolin, cefoperazone, cephalothin, cefoxolin, cefotaxime moxalactam, cefamandole, ceftazidime and ceftriaxone. Similarly, some infections caused by organisms that are resistant to aminoglycosides (gentamycin, amikacin, tobramycin) and / or penicillin (ampicillin, carbenicillin, penicillin G, ticarcillin, piperacillin, azlocillin, mexlocillin) respond to treatment with IMITATIN®.

IMITATIN® is not indicated for the treatment of meningitis.

Prevention (Prophylaxis)

IMITATIN® is also indicated to prevent post-operative contamination infections in patients undergoing surgery or in the event of a postoperative infection that can be very serious.

Dosis :

Dosis yang dianjurkan untuk IMITATIN® dinyatakan dengan jumlah Imipenem dan ekivalen jumlah Cilastatin yang diberikan.

Dosis harian total dan rute pemberian IMITATIN harus didasarkan pada jenis beratnya infeksi dan diberikan dalam dosis terbagi berdasarkan tingkat kerentanan patogen, fungsi ginjal, dan berat badan. Dosis didasarkan pada berat badan 70 kg.

Infus Intravena

Treatment Dose in Adult Patients

Most infections effect the daily dose of 1 – 2 g administered in divided doses 3 – 4 (looked at Table 1). In the treatment of moderate infections, dosing 1 gr twice daily may also be used. In infections caused by less sensitive organisms, the daily dose of IMITATIN® IV may be increased to a maximum of 4 g / day or 50 mg / kg body weight / day, whichever is lower dose.

Any dose of 250 mg or 500 mg IMITATIN® IV should be administered by intravenous infusion for 20-30 minutes. Each dose of 1000 mg should be infused for 40-60 minutes. In patients who experience nausea during intravenous administration, the infusion rate may be slowed.

Tabel 1. Dose on Adult Patients

Severity of the infection Dosage

(mg Imipenem)

 Interval dose

(jam)

 Total daily dose (gram)
Mild 250 6 1
Intermediate 500

1000

 8

12

 1.5

2
Severe until very vulnerable 500 6 2
Severe and / or life-threatening because the organism is less sensitive (especially some strains of P. aeruginosa) 1000

1000

 8

6

 3

4

Due to high IMITATIN® antimicrobial activity, it is recommended that a maximum total daily dose of no more than 50 mg / kg body weight / day or 4 g / day, whichever is lower. However, “cyctic fibrosis” patients with normal renal function may be treated with IMITATIN® doses of up to 90 mg / kg body weight / day in divided doses and not more than 4 g / day.

Although Imitatin / Cilastatin has been shown to be effective for the treatment of “febrile neutropenic cancer” patients, a combination of Imipenem or antipseudomonal β-lactam with aminoglycosides is often used for this indication.

Prevention Dose (Prophylaxis) in Adult Patients

In the prevention of postoperative infections in adults, IMITATIN® IV 1000 mg should be given intravenously during induction of anesthesia and 1000 mg at 3 hours later. For high-risk surgery (eg, colorectal surgery), an additional dose of 2 times 500 mg may be given at 8 and 16 hours after induction.

Doses in Patients with Renal Disorder

As in patients with normal renal function, the dose is based on the severity of the infection. The maximum dose of IMITATIN® IV for patients with varying degrees of renal function impairment is shown in Table 2. The dose is based on a weight of 70 kg. Further proportional dose reductions should be made for patients with low body weight.

Tabel 2. Maximum Dose IMITATIN® IV Associated with Renal Function

Renal Function

(Creatinine Clearance ml/minute/1,73 m2)

 Dosage

(mg)

 Interval dose

(jam)

 Maximum Total Dose Daily (gram)*
Gangguan ringan 31 – 70

Gangguan sedang 21 – 30

Gangguan berat 0 – 20**

 500

500

250 – 500

 6 – 8

8 – 12

12

 1,5 – 2

1 – 1,5

0,5 – 1

* Higher doses should be given to infections caused by less sensitive organsms

**Patients with creatinine clearance 6 – 20 ml / min / 1.73 m2 should be treated with 250 mg (or 3.5 mg / kg body weight, whichever is lower dose) every 12 hours in most pathogens. When a dose of 500 mg is given to this patient, there is a potential increased risk of seizures. Patients with creatinine clearance ≤ 5 ml / min / 1.73 m2 should not receive IMITATIN® unless hemodialysis has been performed within 48 hours.

Imipenem and Cilastatin are cleared of the circulation during hemodialysis. Patients should receive IMITATIN® IV after hemodialysis and at 12 o’clock intervals from the end of the hemodialysis session. Dialysis of patients, especially those with CNS disease backgrounds should be carefully monitored. For hemodialysis patients, IMITATIN® IV is recommended only when the benefit is greater than the potential seizure risk.

Currently, there is not enough data to recommend the use of IMITATIN® IV for peritoneal dialysis patients. Renal conditions of elderly patients may not be accurately described by measurement of blood urea nitrogen (BUN) or creatinine alone. The determination of creatinine clearance is recommended as a guideline for dosing in such patients.

Children

Safety and effectiveness in children younger than 12 years has not been established.

 Reconstitution Intravenous Solution

IMITATIN® IV sterile powder should be reconstituted according to the instructions in Table 3. The solution should be shaken until a clear solution is obtained. Color variations, from colorless to yellow, do not affect product potential.

Tabel 3. Reconstitution IMITATIN® IV

Dose IMITATIN® IV (mg Imipenem) Solvent volume added (ml) ConcentrationIMITATIN® IV average

(mg/ml Imipenem)
500 100 5
250 50 5

 

Reconstitution Vial 20 ml

The vial content should be suspended and transferred to 100 ml of the appropriate infusion solution.

The recommended procedure is to add about 10 ml of the corresponding infusion solution into the vial. Shake well and transfer the resulting suspension to the intravenous fluid container.

ATTENTION: SUSPENSION IS NOT FOR DIRECT INFUS.

Repeat with 10 ml of extra intravenous fluids to make sure all the contents have moved to the vials containing the intravenous fluids. The resulting mixture must be mixed until clear.

IMITATIN® IV can reconstitution with:

  • NaCl 0.9%
  • Dextrose 5% and 10%
  • Dextrose 5% in bikarbonat su=olution02%
  • Dextrose 5% and NaCl 0.9%
  • Dextrose 5% with saline solution225% or 0.45%

After reconstitution, the solution will be stable for 4 hours at room temperature (250C) or for 24 hours if stored in the refrigerator (40C). After exceeding the storage time limit, the solution can not be used.

Presentation and Registration Number:

IMITATIN ® Powder Injection Box, vial @ 1 g; DKL1508023244A1

ON MEDICAL PRESCRIPTION ONLY

 

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