Iropen(500 mg+500 mg)/vial

This is a combination of Imipenem, a penem antibacterial, and Cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: Lower respiratory tract infections Urinary tract infections Intra-abdominal infections ... Read moreThis is a combination of Imipenem, a penem antibacterial, and Cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: Lower respiratory tract infections Urinary tract infections Intra-abdominal infections Gynecologic infections Bacterial septicemia Bone and joint infections Skin and skin structure infections Endocarditis

Other beta-lactam Antibiotics

Imipenem acts as an antimicrobial through the inhibition of cell wall synthesis of various gram-positive and gram-negative bacteria. This inhibition of cell wall synthesis in gram-negative bateria is attained by binding to pencillin binding proteins (PBPs). In E. coli and selected strains of P. aeruginosa, imipenem has shown to have the highest affinity to PBP-2, PBP-1a, and PBP-1b. This preferential binding to PBP-2 and PBP-1b results in the direct conversion of the individual cell to a spheroblast, which leads to rapid cell lysis and death without filament formation.Cilastatin is a specific and reversible renal dehydropeptidase-I inhibitor. Since the antibiotic, imipenem, is hydrolyzed by dehydropeptidase-I, which resides in the brush border of the renal tubule, cilastatin is administered with imipenem to block the metabolism and thus the inactivation of imipenem so that antibacterial levels of imipenem can be attained in the urine. The drug also prevents the metabolism of leukotriene D4 to leukotriene E4 through the inhibition of leukotriene D4 dipeptidase.

The total daily dosage of Imipenem 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 pathogens, renal function and body-weight.Imipenem & Cilastatin IV: Up to 500 mg dose should be given over 20 to 30 minutes; > 500 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.Adult: Normal daily dose is 1-2 g administered in 3-4 divided doses. For the treatment of moderate infection, a 1 g b.i.d. dosage regimen may also be used. In infections due to less susceptible organisms, the daily dosage may be increased to a maximum of 4 g/day or 50 mg/kg/day, whichever is lower. Mild infection: 250 mg 6 hourly (1 gm/day) Moderate infection: 500 mg 8 hourly or 1 gm 12 hourly (1.5-2 gm/day) Severe infection with fully susceptible microorganism: 500 mg 6 hourly (2gm/day) Severe infection with less susceptible organisms (primarily some strains of P. aeruginosa): 1 gm 3-4 times daily (3-4 gm/day) Paediatric Dosing Schedule: ≥ 3 months of age: the recommended dose for non-CNS infections is 15-25 mg/kg/dose administered every six hours. The maximum daily dose for treatment of infections with fully susceptible organisms is 2.0 g per day, and of infections with moderately susceptible organisms is 4.0 g/day. Higher doses (up to 90 mg/kg/day in older children) have been used in patients with cystic fibrosis. ≤3 months of age: Following dosage schedule is recommended for non-CNS infections: <1 week of age: 25 mg/kg every 12 hrs 1-4 weeks of age: 25 mg/kg every 8 hrs 4 weeks-3 months of age: 25 mg/kg every 6 hrs. Imipenem is not recommended for the therapy of meningitis. If meningitis is suspected, an appropriate antibiotic should be used. Imipenem and cilastatin for injection is not recommended in pediatric patients <30 kg with impaired renal function, as no data are available.

The dosage in adult patients: This should be based on suspected or confirmed pathogen susceptibility.For adult patients with normal renal function (creatinine clearance of greater than or equal to 90 mL/min), the recommended dosage regimens are: 500 mg every 6 hours OR 1000 mg every 8 hours OR 1000 mg every 6 hours.A reduction in dose must be made for a patient with a creatinine clearance of less than 90 mL/min.Patients with creatinine clearances of less than 15 mL/min should not receive this combination unless hemodialysis is instituted within 48 hours.Reconstitute this vial with appropriate diluent and dilute the reconstituted suspension with an appropriate infusion solution before administering by intravenous infusion.Recommended Dosage in Pediatric Patients for Non-CNS Infections: Greater than or equal to 3 Months of Age: 15-25 mg/kg in every 6 hoursLess than or equal to 3 months of age (Greater than or equal to 1,500 g body weight): 4 weeks to 3 months of age: 25 mg/kg in every 6 hours 1 to 4 weeks of age: 25 mg/kg in every 8 hours Less than 1 week of age: 25 mg/kg in every 12 hours Doses less than or equal to 500 mg should be given by intravenous infusion over 20 to 30 minutes. Doses greater than 500 mg should be given by intravenous infusion over 40 to 60 minutes Recommend that the maximum total daily dosage not exceed 4g/day.

Concurrent admin with probenecid may increase the half-life of cilastatin. Increased risk of generalised seizures when used concurrently with ganciclovir.

Hypersensitivity to any component of this combination.

Phlebitis Nausea, diarrhea, vomiting Rash, pruritus, urticaria Pain injection site, erythema at injection site, vein induration Fever Hypotension Seizures, dizziness, somnolence

Pregnancy: Category C. There are no adequate and well controlled studies in pregnant women. Cispenam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Lactation: Imipenem has been detected in human milk. If the use of Cispenam is deemed essential, the patient should stop nursing.

Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. If an allergic reaction to this combination occurs, discontinue the drug immediately.Seizure Potential: Seizures and other CNS adverse reactions, such as confusional states and myoclonic activity, have been reported during treatment with this combination. If focal tremors, myoclonus, or seizures occur, patients should be evaluated neurologically, placed on anticonvulsant therapy if not already instituted, and the dosage of this combination re-examined to determine whether it should be decreased or the antibacterial drug discontinued.

In the case of overdosage, discontinue Imipenem/Cilastatin, treat symptomatically, and institute supportive measures as required. Imipenem/Cilastatin Sodium is hemodialyzable.

Store at or below 25° C temperature. Keep away from light and wet place. Keep out of reach of children.

Dosage adjustment in renal impairment: CrCl >71: No changes. CrCl 41-70: Max 37.5 mg/kg/day or 3 g/day. (Range: 9.4 - 37.5 mg/kg/day) divided q6-8h. CrCl 21-40: Max 25 mg/kg/day or 2 g/day. (Range: 6.25 - 25 mg/kg/day) divided q6-12h. CrCl 6-20: Max 12.5 mg/kg/day (max dose 1 g/day). Range: 6.25 - 12.5 mg/kg/day) divided q12h. (Usual: 250mg q12h) Dialysis Hemodialysis: 125 - 500 mg q12h. (Max 12.5 mg/kg/day). Give dose after dialysis. Peritonial Dialysis: 125 - 250 mg q12h

Other beta-lactam Antibiotics

This is a combined preparation of Imipenem and Cilastatin. Imipenem is a penem antibacterial drug. Cilastatin sodium is a renal dehydropeptidase inhibitor that limits the renal metabolism of imipenem. The bactericidal activity of imipenem results from the inhibition of cell wall synthesis. Its greatest affinity is for penicillin binding proteins (PBPs) 1A, 1B, 2, 4, 5 and 6 of Escherichia coli, and 1A, 1B, 2, 4 and 5 of Pseudomonas aeruginosa. The lethal effect is related to binding to PBP 2 and PBP 1B. Imipenem has a high degree of stability in the presence of beta-lactamases, both penicillinases and cephalosporinases produced by Gram-negative and Gram-positive bacteria. It is a potent inhibitor of betalactamases from certain Gram-negative bacteria which are inherently resistant to most beta-lactam antibacterials, e.g., Pseudomonas aeruginosa, Serratia spp., and Enterobacter spp.

Pregnancy Category C. There are no adequate and well-controlled studies of this combination in pregnant women. This combination should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus. It is not known whether Imipenem-Cilastatin sodium is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this combination is administered to a nursing woman.