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Imbac(500 mg+500 mg)/vial
IV Injection
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Medicine overview
Indications of Imbac (500 mg+500 mg)/vial
This is a combination of Imipenema penem antibacterialand Cilastatina renal dehydropeptidase inhibitora penem antibacterialand Cilastatina renal dehydropeptidase inhibitor
Theropeutic Class
Other beta-lactam Antibiotics
Pharmacology
Imipenem acts as an antimicrobial through the inhibition of cell wall synthesis of various gram-positive and gram-negative bacteria.
Absorption
This inhibition of cell wall synthesis in gram-negative bateria is attained by binding to pencillin binding proteins (PBPs).
Distribution
coli and selected strains of P.
Metabolism
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.
Excretion
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.
Dosage & Administration of Imbac (500 mg+500 mg)/vial
Notes: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
Dosage:Up to 500 mg dose should be given over 20 to 30 minutes; > 500 mg dose should be infused over 40 to 60 minutes
Notes:In patients who develop nausea during the infusion, the rate of infusion may be slowed
Adult
Dosage:Normal daily dose is 1-2 g administered in 3-4 divided doses
Notes:For the treatment of moderate infection, a 1 g b. 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
Dosage: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
Notes: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
| Condition | Dosage | Notes |
|---|---|---|
| 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. 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 |
Dosage of Imbac (500 mg+500 mg)/vial
The dosage in adult patients
Dosage:This should be based on suspected or confirmed pathogen susceptibility
Notes: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
| Condition | Dosage | Notes |
|---|---|---|
| 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 |
Interaction of Imbac (500 mg+500 mg)/vial
Concurrent admin with probenecid may increase the half-life of cilastatin. Increased risk of generalised seizures when used concurrently with ganciclovir.
Contraindications
Hypersensitivity to any component of this combination.
Side Effects of Imbac (500 mg+500 mg)/vial
Phlebitis
Nausea, diarrhea, vomiting
Rash, pruritus, urticaria
Pain injection site, erythema
at injection site, vein induration
Fever
Hypotension
Seizures, dizziness, somnolence
Pregnancy & Lactation
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.
Precautions & Warnings
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.
Overdose Effects of Imbac (500 mg+500 mg)/vial
In the case of overdosage, discontinue Imipenem/Cilastatin, treat symptomatically, and institute supportive measures as required. Imipenem/Cilastatin Sodium is hemodialyzable.
Storage Conditions
Store at or below 25° C temperature. Keep away from light and wet place. Keep out of reach of children.
Use In Special Populations
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
Drug Classes
Other beta-lactam Antibiotics
Mode Of Action
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
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.
Frequently Asked Questions
What is Imbac (500 mg+500 mg)/vial used for?
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 d…
What is the dosage of Imbac (500 mg+500 mg)/vial?
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 …
What are the side effects of Imbac (500 mg+500 mg)/vial?
Phlebitis Nausea, diarrhea, vomiting Rash, pruritus, urticaria Pain injection site, erythema at injection site, vein induration Fever Hypotension Seizures, dizziness, somnolence
Who should not take Imbac (500 mg+500 mg)/vial?
Hypersensitivity to any component of this combination.
What precautions should be taken with Imbac (500 mg+500 mg)/vial?
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 treatmen…
Is Imbac (500 mg+500 mg)/vial safe during pregnancy and breastfeeding?
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.
Disclaimer
The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.