More Information About - Iropen IV/IM 500mg + 500mg
Description
Generic Name
Imipenem + Cilastatin
Precaution
Caution when used in patients with known hypersensitivity to other beta-lactams due to possibility of cross-sensitivity. CNS disorders such as epilepsy; renal, hepatic impairment; pregnancy, lactation.
Lactation: Drug distributed in breast milk; use with caution
Indication
Cystic fibrosis, Bacterial septicemia, Endocarditis, Susceptible infections, Lower Respiratory Tract Infections, Gonorrhea, Skin and skin structure infections, Urinary tract infections, Bone and Joint Infections, Surgical Prophylaxis
Contra Indication
Hypersensitivity.
Dose
N/A
Side Effect
1-10%
Phlebitis (2-5%),Eosinophilia (4%),Miscellaneous dermatologic effects (<3%),Potentially false-positive Coombs test (2%),Miscellaneous hematologic effects (<2%),Transient increase in blood urea nitrogen (BUN) or serum creatinine (<2%),Seizures (1.5%),Nausea, diarrhea, vomiting (1-2%)
<1%
Abnormal urinalysis,Agitation,Anaphylaxis,Anemia,Confusion (acute),Dizziness,Dyskinesia,Emergence of resistant strains of Pseudomonas aeruginosa,Fever,Hypersensitivity,Hypotension,Elevated liver function test (LFT) results,Increased prothrombin time (PT),Neutropenia (including agranulocytosis),Palpitations,Pruritus,Pseudomembranous colitis
Potentially Fatal: Stevens-Johnson syndrome, toxic epidermal necrolysis.
Pregnancy Category
Name :
C
Description
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Mode of Action
Imipenem is a potent inhibitor of bacterial cell wall synthesis and is bactericidal against a broad spectrum of pathogens. It is resistant to degradation by bacterial beta-lactamases. Cilastatin is an inhibitor of dehydropeptidase I, an enzyme found in the brush border of the renal tubules. It is given as the sodium salt with imipenem to prevent its renal metabolism and protect against nephrotoxic effects.
Interaction
Concurrent admin with probenecid may increase the half-life of cilastatin. Increased risk of generalised seizures when used concurrently with ganciclovir.
Pregnancy Category Note
Pregnancy
Available data from a small number of postmarketing cases in pregnancy are not sufficient to identify any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes
Animal data
Developmental toxicity studies with imipenem and cilastatin sodium (alone or in combination) administered to mice, rats, rabbits, and monkeys at doses 0.4 to 2.9 times the recommended human dose (RHD), (based on body surface area), showed no drug-induced fetal malformations
Embryofetal development studies with imipenem/cilastatin administered to cynomolgus monkeys at doses similar to RHD (based on body surface area) showed an increase in embryonic loss
Lactation
There are insufficient data on presence of imipenem/cilastatin in human milk, and no data on effects on breastfed child, or on milk production; developmental and health benefits of breastfeeding should be considered along with mother?s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from the underlying maternal condition
Adult Dose
Lower Respiratory Tract, Skin/Skin Structure, & Gynecologic Infections
Mild to moderate: 500-750 mg IV q12hr
Intra-abdominal Infections
Mild to moderate: 250-500 mg IV q6hr
Severe: 500 mg IV q6hr or 1 g q8hr for 4-7 days, provided that infection is brought under control
Pseudomonas Infections
500 mg IV q6hr; higher dosages may be administered, depending on organism sensitivity
Urinary Tract Infections
Uncomplicated: 250 mg IV q6hr
Complicated: 500 mg IV q6hr
Susceptible infections
Moderate infections
IV: Fully susceptible organisms: 500 mg IV q6-8hr
Moderately susceptible organisms: 500 mg IV q6hr or 1 g IV q8hr
Severe infections
Fully susceptible organisms: 500 mg IV q6hr
Moderately susceptible organisms: 1 g IV q6-8hr; not to exceed 50 mg/kg/day or 4 g/day, whichever is lower
Child Dose
Child: IV, IM 60?100 mg/kg/day q6h
IM form not approved for <12 y
Renal Dose
Renal impairment:
CrCl (ml/min)
31-70 500 mg every 6-8 hr
21-30 500 mg every 8-12 hr
6-20 250 mg or 3.5 mg/kg (whichever is lower) every 12 hr
<5 Only give if haemodialysis started within 48 hr
Administration
IV Preparation
Reconstitute infusion bottles with 100 mL of compatible diluent
Reconstitute vials with a portion (usually 10 mL) of IV fluid withdawn from the IV container, dissolve, and return to container; repeat
Reconstituted solutions are stable for 4 hours at room temperature and 24 hours refrigerated (4 C) in NS
Normal color ranges from clear to yellow; these variations do not affect potency, but solution should be discarded if brown
IV Administration
Do not administer by IV push
Final concentration should not exceed 5 mg/mL
Infuse <500 mg over 20-30 minutes (15-30 minutes in children); infuse >500 mg over 40-60 min
Vial contents must be transferred to 100 mL of infusion solution
Disclaimer
The information provided herein are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please note that this information should not be treated as a replacement for physical medical consultation or advice. Great effort has been placed to provide accurate and comprehensive data. However, Medicart along with its authors and editors make no representations or warranties and specifically disclaim all liability for any medical information provided on the site. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company.