Drug Interaction:
Drug interactions- summary-
Concurrent admin. with probenecid may increase the T1/2 of cilastatin
Increase risk of generalized seizures when used concurently with ganciclovir
Indication:
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
1.Imipenem + Cilastin Ani-hypertensive 23-02-2004
2.Imipenem 50mg 14-07-2010
+ Colastin 50mg
Treatment of infection caused by susceptible bacteria for the following
indications as in neonates and infants (below 3 months of age)
1.Lower respiratory infections
2.Urinary tract infections
3.Intra-abdominal infections
4.Bacterial septicemia
5.Bone and joint infections
6.Skin and skin structure infections
7.Bacterial endocarditis
3. Imipenem IP (Sterile) eq.to 28-06-2012
Anhydrous Imipenem 1g
+ Cilastin sodium IP eq.to
Cliastin 1g powder for njection
(Addl.Stgth.)
For the treatment of serious lower respiratory tract infections ,
urinary tract infections, intra-abdominal, bone, and joint infection,
endocardities and bacterial septicemia
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Imipenem as anhydrous 250mg/500mg + 25-07-2003
Cilastatin Sodium eq.to
Cilastatin 250mg/500mg per vial
For the treatment of serious lower respiratory /UTI
intra-abdominal, bone and joint infections, endocarditis
and bacterial septicemia
Susceptible infections
Prophylaxis during surgery
Adverse Reaction:
Skin rashes, urticaria,
Eosinophilia, fever, nausea,
Vomiting, diarrhea,
Tooth or tongue discoloration, and altered tasts
Erythema multiforme, exfoliative dermatitis
Pain and thrombophebitis may occur at the injection site
Stevens - Johmsons syndrome
Toxic epidermal necrolysis
Contra-Indications:
Hypersensitivity
Special precautions-
Caution when used in patients with knownhypersensitivity to other betalactams
due to cross -sensitivity,
CNS disorders such as epilepsy,
Renal , hepatic impairment
Pregnancy, lactaion
Dosages/ Overdosage Etc:
Indication-
Susceptible infections
Prophylaxis during surgery
Dosage-
Susceptible infections
In terms of imipenem 500mg or 750mg every 12 hours
Intravenous -
Adult- in terms of imipenem - 1-2g daily in divided doses every 6-8 hrs. given via IV infusion
doses 250mg or 500mg are infused over 20-30 minutes
and doses of 750mg or 1g over 40-60 minutes
Child- < 40kg 15-25mg /kg every 6 hours by IV infusion
upto 90mg/kg may be given to older child with cystic fibrosis
Neonates and infants < 3mths - 4wk - 3mths
25mg/kg every 6 hrs
1-4 weeks - 25mg/kg every 12 hrs
Max dose -
adults and child- > 40kg 4g/day or 50mg/kg
children- < 40kg - 2g/day
Prophylaxis during surgery
Adult- in terms of imipenem 1g given on induction of anesthesia followed by
1g 3 hour later followed by 500mg at 8 hour and 16 hours if necessary
Patient Information:
Ref - USP PDI Vol II 17th Edition (1997)
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
Imipenem and cilastatin, penicillin or cephalosporin.. Also tell your healthcare
care professional if you are allergic to any other substances such as foods,
preservatives or dyes.
2.Pregnancy-
Studies have not been done in humans. However, imipenem + cilastatin
combination has not shown to cause birth defects or other problems in
in animal stidies
3. Breast-feeding-
This medicine has not been reported to cause any problems in nursing
babies.
4.Children-
This medicine has not been reported to cause different side effects or
problems than it does in adults.
5.Older adults-
This medicine is not expected to different side effects in older people
than in younger adults
6. Other medicines-
Tell your doctor if you are using any other prescription or
non-prescription (Over-the counter) OTC medicine.
7. Other medical problems-
The presence of other medical problems may affect the use of imepenem
+ cilastatin.
Make sure you tell your doctor if you have any other medical problems
especially-
CNS disorders- patients with brain disoders including seizures may be
more likely to have serious side effects
Kidney disease- patients with kidney disease may be more likely to
have side effects
Pregnancy and lactation:
Use contraindicated. Observe caution
