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FEATURED PRODUCTS : IMIPENEM & CILASTATIN SODIUM FOR INJECTION (500MG + 500MG)

IMASAN

Imipenem & Cilastatin Sodium for Injection (500mg + 500mg)

DESCRIPTION:

Imipenem and Cilastatin combination is a broad spectrum beta-lactam antibiotic containing equal quantities of imipenem and cilastatin. It is related to the penicillin/cephalosporin family of antibiotics but is classified as belonging to the carbapenem class. Imipenem is chemically (5R,6S)-6-[(1R)-1-hydroxyethyl]-3-({2-[(iminomethyl)amino]ethyl}thio)-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid and Cislatin is Z)-7-[(2S)-2-amino-3-hydroxy-3-oxopropyl]sulfanyl-2-{[(1S)-2,2-dimethylcyclopropanecarbonyl]amino}hept-2-enoic acid.

Imipenem is an active antbacterial agent but is rapidly degraded by dehydropeptidase enzyme if administered alone, whereas Cislatinis a dehydropeptidase inhibitor and increases the efficacy of Imipenem when co-administered.

Imipenem has extremely broad activity; covers most bacteria except MRSA, coagulasenegative staphylococci, Enterococcus faecium, Clostridium difficile, Stenotrophomonas (formerly Xanthomonas) maltophilia; Burkholderia cenocepacia (formerly Pseudomonas cepacia);

MECHANISAM OF ACTION:

Imipenem acts as an antimicrobial through inhibiting cell wall synthesis of various gram-positive and gram-negative bacteria. It remains very stable in the presence of beta-lactamase (both penicillinase and cephalosporinase) produced by some bacteria, and is a strong inhibitor of beta-lactamases from some gram-negative bacteria that are resistant to most beta-lactam antibiotics.

Cilastatin is a chemical compound which inhibits the human enzyme dehydropeptidase. Dehydropeptidase is found in the kidney and is responsible for degrading the antibiotic imipenem. Cilastatin is therefore combined intravenously with imipenem in order to protect it from dehydropeptidase and prolong its antibacterial effect. However, cilastatin itself does not have antibiotic activity.

INDICATIONS:

Imipenem and Cilastatin for Injection is indicated for the treatment of intra-abdominal infections, bone and joint infections, skin and skin- tissue infections, urinary tract infections, biliary-tract infections, hospital acquired pneumonia, and septicaemia.

It is also used in the treatment of gonorrhoea and for surgical infection prophylaxis.

DOSAGE AND ADMINISTRATION:

IMASAN is given by intravenous infusion and deep intramuscular injection.

When administered intravenously, doses of 250 and 500 mg are infused over 20 to 30 minutes, and doses of 750 mg or 1 g over 40 to 60 minutes. The usual intravenous dose in adult and children weighing more than 40 kg is 1 to 2 g daily in divided doses every 6 or 8 hours, depending on the severity of the infection, although up to maximum daily dose of 4 g or 50 mg/kg has been given in life threatening infections.

Children of 3 months or more and weighing less than 40 kg may be given 15 to 25 mg/kg every 6 hours by intravenous infusion; the total dose should not usually exceed 2g. Higher doses up to 4 g daily have been given to children with moderately susceptible Pseudomonas aeruginosa infection; up to 90 mg/kg daily has been given older children with cystic fibrosis. Neonates and infants up to 3 months of age may be given the following doses: 4 week to 3 months of age, 25 mg/kg every 6 hours; 1 to 4 week of age, 25 mg/kg every 8 hours; upto 1 week of age 25 mg/kg every 1 hour.

For surgical infection prophylaxis in adult, Imipenem and Cislatin for Injection 1 g may be given intravenously on induction of anesthesia, followed by a further 1 g three hours later, with additional doses of 500 mg at 8 and 16 hours after induction if necessary.

Imipenem and Cislatin for Injection may be administered intramuscularly in adult with mild to moderate infections in doses of 500 or 750 mg every 12 hours. A single 500 mg intramuscular dose may be given in uncomplicated gonorrhoea.

Administration in renal impairment: Doses of Imipenem should be reduced in patients with renal impairment. The following are the recommended maximum intravenous doses based on creatinine clearance (CC):

CC 31 to 70 mL/minute : 500 mg every 6 to 8 hours

CC 21 to 30 mL/minute : 500 mg every 8 to 12 hours.

CC 6 to 20 mL/minute : 250 mg (or 3.5 mg/kg , whichever is lower ) every 12 hours or occasionally 500 mg every 12 hours.

CC 5 mL/minute or less : Should only be given imipenem if haemodalysis is started within 48 hours

PREPARATION OF SOLUTION:

Dissolve the content of the vial with 100 ml of the diluent and shake until a clear solution is obtained. After reconstitution the solution contains 5 mg/ml of imipenem and cilastatin respectively.

Imipenem and Cislatin for Injection is reconstituted with the following diluents, maintains satisfactory potency for 4 hours at room temperature or for 24 hours under refrigeration (5oC).

Compatible Diluent Fluids:
  • 0.9% Sodium Chloride Injection
  • 5% or 10% Dextrose Injection
  • 5% Dextrose and 0.9% Sodium Chloride Injection
  • 5% Dextrose Injection with 0.225% or 0.45% saline solution
  • 5% Dextrose Injection with 0.15% Potassium Chloride solution
  • Mannitol 5% and 10%
  • Solutions of Imipenem and Cislatin for Injection should not be frozen.
Adverse Effects:

Imipenem- Cilastatin sodium is generally well tolerated. The most frequently reported systemic side effects are nausea, diarrhea, vomiting, diarrhea (antibiotic associated colitis reported), taste disturbances, tooth or tongue discoloration, hearing loss; blood disorders, positive Coomb's test; allergic reactions (with rash, pruritus, urticaria, Stevens-Johnson syndrome, fever, anaphylactic reactions, rarely toxic epidermal necrolysis, exfoliative dermatitis); myoclonic activity, convulsions, confusion and mental disturbances; slight increases in liver enzymes and bilirubin, hepatitis; increases in serum creatinine and blood urea; red coloration of urine in children. Local side effects include- erythema, pain and induration, and thrombophlebitis.

Contraindications: IMASAN is contraindicated in patients who are hypersensitive to any component of this product.

Presentation: IMASAN is available as Box of 30 ml USP Type I tubular glass vial.


Important: The drug information on this Web page is meant to be educational. It is not a substitute for medical advice. Please see your health care professional for more information about your specific medical condition and the use of the above mentioned drug.
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