IMCIL POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG/500MG PER VIAL [SIN16280P]

Product Info

IMCIL POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG/500MG PER VIAL

[SIN16280P]

INDICATIONS

TREATMENT
The activity of IMCIL against an unusually broad spectrum of pathogens makes it particularly useful in the treatment of polymicrobic and mixed aerobic/anaerobic infections, as well as initial therapy prior to the identification of the causative organisms. IMCIL is indicated for the treatment of the following infections due to susceptible organisms:

• Intra-abdominal infections

• Lower respiratory tract infections

• Gynecological infections

• Septicemia

• Genitourinary tract infections

• Bone and joint infections

• Skin and soft tissue infections

• Endocarditis

IMCIL is indicated for the treatment of mixed infections caused by susceptible strains of aerobic and anaerobic bacteria. The majority of these mixed infections are associated with contamination by fecal flora or flora originating from the vagina, skin, and mouth. In these mixed infections, Bacteroides fragilis is the most commonly encountered anaerobic pathogen and is usually resistant to aminoglycosides, cephalosporins and penicillins. However, Bacteroides fragilis is usually susceptible to IMCIL.
Imipenem and Cilastatin injection has demonstrated efficacy against many infections caused by aerobic and anaerobic gram-positive and gram-negative bacteria resistant to the cephalosporins, including cefazolin, cefoperazone, cephalothin, cefoxitin, cefotaxime, moxalactam, cefamandole, ceftazidime, and ceftriaxone. Similarly, many infections caused by organisms resistant to aminoglycosides (gentamicin, amikacin, tobramycin) and/or penicillins (ampicillin, carbenicillin, penicillin-G, ticarcillin, piperacillin, azlocillin, mezlocillin) responded to treatment with Imipenem and Cilastatin injection.
IMCIL is not indicated for the treatment of meningitis.

DOSAGE AND ADMINISTRATION

IMCIL is available in an intravenous infusion only formulation.
The dosage recommendations for IMCIL represent the quantity of imipenem to be administered. An equivalent amount of cilastatin is also present.
The total daily dosage and route of administration of IMCIL 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 pathogen(s) and renal function.

INTRAVENOUS INFUSION

Dosage in Adults

For Intravenous Injection Only

• The dosage of IMCIL I.V. in adult patients should be based on suspected or confirmed pathogen susceptibility as shown in Table 1 below. The dosage recommendations for IMCIL I.V. represent the quantity of imipenem to be administered. An equivalent amount of cilastatin is also present in the solution.

• These doses should be used for patients with creatinine clearance of greater than or equal to 90 mL/min. A reduction in dose must be made for patients with creatinine clearance less than 90 mL/min as shown in Table 2 (see Dosage in Adult Patients with Renal Impairment).

• Recommend that the maximum total daily dosage not exceed 4 g/day.

• Administer 500 mg by intravenous infusion over 20 to 30 minutes.

• Administer 1000 mg by intravenous infusion over 40 to 60 minutes.

• In patients who develop nausea during the infusion, the rate of infusion may be slowed.

Dosage in Adult Patients with Renal Impairment
Patients with creatinine clearance less than 90 mL/min require dosage reduction of IMCIL I.V. as indicated in Table 2. The serum creatinine should represent a steady state of renal function.
Use the Cockroft-Gault method described below to calculate the creatinine clearance:

In patients with creatinine clearances of less than 30 to greater than or equal to 15 mL/min, there may be an increased risk of seizures (see PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Patients with creatinine clearance less than 15 mL/min should not receive IMCIL I.V. unless hemodialysis is instituted within 48 hours. There is inadequate information to recommend usage of IMCIL I.V. for patients undergoing peritoneal dialysis.

Dosage in Hemodialysis Patients

When treating patients with creatinine clearances of less than 15 mL/min who are undergoing hemodialysis, use the dosage recommendations for patients with creatinine clearances of less than 30 to greater than or equal to 15 mL/min in Table 2 above (see Dosage in Adult Patients with Renal Impairment). Both imipenem and cilastatin are cleared from the circulation during hemodialysis. The patient should receive IMCIL I.V. after hemodialysis and at intervals timed from the end of that hemodialysis session. Dialysis patients, especially those with background CNS disease, should be carefully monitored; for patients on hemodialysis, IMCIL I.V. is recommended only when the benefit outweighs the potential risk of seizures (see Dosage in Adult Patients with Renal Impairment).

Dosage in Pediatric Patients (3 months or older)

For children and infants the following dosage schedule is recommended:

1. CHILDREN ≥ 40 kg body weight should receive adult doses.

2. CHILDREN AND INFANTS < 40 kg body weight should receive 15 mg/kg at six-hour intervals. The total daily dose should not exceed 2 gm.

Clinical data are insufficient to recommend dosing for children less than 3 months of age, or pediatric patients with impaired renal function (serum creatinine > 2 mg/dL).
IMCIL is not recommended for the therapy of meningitis. If meningitis is suspected, an appropriate antibiotic should be used.
IMCIL may be used in children with sepsis as long as they are not suspected of having meningitis.

Preparation of IMCIL Solution for IV Administration
IMCIL I.V. is supplied as a dry powder in a single-dose vial that must be reconstituted and further diluted using aseptic technique prior to IV infusion as outlined below.

• To prepare the infusion solution, contents of the vial must be reconstituted by adding approximately 10 mL of the appropriate diluent to the vial. List of appropriate diluents are as follows:

  • 0.9% Sodium Chloride Injection

  • 5% Dextrose Injection

• Withdraw 20 mL (10 mL times 2) of diluent from the appropriate infusion bag and constitute the vial with 10 mL of the diluent. The reconstituted suspension must not be administered by direct IV infusion.

• After reconstitution, shake vial well and transfer resulting suspension into the remaining 80 mL of the infusion bag.

• Add the additional 10 mL of infusion solution to the vial and shake well to ensure complete transfer of vial contents; repeat transfer of the resulting suspension to the infusion solution before administering. Agitate the resulting mixture until clear.

• Reconstituted solutions of IMCIL I.V. range from colorless to yellow. Variations of color within this range do not affect the potency of the product.

• For patients with renal insufficiency, a reduced dose of IMCIL I.V. will be administered according to the patient’s CrCl, as determined from Table 3. Prepare 100 mL of infusion solution as directed above. Select the volume (mL) of the final infusion solution needed for the appropriate dose of IMCIL I.V. as shown in Table 3.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if discoloration or visible particles are observed.

Storage of Reconstituted Solutions:

• Store the dry powder at or below 30°C

• Vials (After Reconstitution)

  • IMCIL I.V., as supplied in single dose vials and reconstituted with the appropriate diluents (see Preparation of IMCIL Solution for IV Administration), maintains satisfactory potency for 2 hours at room temperature (25°C). Do not freeze solutions of IMCIL. I.V.

Table 4 shows the stability period for IMCIL I.V. when reconstituted with selected infusion solutions, and stored at room temperature or under refrigeration.

CAUTION: IMCIL I.V. is chemically incompatible with lactate and should not be reconstituted in diluents containing lactate.

IMCIL I.V. should not be mixed with or physically added to other antibiotics.

CONTRAINDICATIONS

Hypersensitivity to any component of this product.