Source: Υπουργείο Υγείας (CY) Revision Year: 2022 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Cefoperazone may be indicated in adults, neonates, infants, children and adolescents for the prophylaxis of postoperative infections in patients undergoing abdominal, gynecological, cardiovascular and orthopedic surgeries.
Given the broad spectrum of activity of cefoperazone, most infections can be adequately treated by antibiotic monotherapy. Nevertheless, is possible to administer cefoperazone concomitantly with other antibiotics if such combination is suitable. In case of aminoglycosides co-administration, renal function should be monitored during therapy (see sections 4.2 and 6.2).
Consideration should be given to official guidance on the use of antibiotics.
| Age group of patients | Dosage |
|---|---|
| Adults and adolescents (>12 years) | 2-4 g administered every 12 hours through the i.v. or i.m route. In severe infections, the dose may be increased and the dosing interval shortened. Administration of a daily dose of 12 g divided into equal doses every 8 hours and administration of a daily dose of up to 16 g divided equally into 2, 3 or 4 doses. |
| Infants and children (2 months to 11 years) | 50-200 mg/kg/day dose every 8-12 hours. The maximum dose should not exceed 12 g/day. |
| Newborns | 50 mg/kg given every 12 hours |
i.v. = intravenous; i.m. = intramuscular
Cefoperazone usual dose for adults is 2-4 grams per day divided into equal doses, administrated at 12 hours intervals. In case of severe infections, the daily dose can be increased up to 8 g administered in two equally divided doses every 12 hours. Daily dose of 12 g should be administered in 3 divided doses every 8 hours and administration of a daily dose of up to 16 g divided into 2, 3 or 4 doses, which took place without complications, have also been described. Treatment can be started before susceptibility test results are available.
The recommended dose for the treatment of uncomplicated gonococcal urethritis is 500 mg administrated intramuscularly in a single dose.
Because renal excretion is the major route of elimination of cefoperazone, patients with renal failure require adjustment of dosing schedule when given usual doses (2-4 g per day).
In patients with glomerular filtration rate of less than 18 ml/min or creatininemia above 310 mol/l, a maximum dose of 4 grams/day cefoperazone is required.
The plasma half-life of cefoperazone is slightly reduced during hemodialysis. Therefore, the administration of cefoperazone should follow hemodialysis.
In cases of severe biliary obstruction, severe hepatic disease or concomitant renal impairment it may be necessary to adjust the dose.
In these cases, do not exceed the dose of 2 g /day without close monitoring of serum concentrations.
In patients with simultaneously occurring hepatic and renal function disorder, plasma levels of cefoperazone should be monitored.
If necessary, dosage should be adjusted.
In these cases, do not exceed the dose of 2 g /day without close monitoring of serum concentrations.
Dosage in infants and children: In infants and children (2 months to 11 years), daily doses of 50-200 mg/kg/day should be administered 8-12 hours in divided doses. The maximum daily dose should not exceed 12 g. (see section 4.4).
Dosage in neonates: Newborns are to be treated with 50mg/kg given at 12 hours intervals.
The product is intended for intravenous and intramuscular administration.
The medicine should be administered by deep intramuscular injection into a large muscle mass of the upper outer quadrant of gluteal max. muscle or in the anterior thigh.
For single intravenous infusion, each vial of cefoperazone 1 g should diluted in 20-100 ml of one of the compatible sterile solutions and administered as an infusion over 15 minutes to 1 hour.
Sterile water for injection should not be added to the vial more than 20 ml, when preferably used as the solvent.
For continuous intravenous infusion, each gram of cefoperazone should be reconstituted in 5 ml of sterile water for injection and added into the desired amount of the corresponding intravenous solvent.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
The maximum dose for intravenous injection administration should be 2 g cefoperazone for adults and 50 mg/kg for children. The product should be dissolved in an appropriate solvent to a final concentration of 100 mg/ml, and should be administered for at least 3-5 minutes.
For prophylaxis of surgical procedures, 1-2 g is administered intravenously, 30-90 minutes before the start of the procedure. The dose can be repeated every 12 hours, in most cases, usually no longer than 24 hours.
Where a higher incidence of infections (e.g. colorectal surgery) is known or where the occurrence of infection may have extremely consequences (e.g. open-heart surgery or arthroplasty using artificial materials), prophylactic administration of cefoperazone may be continued for 72 hours after completion of surgery.
Data on acute toxicity of cefoperazone is limited. Cefoperazone overdose can expect manifestations, which are mainly an extension of side effects.
High concentrations of beta-lactam antibiotics in the cerebrospinal fluid can have neurological effects and increase the risk of seizures.
Treatment should be supportive and symptomatic depending on the patient’s clinical condition. No specific antidote is known.
Cefoperazone is removed from the circulation by hemodialysis, therefore in case of overdose in patients with impaired renal function; its excretion from the body can be increased.
2 years
It is recommended to be used immediately after reconstitution.
If necessary it can be stored for 24 hours below 25°C and for 120 hours under refrigeration (2-8°C).
Store below 25°C, in the original package.
For storage conditions after reconstitution of the medicinal product, see section 6.3 and 6.6.
Colourless moulded type I glass vials of 20ml capacity, sealed with a rubber stopper and aluminium overcap. Each vial contains either 1g or 2g of cefoperazone as cefoperazone sodium.
Cartons of 1, 10 or 25, 50 and 100 vials are available.
Not all pack sizes may be marketed.
Reconstitutions and administrations of the contents should be performed under suitable aseptic conditions. The reconstituted solution must be clear, not coloured with no visible particulate matter. Medocef is intended for single administration, any unused solution should be discarded.
For the preparation of the solution, the following two-step procedure is recommended.
Cefoperazone 1g powder for solution for injection or infusion should be dissolved in 2ml of water for injection and then in 0.6ml of 2% lidocaine.
Cefoperazone 2g powder for solution for injection or infusion should be dissolved in 3.8ml of water for injection and then in 1.2ml of 2% lidocaine.
For the initial reconstitution for intravenous use, each 1g of cefoperazone should be dissolved in 5ml of the following diluents:
1. 5% glucose injection
2. 5% glucose and 0.2% sodium chloride
3. 10% glucose
4. 0.9% sodium chloride
5. Ringer Lactate
6. water for injection
The total amount of the resulting solution should then be diluted in any of the above diluents prior to administration.
For intermittent intravenous administration, each vial of cefoperazone 1 g should be diluted in 20-100 ml of one of the compatible sterile solutions and administered as an infusion over 15 minutes to 1 hour.
Sterile water for injection should not be added to the vial more than 20 ml, when preferably used as the solvent.
For the preparation of continuous intravenous infusion, each gram of cefoperazone should be reconstituted in 5 ml of sterile water for injection and added into the desired amount of the corresponding intravenous solvent.
The maximum dose for intravenous injection administration should be 2 g cefoperazone for adults and 50 mg/kg for children. The product should be dissolved in an appropriate solvent to a final concentration of 100 mg/ml, and should be administered for at least 3-5 minutes.
On the basis of the chemical and physical in-use stability, the chemical and microbiological attributes of the solutions are kept within the predetermined specifications for a period of at most 24 hours after reconstitution when the solutions are stored at 25°C or for a period of at most 120 hours after reconstitution when solutions are stored under refrigeration. The above applies to all the aforementioned diluents except for Ringer Lactate where the reconstituted solution keeps its chemical and microbiological properties for 12hours after reconstitution when the solution is stored at 25°C. Similarly with the all other diluents when vials are reconstituted with Ringer Lactate they are stable for over a period of 120hours after reconstitution when solutions are stored at 2-8°C.
From microbiological point of view, the product should be used immediately. If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24hours at 2°C–8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
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