Medicinal Products

AXEPIM 2 g

Generic drug of the therapeutic class: Infectiology - Parasitology
Active ingredients: Cefepime
laboratory: Bristol Myers Squibb

Powder for parenteral use
Box of 1 vial of 2000 mg
All forms

Indication

They arise from the antibacterial activity and pharmacokinetic characteristics of cefepime. They take into account both the clinical studies that the drug has given and its place in the range of antibacterial products currently available.
They include infections caused by cefepime-sensitive germs:
- in adults:
. septicemia and bacteremia,
. low community respiratory infections and severe pneumonia,
. complicated and uncomplicated urinary tract infections
. febrile episodes in neutropenic patients,
. biliary infections.
- in infants over two months old and the child:
febrile episodes during neutropenia when the expected duration of neutropenia is short.
Official recommendations concerning the appropriate use of antibacterials should be taken into account.

Dosage AXEPIM 2 g Powder for parenteral use Box of 1 vial of 2000 mg

Dosage:
Subjects with normal kidney function :
- In adults:
The usual dosages recommended as monotherapy or combination are as follows:
. Community respiratory infections. Uncomplicated pyelonephritis : 1 g IV or IM, 2 times daily.
. Severe infections: septicemia / bacteremia, pneumonia, complicated urinary tract infections, biliary infections : 2 g IV, 2 times daily.
. Febrile episode in neutropenic patients : 2 g IV, 2 to 3 times a day.
The dosage of 2 g, 3 times daily was administered only in monotherapy.
. Severe Pseudomonas Infections : 2 g IV, 3 times daily.
- In infants older than 2 months and children: 50 mg / kg IV, 3 times daily. Clinical data available in infants and children do not recommend the use of cefepime monotherapy.
Patients with renal insufficiency :
Cefepime is eliminated by the renal route exclusively by glomerular filtration. Consequently, in patients with renal insufficiency (glomerular filtration <50 ml / min), the dose should be adjusted to compensate for a lower rate of renal elimination. Glomerular filtration should be estimated to determine the maintenance dosage.
Dosage adjustment protocols for renally impaired patients are described below:
- usual dosage 1 g, twice a day:
. clearance of creatinine 50-30 ml / min: 1 g, 1 time per day.
. creatinine clearance 29-11 ml / min: 500 mg once daily.
. creatinine clearance <= 10 ml / min: 250 mg once daily.
. hemodialysis: loading dose 1 g followed by 500 mg once daily *.
- usual dosage 2 g, twice a day:
. clearance of creatinine 50-30 ml / min: 2 g, 1 time per day.
. clearance of creatinine 29-11 ml / min: 1 g, 1 time per day.
. creatinine clearance <= 10 ml / min: 500 mg once daily.
. hemodialysis: loading dose 1 g followed by 500 mg once daily *.
- usual dosage 2 g, 3 times a day:
. clearance of creatinine 50-30 ml / min: 1 g, 3 times daily.
. clearance of creatinine 29-11 ml / min: 1 g, 2 times daily.
. creatinine clearance <= 10 ml / min: 1 g, 1 time per day.
. hemodialysis: loading dose 1 g followed by 500 mg once daily *.
- usual dosage of 50 mg / kg 3 times daily:
. clearance of creatinine 50-30 ml / min: 25 mg / kg 3 times daily.
. Creatinine clearance 29-11 ml / min: 25 mg / kg twice daily.
. creatinine clearance <= 10 ml / min: 25 mg / kg once daily.
* On dialysis days, a dose must be administered after the dialysis session.
When only creatinine (CRS) is available, the Cockroft equation can be used to estimate creatinine clearance. CRS should represent the steady state of renal function:
Cl.Cr (ml / min) = [Weight (Kg) x (140 - age)] / [7.2 x CRS (mg / L)].
This equation applies to male subjects. For female patients, the clearance of creatinine is equivalent to 0.85 times the calculated Cl.Cr.
- In hemodialysis patients, the pharmacokinetic characteristics of cefepime show that it is necessary to reduce doses. These patients should receive a loading dose of 1 g on the first day, then 500 mg on the following days. About 68% of the total amount of cefepime present in the body is eliminated after 3 hours of dialysis. On the day of dialysis, cefepime should be given after dialysis. If possible, cefepime will be administered at the same time each day.
- In patients on permanent ambulatory peritoneal dialysis, cefepime may be administered at the recommended doses in subjects with normal renal function but every 48 hours.
Administration mode :
Cefepime can be administered intravenously (IV) (0.5 g, 1 g, 2 g) in slow IV for 3 to 5 minutes or as a 30-minute infusion, or deep intramuscular (IM) (0.5). g and 1 g) (see instructions for use, instructions for handling).

Against indications

This medicine MUST NEVER BE USED in case of allergy:
- antibiotics of the cephalosporin group (see warnings and precautions for use),
- with L-Arginine.

Axepim side effects

- Allergic manifestations: infrequently pruritus, urticaria and fever; very rarely severe anaphylaxis (anaphylactic shock).
- Skin manifestations: frequently rash.
- Digestive manifestations: frequently diarrhea; infrequently nausea, vomiting, oral candidiasis; very rarely abdominal pain, colitis especially pseudomembranous type, oral ulceration.
- Moderate and transient hematologic manifestations: rarely hypereosinophilia, neutropenia, thrombocytopenia, increased prothrombin time and activated partial thromboplastin time; very rarely agranulocytosis.
- Hepatic manifestations: rarely moderate and transient elevation of transaminases (ASAT-ALAT).
- Sensory manifestations: rarely cephalal, paresthesia; very rarely confusion, dizziness, convulsions, change of taste, tinnitus.
- As with other betalactamines, rare cases of reversible encephalopathies (disturbances of alertness and consciousness that may go as far as coma, hallucinations, myoclonus, seizures) and / or acute renal failure have been reported. Most cases have occurred in patients with renal insufficiency receiving doses higher than the recommended doses, especially in the elderly. Generally, the symptoms of neurotoxicity have been favorable to stopping treatment and / or after hemodialysis. However, there have been some cases of fatal evolution.
- Other events reported very rarely:
. hypotension, vasodilatation,
. edema, arthralgia,
. vaginitis,
. decreased phosphoremia.
- Local manifestations: infrequently phlebitis and thrombophlebitis after IV administration, pain and inflammation at the IM or IV injection site.

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