Medicinal Products

AXEPIM 1 g

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

Powder for parenteral use
Box of 1 bottle of 1000 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:

o septicemia and bacteremia,

o low community respiratory infections and severe pneumonias,

o complicated and uncomplicated urinary tract infections

o febrile episodes in neutropenic patients,

o biliary infections.

· In infants over two months old and the child:

o 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 1 g Powder for parenteral use Box of 1 vial of 1000 mg

Dosage

· Subjects to normal kidney function

In the adult

The usual dosages recommended as monotherapy or combination are as follows:

Type of infections

Unit dose
way

Frequency of administration

Community respiratory infections
Uncomplicated pyelonephritis

1 g IV or IM

2 times per day

Severe infections:

· Septicemia / bacteremia

· Pneumonia

· Complicated urinary tract infections

· Biliary infections

2 g IV

2 times per day

Febrile episode in neutropenic patients *

2 g IV

2 to 3 times a day

Severe Pseudomonas Infections

2 g IV

3 times a day

* The dosage of 2 g, 3 times daily has been administered only in monotherapy.

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.

· Kidney failure

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 in the table below:

Creatinine clearance (ml / min)

Usual dosage

50 - 30

29 - 11

≤ 10

Hemodialysis

1 g, 2 times a day

1 g, 1 time per day

500 mg, once a day

250 mg once daily

loading dose: 1 g, followed by 500 mg, once a day *

2 g, 2 times a day

2 g, once a day

1 g, 1 time per day

500 mg, once a day

loading dose: 1 g, followed by 500 mg, once a day *

2 g, 3 times a day

1 g, 3 times a day

1 g, 2 times a day

1 g, 1 time per day

loading dose: 1 g, followed by 500 mg, once a day *

50 mg / kg 3 times daily

25 mg / kg 3 times daily

25 mg / kg twice daily

25 mg / kg once daily

* On dialysis days, a dose should be administered after the dialysis session.

When only creatinine (CRS) is available, the Cockcroft equation can be used to estimate creatinine clearance. CRS should represent the steady state of renal function:

This equation applies to male subjects. For female patients, creatinine clearance 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 section Instructions for use, handling and disposal ).

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

· Moderate and transient hematologic manifestations: frequently anemia, eosinophilia, prolongation of prothrombin time and activated partial thromboplastin time; infrequently, leukopenia, neutropenia, thrombocytopenia. Cases of agranulocytosis have been reported (indeterminate incidence).

· Allergic manifestations: infrequently pruritus, urticaria and fever; very rarely severe anaphylaxis (anaphylactic shock).

· Neurological manifestations: rarely headache, paresthesia; very rarely confusion, dizziness, convulsions, change of taste, tinnitus.

As with other beta-lactams, rare cases of reversible encephalopathies (disturbances of alertness and consciousness that can go as far as coma, hallucinations, myoclonus, seizures) have been reported. Most cases have occurred in patients with renal insufficiency receiving doses higher than the recommended doses, especially in the elderly (see section Overdose ). Generally, the symptoms of neurotoxicity have been favorable to stopping treatment and / or after hemodialysis. However, there have been some cases of fatal evolution.

· Digestive manifestations: frequently diarrhea; infrequently nausea, vomiting, oral candidiasis; very rarely abdominal pain, colitis especially pseudomembranous type, oral ulceration.

· Liver manifestations: frequently, moderate and transient elevation of ALT and ASAT transaminases, alkaline phosphatase and total bilirubin.

· Skin manifestations: frequently rash.

· Renal manifestations: infrequent, transient increase in uremia and / or serum creatinine. Rare cases of acute renal failure have been reported.

· Other events reported very rarely:

o hypotension, vasodilatation,

o edema, arthralgia,

o vaginitis,

o decrease in phosphoremia.

· Local manifestations: infrequently phlebitis and thrombophlebitis after IV administration, pain and inflammation at the IM or IV injection site.

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