CEPIM ® Cefepime

CEPIM ® is a drug based on Cefepime dihydrochloride monohydrate

THERAPEUTIC GROUP: General antimicrobials for systemic use - Cephalosporins

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications CEPIM ® Cefepime

CEPIM ® is indicated in the treatment of bacterial infections sustained by microorganisms sensitive to cephalosporins or normally resistant to antibiotic therapy with penicillins.

The efficacy of this antibiotic has been demonstrated for respiratory, genitourinary, cutaneous, soft tissue, abdominal, neurological and hematological infections.

The use of Cefepime has also been approved for the treatment of opportunistic infections in weak and immunosuppressed patients.

Mechanism of action CEPIM ® Cefepime

Cefepime, the active ingredient of CEPIM ®, is a beta-lactam antibiotic parent of the fourth-generation injectable cephalosporin group, which has a high direct therapeutic activity even against generally resistant microorganisms such as Proteus and Pseudomonas.

Taken intramuscularly or intravenously, this active ingredient very quickly reaches the maximum plasma peak with 100% bioavailability, being distributed to most tissues and body fluids, where it performs its bactericidal action.

Thanks to the presence of an ammonium group and the characteristic bipolar distribution of the charges, cefepime can effectively inhibit the synthesis of the bacterial wall, both of Gram positive and Gram negative microorganisms, compromising the structural properties and thus causing death mainly by osmotic lysis.

The high affinity for the target, the wide spectrum of action and the natural resistance to the hydrolytic action of beta-lactamases allows CEPIM ® to be able to effectively carry out its therapeutic action, making it effective even in immunosuppressed patients.

After a half-life of about 2 hours, comparable to that of other cephalosporins, cefepime is eliminated unchanged mainly through the urine.

Studies carried out and clinical efficacy

1. CEFEPIME IN PEDIATRIC AGE

J. Pediatr. 2010 Sep; 157 (3): 490-5, 495.e1.

Extensive review that evaluates the efficacy and safety of antibiotic therapy as a cefepime in pediatric patients suffering from various infectious diseases. The data obtained from the re-evaluation of over 16 clinical studies show that cefepime is effective and free of serious side effects.

2 . CEFEPIME IN THE TREATMENT OF PERITONITIS

Perit Dial Int. 2010 Nov-Dec; 30 (6): 660-1.

Study that tests an innovative method of administration for cefepime, represented by intraperitoneal administration, for the treatment of even complicated abdominal infectious diseases such as peritonitis.

3. ALTERATIONS TO THE MENTAL STATE INDUCED BY CEFEPIME

Rinsho Shinkeigaku. 2012; 52 (5): 356-9.

Interesting study that demonstrates the onset of significant alterations of the electroencephalogram in two patients treated with cefepime, accompanied by mental status disorders. The diagnosis of cefepime-induced changes in mental status highlights the importance of medical supervision throughout the entire therapeutic process.

Method of use and dosage

CEPIM ®

Powder and solvent for solution for injection of 1 g of cefepime for 3 ml of solution.

The dosing schedule, including the route of administration of CEPIM ®, can vary significantly from patient to patient based on the physiopathological characteristics, the severity of the clinical picture and the therapeutic goals.

The therapeutic range, generally between 1 and 4 grams of daily cefepime, is able to guarantee remission of the symptoms present during infections in 7-10 days, adequately controlling bacterial growth.

An adaptation of the dosages used should be expected in patients with liver disease and nephropathy, as well as in subjects of geriatric age.

Cautions CEPIM ® Cefepime

CEPIM ® therapy should be preceded by a careful medical examination to evaluate:

The possible presence of contraindications to antibiotic therapy with cephalosporins;
The sensitivity of the microorganisms responsible for the pathology to cephalosporins;
The prescriptive appropriateness;
The simultaneous presence of hepatic and renal pathologies for which it would be appropriate to suitably adjust the dosages.

Particular caution should also be reserved for patients with a history of hypersensitivity to drugs, given the high risk of developing even hypersensitivity reactions.

Inadequate use of CEPIM ®, as well as that of other antibiotics, could facilitate the emergence of microbial strains resistant to antibiotic therapy, significantly reducing their efficacy.

Prolonged use of antibiotics, altering the intestinal microenvironment due to damage caused to the microflora, could alter the absorption profile of active ingredients such as oral contraceptives, and at the same time increase the risk of developing gastro-enteric diseases sustained by microorganisms such as Clostridium Difficile.

PREGNANCY AND BREASTFEEDING

The absence of clinical trials capable of characterizing the safety profile of cefepime on the fetus does not allow CEPIM ® to be used freely during pregnancy, limiting its use to cases of real need and under strict medical supervision.

Although cefepime is only excreted in small amounts in breast milk, it is advised to avoid taking CEPIM ® during breastfeeding.

Interactions

The various pharmacokinetic studies have not yet identified active ingredients whose simultaneous intake could lead to alterations in the pharmacokinetic and pharmacodynamic characteristics of cefepime.

Glycosuria and positivity to the direct Coombs test could be artifacts associated with antibiotic therapy with CEPIM ®.

Contraindications CEPIM ® Cefepime

The use of CEPIM ® is contraindicated in patients who are hypersensitive to penicillins and cephalosporins or their excipients.

Undesirable effects - Side effects

Treatment with cefepime, like that with other cephalosporins, could determine the appearance of side effects, sometimes even serious, in predisposed patients.

These reactions could be of interest:

The gastro-intestinal system with nausea, vomiting, diarrhea, oral candidiasis and colitis;
The central nervous system with headache and vertigo;
The genital apparatus with vaginitis;
The skin with rash, urticaria and intense itching.

Only in rare cases and in predisposed patients, the appearance of clinically relevant adverse reactions such as phlebitis, thrombocytopenia, anemia, eosinophilia, hypertransaminasemia, hyperbilirubinemia and reduced renal function has been observed.