MAXIPIME ® Cefepime

MAXIPIME ® 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 MAXIPIME ® Cefepime

MAXIPIME ® is useful in the treatment of bacterial infections sustained by Gram positive and negative microorganisms generally resistant to penicillin therapy and responsible for moderate and severe clinical pictures.

Antibiotic therapy with fourth-generation cephalosporins is also indicated in the prophylaxis of surgical wound infections and opportunistic infections in debilitated and immunosuppressed subjects.

Mechanism of action MAXIPIME ® Cefepime

MAXIPIME ® is a widely used antibiotic in the clinical setting thanks to the wide spectrum of action and the high therapeutic efficacy of its cefepime active ingredient.

The cefepime is in fact a beta lactam antibiotic, founder of the fourth generation cephalosporin family, known for its wide spectrum of action, guaranteed by the zwitterionic structure of the molecule, and for the natural resistance to the hydrolytic action of bacterial beta-lactamases.

The mechanism of action, comparable to that of all the other cephalosporins, is realized through the inhibition of the transpeptidation reaction, useful for the formation of cross-linking between the peptidoglycan molecules and the maintenance of the structural properties of the bacterial wall.

These changes result in a low resistance of the bacterial wall to the osmotic gradient and the consequent death of the microorganism.

Taken parenterally, the cefepime reaches maximum plasma concentration in just a few minutes, thus distributing itself between the various tissues and biological fluids where it performs its therapeutic action for a few hours.

Once the microbicide activity is over, it is eliminated mainly in unchanged form through the urine.

Studies carried out and clinical efficacy

1. THE EFFECTIVENESS OF CEFEPIME IN THE THERAPY OF SEPTICEMIES FROM Gram negative

J Antimicrob Chemother. 2011 May; 66 (5): 1156-60. Epub 2011 Mar 8.

Interesting retrospective work that demonstrates how cefepime can be effective in the treatment of septicemia from Gram negative organisms, maintaining low mortality in 28 days of treatment.

2 . CEFEPIME-RESISTANT AEURIGINOUS PSEUDOMONAS STRIPS

Emerg Infect Dis. 2011 Jun; 17 (6): 1037-43.

Epidemiological study that reveals the appearance of Pseudomonas aeuriginosa strains resistant to classic cephalosporins and also to more recent ones such as cefepime.

This resistance could be an independent risk factor for septicemia-related mortality.

3.OBESITY AND ANTIBIOTIC THERAPY

Obes Surg. 2012 Mar; 22 (3): 465-71.

Obesity is a complex multifactorial disease that can also compromise the antibiotic efficacy of common therapies. In this study it was noted that in order to maintain an adequate therapeutic effect in obese patients suffering from post-operative infectious diseases, it was necessary to significantly increase the doses of cefepime

Method of use and dosage

MAXIPIME ®

500 mg powder and solvent for injection of cefepime for 1.5 ml of solution;

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

All antibiotic treatment should be defined by your doctor based on the physio-pathological characteristics of the patient, the severity of the clinical picture and the therapeutic goals.

Doses of between 1 and 4 grams of cefepime per day are generally sufficient to guarantee a remission of the symptomatology taking place in a few days of treatment.

However, it would be useful to continue the therapy for at least 48 hours after the disappearance of the symptoms, in order to avoid the appearance of recurrences.

Adjustments of the dosage used should also be envisaged in hepatopathic and nephropathic patients.

Warnings MAXIPIME ® Cefepime

The use of MAXIPIME ® should necessarily be supervised by your doctor, both during the definition of the dosage and during the entire drug therapy.

Before administering cefepime the doctor should evaluate the risks related to the therapy and the possible contraindications, taking care to characterize the microorganism responsible for the disease and its sensitivity to cephalosporin therapy.

Particular caution should be reserved for patients suffering from liver and kidney disease, geriatric and pediatric age or in patients with a history of drug hypersensitivity.

In fact, adverse reactions from hypersensitivity could be particularly serious, so as to seriously compromise the patient's state of health, configuring health and resuscitation emergencies.

The prolonged use of MAXIPIME ®, and not therapeutically justified, could determine the appearance of microbial strains resistant to cephalosporins and compromise the vitality of the intestinal microflora, altering the absorption profile of other active ingredients such as oral contraceptives and facilitating bacterial colonization to work of opportunistic microorganisms such as Clostridium difficile, the etiological agent of pseudo-membranous colitis.

PREGNANCY AND BREASTFEEDING

The use of MAXIPIME ® during pregnancy should be limited to cases of real need and should only be carried out under the strict supervision of your doctor.

These precautions are due to the absence of clinical trials able to fully characterize the safety profile of the cefepime fetus when taken during pregnancy and during breastfeeding.

Interactions

At the moment there are no known active ingredients whose simultaneous intake could alter the pharmacokinetic characteristics of cefepime, compromising its therapeutic efficacy and safety.

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

Contraindications MAXIPIME ® Cefepime

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

Undesirable effects - Side effects

Different clinical trials and careful post-marketing monitoring have shown that taking cefepime is generally well tolerated and free of particularly serious side effects.

However, in addition to the appearance of local reactions characterized by redness, pain and swelling at the injection site, administration of cefepime could lead to the appearance of nausea, vomiting, diarrhea, oral candidiasis, colitis, headache, dizziness, fever, vaginitis and dermatological reactions from hypersensitivity to the drug.

Phlebitis, thrombocytopenia, anemia, eosinophilia, hypertransaminasemia, hyperbilirubinemia and reduced renal function have also been observed more rarely.