Maxipime

Maxipime - Use | Dosage | Side Effects

Maxipime (Cefepime) is used to treat the following infections caused by microorganisms sensitive to Maxipime:

  • In adults and children over 12 years (body weight 40 kg or more)
  • Infections of the lower respiratory tract (including acute exacerbation of chronic bronchitis and pneumonia)
  • Complicated and uncomplicated urinary tract infections, including pyelonephritis
  • Infections of skin and soft tissue
  • Intra-abdominal infections (including peritonitis, and biliary tract infection)
  • Gynecological infections
  • Sepsis
  • Empiric treatment of febrile episodes in patients with neutropenia.

Maxipime is indicated as monotherapy for the treatment of patients with febrile neutropenia. In patients where is a high risk of serious infection (e.g. in patients who had recently transplanted bone marrow, hypotensive patients, patients with hematologic malignancy and severe or prolonged neutropenia) it may not be appropriate use just a one antibiotic. There is not enough data to support the effectiveness of Maxipime monotherapy in these patients.

  • Prevention of infection after intra-abdominal surgery

Children (aged 2 months to 12 years):

  • Pneumonia
  • Complicated and uncomplicated urinary tract infections, including pyelonephritis
  • Infections of skin and soft tissue
  • Sepsis
  • Empiric treatment of febrile episodes in patients with neutropenia.

Maxipime is indicated as monotherapy for the treatment of patients with febrile neutropenia. Patients  who are at high risk of serious infection (e.g. in patients who had recently transplanted bone core, hypotensive patients, patients with hematologic malignancy and severe or prolonged neutropenia), it may not be appropriate to use just a one antibiotic. There is not enough data to support the effectiveness of Maxipime monotherapy in these patients.

  • Bacterial meningitis

In order to determine possible causes, culture and antibiogram should be done whenever possible. Empirical treatment with Maxipime can be started before the results of these tests were obtained, however, once obtained, antibiotic treatment should be adjusted accordingly. Because of its broad bactericidal activity against gram positive and gram negative microorganisms Maxipime may be used as a single agent, and before identifying the agent.

In patients with a high risk of combined aerobic-anaerobic infection, especially if the present bacteria is not sensitive to the Maxipime, it is recommended that the initial treatment start simultaneously with the anti-anaerobic medicines and before known the possible causes. When results become available, combination treatment with Maxipime and with other antibiotics may not be necessary. You must follow official recommendations for the appropriate use of antibacterial medicines.

Dosage and administration

Dosage and route of administration vary depending on the type and severity of infection, the sensitivity of causes of infection, renal function and general condition of the patient.

It can be administered intravenously (dose of Maxipime 500 mg, 1 g and 2 g) IV slow injection for a period of 3-5 minutes, or short-term infusion (over 30 minutes), or in a deep intramuscular injection of great muscle (the dose of 500 mg and 1 g).

Adults and children over 12 years (body weight greater than 40 kg): Recommendations for dosage in adults and children, body weight greater than 40 kg with normal renal function are listed in the following table:

Type of infection The dose, and the route of administration The frequency of administration
Urinary tract infection (mild to moderate intensity)

500 mg - 1 g

i.v. ili i.m.

Every 12 hours
Other infections to mild medium intensity

1 g

iv. ili i.m.

Every 12 hours
Severe infections

2 g

i.v.

Every 12 hours
Very serious or life-threatening infections

2 g

i.v.

Every 8 hours

The duration of treatment is typically 7 to 10 days. Severe infections may require longer treatment. Empiric treatment of febrile episodes in patients with neutropenia usually takes 7 days, or until the neutropenia withdraws.

Prevention of surgical procedures: For the prevention of infection in intra-abdominal surgical procedures recommended single dose of 2 g Maxipime as a 30 minute infusion of 60 minutes prior to surgery. Immediately afterwards should be given a single dose of metronidazole 500 mg i.v. Due to incompatibilities Maxipime and metronidazole should not be mixed in the same container; recommended wash intravenous line with a compatible liquid prior to injection of metronidazole. If the surgery takes longer than 12 hours, a second dose of Maxipime and metronidazole should be given 12 hours after preventive initial dose.

Experience of application of Maxipime in children younger than 2 months is limited. Based on the pharmacokinetic model to the data in children older than 2 months is recommended for children aged 1-2 months to apply a dose of 30 mg/kg once every 12, or every 8 hours. A dose of 50 mg/kg for children older than 2 months and the dose of 30 mg/kg for children aged 1-2 months are comparable to a dose of 2 g in adults. These patients should be carefully monitored during the application of Maxipime. Of body weight for children over 40 kg, the dosage is as recommended in adults.

The dose administered to children should not surpass the maximum recommended daily dose in adults (2 g every 8 hours). Experience with intramuscular Maxipime in children is limited. Limited data on the absorption intramuscularly administered Maxipime in children.

Elderly: No dose adjustment is required, in addition to the case of damage to the kidney function.

Disorder of renal function in the adult: Maxipime is excreted through the kidneys, almost exclusively by glomerular filtration. Therefore, in patients with renal impairment (GFR Preferred maintenance doses in adults with impaired kidney function) are listed in the table:

Patients on hemodialysis: Approximately 68% of the total amount of Maxipime present in the body will be extracted during a 3 hour dialysis. Maxipime pharmacokinetic properties show that the reduction in dose in these patients is necessary.

Patients on haemodialysis is necessary to first day of treatment provide an initial dose of 1 g of Maxipime, and then 500 mg of daily for all infections except febrile neutropenia, which is administered at 1 g per day. On the day of dialysis the dose of Maxipime should be applied after dialysis. If possible, Maxipime be administered every day, at the same time. In patients on continuous ambulatory peritoneal dialysis Maxipime may be administered in doses recommended for patients with normal renal function, but at intervals of every 48 hours.

Warning and precautions

Do not use this medicine if:

  • You have a hypersensitivity to ceftazidime or a cephalosporin antibiotics such as:
    • cefaclor (Raniclor),
    • cefadroxil (Duricef),
    • cefazolin (Ancef),
    • cefdinir (Omnicef),
    • cefditoren (Spectracef),
    • cefpodoxime (Vantin),
    • cefprozil (Cefzil),
    • cefuroxime (Ceftin),
    • cephalexin (Keflex),
    • cephradine (Velosef).
  • Serious hypersensitivity reactions (e.g. anaphylactic reactions) on any beta-lactam antibiotics (penicillins, monobactams or carbapenems) in history.

Antibiotics and other medicines are in any patient who has already had a hypersensitivity reaction should used with caution. As with other beta-lactam antibiotics, before administering cephalosporins should determine whether the patient ever had a reaction of hypersensitivity to Maxipime, other cephalosporins, penicillin or other medicines.

Since the 5%-10 % of cases occur cross- hypersensitivity between cephalosporins and penicillin, extreme caution is required when Maxipime is administered to patients with known hypersensitivity to penicillin. In case of an allergic reaction to Maxipime, treatment must be discontinued and pursue other proper medication. Severe allergic reactions require immediate treatment.

During the postmarketing period in patients have been reported following serious side effects: reversible encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures (including a non-convulsive status epilepticus), and/or renal failure. In most cases this was a patient with impaired renal function receiving the over of recommended doses. The symptoms of neurotoxicity is typically withdrawn after discontinuation of the medicine and/or dialysis, but some cases had a fatal outcome.

Diarrhea associated with Clostridium difficile was observed in the application of nearly all antibiotics, including Maxipime, and may vary according to the severity from mild diarrhea to pseudomembranous colitis, a life-threatening. Therefore, in patients who during or after the administration of Maxipime have diarrhea, not to forget the colitis as a possible cause of pseudomembranous colitis.In that case you should immediately discontinue treatment with Maxipime and start using the appropriate specific antibiotics against Clostridium difficile.

Do not use medicines who can inhibit peristalsis. In patients with impaired renal function (creatinine clearance that may compromise renal function), a dose of Maxipime should be adjusted to compensate slow-renal elimination of the medicine. Since the application of the usual dose of the medicine can lead to high medicine concentration and prolonged retention in the bloodstream of these patients must reduce the maintenance dose. Further dosage depends on the degree of renal function disorder, the severity of the infection and the sensitivity of the causal microorganisms.

You must carefully monitor renal function in the simultaneous treatment of nephrotoxic medicines such as aminoglycosides or strong diuretics. As well as other antibiotics, Maxipime may lead to excessive growth of microorganisms insensitive. In case of superinfection during the therapy, appropriate measures should be taken. Particular care is necessary to monitor patients with allergies (especially those on medication), patients with bronchial asthma, urticaria and seasonal allergic rhinitis.

Elderly patients: From 6400 adult patients involved in clinical trials, 35 % were older than 65 years, and 16% older than 75 years. Safety and efficacy in elderly patients with normal renal function who are receive the usual adult dose was comparable to the younger adult patients. In these patients its not necessary to adjust the dose. However, since renal function weakens with age, dosage should be adjusted according to the degree of renal function in patients. In elderly patients with impaired renal function with Maxipime dose is not adjusted, they performed serious side effects, including reversible encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures (including a non-convulsive status epilepticus), and/or renal failure.

Use with other medicines (Interactions)

In rare cases during treatment with Maxipime recorded positive Coombs test. In tests on glycosuria may be obtained, false positive results, it is therefore recommended to apply methods with glucose oxidase. You must carefully monitor renal function in patients with Maxipime when is administered with medicines that have nephrotoxic potential, such as aminoglycosides and strong diuretics.

Pregnancy and lactation

Maxipime should be administered during pregnancy only if the anticipated benefit of treatment outweighs the potential risks of application. Maxipime in very small amounts excreted in breast milk. Breast-feeding should be avoided during treatment with Maxipime.

Side effects

Adverse reactions are categorized by system organ class and frequency of occurrence, such as:

  1. Very common (>= 1/10),
  2. common (>= 1/100 to 1/10),
  3. uncommon (>= 1/1000 of and 1/100),
  4. rare (>= 1/10.000 to 1/1000),
  5. very rare (1/10.000)
  6. and not known (can not be estimated from available data). Within the same category incidence of side effects listed from serious to lighter.

Very common side effects (occurring in more than 1 of the 10 patients):

  • A positive Coombs test result.

Common adverse reactions (occurring within 10 to 1 in 100 patients):

  • Blood disorders, including anemia, elevated eosinophil count (subspecies of white blood cells), and prolonged bleeding time.
  • Pain, itching, redness or inflammation at the injection site.
  • Inflammation of the vein at the injection site, with the possible occurrence of a blood clot.
  • Diarrhea,
  • Rash,
  • Changed the results of blood tests that check liver function (bilirubin, AST, ALT, AF).

Maxipime may affect your laboratory tests results.

Less frequent adverse reactions (occurring within 1 to 10 per 1000 patients):

  • Oral candidiasis (thrush), vaginal candidiasis.
  • Blood disorder, including decreased number of white blood cells and platelets, which increases the risk of infection or hemorrhage.
  • Headache
  • Nausea, vomiting and inflammatory bowel disease called pseudomembranous colitis (colitis or related with the use of antibiotics), which causes long-term watery diarrhea with cramping abdominal pain, and fever.
  • Itching, hives, redness of the skin
  • Fever
  • Changed results of blood tests that check kidney function (elevated urea and creatinine in the blood).

Rare side effects (occurring in less than 1 to 10 patients in 10,000 patients):

  • Thrush (candidiasis).
  • Severe allergic reaction which causes difficulty in breathing and low blood pressure.
  • Dizziness, convulsions (involuntary muscle movements).
  • Abnormal sensations (tingling, burning, pricking or tingling).
  • Bad taste in the mouth.
  • Abdominal pain, constipation.
  • Vasodilatation (spreading of blood vessels as a result of relaxation of smooth muscles of their thickness).
  • Dyspnoea (difficulty in breathing with the uncomfortable feeling of fatigue of the respiratory muscles).
  • Itching of the genital organs.
  • Chills.

Side effects of unknown frequency (frequency can not be estimated from the available data):

  • Infections resistant organisms (superinfection), excessive growth of microorganisms that not sensitive to Maxipime.
  • Disorders of the blood picture, including a reduced number of, or damage to the red blood cells, which leads to severe anemia and weakness.
  • A severe allergic reaction (anaphylactic shock).
  • A false positive result of the test for the determination of glucose in urine.
  • Confusion, hallucinations.
  • Coma, stupor (stupor in the absence of psychomotor activity and reaction in full consciousness), encephalopathy (any kind of brain disease or disorder that interferes with personality and neurological symptoms), altered state of consciousness, convulsions or involuntary muscle movements.
  • Bleeding.
  • Kidney failure, kidney damage (nephropathy toxic).
  • Red spots on the skin (erythema multiforme), severe skin rash with bubbles (Stevens-Johnson syndrome) or severe rash with redness, peeling and swelling of the skin as well as in severe burns (toxic epidermal necrolysis).