ADVERSE REACTIONS
Clinical Trials
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials using multiple doses of cefepime, 4137 patients were treated with the recommended dosages of cefepime (500 mg to 2 g intravenous every 12 hours). There were no deaths or permanent disabilities thought related to drug toxicity. Sixty-four (1.5%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. Thirty-three (51%) of these 64 patients who discontinued therapy did so because of rash. The percentage of cefepime-treated patients who discontinued study drug because of drug-related adverse events was very similar at daily doses of 500 mg, 1 g, and 2 g every 12 hours (0.8%, 1.1%, and 2.0%, respectively). However, the incidence of discontinuation due to rash increased with the higher recommended doses.
The following adverse events were thought to be probably related to cefepime during evaluation of the drug in clinical trials conducted in North America (n=3125 cefepime-treated patients).
Table 10: Adverse Reactions Cefepime Multiple-Dose Dosing Regimens Clinical Trials—North America | * Local reactions, irrespective of relationship to cefepime in those patients who received intravenous infusion (n=3048). |
| INCIDENCE EQUAL TO OR GREATER THAN 1% | Local reactions (3.0%), including phlebitis (1.3%), pain and/or inflammation (0.6%)*; rash (1.1%) |
INCIDENCE LESS THAN 1% BUT GREATER
THAN 0.1% | Colitis (including pseudomembranous colitis), diarrhea, fever, headache, nausea, oral moniliasis, pruritus, urticaria, vaginitis, vomiting |
At the higher dose of 2 g every 8 hours, the incidence of probably-related adverse events was higher among the 795 patients who received this dose of cefepime. They consisted of rash (4%), diarrhea (3%), nausea (2%), vomiting (1%), pruritus (1%), fever (1%), and headache (1%).
The following adverse laboratory changes, irrespective of relationship to therapy with cefepime, were seen during clinical trials conducted in North America.
Table 11: Adverse Laboratory Changes Cefepime Multiple-Dose Dosing Regimens Clinical Trials—North America | * Hypocalcemia was more common among elderly patients. Clinical consequences from changes in either calcium or phosphorus were not reported. |
| INCIDENCE EQUAL TO OR GREATER THAN 1% | Positive Coombs’ test (without hemolysis) (16.2%); decreased phosphorus (2.8%); increased ALT/SGPT (2.8%), AST/SGOT (2.4%), eosinophils (1.7%); abnormal PTT (1.6%), PT (1.4%) |
INCIDENCE LESS THAN 1% BUT GREATER
THAN 0.1% | Increased alkaline phosphatase, BUN, calcium, creatinine, phosphorus, potassium, total bilirubin; decreased calcium*, hematocrit, neutrophils, platelets, WBC |
A similar safety profile was seen in clinical trials of pediatric patients (see PRECAUTIONS: Pediatric Use).
Postmarketing Experience
In addition to the events reported during North American clinical trials with cefepime, the following adverse experiences have been reported during worldwide postmarketing experience.
As with some other drugs in this class, encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, and seizures have been reported. Although most cases occurred in patients with renal impairment who received doses of cefepime that exceeded the recommended dosage schedules, some cases of encephalopathy occurred in patients receiving a dosage adjustment for their renal function. (See also WARNINGS.)
If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated. Precautions should be taken to adjust daily dosage in patients with renal insufficiency or other conditions that may compromise renal function to reduce antibiotic concentrations that can lead or contribute to these and other serious adverse events, including renal failure.
As with other cephalosporins, anaphylaxis including anaphylactic shock, transient leukopenia, neutropenia, agranulocytosis and thrombocytopenia have been reported.
Cephalosporin-Class Adverse Reactions
In addition to the adverse reactions listed above that have been observed in patients treated with cefepime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:
Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, hepatic dysfunction including cholestasis, and pancytopenia.
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO MAXIPIME
Below is a sample of reports where side effects / adverse reactions may be related to Maxipime. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Maxipime side effects / adverse reactions in 88 year old female
Reported by a physician from Switzerland on 2007-01-30
Patient: 88 year old female
Reactions: Encephalopathy, Somnolence
Suspect drug(s):
Maxipime
Other drugs received by patient: Nexium; Flagyl
Possible Maxipime side effects / adverse reactions in female
Reported by a health professional (non-physician/pharmacist) from Japan on 2007-02-05
Patient: female
Reactions: Anaphylactic Shock
Adverse event resulted in: death
Suspect drug(s):
Maxipime
Possible Maxipime side effects / adverse reactions in female
Reported by a health professional (non-physician/pharmacist) from Japan on 2007-02-06
Patient: female
Reactions: Cardio-Respiratory Arrest, Anaphylactic Shock
Adverse event resulted in: death
Suspect drug(s):
Maxipime
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