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CEFEPIME FOR is a brand name for Cefepime, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 5 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Cefepime for injection is generally well tolerated. In clinical trials (N=5598) the most common adverse events were gastrointestinal symptoms and hypersensitivity reactions.
Adverse events considered to be of probable relationship to cefepime for injection are listed below. 1% were: abdominal pain, constipation, vasodilation, dyspnea, dizziness, paresthesia, genital pruritus, taste perversion, chills, unspecified moniliasis, vaginal moniliasis, urogenital infection, and vaginitis.
05% included anaphylaxis and seizures. At the higher dose of 2 g q8h in febrile neutropenia, the incidence of probably-related adverse events was higher among 1048 patients who received this dose of cefepime in clinical trials. They consisted of rash (4%), diarrhea (3%), nausea (2%), vomiting (1%), pruritis (1%), fever (1%), and headache (1%).
1%). 6% of patients experiencing pain or inflammation at the injection site. Laboratory test abnormalities that developed during clinical trials in patients with normal baseline values were transient. 7%) also occurred. 8%), increased calcium, decreased calcium (which was more common in elderly patients) and increased potassium were observed.
5% to 1% of patients. 5%). During post- marketing experience, agranulocytosis has been reported rarely. Renal insufficiency and hepatic failure have been reported in conjunction with cefepime treatment. However, a causative relationship to cefepime therapy has not been determined (see also Post Marketing Experience).
The following adverse events and altered laboratory tests have also been reported for cephalosporin-class antibiotics: Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, hepatic dysfunction including cholestasis, false positive test for urinary glucose, and pancytopenia.
Pediatric Patients A similar safety profile has been experienced in infants and children relative to the adult population. No specific concerns have been identified. Post Marketing Experience In addition to the events reported during North American clinical trials with cefepime, the following adverse experiences have been reported during worldwide post marketing experience.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Because of the uncontrolled nature of spontaneous reports, a causal relationship to cefepime for injection treatment has not been determined. As with some other drugs in this class, encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor and coma), seizures (including nonconvulsive status epilepticus), myoclonus, and/or renal failure have been reported.
Most cases occurred in patients with renal impairment who received doses of cefepime for injection that exceeded recommendations outlined in DOSAGE AND ADMINISTRATION. In general, symptoms of neurotoxicity resolved after discontinuation of cefepime and/or after hemodialysis however, some cases included a fatal outcome.
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.
DRUG INTERACTIONS The combination of cefepime with an aminoglycoside has been shown to be synergistic in vitro. Although there is no evidence that cefepime adversely affects renal function at normal therapeutic doses, the usual precautions, such as the monitoring of renal function, should be applied if drugs with nephrotoxic potential (such as aminoglycosides and potential diuretics) are administered with cefepime for injection.
Page 11 of 40 The administration of cefepime may result in a false-positive reaction for glucose in the urine when using a copper reduction test. It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.
DOSAGE AND ADMINISTRATION Cefepime for Injection, USP can be administered either intravenously or intramuscularly. The dosage and route of administration should be determined according to the susceptibility of the causative organisms, the severity of the infection, and the condition and renal function of the patient.
Guidelines for dosage of Cefepime for Injection, USP in adults with normal renal function are provided in […]