Maxipime Side Effects

Generic Name: cefepime

Please note - some side effects for Maxipime may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Maxipime - for the Consumer

Maxipime

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Maxipime:

Diarrhea; headache; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; confusion; decreased urination; fever; hallucinations; hoarseness; loss of consciousness; mental/mood change; muscle twitching; pain, redness, or swelling at the injection site; red, swollen, or blistered skin; seizures; severe diarrhea; severe nausea or vomiting; stomach pain/cramps; unusual bruising or bleeding; unusual tiredness; vaginal irritation or discharge; white patches in the mouth; yellowing of the skin or eyes.

Maxipime Side Effects - for the Professional

Maxipime

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).

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.

A similar safety profile was seen in clinical trials of pediatric patients.

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.

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.

Side Effects by Body System

General

Cefepime is generally well tolerated. It has been reported that 1.5% of patients discontinued medication due to adverse events.

Hypersensitivity

Hypersensitivity reactions have included anaphylaxis, including anaphylactic shock, rash, and pruritus. Acute hypersensitivity myocarditis has been reported. Cephalosporin class antibiotics have been associated with allergic reactions, Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis.

The incidence of discontinuation because of rash has been reported to increase with higher recommended doses.

Anaphylactic reactions are rare, but may occur, especially in patients with a history of penicillin allergy.

Local

Local side effects associated with the administration of cefepime have included phlebitis (1.3%) after intravenous injection, and pain or inflammation (0.6%) after intramuscular injection. Infusion site reaction has also been reported.

Gastrointestinal

Gastrointestinal side effects have included colitis (including pseudomembranous colitis), diarrhea, nausea, vomiting, and oral moniliasis 0.1% to 1% of patients. Abdominal pain, anorexia, stomatitis, and Clostridium difficile-associated diarrhea have also been reported.

If diarrhea occurs which is unresponsive to discontinuation of cefepime and/or standard therapy, pseudomembranous colitis should be considered.

Higher doses (2 grams every 8 hours) have been associated with a greater incidence of side effects, including diarrhea (3%), nausea (2%), and vomiting (1%).

Nervous system

Neurological side effects have included headaches (0.1 to 1%). Encephalopathy (confusion, hallucinations, stupor, and coma), myoclonus, seizures, and nonconvulsive status epilepticus have been reported, mostly in patients receiving higher than recommended dosages. Somnolence has also been reported.

Case reports of seizure activity, with and without convulsions, associated with cefepime have been published in the medical literature. In the vast majority of cases, the patient involved had a clinically significant degree of renal dysfunction. In each case, seizure activity abated upon the discontinuation of cefepime.

Higher doses (2 grams every 8 hours) have been associated with a greater incidence of headache (1%).

A 66-year-old female developed acute renal failure, altered level of consciousness (Glasgow Coma Scale 6), and nonconvulsive status epilepticus after 10 days of cefepime 2 g every 8 hours. Symptoms resolved and she completely recovered 72 hours after discontinuation of cefepime.

Hematologic

Hematological side effects have included transient leukopenia, neutropenia, agranulocytosis, and thrombocytopenia. Cephalosporins as a class have been associated with aplastic anemia, hemolytic anemia, prolonged prothrombin time, hemorrhage, and pancytopenia. Epistaxis has also been reported.

Hepatic

Hepatic side effects associated with cephalosporins as a class have included hepatic dysfunction including cholestasis.

Renal

Renal side effects have included renal failure, mostly in patients with renal impairment who received higher than recommended doses of cefepime. Cephalosporins as a class have been associated with renal dysfunction and toxic nephropathy.

Dermatologic

Higher doses (2 grams every 8 hours) have been associated with a higher incidence of rash (4%) and pruritus (1%).

Dermatologic side effects have included rash (1.1%), urticaria (0.1% to 1%), and pruritus (0.1% to 1%).

Genitourinary

Genitourinary side effects have included vaginitis (0.1% to 1%).

Other

Fever has been reported in 0.1% to 1% of patients.

Higher doses (2 grams every 8 hours) have been associated with a greater incidence of fever (1%).

Metabolic

Metabolic side effects have included hypokalemia, hypomagnesemia, and hypophosphatemia.

Respiratory

Respiratory side effects have included cough and dyspnea.

Cardiovascular

Cardiovascular side effects have included tachycardia.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.