Maxipime Side Effects

Generic name: cefepime

Note: This document contains side effect information about cefepime. Some of the dosage forms listed on this page may not apply to the brand name Maxipime.

Some side effects of Maxipime may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to cefepime: injectable powder for injection, injectable solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking cefepime (the active ingredient contained in Maxipime) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• confusion, hallucinations, or seizure (black-out or convulsions);

• diarrhea that is watery or bloody;

• skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

• fever, chills, body aches, flu symptoms;

• easy bruising or bleeding, unusual weakness; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of cefepime may include:

• pain, swelling, or skin rash where the injection was given;

• stomach pain, nausea, vomiting;

• headache;

• skin rash or itching;

• white patches or sores inside your mouth or on your lips; or

• vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to cefepime: injectable powder for injection, injectable solution

General

Cefepime (the active ingredient contained in Maxipime) is generally well tolerated. It has been reported that 1.5% of patients discontinued medication due to adverse events.

Gastrointestinal

If diarrhea occurs which is unresponsive to discontinuation of cefepime (the active ingredient contained in Maxipime) 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%).

Uncommon (0.1% to 1%): Colitis (including pseudomembranous colitis), diarrhea, nausea, vomiting, oral moniliasis
Frequency not reported: Abdominal pain, anorexia, stomatitis, Clostridium difficile associated diarrhea

Local

Local reactions (3%), including phlebitis (1.3%) and pain and/or inflammation (0.6%), have been reported irrespective to cefepime (the active ingredient contained in Maxipime) in patients who received intravenous infusion.

Common (1% to 10%): Local reactions (3%)
Uncommon (0.1% to 1%): Phlebitis (1.3%), pain and/or inflammation (0.6%)
Frequency not reported: Infusion site reaction

Nervous system

Uncommon (0.1% to 1%): Headache
Frequency not reported: Somnolence
Postmarketing reports: Neurotoxicity, encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, coma), myoclonus, seizures, nonconvulsive status epilepticus

Encephalopathy, myoclonus, seizures, and nonconvulsive status epilepticus have been reported. Although most cases occurred in patients with renal impairment who received higher than recommended doses of cefepime, some cases of neurotoxicity occurred in patients receiving an appropriate dosage for their degree of renal impairment. In the majority of cases, symptoms of neurotoxicity were reversible and resolved after discontinuation of cefepime and/or after hemodialysis.

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 side effects, including 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.

Dermatologic

Common (1% to 10%): Rash (1.1%)
Uncommon (0.1% to 1%): Urticaria, pruritus, erythema
Rare (less than 0.1%): Red man syndrome (at least 1 case)
Frequency not reported: Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis

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

Cephalosporin class antibiotics have been associated with Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis.

Hematologic

Cephalosporins as a class have been associated with aplastic anemia, hemolytic anemia, prolonged prothrombin time, hemorrhage, and pancytopenia.

Very common (10% or more): Positive Coombs' test (without hemolysis; 16.2%)
Common (1% to 10%): Increased eosinophils (1.7%), abnormal PTT (1.6%), abnormal PT (1.4%)
Uncommon (0.1% to 1%): Decreased hematocrit, decreased neutrophils, decreased platelets, decreased white blood cells, anemia
Frequency not reported: Epistaxis, aplastic anemia, hemolytic anemia, prolonged prothrombin time, hemorrhage, pancytopenia

Hypersensitivity

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

Cephalosporin class antibiotics have been associated with allergic reactions.

Frequency not reported: Acute hypersensitivity myocarditis, allergic reactions
Postmarketing reports: Anaphylaxis (including anaphylactic shock, transient leukopenia, neutropenia, agranulocytosis, thrombocytopenia)

Hepatic

Cephalosporins as a class have been associated with hepatic dysfunction including cholestasis.

Common (1% to 10%): Increased ALT (2.8%), increased AST (2.4%)
Uncommon (0.1% to 1%): Increased alkaline phosphatase, increased total bilirubin
Frequency not reported: Hepatic dysfunction including cholestasis

Metabolic

Hypocalcemia was more common among elderly patients. Clinical consequences from changes in either calcium or phosphorus were not reported.

Common (1% to 10%): Decreased phosphorus (2.8%)
Uncommon (0.1% to 1%): Decreased calcium, increased calcium, increased phosphorus, increased potassium
Frequency not reported: Hypokalemia, hypomagnesemia

Other

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

Uncommon (0.1% to 1%): Fever

Renal

Renal failure, mostly in patients with renal impairment who received higher than recommended doses of cefepime (the active ingredient contained in Maxipime) has been reported.

Cephalosporins as a class have been associated with renal dysfunction and toxic nephropathy.

Uncommon (0.1% to 1%): Increased BUN, increased creatinine
Frequency not reported: Renal failure, renal dysfunction, toxic nephropathy

Genitourinary

Uncommon (0.1% to 1%): Vaginitis

Respiratory

Frequency not reported: Cough, dyspnea

Cardiovascular

Frequency not reported: Tachycardia

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