Maxipime

What Is Maxipime?

Maxipime (cefepime hydrochloride) is a broad-spectrum cephalosporin antibiotic used to treat many kinds of bacterial infections, including severe or life-threatening forms.

What Are Side Effects of Maxipime?

Common side effects of Maxipime are:

• injection site reactions (pain, redness, swelling, soreness, or skin rash),
• stomach pain,
• nausea,
• vomiting,
• loss of appetite,
• diarrhea,
• headache,
• skin rash or itching,
• white patches or sores inside your mouth or on your lips, or
• vaginal itching or discharge.

Tell your doctor if you have serious side effects of Maxipime including:

• dark urine,
• easy bruising or bleeding,
• fast/pounding/irregular heartbeat,
• mental/mood changes (such as confusion, hallucinations, decreased alertness),
• seizures,
• jerking movements,
• unusual weakness, or
• yellowing eyes or skin.

Dosage for Maxipime

The dose of Maxipime is determined by a physician and is based on the type of infection and the patient's body weight.

What Drugs, Substances, or Supplements Interact with Maxipime?

Maxipime may interact with antibiotics, and diuretics (water pills). Tell your doctor all medications and supplements you use.

Maxipime During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant during treatment with Maxipime; it is not expected to be harmful to a fetus. Maxipime can pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Maxipime Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Maxipime Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
• confusion, hallucinations;
• trouble speaking, reading, or understanding the words of other people;
• seizure (blackout or convulsions);
• pale skin, easy bruising, unusual bleeding; or
• dark colored urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• nausea, vomiting, diarrhea;
• fever;
• headache;
• itching, rash; or
• abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Maxipime (Cefepime Hydrochloride for Injection)

 

Maxipime Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in the Warnings and Precautions section and below:

• Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
• Neurotoxicity [see WARNINGS AND PRECAUTIONS]
• Clostridioides difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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 reactions. 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 reactions was similar at daily doses of 500 mg, 1 g, and 2 g every 12 hours (0.8%, 1.1%, and 2%, respectively). However, the incidence of discontinuation due to rash increased with the higher recommended doses.

The following adverse reactions (Table 5) were identified in clinical trials conducted in North America (n=3125 cefepime-treated patients).

Table 5: Adverse Reactions in Cefepime Multiple-Dose Dosing Regimens Clinical Trials in North America>br />

Incidence equal to or greater than 1%	Local adverse reactions (3%), 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, erythema, fever, headache, nausea, oral moniliasis, pruritus, urticaria, vaginitis, vomiting, anemia

At the higher dose of 2 g every 8 hours, the incidence of adverse reactions 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 (Table 6) adverse laboratory changes, with cefepime, were seen during clinical trials conducted in North America.

Table 6: Adverse Laboratory Changes in Cefepime Multiple-Dose Dosing Regimens Clinical Trials in North America

Incidence equal to or greater than 1%	Positive Coombs’ test (without hemolysis) (16.2%); decreased phosphorus (2.8%); increased Alanine Transaminase (ALT) (2.8%), Aspartate Transaminase (AST) (2.4%), eosinophils (1.7%); abnormal PTT (1.6%), Prothrombin Time (PT) (1.4%)
Incidence less than 1% but greater than 0.1%	Increased alkaline phosphatase, Blood Urea Nitrogen (BUN), calcium, creatinine, phosphorus, potassium, total bilirubin; decreased calcium*, hematocrit, neutrophils, platelets, White Blood Cells (WBC)
* Hypocalcemia was more common among elderly patients. Clinical consequences from changes in either calcium or phosphorus were not reported.

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

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of MAXIPIME. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In addition to the adverse reactions reported during the North American clinical trials with cefepime, the following adverse reactions have been reported during worldwide postmarketing experience. Encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), aphasia, myoclonus, seizures, and nonconvulsive status epilepticus have been reported [see WARNINGS AND PRECAUTIONS].

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 antibacterial drugs:

Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, hepatic dysfunction including choestasis, and pancytopenia.

DRUG INTERACTIONS

Drug/Laboratory Test Interactions

The administration of cefepime may result in a false-positive reaction for glucose in the urine with certain methods. It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.

Aminoglycosides

Monitor renal function if aminoglycosides are to be administered with MAXIPIME because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs.

Diuretics

Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide. Monitor renal function when cefepime is concomitantly administered with potent diuretics.

Read the entire FDA prescribing information for Maxipime (Cefepime Hydrochloride for Injection)