Maxpime1 gm/vial

Established Indications

Maxpime is indicated for the treatment of the following infections caused by susceptible bacteria:

• Pneumonia: Moderate to severe pneumonia caused by susceptible organisms including Streptococcus pneumoniae, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Enterobacter species.
• Urinary tract infections: Uncomplicated and complicated urinary tract infections, including pyelonephritis.
• Uncomplicated skin and skin structure infections caused by susceptible Staphylococcus aureus (methicillin-susceptible) or Streptococcus pyogenes.

Requires Combination Therapy

Complicated intra-abdominal infections — Maxpime is indicated for this use only in combination with metronidazole; it is not adequate as monotherapy for this indication.

Guideline-Supported Use

Empiric therapy in febrile neutropenia — Maxpime may be used as empiric monotherapy in high-risk patients with febrile neutropenia, consistent with major infectious disease society guidance. The treating physician may add an additional agent (e.g., vancomycin) in specific situations such as suspected catheter-related infection, skin/soft-tissue infection, pneumonia, hemodynamic instability, or suspected resistant organisms.

Each vial contains Cefepime Hydrochloride equivalent to Cefepime 500 mg, 1 g, or 2 g, for reconstitution and injection.

Maxpime is an injectable antibiotic belonging to the fourth-generation cephalosporin class. It works by stopping the growth of a broad range of bacteria, including some strains that are resistant to older antibiotics. Maxpime is used in hospital settings to treat serious infections such as pneumonia, urinary tract infections, skin infections, and infections in people with a weakened immune system due to a low white blood cell count. It is given only by injection into a vein or muscle by a trained healthcare professional and is not available as a tablet or syrup. Maxpime does not treat viral infections such as the common cold or flu.

Antibiotic (4th-generation Cephalosporin)

Cefepime Hydrochloride is a bactericidal antibiotic that works by binding to penicillin-binding proteins and inhibiting bacterial cell wall synthesis, leading to bacterial cell death. It has activity against a broad range of gram-negative bacteria, including Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter species, and Proteus mirabilis, as well as certain gram-positive organisms such as methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, and Streptococcus pyogenes. Following administration, Cefepime Hydrochloride is eliminated primarily unchanged by the kidneys (approximately 85%), with a half-life of about 2 hours in patients with normal kidney function; this half-life is significantly prolonged in patients with renal impairment.

Maxpime is administered only by a doctor, nurse, or other trained healthcare professional in a hospital or clinical setting — it is not self-administered. For intravenous (IV) use, the reconstituted and, where needed, further-diluted solution is typically infused into a vein over approximately 30 minutes. For intramuscular (IM) use, it is injected directly into a large muscle, an option used for certain lower-severity infections. Patients should inform their healthcare team of any allergies, current medications, and kidney problems before each dose. Because Maxpime is prepared and given by trained staff, patients and caregivers do not need to measure or prepare the medicine themselves.

• Aminoglycoside antibiotics (e.g., gentamicin, amikacin): Concurrent use with Maxpime may increase the risk of kidney damage (nephrotoxicity) and hearing damage (ototoxicity); kidney function should be monitored closely.
• Potent diuretics (e.g., furosemide): Concomitant use of cephalosporin antibiotics, including Maxpime, with potent diuretics has been associated with reports of nephrotoxicity.
• Other nephrotoxic drugs: Combining Maxpime with other medicines that can affect the kidneys may increase the overall risk of kidney injury; renal function should be monitored.
• Laboratory tests: Maxpime may cause a false-positive result on certain urine glucose tests (non-enzymatic methods) and a positive direct Coombs' test, and may affect prothrombin time results; inform the laboratory that the patient is receiving Maxpime.

Common Side Effects

• Pain, redness, swelling, or inflammation of the vein at the injection site
• Skin rash
• Diarrhea, nausea, or vomiting
• Headache
• Fever
• Changes in some blood test results (e.g., liver enzymes, phosphorus level, clotting tests)

Serious Side Effects (Seek Medical Attention)

Seek immediate medical attention if any of the following occur while receiving Maxpime:

• Signs of a severe allergic reaction: difficulty breathing, swelling of the face/lips/throat, severe rash, or anaphylaxis
• Signs of a nervous system problem (neurotoxicity), including confusion, reduced alertness, hallucinations, unusual muscle jerking (myoclonus), or seizures — this risk is higher in patients with kidney impairment whose dose has not been adjusted (see Precautions and Warnings)
• Severe or persistent diarrhea, which may be watery or bloody and could indicate Clostridioides difficile-associated diarrhea/colitis; this can occur even weeks after the last dose
• Severe skin reactions such as blistering or peeling skin (possible Stevens-Johnson syndrome or toxic epidermal necrolysis)
• Unusual bleeding, bruising, or signs of a low blood cell count (e.g., unusual tiredness, frequent infections)
• Yellowing of the skin or eyes, or other signs of liver problems

Pregnancy

Published observational studies and case reports on cephalosporin antibiotics in pregnant women, accumulated over several decades, have not established that cephalosporin use is associated with an increased risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies with Maxpime have not shown evidence of embryotoxicity or fetal malformation. However, human data specific to Maxpime are limited, and it should be used during pregnancy only when clearly needed, as determined by the treating physician.

Breastfeeding

Maxpime passes into human breast milk in low concentrations (approximately 0.5 mcg/mL following a single 1000 mg intravenous dose), meaning a breastfeeding infant would receive only a small amount of the drug. The decision to use Maxpime while breastfeeding should weigh the benefits of breastfeeding against the mother's need for the medicine and any potential effects on the infant, in consultation with a healthcare professional.

• Neurotoxicity and encephalopathy in renal impairment: Serious adverse reactions, including life-threatening or fatal encephalopathy (confusion, hallucinations, stupor, or coma), aphasia, myoclonus, seizures, and nonconvulsive status epilepticus, have been reported with Maxpime, most often in patients with kidney impairment who did not receive an appropriately reduced dose. Some cases have occurred even when the dose was adjusted for kidney function. Kidney function should be assessed before and during treatment, with the dose adjusted accordingly; if neurotoxic symptoms occur, Maxpime should be discontinued or the dose adjusted, per the treating physician.
• Hypersensitivity reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported with cephalosporin antibiotics, including Maxpime. Cross-reactivity with penicillins and other beta-lactams may occur in up to 10% of patients with a history of penicillin allergy; use with caution in patients with any beta-lactam allergy history that does not meet the criteria for an absolute contraindication.
• Clostridioides difficile-associated diarrhea (CDAD): Maxpime, like nearly all antibacterial agents, can allow overgrowth of C. difficile, causing diarrhea or colitis ranging from mild to life-threatening; this should be considered in any patient who develops diarrhea during or after treatment.
• Use only for bacterial infections: Maxpime should be prescribed only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria; it does not treat viral infections such as colds or influenza. Unnecessary use increases the risk of drug-resistant bacteria.
• Prolonged use: Prolonged use of Maxpime may result in overgrowth of nonsusceptible organisms, including fungi; patients should be monitored during extended therapy.
• Bleeding risk: Maxpime may affect prothrombin time in some patients; monitor patients at risk of bleeding (e.g., those with renal or hepatic impairment, poor nutritional state, or on anticoagulant therapy).
• History of gastrointestinal disease: Use with caution in patients with a history of colitis or other gastrointestinal disease, given the risk of CDAD described above.

An overdose of Maxpime may cause encephalopathy (confusion, reduced consciousness), myoclonus (involuntary muscle jerking), seizures, and other neuromuscular excitability, particularly in patients with kidney impairment; these effects relate to the neurotoxicity described under Precautions and Warnings. In case of a suspected overdose, seek emergency medical attention or contact a poison control service immediately; do not attempt to induce vomiting unless specifically directed by a healthcare professional. There is no specific antidote; treatment is supportive. In patients with kidney failure, hemodialysis (not peritoneal dialysis) may help remove Maxpime from the body.

Store according to the product label. Unreconstituted Maxpime powder for injection is generally stored at controlled room temperature (20-25°C / 68-77°F) and protected from light, though patients and staff should always follow the specific storage instructions on the product packaging in use. Guidance on handling the reconstituted solution is provided in the Reconstitution section below.

Children

Maxpime is established for use in children 2 months to 16 years of age for pneumonia, urinary tract infections, uncomplicated skin infections, and empiric treatment of febrile neutropenia, using weight-based dosing that does not exceed the adult dose. Safety and effectiveness in infants younger than 2 months have not been established in the manufacturer's prescribing information; current pediatric infectious disease guidance should be consulted for use in this age group.

Elderly

Serious, including life-threatening or fatal, neurotoxic reactions (encephalopathy, myoclonus, seizures) have occurred in elderly patients with reduced kidney function who received unadjusted doses of Maxpime. Kidney function should be assessed in all elderly patients, with the dose adjusted for reduced creatinine clearance as needed (see Precautions and Warnings).

Renal Impairment

Because Maxpime is eliminated mainly by the kidneys, dose or dosing-interval adjustment is required in patients with creatinine clearance of 60 mL/min or less, including those on hemodialysis or continuous ambulatory peritoneal dialysis; this adjustment must be individualized by the treating physician.

Hepatic Impairment

No dose adjustment of Maxpime is considered necessary based on liver function alone.

Duration of treatment with Maxpime depends on the infection being treated and typically ranges from 7 to 10 days, as outlined in the dosing table above, though febrile neutropenia may be treated until neutropenia resolves. The treating physician determines the exact duration for each patient. Maxpime should be given exactly as prescribed; take exactly as prescribed — do not stop, extend, skip, or share this medicine without medical advice, even if symptoms improve before the course is finished.

Maxpime for injection is supplied as a powder that must be reconstituted with a compatible diluent (such as sterile water for injection, 0.9% sodium chloride injection, or 5% dextrose injection) before use, and for intravenous infusion the reconstituted solution is generally further diluted in a compatible IV fluid. This preparation is performed by a pharmacist, nurse, or other trained healthcare professional, using the diluent type and technique specified in the product's official prescribing information — patients and caregivers should never attempt to prepare or reconstitute this injection themselves. According to manufacturer prescribing information for this formulation, properly reconstituted solution may be used for a limited period when stored at room temperature or under refrigeration; the treating facility follows the specific stability time and storage conditions stated on the label of the product actually in use.

Cephalosporin antibiotic — fourth generation (parenteral/injectable)

Cefepime Hydrochloride is a bactericidal antibiotic. It binds to penicillin-binding proteins (PBPs) located in the bacterial cell wall, inhibiting the final cross-linking step of peptidoglycan synthesis. This disrupts the structural integrity of the bacterial cell wall, leading to cell lysis and death of susceptible bacteria.

Maxpime is approved for use in children 2 months through 16 years of age for the treatment of pneumonia, uncomplicated and complicated urinary tract infections, uncomplicated skin and skin structure infections, and empiric therapy of febrile neutropenia. The pediatric dose is generally 50 mg/kg per dose, given every 12 hours (every 8 hours for febrile neutropenia), and must never exceed the recommended adult dose. Data on use in infants younger than 2 months are limited, and use in this age group should follow current pediatric infectious disease guidance and specialist advice. As with adults, kidney function should be considered when dosing children, given the risk of neurotoxicity with inadequate dose adjustment (see Precautions and Warnings).