Ceficard 2000 Injection

Cefepime for Injection is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible strains of the designated microorganisms: • Pneumonia. ( 1.1 ) • Empiric therapy for febrile neutropenic patients. ( 1.2 ) • Uncomplicated and complicated urinary tract infections (including pyelonephritis). ( 1.3 ) • Uncomplicated skin and skin structure infections. ( 1.4 ) • Complicated intra-abdominal infections (used in combination with metronidazole) in adults. …

• § For Pseudomonas aeruginosa , use 2 g IV every 8 hours. *Or until resolution of neutropenia. **Intramuscular route of administration is indicated only for mild to moderate, uncomplicated or complicated UTIs due to E. coli
• Recommended Dosage
• Adults with Creatinine Clearance (CrCL) Greater Than 60 mL/min Site and Type of Infection Dose Frequency Duration (days) Moderate to Severe Pneumonia § 1-2 g IV Every 8-12 hours 10 Empiric Therapy for Febrile Neutropenic Patients 2 g IV Every 8 hours 7* Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections 0.5-1 g IV/IM** Every 12 hours 7-10 Severe Uncomplicated or Complicated Urinary Tract Infections 2 g IV Every 12 hours 10 Moderate to Severe Uncomplicated Skin and Skin Structure Infections 2 g IV Every 12 hours 10 Complicated Intra-abdominal Infections § (used in combination with metronidazole) 2 g IV Every 12 hours 7-10
• Pediatric Patients (2 months to 16 years) Recommended dosage
• In pediatric with CrCL greater than 60 mL/min. • The usual recommended dosage
• Pediatric patients is 50 mg per kg per dose administered every 12 hours (every 8 hours for febrile neutropenia). • Patients with Renal Impairment: Adjust dose in patients with CrCL less than or equal to 60 mL/min
• Dosage for
• Adults The recommended adult dosages and routes of administration are outlined in Table 1 below for patients with creatinine clearance greater than 60 mL/min
• Administer Cefepime for Injection intravenously over approximately 30 minutes. …

Cefepime for Injection, USP is a sterile white to pale yellow powder of cefepime in single-dose vials for reconstitution and it is available in the following strengths: • 0.5 gram per vial • 1 gram per vial • 2 grams per vial Cefepime for Injection, USP is a sterile powder of cefepime in single-dose vials for reconstitution, available in the following strengths: •0.5 gram per vial, 1 gram per vial …

• The safety and effectiveness of cefepime in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, pneumonia, and as empiric therapy for febrile neutropenic patients have been established in the age groups 2 months up to 16 years
• Use of Cefepime for Injection in these age groups is supported by evidence from adequate and well-controlled studies of cefepime
• Adults with additional pharmacokinetic and safety data from pediatric trials [ see Clinical Pharmacology ]. …

Of the more than 6400 adults treated with Cefepime for Injection in clinical studies, 35% were 65 years or older while 16% were 75 years or older. When geriatric patients received the usual recommended adult dose, clinical efficacy and safety were comparable to clinical efficacy and safety in non-geriatric adult patients. …

• Counsel patients that antibacterial drugs including Cefepime for Injection should only be used to treat bacterial infections
• They do not treat viral infections (e.g., the common cold)
• When Cefepime for Injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed
• Skipping doses or not completing the full course of therapy may decrease the effectiveness of the immediate treatment and increase the likelihood that bacteria will develop resistance and will not be treatable by Cefepime for Injection or other antibacterial drugs in the future. …

• Cefepime for Injection is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibacterial drugs, penicillins or other beta-lactam antibacterial drugs
• Patients with known immediate hypersensitivity reactions to cefepime or other cephalosporins, penicillins or other beta-lactam antibacterial drugs

• Aminoglycosides: increased potential of nephrotoxicity and ototoxicity. Monitor renal function. ( 7.2 ) • Diuretics: nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide. Monitor renal function. ( 7.3 ) 7.1 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. …

• Hypersensitivity Reactions: Cross-hypersensitivity among beta-lactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Cefepime for Injection occurs, discontinue the drug. ( 5.1 ) • Neurotoxicity: May occur especially in patients with renal impairment administered unadjusted doses. If neurotoxicity associated with Cefepime for Injection therapy occurs, discontinue the drug. ( 5.2 ) • Clostridioides difficile -Associated Diarrhea (CDAD): Evaluate if diarrhea occurs. …

The following adverse reactions are discussed in the Warnings and Precautions section and below: • Hypersensitivity Reactions [ see Warnings and Precautions (5.1) ] • Neurotoxicity [ see Warnings and Precautions (5.2) ] • Clostridioides difficile -Associated Diarrhea [ see Warnings and Precautions (5.3) ] •The most common adverse reactions (incidence ≥ 1%) were local reactions, positive Coombs’ test, decreased phosphorous, increased ALT and AST, increased PT and PTT and rash. ( 6.1 ) •At the highest dose (2 g every 8 hours), incidence of adverse reactions was ≥1% for rash, diarrhea, nausea, vomiting, pruritis, fever, and headache. …

8.1 Pregnancy Risk Summary There are no cases of Cefepime for Injection exposure during pregnancy reported from postmarketing experience or from clinical trials. Available data from published observational studies and case reports over several decades with cephalosporin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes ( see Data ). …

Patients who receive an overdose should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis, not peritoneal dialysis, is recommended to aid in the removal of cefepime from the body. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, neuromuscular excitability and nonconvulsive status epilepticus [ see Warnings and Precautions (5.2) , Adverse Reactions (6.2) , Dosage and Administration (2.3) ].

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.