Cefepime
Generic Name: cefepime
Brand Names:
Cefepime
11 DESCRIPTION Cefepime Injection in Galaxy Container is a sterile, injectable product consisting of Cefepime Hydrochloride, USP, a semi-synthetic, broad spectrum, cephalosporin antibacterial for parenteral administration.
Overview
11 DESCRIPTION Cefepime Injection in Galaxy Container is a sterile, injectable product consisting of Cefepime Hydrochloride, USP, a semi-synthetic, broad spectrum, cephalosporin antibacterial for parenteral administration.
Uses
1 INDICATIONS AND USAGE Cefepime Injection is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: pneumonia ( 1.1 ); empiric therapy for febrile neutropenic patients ( 1.2 ); uncomplicated and complicated urinary tract infections ( 1.3 ); uncomplicated skin and skin structure infections ( 1.4 ); and complicated intra-abdominal infections (used in combination with metronidazole) ( 1.5 ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefepime Injection and other antibacterial drugs, Cefepime Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Dosage
2 DOSAGE AND ADMINISTRATION Recommended Dosage in Adults With Creatinine Clearance (CrCL) Greater Than 60 mL/min ( 2.1 ) Site and Type of Infection (Adults) Dose (IV) Frequency Duration (Days) Moderate to Severe Pneumonia For Pseudomonas aeruginosa , use 2 g IV every 8 hours ( 2.1 ) 1-2 g Every 8-12 hours 10 Empiric therapy for febrile neutropenic patients 2 g Every 8 hours 7 Or until resolution of neutropenia ( 2.1 ) Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections 0.5-1 g Every 12 hours 7-10 Severe Uncomplicated or Complicated Urinary Tract Infections 2 g Every 12 hours 10 Moderate to Severe Uncomplicated Skin and Skin Structure Infections 2 g Every 12 hours 10 Complicated Intra-abdominal Infections (used in combination with metronidazole) 2 g Every 8-12 hours 7-10...
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: • 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS • Aminoglycosides -- increased potential of nephrotoxicity and ototoxicity. ( 7.2 ) • Diuretics -- nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide. ( 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 [see Warning and Precautions (5.5)] . 7.2 Aminoglycosides Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Cefepime Injection because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs.
Warnings
5 WARNINGS AND PRECAUTIONS • 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 Injection occurs, discontinue the drug. ( 5.1 ) • Neurotoxicity: May occur especially in patients with renal impairment administered unadjusted doses. If neurotoxicity associated with Cefepime Injection therapy occurs, discontinue the drug. ( 5.2 ) • Clostridioides difficile Associated Diarrhea (CDAD): Evaluate if diarrhea occurs. 4 CONTRAINDICATIONS Cefepime Injection is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibacterials, penicillins or other beta-lactam antibacterial drugs. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.
Pregnancy
8.1 Pregnancy Risk summary There are no cases of cefepime 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 ). Cefepime was not associated with adverse developmental outcomes in rats, mice, or rabbits when administered parenterally during the period of organogenesis.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Cefepime Injection is supplied as a frozen, iso-osmotic, sterile, nonpyrogenic solution in 50 mL and 100 mL single-dose Galaxy Containers as follows: 1 g Based on cefepime activity in 50 mL Supplied 24/box NDC 0338-1301-41 2 g in 100 mL Supplied 12/box NDC 0338-1301-48 Store at or below –20°C (-4°F). Handle frozen product containers with care.
Frequently Asked Questions
What is Cefepime used for?▼
1 INDICATIONS AND USAGE Cefepime Injection is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: pneumonia ( 1.1 ); empiric therapy for febrile neutropenic patients ( 1.2 ); uncomplicated and complicated urinary tract infections ( 1.3 ); uncomplicated skin and skin structure infections ( 1.4 ); and complicated intra-abdominal infections (used in combination with metronidazole) ( 1.5 ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefepime Injection and other antibacterial drugs, Cefepime Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
What are the side effects of Cefepime?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: • 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Cefepime during pregnancy?▼
8.1 Pregnancy Risk summary There are no cases of cefepime 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 ). Cefepime was not associated with adverse developmental outcomes in rats, mice, or rabbits when administered parenterally during the period of organogenesis.
What are the important warnings for Cefepime?▼
5 WARNINGS AND PRECAUTIONS • 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 Injection occurs, discontinue the drug. ( 5.1 ) • Neurotoxicity: May occur especially in patients with renal impairment administered unadjusted doses. If neurotoxicity associated with Cefepime Injection therapy occurs, discontinue the drug. ( 5.2 ) • Clostridioides difficile Associated Diarrhea (CDAD): Evaluate if diarrhea occurs. 4 CONTRAINDICATIONS Cefepime Injection is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibacterials, penicillins or other beta-lactam antibacterial drugs. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.
Related Medications
Prednisolone Sodium Phosphate
prednisolone sodium phosphate
DESCRIPTION Prednisolone Sodium Phosphate Oral Solution (10 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (20 mg Prednisolone per 5 mL) and Prednisolone Sodium Phosphate Oral Solution (25 mg Prednisolone per 5 mL) are dye free, pale to light yellow solutions.
Ondansetron
ondansetron
Serotonin-3 Receptor Antagonist [EPC]
11 DESCRIPTION The active ingredient in ondansetron tablets USP is ondansetron hydrochloride USP as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT 3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl) methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The empirical formula is C 18 H 19 N 3 O•HCl•2H 2 O, representing a molecular weight of 365.85.
Pirenzepina Base Pura
pirenzepina base pura
Dosage form: POWDER. Active ingredients: PIRENZEPINE (25 kg/25kg). Category: BULK INGREDIENT.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.