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Brofoxin

Brofoxin

cefoxitin

Manufacturer:

Union Korea Pharm

Distributor:

JustRight Healthcare
Full Prescribing Info
Contents
Cefoxitin sodium.
Description
White to slightly yellow crystalline powder in a vial.
Action
Pharmacological Classification: Antibacterial.
Pharmacology: Mechanism of Action: Cefoxitin is a cephamycin antibacterial which, like the other beta lactams, is bactericidal and is considered to act through the inhibition of bacterial cell wall synthesis. It has a similar spectrum of activity to cefamandole but is more active against anaerobic bacteria, especially Bacteroides fragilis. Cefoxitin can induce the production of beta-lactamases by some bacteria, and use of cefoxitin with other beta lactams have been shown to be antagonistic in vitro. Cefoxitin itself is considered to be resistant to a wide range of beta-lactamases, including those produced by Bacteroides spp. However, acquired resistance to cefoxitin has been reported in B. fragilis and has been attributed to beta-lactamase as well as to alterations in penicillin-binding proteins or to outer membrane proteins; there may be cross-resistance to other antibacterials.
Pharmacokinetics: Absorption: Not absorbed from the gastrointestinal tract; given parenterally as sodium salt.
Administration: Intramuscular (IM) injection: After 1 g, peak plasma concentration up to 30 μg/mL at 20-30 minutes.
Intravenous (IV) administration: 1 g over 3 minutes: 125 μg/mL, 1 g over 30 minutes: 72 μg/mL, 1 g over 120 minutes: 25 μg/mL.
Distribution: About 70% bound to plasma proteins.
Plasma half-life: 45-60 minutes (prolonged in renal impairment).
Widely distributed in the body.
Little penetration into CSF, even with inflamed meninges.
Crosses the placenta and detected in breast milk.
High concentrations in bile.
Metabolism: Majority excreted unchanged by kidneys.
Up to 2% metabolized to descarbamylcefoxitin (virtually inactive).
Excretion: Excreted in urine by glomerular filtration and tubular secretion.
About 85% of dose recovered within 6 hours; slowed by probenecid.
Peak urine concentrations >3 mg/mL after 1 g IM dose.
Removed to some extent by hemodialysis.
Indications/Uses
It is used in the treatment and prophylaxis of anaerobic bacteria and mixed bacterial infections, especially intra-abdominal and pelvic infections. It included endometriosis (prophylaxis at cesarian section), pelvic inflammatory disease, and surgical infection (prophylaxis). It may also be used in the treatment of gonorrhea and urinary tract infections.
Dosage/Direction for Use
Dosage Forms: 1 g Powder for Injection (IM/IV).
Administration Routes: Given as sodium salt by deep intramuscular (IM) injection.
Slow intravenous (IV) injection over 3 to 5 minutes.
Intermittent or continuous IV infusion.
Dosage Equivalents: 1.05 g of cefoxitin sodium ≈ 1 g of cefoxitin.
Usual Adult Dose: 1 or 2 g every 8 hours.
Severe infections: up to 12 g daily.
Pediatric Dosage: Neonates (up to 1 week old): 20-40 mg/kg every 12 hours.
Neonates (1 to 4 weeks old): 20-40 mg/kg every 8 hours.
Older infants and children: 20-40 mg/kg every 6 to 8 hours.
Severe infections: up to 200 mg/kg daily, maximum 12 g daily.
Specific Treatments: Uncomplicated UTI: 1 g IM twice daily.
Uncomplicated gonorrhea: Single dose of 2 g IM with 1 g oral probenecid.
Surgical infection prophylaxis: Adults: 2 g IM or IV 30-60 minutes before procedure, then every 6 hours for up to 24 hours.
Infants/children: 30-40 mg/kg at same intervals as adults.
Neonates: 30-40 mg/kg every 8 to 12 hours.
Cesarean section: Single 2 g IV dose after umbilical cord clamping; optional 3-dose regimen with further 2 g doses 4 and 8 hours later.
Renal Impairment Dosage Adjustments: In adults, after an initial loading dose of 1 to 2 g, maintenance doses are: Creatinine Clearance (CC) 30-50 mL/min: 1-2 g every 8-12 hours.
CC 10-29 mL/min: 1-2 g every 12-24 hours.
CC 5-9 mL/min: 0.5-1 g every 12-24 hours.
CC <5 mL/min: 0.5-1 g every 24-48 hours.
Hemodialysis patients: Repeat loading dose after each session.
Overdosage
No specific information available.
Cefoxitin has a half-life of 45 to 60 minutes with 70% plasma protein binding.
Parenteral doses are carefully controlled; no cases of overdosage recorded.
No antidote available.
Contraindications
Hypersensitivity: Contraindicated in patients with known hypersensitivity to cefoxitin or other cephalosporins.
Special Precautions
Renal Impairment: Use with caution; dosage reduction may be necessary.
Monitor renal and hematological status, especially during prolonged or high-dose therapy.
Interferes with the Jaffe method for measuring creatinine; may produce falsely high values.
Effects on Gastrointestinal Tract: Significant changes in anaerobic, facultative, and aerobic flora observed.
Use in Lactation: See Use in Pregnancy & Lactation section for further information.
Use In Pregnancy & Lactation
Lactation: Excreted in human milk; caution advised.
Adverse Reactions
Common Hypersensitivity Reactions: Skin rashes, urticaria, eosinophilia, fever, reactions resembling serum sickness, anaphylaxis.
Hematological Effects: Positive Coombs test (rare hemolytic anemia), neutropenia, thrombocytopenia (occasional), agranulocytosis (rarely with some cephalosporins), bleeding complications (related to hypoprothrombinemia and/or platelet dysfunction).
Drug Interactions
Probenecid: Reduces renal clearance of cefoxitin.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Cephalosporins
ATC Classification
J01DC01 - cefoxitin ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Form
Brofoxin powd for inj 1 g
Packing/Price
10's
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