Mefoxin Information
Mefoxin (Cefoxitin sodium)
Mefoxin (Cefoxitin sodium) Description
Cefoxitin sodium is a semi-synthetic, broad-spectrum cepha antibiotic for intravenous administration. It is derived from cephamycin C, which is produced by . Its chemical name is sodium (6R,7S)-3-(hydroxymethyl)-7-methoxy-8-oxo-7-[2-(2-thienyl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate carbamate (ester). The empirical formula is CHNNaOS, and the molecular weight is 449.44. The structural formula is:
Cefoxitin sodium contains approximately 53.8 mg (2.3 milliequivalents) of sodium per gram of cefoxitin activity.
Premixed Intravenous Solution Mefoxin (Cefoxitin sodium) (Cefoxitin Injection) is supplied as a sterile, nonpyrogenic, frozen iso-osmotic solution of cefoxitin sodium. Each 50 mL contains Cefoxitin Sodium, USP equivalent to either 1 gram or 2 grams cefoxitin. Dextrose Hydrous, USP has been added to the above dosages to adjust osmolality (approximately 2 grams and 1.1 grams to 1 gram and 2 gram dosages, respectively). The pH is adjusted with sodium bicarbonate and may have been adjusted with hydrochloric acid. The pH is approximately 6.5. After thawing, the solution is intended for intravenous use only. Solutions of Mefoxin (Cefoxitin sodium) range from colorless to light amber.
The plastic container is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability and safety of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.
Mefoxin (Cefoxitin sodium) Clinical Pharmacology
Following an intravenous dose of 1 gram of cefoxitin, serum concentrations were 110 mcg/mL at 5 minutes, declining to less than 1 mcg/mL at 4 hours. The half-life after an intravenous dose is 41 to 59 minutes. Approximately 85 percent of cefoxitin is excreted unchanged by the kidneys over a 6-hour period, resulting in high urinary concentrations. Probenecid slows tubular excretion and produces higher serum levels and increases the duration of measurable serum concentrations.
Cefoxitin passes into pleural and joint fluids and is detectable in antibacterial concentrations in bile.
In a published study of geriatric patients ranging in age from 64 to 88 years with normal renal function for their age (creatinine clearance ranging from 31.5 to 174.0 mL/min), the half-life for cefoxitin ranged from 51 to 90 minutes, resulting in higher plasma concentrations than in younger adults. These changes were attributed to decreased renal function associated with the aging process.
The bactericidal action of cefoxitin results from inhibition of cell wall synthesis. Cefoxitin hasactivity against a wide range of gram-positive and gram-negative organisms. The methoxy group in the 7α position provides cefoxitin with a high degree of stability in the presence of beta-lactamases, both penicillinases and cephalosporinases, of gram-negative bacteria.
Cefoxitin has been shown to be active against most strains of the following microorganisms, bothand in clinical infections as described in thesection.
Mefoxin (Cefoxitin sodium) Indications And Usage
Mefoxin (Cefoxitin sodium) , supplied as a premixed solution in plastic containers, is intended for intravenous use only.
Mefoxin (Cefoxitin sodium) is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below.
Appropriate culture and susceptibility studies should be performed to determine the susceptibility of the causative organisms to Mefoxin (Cefoxitin sodium) . Therapy may be started while awaiting the results of these studies.
In randomized comparative studies, cefoxitin and cephalothin were comparably safe and effective in the management of infections caused by gram-positive cocci and gram-negative rods susceptible to the cephalosporins. Mefoxin (Cefoxitin sodium) has a high degree of stability in the presence of bacterial beta-lactamases, both penicillinases and cephalosporinases.
Many infections caused by aerobic and anaerobic gram-negative bacteria resistant to some cephalosporins respond to Mefoxin (Cefoxitin sodium) . Similarly, many infections caused by aerobic and anaerobic bacteria resistant to some penicillin antibiotics (ampicillin, carbenicillin, penicillin G) respond to treatment with Mefoxin (Cefoxitin sodium) . Many infections caused by mixtures of susceptible aerobic and anaerobic bacteria respond to treatment with Mefoxin (Cefoxitin sodium) .
Mefoxin (Cefoxitin sodium) is indicated for the prophylaxis of infection in patients undergoing uncontaminated gastrointestinal surgery, vaginal hysterectomy, abdominal hysterectomy, or cesarean section.
If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate treatment may be instituted.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Mefoxin (Cefoxitin sodium) and other antibacterial drugs, Mefoxin (Cefoxitin sodium) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Mefoxin (Cefoxitin sodium) Contraindications
Mefoxin (Cefoxitin sodium) is contraindicated in patients who have shown hypersensitivity to cefoxitin and the cephalosporin group of antibiotics.
Mefoxin (Cefoxitin sodium) Warnings
BEFORE THERAPY WITH 'Mefoxin (Cefoxitin sodium) ' IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFOXITIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN WITH CAUTION TO PENICILLIN-SENSITIVE PATIENTS. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS. IF AN ALLERGIC REACTION TO 'Mefoxin (Cefoxitin sodium) ' OCCURS, DISCONTINUE THE DRUG. SERIOUS HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES.
Hypertoxin producing strains ofcause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed againstmay need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of, and surgical evaluation should be instituted as clinically indicated.
Mefoxin (Cefoxitin sodium) Precautions
The total daily dose should be reduced when Mefoxin (Cefoxitin sodium) is administered to patients with transient or persistent reduction of urinary output due to renal insufficiency (see), because high and prolonged serum antibiotic concentrations can occur in such individuals from usual doses.
Antibiotics (including cephalosporins) should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
As with other antibiotics, prolonged use of Mefoxin (Cefoxitin sodium) may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Do not use unless solution is clear and seal is intact.
Prescribing Mefoxin (Cefoxitin sodium) in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Patients should be counseled that antibacterial drugs including Mefoxin (Cefoxitin sodium) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Mefoxin (Cefoxitin sodium) 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 (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Mefoxin (Cefoxitin sodium) or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics, which usually ends when the antibiotic is discontinued. Sometimes after starting the treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
As with cephalothin, high concentrations of cefoxitin (>100 micrograms/mL) may interfere with measurement of serum and urine creatinine levels by the Jaffé reaction, and produce false increases of modest degree in the levels of creatinine reported. Serum samples from patients treated with cefoxitin should not be analyzed for creatinine if withdrawn within 2 hours of drug administration.
High concentrations of cefoxitin in the urine may interfere with measurement of urinary 17–hydroxy-corticosteroids by the Porter-Silber reaction, and produce false increases of modest degree in the levels reported.
A false-positive reaction for glucose in the urine may occur. This has been observed with CLINITEST reagent tablets.
Safety and efficacy in pediatric patients from birth to three months of age have not yet been established. In pediatric patients three months of age and older, higher doses of cefoxitin have been associated with an increased incidence of eosinophilia and elevated SGOT.
The potential for toxic effects in pediatric patients from chemicals that may leach from the single-dose I.V. preparation in plastic has not been determined.
Of the 1,775 subjects who received cefoxitin in clinical studies, 424 (24%) were 65 and over, while 124 (7%) were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out (see).
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (seeand).
Mefoxin (Cefoxitin sodium) Adverse Reactions
Cefoxitin is generally well tolerated. The most common adverse reactions have been local reactions following intravenous injection. Other adverse reactions have been encountered infrequently.
Elevations in serum creatinine and/or blood urea nitrogen levels have been observed. As with the cephalosporins, acute renal failure has been reported rarely. The role of Mefoxin (Cefoxitin sodium) in changes in renal function tests is difficult to assess, since factors predisposing to prerenal azotemia or to impaired renal function usually have been present.
In addition to the adverse reactions listed above which have been observed in patients treated with Mefoxin (Cefoxitin sodium) , the following adverse reactions and altered laboratory test results have been reported for cephalosporin class antibiotics:
Urticaria, erythema multiforme, Stevens-Johnson syndrome, serum sickness-like reactions, abdominal pain, colitis, renal dysfunction, toxic nephropathy, false-positive test for urinary glucose, hepatic dysfunction including cholestasis, elevated bilirubin, aplastic anemia, hemorrhage, prolonged prothrombin time, pancytopenia, agranulocytosis, superinfection, vaginitis including vaginal candidiasis.
Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. (See.) If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
Mefoxin (Cefoxitin sodium) Overdosage
The acute intravenous LD in the adult female mouse and rabbit was about 8.0 g/kg and greater than 1.0 g/kg, respectively. The acute intraperitoneal LD in the adult rat was greater than 10.0 g/kg.
Mefoxin (Cefoxitin sodium) Dosage And Administration
NOTE: Mefoxin (Cefoxitin sodium) in Galaxy container is for intravenous infusion only.
Effective prophylactic use depends on the time of administration. Mefoxin (Cefoxitin sodium) usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.
For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:
This premixed solution is for intravenous use only
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The intravenous route is preferred for patients with bacteremia, bacterial septicemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.
Mefoxin (Cefoxitin sodium) , supplied as frozen, premixed, iso-osmotic solution in Galaxy containers (PL 2040 Plastic), maintains satisfactory potency after thawing for 24 hours at a room temperature of 25°C (77°F) or 21 days under refrigeration, 2-8°C (36-46°F). After these periods, any unused solutions should be discarded.
DO NOT REFREEZE.
Mefoxin (Cefoxitin sodium) How Supplied
Premixed Intravenous Solution Mefoxin (Cefoxitin sodium) is supplied in single dose Galaxy containers (PL 2040 Plastic) containing cefoxitin sodium as follows:
No. 2G3506 - 1 gram cefoxitin equivalent, iso-osmotic in 50 mL diluent containing approximately 2 grams dextrose hydrous USP
No. 2G3507 - 2 grams cefoxitin equivalent, iso-osmotic in 50 mL diluent containing approximately 1.1 grams dextrose hydrous USP
Mefoxin (Cefoxitin sodium) Clinical Studies
A prospective, randomized, double-blind, placebo-controlled clinical trial was conducted to determine the efficacy of short-term prophylaxis with Mefoxin (Cefoxitin sodium) in patients undergoing cesarean section who were at high risk for subsequent endometritis because of ruptured membranes. Patients were randomized to receive either three doses of placebo (n=58), a single dose of Mefoxin (Cefoxitin sodium) (2 g) followed by two doses of placebo (n=64), or a three-dose regimen of Mefoxin (Cefoxitin sodium) (each dose consisting of 2 g) (n=60), given intravenously, usually beginning at the time of clamping of the umbilical cord, with the second and third doses given 4 and 8 hours post-operatively. Endometritis occurred in 16/58 (27.6%) patients given placebo, 5/63 (7.9%) patients given a single dose of Mefoxin (Cefoxitin sodium) , and 3/58 (5.2%) patients given three doses of Mefoxin (Cefoxitin sodium) . The differences between the two groups treated with Mefoxin (Cefoxitin sodium) and placebo with respect to endometritis were statistically significant (p
Two double-blind, randomized studies compared the efficacy of a single 2 gram intravenous dose of Mefoxin (Cefoxitin sodium) to a single 2 gram intravenous dose of cefotetan in the prevention of surgical site-related infection (major morbidity) and non-site-related infections (minor morbidity) in patients following cesarean section. In the first study, 82/98 (83.7%) patients treated with Mefoxin (Cefoxitin sodium) and 71/95 (74.7%) patients treated with cefotetan experienced no major or minor morbidity. The difference in the outcomes in this study (95% CI: -0.03, +0.21) was not statistically significant. In the second study, 65/75 (86.7%) patients treated with Mefoxin (Cefoxitin sodium) and 62/76 (81.6%) patients treated with cefotetan experienced no major or minor morbidity. The difference in the outcomes in this study (95% CI: -0.08, +0.18) was not statistically significant.
In clinical trials of patients with intra-abdominal infections due to group microorganisms, eradication rates at 1 to 2 weeks posttreatment for isolates were in the range of 70% to 80%. Eradication rates for individual species are listed below:
Mefoxin (Cefoxitin sodium)
Mefoxin (Cefoxitin sodium) Principal Display Panel - Ml Bag
Each 50 mL contains: Cefoxitin Sodium, USP equivalent to 1 g cefoxitin withapproximately 2 g Dextrose Hydrous, USP added to adjust osmolality. pH adjusted with sodium bicarbonate and may have been adjusted with hydrochloric acid.
USUAL DOSAGE: See package insert. Administer intravenously as directed by aphysician.
CAUTIONS: Do not add supplementary medication. Must not be used in seriesconnections. Check for minute leaks by squeezing thawed bag firmly. Discard bagif leaks are found or solution is not clear.
Store at or below -20°C (-4°F). Thaw at room temperature, 25°C (77°F), or underrefrigeration, 2-8°C (36-46°F).Thawed solution is stable for 21 daysunder refrigeration or 24 hours at room temperature.
Mefoxin (Cefoxitin sodium) is a registered trademark of Bioniche Teoranta.GALAXY is a trademark of Baxter International Inc.Manufactured for, Lake Forest, IL 60045
by, Deerfield, IL 60015 USA
PL 2040 Plastic
07-34-56-30007-34-56-300
Mefoxin (Cefoxitin sodium) Principal Display Panel - Ml Bag
Each 50 mL contains: Cefoxitin Sodium, USP equivalent to 2 g cefoxitin withapproximately 1.1 g Dextrose Hydrous, USP added to adjust osmolality. pHadjusted with sodium bicarbonate and may have been adjusted with hydrochloricacid.
USUAL DOSAGE: See package insert. Administer intravenously as directed by aphysician.
CAUTIONS: Do not add supplementary medication. Must not be used in seriesconnections. Check for minute leaks by squeezing thawed bag firmly. Discard bagif leaks are found or solution is not clear.
Store at or below -20°C (-4°F). Thaw at room temperature, 25°C (77°F), or underrefrigeration, 2-8°C (36-46°F).Thawed solution is stable for 21 daysunder refrigeration or 24 hours at room temperature.
Mefoxin (Cefoxitin sodium) is a registered trademark of Bioniche Teoranta.GALAXY is a trademark of Baxter International Inc.Manufactured for, Lake Forest, IL 60045
by, Deerfield, IL 60015 USA
PL 2040 Plastic
07-34-61-60507-34-61-605
