Mefoxin

Mefoxin Manufacturers

• Bioniche Pharma Usa Llc
  

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  Mefoxin | Bioniche Pharma Usa Llc

  

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  NOTE: MEFOXIN® in Galaxy12 container is for intravenous infusion only.

  12

  Galaxy® is a registered trademark of Baxter International Inc.

  TREATMENT Adults

  The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 1 for dosage guidelines).

  If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefoxitin sodium has no activity against this organism.

  MEFOXIN may be used in patients with reduced renal function with the following dosage adjustments:

  In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 2) may be used as a guide.

  When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

  Males: Weight (kg) × (140-age) 72 × serum creatinine (mg/100 mL)
  Females:
  0.85 × male value

  In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 2.

  Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

  Pediatric Patients

  The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams.

  At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).

  In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be modified consistent with the recommendations for adults (see Table 2).

  PREVENTION

  Effective prophylactic use depends on the time of administration. MEFOXIN 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:

  Adults

  2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

  Pediatric Patients (3 months and older)

  30 to 40 mg/kg doses may be given at the times designated above.

  Cesarean section patients

  For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3-dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended. (See CLINICAL STUDIES.)

  Table 1 - Guidelines for Dosage of MEFOXIN Type of Infection Daily Dosage Frequency and Route * Including patients in whom bacteremia is absent or unlikely. Uncomplicated forms* of infections such as pneumonia, urinary tract infection, cutaneous infection 3-4 grams 1 gram every 6-8 hours IV Moderately severe or severe infections 6-8 grams 1 gram every 4 hours
  or
  2 grams every 6-8 hours IV Infections commonly needing antibiotics in higher dosage (e.g., gas gangrene) 12 grams 2 grams every 4 hours
  or
  3 grams every 6 hours IV Table 2 - Maintenance Dosage of MEFOXIN in Adults with Reduced Renal Function Renal Function Creatinine Clearance
  (mL/min) Dose (grams) Frequency Mild impairment 50-30 1-2 every 8-12 hours Moderate impairment 29-10 1-2 every 12-24 hours Severe impairment 9-5 0.5-1 every 12-24 hours Essentially no function <5 0.5-1 every 24-48 hours ADMINISTRATION

  This premixed solution is for intravenous use only. Premixed Intravenous Solution MEFOXIN in Galaxy® containers (PL 2040 Plastic) is to be administered either as a continuous or intermittent infusion using sterile equipment. Scalp vein-type needles are preferred for this type of infusion. It is recommended that the intravenous administration apparatus be replaced at least once every 48 hours.

  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.

  Directions for Use of Galaxy® Containers (PL 2040 Plastic)

  Thaw frozen container at room temperature, 25°C (77°F), or under refrigeration, 2-8°C (36-46°F). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.

  After thawing, check for minute leaks by squeezing container firmly. If leaks are detected, discard solution as sterility may be impaired.

  The container should be visually inspected for particulate matter and discoloration prior to administration. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Agitate after solution has reached room temperature.

  Do not use if the solution is cloudy or a precipitate has formed. If any seals or outlet ports are not intact, the container should be discarded. Solutions of MEFOXIN tend to darken depending on storage conditions; product potency, however, is not adversely affected.

  Additives should not be introduced into this solution.

  CAUTION: Do not use plastic containers in series connections. Such use would result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

  Preparation for Intravenous Administration 1Suspend container from eyelet support. 2Remove plastic protector from outlet port at bottom of container. 3Attach administration set. Refer to complete directions accompanying set.

  MEFOXIN may be administered through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing MEFOXIN, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  Solutions of MEFOXIN, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions (e.g., gentamicin sulfate, tobramycin sulfate, amikacin sulfate) because of potential interaction. However, MEFOXIN and aminoglycosides may be administered separately to the same patient.

  STABILITY

  MEFOXIN, 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.

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