Fujisawa Healthcare, Inc.

Fujisawa Healthcare, Inc. Drugs

• Cefizox
  

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  Cefizox

  

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  The usual adult dosage is 1 or 2 grams of Cefizox (ceftizoxime for injection, USP) every 8 to 12 hours. Proper dosage and route of administration should be determined by the condition of the patient, severity of the infection, and susceptibility of the causative organisms.

  General Guidelines for Dosage of Cefizox

  Type of

  Infection

  Daily Dose

  (Grams)

  Frequency

  and Route * When administering 2 gram IM doses, the dose should be divided and given in different large muscle masses. † If C. trachomatis is a suspected pathogen, appropriate anti­chlamydial coverage should be added, because ceftizoxime has no activity against this organism. ‡ In life­threatening infections, dosages up to 2 grams every 4 hours have been given.

  Uncomplicated

  Urinary Tract 1 500 mg q12h IM or IV Other Sites 2-3 1 gram q8-12h IM or IV

  Severe or

  Refractory 3-6

  1 gram q8h IM or IV

  2 grams q8-12h IM* or IV PID† 6 2 grams q8h IV Life-Threatening‡ 9-12 3-4 grams q8h IV

  ______________________________________________________________________________

  Because of the serious nature of urinary tract infections due to P. aeruginosa and because many strains of Pseudomonas species are only moderately susceptible to Cefizox, higher dosage is recommended. Other therapy should be instituted if the response is not prompt.

  A single, 1 gram IM dose is the usual dose for treatment of uncomplicated gonorrhea.

  The IV route may be preferable for patients with bacterial septicemia, localized parenchymal abscesses (such as intra­abdominal abscess), peritonitis, or other severe or life­threatening infections.

  In those with normal renal function, the IV dosage for such infections is 2 to 12 grams of Cefizox (ceftizoxime for injection, USP) daily. In conditions such as bacterial septicemia, 6 to 12 grams/day may be given initially by the IV route for several days, and the dosage may then be gradually reduced according to clinical response and laboratory findings.

  Pediatric Dosage Schedule Unit Dose Frequency

  Pediatric patients

  6 months or older 50 mg/kg q6-8h

  Dosage may be increased to a total daily dose of 200 mg/kg (not to exceed the maximum adult dose for serious infection).

  Impaired Renal Function

  Modification of Cefizox dosage is necessary in patients with impaired renal function. Following an initial loading dose of 500 mg-1 gram IM or IV, the maintenance dosing schedule shown below should be followed. Further dosing should be determined by therapeutic monitoring, severity of the infection, and susceptibility of the causative organisms.

  When only the serum creatinine level is available, creatinine clearance may be calculated from the following formula. The serum creatinine level should represent current renal function at the steady state.

  Males

       Clcr =Weight (kg) x (140 ­ age)

                    72 x serum creatinine

                    (mg/100 mL)

  Females are 0.85 of the calculated clearance values for males.

  In patients undergoing hemodialysis, no additional supplemental dosing is required following hemodialysis; however, dosing should be timed so that the patient receives the dose (according to the table below) at the end of the dialysis.

  Dosage in Adults with Reduced Renal Function Creatinine Clearance mL/min Renal Function Less Severe Infections Life-Threatening Infections 79-50

  Mild

  Impairment 500 mg q8h

  0.75-1.5 grams

  q8h 49-5

  Moderate

  to severe

  impairment

  250-500 mg

  q12h

  0.5-1 gram

  q12h 4-0

  Dialysis

  Patients

  500 mg q48h

  or

  250 mg q24h

  0.5-1 gram

  q48h

  or

  0.5 gram q24h

  Preparation of Parenteral Solution

  RECONSTITUTION

  IM Administration: Reconstitute with Sterile Water for Injection. SHAKE WELL.

  Vial Size Diluent to Be Added Approx. Avail. Vol. Approx. Avg. Concentration Room Temp. Stability * When administering 2 gram IM doses, the dose should be divided and given in different large muscle masses. 500 mg 1.5 mL 1.8 mL 280 mg/mL 16 hours 1 gram 3.0 mL 3.7 mL 270 mg/mL 16 hours 2 grams* 6.0 mL 7.4 mL 270 mg/mL 16 hours

  IV Administration: Reconstitute with Sterile Water for Injection. SHAKE WELL.

  Vial Size Diluent to Be Added Approx. Avail. Vol. Approx. Avg. Concentration Room Temp. Stability 500 mg 5 mL 5.3 mL 95 mg/mL 24 hours 1 gram 10 mL 10.7 mL 95 mg/mL 24 hours 2 grams 20 mL 21.4 mL 95 mg/mL 24 hours

  These solutions of Cefizox are stable 24 hours at room temperature or 96 hours if refrigerated (5ºC).

  Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, then the drug solution should be discarded. Reconstituted solutions may range from yellow to amber without changes in potency.

  Piggyback Vials: Reconstitute with 50 to 100 mL of Sodium Chloride Injection or any other IV solution listed below.

  SHAKE WELL.

  Administer with primary IV fluids, as a single dose. These Piggyback vial solutions of Cefizox are stable 24 hours at room temperature or 96 hours if refrigerated (5ºC).

  A solution of 1 gram Cefizox in 13 mL Sterile Water for Injection is isotonic.

  IM Injection

  Inject well within the body of a relatively large muscle. Aspiration is necessary to avoid inadvertent injection into a blood vessel. When administering 2 gram IM doses, the dose should be divided and given in different large muscle masses.

  IV Administration

  Direct (bolus) injection, slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below). Intermittent or continuous infusion, dilute reconstituted Cefizox in 50 to 100 mL of one of the following solutions:

  Sodium Chloride Injection 5% or 10% Dextrose Injection 5% Dextrose and 0.9%, 0.45%, or 0.2% Sodium Chloride Injection Ringer’s Injection Lactated Ringer’s Injection Invert Sugar 10% in Sterile Water for Injection 5% Sodium Bicarbonate in Sterile Water for Injection 5% Dextrose in Lactated Ringer’s Injection (only when reconstituted with 4% Sodium Bicarbonate Injection)

  In these fluids, Cefizox is stable 24 hours at room temperature or 96 hours if refrigerated (5ºC).

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