Claforan

Claforan Manufacturers

• General Injectables & Vaccines, Inc
  

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  Claforan | General Injectables & Vaccines, Inc

  

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  Adults

  Dosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient (see table for dosage guideline). CLAFORAN may be administered IM or IV after reconstitution. Premixed CLAFORAN Injection is intended for IV administration after thawing. The maximum daily dosage should not exceed 12 grams.

  GUIDELINES FOR DOSAGE OF CLAFORAN

  Type of Infection Daily Dose (grams) Frequency and Route Gonococcal urethritis/cervicitis in males and females 0.5 0.5 gram IM (single dose) Rectal gonorrhea in females

  0.5

  0.5 gram IM (single dose) Rectal gonorrhea in males 1 1 gram IM (single dose) Uncomplicated infections 2 1 gram every 12 hours IM or IV Moderate to severe infections 3-6 1-2 grams every 8 hours IM or IV Infections commonly needing antibiotics in higher dosage (e.g., septicemia) 6-8 2 grams every 6-8 hours IV Life-threating infections up to 12 2 grams every 4 hours IV

  If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefotaxime sodium has no activity against this organism. To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 gram IM or IV administered 30 to 90 minutes prior to start of surgery.

  Cesarean Section Patients

  The first dose of 1 gram is administered intravenously as soon as the umbilical cord is clamped. The second and third doses should be given as 1 gram intravenously or intramuscularly at 6 and 12 hours after the first dose.

  Neonates, Infants, and Children

  The following dosage schedule is recommended:

  Neonates (birth to 1 month):

  0–1 week of age 50 mg/kg per dose every 12 hours IV

  1–4 weeks of age 50 mg/kg per dose every 8 hours IV

  It is not necessary to differentiate between premature and normal-gestational age infants.

  Infants and Children (1 month to 12 years):

  For body weights less than 50 kg, the recommended daily dose is 50 to 180 mg/kg IM or IV body weight divided into four to six equal doses. The higher dosages should be used for more severe or serious infections, including meningitis. For body weights 50 kg or more, the usual adult dosage should be used; the maximum daily dosage should not exceed 12 grams.

  Geriatric Use

  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. (See PRECAUTIONS, General and PRECAUTIONS, Geriatric Use.)

  Impaired Renal Function - see PRECAUTIONS, General.

  NOTE:  As with antibiotic therapy in general, administration of CLAFORAN should be continued for a minimum of 48 to 72 hours after the patient defervesces or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended for infections caused by Group A beta-hemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment of several weeks and doses smaller than those indicated above should not be used.

  Preparation of CLAFORAN Sterile

  CLAFORAN for IM or IV administration should be reconstituted as follows:

        Approximate   Diluent Withdrawable Concentration Strength (mL) Volume (mL) (mg/mL) 500 mg vial*(IM) 2 2.2 230 1g vial* (IM) 3 3.4 300 2g vial* (IM) 5 6.0 330 500 mg vial* (IV) 10 10.2 50 1g vial* (IV) 10 10.4 95 2g vial*(IV) 10 11.0 180 1g infusion 50-100 50-100 20-10 2g infusion 50-100 50-100 40-20 (*) in conventional vials      

  Shake to dissolve; inspect for particulate matter and discoloration prior to use. Solutions of CLAFORAN range from very pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.

  For intramuscular use:  Reconstitute VIALS with Sterile Water for Injection or Bacteriostatic Water for Injection as described above.

  For intravenous use:  Reconstitute VIALS with at least 10 mL of Sterile Water for Injection. Reconstitute INFUSION BOTTLES with 50 or 100 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection. For other diluents, see COMPATIBILITY AND STABILITY section.

  NOTE:  Solutions of CLAFORAN must not be admixed with aminoglycoside solutions. If CLAFORAN and aminoglycosides are to be administered to the same patient, they must be administered separately and not as mixed injection.

  A SOLUTION OF 1 G CLAFORAN IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.

  IM Administration:  As with all IM preparations, CLAFORAN should be injected well within the body of a relatively large muscle such as the upper outer quadrant of the buttock (i.e., gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel. Individual IM doses of 2 grams may be given if the dose is divided and is administered in different intramuscular sites.

  IV Administration:  The IV route is preferable for patients with bacteremia, bacterial septicemia, peritonitis, meningitis, 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.

  For intermittent IV administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Cefotaxime should not be administered over a period of less than three minutes. (See WARNINGS). With an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing CLAFORAN, it is advisable to discontinue temporarily the administration of other solutions at the same site.

  For the administration of higher doses by continuous IV infusion, a solution of CLAFORAN may be added to IV bottles containing the solutions discussed below.

  Directions for use of CLAFORAN Injection in Galaxy Container (PL 2040 Plastic)

  CLAFORAN Injection in Galaxy containers (PL 2040 plastic) is for continuous or intermittent infusion using sterile equipment.

  Storage

  Store in a freezer capable of maintaining a temperature of -20°C/-4°F.

  Thawing of Plastic Container

  Thaw frozen container at room temperature or under refrigeration (at or below 5°C). [DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.]

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

  DO NOT ADD SUPPLEMENTARY MEDICATION.

  The container should be visually inspected. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Agitate after solution has reached room temperature. If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted or if any seals or outlet ports are not intact, the container should be discarded.

  The thawed solution is stable for 10 days under refrigeration (at or below 5°C) or 24 hours at or below 22°C. Do not refreeze thawed antibiotics.

  CAUTION:  Do not use plastic containers in series connections. Such use could 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:

  Suspend container from eyelet support. Remove protector from outlet port at bottom of container. Attach administration set. Refer to complete directions accompanying set.

  Preparation of CLAFORAN Sterile in ADD-Vantage System

  CLAFORAN Sterile 1 g or 2 g may be reconstituted in 50 mL or 100 mL of 5% Dextrose or 0.9% Sodium Chloride in the ADD-Vantage diluent container. Refer to enclosed, separate INSTRUCTIONS FOR ADD-VANTAGE SYSTEM.

  Compatibility and Stability

  Solutions of CLAFORAN Sterile reconstituted as described above (Preparation of CLAFORAN Sterile) remain chemically stable (potency remains above 90%) as follows when stored in original containers and disposable plastic syringes:

  Strength Reconstitured Stability at or Stability under     Concentration below 22°C Refrigeration     mg/mL   (at or below 5°C)         Original Plastic       Containers Syringes 500 mg vial IM 230 12 hours 7 days 5 days 1g vial IM 300 12 hours 7 days 5 days 2g vial IM 330 12 hours 7 days 5 days 500 mg vial IV 50 24 hours 7 days 5 days 1g vial IV 95 24 hours 7 days 5 days 2g vial IV 180 12 hours 7 days 5 days 1g infusion bottle 10-20 24 hours 10 days   2g infusion bottle 20-40 24 hours 10 days  

  Reconstituted solutions stored in original containers and plastic syringes remain stable for 13 weeks frozen.

  Reconstituted solutions may be further diluted up to 1000 mL with the following solutions and maintain satisfactory potency for 24 hours at or below 22°C, and at least 5 days under refrigeration (at or below 5°C): 0.9% Sodium Chloride Injection; 5 or 10% Dextrose  Injection; 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.2% Sodium Chloride Injection; Lactated Ringer's Solution; Sodium Lactate Injection (M/6); 10% Invert Sugar Injection, 8.5% TRAVASOL® (Amino Acid) Injection without Electrolytes.

  Solutions of CLAFORAN Sterile reconstituted in 0.9% Sodium Chloride Injection or 5% Dextrose Injection in Viaflex® plastic containers maintain satisfactory potency for 24 hours at or below 22°C, 5 days under refrigeration (at or below 5°C) and 13 weeks frozen. Solutions of CLAFORAN Sterile reconstituted in 0.9% Sodium Chloride Injection or 5% Dextrose Injection in the ADD-Vantage flexible containers maintain satisfactory potency for 24 hours at or below 22°C. DO NOT FREEZE. NOTE:  CLAFORAN solutions exhibit maximum stability in the pH 5–7 range. Solutions of CLAFORAN should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• Sanofi-aventis U.s. Llc
  

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  Claforan | Sanofi-aventis U.s. Llc

  

  ---

  Adults

  Dosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient (see table for dosage guideline). CLAFORAN may be administered IM or IV after reconstitution. Premixed CLAFORAN Injection is intended for IV administration after thawing. The maximum daily dosage should not exceed 12 grams.

  GUIDELINES FOR DOSAGE OF CLAFORAN Type of Infection Daily Dose (grams) Frequency and Route Gonococcal urethritis/
    cervicitis in males and
    females   0.5 0.5 gram IM (single dose) Rectal gonorrhea in females   0.5 0.5 gram IM (single dose) Rectal gonorrhea in males     1 1 gram IM (single dose) Uncomplicated infections     2 1 gram every 12 hours IM or IV Moderate to severe infections 3–6 1–2 grams every 8 hours IM or IV Infections commonly needing
  antibiotics in higher dosage
  (e.g., septicemia) 6–8 2 grams every 6–8 hours IV Life-threatening infections up to 12         2 grams every 4 hours IV

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

  To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 gram IM or IV administered 30 to 90 minutes prior to start of surgery.

  Cesarean Section Patients

  The first dose of 1 gram is administered intravenously as soon as the umbilical cord is clamped. The second and third doses should be given as 1 gram intravenously or intramuscularly at 6 and 12 hours after the first dose.

  Neonates, Infants, and Children

  The following dosage schedule is recommended:

    Neonates (birth to 1 month):

      0–1 week of age      50 mg/kg per dose every 12 hours IV
      1–4 weeks of age      50 mg/kg per dose every 8 hours IV

  It is not necessary to differentiate between premature and normal-gestational age infants.

  Infants and Children (1 month to 12 years):

  For body weights less than 50 kg, the recommended daily dose is 50 to 180 mg/kg IM or IV body weight divided into four to six equal doses. The higher dosages should be used for more severe or serious infections, including meningitis. For body weights 50 kg or more, the usual adult dosage should be used; the maximum daily dosage should not exceed 12 grams.

  Geriatric Use

  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. (See PRECAUTIONS, General and PRECAUTIONS, Geriatric Use.)

  Impaired Renal Function

  see PRECAUTIONS, General.

  NOTE: As with antibiotic therapy in general, administration of CLAFORAN should be continued for a minimum of 48 to 72 hours after the patient defervesces or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended for infections caused by Group A beta-hemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment of several weeks and doses smaller than those indicated above should not be used.

  Preparation of CLAFORAN Sterile

  CLAFORAN for IM or IV administration should be reconstituted as follows:

  Strength Diluent
  (mL) Withdrawable
  Volume (mL) Approximate Concentration
  (mg/mL) * in conventional vials 500 mg vial* (IM) 2 2.2 230 1g vial* (IM) 3 3.4 300 2g vial* (IM) 5 6.0 330 500 mg vial* (IV) 10 10.2 50 1g vial* (IV) 10 10.4 95 2g vial* (IV) 10 11.0 180 1g infusion 50–100 50–100 20–10 2g infusion 50–100 50–100 40–20

  Shake to dissolve; inspect for particulate matter and discoloration prior to use. Solutions of CLAFORAN range from very pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.

  For intramuscular use

  Reconstitute VIALS with Sterile Water for Injection or Bacteriostatic Water for Injection as described above.

  For intravenous use

  Reconstitute VIALS with at least 10 mL of Sterile Water for Injection. Reconstitute INFUSION BOTTLES with 50 or 100 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection. For other diluents, see COMPATIBILITY AND STABILITY section.

  NOTE: Solutions of CLAFORAN must not be admixed with aminoglycoside solutions. If CLAFORAN and aminoglycosides are to be administered to the same patient, they must be administered separately and not as mixed injection.

  A SOLUTION OF 1 G CLAFORAN IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.

  IM Administration

  As with all IM preparations, CLAFORAN should be injected well within the body of a relatively large muscle such as the upper outer quadrant of the buttock (i.e., gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel. Individual IM doses of 2 grams may be given if the dose is divided and is administered in different intramuscular sites.

  IV Administration

  The IV route is preferable for patients with bacteremia, bacterial septicemia, peritonitis, meningitis, 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.

  For intermittent IV administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Cefotaxime should not be administered over a period of less than three minutes. (See WARNINGS). With an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing CLAFORAN, it is advisable to discontinue temporarily the administration of other solutions at the same site.

  For the administration of higher doses by continuous IV infusion, a solution of CLAFORAN may be added to IV bottles containing the solutions discussed below.

  Directions for use of CLAFORAN Injection in Galaxy® Container (PL 2040 Plastic)

  CLAFORAN Injection in Galaxy® Containers (PL 2040 plastic) is for continuous or intermittent infusion using sterile equipment.

  Storage

  Store in a freezer capable of maintaining a temperature of -20°C/-4°F.

  Thawing of Plastic Container

  Thaw frozen container at room temperature or under refrigeration (at or below 5°C). [DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.]

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

  DO NOT ADD SUPPLEMENTARY MEDICATION.

  The container should be visually inspected. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Agitate after solution has reached room temperature. If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted or if any seals or outlet ports are not intact, the container should be discarded.

  The thawed solution is stable for 10 days under refrigeration (at or below 5°C) or 24 hours at or below 22°C. Do not refreeze thawed antibiotics.

  CAUTION: Do not use plastic containers in series connections. Such use could 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 Suspend container from eyelet support. Remove protector from outlet port at bottom of container. Attach administration set. Refer to complete directions accompanying set. Preparation of CLAFORAN Sterile in ADD-Vantage System

  CLAFORAN Sterile 1 g or 2 g may be reconstituted in 50 mL or 100 mL of 5% Dextrose or 0.9% Sodium Chloride in the ADD-Vantage diluent container. Refer to enclosed, separate INSTRUCTIONS FOR ADD-VANTAGE SYSTEM.

  Compatibility and Stability

  Solutions of CLAFORAN Sterile reconstituted as described above (Preparation of CLAFORAN Sterile) remain chemically stable (potency remains above 90%) as follows when stored in original containers and disposable plastic syringes:

  Strength Reconstituted
  Concentration
  mg/mL Stability at or
  below 22°C Stability under Refrigeration
  (at or below 5°C)
  Original
  Containers Plastic
  Syringes 500 mg vial IM 230 12 hours 7 days 5 days 1g vial IM 300 12 hours 7 days 5 days 2g vial IM 330 12 hours 7 days 5 days 500 mg vial IV 50 24 hours 7 days 5 days 1g vial IV 95 24 hours 7 days 5 days 2g vial IV 180 12 hours 7 days 5 days 1g infusion bottle     10–20 24 hours 10 days 2g infusion bottle 20–40 24 hours 10 days

  Reconstituted solutions stored in original containers and plastic syringes remain stable for 13 weeks frozen.

  Reconstituted solutions may be further diluted up to 1000 mL with the following solutions and maintain satisfactory potency for 24 hours at or below 22°C, and at least 5 days under refrigeration (at or below 5°C): 0.9% Sodium Chloride Injection; 5 or 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.2% Sodium Chloride Injection; Lactated Ringer's Solution; Sodium Lactate Injection (M/6); 10% Invert Sugar Injection, 8.5% Travasol® (Amino Acid) Injection without Electrolytes.

  Solutions of CLAFORAN Sterile reconstituted in 0.9% Sodium Chloride Injection or 5% Dextrose Injection in Viaflex® plastic containers maintain satisfactory potency for 24 hours at or below 22°C, 5 days under refrigeration (at or below 5°C) and 13 weeks frozen. Solutions of CLAFORAN Sterile reconstituted in 0.9% Sodium Chloride Injection or 5% Dextrose Injection in the ADD-Vantage flexible containers maintain satisfactory potency for 24 hours at or below 22°C. DO NOT FREEZE.

  NOTE: CLAFORAN solutions exhibit maximum stability in the pH 5–7 range. Solutions of CLAFORAN should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Close
  No Recall

  More Info