Wg Critical Care, Llc

Wg Critical Care, Llc Drugs

• Cefoxitin
  

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  Cefoxitin

  

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  The intent of this pharmacy bulk package is for the preparation of solutions for intravenous infusion only.

  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 3 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.

  Cefoxitin for Injection 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 4) 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) x (140-age)

  72 x serum creatinine (mg/100 mL)

  Females: 0.85 x above valueIn 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 4.

  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 4).

  PREVENTION

  Effective prophylactic use depends on the time of administration. Cefoxitin for Injection 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 3 - Guidelines for Dosage of Cefoxitin for Injection

  Type of Infection

  Daily Dosage

  Frequency and Route

  Uncomplicated forms* of infections such as pneumonia, urinary tract infection, cutaneous infection

  3 to 4 grams

  1 gram every

  6 to 8 hours IV

  Moderately severe or severe infections

  6 to 8 grams

  1 gram every 4 hours

  or

  2 grams every 6 to 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

  *Including patients in whom bacteremia is absent or unlikely.

  Table 4 - Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function

  Renal Function

  Creatinine

  Clearance (mL/min)

  Dose (grams)

  Frequency

  Mild impairment

  50 to 30

  1 to 2

  Every 8 to 12 hours

  Moderate impairment

  29 to 10

  1 to 2

  Every 12 to 24 hours

  Severe impairment

  9 to 5

  0.5 to 1

  Every 12 to 24 hours

  Essentially no function

  < 5

  0.5 to 1

  Every 24 to 48 hours

  Table 5 - Preparation of Solution for Intravenous Administration

  Strength

  Amount of Diluent to be Added (mL)**

  Approximate Withdrawable Volume (mL)

  Approximate

  Average

  Concentration (mg/mL)

  Pharmacy Bulk Package - 10 grams

  43 or 93

  49 or 98.5

  200 or 100

  **Shake to dissolve and let stand until clear.

  PREPARATION OF SOLUTION

  Table 5 is provided for convenience in constituting Cefoxitin for Injection for intravenous administration.

  The 10 gram pharmacy bulk package bottle should be constituted with 43 or 93 mL of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. CAUTION: THE 10 GRAM BULK STOCK SOLUTION IS NOT FOR DIRECT INFUSION. RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION. RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the Bulk Packages portion of the COMPATIBILITY AND STABILITY section.

  Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, in whom use of Cefoxitin for Injection may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when Cefoxitin for Injection is constituted for administration to pediatric patients in this age range.

  ADMINISTRATION

  Cefoxitin for Injection may be administered intravenously after constitution.

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

  Intravenous Administration

  The intravenous route is preferable 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.

  For intermittent intravenous administration: Using an infusion system, a solution containing 1 gram or 2 grams may be given over a period of time through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing Cefoxitin for Injection, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For the administration of higher doses by continuous intravenous infusion, a solution of Cefoxitin for Injection may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY®†† or scalp vein-type needles are preferred for this type of infusion.

  Solutions of Cefoxitin for Injection, 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, Cefoxitin for Injection and aminoglycosides may be administered separately to the same patient.

  Directions for Proper Use of Pharmacy Bulk Package bottle:

  Pharmacy Bulk Package

  Not for Direct Infusion

  RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION

  The Pharmacy Bulk Package bottle is for use in a pharmacy admixture service under a laminar flow hood. Penetration into the Pharmacy Bulk Package bottle should be made only one time after reconstitution with a sterile transfer set or other sterile dispensing device, which allows measured distribution of the contents. Dispense the contents in aliquots using aseptic technique. The use of a syringe with a needle is not recommended as it may cause leakage. AFTER INITIAL ENTRY USE ENTIRE CONTENTS OF THE PHARMACY BULK PACKAGE PROMPTLY. A maximum time of 4 HOURS from initial entry is permitted to complete fluid transfer operations. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS. This time limit should begin with the introducing of solvent or diluent into the Pharmacy Bulk Package bottle. RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION. RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION.

  COMPATIBILITY AND STABILITY

  Pharmacy Bulk Package

  Cefoxitin for Injection, as supplied in pharmacy bulk package bottles and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, (see PREPARATION OF SOLUTION), 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, should be DISCARDED 4 HOURS AFTER INITIAL ENTRY. FURTHER DILUTION IS REQUIRED BEFORE USE. RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION. RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION.

  These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration:

    0.9 percent Sodium Chloride Injection   5 percent or 10 percent Dextrose Injection   5 percent Dextrose and 0.9 percent Sodium Chloride Injection   5 percent Dextrose Injection with 0.2 percent or 0.45 percent saline solution   Lactated Ringer’s Injection   5 percent Dextrose in Lactated Ringer’s Injection   5 percent Sodium Bicarbonate Injection   M/6 sodium lactate solution   Mannitol 5% and 10%

  After the periods mentioned above, any unused solutions should be discarded.

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• Cefoxitin
  

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  Cefoxitin

  

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  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 3 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.

  Cefoxitin for Injection 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 4) 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) x (140-age)

  72 x serum creatinine (mg/100 mL)

  Females: 0.85 x above 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 4.

  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 4).

  PREVENTION

  Effective prophylactic use depends on the time of administration. Cefoxitin for Injection 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 3. Guidelines for Dosage of Cefoxitin for Injection

  Type of Infection

  Daily Dosage

  Frequency and Route

  Uncomplicated forms* of infections such as pneumonia, urinary tract infection, cutaneous infection

  3 to 4 grams

  1 gram every

  6 to 8 hours IV

  Moderately severe or severe infections

  6 to 8 grams

  1 gram every 4 hours

  or

  2 grams every 6 to 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

  *Including patients in whom bacteremia is absent or unlikely.

  Table 4. Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function

  Renal Function

  Creatinine

  Clearance (mL/min)

  Dose (Grams)

  Frequency

  Mild impairment

  50 to 30

  1 to 2

  Every 8 to 12 hours

  Moderate impairment

  29 to 10

  1 to 2

  Every 12 to 24 hours

  Severe impairment

  9 to 5

  0.5 to 1

  Every 12 to 24 hours

  Essentially no function

  < 5

  0.5 to 1

  Every 24 to 48 hours

  Table 5. Preparation of Solution for Intravenous Administration

  Strength

  Amount of Diluent to be Added (mL)**

  Approximate Withdrawable Volume (mL)

  Approximate

  Average

  Concentration (mg/mL)

  1 gram Vial

  10

  10.5

  95

  2 gram Vial

  10 or 20

  11.1 or 21

  180 or 95

  **Shake to dissolve and let stand until clear.

  PREPARATION OF SOLUTION

  Table 5 is provided for convenience in constituting Cefoxitin for Injection for intravenous administration.

  For Vials

  One gram should be constituted with at least 10 mL, and 2 grams with 10 or 20 mL, of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the Vials portion of the COMPATIBILITY AND STABILITY section.

  Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, in whom use of Cefoxitin for Injection may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when Cefoxitin for Injection is constituted for administration to pediatric patients in this age range.

  ADMINISTRATION

  Cefoxitin for Injection may be administered intravenously after constitution.

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

  Intravenous Administration

  The intravenous route is preferable 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.

  For intermittent intravenous 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. Using 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 intravenous solutions. However, during infusion of the solution containing Cefoxitin for Injection, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For the administration of higher doses by continuous intravenous infusion, a solution of Cefoxitin for Injection may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY®†† or scalp vein-type needles are preferred for this type of infusion.

  Solutions of Cefoxitin for Injection, 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, Cefoxitin for Injection and aminoglycosides may be administered separately to the same patient.

  COMPATIBILITY AND STABILITY

  Vials

  Cefoxitin for Injection, as supplied in vials and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, (see PREPARATION OF SOLUTION), 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, maintains satisfactory potency for 6 hours at room temperature or for one week under refrigeration (below 5ºC).

  These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration:

    0.9 percent Sodium Chloride Injection   5 percent or 10 percent Dextrose Injection   5 percent Dextrose and 0.9 percent Sodium Chloride Injection   5 percent Dextrose Injection with 0.2 percent or 0.45 percent saline solution   Lactated Ringer’s Injection   5 percent Dextrose in Lactated Ringer’s Injection   5 percent Sodium Bicarbonate Injection   M/6 sodium lactate solution   Mannitol 5% and 10%

  After the periods mentioned above, any unused solutions should be discarded.

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• Amlodipine
  

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  Amlodipine

  

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  NOTE: Contact of undiluted teniposide with plastic equipment or devices used to prepare solutions for infusion may result in softening or cracking and possible drug product leakage. This effect has not been reported with diluted solutions of teniposide.

  In order to prevent extraction of the plasticizer DEHP [di(2-ethylhexyl) phthalate], solutions of teniposide should be prepared in non-DEHP containing large volume parenteral (LVP) containers such as glass or polyolefin plastic bags or containers.

  Teniposide solutions should be administered with non-DEHP containing intravenous administration sets.

  In one study, childhood ALL patients failing induction therapy with a cytarabine-containing regimen were treated with the combination of teniposide 165 mg/m2 and cytarabine 300 mg/m2 intravenously, twice weekly for 8 to 9 doses. In another study, patients with childhood ALL refractory to vincristine/prednisone-containing regimens were treated with the combination of teniposide 250 mg/m2 and vincristine 1.5 mg/m2 intravenously, weekly for 4 to 8 weeks and prednisone 40 mg/m2 orally for 28 days.

  Adequate data in patients with hepatic insufficiency and/or renal insufficiency are lacking, but dose adjustments may be necessary for patients with significant renal or hepatic impairment.

  Preparation and Administration Precautions

  Caution should be exercised in handling and preparing the solution of teniposide. Several guidelines on proper handling and disposal of anticancer drugs have been published.1-4 Skin reactions associated with accidental exposure to teniposide may occur. To minimize the risk of dermal exposure, always wear impervious gloves when handling ampules containing teniposide. If teniposide solution contacts the skin, immediately wash the skin thoroughly with soap and water. If teniposide contacts mucous membranes, the membranes should be flushed immediately and thoroughly with water. More information is available in the references listed below.

  Preparation for Intravenous Administration

  Teniposide Injection must be diluted with either 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP, to give final teniposide concentrations of 0.1 mg/mL, 0.2 mg/mL, 0.4 mg/mL, or 1.0 mg/mL. Solutions prepared in 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP at teniposide concentrations of 0.1 mg/mL, 0.2 mg/mL, or 0.4 mg/mL are stable at room temperature for up to 24 hours after preparation. Teniposide solutions prepared at a final teniposide concentration of 1.0 mg/mL should be administered within 4 hours of preparation to reduce the potential for precipitation. Refrigeration of teniposide solutions is not recommended. Stability and use times are identical in glass and plastic parenteral solution containers.

  Although solutions are chemically stable under the conditions indicated, precipitation of teniposide may occur at the recommended concentrations, especially if the diluted solution is subjected to more agitation than is recommended to prepare the drug solution for parenteral administration. In addition, storage time prior to administration should be minimized and care should be taken to avoid contact of the diluted solution with other drugs or fluids. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Precipitation has been reported during 24-hour infusions of teniposide diluted to teniposide concentrations of 0.1 to 0.2 mg/mL, resulting in occlusion of central venous access catheters in several patients. Heparin solution can cause precipitation of teniposide, therefore, the administration apparatus should be flushed thoroughly with 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP before and after administration of teniposide.

  Hypotension has been reported following rapid intravenous administration; it is recommended that the teniposide solution be administered over at least a 30- to 60-minute period. Teniposide should not be given by rapid intravenous injection.

  In a 24-hour study under simulated conditions of actual use of the product relative to dilution strength, diluent and administration rates, dilutions at 0.1 to 1.0 mg/mL were chemically stable for at least 24 hours. Data collected for the presence of the extractable DEHP [di(2-ethylhexyl) phthalate] from PVC containers show that levels increased with time and concentration of the solutions. The data appeared similar for 0.9% Sodium Chloride Injection, USP, and 5% Dextrose Injection, USP. Consequently, the use of PVC containers is not recommended.

  Similarly, the use of non-DEHP intravenous administration sets is recommended. Lipid administration sets or low DEHP-containing nitroglycerin sets will keep patient’s exposure to DEHP at low levels and are suitable for use. The diluted solutions are chemically and physically compatible with the recommended intravenous administration sets and LVP containers for up to 24 hours at ambient room temperature and lighting conditions. Because of the potential for precipitation, compatibility with other drugs, infusion materials, or intravenous pumps cannot be assured.

  Stability

  Unopened ampules of Teniposide Injection are stable until the date indicated on the package when stored under refrigeration 2° to 8°C (36° to 46°F) in the original package. Freezing does not adversely affect the product.

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• Ibuprofen
  

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  Ibuprofen

  

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  Dosage

  The usual adult dosage is 1 gram administered intravenously or intramuscularly every 8 to 12 hours. The dosage and route should be determined by the susceptibility of the causative organisms, the severity of infection, and the condition and renal function of the patient.

  The guidelines for dosage of ceftazidime for injection are listed in Table 5. The following dosage schedule is recommended.

  Table 5. Recommended Dosage Schedule * Although clinical improvement has been shown, bacteriologic cures cannot be expected in patients with chronic respiratory disease and cystic fibrosis. † The higher dose should be reserved for immunocompromised pediatric patients or pediatric patients with cystic fibrosis or meningitis.

  Dose

  Frequency

  Adults

  Usual recommended dosage

  1 gram IV or IM

  q8hr to 12hr

  Uncomplicated urinary tract infections

  250 mg IV or IM

  q12hr

  Bone and joint infections

  2 grams IV

  q12hr

  Complicated urinary tract infections

  500 mg IV or IM

  q8hr to 12hr

  Uncomplicated pneumonia;

  mild skin and skin-structure infections

  500 mg to 1 gram

  IV or IM

  q8hr

  Serious gynecologic and

  intra-abdominal infections

  2 grams IV

  q8hr

  Meningitis

  2 grams IV

  q8hr

  Very severe life-threatening

  infections, especially in immunocompromised patients

  2 grams IV

  q8hr

  Lung infections caused by Pseudomonas spp. in patients with cystic fibrosis with

  normal renal function*

  30 to 50 mg/kg IV to a maximum of 6 grams per day

  q8hr

  Neonates (0 to 4 weeks)

  30 mg/kg IV

  q12hr

  Infants and children (1 month to 12 years)

  30 to 50 mg/kg IV to a

  maximum of 6 grams per day†

  q8hr

  Impaired Hepatic Function

  No adjustment in dosage is required for patients with hepatic dysfunction.

  Impaired Renal Function

  Ceftazidime is excreted by the kidneys, almost exclusively by glomerular filtration. Therefore, in patients with impaired renal function (glomerular filtration rate [GFR] <50 mL/min), it is recommended that the dosage of ceftazidime be reduced to compensate for its slower excretion. In patients with suspected renal insufficiency, an initial loading dose of 1 gram of ceftazidime may be given. An estimate of GFR should be made to determine the appropriate maintenance dosage. The recommended dosage is presented in Table 6.

  NOTE: IF THE DOSE RECOMMENDED IN TABLE 5 ABOVE IS LOWER THAN THAT RECOMMENDED FOR PATIENTS WITH RENAL INSUFFICIENCY AS OUTLINED IN TABLE 6, THE LOWER DOSE SHOULD BE USED.

  Table 6. Recommended Maintenance Dosages of Ceftazidime for Injection in Renal Insufficiency

  Creatinine Clearance

  (mL/min)

  Recommended Unit

  Dose of Ceftazidime for Injection

  Frequency of

  Dosing

  50 to 31

  1 gram

  q12hr

  30 to 16

  1 gram

  q24hr

  15 to 6

  500 mg

  q24hr

  <5

  500 mg

  q48hr

  When only serum creatinine is available, the following formula (Cockcroft’s equation)5 may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function:

  Males: Creatinine clearance (mL/min) = Weight (kg) x (140 - age) __

  72 x serum creatinine (mg/dL)

  Females: 0.85 x male value

  In patients with severe infections who would normally receive 6 grams of ceftazidime for injection daily were it not for renal insufficiency, the unit dose given in the table above may be increased by 50% or the dosing frequency may be increased appropriately. Further dosing should be determined by therapeutic monitoring, severity of the infection, and susceptibility of the causative organism.

  In pediatric patients as for adults, the creatinine clearance should be adjusted for body surface area or lean body mass, and the dosing frequency should be reduced in cases of renal insufficiency.

  In patients undergoing hemodialysis, a loading dose of 1 gram is recommended, followed by 1 gram after each hemodialysis period.

  Ceftazidime for injection can also be used in patients undergoing intraperitoneal dialysis and continuous ambulatory peritoneal dialysis. In such patients, a loading dose of 1 gram of ceftazidime for injection may be given, followed by 500 mg every 24 hours. In addition to IV use, ceftazidime for injection can be incorporated in the dialysis fluid at a concentration of 250 mg for 2 L of dialysis fluid.

  Note: Generally ceftazidime for injection should be continued for 2 days after the signs and symptoms of infection have disappeared, but in complicated infections longer therapy may be required.

  Administration

  Ceftazidime for injection may be given intravenously or by deep IM injection into a large muscle mass such as the upper outer quadrant of the gluteus maximus or lateral part of the thigh. Intra-arterial administration should be avoided (see PRECAUTIONS).

  Intramuscular Administration: For IM administration, ceftazidime for injection should be constituted with one of the following diluents: Sterile Water for Injection, Bacteriostatic Water for Injection, or 0.5% or 1% Lidocaine Hydrochloride Injection. Refer to Table 7.

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

  For direct intermittent IV administration, constitute ceftazidime for injection as directed in Table 7 with Sterile Water for Injection. Slowly inject directly into the vein over a period of 3 to 5 minutes or give through the tubing of an administration set while the patient is also receiving one of the compatible IV fluids (see COMPATIBILITY AND STABILITY).

  For IV infusion, constitute the 1 gram, or 2 gram vial and add an appropriate quantity of the resulting solution to an IV container with one of the compatible IV fluids listed under the COMPATIBILITY AND STABILITY section.

  Intermittent IV infusion with a Y-type administration set can be accomplished with compatible solutions. However, during infusion of a solution containing ceftazidime, it is desirable to discontinue the other solution.

  Table 7. Preparation of Solutions of Ceftazidime for Injection * To obtain a dose of 1 g, withdraw 10 mL from the vial following reconstitution. † To obtain a dose of 2 g, withdraw 11.5 mL from the vial following reconstitution.

  Size

  Amount of Diluent to be Added

  (mL)

  Approximate Available Volume

  (mL)

  Approximate Ceftazidime Concentration

  (mg/mL)

  Intramuscular

  1 gram vial

  3

  3.6

  280

  Intravenous

  1 gram vial

  2 gram vial

  10

  10

  10.8*

  11.5†

  100

  170

  All vials of ceftazidime for injection as supplied are under reduced pressure. When ceftazidime for injection is dissolved, carbon dioxide is released and a positive pressure develops. For ease of use please follow the recommended techniques of constitution described on the detachable Instructions for Constitution section of this insert.

  Solutions of ceftazidime for injection, like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction.

  However, if concurrent therapy with ceftazidime for injection and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.

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• Hydrocodone Bitapap
  

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  Hydrocodone Bitapap

  

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  This insert is for the Pharmacy Bulk Package and is intended for preparing IV admixtures only. Dosage recommendations for intramuscular or direct intravenous injection are for informational purposes only.

  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8-hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6-to 8-hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Urethritis in males due to N. gonorrhoeae:

  Adults: Two doses of 500 mg each at an interval of 8 to 12 hours.

  Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months.

  The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis.

  Adults and children: 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia.

  Adults and children: 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

  For Administration by Intravenous Infusion

  Reconstitute as directed below (Directions for Proper Use of Pharmacy Bulk Package) prior to diluting with an intravenous solution.

  IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible. Stability studies on ampicillin sodium at several concentrations in various intravenous solutions indicate the drug will lose less than 10% activity at the temperatures noted for the time periods stated.

  Room Temperature (25°C)

  Diluent

  Concentrations

  Stability Periods

  Sterile Water for Injection

  up to 30 mg/mL

  8 hours

  Sodium Chloride Injection, USP 0.9%

  up to 30 mg/mL

  8 hours

  5% Dextrose in Water

  10 to 20 mg/mL

  1 hour

  5% Dextrose in Water

  up to 2 mg/mL

  2 hours

  5% Dextrose in 0.45% NaCl Inj.

  up to 2 mg/mL

  2 hours

  Lactated Ringer’s Solution

  up to 30 mg/mL

  8 hours

  Refrigerated (4°C)

  Sterile Water for Injection

  30 mg/mL

  48 hours

  Sterile Water for Injection

  up to 20 mg/mL

  72 hours

  Sodium Chloride Injection, USP, 0.9%

  30 mg/mL

  24 hours

  Sodium Chloride Injection, USP, 0.9%

  up to 20 mg/mL

  48 hours

  Lactated Ringer’s Solution

  up to 30 mg/mL

  24 hours

  5% Dextrose in Water

  up to 20 mg/mL

  1 hour

  5% Dextrose in 0.45% NaCl Inj.

  up to 10 mg/mL

  1 hour

  Only those solutions listed above should be used for the intravenous infusion of Ampicillin for Injection, USP. The concentrations should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of Ampicillin for Injection, USP is administered before the drug loses its stability in the solution in use.

  Directions for Proper Use of Pharmacy Bulk Package

  This glass Pharmacy Bulk Package bottle contains 10 grams Ampicillin and is designed for use in the pharmacy in preparing IV admixtures.

  a) Add 94 mL Sterile Water for Injection, USP. The resulting soluton will contain 100 milligrams ampicillin activity per mL, and is stable up to one hour at room temperature.

  b) Dilute further within ONE HOUR to a concentration of 5 mg to 10 mg per mL. See TABLE for suitable fluid. Use promptly. This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  c) Using aseptic technique under a laminar flow hood, the closure should be penetrated only one time after reconstitution using a suitable sterile dispensing set which allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage.

  d) After entry, use entire contents of Pharmacy Bulk Package bottle promptly. The entire contents of the Pharmacy Bulk Package bottle must be dispensed within ONE HOUR of reconstitution. This time limit should begin with the introduction of solvent in the Pharmacy Bulk Package Bottle.

  e) The hanger label on the Pharmacy Bulk Package provides a suitable hanging device while dispensing contents. If the Pharmacy Bulk Package does not have a hanger label, a plastic bail band will provide a suitable hanging device.

  Use of this product is restricted to a suitable work area, such as a laminar flow hood. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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  Cefuroxime

  

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  Dosage

  Adults: The usual adult dosage range for Cefuroxime for Injection, USP is 750 mg to 1.5 grams every 8 hours, usually for 5 to 10 days. In uncomplicated urinary tract infections, skin and skin structure infections, disseminated gonococcal infections, and uncomplicated pneumonia, a 750 mg dose every 8 hours is recommended. In severe or complicated infections, a 1.5 gram dose every 8 hours is recommended.

  In bone and joint infections, a 1.5 gram dose every 8 hours is recommended. In clinical trials, surgical intervention was performed when indicated as an adjunct to therapy with Cefuroxime for Injection, USP. A course of oral antibiotics was administered when appropriate following the completion of parenteral administration of Cefuroxime for Injection, USP.

  In life-threatening infections or infections due to less susceptible organisms, 1.5 grams every 6 hours may be required. In bacterial meningitis, the dosage should not exceed 3 grams every 8 hours. The recommended dosage for uncomplicated gonococcal infection is 1.5 grams given intramuscularly as a single dose at 2 different sites together with 1 gram of oral probenecid. For preventive use for clean-contaminated or potentially contaminated surgical procedures, a 1.5 gram dose administered intravenously just before surgery (approximately one-half to 1 hour before the initial incision) is recommended. Thereafter, give 750 mg intravenously or intramuscularly every 8 hours when the procedure is prolonged.

  For preventive use during open heart surgery, a 1.5 gram dose administered intravenously at the induction of anesthesia and every 12 hours thereafter for a total of 6 grams is recommended.

  Impaired Renal Function: A reduced dosage must be employed when renal function is impaired. Dosage should be determined by the degree of renal impairment and the susceptibility of the causative organism (see Table 2).

  Table 2:Dosage of Cefuroxime for Injection, USP in Adults With Reduced Renal Function * Since Cefuroxime for Injection, USP is dialyzable, patients on hemodialysis should be given a further dose at the end of the dialysis.

  Creatinine Clearance

  (mL/min) Dose Frequency >20 750 mg-1.5 grams q8h 10-20 750 mg q12h <10 750 mg q24h*

  When only serum creatinine is available, the following formula2 (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: Creatinine clearance (mL/min) = Weight (kg) x (140 – age) 72 x serum creatinine (mg/dL) Females: 0.85 x male value

  NOTE: As with antibiotic therapy in general, administration of Cefuroxime for Injection, USP should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended in infections caused by Streptococcus pyogenes 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 for several weeks; and doses smaller than those indicated above should not be used. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

  Pediatric Patients Above 3 Months of Age: Administration of 50 to 100 mg/kg per day in equally divided doses every 6 to 8 hours has been successful for most infections susceptible to cefuroxime. The higher dosage of 100 mg/kg per day (not to exceed the maximum adult dosage) should be used for the more severe or serious infections.

  In bone and joint infections, 150 mg/kg per day (not to exceed the maximum adult dosage) is recommended in equally divided doses every 8 hours. In clinical trials, a course of oral antibiotics was administered to pediatric patients following the completion of parenteral administration of Cefuroxime for Injection, USP.

  In cases of bacterial meningitis, a larger dosage of Cefuroxime for Injection, USP is recommended, 200 to 240 mg/kg per day intravenously in divided doses every 6 to 8 hours.

  In pediatric patients with renal insufficiency, the frequency of dosing should be modified consistent with the recommendations for adults.

  Preparation of Solution and Suspension

  The directions for preparing Cefuroxime for Injection, USP for both IV and IM use are summarized in Table 3.

  For Intramuscular Use: Each 750 mg vial of Cefuroxime for Injection, USP should be constituted with 3 mL of Sterile Water for Injection. Shake gently to disperse and withdraw completely the resulting suspension for injection.

  For Intravenous Use: Each 750 mg vial should be constituted with 8.3 mL of Sterile Water for Injection. Withdraw completely the resulting solution for injection.

  Each 1.5 gram vial should be constituted with 16 mL of Sterile Water for Injection, and the solution should be completely withdrawn for injection.

  Each 750 mg and 1.5 gram infusion bottle should be constituted with 100 mL of Sterile Water for Injection, 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or any of the solutions listed under the Intravenous portion of the Compatibility and Stability section.

  Table 3: Preparation of Solution and Suspension * Note: Cefuroxime for Injection, USP is a suspension at IM concentrations. Strength

  Amount of

  Diluent to

  be Added (mL)

  Volume to be

  Withdrawn

  Approximate

  Cefuroxime

  Concentration

  (mg/mL) 750 mg Vial 3 (IM) Total* 225 750 mg Vial 8.3 (IV) Total 90 1.5 gram Vial 16 (IV) Total 90 750 mg Infusion bottle 100 (IV) - 7.5 1.5 gram Infusion bottle 100 (IV) - 15

  Administration

  After constitution, Cefuroxime for Injection, USP may be given intravenously or by deep IM injection into a large muscle mass (such as the gluteus or lateral part of the thigh). Before injecting intramuscularly, aspiration is necessary to avoid inadvertent injection into a blood vessel.

  Intravenous Administration: The IV route may be preferable for patients with bacterial septicemia or other severe or life-threatening infections or for patients who may be poor risks because of lowered resistance, particularly if shock is present or impending.

  For direct intermittent IV administration, slowly inject the solution into a vein over a period of 3 to 5 minutes or give it through the tubing system by which the patient is also receiving other IV solutions.

  For intermittent IV infusion with a Y-type administration set, dosing can be accomplished through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing Cefuroxime for Injection, USP, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For continuous IV infusion, a solution of Cefuroxime for Injection, USP may be added to an IV infusion pack containing one of the following fluids: 0.9% Sodium Chloride Injection; 5% Dextrose Injection; 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; or 1/6 M Sodium Lactate Injection.

  Solutions of Cefuroxime for Injection, USP, like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction.

  However, if concurrent therapy with Cefuroxime for Injection, USP and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.

  Compatibility and Stability

  Intramuscular: When constituted as directed with Sterile Water for Injection, suspensions of cefuroxime for IM injection maintain satisfactory potency for 24 hours at room temperature and for 48 hours under refrigeration (5°C).

  After the periods mentioned above any unused suspensions should be discarded.

  Intravenous: When the 750 mg and 1.5 g vials are constituted as directed with Sterile Water for Injection, the solutions Cefuroxime for Injection, USP for IV administration maintain satisfactory potency for 24 hours at room temperature and for 48 hours (750 mg and 1.5 g vials) under refrigeration (5°C). More dilute solutions, such as 750 mg or 1.5 g plus 100 mL of Sterile Water for Injection, 5% Dextrose Injection, or 0.9% Sodium Chloride Injection, also maintain satisfactory potency for 24 hours at room temperature and for 7 days under refrigeration.

  These solutions may be further diluted to concentrations of between 1 and 30 mg/mL in the following solutions and will lose not more than 10% activity for 24 hours at room temperature or for at least 7 days under refrigeration: 0.9% Sodium Chloride Injection; 1/6 M Sodium Lactate Injection; Ringer’s Injection, USP; Lactated Ringer’s Injection, USP; 5% Dextrose and 0.9% Sodium Chloride Injection; 5% Dextrose Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.225% Sodium Chloride Injection; 10% Dextrose Injection; and 10% Invert Sugar in Water for Injection.

  Unused solutions should be discarded after the time periods mentioned above.

  Cefuroxime for Injection, USP has also been found compatible for 24 hours at room temperature when admixed in IV infusion with heparin (10 and 50 U/mL) in 0.9% Sodium Chloride Injection and Potassium Chloride (10 and 40 mEq/L) in 0.9% Sodium Chloride Injection. Sodium Bicarbonate Injection, USP is not recommended for the dilution of Cefuroxime for Injection, USP.

  Frozen Stability: Constitute the 750 mg or 1.5 g vial as directed for IV administration in Table 3. Immediately withdraw the total contents of the 750 mg or 1.5 g vial and add to a minibag containing 50 or 100 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection and freeze. Frozen solutions are stable for 6 months when stored at -20°C. Frozen solutions should be thawed at room temperature and not refrozen. Do not force thaw by immersion in water baths or by microwave irradiation. Thawed solutions may be stored for up to 24 hours at room temperature or for 7 days in a refrigerator.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  As with other cephalosporins, Cefuroxime for Injection, USP powder as well as solutions and suspensions tend to darken, depending on storage conditions, without adversely affecting product potency.

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  Cefuroxime

  

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  This insert labeling is for a Pharmacy Bulk Package and is intended for preparing admixtures for intravenous infusion only.

  Dosage

  Adults: The usual adult dosage range for Cefuroxime for Injection, USP is 750 mg to 1.5 grams every 8 hours, usually for 5 to 10 days. In uncomplicated urinary tract infections, skin and skin structure infections, disseminated gonococcal infections, and uncomplicated pneumonia, a 750 mg dose every 8 hours is recommended. In severe or complicated infections, a 1.5 gram dose every 8 hours is recommended.

  In bone and joint infections, a 1.5 gram dose every 8 hours is recommended. In clinical trials, surgical intervention was performed when indicated as an adjunct to therapy with Cefuroxime for Injection, USP. A course of oral antibiotics was administered when appropriate following the completion of parenteral administration of Cefuroxime for Injection, USP.

  In life-threatening infections or infections due to less susceptible organisms, 1.5 grams every 6 hours may be required. In bacterial meningitis, the dosage should not exceed 3 grams every 8 hours. For preventive use for clean-contaminated or potentially contaminated surgical procedures, a 1.5 gram dose administered intravenously just before surgery (approximately one-half to 1 hour before the initial incision) is recommended. Thereafter, give 750 mg intravenously every 8 hours when the procedure is prolonged.

  For preventive use during open heart surgery, a 1.5 gram dose administered intravenously at the induction of anesthesia and every 12 hours thereafter for a total of 6 grams is recommended.

  Impaired Renal Function: A reduced dosage must be employed when renal function is impaired. Dosage should be determined by the degree of renal impairment and the susceptibility of the causative organism (see Table 2).

  Table 2:Dosage of Cefuroxime for Injection, USP in Adults With Reduced Renal Function * Since Cefuroxime for Injection, USP is dialyzable, patients on hemodialysis should be given a further dose at the end of the dialysis.

  Creatinine Clearance

  (mL/min) Dose Frequency >20 750 mg-1.5 grams q8h 10-20 750 mg q12h <10 750 mg q24h*

  When only serum creatinine is available, the following formula2 (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: clearance (mL/min) = Weight (kg) x (140 – age) 72 x serum creatinine (mg/dL) Females: 0.85 x male value

  NOTE: As with antibiotic therapy in general, administration of Cefuroxime for Injection, USP should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended in infections caused by Streptococcus pyogenes 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 for several weeks; and doses smaller than those indicated above should not be used. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

  Pediatric Patients Above 3 Months of Age: Administration of 50 to 100 mg/kg per day in equally divided doses every 6 to 8 hours has been successful for most infections susceptible to cefuroxime. The higher dosage of 100 mg/kg per day (not to exceed the maximum adult dosage) should be used for the more severe or serious infections.

  In bone and joint infections, 150 mg/kg per day (not to exceed the maximum adult dosage) is recommended in equally divided doses every 8 hours. In clinical trials, a course of oral antibiotics was administered to pediatric patients following the completion of parenteral administration of Cefuroxime for Injection, USP.

  In cases of bacterial meningitis, a larger dosage of Cefuroxime for Injection, USP is recommended, 200 to 240 mg/kg per day intravenously in divided doses every 6 to 8 hours.

  In pediatric patients with renal insufficiency, the frequency of dosing should be modified consistent with the recommendations for adults.

  Directions for Dispensing

  Pharmacy Bulk Package – Not for Direct Infusion: The pharmacy bulk package is for use in a pharmacy admixture service only under a laminar flow hood. Entry into the vial must be made with a sterile transfer set or other sterile dispensing device, and the contents dispensed in aliquots using aseptic technique, the closure should be penetrated only one time using a suitable sterile dispensing set; which allows measured dispensing of the contents. The use of a syringe and needle is not recommended as it may cause leakage (see DOSAGE AND ADMINISTRATION). AFTER INITIAL WITHDRAWAL USE ENTIRE CONTENTS OF VIAL PROMPTLY. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS.

  Preparation of Solution

  Pharmacy Bulk Package – Not for Direct Infusion: This pharmacy bulk package is designed for use in the pharmacy in preparing admixtures for intravenous infusion only. Use of this product is restricted to a suitable work area, such as a laminar flow hood. The 7.5 grams pharmacy bulk package should be constituted with 77 mL of Sterile Water for Injection; each 8 mL of the resulting solution contains 750 mg of cefuroxime; 16 mL of solution contains 1.5 grams of cefuroxime (approximate cefuroxime concentration equals 95 mg/mL).

  THIS PACKAGE IS NOT TO BE DISPENSED AS A UNIT.

  Administration

  After constitution, the intent of this pharmacy bulk package is for the preparation of solutions for IV infusion only.

  Intravenous Administration: The IV route may be preferable for patients with bacterial septicemia or other severe or life-threatening infections or for patients who may be poor risks because of lowered resistance, particularly if shock is present or impending.

  For intermittent IV infusion with a Y-type administration set, dosing can be accomplished through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing Cefuroxime for Injection, USP, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For continuous IV infusion, a solution of Cefuroxime for Injection, USP may be added to an IV infusion pack containing one of the following fluids: 0.9% Sodium Chloride Injection; 5% Dextrose Injection; 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; or 1/6 M Sodium Lactate Injection.

  Solutions of Cefuroxime for Injection, USP, like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction.

  However, if concurrent therapy with Cefuroxime for Injection, USP and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.

  Compatibility and Stability

  Intravenous: When the 7.5 g pharmacy bulk package is constituted as directed with Sterile Water for Injection the contents should be withdrawn without delay. However, should this not be possible, a maximum time of 4 hours from initial closure entry is permitted to complete fluid transfer operations. More dilute solutions, such as 750 mg or 1.5 g plus 100 mL of Sterile Water for Injection, 5% Dextrose Injection, or 0.9% Sodium Chloride Injection, also maintain satisfactory potency for 24 hours at room temperature and for 7 days under refrigeration.

  These solutions may be further diluted to concentrations of between 1 and 30 mg/mL in the following solutions and will lose not more than 10% activity for 24 hours at room temperature or for at least 7 days under refrigeration: 0.9% Sodium Chloride Injection; 1/6 M Sodium Lactate Injection; Ringer’s Injection, USP; Lactated Ringer’s Injection, USP; 5% Dextrose and 0.9% Sodium Chloride Injection; 5% Dextrose Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.225% Sodium Chloride Injection; 10% Dextrose Injection; and 10% Invert Sugar in Water for Injection.

  Unused solutions should be discarded after the time periods mentioned above.

  Cefuroxime for Injection, USP has also been found compatible for 24 hours at room temperature when admixed in IV infusion with heparin (10 and 50 U/mL) in 0.9% Sodium Chloride Injection and Potassium Chloride (10 and 40 mEq/L) in 0.9% Sodium Chloride Injection. Sodium Bicarbonate Injection, USP is not recommended for the dilution of Cefuroxime for Injection, USP.

  Frozen Stability: Constitute the 7.5 g pharmacy bulk package vial as directed for IV administration. Immediately withdraw 8 mL or 16 mL from the 7.5 g pharmacy bulk package vial and add to a minibag containing 50 or 100 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection and freeze. Frozen solutions are stable for 6 months when stored at -20°C. Frozen solutions should be thawed at room temperature and not refrozen. Do not force thaw by immersion in water baths or by microwave irradiation. Thawed solutions may be stored for up to 24 hours at room temperature or for 7 days in a refrigerator.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  As with other cephalosporins, Cefuroxime for Injection, USP powder as well as solutions and suspensions tend to darken, depending on storage conditions, without adversely affecting product potency.

  The container may be hung by the attached bail band during dispensing of the contents.

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  Piperacillin And Tazobactam

  

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  Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.

  2.1     Adult Patients

  The usual total daily dose of piperacillin and tazobactam for injection for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam).  The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.

  Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.

  2.2     Nosocomial Pneumonia

  Initial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g piperacillin/2.0 g tazobactam).  The recommended duration of piperacillin and tazobactam for injection treatment for nosocomial pneumonia is 7 to 14 days.  Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.

  2.3     Renal Impairment

  In patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of actual renal function impairment.  The recommended daily doses of piperacillin and tazobactam for injection for patients with renal impairment are as follows:

  Table 1:  Recommended Dosing of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal Impairment (As total grams piperacillin/tazobactam)

  Renal Function

        

  (creatinine clearance,

  All Indications

  Nosocomial

  mL/min)

  (except nosocomial pneumonia)

  Pneumonia

  >40 mL/min

  3.375 q6h

  4.5 q6h

  20-40 mL/min*

  2.25 q6h

  3.375 q6h

  <20 mL/min*

  2.25 q8h

  2.25 q6h

  Hemodialysis**

  2.25 q12h

  2.25 q8h

  CAPD

  2.25 q12h

  2.25 q8h

  *Creatinine clearance for patients not receiving hemodialysis**0.75 g (0.67 g piperacillin/0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis days

  For patients on hemodialysis, the maximum dose is 2.25 g every twelve hours for all indications other than nosocomial pneumonia and 2.25 g every eight hours for nosocomial pneumonia.  Since hemodialysis removes 30% to 40% of the administered dose, an additional dose of 0.75 g piperacillin and tazobactam for injection (0.67 g piperacillin/0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days.  No additional dosage of piperacillin and tazobactam for injection is necessary for CAPD patients.

  2.4     Pediatric Patients

  For children with appendicitis and/or peritonitis 9 months of age or older, weighing up to 40 kg, and with normal renal function, the recommended piperacillin and tazobactam for injection dosage is 100 mg piperacillin/12.5 mg tazobactam per kilogram of body weight, every 8 hours.  For pediatric patients between 2 months and 9 months of age, the recommended piperacillin and tazobactam for injection dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)].  Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose.  It has not been determined how to adjust piperacillin and tazobactam for injection dosage in pediatric patients with renal impairment.

  2.5     Reconstitution and Dilution of Powder Formulations

  Single Dose Vials

  Reconstitute piperacillin and tazobactam for injection vials with a compatible reconstitution diluent from the list provided below.

  2.25 g, 3.375 g, and 4.5 g piperacillin and tazobactam for injection should be reconstituted with 10 mL, 15 mL, and 20 mL, respectively.  Swirl until dissolved.

  Compatible Reconstitution Diluents for Single Dose Vials 0.9% Sodium chloride for injectionSterile water for injection‡ Dextrose 5%Bacteriostatic saline/parabensBacteriostatic water/parabensBacteriostatic saline/benzyl alcoholBacteriostatic water/benzyl alcohol

  Reconstituted piperacillin and tazobactam for injection solution should be further diluted (recommended volume per dose of 50 mL to 150 mL) in a compatible intravenous solution listed below.  Administer by infusion over a period of at least 30 minutes.  During the infusion it is desirable to discontinue the primary infusion solution.

  Compatible Intravenous Solutions for Single Dose Vials 0.9% Sodium chloride for injectionSterile water for injection‡ Dextran 6% in salineDextrose 5%

  LACTATED RINGER’S SOLUTION IS NOT COMPATIBILE WITH PIPERACILLIN AND TAZOBACTAM FOR INJECTION. ‡ Maximum recommended volume per dose of sterile water for injection is 50 mL.

  Piperacillin and tazobactam for injection should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.

  Piperacillin and tazobactam for injection is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.

  Piperacillin and tazobactam for injection should not be added to blood products or albumin hydrolysates.

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

  Stability of Piperacillin and Tazobactam for Injection Powder Formulations Following Reconstitution

  Piperacillin and tazobactam for injection reconstituted from single vials is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents.  Discard unused portions after storage for 24 hours at room temperature or after storage for 48 hours at refrigerated temperature 2°C to 8°C (36°F to 46°F).

  Single dose vials should be used immediately after reconstitution.  Discard any unused portion after 24 hours if stored at room temperature 20°C to 25°C (68°F to 77°F), or after 48 hours if stored at refrigerated temperature 2°C to 8°C (36°F to 46°F).  Vials should not be frozen after reconstitution.

  Stability studies in the I.V. bags have demonstrated chemical stability (potency, pH of reconstituted solution and clarity of solution) for up to 24 hours at room temperature and up to one week at refrigerated temperature.  Piperacillin and tazobactam for injection contains no preservatives.  Appropriate consideration of aseptic technique should be used.

  Piperacillin and tazobactam for injection reconstituted from single vials can be used in ambulatory intravenous infusion pumps.  Stability of piperacillin and tazobactam for injection in an ambulatory intravenous infusion pump has been demonstrated for a period of 12 hours at room temperature.  Each dose was reconstituted and diluted to a volume of 37.5 mL or 25 mL.  One-day supplies of dosing solution were aseptically transferred into the medication reservoir (I.V. bags or cartridge).  The reservoir was fitted to a preprogrammed ambulatory intravenous infusion pump per the manufacturer's instructions.  Stability of piperacillin and tazobactam for injection is not affected when administered using an ambulatory intravenous infusion pump.

  2.6     Compatibility with Aminoglycosides

  Due to the in vitro inactivation of aminoglycosides by piperacillin, Piperacillin and tazobactam for injection and aminoglycosides are recommended for separate administration.  Piperacillin and tazobactam for injection and aminoglycosides should be reconstituted, diluted, and administered separately when concomitant therapy with aminoglycosides is indicated [see Drug Interactions (7.1)].

  In circumstances where co-administration via Y-site is necessary, piperacillin and tazobactam for injection is compatible for simultaneous coadministration via Y-site infusion only with the following aminoglycosides under the following conditions:

  Table 2: Compatibility with Aminoglycosides

  Aminoglycoside

  Piperacillin and Tazobactam Dose (grams)

  Piperacillin and Tazobactam Diluent Volume (mL)

  Aminoglycoside Concentration Range a (mg/mL)

  Acceptable Diluents

  Amikacin

  2.25, 3.375, 4.5

  50, 100, 150

  1.75 – 7.5

  0.9% sodium chloride or 5% dextrose

  Gentamicin

  2.25, 3.375, 4.5

  50, 100 150

  0.7 – 3.32

  0.9% sodium chloride or 5% dextrose

  aThe concentration ranges in Table 2 are based on administration of the aminoglycoside in divided doses (10-15 mg/kg/day in two daily doses for amikacin and 3-5 mg/kg/day in three daily doses for gentamicin).  Administration of amikacin or gentamicin in a single daily dose or in doses exceeding those stated above via Y-site with piperacillin and tazobactam has not been evaluated.  See package insert for each aminoglycoside for complete Dosage and Administration instructions.

  Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam for injection listed above have been established as compatible for coadministration via Y-site infusion.  Simultaneous coadministration via Y-site infusion in any manner other than listed above may result in inactivation of the aminoglycoside by piperacillin and tazobactam for injection.

  Piperacillin and tazobactam for injection is not compatible with tobramycin for simultaneous coadministration via Y-site infusion.  Compatibility of piperacillin and tazobactam with other aminoglycosides has not been established.

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

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• Nafcillin
  

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  Nafcillin

  

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  Nafcillin for Injection is available for intramuscular and intravenous injection. The usual I.V. dosage for adults is 500 mg every 4 hours. For severe infections, 1 g every 4 hours is recommended. Administer slowly over at least 30 to 60 minutes to minimize the risk of vein irritation and extravasation.

  RECOMMENDED DOSAGE FOR NAFCILLIN FOR INJECTION, USP

  Drug

  Adults

  Infants and Children < 40 kg (88 lbs)

  Other Recommendations

  Nafcillin

  500 mg IM every 4 to 6 hours. IV every 4 hours

  25 mg/kg IM twice daily

  Neonates 10 mg/kg IM twice daily

  1 gram IM or IV every 4 hours (severe infections)

  Bacteriologic studies to determine the causative organisms and their susceptibility to nafcillin should always be performed. Duration of therapy varies with the type and severity of infection as well as the overall condition of the patient, therefore it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with nafcillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. The treatment of endocarditis and osteomyelitis may require a longer duration of therapy.

  Nafcillin-probenecid therapy is generally limited to those infections where very high serum levels of nafcillin are necessary.

  No dosage alterations are necessary for patients with renal dysfunction, including those on hemodialysis. Hemodialysis does not accelerate nafcillin clearance from the blood.

  For patients with hepatic insufficiency and renal failure, measurement of nafcillin serum levels should be performed and dosage adjusted accordingly.

  With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

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

  DIRECTIONS FOR USE

  For Intramuscular Use

  Reconstitute with Sterile Water for Injection, USP, 0.9% Sodium Chloride Injection, USP or Bacteriostatic Water for Injection, USP (with benzyl alcohol or parabens); add 3.4 mL to the 1 g vial for 4 mL resulting solution; 6.6 mL to the 2 g vial for 8 mL resulting solution. All reconstituted vials have a concentration of 250 mg per mL.

  The clear solution should be administered by deep intragluteal injection immediately after reconstitution.

  Reconstituted Stability

  Reconstitute with the required amount of Sterile Water for Injection, USP, 0.9% Sodium Chloride Injection, USP or Bacteriostatic Water for Injection, USP (with benzyl alcohol or parabens). The resulting solutions are stable for 3 days at room temperature or 7 days under refrigeration and 90 days frozen.

  For Direct Intravenous Use

  The required amount of drug should be diluted in 15 to 30 mL of Sterile Water for Injection, USP or Sodium Chloride Injection, USP and injected over a 5- to 10- minute period. This may be accomplished through the tubing of an intravenous infusion if desirable.

  For Administration by Intravenous Drip

  Reconstitute as directed above (for intravenous use) prior to diluting with intravenous Solution.

  STABILITY PERIODS FOR NAFCILLIN FOR INJECTION, USP*

  Concentration mg/mL

  Sterile Water for Injection, USP

  Sodium Chloride Injection, USP (0.9%)

  Sodium Lactate Solution, USP (M/6 Molar)

  Dextrose Injection, USP (5%)

  Dextrose and Sodium Chloride Injection USP (5% Dextrose and 0.45% Sodium Chloride)

  Invert Sugar Injection USP (10%)

  Lactated Ringer’s Injection, USP

  ROOM TEMPERATURE (25° C)

  10-200

  24 Hrs

  24 Hrs

  30

  24 Hrs

  2-30

  24 Hrs

  24 Hrs

  10-30

  24 Hrs

  24 Hrs

  REFRIGERATION (4° C)

  10-200

  7 Days

  7 Days

  10-30

  7 Days

  7 Days

  7 Days

  7 Days

  7 Days

  FROZEN (-15° C)

  250

  90 Days

  90 Days

  10-250

  90 Days

  90 Days

  90 Days

  90 Days

  90 Days

  *IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practices suggest that a product should be used as soon after preparation as feasible.

  Only those solutions listed above should be used for the intravenous infusion of Nafcillin for Injection, USP. The concentration of the antibiotic should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of nafcillin is administered before the drug loses its stability in the solution in use.

  There is no clinical experience available on the use of this agent in neonates or infants for this route of administration.

  This route of administration should be used for relatively short-term therapy (24 to 48 hours) because of the occasional occurrence of thrombophlebitis particularly in elderly patients.

  If another agent is used in conjunction with nafcillin therapy, it should not be physically mixed with nafcillin but should be administered separately.

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• Piperacillin And Tazoba...
  

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  Piperacillin And Tazobactam

  

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  Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.

  2.1 Adult Patients

  The usual total daily dose of piperacillin and tazobactam for injection for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam).  The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.

  Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.

  2.2 Nosocomial Pneumonia

  Initial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g piperacillin/2.0 g tazobactam).  The recommended duration of piperacillin and tazobactam for injection treatment for nosocomial pneumonia is 7 to 14 days.  Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.

  2.3 Renal Impairment

  In patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of actual renal function impairment.  The recommended daily doses of piperacillin and tazobactam for injection for patients with renal impairment are as follows:

  Table 1:  Recommended Dosing of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal Impairment (As total grams piperacillin/tazobactam)

  Renal Function

     

       

  (creatinine clearance,

  All Indications

  Nosocomial

  mL/min)

  (except nosocomial pneumonia)

  Pneumonia

  >40 mL/min

  3.375 q6h

  4.5 q6h

  20-40 mL/min*

  2.25 q6h

  3.375 q6h

  <20 mL/min*

  2.25 q8h

  2.25 q6h

  Hemodialysis**

  2.25 q12h

  2.25 q8h

  CAPD

  2.25 q12h

  2.25 q8h

  *Creatinine clearance for patients not receiving hemodialysis **0.75 g (0.67 g piperacillin/0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis days

  For patients on hemodialysis, the maximum dose is 2.25 g every twelve hours for all indications other than nosocomial pneumonia and 2.25 g every eight hours for nosocomial pneumonia.  Since hemodialysis removes 30% to 40% of the administered dose, an additional dose of 0.75 g piperacillin and tazobactam for injection (0.67 g piperacillin/0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days.  No additional dosage of piperacillin and tazobactam for injection is necessary for CAPD patients.

  2.4 Pediatric Patients

  For children with appendicitis and/or peritonitis 9 months of age or older, weighing up to 40 kg, and with normal renal function, the recommended piperacillin and tazobactam for injection dosage is 100 mg piperacillin/12.5 mg tazobactam per kilogram of body weight, every 8 hours.  For pediatric patients between 2 months and 9 months of age, the recommended piperacillin and tazobactam for injection dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)].  Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose.  It has not been determined how to adjust piperacillin and tazobactam for injection dosage in pediatric patients with renal impairment.

  2.5 Reconstitution and Dilution of Powder Formulations

  Pharmacy Bulk Package Bottles

  Reconstituted stock solution must be transferred and further diluted for intravenous infusion.

  The pharmacy bulk package bottle is for use in a hospital pharmacy admixture service only under a laminar flow hood.  After reconstitution, entry into the vial must be made with a sterile transfer set or other sterile dispensing device, and contents should be dispensed as aliquots into intravenous solution using aseptic technique.  Use entire contents of pharmacy bulk package bottle promptly.  Discard unused portion after 24 hours if stored at room temperature 20°C to 25°C (68°F to 77°F), or after 48 hours if stored at refrigerated temperature 2°C to 8°C (36°F to 46°F).

  Reconstitute the pharmacy bulk package bottle with exactly 152 mL of a compatible reconstitution diluent, listed below, to a concentration of 200 mg/mL of piperacillin and 25 mg/mL of tazobactam.  Shake well until dissolved.  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to and during administration whenever solution and container permit.

  Compatible Reconstitution Diluents for Pharmacy Bulk Bottles 0.9% Sodium chloride for injectionSterile water for injection‡ Dextrose 5%Bacteriostatic saline/parabensBacteriostatic water/parabensBacteriostatic saline/benzyl alcoholBacteriostatic water/benzyl alcohol

  Reconstituted piperacillin and tazobactam for injection solution should be further diluted (recommended volume per dose of 50 mL to 150 mL) in a compatible intravenous solution listed below.  Administer by infusion over a period of at least 30 minutes.  During the infusion it is desirable to discontinue the primary infusion solution.

  Compatible Intravenous Solutions for Pharmacy Bulk Package Bottles and Single Dose Vials 0.9% Sodium chloride for injectionSterile water for injection‡ Dextran 6% in salineDextrose 5%

  LACTATED RINGER’S SOLUTION IS NOT COMPATIBILE WITH PIPERACILLIN AND TAZOBACTAM FOR INJECTION.

  ‡ Maximum recommended volume per dose of sterile water for injection is 50 mL.

  Piperacillin and tazobactam for injection should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.

  Piperacillin and tazobactam for injection is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.

  Piperacillin and tazobactam for injection should not be added to blood products or albumin hydrolysates.

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

  Stability of Piperacillin and Tazobactam for Injection Powder Formulations Following Reconstitution

  Piperacillin and tazobactam for injection reconstituted from pharmacy bulk package bottles is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents.  The pharmacy bulk package bottle should NOT be frozen after reconstitution.  Discard unused portions after storage for 24 hours at room temperature or after storage for 48 hours at refrigerated temperature 2°C to 8°C (36°F to 46°F).

  Pharmacy bulk package bottles should be used immediately after reconstitution.  Discard any unused portion after 24 hours if stored at room temperature 20°C to 25°C (68°F to 77°F),  or after 48 hours if stored at refrigerated temperature 2°C to 8°C (36°F to 46°F).  Pharmacy bulk package bottles should not be frozen after reconstitution.

  Stability studies in the I.V. bags have demonstrated chemical stability (potency, pH of reconstituted solution and clarity of solution) for up to 24 hours at room temperature and up to one week at refrigerated temperature.  Piperacillin and tazobactam for injection contains no preservatives.  Appropriate consideration of aseptic technique should be used.

  Piperacillin and tazobactam for injection reconstituted from bulk package bottles can be used in ambulatory intravenous infusion pumps.  Stability of piperacillin and tazobactam for injection in an ambulatory intravenous infusion pump has been demonstrated for a period of 12 hours at room temperature.  Each dose was reconstituted and diluted to a volume of 37.5 mL or 25 mL.  One-day supplies of dosing solution were aseptically transferred into the medication reservoir (I.V. bags or cartridge).  The reservoir was fitted to a preprogrammed ambulatory intravenous infusion pump per the manufacturer's instructions.  Stability of piperacillin and tazobactam for injection is not affected when administered using an ambulatory intravenous infusion pump.

  2.6 Compatibility with Aminoglycosides

  Due to the in vitro inactivation of aminoglycosides by piperacillin, piperacillin and tazobactam for injection and aminoglycosides are recommended for separate administration.  Piperacillin and tazobactam for injection and aminoglycosides should be reconstituted, diluted, and administered separately when concomitant therapy with aminoglycosides is indicated [see Drug Interactions (7.1)].

  In circumstances where co-administration via Y-site is necessary, piperacillin and tazobactam is compatible for simultaneous coadministration via Y-site infusion only with the following aminoglycosides under the following conditions:

  Table 2: Compatibility with Aminoglycosides

  Aminoglycoside

  Piperacillin and Tazobactam Dose (grams)

  Piperacillin and Tazobactam Diluent Volume (mL)

  Aminoglycoside Concentration Rangea (mg/mL)

  Acceptable Diluents

  Amikacin

  2.25, 3.375, 4.5

  50, 100, 150

  1.75 – 7.5

  0.9% sodium chloride or 5% dextrose

  Gentamicin

  2.25, 3.375, 4.5

  50, 100 150

  0.7 – 3.32

  0.9% sodium chloride or 5% dextrose

  aThe concentration ranges in Table 2 are based on administration of the aminoglycoside in divided doses (10-15 mg/kg/day in two daily doses for amikacin and 3-5 mg/kg/day in three daily doses for gentamicin).  Administration of amikacin or gentamicin in a single daily dose or in doses exceeding those stated above via Y-site with piperacillin and tazobactam has not been evaluated.  See package insert for each aminoglycoside for complete Dosage and Administration instructions.

  Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam for injection listed above have been established as compatible for coadministration via Y-site infusion.  Simultaneous coadministration via Y-site infusion in any manner other than listed above may result in inactivation of the aminoglycoside by piperacillin and tazobactam.

  Piperacillin and tazobactam for injection is not compatible with tobramycin for simultaneous coadministration via Y-site infusion.  Compatibility of piperacillin and tazobactam with other aminoglycosides has not been established.

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

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• Paclitaxel
  

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  Paclitaxel

  

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  Note: Contact of the undiluted concentrate with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended. In order to minimize patient exposure to the plasticizer DEHP [di-(2-ethylhexyl)phthalate], which may be leached from PVC infusion bags or sets, diluted paclitaxel solutions should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets.

  All patients should be premedicated prior to paclitaxel administration in order to prevent severe hypersensitivity reactions. Such premedication may consist of dexamethasone 20 mg PO administered approximately 12 and 6 hours before paclitaxel, diphenhydramine (or its equivalent) 50 mg I.V. 30 to 60 minutes prior to paclitaxel, and cimetidine (300 mg) or ranitidine (50 mg) I.V. 30 to 60 minutes before paclitaxel.

  For patients with carcinoma of the ovary, the following regimens are recommended (see CLINICAL STUDIES, Ovarian Carcinoma):

  1. For previously untreated patients with carcinoma of the ovary, one of the following recommended regimens may be given every 3 weeks. In selecting the appropriate regimen, differences in toxicities should be considered (see TABLE 11 in ADVERSE REACTIONS, Disease-Specific Adverse Event Experiences). 1. Paclitaxel administered intravenously over 3 hours at a dose of 175 mg/m 2 followed by cisplatin at a dose of 75 mg/m 2; or 2. Paclitaxel administered intravenously over 24 hours at a dose of 135 mg/m 2 followed by cisplatin at a dose of 75 mg/m 2. 2. In patients previously treated with chemotherapy for carcinoma of the ovary, paclitaxel has been used at several doses and schedules; however, the optimal regimen is not yet clear (see CLINICAL STUDIES, Ovarian Carcinoma). The recommended regimen is paclitaxel 135 mg/m2 or 175 mg/m 2 administered intravenously over 3 hours every 3 weeks.

  For patients with carcinoma of the breast, the following is recommended (see CLINICAL STUDIES, Breast Carcinoma):

  1. For the adjuvant treatment of node-positive breast cancer, the recommended regimen is paclitaxel, at a dose of 175 mg/m 2 intravenously over 3 hours every 3 weeks for 4 courses administered sequentially to doxorubicin-containing combination chemotherapy. The clinical trial used 4 courses of doxorubicin and cyclophosphamide (see CLINICAL STUDIES, Breast Carcinoma). 2. After failure of initial chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy, paclitaxel at a dose of 175 mg/m 2 administered intravenously over 3 hours every 3 weeks has been shown to be effective.

  For patients with non-small cell lung carcinoma, the recommended regimen, given every 3 weeks, is paclitaxel administered intravenously over 24 hours at a dose of 135 mg/m2 followed by cisplatin, 75 mg/m2.

  For patients with AIDS-related Kaposi’s sarcoma, paclitaxel administered at a dose of 135 mg/m2 given intravenously over 3 hours every 3 weeks or at a dose of 100 mg/m2 given intravenously over 3 hours every 2 weeks is recommended (dose intensity 45 to 50 mg/m2/week). In the 2 clinical trials evaluating these schedules (see CLINICAL STUDIES, AIDS-Related Kaposi’s Sarcoma), the former schedule (135 mg/m2 every 3 weeks) was more toxic than the latter. In addition, all patients with low performance status were treated with the latter schedule (100 mg/m2 every 2 weeks).

  Based upon the immunosuppression in patients with advanced HIV disease, the following modifications are recommended in these patients:

  1. Reduce the dose of dexamethasone as 1 of the 3 premedication drugs to 10 mg PO (instead of 20 mg PO); 2. Initiate or repeat treatment with paclitaxel only if the neutrophil count is at least 1,000 cells/mm 3; 3. Reduce the dose of subsequent courses of paclitaxel by 20% for patients who experience severe neutropenia (neutrophil <500 cells/mm 3 for a week or longer); and 4. Initiate concomitant hematopoietic growth factor (G-CSF) as clinically indicated.

  For the therapy of patients with solid tumors (ovary, breast, and NSCLC), courses of paclitaxel should not be repeated until the neutrophil count is at least 1,500 cells/mm3 and the platelet count is at least 100,000 cells/mm3. Paclitaxel should not be given to patients with AIDS-related Kaposi’s sarcoma if the baseline or subsequent neutrophil count is less than 1,000 cells/mm3. Patients who experience severe neutropenia (neutrophil <500 cells/mm3 for a week or longer) or severe peripheral neuropathy during paclitaxel therapy should have dosage reduced by 20% for subsequent courses of paclitaxel. The incidence of neurotoxicity and the severity of neutropenia increase with dose.

  Preparation and Administration Precautions:

  Paclitaxel is a cytotoxic anticancer drug and, as with other potentially toxic compounds, caution should be exercised in handling paclitaxel. The use of gloves is recommended. If paclitaxel solution contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure, events have included tingling, burning and redness. If paclitaxel contacts mucous membranes, the membranes should be flushed thoroughly with water. Upon inhalation, dyspnea, chest pain, burning eyes, sore throat, and nausea have been reported.

  Hepatic Impairment

  Patients with hepatic impairment may be at increased risk of toxicity, particularly grade III–IV myelosuppression (see CLINICAL PHARMACOLOGY and PRECAUTIONS, Hepatic). Recommendations for dosage adjustment for the first course of therapy are shown in TABLE 17 for both 3- and 24-hour infusions. Further dose reduction in subsequent courses should be based on individual tolerance. Patients should be monitored closely for the development of profound myelosuppression.

  Table 17. Recommendations for Dosing in Patients with Hepatic Impairment Based on Clinical Trial Dataa

  Degree of Hepatic Impairment

  Recommended Paclitaxel Dosec

  Transaminase

  Levels

  Bilirubin Levelsb

  24-Hour Infusion

  <2 x ULN

  and

  ≤1.5 mg/dL

  135 mg/m2

  2 to <10 x ULN

  and

  ≤1.5 mg/dL

  100 mg/m2

  <10 x ULN

  and

  1.6 to 7.5 mg/dL

  50 mg/m2

  ≥10 x ULN

  or

  >7.5 mg/dL

  Not recommended

  3-Hour Infusion

  <10 x ULN

  and

  ≤1.25 x ULN

  175 mg/m2

  <10 x ULN

  and

  1.26 to 2.0 x ULN

  135 mg/m2

  <10 x ULN

  and

  2.01 to 5.0 x ULN

  90 mg/m2

  ≥10 x ULN

  or

  >5.0 x ULN

  Not recommended

  a   These recommendations are based on dosages for patients without hepatic imairement of 135 mg/m2 over 24 hours or 175 mg/m2 over 3 hours; data are not available to make dose adjustment recommendations for other regimens (eg, for AIDS-related Kaposi’s sarcoma).

  b   Differences in criteria for bilirubin levels between the 3- and 24-hour infusion are due to differences in clinical trial design.

  c   Dosage recommendations are for the first course of therapy; further dose reduction in subsequent courses should be based on individual tolerance.

  Preparation and Administration Precautions

  Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing paclitaxel injection. If paclitaxel solution contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure, events have included tingling, burning, and redness. If paclitaxel contacts mucous membranes, the membranes should be flushed thoroughly with water. Upon inhalation, dyspnea, chest pain, burning eyes, sore throat, and nausea have been reported.

  Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during drug administration (see PRECAUTIONS, Injection Site Reaction).

  Preparation for Intravenous Administration

  Paclitaxel must be diluted prior to infusion. Paclitaxel should be diluted in 0.9% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP; 5% Dextrose and 0.9% Sodium Chloride Injection, USP; or 5% Dextrose in Ringer’s Injection to a final concentration of 0.3 to 1.2 mg/mL. The solutions are physically and chemically stable for up to 27 hours at ambient temperature (approximately 25° C) and room lighting conditions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

  Upon preparation, solutions may show haziness, which is attributed to the formulation vehicle. No significant losses in potency have been noted following simulated delivery of the solution through IV tubing containing an in-line (0.22 micron) filter.

  Data collected for the presence of the extractable plasticizer DEHP [di-(2-ethylhexyl)phthalate] show that levels increase with time and concentration when dilutions are prepared in PVC containers. Consequently, the use of plasticized PVC containers and administration sets is not recommended. Paclitaxel solutions should be prepared and stored in glass, polypropylene, or polyolefin containers. Non-PVC containing administration sets, such as those which are polyethylene-lined, should be used.

  Paclitaxel should be administered through an in-line filter with a microporous membrane not greater than 0.22 microns. Use of filter devices such as IVEX-2® filters which incorporate short inlet and outlet PVC-coated tubing has not resulted in significant leaching of DEHP.

  The Chemo Dispensing Pin™ device or similar devices with spikes should not be used with vials of paclitaxel since they can cause the stopper to collapse resulting in loss of sterile integrity of the paclitaxel solution.

  Stability

  Unopened vials of paclitaxel are stable until the date indicated on the package when stored between 20° to 25°C (68° to 77°F), in the original package. Neither freezing nor refrigeration adversely affects the stability of the product. Upon refrigeration, components in the paclitaxel vial may precipitate, but will redissolve upon reaching room temperature with little or no agitation. There is no impact on product quality under these circumstances. If the solution remains cloudy or if an insoluble precipitate is noted, the vial should be discarded. Solutions for infusion prepared as recommended are stable at ambient temperature (approximately 25°C) and lighting conditions for up to 27 hours.

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• Cefoxitin
  

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  Cefoxitin

  

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  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 3 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.

  Cefoxitin for Injection 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 4) 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) x (140-age)

  72 x serum creatinine (mg/100 mL)

  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 4.

  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 4).

  PREVENTION

  Effective prophylactic use depends on the time of administration. Cefoxitin for Injection 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 3. Guidelines for Dosage of Cefoxitin for Injection

  Type of Infection

  Daily Dosage

  Frequency and Route

  Uncomplicated forms* of infections such as pneumonia, urinary tract infection, cutaneous infection

  3 to 4 grams

  1 gram every

  6 to 8 hours IV

  Moderately severe or severe infections

  6 to 8 grams

  1 gram every 4 hours

  or

  2 grams every 6 to 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

  *Including patients in whom bacteremia is absent or unlikely.

  Table 4. Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function

  Renal Function

  Creatinine

  Clearance (mL/min)

  Dose (Grams)

  Frequency

  Mild impairment

  50 to 30

  1 to 2

  Every 8 to 12 hours

  Moderate impairment

  29 to 10

  1 to 2

  Every 12 to 24 hours

  Severe impairment

  9 to 5

  0.5 to 1

  Every 12 to 24 hours

  Essentially no function

  < 5

  0.5 to 1

  Every 24 to 48 hours

  Table 5. Preparation of Solution for Intravenous Administration

  Strength

  Amount of Diluent to be Added (mL)**

  Approximate Withdrawable Volume (mL)

  Approximate

  Average

  Concentration (mg/mL)

  1 gram Vial

  10

  10.5

  95

  2 gram Vial

  10 or 20

  11.1 or 21

  180 or 95

  **Shake to dissolve and let stand until clear.

  PREPARATION OF SOLUTION

  Table 5 is provided for convenience in constituting Cefoxitin for Injection for intravenous administration.

  One gram should be constituted with at least 10 mL, and 2 grams with 10 or 20 mL, of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the COMPATIBILITY AND STABILITY section.

  Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, in whom use of Cefoxitin for Injection may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when Cefoxitin for Injection is constituted for administration to pediatric patients in this age range.

  ADMINISTRATION

  Cefoxitin for Injection may be administered intravenously after constitution.

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

  Intravenous Administration

  The intravenous route is preferable 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.

  For intermittent intravenous 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. Using 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 intravenous solutions. However, during infusion of the solution containing Cefoxitin for Injection, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For the administration of higher doses by continuous intravenous infusion, a solution of Cefoxitin for Injection may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY®†† or scalp vein-type needles are preferred for this type of infusion.

  Solutions of Cefoxitin for Injection, 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, Cefoxitin for Injection and aminoglycosides may be administered separately to the same patient.

  COMPATIBILITY AND STABILITY

  Cefoxitin for Injection, as supplied in vials and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, (see PREPARATION OF SOLUTION), 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, maintains satisfactory potency for 6 hours at room temperature or for one week under refrigeration (below 5ºC).

  These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration:

    0.9 percent Sodium Chloride Injection   5 percent or 10 percent Dextrose Injection   5 percent Dextrose and 0.9 percent Sodium Chloride Injection   5 percent Dextrose Injection with 0.2 percent or 0.45 percent saline solution   Lactated Ringer’s Injection   5 percent Dextrose in Lactated Ringer’s Injection   5 percent Sodium Bicarbonate Injection   M/6 sodium lactate solution   Mannitol 5% and 10%

  After the periods mentioned above, any unused solutions should be discarded.

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• Cefoxitin
  

  ×

  Cefoxitin

  

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   The intent of this pharmacy bulk package is for the preparation of solutions for intravenous infusion only.

  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 3 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.

  Cefoxitin for Injection 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 4) 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) x (140-age) 72 x serum creatinine (mg/100 mL)

  Females: 0.85 x above valueIn 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 4.

  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 4).

  PREVENTION

  Effective prophylactic use depends on the time of administration. Cefoxitin for Injection 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 3. Guidelines for Dosage of Cefoxitin for Injection

  Type of Infection Daily Dosage Frequency and Route Uncomplicated forms* of infections such as pneumonia, urinary tract infection, cutaneous infection 3 to 4 grams

  1 gram every

  6 to 8 hours IV Moderately severe or severe infections 6 to 8 grams

  1 gram every 4 hours

  or

  2 grams every 6 to 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

  *Including patients in whom bacteremia is absent or unlikely.

   Table 4. Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function

  Renal Function

  Creatinine

  Clearance (mL/min) Dose (Grams) Frequency Mild impairment 50 to 30 1 to 2 Every 8 to 12 hours Moderate impairment 29 to 10 1 to 2 Every 12 to 24 hours Severe impairment 9 to 5 0.5 to 1 Every 12 to 24 hours Essentially no function < 5 0.5 to 1 Every 24 to 48 hours

   Table 5. Preparation of Solution for Intravenous Administration

  Strength Amount of Diluent to be Added (mL)** Approximate Withdrawable Volume (mL)

  Approximate

  Average

  Concentration (mg/mL) Pharmacy Bulk Package - 10 grams 43 or 93 49 or 98.5 200 or 100

  **Shake to dissolve and let stand until clear.

  Directions for Proper Use of Pharmacy Bulk Package Bottle - Not for Direct Infusion: The Pharmacy Bulk Package Bottle is for use in a pharmacy admixture service only under a laminar flow hood. Penetration into the Pharmacy Bulk Package Bottle should be made only one time after reconstitution with a sterile transfer set or other sterile dispensing device, which allows measured distribution of the contents. Dispense the contents in aliquots using aseptic technique. The use of syringe with a needle is not recommended as it may cause leakage (See DOSAGE AND ADMINISTRATION). AFTER INITIAL ENTRY USE ENTIRE CONTENTS OF THE PHARMACY BULK PACKAGE PROMPTLY. A maximum time of 4 HOURS from initial entry is permitted to complete fluid transfer operations. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS. This time limit should begin with the introducing of solvent or diluent into the Pharmacy Bulk Package bottle. RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION.

  PREPARATION OF SOLUTION

  Table 5 is provided for convenience in constituting Cefoxitin for Injection for intravenous administration.

  For Bulk Packages

  The 10 gram bulk packages should be constituted with 43 or 93 mL of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. CAUTION: THE 10 GRAM BULK STOCK SOLUTION IS NOT FOR DIRECT INFUSION. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the COMPATIBILITY AND STABILITY section.

  Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, in whom use of Cefoxitin for Injection may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when Cefoxitin for Injection is constituted for administration to pediatric patients in this age range.

  ADMINISTRATION

  Cefoxitin for Injection may be administered intravenously after constitution.

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

  Intravenous Administration

  The intravenous route is preferable 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.

  For intermittent intravenous administration, using an infusion system, a solution containing 1 gram or 2 grams may be given over a period of time through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing Cefoxitin for Injection, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For the administration of higher doses by continuous intravenous infusion, a solution of Cefoxitin for Injection may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY®†† or scalp vein-type needles are preferred for this type of infusion.

  Solutions of Cefoxitin for Injection, 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, Cefoxitin for Injection and aminoglycosides may be administered separately to the same patient.

  COMPATIBILITY AND STABILITY

  Pharmacy Bulk Package

  Cefoxitin for Injection, as supplied in pharmacy bulk package bottles and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, (see PREPARATION OF SOLUTION), 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, should be DISCARDED 4 HOURS AFTER INITIAL ENTRY. FURTHER DILUTION IS REQUIRED BEFORE USE.

  These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration:

    0.9 percent Sodium Chloride Injection   5 percent or 10 percent Dextrose Injection   5 percent Dextrose and 0.9 percent Sodium Chloride Injection   5 percent Dextrose Injection with 0.2 percent or 0.45 percent saline solution   Lactated Ringer’s Injection   5 percent Dextrose in Lactated Ringer’s Injection   5 percent Sodium Bicarbonate Injection   M/6 sodium lactate solution   Mannitol 5% and 10%

  After the periods mentioned above, any unused solutions should be discarded.

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• Sodium Fluoride F 18
  

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  Sodium Fluoride F 18

  

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  Nafcillin for Injection, in the Pharmacy Bulk Package Bottle is for intravenous injection only.

  The usual IV dosage for adults is 500 mg every 4 hours.  For severe infections, 1 g every 4 hours is recommended.  Administer slowly over at least 30 to 60 minutes to minimize the risk of vein irritation and extravasation.  Bacteriologic studies to determine the causative organisms and their susceptibility to nafcillin should always be performed.  Duration of therapy varies with the type and severity of infection as well as the overall condition of the patient; therefore, it should be determined by the clinical and bacteriological response of the patient.  In severe staphylococcal infections, therapy with nafcillin should be continued for at least 14 days.  Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative.  The treatment of endocarditis and osteomyelitis may require a longer duration of therapy.

  Nafcillin-probenecid therapy is generally limited to those infections where very high serum levels of nafcillin are necessary.

  No dosage alterations are necessary for patients with renal dysfunction, including those on hemodialysis.  Hemodialysis does not accelerate nafcillin clearance from the blood.

  For patients with hepatic insufficiency and renal failure, measurement of nafcillin serum levels should be performed and dosage adjusted accordingly.

  With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

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

  Do not add supplementary medication to Nafcillin for Injection, USP.

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• Penicillin G Potassium
  

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  Penicillin G Potassium

  

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  Penicillin G potassium may be given intravenously or intramuscularly. The usual dose recommendations are as follows:

  Adult Patients

  (*)Because of its short half-life, Penicillin G is administered in divided doses, usually every 4-6 hours with the exception of meningococcal meningitis/septicemia, i.e., every 2 hours.

  * Because of its short half-life, Penicillin G is administered in divided doses, usuallyevery 4-6 hours with the exception of meningococcal meningitis/septicemia, i.e., every 2 hours. Clinical Indication Dosage Serious infections due to susceptible strains of streptococci (including S. pneumoniae) -septicemia, empyema, pneumonia, pericarditis, endocarditis and meningitis 12 to 24 million units/day depending on the infection and its severity administered in equally divided doses every 4 to 6 hours. Serious infections due to susceptible strains of staphylococci-septicemia, empyema, pneumonia, pericarditis, endocarditis and meningitis 5 to 24 million units/day depending on the infection and its severity administered in equally divided doses every 4 to 6 hours. Anthrax Minimum of 8 million units/day in divided doses every 6 hours. Higher doses may be required depending on susceptibility of organism. Actinomycosis Cervico-facial disease 1 to 6 million units/day * Thoracic and abdominal disease 10 to 20 million units/day * Clostridial Infections Botulism (adjunctive therapy to antitoxin) 20 million units/day * Gas gangrene (debridement and/or surgery as indicated) Tetanus (adjunctive therapy to human tetanus immune globulin) Diphtheria (adjunctive therapy to antitoxin and for the prevention of the carrier state) 2 to 3 million units/day in divided doses for 10 to 12 days* Erysipelothrix endocarditis 12 to 20 million units/day for 4 to 6 weeks* Fusospirochetosis (severe infections of the oropharynx [Vincent’s], lower respiratory tract and genital area) 5 to 10 million units/day * Listeria infections Meningitis 15 to 20 million units/day for 2 weeks * Endocarditis 15 to 20 million units/day for 4 weeks* Pasteurella infections including bacteremia and meningitis 4 to 6 million units/day for 2 weeks* Haverhill fever, Rat-bite fever 12 to 20 million units/day for 3 to 4 weeks*

  Disseminated gonococcal infections,

  such as meningitis, endocarditis,

  arthritis, etc., caused by penicillinsusceptible

  organisms 10 million units/day*; duration depends on the type of infection Syphilis (neurosyphilis)

  12 to 24 million units/day, as 2 to 4 MU every 4 hours for 10 to 14 days; many experts recommend additional therapy with Benzathine PCN G 2.4 MU IM weekly for 3 doses after completion of IV therapy Meningococcal meningitis and/or septicemia

  24 million units/day as 2 million units

  Meningococcal meningitis and/or

  septicemia 24 million units/day as 2 million units every 2 hours

   Pediatric Patients

  This product should not be administered to patients requiring less than one million units per dose. (see PRECAUTIONS, Pediatric Use)

  Clinical Indication Dosage Serious infections, such as pneumonia and endocarditis, due to susceptible strains of streptococci (including S. pneumoniae) and meningococcus 150,000 - 300,000 units/kg/day divided in equal doses every 4 to 6 hours; duration depends on infecting organ-ism and type of infection Meningitis caused by susceptible strains of pneumococcus and menin-gococcus 250,000 units/kg/day divided in equal doses every 4 hours for 7 to 14 days depending on the infecting organism (maximum dose of 12 to 20 million units/day) Disseminated Gonococcal infections (penicillin –susceptible strains) Weight less than 45 kg.: Arthritis 100,000 units/kg/day in 4 equally divided doses for 7 to 10 days Meningitis 250,000 units/kg/day in equal doses every 4 hours for 10 to 14 days Endocarditis 250,000 units/kg/day in equal doses every 4 hours for 4 weeks Arthritis, meningitis, endocarditis Weight 45 kg or greater: 10 million units/day in 4 equally divided doses with the duration of therapy depending on type of infection Syphilis (congenital and neurosyphilis) after the newborn period 200,000 to 300,000 units/kg/day (administered as 50,000 units/kg every 4 to 6 hours) for 10 to 14 days Diphtheria (adjunctive therapy to antitoxin and for prevention of the carrier state) 150,000 to 250,000 units/kg/day in equal doses every 6 hours for 7 to 10 days Rat-bite fever; Haverhill fever (with endocarditis caused by S. moniliformis) 150,000 to 250,000 units/kg/day in equal doses every 4 hours for 4 weeks

   Renal Impairment: Penicillin G is relatively nontoxic, and dosage adjustments are generally required only in cases of severe renal impairment. The recommended dosage regimens are as follows:

  Creatinine clearance less than 10 mL/min/1.73m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 8 to 10 hours.

  Uremic patients with a creatinine clearance greater than 10 mL/min/1.73m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 4 to 5 hours. Additional dosage modifications should be made in patients with hepatic disease and renal impairment.

  For most acute infections, treatment should be continued for at least 48 to 72 hours after the patient becomes asymptomatic. Antibiotic therapy for Group A β-hemolytic streptococcal infections should be maintained for at least 10 days to reduce the risk of rheumatic fever. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Preparation of Solution: Solutions of penicillin should be prepared as follows: Loosen powder. Hold vial horizontally and rotate it while slowly directing the stream of diluent against the wall of the vial. Shake vial vigorously after all the diluent has been added. Depending on the route of administration, use Sterile Water for Injection, USP or Sterile Isotonic Sodium Chloride for Parenteral use.

  Note: Penicillins are rapidly inactivated in the presence of carbohydrate solutions at alkaline pH.

  Reconstitution: The following table shows the amount of solvent required for solution of various concentrations:

  Approx. Desired

  Concentration

  (units/ mL)

  Approx. Volume

  for 1,000,000

  units (mL)

  Solvent for Vial of

  5,000,000

  units (mL)

  Infusion Only

  20,000,000

  units (mL) 50,000 20 - - 100,000 10 - - 250,000 4 18.2 75 500,000 1.8 8.2 33 750,000 - 4.8 - 1,000,000 - 3.2 11.5

  When the required volume of solvent is greater than the capacity of the vial, the penicillin can be dissolved by first injecting only a portion of the solvent into the vial, then withdrawing the resultant solution and combining it with the remainder of the solvent in a larger sterile container.

  Penicillin G potassium is highly water soluble. It may be dissolved in small amounts of Water for Injection, or Sterile Isotonic Sodium Chloride Solution for Parenteral Use. All solutions should be stored in a refrigerator. When refrigerated, penicillin solutions may be stored for seven days without significant loss of potency.

  Penicillin G potassium may be given intramuscularly or by continuous intravenous drip for dosages of 500,000, 1,000,000, or 5,000,000 units. It is also suitable for intrapleural, intraarticular, and other local instillations.

  THE 20,000,000 UNITS (20 MILLION UNITS) DOSAGE MAY BE ADMINISTERED BY INTRAVENOUS INFUSION ONLY.

  (1) Intramuscular Injection: Keep total volume of injection small. The intramuscular route is the preferred route of administration. Solutions containing up to 100,000 units of penicillin per mL of diluent may be used with a minimum of discomfort. Greater concentration of penicillin G per mL is physically possible and may be employed where therapy demands. When large doses are required, it may be advisable to administer aqueous solutions of penicillin by means of continuous intravenous drip.

  (2) Continuous Intravenous Drip: Determine the volume of fluid and rate of its administration required by the patient in a 24 hour period in the usual manner for fluid therapy, and add the appropriate daily dosage of penicillin to this fluid. For example, if an adult patient requires 2 liters of fluid in 24 hours and a daily dosage of 10 million units of penicillin, add 5 million units to 1 liter and adjust the rate of flow so the liter will be infused in 12 hours.

  (3) Intrapleural or Other Local Infusion: If fluid is aspirated, give infusion in a volume equal to ¼ or ½ the amount of fluid aspirated, otherwise, prepare as for an intramuscular injection.

  (4) Intrathecal Use: The intrathecal use of penicillin in meningitis must be highly individualized. It should be employed only with full consideration of the possible irritating effects of penicillin when used by this route. The preferred route of therapy in bacterial meningitides is intravenous, supplemented by intramuscular injection.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Sterile solution may be left in refrigerator for one week without significant loss of potency.

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• Ampicillin And Sulbacta...
  

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  Ampicillin And Sulbactam

  

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  Ampicillin and Sulbactam for Injection may be administered by either the IV or the IM routes.

  For IV administration, the dose can be given by slow intravenous injection over at least 10-15 minutes or can also be delivered in greater dilutions with 50-100 mL of a compatible diluent as an intravenous infusion over 15-30 minutes.

  Ampicillin and Sulbactam for Injection may be administered by deep intramuscular injection (see DIRECTIONS FOR USE - Preparation for Intramuscular Injection section). The recommended adult dosage of Ampicillin and Sulbactam for Injection is 1.5 g (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) to 3 g (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) every six hours. This 1.5 to 3 g range represents the total of ampicillin content plus the sulbactam content of Ampicillin and Sulbactam for Injection, and corresponds to a range of 1 g ampicillin/0.5 g sulbactam to 2 g ampicillin/1 g sulbactam. The total dose of sulbactam should not exceed 4 grams per day.

  Pediatric Patients 1 Year of Age or Older

  The recommended daily dose of Ampicillin and Sulbactam for Injection in pediatric patients is 300 mg per kg of body weight administered via intravenous infusion in equally divided doses every 6 hours. This 300 mg/kg/day dosage represents the total ampicillin content plus the sulbactam content of Ampicillin and Sulbactam for Injection, and corresponds to 200 mg ampicillin/100 mg sulbactam per kg per day. The safety and efficacy of Ampicillin and Sulbactam for Injection administered via intramuscular injection in pediatric patients have not been established. Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations, and the total dose of sulbactam should not exceed 4 grams per day. The course of intravenous therapy sshould not routinely exceed 14 days. In clinical trials, most children received a course of ooral antimicrobials following initial treatment with intravenous Ampicillin and Sulbactam ffor Injection (see CLINICAL STUDIES section).

  Impaired Renal Function

  In patients with impairment of renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function. The dose of Ampicillin and Sulbactam for Injection in such patients should be administered less frequently in accordance with the usual practice for ampicillin and according to the following recommendations:

  TABLE 5 Ampicillin And Sulbactam For Injection Dosage Guide for Patients With Renal Impairment Creatinine Clearance (mL/min/1.73m2) Ampicillin/ Sulbactam Half-Life (Hours) Recommended Ampicillin/Sulbactam Dosage ≥ 30 1 1.5-3 g q 6 h-q 8h 15-29 5 1.5-3 g q 12h 5-14 9 1.5-3 g q 24h

  When only serum creatinine 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 Females 0.85 × above value

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

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• Ampicillin And Sulbacta...
  

  ×

  Ampicillin And Sulbactam

  

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  Ampicillin and Sulbactam for Injection may be used for parenteral administration.

  THE INTENT OF THE PHARMACY BULK PACKAGE IS FOR PREPARATION OFSOLUTIONS FOR IV INFUSION ONLY.

  For IV administration, the dose can be given by slow intravenous injection over at least 10-15 minutes or can also be delivered in greater dilutions with 50-100 mL of a compatible diluent as an intravenous infusion over 15-30 minutes.

  The recommended adult dosage of Ampicillin and Sulbactam is 1.5 g (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) to 3 g (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) every six hours. This 1.5 to 3 g range represents the total of ampicillin content plus the sulbactam content of Ampicillin and Sulbactam for Injection, and corresponds to a range of 1 g ampicillin/0.5 g sulbactam to 2 g ampicillin/1 g sulbactam. The total dose of sulbactam should not exceed 4 grams per day.

  Pediatric Patients 1 Year of Age or Older

  The recommended daily dose of Ampicillin and Sulbactam for Injection in pediatric patients is 300 mg per kg of body weight administered via intravenous infusion in equally divided doses every 6 hours. This 300 mg/kg/day dosage represents the total ampicillin content plus the sulbactam content of Ampicillin and Sulbactam for Injection, and corresponds to 200 mg ampicillin/100 mg sulbactam per kg per day. The safety and efficacy of Ampicillin and Sulbactam for Injection administered via intramuscular injection in pediatric patients have not been established. Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations, and the total dose of sulbactam should not exceed 4 grams per day. The course of intravenous therapy should not routinely exceed 14 days. In clinical trials, most children received a course of oral antimicrobials following initial treatment with intravenous Ampicillin and Sulbactam for Injection (see CLINICAL STUDIES section).

  Impaired Renal Function

  In patients with impairment of renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function. The dose of Ampicillin and Sulbactam for Injection in such patients should be administered less frequently in accordance with the usual practice for ampicillin and according to the following recommendations:

  TABLE 5 Ampicillin and Sulbactam For Injection Dosage Guide for Patients With Renal Impairment Creatinine Clearance (mL/min/1.73m2) Ampicillin/ Sulbactam Half-Life (Hours) Recommended Ampicillin And Sulbactam For Injection Dosage ≥ 30 1 1.5-3 g q 6h-q 8h 15-29 5 1.5-3 g q 12h 5-14 9 1.5-3 g q 24h

  When only serum creatinine 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 Females 0.85 × above value

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• Cefazolin
  

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  Cefazolin

  

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  2.1 Adult Population

  The recommended adult dosages are outlined in Table 1. Cefazolin for Injection should be administered intravenously (IV) over approximately 30 minutes.

  After constitution, cefazolin can be administered by parenteral administration. However, the intent of this pharmacy bulk package is for the preparation of the solutions for intravenous infusion only.

  Table 1: Recommended Dosing Schedule in Adult Patients with CrCl Greater Than or Equal To 55 mL/min.

  Site and Type of Infection

  Dose

  Frequency

  Moderate to severe infections

  500 mg to

  1 gram

  every 6 to 8 hours

  Mild infections caused by susceptible gram-positive cocci

  250 mg to

  500 mg

  every 8 hours

  Acute, uncomplicated urinary tract infections

  1 gram

  every 12 hours

  Pneumococcal pneumonia

  500 mg

  every 12 hours

  Severe, life-threatening infections (e.g., endocarditis, septicemia)*

  1 gram to

  1.5 grams

  every 6 hours

  * In rare instances, doses of up to 12 grams of cefazolin per day have been used.

  2.2 Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  • 1 gram IV administered ½ hour to 1 hour prior to the start of surgery. • For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure). • 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.

  It is important that (i) the preoperative dose be given just prior (1/2 hour to 1 hour) to the start of surgery so that adequate antibacterial concentrations are present in the serum and tissues at the time of initial surgical incision and (ii) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient concentrations of the antibacterial drug at the anticipated moments of greatest exposure to infective organisms.

  The prophylactic administration of cefazolin should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

  2.3 Patients with Renal Impairment

  Cefazolin may be used in patients with renal impairment with the dosage adjustments outlined in Table 2. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection.

  Table 2: Dosage Adjustment for Patients with Renal Impairment

  Creatinine Clearance

  Dose

  Frequency

  55 mL/min. or greater

  full dose

  normal frequency

  35 to 54 mL/min.

  full dose

  every 8 hours or longer

  11 to 34 mL/min.

  1/2 usual dose

  every 12 hours

  10 mL/min. or less

  1/2 usual dose

  every 18 to 24 hours

  2.4 Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for Injection in these patients is not recommended.

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  2.5 Preparation for Use of Cefazolin for Injection

  Reconstitution

  Preparation of Parenteral Solution: Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  Directions for Proper Use of a Pharmacy Bulk Package

  Not for direct infusion. The Pharmacy Bulk Packageis for use in the hospital pharmacy admixture service only in a suitable work area, such as a laminar flow hood. Using aseptic technique, the closure may be penetrated only one time using a suitable sterile dispensing set that allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage. After entry, use entire contents of Pharmacy Bulk Package promptly. The entire contents of the Pharmacy Bulk Package should be dispensed within 4 hours of initial entry. This time limit should begin with the introduction of the solvent or diluent into the Pharmacy Bulk Package. Discard Pharmacy Bulk Package within 4 hours after initial entry.

  Pharmacy Bulk Packages

  Add Sterile Water for Injection, Bacteriostatic Water for Injection or Sodium Chloride Injection according to the table below. SHAKE WELL.

  Pharmacy Bulk Package Size

  Amount of Diluent

  Approximate

  Concentration

  Approximate

  Available Volume

  10 grams

  45 mL

  1 gram/5 mL

  51 mL

  10 grams

  96 mL

  1 gram/10 mL

  102 mL

  Administration

  Intermittent or continuous infusion: Dilute reconstituted Cefazolin for Injection in 50 to 100 mL of one of the following solutions:

    Sodium Chloride Injection, USP   5% or 10% Dextrose Injection, USP   5% Dextrose in Lactated Ringer’s Injection, USP   5% Dextrose and 0.9% Sodium Chloride Injection, USP   5% Dextrose and 0.45% Sodium Chloride Injection, USP   5% Dextrose and 0.2% Sodium Chloride Injection, USP   Lactated Ringer’s Injection, USP   Invert Sugar 5% or 10% in Sterile Water for Injection   Ringer’s Injection, USP   5% Sodium Bicarbonate Injection, USP

  When diluted according to the instructions above, Cefazolin for Injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F).

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

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• Farxiga
  

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  Farxiga

  

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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• Ceftriaxone
  

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  Ceftriaxone

  

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  Ceftriaxone may be administered intravenously or intramuscularly.

  Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same IV administration line. Ceftriaxone must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid (see WARNINGS).

  There have been no reports of an interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (IV or oral).

  Neonates

  Hyperbilirubinemic neonates, especially prematures, should not be treated with ceftriaxone (see CONTRAINDICATIONS).

  Ceftriaxone is contraindicated in neonates if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium (see CONTRAINDICATIONS).

  Pediatric Patients

  For the treatment of skin and skin structure infections, the recommended total daily dose is 50 to 75 mg/kg given once a day (or in equally divided doses twice a day). The total daily dose should not exceed 2 grams.

  For the treatment of acute bacterial otitis media, a single intramuscular dose of 50 mg/kg (not to exceed 1 gram) is recommended (see INDICATIONS AND USAGE).

  For the treatment of serious miscellaneous infections other than meningitis, the recommended total daily dose is 50 to 75 mg/kg, given in divided doses every 12 hours. The total daily dose should not exceed 2 grams.

  In the treatment of meningitis, it is recommended that the initial therapeutic dose be 100 mg/kg (not to exceed 4 grams). Thereafter, a total daily dose of 100 mg/kg/day (not to exceed 4 grams daily) is recommended. The daily dose may be administered once a day (or in equally divided doses every 12 hours). The usual duration of therapy is 7 to 14 days.

  Adults

  The usual adult daily dose is 1 to 2 grams given once a day (or in equally divided doses twice a day) depending on the type and severity of infection. For infections caused by Staphylococcus aureus (MSSA), the recommended daily dose is 2 to 4 grams, in order to achieve > 90% target attainment. The total daily dose should not exceed 4 grams.

  If Chlamydia trachomatis is a suspected pathogen, appropriate antichlamydial coverage should be added, because ceftriaxone sodium has no activity against this organism.

  For the treatment of uncomplicated gonococcal infections, a single intramuscular dose of 250 mg is recommended.

  For preoperative use (surgical prophylaxis), a single dose of 1 gram administered intravenously 1/2 to 2 hours before surgery is recommended.

  Generally, ceftriaxone therapy should be continued for at least 2 days after the signs and symptoms of infection have disappeared. The usual duration of therapy is 4 to 14 days; in complicated infections, longer therapy may be required.

  When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days.

  No dosage adjustment is necessary for patients with impairment of renal or hepatic function.

  Directions for Use

  Intramuscular Administration

  Reconstitute ceftriaxone powder with the appropriate diluent (see COMPATIBILITY AND STABILITY).

  Inject diluent into vial, shake vial thoroughly to form solution. Withdraw entire contents of vial into syringe to equal total labeled dose.

  After reconstitution, each 1 mL of solution contains approximately 250 mg or 350 mg equivalent of ceftriaxone according to the amount of diluent indicated below. If required, more dilute solutions could be utilized.

  As with all intramuscular preparations, ceftriaxone should be injected well within the body of a relatively large muscle; aspiration helps to avoid unintentional injection into a blood vessel.

  Vial Dosage Size

  Amount of Diluent to be Added

  250 mg/mL

  350 mg/mL

  500 mg

  1.8 mL

  1.0 mL

  1 g

  3.6 mL

  2.1 mL

  2 g

  7.2 mL

  4.2 mL

  Intravenous Administration

  Ceftriaxone should be administered intravenously by infusion over a period of 30 minutes. Concentrations between 10 mg/mL and 40 mg/mL are recommended; however, lower concentrations may be used if desired. Reconstitute vials with an appropriate IV diluent (see COMPATIBILITY AND STABILITY).

  Vial Dosage Size

  Amount of Diluent to be Added

  500 mg

  4.8 mL

  1 g

  9.6 mL

  2 g

  19.2 mL

  After reconstitution, each 1 mL of solution contains approximately 100 mg equivalent of ceftriaxone. Withdraw entire contents and dilute to the desired concentration with the appropriate IV diluent.

  Compatibility and Stability

  Ceftriaxone has been shown to be compatible with Flagyl® IV (metronidazole hydrochloride). The concentration should not exceed 5 to 7.5 mg/mL metronidazole hydrochloride with ceftriaxone 10 mg/mL as an admixture. The admixture is stable for 24 hours at room temperature only in 0.9% sodium chloride injection or 5% dextrose in water (D5W). No compatibility studies have been conducted with the Flagyl® IV RTU® (metronidazole) formulation or using other diluents. Metronidazole at concentrations greater than 8 mg/mL will precipitate. Do not refrigerate the admixture as precipitation will occur.

  Vancomycin, amsacrine, aminoglycosides, and fluconazole are physically incompatible with ceftriaxone in admixtures. When any of these drugs are to be administered concomitantly with ceftriaxone by intermittent intravenous infusion, it is recommended that they be given sequentially, with thorough flushing of the intravenous lines (with one of the compatible fluids) between the administrations.

  Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for IV administration. Particulate formation can result.

  Ceftriaxone for Injection solutions should not be physically mixed with or piggybacked into solutions containing other antimicrobial drugs or into diluent solutions other than those listed above, due to possible incompatibility (see WARNINGS).

  Ceftriaxone for Injection sterile powder should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and protected from light. After reconstitution, protection from normal light is not necessary. The color of solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used.

  Ceftriaxone intramuscular solutions remain stable (loss of potency less than 10%) for the following time periods:

  Storage

  Diluent

  Concentration

  mg/mL

  Room Temp.

  (25°C)

  Refrigerated

  (4°C)

  Sterile Water for Injection

  100

  2 days

  10 days

  250, 350

  24 hours

  3 days

  0.9% Sodium Chloride

  100

  2 days

  10 days

  Solution

  250, 350

  24 hours

  3 days

  5% Dextrose Solution

  100

  2 days

  10 days

  250, 350

  24 hours

  3 days

  Bacteriostatic Water + 0.9%

  100

  24 hours

  10 days

  Benzyl Alcohol

  250, 350

  24 hours

  3 days

  1% Lidocaine Solution

  100

  24 hours

  10 days

  (without epinephrine)

  250, 350

  24 hours

  3 days

  Ceftriaxone intravenous solutions, at concentrations of 10, 20 and 40 mg/mL, remain stable (loss of potency less than 10%) for the following time periods stored in glass or PVC containers:

  * Data available for 10 to 40 mg/mL concentrations in this diluent in PVC containers only

  Storage

  Diluent

  Room Temp.

  (25°C)

  Refrigerated

  (4°C)

  Sterile Water

  2 days

  10 days

  0.9% Sodium Chloride Solution

  2 days

  10 days

  5% Dextrose Solution

  2 days

  10 days

  10% Dextrose Solution

  2 days

  10 days

  5% Dextrose + 0.9% Sodium Chloride Solution*

  2 days

  Incompatible

  5% Dextrose + 0.45% Sodium Chloride Solution

  2 days

  Incompatible

  The following intravenous ceftriaxone solutions are stable at room temperature (25°C) for 24 hours, at concentrations between 10 mg/mL and 40 mg/mL: Sodium Lactate (PVC container), 10% Invert Sugar (glass container), 5% Sodium Bicarbonate (glass container), Freamine III (glass container), Normosol-M in 5% Dextrose (glass and PVC containers), Ionosol-B in 5% Dextrose (glass container), 5% Mannitol (glass container), 10% Mannitol (glass container).

  After the indicated stability time periods, unused portions of solutions should be discarded.

  NOTE: Parenteral drug products should be inspected visually for particulate matter before administration.

  Ceftriaxone reconstituted with 5% Dextrose or 0.9% Sodium Chloride solution at concentrations between 10 mg/mL and 40 mg/mL, and then stored in frozen state (-20°C) in PVC or polyolefin containers, remains stable for 26 weeks.

  Frozen solutions of ceftriaxone should be thawed at room temperature before use. After thawing, unused portions should be discarded. DO NOT REFREEZE.

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• Ceftriaxone
  

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  Ceftriaxone

  

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  Ceftriaxone may be administered intravenously or intramuscularly. However, the intent of this Pharmacy Bulk Package is for the preparation of solutions for intravenous infusion only. Ceftriaxone should be administered intravenously by infusion over a period of 30 minutes.

  Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same IV administration line. Ceftriaxone must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid (see WARNINGS).

  There have been no reports of an interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (IV or oral).

  Neonates

  Hyperbilirubinemic neonates, especially prematures, should not be treated with ceftriaxone (see CONTRAINDICATIONS).

  Ceftriaxone is contraindicated in neonates if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium (see CONTRAINDICATIONS).

  Pediatric Patients

  For the treatment of skin and skin structure infections, the recommended total daily dose is 50 to 75 mg/kg given once a day (or in equally divided doses twice a day). The total daily dose should not exceed 2 grams.

  For the treatment of serious miscellaneous infections other than meningitis, the recommended total daily dose is 50 to 75 mg/kg, given in divided doses every 12 hours. The total daily dose should not exceed 2 grams.

  In the treatment of meningitis, it is recommended that the initial therapeutic dose be 100 mg/kg (not to exceed 4 grams). Thereafter, a total daily dose of 100 mg/kg/day (not to exceed 4 grams daily) is recommended. The daily dose may be administered once a day (or in equally divided doses every 12 hours). The usual duration of therapy is 7 to 14 days.

  Adults

  The usual adult daily dose is 1 to 2 grams given once a day (or in equally divided doses twice a day) depending on the type and severity of infection. For infections caused by Staphylococcus aureus (MSSA), the recommended daily dose is 2 to 4 grams, in order to achieve > 90% target attainment. The total daily dose should not exceed 4 grams.

  If Chlamydia trachomatis is a suspected pathogen, appropriate antichlamydial coverage should be added, because ceftriaxone sodium has no activity against this organism.

  For preoperative use (surgical prophylaxis), a single dose of 1 gram administered intravenously 1/2 to 2 hours before surgery is recommended.

  Generally, ceftriaxone therapy should be continued for at least 2 days after the signs and symptoms of infection have disappeared. The usual duration of therapy is 4 to 14 days; in complicated infections, longer therapy may be required.

  When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days.

  No dosage adjustment is necessary for patients with impairment of renal or hepatic function.

  Directions for Proper Use of Pharmacy Bulk Package

  The 10 gram bottle should be reconstituted with 95 mL of an appropriate IV diluent in a suitable work area such as a laminar flow hood. The resulting solution will contain approximately 100 mg/mL of ceftriaxone. This closure may be penetrated only one time after reconstitution, using a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents.

  The withdrawal of container contents should be accomplished without delay. However, should this not be possible, a maximum time of 4 hours from initial closure entry is permitted to complete fluid transfer operations. Unused portions of solution held longer than the recommended time periods should be discarded.

  Reconstituted Bulk Solutions Should Not Be Used For Direct Infusion.

  Transfer individual dose to appropriate intravenous solutions as soon as possible following reconstitution of the bulk package. The stability of the solution that has been transferred to a container varies according to diluent, concentration and temperature (See COMPATIBILITY AND STABILITY). Concentrations between 10 mg/mL and 40 mg/mL are recommended; however, lower concentrations may be used if desired.

  Compatibility and Stability

  Ceftriaxone has been shown to be compatible with Flagyl® IV (metronidazole hydrochloride). The concentration should not exceed 5 to 7.5 mg/mL metronidazole hydrochloride with ceftriaxone 10 mg/mL as an admixture. The admixture is stable for 24 hours at room temperature only in 0.9% sodium chloride injection or 5% dextrose in water (D5W). No compatibility studies have been conducted with the Flagyl® IV RTU® (metronidazole) formulation or using other diluents. Metronidazole at concentrations greater than 8 mg/mL will precipitate. Do not refrigerate the admixture as precipitation will occur.

  Vancomycin, amsacrine, aminoglycosides, and fluconazole are physically incompatible with ceftriaxone in admixtures. When any of these drugs are to be administered concomitantly with ceftriaxone by intermittent intravenous infusion, it is recommended that they be given sequentially, with thorough flushing of the intravenous lines (with one of the compatible fluids) between the administrations.

  Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for IV administration. Particulate formation can result.

  Ceftriaxone for Injection solutions should not be physically mixed with or piggybacked into solutions containing other antimicrobial drugs or into diluent solutions other than those listed above, due to possible incompatibility (see WARNINGS).

  Ceftriaxone for Injection sterile powder should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and protected from light. After reconstitution, protection from normal light is not necessary. The color of solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used.

  Ceftriaxone for Injection intravenous solutions, at concentrations of 10, 20 and 40 mg/mL, remain stable (loss of potency less than 10%) for the following time periods stored in glass or PVC containers:

  * Data available for 10 to 40 mg/mL concentrations in this diluent in PVC containers only

  Storage

  Diluent

  Room Temp.

  (25°C)

  Refrigerated

  (4°C)

  Sterile Water

  2 days

  10 days

  0.9% Sodium Chloride Solution

  2 days

  10 days

  5% Dextrose Solution

  2 days

  10 days

  10% Dextrose Solution

  2 days

  10 days

  5% Dextrose + 0.9% Sodium Chloride Solution*

  2 days

  Incompatible

  5% Dextrose + 0.45% Sodium Chloride Solution

  2 days

  Incompatible

  The following intravenous ceftriaxone solutions are stable at room temperature (25°C) for 24 hours, at concentrations between 10 mg/mL and 40 mg/mL: Sodium Lactate (PVC container), 10% Invert Sugar (glass container), 5% Sodium Bicarbonate (glass container), Freamine III (glass container), Normosol-M in 5% Dextrose (glass and PVC containers), Ionosol-B in 5% Dextrose (glass container), 5% Mannitol (glass container), 10% Mannitol (glass container).

  After the indicated stability time periods, unused portions of solutions should be discarded.

  NOTE: Parenteral drug products should be inspected visually for particulate matter before administration.

  Ceftriaxone reconstituted with 5% Dextrose or 0.9% Sodium Chloride solution at concentrations between 10 mg/mL and 40 mg/mL, and then stored in frozen state (-20°C) in PVC or polyolefin containers, remains stable for 26 weeks.

  Frozen solutions of ceftriaxone should be thawed at room temperature before use. After thawing, unused portions should be discarded. DO NOT REFREEZE.

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• Cisplatin
  

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  Cisplatin

  

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  Cisplatin Injection is administered by slow intravenous infusion. CISPLATIN INJECTION SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION.

  Note: Needles or intravenous sets containing aluminum parts that may come in contact with Cisplatin Injection should not be used for preparation or administration. Aluminum reacts with Cisplatin Injection, causing precipitate formation and a loss of potency.

  Metastatic Testicular Tumors

  The usual Cisplatin Injection dose for the treatment of testicular cancer in combination with other approved chemotherapeutic agents is 20 mg/m2 IV daily for 5 days per cycle.

  Metastatic Ovarian Tumors

  The usual Cisplatin Injection dose for the treatment of metastatic ovarian tumors in combination with cyclophosphamide is 75 to 100 mg/m2 IV per cycle once every four weeks (DAY 1).

  The dose of cyclophosphamide when used in combination with Cisplatin Injection is 600 mg/m2 IV once every 4 weeks (DAY 1).

  For directions for the administration of cyclophosphamide, refer to the cyclophosphamide package insert.

  In combination therapy, Cisplatin Injection and cyclophosphamide are administered sequentially.

  As a single agent, Cisplatin Injection should be administered at a dose of 100 mg/m2 IV per cycle once every four weeks.

  Advanced Bladder Cancer

  Cisplatin Injection should be administered as a single agent at a dose of 50 to 70 mg/m2 IV per cycle once every 3 to 4 weeks depending on the extent of prior exposure to radiation therapy and/or prior chemotherapy. For heavily pretreated patients an initial dose of 50 mg/m2 per cycle repeated every 4 weeks is recommended.

  All Patients

  Pretreatment hydration with 1 to 2 liters of fluid infused for 8 to 12 hours prior to a Cisplatin Injection dose is recommended. The drug is then diluted in 2 liters of 5% Dextrose in 1/2 or 1/3 normal saline containing 37.5 g of mannitol, and infused over a 6- to 8-hour period. If diluted solution is not to be used within 6 hours, protect solution from light. Do not dilute Cisplatin Injection in just 5% Dextrose Injection. Adequate hydration and urinary output must be maintained during the following 24 hours.

  A repeat course of Cisplatin Injection should not be given until the serum creatinine is below 1.5 mg/100 mL, and/or the BUN is below 25 mg/100 mL. A repeat course should not be given until circulating blood elements are at an acceptable level (platelets ≥100,000/mm3, WBC ≥4000/mm3). Subsequent doses of Cisplatin Injection should not be given until an audiometric analysis indicates that auditory acuity is within normal limits.

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• Ampicillin
  

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  Ampicillin

  

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  Infections of the respiratory tract and soft tissues.

  Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8-hour intervals.

  Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).

  Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.

  Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8-hour intervals.

  In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Urethritis in males due to N. gonorrhoeae:

  Adults: Two doses of 500 mg each at an interval of 8 to 12 hours.

  Treatment may be repeated if necessary or extended if required.

  In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months.

  The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

  Bacterial Meningitis.

  Adults and children: 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

  Septicemia.

  Adults and children: 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.

  Treatment of all infections should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

  DIRECTIONS FOR USE

  Use only freshly prepared solutions. Intramuscular and intravenous injections should be administered within one hour after preparation, since the potency may decrease significantly after this period.

  For Intramuscular Use: Dissolve contents of a vial with the amount of Sterile Water for Injection, USP or Bacteriostatic Water for Injection, USP, listed in the table below:

  Vial Label Claim

  Recommended Amount of Diluent

  Withdrawable Volume

  Concentration (in mg/mL)

  125 mg

  1.2 mL

  1 mL

  125 mg

  250 mg

  1 mL

  1 mL

  250 mg

  500 mg

  1.8 mL

  2 mL

  250 mg

  1 gram

  3.5 mL

  4 mL

  250 mg

  2 grams

  6.8 mL

  8 mL

  250 mg

  While Ampicillin for Injection, USP 1 g and 2 g, are primarily for intravenous use, they may be administered intramuscularly when the 250 mg or 500 mg vials are unavailable. In such instances, dissolve in 3.5 or 6.8 mL Sterile Water for Injection, USP or Bacteriostatic Water for Injection, USP, respectively. The resulting solution will provide a concentration of 250 mg per mL.

  Ampicillin for Injection, USP 125 mg, is intended primarily for pediatric use. It also serves as a convenient dosage form when small parenteral doses of the antibiotic are required.

  Note: Bacteriostatic Water for Injection, USP is not to be used as a diluent when the product will be used in newborns.

  For Direct Intravenous Use

  Add 5 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP to the 125, 250, and 500 mg vials and administer slowly over a 3 to 5 minute period. Ampicillin for Injection, USP 1 g or 2 g, may also be given by direct intravenous administration. Dissolve in 7.4 or 14.8 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, respectively, and administer slowly over at least 10 to 15 minutes. CAUTION: More rapid administration may result in convulsive seizures.

  For Administration by Intravenous Drip:

  Reconstitute as directed above (For Direct Intravenous Use) prior to diluting with Intravenous Solution. Stability studies on ampicillin sodium at several concentrations in various intravenous solutions indicate the drug will lose less than 10% activity at the temperatures noted for the time periods stated.

  Room Temperature (25°C)

  Diluent

  Concentrations

  Stability Periods

  Sterile Water for Injection

  up to 30 mg/mL

  8 hours

  0.9% Sodium Chloride Injection

  up to 30 mg/mL

  8 hours

  5% Dextrose in Water

  10 to 20 mg/mL

  1 hour

  5% Dextrose in Water

  up to 2 mg/mL

  2 hours

  5% Dextrose in 0.45% NaCl

  up to 2 mg/mL

  2 hours

  Lactated Ringer’s Solution

  up to 30 mg/mL

  8 hours

  Refrigerated (4°C)

  Sterile Water for Injection

  30 mg/mL

  48 hours

  Sterile Water for Injection

  up to 20 mg/mL

  72 hours

  0.9% Sodium Chloride Injection

  30 mg/mL

  24 hours

  0.9% Sodium Chloride Injection

  up to 20 mg/mL

  48 hours

  Lactated Ringer’s Solution

  up to 30 mg/mL

  24 hours

  5% Dextrose in Water

  up to 20 mg/mL

  1 hour

  5% Dextrose in 0.45% NaCl

  up to 10 mg/mL

  1 hour

  Only those solutions listed above should be used for the intravenous infusion of Ampicillin for Injection, USP. The concentrations should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of ampicillin is administered before the drug loses its stability in the solution in use.

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

  Piggyback IV Package: These glass vials contain the labeled quantity of Ampicillin for Injection and are intended for intravenous administration. The diluent and volume are specified on the label of each package.

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• Cefepime
  

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  Cefepime

  

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  The recommended adult and pediatric dosages and routes of administration are outlined in the following Table 10. Cefepime for injection should be administered intravenously over approximately 30 minutes.

  Table 10: Recommended Dosage Schedule for Cefepime for Injection in Patients with CrCL Greater Than 60 mL/minError! Reference source not found. * including cases associated with concurrent bacteremia † For Pseudomonas aeruginosa, use 2 g IV every 8 hours (50 mg per kg per dose in pediatric patients 2 months up to 16 years) ‡ or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re-evaluated frequently. § Intramuscular route of administration is indicated only for mild to moderate, uncomplicated or complicated UTIs due to E. coli when the intramuscular route is considered to be a more appropriate route of drug administration.

  Site and Type of Infection

  Dose

  Frequency

  Duration

  (days)

  Adults

  Moderate to Severe Pneumonia due to S. pneumoniae*, P. aeruginosa†, K. pneumoniae, or Enterobacter species

  1 to 2 g IV

  Every 8 to 12 hours

  10

  Empiric therapy for febrile neutropenic patients (seeINDICATIONS AND USAGE and CLINICAL STUDIES.)

  2 g IV

  Every 8 hours

  7‡

  Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis*

  0.5 to 1 g IV/IM§

  Every 12 hours

  7 to 10

  Severe Uncomplicated or Complicated Urinary Tract Infections,

  including pyelonephritis, due to E. coli or K. pneumoniae*

  2 g IV

  Every 12 hours

  10

  Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes

  2 g IV

  Every 12 hours

  10

  Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa†, K. pneumoniae, Enterobacter species, or B. fragilis (see CLINICAL STUDIES.)

  2 g IV

  Every 8 to 12 hours

  7 to 10

  Pediatric Patients (2 months up to 16 years)

  The maximum dose for pediatric patients should not exceed the recommended adult dose. The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg per kg per dose, administered every 12 hours (50 mg per kg per dose, every 8 hours for febrile neutropenic patients), for durations as given above.

  Patients with Hepatic Impairment

  No adjustment is necessary for patients with hepatic impairment.

  Patients with Renal Impairment

  In patients with creatinine clearance less than or equal to 60 mL/min, the dose of cefepime for injection should be adjusted to compensate for the slower rate of renal elimination. The recommended initial dose of cefepime for injection should be the same as in patients with normal renal function except in patients undergoing hemodialysis. The recommended doses of cefepime for injection in patients with renal impairment are presented in Table 11.

  When only serum creatinine is available, the following formula (Cockcroft and Gault equation)4 may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function:

  Males: Creatinine Clearance (mL/min) =

  Weight (kg) × (140-age)

  72 × serum creatinine (mg/dL)

  Females: 0.85 × above value

  Table 11: Recommended Dosing Schedule for Cefepime for Injection in Adult Patients (Normal Renal Function, Renal Impairment, and Hemodialysis) * On hemodialysis days, cefepime should be administered following hemodialysis. Whenever possible, cefepime should be administered at the same time each day.

  Creatinine Clearance (mL/min)

  Recommended Maintenance Schedule

  Greater than 60 Normal recommended dosing schedule

  500 mg

  every 12 hours

  1 g

  every 12 hours

  2 g

  every 12 hours

  2 g

  every 8 hours

  30 to 60

  500 mg

  every 24 hours

  1 g

  every 24 hours

  2 g

  every 24 hours

  2 g

  every 12 hours

  11 to 29

  500 mg

  every 24 hours

  500 mg

  every 24 hours

  1 g

  every 24 hours

  2 g

  every 24 hours

  Less than 11

  250 mg

  every 24 hours

  250 mg

  every 24 hours

  500 mg

  every 24 hours

  1 g

  every 24 hours

  CAPD

  500 mg

  every 48 hours

  1 g

  every 48 hours

  2 g

  every 48 hours

  2 g

  every 48 hours

  Hemodialysis*

  1 g on day 1, then 500 mg every 24 hours thereafter

  1 g

  every 24 hours

  In patients undergoing continuous ambulatory peritoneal dialysis, cefepime for injection may be administered at normally recommended doses at a dosage interval of every 48 hours (see Table 11).

  In patients undergoing hemodialysis, approximately 68% of the total amount of cefepime present in the body at the start of dialysis will be removed during a 3-hour dialysis period. The dosage of cefepime for injection for hemodialysis patients is 1 g on Day 1 followed by 500 mg every 24 hours for the treatment of all infections except febrile neutropenia, which is 1 g every 24 hours.

  Cefepime for injection should be administered at the same time each day and following the completion of hemodialysis on hemodialysis days (see Table 11).

  Data in pediatric patients with impaired renal function are not available; however, since cefepime pharmacokinetics are similar in adults and pediatric patients (see CLINICAL PHARMACOLOGY), changes in the dosing regimen proportional to those in adults (see Tables 10 and 11) are recommended for pediatric patients.

  Administration

  For Intravenous Infusion, Dilute with a suitable parenteral vehicle prior to intravenous infusion. Constitute the 1 g, or 2 g vial, and add an appropriate quantity of the resulting solution to an intravenous container with one of the compatible intravenous fluids listed in the Compatibility and Stability subsection. THE RESULTING SOLUTION SHOULD BE ADMINISTERED OVER APPROXIMATELY 30 MINUTES.

  Intermittent intravenous infusion with a Y-type administration set can be accomplished with compatible solutions. However, during infusion of a solution containing cefepime, it is desirable to discontinue the other solution.

  Intramuscular Administration: For intramuscular administration, cefepime for injection should be constituted with one of the following diluents: Sterile Water for Injection, 0.9% Sodium Chloride, 5% Dextrose Injection, 0.5% or 1% Lidocaine Hydrochloride, or Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol (refer to Table 12).

  Preparation of cefepime for injection solutions is summarized in Table 12.

  Table 12: Preparation of Solutions of Cefepime for Injection

  Single-Dose Vials for Intravenous/Intramuscular Administration

  Amount of Diluent to be added (mL)

  Approximate Available

  Volume (mL)

  Approximate Cefepime Concentration

  (mg/mL)

  cefepime vial content

  1 g (IV)

  10

  11.3

  100

  1 g (IM)

  2.4

  3.6

  280

  2 g (IV)

  10

  12.5

  160

  Compatibility and Stability

  Intravenous: Cefepime for injection is compatible at concentrations between 1 mg per mL and 40 mg per mL with the following intravenous infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection, Normosol™-R, and Normosol™-M in 5% Dextrose Injection. These solutions may be stored up to 24 hours at controlled room temperature 20° to 25°C (68° to 77°F) or 7 days in a refrigerator 2° to 8°C (36° to 46°F).

  Cefepime for injection admixture compatibility information is summarized in Table 13.

  Table 13: Cefepime Admixture Stability

  Cefepime for Injection Concentration

  Admixture and Concentration

  IV Infusion Solutions

  Stability Time for

  RT/L

  (20º to 25ºC)

  Refrigeration

  (2º to 8ºC)

  40 mg/mL

  Amikacin

  6 mg/mL

  NS or D5W

  24 hours

  7 days

  40 mg/mL

  Ampicillin

  1 mg/mL

  D5W

  8 hours

  8 hours

  40 mg/mL

  Ampicillin

  10 mg/mL

  D5W

  2 hours

  8 hours

  40 mg/mL

  Ampicillin

  1 mg/mL

  NS

  24 hours

  48 hours

  40 mg/mL

  Ampicillin

  10 mg/mL

  NS

  8 hours

  48 hours

  4 mg/mL

  Ampicillin

  40 mg/mL

  NS

  8 hours

  8 hours

  4 to 40 mg/mL

  Clindamycin Phosphate 0.25 to 6 mg/mL

  NS or D5W

  24 hours

  7 days

  4 mg/mL

  Heparin

  10 to 50 units/mL

  NS or D5W

  24 hours

  7 days

  4 mg/mL

  Potassium Chloride

  10 to 40 mEq/L

  NS or D5W

  24 hours

  7 days

  4 mg/mL

  Theophylline 0.8 mg/mL

  D5W

  24 hours

  7 days

  1 to 4 mg/mL

  na

  Aminosyn™ II 4.25% with electrolytes and calcium

  8 hours

  3 days

  0.125 to 0.25 mg/mL

  na

  Inpersol™ with 4.25% dextrose

  24 hours

  7 days

  NS = 0.9% Sodium Chloride Injection

  D5W = 5% Dextrose Injection

  na = not applicable

  RT/L = Ambient room temperature and light

  Solutions of cefepime for injection, like those of most beta-lactam antibiotics, should not be added to solutions of ampicillin at a concentration greater than 40 mg per mL, and should not be added to metronidazole, vancomycin, gentamicin, tobramycin, netilmicin sulfate, or aminophylline because of potential interaction. However, if concurrent therapy with cefepime for injection is indicated, each of these antibiotics can be administered separately.

  Intramuscular: Cefepime for injection constituted as directed is stable for 24 hours at controlled room temperature 20° to 25°C (68° to 77°F) or for 7 days in a refrigerator 2° to 8°C (36° to 46°F) with the following diluents: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol, or 0.5% or 1% Lidocaine Hydrochloride.

  NOTE: PARENTERAL DRUGS SHOULD BE INSPECTED VISUALLY FOR PARTICULATE MATTER BEFORE ADMINISTRATION. IF PARTICULATE MATTER IS EVIDENT IN RECONSTITUTED FLUIDS, THE DRUG SOLUTION SHOULD BE DISCARDED.

  As with other cephalosporins, the color of cefepime for injection powder, as well as its solutions, tend to darken depending on storage conditions; however, when stored as recommended, the product potency is not adversely affected.

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