Vancomycin Hydrochloride

Vancomycin Hydrochloride Manufacturers

• Fresenius Kabi Usa, Llc
  

  ×

  Vancomycin Hydrochloride | Fresenius Kabi Usa, Llc

  

  ---

  2.1 Adults

  Vancomycin hydrochloride capsules are used in treating C. difficile-associated diarrhea and staphylococcal enterocolitis.

  C. difficile-associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days. Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days. 2.2 Pediatric Patients

  The usual daily dosage is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days.  The total daily dosage should not exceed 2 g.

  2.1 Adults

  Vancomycin hydrochloride capsules are used in treating C. difficile-associated diarrhea and staphylococcal enterocolitis.

  C. difficile-associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days. Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days. 2.2 Pediatric Patients

  The usual daily dosage is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days.  The total daily dosage should not exceed 2 g.

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• Mylan Institutional Llc
  

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  Vancomycin Hydrochloride | Mylan Institutional Llc

  

  ---

  Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations). In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (seeADVERSE REATIONS). Infusion-related events may occur, however, at any rate or concentration.

  Patients with Normal Renal Function Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every six hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric Patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants.  Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Meollering et al)4

  Creatinine Clearance
  mL/min

  Vancomycin Dose
  mg/24 hr

  100

  1,545

  90

  1,390

  80

  1,235

  70

  1,080

  60

  925

  50

  770

  40

  620

  30

  465

  20

  310

  10

  155

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.

  The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men:                 Weight (kg) x (140-age in years)

                            72 x serum creatinine concentration (mg/dL)

  Women:            0.85 x above value

  The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity.

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) route have not been established.

  Intermittent infusion is the recommended method of administration.

  COMPATIBILITY WITH OTHER DRUGS AND IV FLUIDS

  The following diluents are physically and chemically compatible (with 4g/L vancomycin hydrochloride):

  5% Dextrose Injection, USP

  5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP

  Lactated Ringer’s Injection, USP

  5% Dextrose and Lactated Ringer’s Injection

  Normosol®-M and 5% Dextrose

  0.9% Sodium Chloride Injection, USP

  Isolyte® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability of other compounds.

  DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE-NOT FOR DIRECT INFUSION

  Pharmacy bulk packages are for use in pharmacy admixture service only in a suitable work area, such as a laminar flow hood. They should be hung by the integral hanger provided and suspended as a unit in the laminar flow hood. Using aseptic technique the container closure should be penetrated only one time after reconstitution utilizing a suitable sterile dispensing set which allows measured distribution of the contents. Use of a syringe and needle is not recommended as it may cause leakage. Swab vial stopper with an antiseptic solution.

  Once the sterile dispensing set has been inserted into the container, withdrawal of the contents should be accomplished without delay. However, if this is not possible, a maximum time of 4 hours from the initial closure entry may be permitted for complete fluid transfer operations. Discard the container no later than 4 hours after initial closure puncture. The time limit should begin with introduction of solvent or diluent in to Pharmacy Package bottle.

  PREPARATION AND STABILITY

  10 g Pharmacy Bulk Package bottle

  At the time of use, reconstitute by adding 95 mL of Sterile Water for Injection, USP to the 10 g Pharmacy Bulk package bottle of dry, vancomycin powder at a time. The resultant solution is a tan coloured solution will contain vancomycin equivalent to 500 mg/5 mL (1 g/10 mL). AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED.

  Reconstituted solutions of vancomycin (500 mg/5 mL) must be further diluted in at least 100 mL of a suitable infusion solution. For doses of 1 gram (10 mL), at least 200 mL of solution must be used. The desired dose diluted in this manner should be administered by intermittent IV infusion over a period of at least 60 minutes.

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

  For Oral Administration

  Oral vancomycin is used in treating antibiotic associated pseudomembranous colitis caused by C .difficile and for staphylococcal enterocolitis. Vancomycin is not effective by the oral route for other types of infections. The usual adult total daily dosage is 500 mg to 2 g given in 3 or 4 divided doses for 7 to 10 days. The total daily dosage in children is 40 mg/kg of body weight in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. The appropriate dose may be diluted in 1 oz of water and given to the patient to drink. Common flavoring syrups may added to the solution to improve the taste for oral administration. The diluted solution may be administered via a nasogastric tube.

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  More Info
• Mylan Institutional Llc
  

  ×

  Vancomycin Hydrochloride | Mylan Institutional Llc

  

  ---

  Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations). In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion-related events may occur, however, at any rate or concentration.

  Patients With Normal Renal Function

  Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants.  Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography. If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min:

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Meollering et al)4

  Creatinine Clearance
  mL/min

  Vancomycin Dose
  mg/24 hr

  100

  1,545

  90

  1,390

  80

  1,235

  70

  1,080

  60

  925

  50

  770

  40

  620

  30

  465

  20

  310

  10

  155

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency. The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1,000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1,000 mg every 7 to 10 days has been recommended.

  When only the serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men:                 Weight (kg) x (140-age in years)

                            72 x serum creatinine concentration (mg/dL)

  Women:            0.85 x above value

  The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity. The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) route have not been established.

  Intermittent infusion is the recommended method of administration.

  Preparation and stability

  At the time of use, reconstitute by adding either 10 mL of Sterile Water for Injection to the 500-mg vial or 20 mL of Sterile Water for Injection to the 1-g vial of dry, sterile vancomycin powder. FURTHER DILUTION IS REQUIRED.

  After reconstitution with Sterile Water for Injection, 5% Dextrose Injection, or 0.9% Sodium Chloride Injection, the vials may be stored in a refrigerator for 14 days without significant loss of potency.

  Reconstituted solutions containing 500 mg/10 mL must be further diluted with at least 100 mL of suitable infusion solution. Reconstituted solutions containing 1 g/20 mL must be further diluted with at least 200 mL of suitable infusion solution. The desired dose, diluted in this manner, should be administered by intermittent intravenous infusion over a period of at least 60 minutes.

  Compatibility with Other Drugs and Intravenous Fluids

  Solutions that are diluted with 5% Dextrose Injection or 0.9% Sodium Chloride Injection may be stored in a refrigerator for 14 days without significant loss of potency. Solutions that are diluted with the following infusion fluids may be stored in a refrigerator for 96 hours:

  5% Dextrose Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  Lactated Ringer’s Injection, USP

  Lactated Ringer’s and 5% Dextrose Injection, USP

  Normosol®-M and 5% Dextrose

  ISOLYTE® E

  Vancomycin solution has a low pH and may cause physical instability when it is mixed with other compounds.

  Mixtures of solutions of vancomycin and beta-lactam antibiotics have been shown to be physically incompatible. The likelihood of precipitation increases with higher concentrations of vancomycin. It is recommended to adequately flush the intravenous lines between the administration of these antibiotics. It is also recommended to dilute solutions of vancomycin to 5 mg/mL or less.

  Although intravitreal injection is not an approved route of administration for vancomycin, precipitation has been reported after intravitreal injection of vancomycin and ceftazidime for endophthalmitis using different syringes and needles. The precipitates dissolved gradually, with complete clearing of the vitreous cavity over two months and with improvement of visual acuity.

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

  For Oral Administration

  Oral vancomycin is used in treating antibiotic-associated pseudomembranous colitis caused by C. difficile and for staphylococcal enterocolitis. Vancomycin is not effective by the oral route for other types of infection. The usual adult total daily dosage is 500 mg to 2 g given in 3 or 4 divided doses for 7 to 10 days. The total daily dose in children is 40 mg/kg of body weight in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. The appropriate dose may be diluted in 1 oz of water and given to the patient to drink. Common flavoring syrups may be added to the solution to improve the taste for oral administration. The diluted solution may be administered via a nasogastric tube.

  Close
  No Recall

  More Info
• Mylan Institutional Llc
  

  ×

  Vancomycin Hydrochloride | Mylan Institutional Llc

  

  ---

  Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations). In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion-related events may occur, however, at any rate or concentration.

  Patients With Normal Renal Function

  Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants.  Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography. If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min:

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Meollering et al)4

  Creatinine Clearance
  mL/min

  Vancomycin Dose
  mg/24 hr

  100

  1,545

  90

  1,390

  80

  1,235

  70

  1,080

  60

  925

  50

  770

  40

  620

  30

  465

  20

  310

  10

  155

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency. The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1,000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1,000 mg every 7 to 10 days has been recommended.

  When only the serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men:                 Weight (kg) x (140-age in years)

                            72 x serum creatinine concentration (mg/dL)

  Women:            0.85 x above value

  The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity. The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) route have not been established.

  Intermittent infusion is the recommended method of administration.

  Preparation and stability

  DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION.

  The Pharmacy Bulk Package is for use in the Hospital Pharmacy Admixture Service. Use of this product is restricted to a suitable work area, such as a laminar flow hood. Using aseptic technique, the closure should be penetrated one time using a suitable work area such as a laminar flow hood. Using aseptic technique, the closure may be penetrated only one time after reconstitution using a suitable sterile transfer device or dispensing set, allows measured distribution of the contents. Use of a syringe and needle is not recommended as it may cause leakage. After entry use entire content promptly. The withdrawal of the contents of the Pharmacy Bulk Package bottle should be completed within 4 hours after entry. This time limit should begin with the introduction of solvent or diluent into Pharmacy Bulk Package bottle.

  At the time of use, reconstitute by adding 100 mL of Sterile Water for Injection to the 5 g Pharmacy Bulk Package. Reconstituted solution contains 500 mg/10 mL and 1 g/20 mL. AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED. RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION.

  Reconstituted solutions with 10 mL containing 500 mg of vancomycin hydrochloride must be further diluted with at least 100 mL of diluent. Reconstituted solutions containing 1 gram/20 mL must be further diluted with at least 200 mL of diluent. The desired dose, diluted in this manner, should be administered by intermittent intravenous infusion over a period of at least 60 minutes.

  Compatibility with Other Drugs and Intravenous Fluids

  The following diluents are physically and chemically compatible (with 5 mg/mL vancomycin, present as the HCl):

  5% Dextrose Injection, USP

  5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP

  Lactated Ringer's Injection, USP

  5% Dextrose and Lactated Ringer's Injection

  Normosol® –M and 5% Dextrose

  0.9% Sodium Chloride Injection, USP

  ISOLYTE® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability when it is mixed with other compounds.

  Mixtures of solutions of vancomycin and beta-lactam antibiotics have been shown to be physically incompatible. The likelihood of precipitation increases with higher concentrations of vancomycin. It is recommended to adequately flush the intravenous lines between the administration of these antibiotics. It is also recommended to dilute solutions of vancomycin to 5 mg/mL or less.

  Although intravitreal injection is not an approved route of administration for vancomycin, precipitation has been reported after intravitreal injection of vancomycin and ceftazidime for endophthalmitis using different syringes and needles. The precipitates dissolved gradually, with complete clearing of the vitreous cavity over two months and with improvement of visual acuity.

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

  For Oral Administration

  Oral vancomycin is used in treating antibiotic-associated pseudomembranous colitis caused by C. difficile and for staphylococcal enterocolitis. Vancomycin is not effective by the oral route for other types of infection. The usual adult total daily dosage is 500 mg to 2 g given in 3 or 4 divided doses for 7 to 10 days. The total daily dose in children is 40 mg/kg of body weight in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. The appropriate dose may be diluted in 1 oz of water and given to the patient to drink. Common flavoring syrups may be added to the solution to improve the taste for oral administration. The diluted solution may be administered via a nasogastric tube.

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  More Info
• Watson Laboratories, Inc.
  

  ×

  Vancomycin Hydrochloride | Watson Laboratories, Inc.

  

  ---

  2.1 Adults

  Vancomycin hydrochloride capsules, USP are used in treating C. difficile-associated diarrhea and staphylococcal enterocolitis.

  C. difficile-associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days.      
  Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days. 2.2 Pediatric Patients

  The usual daily dosage is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.

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• Prasco Laboratories
  

  ×

  Vancomycin Hydrochloride | Prasco Laboratories

  

  ---

  2.1 Adults

  Vancomycin Hydrochloride Capsules are used in treating C. difficile-associated diarrhea and staphylococcal enterocolitis.

  C. difficile-associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days. Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days. 2.2 Pediatric Patients

  The usual daily dosage is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.

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  More Info
• App Pharmaceuticals, Llc
  

  ×

  Vancomycin Hydrochloride | App Pharmaceuticals, Llc

  

  ---

  2.1 Adults
  

  Vancomycin hydrochloride capsules are used in treating C. difficile-associated diarrhea and staphylococcal enterocolitis.

  C. difficile-associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days. Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days. 2.2 Pediatric Patients
  

  The usual daily dosage is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days.  The total daily dosage should not exceed 2 g.

  2.1 Adults
  

  Vancomycin hydrochloride capsules are used in treating C. difficile-associated diarrhea and staphylococcal enterocolitis.

  C. difficile-associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days. Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days. 2.2 Pediatric Patients
  

  The usual daily dosage is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days.  The total daily dosage should not exceed 2 g.

  Close
  No Recall

  More Info
• App Pharmaceuticals, Llc
  

  ×

  Vancomycin Hydrochloride | App Pharmaceuticals, Llc

  

  ---

  Infusion-related events are related to both the concentration and the rate of administration of vancomycin.  Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations).  In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events.  Infusion-related events may occur, however, at any rate or concentration.

  Patients with Normal Renal Function
  

  Adults

  The usual daily dose is 2 g divided either as 500 mg every six hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer.  Other patients factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Children

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours.  Each dose should be administered over a period of at least 60 minutes.  

  Infants and Neonates

  In neonates and young infants, the total daily IV dosage may be lower.  In both neonates and infants, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the first week of life and every eight hours thereafter up to the age of one month.  Each dose should be administered over 60 minutes.  Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Patients with Impaired Renal Fuction and Elderly Patients
  

  Dosage adjustment must be made in patients with impaired renal function.  In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function.  Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function.  Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay or high-pressure liquid chromatography.  

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table.  The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).

   

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION

                                              (Adapted from Moellering et al.3)

  Creatinine Clearance                                                                        Vancomycin Dose

  _______mL/min                                                                                          mg/24 hr_____

                 100                                                                                                   1545

                  90                                                                                                    1390

                  80                                                                                                    1235

                  70                                                                                                    1080

                  60                                                                                                      925

                  50                                                                                                      770

                  40                                                                                                      620

                  30                                                                                                      465

                  20                                                                                                      310

                  10                                                                                                      155

   

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.  

  The table is not valid for functionally anephric patients.  For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr.  In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis.  In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only serum creatinine is known, the following formula (based on sex, weight and age of the patient) may be used to calculate creatinine clearance.  Calculated creatinine clearances (mL/min) are only estimates.  The creatinine clearance should be measured promptly.

  Men:                                        Weight (kg) x (140 – age in years)          

                                            72 x serum creatinine concentration (mg/dL)

  Women:                            0.85 x above value

  The serum creatinine must represent a steady state of renal function or the estimated value for creatinine clearance will not be valid.  Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition or inactivity.  

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) route have not been assessed.

  Intermittent infusion is the recommended method of administration.

  Preparation and Stability
  

  At the time of use, reconstitute vials of vancomycin with Sterile Water for Injection to a concentration of 50 mg of vancomycin/mL. (See following table for volume of diluent.)

   Concentration/Vial  Volume of Diluent  500 mg
   10 mL
   1 g
   20 mL
  

  After reconstitution, the vials may be stored in a refrigerator for 96 hours without significant loss of potency.

  Reconstituted solutions of vancomycin (500 mg/10 mL) must be further diluted in at least 100 mL of a suitable infusion solution.  For doses of 1 gram (20 mL), at least 200 mL of solution must be used.  The desired dose diluted in this manner should be administered by intermittent IV infusion over a period of at least 60 minutes.

  Compatibility with Other Drugs and IV Fluids
  

  The following diluents are physically and chemically compatible (with 4 g/L vancomycin hydrochloride):

     5% Dextrose Injection, USP

     5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP

     Lactated Ringer’s Injection, USP

     5% Dextrose and Lactated Ringer’s Injection

     Normosol®-M and 5% Dextrose

     0.9% Sodium Chloride Injection, USP

     Isolyte® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability of other compounds.

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

  For Oral Administration
  

  Oral vancomycin is used in treating antibiotic-associated pseudomembranous colitis caused by C. difficile and for staphylococcal enterocolitis.  Vancomycin is not effective by the oral route for other types of infections.  The usual adult total daily dosage is 500 mg to 2 g given in 3 or 4 divided doses for 7 to 10 days.  The total daily dose in children is 40 mg/kg of body weight in 3 or 4 divided doses for 7 to 10 days.  The total daily dosage should not exceed 2 g.  The appropriate dose may be diluted in 1 oz of water and given to the patient to drink.  Common flavoring syrups may be added to the solution to improve the taste for oral administration.  The diluted solution may be administered via a nasogastric tube.

  Patients with Normal Renal Function
  

  Adults

  The usual daily dose is 2 g divided either as 500 mg every six hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer.  Other patients factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Children

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours.  Each dose should be administered over a period of at least 60 minutes.  

  Infants and Neonates

  In neonates and young infants, the total daily IV dosage may be lower.  In both neonates and infants, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the first week of life and every eight hours thereafter up to the age of one month.  Each dose should be administered over 60 minutes.  Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Patients with Impaired Renal Fuction and Elderly Patients
  

  Dosage adjustment must be made in patients with impaired renal function.  In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function.  Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function.  Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay or high-pressure liquid chromatography.  

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table.  The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).

   

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION

                                              (Adapted from Moellering et al.3)

  Creatinine Clearance                                                                        Vancomycin Dose

  _______mL/min                                                                                          mg/24 hr_____

                 100                                                                                                   1545

                  90                                                                                                    1390

                  80                                                                                                    1235

                  70                                                                                                    1080

                  60                                                                                                      925

                  50                                                                                                      770

                  40                                                                                                      620

                  30                                                                                                      465

                  20                                                                                                      310

                  10                                                                                                      155

   

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.  

  The table is not valid for functionally anephric patients.  For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr.  In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis.  In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only serum creatinine is known, the following formula (based on sex, weight and age of the patient) may be used to calculate creatinine clearance.  Calculated creatinine clearances (mL/min) are only estimates.  The creatinine clearance should be measured promptly.

  Men:                                        Weight (kg) x (140 – age in years)          

                                            72 x serum creatinine concentration (mg/dL)

  Women:                            0.85 x above value

  The serum creatinine must represent a steady state of renal function or the estimated value for creatinine clearance will not be valid.  Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition or inactivity.  

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) route have not been assessed.

  Intermittent infusion is the recommended method of administration.

  Preparation and Stability
  

  At the time of use, reconstitute vials of vancomycin with Sterile Water for Injection to a concentration of 50 mg of vancomycin/mL. (See following table for volume of diluent.)

   Concentration/Vial  Volume of Diluent  500 mg
   10 mL
   1 g
   20 mL
  

  After reconstitution, the vials may be stored in a refrigerator for 96 hours without significant loss of potency.

  Reconstituted solutions of vancomycin (500 mg/10 mL) must be further diluted in at least 100 mL of a suitable infusion solution.  For doses of 1 gram (20 mL), at least 200 mL of solution must be used.  The desired dose diluted in this manner should be administered by intermittent IV infusion over a period of at least 60 minutes.

  Compatibility with Other Drugs and IV Fluids
  

  The following diluents are physically and chemically compatible (with 4 g/L vancomycin hydrochloride):

     5% Dextrose Injection, USP

     5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP

     Lactated Ringer’s Injection, USP

     5% Dextrose and Lactated Ringer’s Injection

     Normosol®-M and 5% Dextrose

     0.9% Sodium Chloride Injection, USP

     Isolyte® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability of other compounds.

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

  For Oral Administration
  

  Oral vancomycin is used in treating antibiotic-associated pseudomembranous colitis caused by C. difficile and for staphylococcal enterocolitis.  Vancomycin is not effective by the oral route for other types of infections.  The usual adult total daily dosage is 500 mg to 2 g given in 3 or 4 divided doses for 7 to 10 days.  The total daily dose in children is 40 mg/kg of body weight in 3 or 4 divided doses for 7 to 10 days.  The total daily dosage should not exceed 2 g.  The appropriate dose may be diluted in 1 oz of water and given to the patient to drink.  Common flavoring syrups may be added to the solution to improve the taste for oral administration.  The diluted solution may be administered via a nasogastric tube.

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  More Info
• App Pharmaceuticals, Llc
  

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  Vancomycin Hydrochloride | App Pharmaceuticals, Llc

  

  ---

  Infusion-related events are related to both the concentration and the rate of administration of vancomycin.  Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations).  In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events.  Infusion-related events may occur, however, at any rate or concentration.

  Patients with Normal Renal Function
  

  Adults

  The usual daily dose is 2 g divided either as 500 mg every six hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer.  Other patients factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Children

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours.  Each dose should be administered over a period of at least 60 minutes.  

  Infants and Neonates

  In neonates and young infants, the total daily IV dosage may be lower.  In both neonates and infants, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the first week of life and every eight hours thereafter up to the age of one month.  Each dose should be administered over 60 minutes.  Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Patients with Impaired Renal Function and Elderly Patients
  

  Dosage adjustment must be made in patients with impaired renal function.  In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function.  Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay or high-pressure liquid chromatography.  

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table.  The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION

                                              (Adapted from Moellering et al.3)

  Creatinine Clearance                                                                        Vancomycin Dose

  _______mL/min                                                                                          mg/24 hr_____

               100                                                                                                       1545

                90                                                                                                        1390

                80                                                                                                        1235

                70                                                                                                        1080

                60                                                                                                         925

                50                                                                                                         770

                40                                                                                                         620

                30                                                                                                         465

                20                                                                                                         310

                10                                                                                                         155

   

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.  

  The table is not valid for functionally anephric patients.  For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr.  In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis.  In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only serum creatinine is known, the following formula (based on sex, weight and age of the patient) may be used to calculate creatinine clearance.  Calculated creatinine clearances (mL/min) are only estimates.  The creatinine clearance should be measured promptly.

  Men:                                        Weight (kg) x (140 – age in years)        
  

                                          72 x serum creatinine concentration (mg/dL)

   Women:                           0.85 x above value

  The serum creatinine must represent a steady state of renal function or the estimated value for creatinine clearance will not be valid.  Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition or inactivity.  

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) route have not been assessed.

  Intermittent infusion is the recommended method of administration.

  Compatibility with Other Drugs and IV Fluids
  

  The following diluents are physically and chemically compatible (with 4 g/L vancomycin hydrochloride):

     5% Dextrose Injection, USP

     5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP

     Lactated Ringer’s Injection, USP

     5% Dextrose and Lactated Ringer’s Injection

     Normosol®-M and 5% Dextrose

     0.9% Sodium Chloride Injection, USP

     Isolyte® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability of other compounds.

  Patients with Normal Renal Function
  

  Adults

  The usual daily dose is 2 g divided either as 500 mg every six hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer.  Other patients factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Children

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours.  Each dose should be administered over a period of at least 60 minutes.  

  Infants and Neonates

  In neonates and young infants, the total daily IV dosage may be lower.  In both neonates and infants, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the first week of life and every eight hours thereafter up to the age of one month.  Each dose should be administered over 60 minutes.  Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Patients with Impaired Renal Function and Elderly Patients
  

  Dosage adjustment must be made in patients with impaired renal function.  In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function.  Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay or high-pressure liquid chromatography.  

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table.  The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION

                                              (Adapted from Moellering et al.3)

  Creatinine Clearance                                                                        Vancomycin Dose

  _______mL/min                                                                                          mg/24 hr_____

               100                                                                                                       1545

                90                                                                                                        1390

                80                                                                                                        1235

                70                                                                                                        1080

                60                                                                                                         925

                50                                                                                                         770

                40                                                                                                         620

                30                                                                                                         465

                20                                                                                                         310

                10                                                                                                         155

   

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.  

  The table is not valid for functionally anephric patients.  For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr.  In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis.  In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only serum creatinine is known, the following formula (based on sex, weight and age of the patient) may be used to calculate creatinine clearance.  Calculated creatinine clearances (mL/min) are only estimates.  The creatinine clearance should be measured promptly.

  Men:                                        Weight (kg) x (140 – age in years)        
  

                                          72 x serum creatinine concentration (mg/dL)

   Women:                           0.85 x above value

  The serum creatinine must represent a steady state of renal function or the estimated value for creatinine clearance will not be valid.  Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition or inactivity.  

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) route have not been assessed.

  Intermittent infusion is the recommended method of administration.

  Compatibility with Other Drugs and IV Fluids
  

  The following diluents are physically and chemically compatible (with 4 g/L vancomycin hydrochloride):

     5% Dextrose Injection, USP

     5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP

     Lactated Ringer’s Injection, USP

     5% Dextrose and Lactated Ringer’s Injection

     Normosol®-M and 5% Dextrose

     0.9% Sodium Chloride Injection, USP

     Isolyte® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability of other compounds.

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  More Info
• Pfizer Laboratories Div Pfizer Inc.
  

  ×

  Vancomycin Hydrochloride | Pfizer Laboratories Div Pfizer Inc.

  

  ---

  Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations). In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. An infusion rate of 10 mg/min or less is associated with fewer infusion -related events (see ADVERSE REACTIONS).Infusion-related events may occur, however, at any rate or concentration.

  Patients with Normal Renal Function

  Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every six hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric Patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower.  In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).

  DOSAGE TABLE FOR VANCOMYCIN
  IN PATIENTS WITH IMPAIRED RENAL FUNCTION
  (Adapted from Moellering et al.4)
  Creatinine Clearance mL/min
  Vancomycin Dose mg/24 hr
  100
  1,545
  90
  1,390
  80
  1,235
  70
  1,080
  60
  925
  50
  770
  40
  620
  30
  465
  20
  310
  10
  155
  

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.

  The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men:
  Weight (kg) x (140 - age in years)
  
  72 x serum creatinine concentration (mg/dL)
  
  
  Women:
  0.85 x above value
  

  The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity.

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) route have not been established.

  Intermittent infusion is the recommended method of administration.

  COMPATIBILITY WITH OTHER DRUGS AND IV FLUIDS

  The following diluents are physically and chemically compatible (with 4g/L vancomycin hydrochloride):

  5% Dextrose Injection, USP

  5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP

  Lactated Ringer's Injection, USP

  5% Dextrose and Lactated Ringer's Injection

  Normosol®-M and 5% Dextrose

  0.9% Sodium Chloride Injection, USP

  Isolyte® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability of other compounds.

  DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE-NOT FOR DIRECT INFUSION

  Pharmacy bulk packages are for use in pharmacy admixture service only in a suitable work area, such as a laminar flow hood. They should be hung by the integral hanger provided and suspended as a unit in the laminar flow hood. Using aseptic technique the container closure should be penetrated only one time after reconstitution utilizing a suitable sterile dispensing set which allows measured distribution of the contents. Use of a syringe and needle is not recommended as it may cause leakage. Swab vial stopper with an antiseptic solution.

  Once the sterile dispensing set has been inserted into the container, withdrawal of the contents should be accomplished without delay. However, if this is not possible, a maximum time of 4 hours from the initial closure entry may be permitted for complete fluid transfer operations. Discard the container no later than 4 hours after initial closure puncture. The time limit should begin with introduction of solvent or diluent into the Pharmacy package bottle.

  PREPARATION AND STABILITY

  10 g Pharmacy Bulk package bottle

  At the time of use, reconstitute by adding 95 mL of Sterile Water for Injection, USP to the 10 g Pharmacy Bulk package bottle of dry, sterile vancomycin powder. The resultant solution will contain vancomycin equivalent to 500 mg/5 mL (1 g/10 mL). AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED.

  Reconstituted solutions of vancomycin (500 mg/5 mL) must be further diluted in at least 100 mL of a suitable infusion solution. For doses of 1 gram (10 mL), at least 200 mL of solution must be used. The desired dose diluted in this manner should be administered by intermittent IV infusion over a period of at least 60 minutes.

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

  For oral Administration

  Oral vancomycin is used in treating antibiotic associated pseudomembranous colitis caused by C .difficile and for staphylococcal enterocolitis. Vancomycin is not effective by the oral route for other types of infections. The usual adult total daily dosage is 500 mg to 2 g given in 3 or 4 divided doses for 7 to 10 days. The total daily dose in children is 40 mg/kg of body weight in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. The appropriate dose may be diluted in 1 oz of water and given to the patient to drink. Common flavoring syrups may added to the solution to improve the taste for oral administration. The diluted solution may be administered via a nasogastric tube.

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  More Info
• Agila Specialties Private Limited
  

  ×

  Vancomycin Hydrochloride | Agila Specialties Private Limited

  

  ---

  Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations). In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS).Infusion-related events may occur, however, at any rate or concentration.

  Patients with Normal Renal Function Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every six hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric Patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower.  In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION(Adapted from Moellering et al.4) Creatinine Clearance
  mL/min
  Vancomycin Dose
  mg/24 hr
  100
  1,545
  90
  1,390
  80
  1,235
  70
  1,080
  60
  925
  50
  770
  40
  620
  30
  465
  20
  310
  10
  155
  

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.

  The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men:
  Weight (kg) x (140 - age in years)
  
  72 x serum creatinine concentration (mg/dL)
  
  
  Women: 
  0.85 x above value
  

  The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity.

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) route have not been established.

  Intermittent infusion is the recommended method of administration.

  COMPATIBILITY WITH OTHER DRUGS AND IV FLUIDS

  The following diluents are physically and chemically compatible (with 4g/L vancomycin hydrochloride):  

  5% Dextrose Injection, USP

  5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP

  Lactated Ringer’s Injection, USP

  5% Dextrose and Lactated Ringer’s Injection

  Normosol®-M and 5% Dextrose

  0.9% Sodium Chloride Injection, USP

  Isolyte® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability of other compounds.

  DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE-NOT FOR DIRECT INFUSION

  Pharmacy bulk packages are for use in pharmacy admixture service only in a suitable work area, such as a laminar flow hood. They should be hung by the integral hanger provided and suspended as a unit in the laminar flow hood. Using aseptic technique the container closure should be penetrated only one time after reconstitution utilizing a suitable sterile dispensing set which allows measured distribution of the contents. Use of a syringe and needle is not recommended as it may cause leakage. Swab vial stopper with an antiseptic solution.

  Once the sterile dispensing set has been inserted into the container, withdrawal of the contents should be accomplished without delay. However, if this is not possible, a maximum time of 4 hours from the initial closure entry may be permitted for complete fluid transfer operations. Discard the container no later than 4 hours after initial closure puncture. The time limit should begin with introduction of solvent or diluent into Pharmacy package bottle.

  PREPARATION AND STABILITY

  10 g Pharmacy Bulk package bottle

  At the time of use, reconstitute by adding 95 mL of Sterile Water for Injection, USP to the 10 g Pharmacy Bulk package bottle of dry, sterile vancomycin powder. The resultant solution will contain vancomycin equivalent to 500 mg/5 mL (1 g/10 mL). AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED.

  Reconstituted solutions of vancomycin (500 mg/5 mL) must be further diluted in at least 100 mL of a suitable infusion solution. For doses of 1 gram (10 mL), at least 200 mL of solution must be used. The desired dose diluted in this manner should be administered by intermittent IV infusion over a period of at least 60 minutes.

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

  For oral Administration

  Oral vancomycin is used in treating antibiotic associated pseudomembranous colitis caused by C. difficile and for staphylococcal enterocolitis. Vancomycin is not effective by the oral route for other types of infections. The usual adult total daily dosage is 500 mg to 2 g given in 3 or 4 divided doses for 7 to 10 days. The total daily dose in children is 40 mg/kg of body weight in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. The appropriate dose may be diluted in 1 oz of water and given to the patient to drink. Common flavoring syrups may added to the solution to improve the taste for oral administration. The diluted solution may be administered via a nasogastric tube.

  Close
  No Recall

  More Info
• Pfizer Laboratories Div Pfizer Inc
  

  ×

  Vancomycin Hydrochloride | Pfizer Laboratories Div Pfizer Inc

  

  ---

  Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations). In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion-related events may occur, however, at any rate or concentration.

  Patients With Normal Renal Function Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography. If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min:

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Meollering et al)4 Creatinine Clearance
  mL/min Vancomycin Dose
  mg/24 hr 100 1,545 90 1,390 80 1,235 70 1,080 60 925 50 770 40 620 30 465 20 310 10 155

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency. The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1,000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1,000 mg every 7 to 10 days has been recommended.

  When only the serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men: Weight (kg) × (140-age in years)
  72 × serum creatinine concentration (mg/dL) Women: 0.85 × above value

  The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity. The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) route have not been established.

  Intermittent infusion is the recommended method of administration.

  Preparation and stability

  At the time of use, reconstitute by adding either 10 mL of Sterile Water for Injection to the 500-mg vial or 20 mL of Sterile Water for Injection to the 1-g vial of dry, sterile vancomycin powder. FURTHER DILUTION IS REQUIRED.

  After reconstitution with Sterile Water for Injection, 5% Dextrose Injection, or 0.9% Sodium Chloride Injection, the vials may be stored in a refrigerator for 14 days without significant loss of potency.

  Reconstituted solutions containing 500 mg/10 mL must be further diluted with at least 100 mL of suitable infusion solution. Reconstituted solutions containing 1 g/20 mL must be further diluted with at least 200 mL of suitable infusion solution. The desired dose, diluted in this manner, should be administered by intermittent intravenous infusion over a period of at least 60 minutes.

  Compatibility with Other Drugs and Intravenous Fluids

  Solutions that are diluted with 5% Dextrose Injection or 0.9% Sodium Chloride Injection may be stored in a refrigerator for 14 days without significant loss of potency. Solutions that are diluted with the following infusion fluids may be stored in a refrigerator for 96 hours:

  5% Dextrose Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  Lactated Ringer's Injection, USP

  Lactated Ringer's and 5% Dextrose Injection, USP

  Normosol®-M and 5% Dextrose

  ISOLYTE® E

  Vancomycin solution has a low pH and may cause chemical or physical instability when it is mixed with other compounds.

  Mixtures of solutions of vancomycin and beta-lactam antibiotics have been shown to be physically incompatible. The likelihood of precipitation increases with higher concentrations of vancomycin. It is recommended to adequately flush the intravenous lines between the administration of these antibiotics. It is also recommended to dilute solutions of vancomycin to 5 mg/mL or less.

  Although intravitreal injection is not an approved route of administration for vancomycin, precipitation has been reported after intravitreal injection of vancomycin and ceftazidime for endophthalmitis using different syringes and needles. The precipitates dissolved gradually, with complete clearing of the vitreous cavity over two months and with improvement of visual acuity.

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

  For Oral Administration

  Oral vancomycin is used in treating antibiotic-associated pseudomembranous colitis caused by C. difficile and for staphylococcal enterocolitis. Vancomycin is not effective by the oral route for other types of infections. The usual adult total daily dosage is 500 mg to 2 g given in 3 or 4 divided doses for 7 to 10 days. The total daily dose in children is 40 mg/kg of body weight in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. The appropriate dose may be diluted in 1 oz of water and given to the patient to drink. Common flavoring syrups may be added to the solution to improve the taste for oral administration. The diluted solution may be administered via a nasogastric tube.

  Close
  No Recall

  More Info
• Pfizer Laboratories Div Pfizer Inc
  

  ×

  Vancomycin Hydrochloride | Pfizer Laboratories Div Pfizer Inc

  

  ---

  Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations). In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion-related events may occur, however, at any rate or concentration.

  Patients with Normal Renal Function Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every six hours or 1 g every 12 hours.

  Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric Patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Meollering et al) 4 Creatinine Clearance mL/min Vancomycin Dose mg/24 hr 100 1,545 90 1,390 80 1,235 70 1,080 60 925 50 770 40 620 30 465 20 310 10 155

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.

  The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men: Weight (kg) × (140 - age in years) 72 × serum creatinine concentration (mg/dL)

  Women:     0.85 × above value

  The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity.

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) route have not been established.

  Intermittent infusion is the recommended method of administration.

  COMPATIBILITY WITH OTHER DRUGS AND IV FLUIDS

  The following diluents are physically and chemically compatible (with 4g/L vancomycin hydrochloride):
  5% Dextrose Injection, USP
  5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP
  Lactated Ringer's Injection, USP
  5% Dextrose and Lactated Ringer's Injection
  Normosol®-M and 5% Dextrose
  0.9% Sodium Chloride Injection, USP
  Isolyte® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability of other compounds.

  DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE-NOT FOR DIRECT INFUSION

  Pharmacy bulk packages are for use in pharmacy admixture service only in a suitable work area, such as a laminar flow hood. They should be hung by the integral hanger provided and suspended as a unit in the laminar flow hood. Using aseptic technique the container closure should be penetrated only one time after reconstitution utilizing a suitable sterile dispensing set which allows measured distribution of the contents. Use of a syringe and needle is not recommended as it may cause leakage. Swab vial stopper with an antiseptic solution.

  Once the sterile dispensing set has been inserted into the Pharmacy Bulk Package, withdrawal of the contents should be accomplished without delay. However, if this is not possible, a maximum time of 4 hours from the initial closure entry may be permitted to complete fluid transfer operations. Discard the container no later than 4 hours after initial closure puncture. This time limit should begin with introduction of solvent or diluent into the Pharmacy Package bottle.

  PREPARATION AND STABILITY 10 g Pharmacy Bulk Package bottle

  At the time of use, reconstitute by adding 95 mL of Sterile Water for Injection, USP to the 10 g Pharmacy Bulk package bottle of dry, sterile vancomycin powder at a time. The resultant solution is a tan colored solution and will contain vancomycin equivalent to 500 mg/5 mL (1 g/10 mL). AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED.

  Reconstituted solutions of vancomycin (500 mg/5 mL) must be further diluted in at least 100 mL of a suitable infusion solution. For doses of 1 gram (10 mL), at least 200 mL of solution must be used. The desired dose diluted in this manner should be administered by intermittent IV infusion over a period of at least 60 minutes.

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

  For Oral Administration

  Oral vancomycin is used in treating antibiotic-associated pseudomembranous colitis caused by C. difficile and for staphylococcal enterocolitis. Vancomycin is not effective by the oral route for other types of infections. The usual adult total daily dosage is 500 mg to 2 g given in 3 or 4 divided doses for 7 to10 days. The total daily dosage in children is 40 mg/kg of body weight in 3 or 4 divided doses for 7 to10 days. The total daily dosage should not exceed 2 g. The appropriate dose may be diluted in 1 oz of water and given to the patient to drink. Common flavoring syrups may be added to the solution to improve the taste for oral administration. The diluted solution may be administered via a nasogastric tube.

  Close
  No Recall

  More Info
• Cardinal Health
  

  ×

  Vancomycin Hydrochloride | Cardinal Health

  

  ---

  An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion-related events are related to both concentration and rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations).

  In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. Infusion-related events may occur, however, at any rate or concentration.

  The use of ADD-Vantage vials of vancomycin hydrochloride is indicated only when doses of 500 mg, 750 mg or 1 g are appropriate. Patient factors, such as renal function and age, are critical in calculating correct dosage regimens (see below). If doses of 500 mg, 750 mg or 1 g are determined to be inappropriate, conventional vials of vancomycin hydrochloride should be used. ADD-VANTAGE VIALS OF VANCOMYCIN HYDROCHLORIDE SHOULD NOT BE USED IN NEONATES, INFANTS, OR PEDIATRIC PATIENTS WHO REQUIRE DOSES OF LESS THAN 500 MG.

  Patients with Normal Renal Function

  Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every six hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual daily dose.

  Pediatric Patients

  The usual intravenous dosage of vancomycin hydrochloride is 10 mg/kg per dose given every six hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the first week of life and every eight hours thereafter up to the age of one month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In premature infants and in the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin hydrochloride per day in mg is about 15 times the glomerular filtration rate in mL/min:

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Moellering et al)4

  Creatinine Clearance 
  mL/min

  Vancomycin Dose
  mg/24 h

  100
  90
  80
  70
  60
  50
  40
  30
  20
  10

  1,545
  1,390
  1,235
  1,080
  925
  770
  620
  465
  310
  155

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.

  The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men:        Weight (kg) x (140 - age in years)

                  72 x serum creatinine concentration (mg/dL)

  Women:    0.85 x above value

  The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity.

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) route have not been assessed.

  Intermittent infusion is the recommended method of administration.

  Close
  No Recall

  More Info
• Cardinal Health
  

  ×

  Vancomycin Hydrochloride | Cardinal Health

  

  ---

  An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion-related events are related to both concentration and rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations).

  In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. Infusion-related events may occur, however, at any rate or concentration.

  The use of ADD-Vantage vials of vancomycin hydrochloride is indicated only when doses of 500 mg, 750 mg or 1 g are appropriate. Patient factors, such as renal function and age, are critical in calculating correct dosage regimens (see below). If doses of 500 mg, 750 mg or 1 g are determined to be inappropriate, conventional vials of vancomycin hydrochloride should be used. ADD-VANTAGE VIALS OF VANCOMYCIN HYDROCHLORIDE SHOULD NOT BE USED IN NEONATES, INFANTS, OR PEDIATRIC PATIENTS WHO REQUIRE DOSES OF LESS THAN 500 MG.

  Patients with Normal Renal Function

  Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every six hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual daily dose.

  Pediatric Patients

  The usual intravenous dosage of vancomycin hydrochloride is 10 mg/kg per dose given every six hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the first week of life and every eight hours thereafter up to the age of one month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In premature infants and in the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin hydrochloride per day in mg is about 15 times the glomerular filtration rate in mL/min:

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Moellering et al)4

  Creatinine Clearance 
  mL/min

  Vancomycin Dose
  mg/24 h

  100
  90
  80
  70
  60
  50
  40
  30
  20
  10

  1,545
  1,390
  1,235
  1,080
  925
  770
  620
  465
  310
  155

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.

  The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men:        Weight (kg) x (140 - age in years)

                  72 x serum creatinine concentration (mg/dL)

  Women:    0.85 x above value

  The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity.

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) route have not been assessed.

  Intermittent infusion is the recommended method of administration.

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  More Info
• Sandoz Inc
  

  ×

  Vancomycin Hydrochloride | Dolgencorp, Llc

  

  ---

  adults and children 12 years and over: take 1 tablet not more often than every 3 to 4 hours

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• Akorn, Inc.
  

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  Vancomycin Hydrochloride | Akorn, Inc.

  

  ---

  2.1 Adults

  Vancomycin HCl Capsules are used in treating C. difficile-associated diarrhea and staphylococcal enterocolitis.

  C. difficile-associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days. Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days. 2.2 Pediatric Patients

  The usual daily dosage is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.

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• Mylan Institutional Llc
  

  ×

  Vancomycin Hydrochloride | Mylan Institutional Llc

  

  ---

  Vancomycin hydrochloride is intended for intravenous use only.

  Vancomycin hydrochloride is not to be administered orally. Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations) (see ADVERSE REACTIONS). In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion related events may occur, however, at any rate or concentration.

  For Oral Administration

  Oral vancomycin is used in treating antibiotic-associated pseudomembranous colitis caused by C. difficile and for staphylococcal enterocolitis. Vancomycin is not effective by the oral route for other types of infections. The usual adult total daily dosage is 500 mg to 2 g given in 3 or 4 divided doses for 7 to 10 days. The total daily dose in children is 40 mg/kg of body weight in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. The appropriate dose may be diluted in 1 oz of water and given to the patient to drink. Common flavoring syrups may be added to the solution to improve the taste for oral administration. The diluted solution may be administered via a nasogastric tube.

  Patients with Normal Renal Function

  Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric Patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Neonates

  In pediatric patients up to the age of one month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of one month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay or high-pressure liquid chromatography. If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min:

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Moellering et al)4

  Creatinine Clearance

  Vancomycin Dose

  mL/min

  mg/24 h

  100

  1545

  90

  1390

  80

  1235

  70

  1080

  60

  925

  50

  770

  40

  620

  30

  465

  20

  310

  10

  155

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency. The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 mg to 1000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only the serum creatinine concentration is known, the following formula (based on sex, weight and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men:

  Weight (kg) × (140 - age in years)

   

  72 × serum creatinine concentration (mg/dL)

  Women:

  0.85 × above value

  The serum creatinine must represent a steady-state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as obese patients or those with liver disease, edema or ascites; and (3) accompanied by debilitation, malnutrition or inactivity. The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) routes have not been established.

  Intermittent infusion is the recommended method of administration.

  Preparation and Stability

  At the time of use, reconstitute vials of vancomycin hydrochloride with sterile water for injection to a concentration of 50 mg of vancomycin/mL. (See following table for volume of diluent.)

  Concentration/Vial

  Volume of Diluent

  500 mg

  10 mL

  1g

  20 mL

  After reconstitution, the vials may be stored in a refrigerator for 96 hours without significant loss of potency.

  Reconstituted solutions of vancomycin (500 mg/10 mL) must be further diluted in at least 100 mL of a suitable infusion solution. For doses of 1 gram (20 mL), at least 200 mL of solution must be used. The desired dose diluted in this manner should be administered by intermittent IV infusion over a period of at least 60 minutes.

  Compatibility with Other Drugs and IV Fluids

  The following diluents are physically and chemically compatible (with 4 g/L vancomycin hydrochloride):

    5% Dextrose Injection, USP   5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP   Lactated Ringer's Injection, USP   5% Dextrose and Lactated Ringer's Injection   Normosol®-M and 5% Dextrose   0.9% Sodium Chloride Injection, USP   Isolyte® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability of other compounds.

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

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• Hospira, Inc.
  

  ×

  Vancomycin Hydrochloride | Hospira, Inc.

  

  ---

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

  Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations). In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion-related events may occur, however, at any rate or concentration.

  Patients with Normal Renal Function

  Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric Patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin hydrochloride for injection per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Moellering et al.4)

  Creatinine Clearance

  mL/min

  Vancomycin Dose

  mg/24 h

  100

  90

  80

  70

  60

  50

  40

  30

  20

  10

  1,545

  1,390

  1,235

  1,080

  925

  770

  620

  465

  310

  155

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.

  The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1,000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1,000 mg every 7 to 10 days has been recommended.

  When only serum creatinine is known, the following formula (based on sex, weight and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men:

                Weight (kg) x (140 - age in years)               

       72 x serum creatinine concentration (mg/dL)

   

   

  Women:

       0.85 x above value

  The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions:

  (1) characterized by decreasing renal function, such as shock, severe heart failure or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema or ascites; and (3) accompanied by debilitation, malnutrition or inactivity.

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) routes have not been established.

  Intermittent infusion is the recommended method of administration.

  Compatibility with Other Drugs and IV Fluids

  The following diluents are physically and chemically compatible (with 4 g/L vancomycin hydrochloride):

       5% Dextrose Injection, USP
       5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP
       Lactated Ringer’s Injection, USP
       5% Dextrose and Lactated Ringer’s Injection
       Normosol®-M and 5% Dextrose
       0.9% Sodium Chloride Injection, USP
       Isolyte® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability of other compounds.

  Mixtures of solutions of vancomycin and beta-lactam antibiotics have been shown to be physically incompatible. The likelihood of precipitation increases with higher concentrations of vancomycin. It is recommended to adequately flush the intravenous lines between the administration of these antibiotics. It is also recommended to dilute solutions of vancomycin to 5 mg/mL or less.

  Although intravitreal injection is not an approved route of administration for vancomycin, precipitation has been reported after intravitreal injection of vancomycin and ceftazidime for endophthalmitis using different syringes and needles. The precipitates dissolved gradually, with complete clearing of the vitreous cavity over two months and with improvement of visual acuity.

  Close
  No Recall

  More Info
• Mylan Institutional Llc
  

  ×

  Vancomycin Hydrochloride | Mylan Institutional Llc

  

  ---

  Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations). In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS ).Infusion-related events may occur, however, at any rate or concentration.

  Patients with Normal Renal Function

  Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every six hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric Patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).

                                                                             DOSAGE TABLE FOR VANCOMYCIN PATIENTS WITH IMPAIRED RENAL FUNCTION

                                                                                                                         (Adapted from Moellering et al) 4

  Creatinine Clearance mL/min
  Vancomycin Dose mg/24 hr
  100
  90
  80
  70
  60
  50
  40
  30
  20
  10
  1,545
  1,390
  1,235
  1,080
  925
  770
  620
  465
  310
  155
  

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.

  The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men:                 Weight (kg) x (140 - age in years)         

                     72 x serum creatinine concentration (mg/dL)

  Women: 0.85 x above value

  The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity.

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) route have not been established.

  Intermittent infusion is the recommended method of administration.

  COMPATIBILITY WITH OTHER DRUGS AND IV FLUIDS

  The following diluents are physically and chemically compatible (with 4g/L vancomycin hydrochloride): 

  5% Dextrose Injection, USP

  5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP

  Lactated Ringer's Injection, USP

  5% Dextrose and Lactated Ringer's Injection

  Normosol®-M and 5% Dextrose

  0.9% Sodium Chloride Injection, USP

  Isolyte® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability of other compounds.

  DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE-NOT FOR DIRECT INFUSION

  Pharmacy bulk packages are for use in pharmacy admixture service only in a suitable work area, such as a laminar flow hood. They should be hung by the integral hanger provided and suspended as a unit in the laminar flow hood. Using aseptic technique the container closure should be penetrated only one time after reconstitution utilizing a suitable sterile dispensing set which allows measured distribution of the contents. Use of a syringe and needle is not recommended as it may cause leakage. Swab vial stopper with an antiseptic solution.

  Once the sterile dispensing set has been inserted into the container, withdrawal of the contents should be accomplished without delay. However, if this is not possible, a maximum time of 4 hours from the initial closure entry may be permitted to complete fluid transfer operations. Discard the container no later than 4 hours after initial closure puncture. The time limit should begin with introduction of solvent or diluent into Pharmacy package bottle.

  PREPARATION AND STABILITY

  10 g Pharmacy Bulk Package bottle

  At the time of use, reconstitute by adding 95 mL of Sterile Water for Injection, USP to the 10 g Pharmacy Bulk package bottle of dry, vancomycin powder at a time. The resultant solution is a tan colored solution and will contain vancomycin equivalent to 500 mg/5 mL (1 g/10 mL). AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED.

  Reconstituted solutions of vancomycin (500 mg/5 mL) must be further diluted in at least 100 mL of a suitable infusion solution. For doses of 1 gram (10 mL), at least 200 mL of solution must be used. The desired dose diluted in this manner should be administered by intermittent IV infusion over a period of at least 60 minutes.

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

  For Oral Administration

  Oral vancomycin is used in treating antibiotic-associated pseudomembranous colitis caused by C .difficile and for staphylococcal enterocolitis. Vancomycin is not effective by the oral route for other types of infections. The usual adult total daily dosage is 500 mg to 2 g given in 3 or 4 divided doses for 7 to 10 days. The total daily dosage in children is 40 mg/kg of body weight in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. The appropriate dose may be diluted in 1 oz of water and given to the patient to drink. Common flavoring syrups may be added to the solution to improve the taste for oral administration. The diluted solution may be administered via a nasogastric tube.

  Close
  No Recall

  More Info
• Mylan Institutional Llc
  

  ×

  Vancomycin Hydrochloride | Mylan Institutional Llc

  

  ---

  Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations). In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion-related events may occur, however, at any rate or concentration.

  Patients With Normal Renal Function

  Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants.  Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography. If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min:

                                                                     DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION

                                                                                                                                     (Adapted from Meollering et al) 4

  Creatinine Clearance mL/min
  Vancomycin Dose mg/24 hr
  100
  1,545
  90
  1,390
  80
  1,235
  70
  1,080
  60
  925
  50
  770
  40
  620
  30
  465
  20
  310
  10
  155
  

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency. The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1,000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1,000 mg every 7 to 10 days has been recommended.

  When only the serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men:                     Weight (kg) x (140-age in years)

                       72 x serum creatinine concentration (mg/dL)

  Women:            0.85 x above value

  The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity. The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) route have not been established.

  Intermittent infusion is the recommended method of administration.

  Preparation and stability

  DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION.

  The Pharmacy Bulk Package is for use in the Hospital Pharmacy Admixture Service. Use of this product is restricted to a suitable work area, such as a laminar flow hood. Using aseptic technique, the closure should be penetrated one time using a suitable work area such as a laminar flow hood. Using aseptic technique, the closure may be penetrated only one time after reconstitution using a suitable sterile transfer device or dispensing set, allows measured distribution of the contents. Use of a syringe and needle is not recommended as it may cause leakage. After entry use entire content promptly. The withdrawal of the contents of the Pharmacy Bulk Package bottle should be completed within 4 hours after entry. This time limit should begin with the introduction of solvent or diluent into Pharmacy Bulk Package bottle.

  At the time of use, reconstitute by adding 100 mL of Sterile Water for Injection to the 5 g Pharmacy Bulk Package. Reconstituted solution contains 500 mg/10 mL and 1 g/20 mL. AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED. RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION. 

  Reconstituted solutions with 10 mL containing 500 mg of vancomycin hydrochloride must be diluted with at least 100 mL of diluent. Reconstituted solutions containing 1 gram/20 mL must be further diluted with at least 200 mL of diluent. . The desired dose, diluted in this manner, should be administered by intermittent intravenous infusion over a period of at least 60 minutes.

  Compatibility with Other Drugs and Intravenous Fluids

  The following diluents are physically and chemically compatible (with 5 mg/mL vancomycin, present as the HCl):

  5% Dextrose Injection, USP

  5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP

  Lactated Ringer's Injection, USP

  5% Dextrose and Lactated Ringer's Injection

  Normosol® –M and 5% Dextrose

  0.9% Sodium Chloride Injection, USP

  ISOLYTE® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability when it is mixed with other compounds.

  Mixtures of solutions of vancomycin and beta-lactam antibiotics have been shown to be physically incompatible. The likelihood of precipitation increases with higher concentrations of vancomycin. It is recommended to adequately flush the intravenous lines between the administration of these antibiotics. It is also recommended to dilute solutions of vancomycin to 5 mg/mL or less.

  Although intravitreal injection is not an approved route of administration for vancomycin, precipitation has been reported after intravitreal injection of vancomycin and ceftazidime for endophthalmitis using different syringes and needles. The precipitates dissolved gradually, with complete clearing of the vitreous cavity over two months and with improvement of visual acuity.

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

  For Oral Administration

  Oral vancomycin is used in treating antibiotic-associated pseudomembranous colitis caused by C. difficile and for staphylococcal enterocolitis.  Vancomycin is not effective by the oral route for other types of infection.  The usual adult total daily dosage is 500 mg to 2 g given in 3 or 4 divided doses for 7 to 10 days.  The total daily dose in children is 40 mg/kg of body weight in 3 or 4 divided doses for 7 to 10 days.  The total daily dosage should not exceed 2 g.  The appropriate dose may be diluted in 1 oz of water and given to the patient to drink.  Common flavoring syrups may be added to the solution to improve the taste for oral administration.  The diluted solution may be administered via a nasogastric tube.

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  Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, specific references should be checked for any possible incompatibility with sodium chloride. The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacture.

  Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing intravenous catheters. Prior to and after administration of the medication, the intravenous catheter should be flushed in its entirety with Sodium Chloride Injection, USP, 0.9%. Use in accord with any warnings or precautions appropriate to the medication being administered. Parental drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  INSTRUCTIONS FOR USE

  To open ampuls, using gauze, place thumb and forefinger on color line, break at constriction.

  Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Lidocaine Hydrochloride Injection, USP for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes are required only solutions containing epinephrine should be used, except in those cases where vasopressor drugs may be contraindicated.

  There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Lidocaine is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

  These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes and concentrations to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia and degree of muscular relaxation required, duration of anesthesia required, and the physical condition of the patient. In all cases the lowest concentration and smallest dose that will produce the desired result should be given. Dosages should be reduced for children and for elderly and debilitated patients and patients with cardiac and/or liver disease.

  The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Thus, an increase in volume and concentration of Lidocaine Hydrochloride Injection will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. However, increasing the volume and concentration of Lidocaine Hydrochloride Injection may result in a more profound fall in blood pressure when used in epidural anesthesia. Although the incidence of side effects with lidocaine is quite low, caution should be exercised when employing large volumes and concentrations, since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected.

  For intravenous regional anesthesia, only the 50 mL single-dose vial containing 0.5% Lidocaine Hydrochloride Injection, USP should be used.

  Epidural Anesthesia

  For epidural anesthesia, only the following available specific products of Lidocaine Hydrochloride Injection by Hospira are recommended:

  1%. . . . . . . . . . . . . . . . . . . . 30 mL single-dose teartop vials

  1.5%. . . . . . . . . . . . . . . . . . . . . . . 20 mL single-dose ampuls

  2%. . . . . . . . . . . . . . . . . . . . . . . . . 10 mL single-dose ampuls

  Although these solutions are intended specifically for epidural anesthesia, they may also be used for infiltration and peripheral nerve block provided they are employed as single dose units. These solutions contain no bacteriostatic agent. In epidural anesthesia, the dosage varies with the number of dermatomes to be anesthetized (generally 2−3 mL of the indicated concentration per dermatome).

  Caudal and Lumbar Epidural Block: As a precaution against the adverse experiences sometimes observed following unintentional penetration of the subarachnoid space, a test dose such as 2−3 mL of 1.5% lidocaine hydrochloride should be administered at least 5 minutes prior to injecting the total volume required for a lumbar or caudal epidural block. The test dose should be repeated if the patient is moved in a manner that may have displaced the catheter. Epinephrine, if contained in the test dose (10−15 mcg have been suggested), may serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient "epinephrine response" within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Patients on beta-blockers may not manifest changes in heart rate, but blood pressure monitoring can detect an evanescent rise in systolic blood pressure. Adequate time should be allowed for onset of anesthesia after administration of each test dose. The rapid injection of a large volume of Lidocaine Hydrochloride Injection through the catheter should be avoided, and, when feasible, fractional doses should be administered.

  In the event of the known injection of a large volume of local anesthetic solutions into the subarachnoid space, after suitable resuscitation and if the catheter is in place, consider attempting the recovery of drug by draining a moderate amount of cerebrospinal fluid (such as 10 mL) through the epidural catheter.

  Maximum Recommended Dosages

  NOTE: The products accompanying this insert do not contain epinephrine.

  Adults: For normal healthy adults, the individual maximum recommended dose of lidocaine HCl with epinephrine should not exceed 7 mg/kg (3.5 mg/lb) of body weight and in general it is recommended that the maximum total dose not exceed 500 mg. When used without epinephrine, the maximum individual dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight and in general it is recommended that the maximum total dose does not exceed 300 mg. For continuous epidural or caudal anesthesia, the maximum recommended dosage should not be administered at intervals of less than 90 minutes. When continuous lumbar or caudal epidural anesthesia is used for non-obstetrical procedures, more drug may be administered if required to produce adequate anesthesia.

  The maximum recommended dose per 90 minute period of lidocaine hydrochloride for paracervical block in obstetrical patients and non-obstetrical patients is 200 mg total. One-half of the total dose is usually administered to each side. Inject slowly five minutes between sides. (See also discussion of paracervical block in PRECAUTIONS).

  For intravenous regional anesthesia, the dose administered should not exceed 4 mg/kg in adults.

  Children: It is difficult to recommend a maximum dose of any drug for children, since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child’s age and weight. For example, in a child of 5 years weighing 50 lbs., the dose of lidocaine HCl should not exceed 75 — 100 mg (1.5 — 2 mg/lb). The use of even more dilute solutions (i.e., 0.25 — 0.5%) and total dosages not to exceed 3 mg/kg (1.4 mg/lb) are recommended for induction of intravenous regional anesthesia in children.

  In order to guard against systemic toxicity, the lowest effective concentration and lowest effective dose should be used at all times. In some cases it will be necessary to dilute available concentrations with 0.9% sodium chloride injection in order to obtain the required final concentration.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions that are discolored and/or contain particulate matter should not be used.

  Table 1

  Recommended Dosages of Lidocaine Hydrochloride Injection, USP for Various Anesthetic

  Procedures in Normal Healthy Adults

  Lidocaine Hydrochloride Injection, USP (without Epinephrine)

  Procedure

  Conc. (%)

  Vol. (mL)

  Total Dose (mg)

  Infiltration

  Percutaneous

  0.5 or 1.0

  1−60

  5−300

  Intravenous Regional

  0.5

  10−60

  50−300

  Peripheral Nerve Blocks, e.g.

  Brachial

  1.5

  15−20

  225−300

  Dental

  2.0

  1−5

  20−100

  Intercostal

  1.0

  3

  30

  Paravertebral

  1.0

  3−5

  30−50

  Pudendal (each side)

  1.0

  10

  100

  Paracervical

  Obstetrical Analgesia

  (each side)

  1.0

  10

  100

  Sympathetic Nerve Blocks, e.g.

  Cervical (stellate ganglion)

  1.0

  5

  50

  Lumbar

  1.0

  5−10

  50−100

  Central Neural Blocks

  Epidural*

  Thoracic

  1.0

  20−30

  200−300

  Lumbar

  Analgesia

  1.0

  25−30

  250−300

  Anesthesia

  1.5

  15−20

  225−300

  2.0

  10−15

  200−300

  Caudal

  Obstetrical Analgesia

  1.0

  20−30

  200−300

  Surgical Anesthesia

  1.5

  15−20

  225−300

  *Dose determined by number of dermatomes to be anesthetized (2 to 3 mL/dermatome).

  THE ABOVE SUGGESTED CONCENTRATIONS AND VOLUMES SERVE ONLY AS A GUIDE. OTHER VOLUMES AND CONCENTRATIONS MAY BE USED PROVIDED THE TOTAL MAXIMUM RECOMMENDED DOSE IS NOT EXCEEDED.

  Sterilization, Storage and Technical Procedures: Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc.) should not be used for skin or mucous membrane disinfection as they have been related to incidence of swelling and edema. When chemical disinfection of multi-dose vials is desired, either isopropyl alcohol (91%) or 70% ethyl alcohol is recommended. Many commercially available brands of rubbing alcohol, as well as solutions of ethyl alcohol not of USP grade, contain denaturants which are injurious to rubber and, therefore, are not to be used. It is recommended that chemical disinfection be accomplished by wiping the vial stopper thoroughly with cotton or gauze that has been moistened with the recommended alcohol just prior to use.

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  Vancomycin Hydrochloride | Heritage Pharmaceuticals Inc.

  

  ---

  Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min, are recommended in adults (see also age-specific recommendations). In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS).  Infusion-related events may occur, however, at any rate or concentration.

  Patients With Normal Renal Function

  Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients With Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin hydrochloride for injection per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).

  DOSAGE TABLE FOR VANCOMYCIN

  IN PATIENTS WITH IMPAIRED RENAL FUNCTION

   (Adapted from Moellering et al.4)

  Creatinine Clearance
  Vancomycin Dose
   mL/min
   mg/24 h
  100
  1,545
  90
  1,390
  80
  1,235
  70
  1,080
  60
  925
  50
  770
  40
  620
  30
  465
  20
  310
  10
  155
  

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency. The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1,000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1,000 mg every 7 to 10 days has been recommended.

  When only serum creatinine is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men:                 Weight (kg) x (140 — age in years)            

                     72 x serum creatinine concentration (mg/dL)

  Women:           0.85 x above value

  The serum creatinine must represent a steady state of renal function. Otherwise the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity. The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) routes have not been established. Intermittent infusion is the recommended method of administration.

  Compatibility with Other Drugs and IV Fluids

  The following diluents are physically and chemically compatible (with 4 g/L vancomycin hydrochloride):

  5% Dextrose Injection, USP

  5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP

  Lactated Ringer's Injection, USP

  5% Dextrose and Lactated Ringer's Injection

  Normosol®-M and 5% Dextrose

  0.9% Sodium Chloride Injection, USP

  Isolyte® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability of other compounds.

  Mixtures of solutions of vancomycin and beta-lactam antibiotics have been shown to be physically incompatible. The likelihood of precipitation increases with higher concentrations of vancomycin. It is recommended to adequately flush the intravenous lines between the administration of these antibiotics. It is also recommended to dilute solutions of vancomycin to 5 mg/mL or less.

  Although intravitreal injection is not an approved route of administration for vancomycin, precipitation has been reported after intravitreal injection of vancomycin and ceftazidime for endophthalmitis using different syringes and needles. The precipitates dissolved gradually, with complete clearing of the vitreous cavity over two months and with improvement of visual acuity.

  Preparation and stability

  At the time of use, reconstitute the vials of Vancomycin Hydrochloride for Injection, USP with Sterile Water for Injection to a concentration of 50 mg of vancomycin/mL

  (see following table for volume of diluent).

  Concentration/Vial
  Volume of Diluent
  500 mg
  10 mL
  1 g
  20 mL
  

  After reconstitution, the vials may be stored in a refrigerator for 96 hours without significant loss of potency.

  Reconstituted solutions of vancomycin (500 mg/10 mL) must be further diluted in at least 100 mL of a suitable infusion solution. For doses of 1 gram (20 mL), at least 200 mL of solution must be used. The desired dose diluted in this manner should be administered by intermittent IV infusion over a period of at least 60 minutes.

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

  For Oral Administration

  Oral vancomycin is used in treating antibiotic-associated pseudomembranous colitis caused by C. difficile and for staphylococcal enterocolitis. Vancomycin is not effective by the oral route for other types of infections. The usual adult total daily dosage is 500 mg to 2 g given in 3 or 4 divided doses for 7 to 10 days. The total daily dose in children is 40 mg/kg of body weight in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. The appropriate dose may be diluted in 1 oz of water and given to the patients to drink. Common flavoring syrups may be added to the solution to improve the taste for oral administration. The diluted solution may be administered via a nasogastric tube.

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• Heritage Pharmaceuticals Inc.
  

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  ---

  Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations). In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion-related events may occur, however, at any rate or concentration.

  Patients With Normal Renal Function

  Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric Patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients With Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin hydrochloride for injection per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).

  DOSAGE TABLE FOR VANCOMYCIN

   IN PATIENTS WITH IMPAIRED RENAL FUNCTION

  (Adapted from Moellering et al.4)

  Creatinine Clearance
  mL/min
  Vancomycin Dose
  mg/24 h 
  100
  1,545
  90
  1,390
  80
  1,235
  70
  1,080
  60
  925
  50
  770
  40
  620
  30
  465
  20
  310
  10
  155
  

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.

  The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1,000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1,000 mg every 7 to 10 days has been recommended.

  When only serum creatinine is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men:                 [Weight (kg) x (140 — age in years)]

                   72 x serum creatinine concentration (mg/dL)

  Women:           0.85 x above value

  The serum creatinine must represent a steady state of renal function. Otherwise the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity.

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) routes have not been established. Intermittent infusion is the recommended method of administration.

  Compatibility with Other Drugs and IV Fluids

  The following diluents are physically and chemically compatible (with 4 g/L vancomycin hydrochloride):

  5% Dextrose Injection, USP

  5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP

  Lactated Ringer's Injection, USP

  5% Dextrose and Lactated Ringer's Injection

  Normosol®-M and 5% Dextrose

  0.9% Sodium Chloride Injection, USP

  Isolyte® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability of other compounds.

  Mixtures of solutions of vancomycin and beta-lactam antibiotics have been shown to be physically incompatible. The likelihood of precipitation increases with higher concentrations of vancomycin. It is recommended to adequately flush the intravenous lines between the administration of these antibiotics. It is also recommended to dilute solutions of vancomycin to 5 mg/mL or less.

  Although intravitreal injection is not an approved route of administration for vancomycin, precipitation has been reported after intravitreal injection of vancomycin and ceftazidime for endophthalmitis using different syringes and needles. The precipitates dissolved gradually, with complete clearing of the vitreous cavity over two months and with improvement of visual acuity.

  PREPARATION AND STABILITY

  Directions for Proper Use of a Pharmacy Bulk Package

  DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE

  Not for direct infusion. The pharmacy bulk package is for use in the 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 after reconstitution using a suitable sterile transfer device or dispensing set, which 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 the Pharmacy Bulk Package bottle

  promptly. The entire contents of the Pharmacy Bulk Package bottle should be dispensed within 4 hours after initial entry. A maximum time of 4 hours from the initial entry may be allowed to complete fluid aliquoting/transferring operations. Discard the container no later than 4 hours

  after initial closure puncture. This time limit should begin with the introduction of solvent or diluent into the Pharmacy Bulk Package bottle.

  Preparation and Stability

  5 g Pharmacy Bulk Package bottle

  At the time of use, reconstitute by adding 100 mL of Sterile Water for Injection to the 5 g Pharmacy Bulk Package bottle of dry, sterile vancomycin powder. The resultant solution will contain vancomycin equivalent to 500 mg/10 mL. FURTHER DILUTION IS REQUIRED.

  Reconstituted solutions of vancomycin (500 mg/10 mL) must be further diluted in at least 100 mL of a suitable infusion solution. Doses of 1 gram/20 mL must be further diluted in at least 200 mL of a suitable infusion solution. The desired dose diluted in this manner should be administered by intermittent intravenous infusion over a period of at least 60 minutes.

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

  For Oral Administration

  Oral vancomycin is used in treating antibiotic-associated pseudomembranous colitis caused by C. difficile and for staphylococcal enterocolitis. Vancomycin is not effective by the oral route for other types of infections. The usual adult total daily dosage is 500 mg to 2 g given in 3 or 4 divided doses for 7 to 10 days. The total daily dose in children is 40 mg/kg of body weight in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. The appropriate dose may be diluted in 1 oz. of water and given to the patient to drink. Common flavoring syrups may be added to the solution to improve the taste for oral administration. The diluted solution may be administered via a nasogastric tube.

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• Cardinal Health
  

  ×

  Vancomycin Hydrochloride | Cardinal Health

  

  ---

  An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion-related events are related to both concentration and rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations).

  In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. Infusion-related events may occur, however, at any rate or concentration.

  Patients with Normal Renal Function

  Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric Patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the first week of life and every eight hours thereafter up to the age of one month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min:

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Moellering et al)4

  Creatinine Clearance

  mL/min

  Vancomycin Dose

  mg/24 h

  100

  90

  80

  70

  60

  50

  40

  30

  20

  10

  1,545

  1,390

  1,235

  1,080

  925

  770

  620

  465

  310

  155

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.

  The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only the serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

       Men:           Weight (kg) x (140 - age in years)                         
                          72 x serum creatinine concentration (mg/dL)

       Women:     0.85 x above value

  The serum creatinine must represent a steady state of renal function. Otherwise the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity.

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) routes have not been established.

  Intermittent infusion is the recommended method of administration.

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  2.1 Dosage for Postherpetic Neuralgia

  In adults with postherpetic neuralgia, gabapentin tablets may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1800 mg/day was not demonstrated.

  2.2 Dosage for Epilepsy with Partial Onset Seizures

  Patients 12 years of age and above

  The starting dose is 300 mg three times a day. The recommended maintenance dose of gabapentin tablets is 300 mg to 600 mg three times a day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. Administer gabapentin tablets three times a day using 600 mg or 800 mg tablets. The maximum time between doses should not exceed 12 hours.

  Pediatric Patients Age 3 to 11 years

  The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the recommended maintenance dose reached by upward titration over a period of approximately 3 days. The recommended maintenance dose of gabapentin tablets in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of gabapentin tablets in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. Gabapentin may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.

  2.3 Dosage Adjustment in Patients with Renal Impairment

  Dosage adjustment in patients 12 years of age and older with renal impairment or undergoing hemodialysis is recommended, as follows (see dosing recommendations above for effective doses in each indication):

  Table 1: Gabapentin Tablets Dosage Based on Renal Function * For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive). † Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.

  Renal Function Creatinine Clearance (mL/min)

  Total Daily Dose Range (mg/day)

  Dose Regimen (mg)

  ≥ 60

  900 to 3600

  300 TID

  400 TID

  600 TID

  800 TID

  1200 TID

  >30 to 59

  400 to 1400

  200 BID

  300 BID

  400 BID

  500 BID

  700 BID

  >15 to 29

  200 to 700

  200 QD

  300 QD

  400 QD

  500 QD

  700 QD

  15*

  100 to 300

  100 QD

  125 QD

  150 QD

  200 QD

  300 QD

  Post-Hemodialysis Supplemental Dose (mg)†

  Hemodialysis

  125†

  150†

  200†

  250†

  350†

  TID = Three times a day; BID = Two times a day; QD = Single daily dose

  Creatinine clearance (CLCr) is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault:

  The use of gabapentin in patients less than 12 years of age with compromised renal function has not been studied.

  2.4 Dosage in Elderly

  Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.

  2.5 Administration Information

  Administer gabapentin tablets orally with or without food.

  Inform patients that, should they divide the scored 600 mg or 800 mg gabapentin tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half-tablets not used within 28 days of dividing the scored tablet should be discarded.

  If the gabapentin tablets dose is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).

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  Vancomycin Hydrochloride | Pd-rx Pharmaceuticals, Inc.

  

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  Cephalexin is administered orally.

  Adults — The adult dosage ranges from 1 to 4 g daily in divided doses. The 333 mg and 750 mg strengths should be administered such that the daily dose is within 1 to 4 grams per day. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.

  Pediatric Patients — The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.

  In severe infections, the dosage may be doubled.

  In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.

  In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of Cephalexin should be administered for at least 10 days.

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  Vancomycin Hydrochloride | Hospira, Inc.

  

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  Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations).

  In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion-related events may occur, however, at any rate or concentration.

  Patients with Normal Renal Function

  Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric Patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the first week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin hydrochloride for injection per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Moellering et al)4

  Creatinine Clearance

  mL/min

  Vancomycin Dose

  mg/24 h

  100

  90

  80

  70

  60

  50

  40

  30

  20

  10

  1,545

  1,390

  1,235

  1,080

  925

  770

  620

  465

  310

  155

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.

  The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1,000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1,000 mg every 7 to 10 days has been recommended.

  When only the serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

       Men:          Weight (kg) x (140 – age in years)                         
                          72 x serum creatinine concentration (mg/dL)

       Women:     0.85 x above value

  The serum creatinine must represent a steady state of renal function. Otherwise the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity.

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) routes have not been established.

  Intermittent infusion is the recommended method of administration.

  Compatibility with Other Drugs and Intravenous Fluids

  The following diluents are physically and chemically compatible (with 4 g/L vancomycin hydrochloride):

       5% Dextrose Injection, USP
       5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP
       Lactated Ringer’s Injection, USP
       5% Dextrose and Lactated Ringer’s Injection
       Normosol®-M and 5% Dextrose
       0.9% Sodium Chloride Injection, USP
       ISOLYTE® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability of other compounds.

  Mixtures of solutions of vancomycin and beta-lactam antibiotics have been shown to be physically incompatible. The likelihood of precipitation increases with higher concentrations of vancomycin. It is recommended to adequately flush the intravenous lines between the administration of these antibiotics. It is also recommended to dilute solutions of vancomycin to 5 mg/mL or less.

  Although intravitreal injection is not an approved route of administration for vancomycin, precipitation has been reported after intravitreal injection of vancomycin and ceftazidime for endophthalmitis using different syringes and needles. The precipitates dissolved gradually, with complete clearing of the vitreous cavity over two months and with improvement of visual acuity.

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  Vancomycin Hydrochloride | Hospira, Inc.

  

  ---

  An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion-related events are related to both concentration and rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations).

  In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. Infusion-related events may occur, however, at any rate or concentration.

  Patients with Normal Renal Function

  Adults

  The usual intravenous daily dose is 2 g divided either as 500 mg every six hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric Patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every six hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the first week of life and every eight hours thereafter up to the age of one month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In premature infants and in the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min:

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Moellering et al)4

  Creatinine Clearance

  mL/min

  Vancomycin Dose

  mg/24 h

  100

  90

  80

  70

  60

  50

  40

  30

  20

  10

  1,545

  1,390

  1,235

  1,080

  925

  770

  620

  465

  310

  155

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.

  The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only the serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men:

  Weight (kg) x (140 - age in years)

   

  72 x serum creatinine concentration (mg/dL)

  Women:

  0.85 x above value

  The serum creatinine must represent a steady state of renal function. Otherwise the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity.

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) routes have not been established.

  Intermittent infusion is the recommended method of administration.

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• Hospira, Inc.
  

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  Vancomycin Hydrochloride | Hospira, Inc.

  

  ---

  An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion-related events are related to both concentration and rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations).

  In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. Infusion-related events may occur, however, at any rate or concentration.

  Patients with Normal Renal Function

  Adults

  The usual intravenous daily dose is 2 g divided either as 500 mg every six hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual daily dose.

  Pediatric Patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every six hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the first week of life and every eight hours thereafter up to the age of one month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In premature infants and in the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin hydrochloride per day in mg is about 15 times the glomerular filtration rate in mL/min:

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Moellering et al)4

  Creatinine Clearance

  mL/min

  Vancomycin Dose

  mg/24 h

  100

  90

  80

  70

  60

  50

  40

  30

  20

  10

  1,545

  1,390

  1,235

  1,080

  925

  770

  620

  465

  310

  155

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.

  The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men:

  Weight (kg) x (140 - age in years)

  72 x serum creatinine concentration (mg/dL)

  Women:

  0.85 x above value

  The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity.

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) routes have not been established.

  Intermittent infusion is the recommended method of administration.

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• Hospira, Inc.
  

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  Vancomycin Hydrochloride | Hospira, Inc.

  

  ---

  An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion-related events are related to both concentration and rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations).

  In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. Infusion-related events may occur, however, at any rate or concentration.

  The use of ADD-Vantage vials of vancomycin hydrochloride is indicated only when doses of 500 mg, 750 mg or 1 g are appropriate. Patient factors, such as renal function and age, are critical in calculating correct dosage regimens (see below). If doses of 500 mg, 750 mg or 1 g are determined to be inappropriate, conventional vials of vancomycin hydrochloride should be used. ADD-VANTAGE VIALS OF VANCOMYCIN HYDROCHLORIDE SHOULD NOT BE USED IN NEONATES, INFANTS, OR PEDIATRIC PATIENTS WHO REQUIRE DOSES OF LESS THAN 500 MG.

  Patients with Normal Renal Function

  Adults

  The usual intravenous daily dose is 2 g divided either as 500 mg every six hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual daily dose.

  Pediatric Patients

  The usual intravenous dosage of vancomycin hydrochloride is 10 mg/kg per dose given every six hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the first week of life and every eight hours thereafter up to the age of one month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In premature infants and in the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin hydrochloride per day in mg is about 15 times the glomerular filtration rate in mL/min:

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Moellering et al)4

  Creatinine Clearance

  mL/min

  Vancomycin Dose

  mg/24 h

  100

  90

  80

  70

  60

  50

  40

  30

  20

  10

  1,545

  1,390

  1,235

  1,080

  925

  770

  620

  465

  310

  155

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.

  The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men:

  Weight (kg) x (140 - age in years)              
  72 x serum creatinine concentration (mg/dL)

  Women:

  0.85 x above value

  The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity.

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) routes have not been established.

  Intermittent infusion is the recommended method of administration.

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  Vancomycin Hydrochloride | Baxter Healthcare Corporation

  

  ---

  Vancomycin Injection, USP in the GALAXY plastic container (PL 2040) is intended for intravenous use only.

  Vancomycin in the GALAXY Container (PL 2040 Plastic) is not to be administered orally. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion related events may occur, however, at any rate or concentration.

  Patients With Normal Renal Function Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients With Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography. If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min:

  DOSAGE TABLE FOR VANCOMYCIN
  IN PATIENTS WITH IMPAIRED RENAL FUNCTION
  (Adapted from Moellering et al)4

  Creatinine Clearance
  mL/min

  Vancomycin Dose
  mg/24 h

  100

  1,545

  90

  1,390

  80

  1,235

  70

  1,080

  60

  925

  50

  770

  40

  620

  30

  465

  20

  310

  10

  155

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency. The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1,000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1,000 mg every 7 to 10 days has been recommended.

  When only the serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men:

  Weight (kg) x (140 – age in years)

   

  72 x serum creatinine concentration (mg/dL)

  Women:  

  0.85 x above value

  The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity. The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) routes have not been established.

  Intermittent infusion is the recommended method of administration.

  Directions for use of Vancomycin Injection, USP in GALAXY plastic container (PL 2040)

  Vancomycin Injection, USP in GALAXY plastic container (PL 2040) is for intravenous administration only.

  Storage

  Store in a freezer capable of maintaining a temperature at or below -20°C (-4°F).

  Thawing of Plastic Containers: 1. Thaw frozen containers at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. 2. Check for minute leaks by squeezing the bag firmly. If leaks are detected, discard solution because sterility may be impaired. 3. DO NOT ADD SUPPLEMENTARY MEDICATION. 4. Visually inspect the container.  If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired.  Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Agitate after solution has reached room temperature. If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted or if any seals are not intact, the container should be discarded. 5. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature (25°C/77°F) or for 30 days when stored under refrigeration (5°C/41°F). 6. Do not refreeze thawed antibiotics. Preparation for Intravenous Administration: 1. Suspend container from eyelet support. 2. Remove protector from outlet port at bottom of container. 3. Attach administration set. Refer to complete directions accompanying set. 4. Use sterile equipment.

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

  Rx only.

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• Alvogen, Inc.
  

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  Vancomycin Hydrochloride | Alvogen, Inc.

  

  ---

  2.1 Adults

  Vancomycin hydrochloride capsules are used in treating C. difficile-associated diarrhea and staphylococcal enterocolitis.

  C. difficile-associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days. Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days. 2.2 Pediatric Patients

  The usual daily dosage is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.

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• Agila Specialties Private Limited
  

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  Vancomycin Hydrochloride | Agila Specialties Private Limited

  

  ---

  Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations). In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion-related events may occur, however, at any rate or concentration.

  Patients with Normal Renal Function

  Adults

  The usual daily intravenous dose is 2 g divided either as 500 mg every six hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric Patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Neonates

  In pediatric patients up to the age of of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Meollering et al)4 Creatinine Clearance mL/min
  Vancomycin Dose mg/24 hr
  100
  1,545
  90
  1,390
  80
  1,235
  70
  1,080
  60
  925
  50
  770
  40
  620
  30
  465
  20
  310
  10
  155
  

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.

  The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  Men:                 Weight (kg) x (140 - age in years)                          

                     72 x serum creatinine concentration (mg/dL)

  Women:           0.85 x above value

  The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity.

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) routes have not been established.

  Intermittent infusion is the recommended method of administration.

  COMPATIBILITY WITH OTHER DRUGS AND IV FLUIDS

  The following diluents are physically and chemically compatible (with 4g/L vancomycin hydrochloride): 

  5% Dextrose Injection, USP

  5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP

  Lactated Ringer's Injection, USP

  5% Dextrose and Lactated Ringer's Injection

  Normosol®-M and 5% Dextrose

  0.9% Sodium Chloride Injection, USP

  Isolyte® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability of other compounds.

  DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE-NOT FOR DIRECT INFUSION

  Pharmacy bulk packages are for use in pharmacy admixture service only in a suitable work area, such as a laminar flow hood. They should be hung by the integral hanger provided and suspended as a unit in the laminar flow hood. Using aseptic technique the container closure should be penetrated only one time after reconstitution utilizing a suitable sterile dispensing set which allows measured distribution of the contents. Use of a syringe and needle is not recommended as it may cause leakage. Swab vial stopper with an antiseptic solution.

  Once the sterile dispensing set has been inserted into the container, withdrawal of the contents should be accomplished without delay. However, if this is not possible, a maximum time of 4 hours from the initial closure entry may be permitted to complete fluid transfer operations. Discard the container no later than 4 hours after initial closure puncture. This time limit should begin with introduction of solvent or diluent into the Pharmacy Bulk Package bottle.

  PREPARATION AND STABILITY

  10 g Pharmacy Bulk Package bottle

  At the time of use, reconstitute by adding 95 mL of Sterile Water for Injection, USP to the 10 g of Pharmacy Bulk Package bottle of dry, vancomycin powder. The resultant solution is a tan colored solution and will contain vancomycin equivalent to 500 mg/5 mL (1 g/10 mL). AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED.

  Reconstituted solutions of vancomycin (500 mg/5 mL) must be further diluted in at least 100 mL of a suitable infusion solution. For doses of 1 gram (10 mL), at least 200 mL of solution must be used. The desired dose diluted in this manner should be administered by intermittent IV infusion over a period of at least 60 minutes.

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

  For Oral Administration

  Oral vancomycin is used in treating antibiotic-associated pseudomembranous colitis caused by C. difficile and for staphylococcal enterocolitis. Vancomycin is not effective by the oral route for other types of infections. The usual adult total daily dose is 500 mg to 2 g given in 3 or 4 divided doses for 7 to 10 days. The total daily dose in children is 40 mg/kg of body weight in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. The appropriate dose may be diluted in 1 oz of water and given to the patient to drink. Common flavoring syrups may be added to the solution to improve the taste for oral administration. The diluted solution may be administered via a nasogastric tube.

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• Fresenius Kabi Usa, Llc
  

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  Vancomycin Hydrochloride | Fresenius Kabi Usa, Llc

  

  ---

  Infusion-related events are related to both the concentration and the rate of administration of vancomycin.  Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations).  In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events.  Infusion-related events may occur, however, at any rate or concentration.

  Patients with Normal Renal Function

  Adults

  The usual daily dose is 2 g divided either as 500 mg every six hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer.  Other patients factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Children

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours.  Each dose should be administered over a period of at least 60 minutes.  

  Infants and Neonates

  In neonates and young infants, the total daily IV dosage may be lower.  In both neonates and infants, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the first week of life and every eight hours thereafter up to the age of one month.  Each dose should be administered over 60 minutes.  Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function.  In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function.  Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay or high-pressure liquid chromatography.  

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table.  The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION

                                              (Adapted from Moellering et al.3)

  Creatinine Clearance                                                                        Vancomycin Dose

          mL/min                                                                                                 mg/24 hr

               100                                                                                                       1545

                90                                                                                                        1390

                80                                                                                                        1235

                70                                                                                                        1080

                60                                                                                                         925

                50                                                                                                         770

                40                                                                                                         620

                30                                                                                                         465

                20                                                                                                         310

                10                                                                                                         155

  
  

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.  

  The table is not valid for functionally anephric patients.  For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr.  In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis.  In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only serum creatinine is known, the following formula (based on sex, weight and age of the patient) may be used to calculate creatinine clearance.  Calculated creatinine clearances (mL/min) are only estimates.  The creatinine clearance should be measured promptly.

  Men:                                        Weight (kg) x (140–age in years)        
  

                                          72 x serum creatinine concentration (mg/dL)

   Women:                           0.85 x above value

  The serum creatinine must represent a steady state of renal function or the estimated value for creatinine clearance will not be valid.  Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition or inactivity.  

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) route have not been assessed.

  Intermittent infusion is the recommended method of administration.

  Compatibility with Other Drugs and IV Fluids

  The following diluents are physically and chemically compatible (with 4 g/L vancomycin hydrochloride):

     5% Dextrose Injection, USP

     5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP

     Lactated Ringer’s Injection, USP

     5% Dextrose and Lactated Ringer’s Injection

     Normosol®-M and 5% Dextrose

     0.9% Sodium Chloride Injection, USP

     Isolyte® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability of other compounds.

  Patients with Normal Renal Function

  Adults

  The usual daily dose is 2 g divided either as 500 mg every six hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer.  Other patients factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Children

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours.  Each dose should be administered over a period of at least 60 minutes.  

  Infants and Neonates

  In neonates and young infants, the total daily IV dosage may be lower.  In both neonates and infants, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the first week of life and every eight hours thereafter up to the age of one month.  Each dose should be administered over 60 minutes.  Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function.  In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function.  Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay or high-pressure liquid chromatography.  

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table.  The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION

                                              (Adapted from Moellering et al.3)

  Creatinine Clearance                                                                        Vancomycin Dose

          mL/min                                                                                                 mg/24 hr

               100                                                                                                       1545

                90                                                                                                        1390

                80                                                                                                        1235

                70                                                                                                        1080

                60                                                                                                         925

                50                                                                                                         770

                40                                                                                                         620

                30                                                                                                         465

                20                                                                                                         310

                10                                                                                                         155

  
  

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.  

  The table is not valid for functionally anephric patients.  For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr.  In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis.  In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only serum creatinine is known, the following formula (based on sex, weight and age of the patient) may be used to calculate creatinine clearance.  Calculated creatinine clearances (mL/min) are only estimates.  The creatinine clearance should be measured promptly.

  Men:                                        Weight (kg) x (140–age in years)        
  

                                          72 x serum creatinine concentration (mg/dL)

   Women:                           0.85 x above value

  The serum creatinine must represent a steady state of renal function or the estimated value for creatinine clearance will not be valid.  Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition or inactivity.  

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) route have not been assessed.

  Intermittent infusion is the recommended method of administration.

  Compatibility with Other Drugs and IV Fluids

  The following diluents are physically and chemically compatible (with 4 g/L vancomycin hydrochloride):

     5% Dextrose Injection, USP

     5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP

     Lactated Ringer’s Injection, USP

     5% Dextrose and Lactated Ringer’s Injection

     Normosol®-M and 5% Dextrose

     0.9% Sodium Chloride Injection, USP

     Isolyte® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability of other compounds.

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• Ani Pharmaceuticals, Inc.
  

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  Vancomycin Hydrochloride | Ani Pharmaceuticals, Inc.

  

  ---

  2.1 Adults

  Vancomycin Hydrochloride Capsules are used in treating C. difficile-associated diarrhea and staphylococcal enterocolitis.

  • C. difficile-associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days. • Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days. 2.2 Pediatric Patients

  The usual daily dosage is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.

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