Clindamycin

Clindamycin Manufacturers

• App Pharmaceuticals, Llc
  

  ×

  Clindamycin | App Pharmaceuticals, Llc

  

  ---

  If diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).

  Adults

  Parenteral IV administration

  Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis, Peptococcus species and Clostridium species other than Clostridium perfringens): 600 to 1200 mg/day in 2, 3 or 4 equal doses.

  More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens: 1200 to 2700 mg/day in 2, 3 or 4 equal doses.

  For more serious infections, these doses may have to be increased.

  In life-threatening situations due to either aerobes or anaerobes these doses may be increased.  Doses of as much as 4800 mg daily have been given intravenously to adults. See Dilution and Infusion Rates below.

  Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows:

  To maintain serum

  clindamycin levels

  Rapid infusion

  rate

  Maintenance

  infusion rate

  Above 4 mcg/mL

  Above 5 mcg/mL

  Above 6 mcg/mL

  10 mg/min for 30 min

  15 mg/min for 30 min

  20 mg/min for 30 min

  0.75 mg/min

  1 mg/min

  1.25 mg/min

  Neonates (less than 1 month)
  

  15 to 20 mg/kg/day in 3 to 4 equal doses.  The lower dosage may be adequate for small prematures.

  Pediatric Patients (1 month of age to 16 years)
  

  Parenteral IV administration: 20 to 40 mg/kg/day in 3 or 4 equal doses.  The higher doses would be used for more severe infections.  As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m2/day for serious infections and 450 mg/m2/day for more severe infections.

  Parenteral therapy may be changed to oral clindamycin flavored granules (clindamycin palmitate hydrochloride) or clindamycin capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.

  In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

  Dilution and Infusion Rates
  

  Clindamycin Injection, USP must be diluted prior to IV administration.  The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL.  Infusion rates should not exceed 30 mg per minute.  The usual infusion dilutions and rates are as follows:

  Dose

  Diluent

  Time

  300 mg

  600 mg

  900 mg

  1200 mg

  50 mL

  50 mL

  50 to 100 mL

  100 mL

  10 min

  20 min

  30 min

  40 min

  Administration of more than 1200 mg in a single 1-hour infusion is not recommended.

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

  Dilution and Compatibility
  

  Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin Injection, USP in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically.  No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

  The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.

  The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions.

  For current information regarding compatibilities of clindamycin phosphate under specific conditions, please visit www.APPpharma.com or call our medical information and safety department toll-free at 1-800-551-7176.

  Physico-Chemical Stability of Diluted Solutions of Clindamycin
  

  Room temperature: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in  5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.  Also 18 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, in minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.

  Refrigeration: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 32 days at 4°C.

  IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Frozen: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringers Injection in minibags demonstrated physical and chemical stability for at least eight weeks at -10°C.

  Frozen solutions should be thawed at room temperature and not refrozen.

  Adults

  Parenteral IV administration

  Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis, Peptococcus species and Clostridium species other than Clostridium perfringens): 600 to 1200 mg/day in 2, 3 or 4 equal doses.

  More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens: 1200 to 2700 mg/day in 2, 3 or 4 equal doses.

  For more serious infections, these doses may have to be increased.

  In life-threatening situations due to either aerobes or anaerobes these doses may be increased.  Doses of as much as 4800 mg daily have been given intravenously to adults. See Dilution and Infusion Rates below.

  Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows:

  To maintain serum

  clindamycin levels

  Rapid infusion

  rate

  Maintenance

  infusion rate

  Above 4 mcg/mL

  Above 5 mcg/mL

  Above 6 mcg/mL

  10 mg/min for 30 min

  15 mg/min for 30 min

  20 mg/min for 30 min

  0.75 mg/min

  1 mg/min

  1.25 mg/min

  Neonates (less than 1 month)
  

  15 to 20 mg/kg/day in 3 to 4 equal doses.  The lower dosage may be adequate for small prematures.

  Pediatric Patients (1 month of age to 16 years)
  

  Parenteral IV administration: 20 to 40 mg/kg/day in 3 or 4 equal doses.  The higher doses would be used for more severe infections.  As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m2/day for serious infections and 450 mg/m2/day for more severe infections.

  Parenteral therapy may be changed to oral clindamycin flavored granules (clindamycin palmitate hydrochloride) or clindamycin capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.

  In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

  Dilution and Infusion Rates
  

  Clindamycin Injection, USP must be diluted prior to IV administration.  The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL.  Infusion rates should not exceed 30 mg per minute.  The usual infusion dilutions and rates are as follows:

  Dose

  Diluent

  Time

  300 mg

  600 mg

  900 mg

  1200 mg

  50 mL

  50 mL

  50 to 100 mL

  100 mL

  10 min

  20 min

  30 min

  40 min

  Administration of more than 1200 mg in a single 1-hour infusion is not recommended.

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

  Dilution and Compatibility
  

  Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin Injection, USP in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically.  No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

  The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.

  The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions.

  For current information regarding compatibilities of clindamycin phosphate under specific conditions, please visit www.APPpharma.com or call our medical information and safety department toll-free at 1-800-551-7176.

  Physico-Chemical Stability of Diluted Solutions of Clindamycin
  

  Room temperature: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in  5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.  Also 18 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, in minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.

  Refrigeration: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 32 days at 4°C.

  IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Frozen: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringers Injection in minibags demonstrated physical and chemical stability for at least eight weeks at -10°C.

  Frozen solutions should be thawed at room temperature and not refrozen.

  Close
  No Recall

  More Info
• App Pharmaceuticals, Llc
  

  ×

  Clindamycin | App Pharmaceuticals, Llc

  

  ---

  If diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).

  Adults

  Parenteral (IM or IV administration)

  Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis, Peptococcus species and Clostridium species other than Clostridium perfringens): 600 to 1200 mg/day in 2, 3 or 4 equal doses. 

  More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens: 1200 to 2700 mg/day in 2, 3 or 4 equal doses.

  For more serious infections, these doses may have to be increased.

  In life-threatening situations due to either aerobes or anaerobes these doses may be increased.  Doses of as much as 4800 mg daily have been given intravenously to adults.  See Dilution and Infusion Rates below.

  Single intramuscular injections of greater than 600 mg are not recommended.

  Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows:

  To maintain serum clindamycin levels

  Rapid infusion rate

  Maintenance infusion rate

  Above 4 mcg/mL

  10 mg/min for 30 min

  0.75 mg/min

  Above 5 mcg/mL

  15 mg/min for 30 min

  1 mg/min

  Above 6 mcg/mL

  20 mg/min for 30 min

  1.25 mg/min

  Neonates (less than 1 month)
  

  15 to 20 mg/kg/day in 3 to 4 equal doses.  The lower dosage may be adequate for small prematures.

  Pediatric Patients (1 month of age to 16 years)
  

  Parenteral (IM or IV) administration: 20 to 40 mg/kg/day in 3 or 4 equal doses.  The higher doses would be used for more severe infections.  As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m2/day for serious infections and 450 mg/m2/day for more severe infections.

  Parenteral therapy may be changed to clindamycin palmitate hydrochloride for oral solution or clindamycin capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.

  In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

  Dilution and Infusion Rates
  

  Clindamycin Injection, USP must be diluted prior to IV administration.  The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL.  Infusion rates should not exceed 30 mg per minute.  The usual infusion dilutions and rates are as follows:

  Dose

  Diluent

  Time

  300 mg

  50 mL

  10 min

  600 mg

  50 mL

  20 min

  900 mg

  50 to 100 mL

  30 min

  1200 mg

  100 mL

  40 min

  Administration of more than 1200 mg in a single 1-hour infusion is not recommended.

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

  Dilution and Compatibility
  

  Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin Injection, USP in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically.  No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

  The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.

  The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions.

  For current information regarding compatibilities of clindamycin phosphate under specific conditions, please visit www.APPpharma.com or call our medical information and safety department toll-free at 1-800-551-7176.

  Physico-Chemical Stability of Diluted Solutions of Clindamycin
  

  Room temperature: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.  Also 18 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, in minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.

  Refrigeration: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 32 days at 4°C. 

  IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time.  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible. 

  Frozen: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringers Injection in minibags demonstrated physical and chemical stability for at least eight weeks at –10°C.

  Frozen solutions should be thawed at room temperature and not refrozen.

  Adults

  Parenteral (IM or IV administration)

  Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis, Peptococcus species and Clostridium species other than Clostridium perfringens): 600 to 1200 mg/day in 2, 3 or 4 equal doses. 

  More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens: 1200 to 2700 mg/day in 2, 3 or 4 equal doses.

  For more serious infections, these doses may have to be increased.

  In life-threatening situations due to either aerobes or anaerobes these doses may be increased.  Doses of as much as 4800 mg daily have been given intravenously to adults.  See Dilution and Infusion Rates below.

  Single intramuscular injections of greater than 600 mg are not recommended.

  Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows:

  To maintain serum clindamycin levels

  Rapid infusion rate

  Maintenance infusion rate

  Above 4 mcg/mL

  10 mg/min for 30 min

  0.75 mg/min

  Above 5 mcg/mL

  15 mg/min for 30 min

  1 mg/min

  Above 6 mcg/mL

  20 mg/min for 30 min

  1.25 mg/min

  Neonates (less than 1 month)
  

  15 to 20 mg/kg/day in 3 to 4 equal doses.  The lower dosage may be adequate for small prematures.

  Pediatric Patients (1 month of age to 16 years)
  

  Parenteral (IM or IV) administration: 20 to 40 mg/kg/day in 3 or 4 equal doses.  The higher doses would be used for more severe infections.  As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m2/day for serious infections and 450 mg/m2/day for more severe infections.

  Parenteral therapy may be changed to clindamycin palmitate hydrochloride for oral solution or clindamycin capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.

  In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

  Dilution and Infusion Rates
  

  Clindamycin Injection, USP must be diluted prior to IV administration.  The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL.  Infusion rates should not exceed 30 mg per minute.  The usual infusion dilutions and rates are as follows:

  Dose

  Diluent

  Time

  300 mg

  50 mL

  10 min

  600 mg

  50 mL

  20 min

  900 mg

  50 to 100 mL

  30 min

  1200 mg

  100 mL

  40 min

  Administration of more than 1200 mg in a single 1-hour infusion is not recommended.

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

  Dilution and Compatibility
  

  Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin Injection, USP in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically.  No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

  The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.

  The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions.

  For current information regarding compatibilities of clindamycin phosphate under specific conditions, please visit www.APPpharma.com or call our medical information and safety department toll-free at 1-800-551-7176.

  Physico-Chemical Stability of Diluted Solutions of Clindamycin
  

  Room temperature: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.  Also 18 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, in minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.

  Refrigeration: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 32 days at 4°C. 

  IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time.  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible. 

  Frozen: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringers Injection in minibags demonstrated physical and chemical stability for at least eight weeks at –10°C.

  Frozen solutions should be thawed at room temperature and not refrozen.

  Close
  No Recall

  More Info
• Cardinal Health
  

  ×

  Clindamycin | Cardinal Health

  

  ---

  Clindamycin Injection, USP can be administered by IM or IV injection (following dilution). However, the intent of the ADD-VANTAGE vial is for the preparation of solutions for IV infusion only.

  If diarrhea occurs during therapy, this antibiotic should be discontinued. (See WARNING box.)

  Adults:

  Parenteral (IM or IV) Administration:

  Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis, Peptococcus species and Clostridium species other than Clostridium perfringens):

  600 to 1200 mg/day in 2, 3 or 4 equal doses

  More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens:

  1200 to 2700 mg/day in 2, 3 or 4 equal doses

  For more serious infections, these doses may have to be increased. In life threatening situations due to either aerobes or anaerobes, these doses may be increased. Doses of as much as 4800 mg daily have been given intravenously to adults. See Dilution and Infusion Rates section below.

  Single intramuscular injections of greater than 600 mg are not recommended.

  Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows:

  To maintain serum clindamycin levels

  Rapid infusion rate

  Maintenance infusion rate

  Above 4 mcg/mL

  Above 5 mcg/mL

  Above 6 mcg/mL

  10 mg/min for 30 min

  15 mg/min for 30 min

  20 mg/min for 30 min

  0.75 mg/min

  1 mg/min

  1.25 mg/min

  Neonates (less than 1 month):

  15 to 20 mg/kg/day in three to four equal doses. The lower dosage may be adequate for small prematures.

  Pediatric patients (1 month of age to 16 years):

  Parenteral (IM or IV) Administration: 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections. As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m2/day for serious infections and 450 mg/m2/day for more severe infections.

  Parenteral therapy may be changed to clindamycin palmitate hydrochloride for oral solution or clindamycin hydrochloride capsules when the condition warrants and at the discretion of the physician.

  In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

  Dilution and Infusion Rates:

  Clindamycin phosphate must be diluted prior to IV administration with the ADD-VANTAGE Flexible Diluent Container. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL. Infusion rates should not exceed 30 mg per minute. The usual infusion dilutions and rates are as follows:

  Dose

  Diluent

  Time

  300 mg

  600 mg

  900 mg

  1200 mg

  50 mL

  50 mL

  50 to 100 mL

  100 mL

  10 min

  20 min

  30 min

  40 min

  Administration of more than 1200 mg in a 1-hour infusion is not recommended.

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

  Dilution and Compatibility:

  Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of clindamycin phosphate in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

  The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.

  The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions.

  Physico-Chemical Stability of Diluted Solutions of Clindamycin:

  Room temperature: 6, 9, and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 16 days at 25°C. Also 18 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, in minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.

  Refrigeration: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 32 days at 4°C.

  IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Frozen: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in minibags demonstrated physical and chemical stability for at least eight weeks at -10°C.

  Frozen solutions should be thawed at room temperature and not refrozen.

  
  

  INSTRUCTIONS FOR USE

  To Open Diluent Container:

  Peel overwrap from the corner and remove container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

  To Assemble Vial and Flexible Diluent Container:

  (Use Aseptic Technique)

  Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:

  
  

  a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (SEE FIGURE 1.), then pull straight up to remove the cap. (SEE FIGURE 2.) NOTE: Do not access vial with syringe.

  Fig. 1

  Fig. 2

  Fig. 1

  Fig. 2

  b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (SEE FIGURE 3.)

  Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click. (SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go.

  
  

  NOTE: Once vial is seated, do not attempt to remove. (SEE FIGURE 4.)

  Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly.

  Label appropriately.

  Fig. 3

  Fig. 4

  To Prepare Admixture:

  Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial.

  With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (SEE FIGURE 5.)

  Pull the inner cap from the drug vial. (SEE FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix.

  Mix container contents thoroughly and use within the specified time.

  Fig. 5

  Fig. 6

  Fig. 5

  Fig. 6

  Preparation for Administration

  (Use Aseptic Technique)

  Confirm the activation and admixture of vial contents.

  Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired.

  Close flow control clamp of administration set.

  Remove cover from outlet port at bottom of container.

  Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.

  
  

  NOTE: See full directions on administration set carton.

  Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger.

  Squeeze and release drip chamber to establish proper fluid level in chamber.

  Open flow control clamp and clear air from set. Close clamp.

  Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.

  Regulate rate of administration with flow control clamp.

  WARNING: Do not use flexible container in series connections.

  Close
  No Recall

  More Info
• Akorn, Inc.
  

  ×

  Clindamycin | Akorn, Inc.

  

  ---

  If diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).

  Adults

  Parenteral (IV Administration): Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis, Peptococcus species and Clostridium species other than Clostridium perfringens):

  600 to 1200 mg/day in 2, 3 or 4 equal doses.

  More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens:

  1200 to 2700 mg/day in 2, 3 or 4 equal doses.

  For more serious infections, these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes these doses may be increased. Doses of as much as 4800 mg daily have been given intravenously to adults. See Infusion Rates section below.

  Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows:

  To maintain serum Maintenance clindamycin levels Rapid infusion rate infusion rate Above 4 mcg/mL 10 mg/min for 30 min 0.75 mg/min Above 5 mcg/mL 15 mg/min for 30 min 1.00 mg/min Above 6 mcg/mL 20 mg/min for 30 min 1.25 mg/min Neonates (less than 1 month)

  15 to 20 mg/kg/day in 3 to 4 equal doses. The lower dosage may be adequate for small prematures.

  Pediatric patients 1 month of age to 16 years

  Parenteral (IV) Administration: 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections. As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m2/day for serious infections and 450 mg/m2/day for more severe infections.

  Parenteral therapy may be changed to oral clindamycin palmitate hydrochloride for oral solution or clindamycin hydrochloride capsules when the condition warrants and at the discretion of the physician.

  In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

  Infusion Rates

  Infusion rates for Clindamycin in 5% Dextrose Injection should not exceed 30 mg per minute. The usual infusion rates are as follows:

  Dose Strength Time 300 mg/50 mL 6 mg/mL 10 min 600 mg/50 mL 12 mg/mL 20 min 900 mg/50 mL 18 mg/mL 30 min

  Administration of more than 1200 mg in a single 1-hour infusion is not recommended.

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

  Compatibility

  Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of clindamycin in 5% dextrose injection in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

  The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.

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• Sagent Pharmaceuticals
  

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  Clindamycin | Heritage Pharmaceuticals Inc.

  

  ---

  The dose of verapamil must be individualized by titration. The usefulness and safety of dosages exceeding 480 mg/day have not been established; therefore, this daily dosage should not be exceeded. Since the half-life of verapamil increases during chronic dosing, maximum response may be delayed.

  Angina: Clinical trials show that the usual dose is 80 mg to 120 mg three times a day. However, 40 mg three times a day may be warranted in patients who may have an increased response to verapamil (eg, decreased hepatic function, elderly, etc). Upward titration should be based on therapeutic efficacy and safety evaluated approximately eight hours after dosing. Dosage may be increased at daily (eg, patients with unstable angina) or weekly intervals until optimum clinical response is obtained.

  Arrhythmias: The dosage in digitalized patients with chronic atrial fibrillation (see PRECAUTIONS) ranges from 240 to 320 mg/day in divided (t.i.d. or q.i.d.) doses. The dosage for prophylaxis of PSVT (non-digitalized patients) ranges from 240 to 480 mg/day in divided (t.i.d. or q.i.d.) doses. In general, maximum effects for any given dosage will be apparent during the first 48 hours of therapy.

  Essential hypertension: Dose should be individualized by titration. The usual initial monotherapy dose in clinical trials was 80 mg three times a day (240 mg/ day). Daily dosages of 360 and 480 mg have been used but there is no evidence that dosages beyond 360 mg provided added effect. Consideration should be given to beginning titration at 40 mg three times per day in patients who might respond to lower doses, such as the elderly or people of small stature. The antihypertensive effects of verapamil hydrochloride are evident within the first week of therapy. Upward titration should be based on therapeutic efficacy, assessed at the end of the dosing interval.

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• Sagent Pharmaceuticals
  

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  Clindamycin | Mylan Pharmaceuticals Inc.

  

  ---

  While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined.

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  Clindamycin | Teva Women's Health, Inc.

  

  ---

  A single vaccine dose is administered orally as two tablets: one tablet of Adenovirus Type 4 and one tablet of Adenovirus Type 7. (2)

  The tablets should be swallowed whole, without chewing, to avoid releasing the virus in the upper respiratory tract. [See Mechanism of Action (12.1)]

  Postpone administration to individuals with vomiting and/or diarrhea because the effectiveness of the vaccine depends upon the multiplication of orally administered live adenovirus within the intestinal tract. [See Mechanism of Action (12.1)]

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• Hospira, Inc.
  

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  Clindamycin | Hospira, Inc.

  

  ---

  If diarrhea occurs during therapy, this antibiotic should be discontinued. (See WARNING box).

  Adults

  Parenteral (IM or IV Administration):

  Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis, Peptococcus species and Clostridium species other than Clostridium perfringens):

  600 to 1200 mg/day in 2, 3 or 4 equal doses.

  More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens:

  1200 to 2700 mg/day in 2, 3 or 4 equal doses.

  For more serious infections, these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes these doses may be increased. Doses of as much as 4800 mg daily have been given intravenously to adults. See Dilution and Infusion Rates section below.

  Single IM injections of greater than 600 mg are not recommended.

  Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows: 

  To maintain serum
  clindamycin levels

  Rapid infusion rate

  Maintenance
  infusion rate

  Above 4 mcg/mL

  10 mg/min for 30 min

  0.75 mg/min

  Above 5 mcg/mL

  15 mg/min for 30 min

  1.00 mg/min

  Above 6 mcg/mL

  20 mg/min for 30 min

  1.25 mg/min

  Neonates (less than 1 month)

  15 to 20 mg/kg/day in three to four equal doses. The lower dosage may be adequate for small prematures.

  Pediatric patients (1 month of age to 16 years)

  Parenteral (IM or IV) administration: 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections. As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m2/day for serious infections and 450 mg/m2/day for more severe infections.

  Parenteral therapy may be changed to clindamycin palmitate hydrochloride for oral solution or clindamycin hydrochloride capsules when the condition warrants and at the discretion of the physician.

  In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

  Dilution and Infusion Rates

  Clindamycin phosphate must be diluted prior to I.V. administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL. Infusion rates should not exceed 30 mg per minute.

  The usual infusion dilutions and rates are as follows: 

  Dose

  Diluent

  Time

  300 mg

  50 mL

  10 min

  600 mg

  50 mL

  20 min

  900 mg

  50-100 mL

  30 min

  1200 mg

  100 mL

  40 min

  Administration of more than 1200 mg in a single 1-hour infusion is not recommended.

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

  Dilution and Compatibility

  Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of clindamycin phosphate in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

  The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.

  The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions.

  Physico-Chemical Stability of Diluted Solutions of Clindamycin

  Room temperature: 6, 9, and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 16 days at 25°C. Also, 18 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, in minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.

  Refrigeration: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 32 days at 4°C.

  IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Frozen: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection,
  0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in minibags demonstrated physical and chemical stability for at least eight weeks at -10°C.

  Frozen solutions should be thawed at room temperature and not refrozen.

  Dilution and Infusion Rates

  Clindamycin phosphate must be diluted prior to I.V. administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL. Infusion rates should not exceed 30 mg per minute.

  The usual infusion dilutions and rates are as follows: 

  Dose

  Diluent

  Time

  300 mg

  50 mL

  10 min

  600 mg

  50 mL

  20 min

  900 mg

  50-100 mL

  30 min

  1200 mg

  100 mL

  40 min

  Administration of more than 1200 mg in a single 1-hour infusion is not recommended.

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

  Dilution and Compatibility

  Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of clindamycin phosphate in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

  The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.

  The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions.

  Physico-Chemical Stability of Diluted Solutions of Clindamycin

  Room temperature: 6, 9, and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 16 days at 25°C. Also, 18 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, in minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.

  Refrigeration: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 32 days at 4°C.

  IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Frozen: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection,
  0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in minibags demonstrated physical and chemical stability for at least eight weeks at -10°C.

  Frozen solutions should be thawed at room temperature and not refrozen.

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• Hospira, Inc.
  

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  Clindamycin | Astrazeneca Lp

  

  ---

  The usual recommended starting dose of candesartan cilexetil is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. ATACAND can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. Patients requiring further reduction in blood pressure should be titrated to 32 mg. Doses larger than 32 mg do not appear to have a greater blood pressure lowering effect.

  Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily.

  Use in Renal Impairment: Dosing recommendations for ATACAND HCT in patients with creatinine clearance < 30 mg/min cannot be provided (see SPECIAL POPULATIONS, Renal Insufficiency).

  Use in moderate to severe Hepatic Impairment: ATACAND HCT is not recommended for initiation because the appropriate starting dose, 8 mg, cannot be given (see SPECIAL POPULATIONS, Hepatic Insufficiency).

  Replacement Therapy: The combination may be substituted for the titrated components.

  Dose Titration by Clinical Effect: A patient whose blood pressure is not controlled on 25 mg of hydrochlorothiazide once daily can expect an incremental effect from ATACAND HCT 16-12.5 mg. A patient whose blood pressure is controlled on 25 mg of hydrochlorothiazide but is experiencing decreases in serum potassium can expect the same or incremental blood pressure effects from ATACAND HCT 16-12.5 mg and serum potassium may improve.

  A patient whose blood pressure is not controlled on 32 mg of ATACAND can expect incremental blood pressure effects from ATACAND HCT 32-12.5 mg and then 32-25 mg. The maximal antihypertensive effect of any dose of ATACAND HCT can be expected within 4 weeks of initiating that dose.

  ATACAND HCT may be administered with other antihypertensive agents.

  ATACAND HCT may be administered with or without food.

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• Hospira, Inc.
  

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  Clindamycin | Hospira, Inc.

  

  ---

  Clindamycin Injection, USP can be administered by IM or IV injection (following dilution); however, the intent of this Pharmacy Bulk Package is for the preparation of solutions for IV infusion only.

  If diarrhea occurs during therapy, this antibiotic should be discontinued. (See WARNING box.)

  Adults

  Parenteral (IM or IV) Administration:

  Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis, Peptococcus species and Clostridium species other than Clostridium perfringens):

  600 to 1200 mg/day in 2, 3 or 4 equal doses.

  More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens:

  1200 to 2700 mg/day in 2, 3 or 4 equal doses.

  For more serious infections, these doses may have to be increased. In life threatening situations due to either aerobes or anaerobes these doses may be increased. Doses of as much as 4800 mg daily have been given intravenously to adults. See Dilution and Infusion Rates section below.

  Single IM injections of greater than 600 mg are not recommended.

  Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows:

  To maintain serum clindamycin levels

  Rapid infusion rate

  Maintenance infusion rate

  Above 4 mcg/mL

  10 mg/min for 30 min

  0.75 mg/min

  Above 5 mcg/mL

  15 mg/min for 30 min

  1.00 mg/min

  Above 6 mcg/mL

  20 mg/min for 30 min

  1.25 mg/min

  Neonates (less than 1 month)

  15 to 20 mg/kg/day in three to four equal doses. The lower dosage may be adequate for small prematures.

  Pediatric patients (1 month of age to 16 years)

  Parenteral (IM or IV) administration: 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections. As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m2/day for serious infections and 450 mg/m2/day for more severe infections.

  Parenteral therapy may be changed to clindamycin palmitate hydrochloride for oral solution or clindamycin hydrochloride capsules when the condition warrants and at the discretion of the physician.

  In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

  Dilution and Infusion Rates

  Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL. Infusion rates should not exceed 30 mg per minute. The usual infusion dilutions and rates are as follows:

  Dose

  Diluent

  Time

  300 mg

  50 mL

  10 min

  600 mg

  50 mL

  20 min

  900 mg

  50-100 mL

  30 min

  1200 mg

  100 mL

  40 min

  Administration of more than 1200 mg in a single 1-hour infusion is not recommended.

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

  Dilution and Compatibility

  Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of clindamycin phosphate in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

  The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.

  The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions.

  Physico-Chemical Stability of Diluted Solutions of Clindamycin

  Room temperature: 6, 9, and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 16 days at 25°C. Also, 18 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, in minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.

  Refrigeration: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 32 days at 4°C.

  IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Frozen: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in minibags demonstrated physical and chemical stability for at least eight weeks at -10°C.

  Frozen solutions should be thawed at room temperature and not refrozen.

  Directions for Proper Use of Pharmacy Bulk Package

  Use Aseptic Technique

  1. For hanger application, peel off the paper liner from both ends of the tape hanger to expose 3/4 in. long adhesive portions. Adhere each end to the label on the bottle. 2. During use, container must be stored and all manipulations performed in an appropriate laminar flow hood. 3. Remove cover from container and cleanse closure with antiseptic. 4. Insert suitable sterile dispensing set or transfer device and suspend unit in a laminar flow hood. The closure should be entered only once and after initial entry, the withdrawal of container contents should be completed promptly in one continuous operation. Should this not be possible, a maximum time of 4 hours from initial closure puncture is permitted to complete fluid transfer operations; i.e., discard container no later than 4 hours after initial closure puncture. 5. Sequentially dispense aliquots of Clindamycin Injection, USP into IV containers using appropriate transfer device. During fluid transfer operations, the Pharmacy Bulk Package should be maintained under the storage conditions recommended in the labeling.

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• Cardinal Health
  

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  Clindamycin | Cardinal Health

  

  ---

  If diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).

  Adults

  Parenteral (IM or IV Administration): Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis, Peptococcus species and Clostridium species other than Clostridium perfringens):

    600 mg to 1200 mg/day in 2, 3 or 4 equal doses.

  More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens:

    1200 mg to 2700 mg/day in 2, 3 or 4 equal doses.

  For more serious infections, these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes these doses may be increased. Doses of as much as 4800 mg daily have been given intravenously to adults. See Dilution and Infusion Rates section below.

  Single intramuscular injections of greater than 600 mg are not recommended.

  Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows:

  To maintain serum
  clindamycin levels

  Rapid infusion rate

  Maintenance
  infusion rate

  Above 4 mcg/mL
  Above 5 mcg/mL
  Above 6 mcg/mL

  10 mg/min for 30 min
  15 mg/min for 30 min
  20 mg/min for 30 min

  0.75 mg/min
  1 mg/min
  1.25 mg/min

  Neonates (less than 1 month)

  15 to 20 mg/kg/day in 3 to 4 equal doses. The lower dosage may be adequate for small prematures.

  Pediatric patients 1 month of age to 16 years

  Parenteral (IM or IV) Administration: 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections. As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m2/day for serious infections and 450 mg/m2/day for more severe infections.

  Parenteral therapy may be changed to oral clindamycin flavored granules (clindamycin palmitate hydrochloride) or clindamycin capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.

  In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

  Dilution and Infusion Rates

  Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL. Infusion rates should not exceed 30 mg per minute. The usual infusion dilutions and rates are as follows:

  Dose

  Diluent

  Time

  300 mg
  600 mg
  900 mg
  1200 mg

  50 mL
  50 mL
  50 to 100 mL
  100 mL

  10 min
  20 min
  30 min
  40 min

  Administration of more than 1200 mg in a single 1-hour infusion is not recommended.

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

  Dilution and Compatibility

  Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of clindamycin injection (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

  The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.

  The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions. For current information regarding compatibilities of clindamycin phosphate under specific conditions, please contact the medical affairs department toll-free at 1-866-625-1618.

  Physico-Chemical Stability of diluted solutions of Clindamycin Injection

  Room temperature: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 16 days at 25°C. Also, 18 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, in minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.

  Refrigeration: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 32 days at 4°C.

  IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Frozen: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in minibags demonstrated physical and chemical stability for at least eight weeks at -10°C.

  Frozen solutions should be thawed at room temperature and not refrozen.

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• Sagent Pharmaceuticals
  

  ×

  Clindamycin | Sagent Pharmaceuticals

  

  ---

  If diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).

  Clindamycin injection IM administration should be used undiluted. Clindamycin injection IV administration should be diluted. (See Dilution for IV use and IV Infusion Rates below.)

  Adults: Parenteral (IM or IV Administration): Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis, Peptococcus species and Clostridium species other than Clostridium perfringens):

  600 mg to 1200 mg/day in 2, 3 or 4 equal doses.More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens: 1200 mg to 2700 mg/day in 2, 3 or 4 equal doses.For more serious infections, these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes these doses may be increased. Doses of as much as 4800 mg daily have been given intravenously to adults. See Dilution for IV use and IV Infusion Rates section below. Single intramuscular injections of greater than 600 mg are not recommended. Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows: To maintain serum clindamycin levels Rapid infusion rate Maintenance infusion rate Above 4 mcg/mL Above 5 mcg/mL Above 6 mcg/mL 10 mg/min for 30 min 15 mg/min for 30 min 20 mg/min for 30 min 0.75 mg/min 1 mg/min 1.25 mg/min

  Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower dosage may be adequate for small prematures.

  Pediatric patients 1 month of age to 16 years: Parenteral (IM or IV) Administration: 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections. As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m2/day for serious infections and 450 mg/m2/day for more severe infections.

  Parenteral therapy may be changed to oral clindamycin flavored granules (clindamycin palmitate hydrochloride) or clindamycin capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician. In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

  Dilution for IV use and IV Infusion Rates: The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL. Infusion rates should not exceed 30 mg per minute. The usual infusion dilutions and rates are as follows:

  Dose Diluent Time 300 mg 600 mg 900 mg 1200 mg 50 mL 50 mL 50 to 100 mL 100 mL 10 min 20 min 30 min 40 min Administration of more than 1200 mg in a single 1-hour infusion is not recommended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of clindamycin injection (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

  The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate. The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions. For current information regarding compatibilities of clindamycin phosphate under specific conditions, please contact the medical affairs department toll-free at 1-866-625-1618. Physico-Chemical Stability of diluted solutions of Clindamycin Injection

  Room temperature: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 16 days at 25°C. Also, 18 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, in minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.

  Refrigeration: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 32 days at 4°C. IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible. Frozen: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in minibags demonstrated physical and chemical stability for at least eight weeks at -10°C. Frozen solutions should be thawed at room temperature and not refrozen.

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