Clindamycin phosphate is available in 2-, 4-, and 6-mL single-dose and ADD-Vantage vials and a 60-mL pharmacy bulk package containing the equivalent of clindamycin base 150 mg/mL.3384 Single-dose vials and the pharmacy bulk package are intended for intravenous or intramuscular use; ADD-Vantage vials are intended for intravenous use only.3384 Each mL of solution also contains benzyl alcohol 9.45 mg and disodium edetate 0.5 mg.3384 Sodium hydroxide and/or hydrochloric acid may have been added to adjust the pH.3384 For intravenous administration, the injection solution should be diluted in a compatible diluent; clindamycin doses of 300 and 600 mg should be diluted in 50 mL, doses of 900 mg should be diluted in 50 to 100 mL, and doses of 1200 mg should be diluted in 100 mL.3384 The injection solution should be used undiluted for intramuscular administration.3384 ADD-Vantage vials of clindamycin should be prepared with 50 mL (for the 300- and 600-mg vials) or 100 mL (for the 900-mg vials) of dextrose 5% or sodium chloride 0.9% in ADD-Vantage diluent bags.3384
Clindamycin phosphate also is available in several ready-to-use formulations.3384; 3385; 3386; 3387 Clindamycin phosphate is available as a premixed injection solution containing the equivalent of 300, 600, and 900 mg of clindamycin base in 50 mL of dextrose 5% in single-dose Galaxy3384 and Cryovac3387 plastic containers and glass bottles3386 and in 50 mL of sodium chloride 0.9% in single-dose Galaxy containers.3385 Premixed injection solutions also contain disodium edetate 0.04 mg/mL.3384; 3385; 3386; 3387 Sodium hydroxide and/or hydrochloric acid have been added to adjust the pH.3384; 3385; 3386; 3387
pH
Clindamycin (Alvogen) 150-mg/mL injection solution has a pH ranging from 5.5 to 7.3388
Clindamycin (Akorn) 6-, 12-, and 18-mg/mL premixed infusion solutions in dextrose 5% have a pH ranging from 5.9 to 6.3.3390
Clindamycin (Baxter) 6-, 12-, and 18-mg/mL premixed infusion solutions in sodium chloride 0.9% have a pH ranging from 5.5 to 6.5.3389
Osmolality
Clindamycin (Upjohn) 150 mg/mL has been reported to have an osmolality of 795 mOsm/kg50 or 835 mOsm/kg1071 as determined by freezing-point depression. However, the manufacturer has stated that the osmolality is usually 825 to 880 mOsm/kg.1705
The osmolality of clindamycin (Upjohn) 12 mg/mL was determined to be 293 mOsm/kg in dextrose 5% and 309 mOsm/kg in sodium chloride 0.9%.1375
One manufacturer has stated that the osmolalities of clindamycin (Akorn) 300-, 600-, and 900-mg premixed infusion solutions in dextrose 5% are 260 to 340, 280 to 370, and 300 to 400 mOsm/kg, respectively.3390 One manufacturer has stated that the osmolalities of clindamycin (Baxter) 300-, 600-, and 900-mg premixed infusions in sodium chloride 0.9% are 285 to 345, 305 to 370, and 335 to 395 mOsm/kg, respectively.3389
The osmolality of clindamycin 600 mg was calculated for the following dilutions:1054
Osmolality (mOsm/kg) | ||
---|---|---|
Diluent | 50 mL | 100 mL |
Dextrose 5% | 279 | 268 |
Sodium chloride 0.9% | 306 | 294 |
Trade Name(s)
Cleocin Phosphate
Clindamycin phosphate is administered by intermittent intravenous infusion at concentrations not exceeding 18 mg/mL of clindamycin.3384; 3384; 3385; 3386; 3387 Intermittent infusions should be administered over 10 to 60 minutes at a rate not exceeding 30 mg/min; clindamycin doses of 300, 600, 900, and 1200 mg should be infused over 10, 20, 30, and 40 minutes, respectively.3384; 3385; 3386 Not more than 1200 mg of clindamycin should be administered in a single 1-hour infusion period.3384; 3386 Alternatively, following an initial single rapid infusion over 30 minutes with an infusion rate ranging from 10 to 20 mg/min, the drug also can be administered by continuous intravenous infusion at maintenance infusion rates of 0.75 to 1.25 mg/min in adult patients, with infusion rates determined by the desired serum clindamycin concentration.3384; 3385; 3386 The drug should not be administered undiluted as a bolus.3384
Clindamycin phosphate also can be administered by intramuscular injection as an undiluted solution in some patients.3384 Single injections exceeding 600 mg are not recommended.3384
Intact containers of clindamycin phosphate should be stored at controlled room temperature; exposure to heat should be minimized and temperatures above 30°C should be avoided.3384; 3385; 3386; 3387 Some manufacturers state that vials should not be refrigerated.3388 Crystallization may occur if refrigerated; the crystals resolubilize when warmed to room temperature, but care should be exercised to ensure that all crystals have redissolved.102 Solutions should be visually inspected for particulate matter and discoloration prior to administration; only clear solutions should be used.3384; 3385; 3386; 3387; 3388
Less than 10% decomposition occurs in 2 years at 25°C at pH 3.5 to 6.5.102; 103
pH Effects
Maximum stability occurs at pH 4, but an acceptable long-term shelf life is attained at pH 1 to 6.5.1072
Freezing Solutions
Manufacturers state that clindamycin 6, 9, and 12 mg/mL in dextrose 5%, sodium chloride 0.9%, or Ringers injection, lactated is physically compatible and chemically stable for 56 days at -10°C.3384; 3388 Frozen solutions should be thawed at room temperature and should not be refrozen.3384; 3388
Some manufacturers state that vials of clindamycin phosphate should not be refrigerated.3384; 3388 Crystallization may occur if refrigerated; the crystals resolubilize when warmed to room temperature, but care should be exercised to ensure that all crystals have redissolved. This would also apply if the product is frozen.102
Syringes
Clindamycin 900 mg/6 mL in polypropylene syringes (Becton Dickinson) retained more than 95% of the initial concentration over at least 48 hours at room temperature.172 Diluted with sterile water for injection to concentrations of 20, 40, 60, and 120 mg/mL and stored in Monoject plastic syringes or glass vials, clindamycin exhibited little change in concentration and was free of particulate matter over 30 days at 25°C and 60 days at -15°C.173
Clindamycin (Upjohn) 900 mg/6 mL showed no more than a 4 to 5% loss when stored in polypropylene syringes (Becton Dickinson) for 48 hours at 25°C under fluorescent light.1159
Clindamycin (Upjohn) 600 mg stored in polypropylene syringes (3M) at 25°C under fluorescent light exhibited no loss in 48 hours.1164
Vials
Dilution of clindamycin 300 and 900 mg in glass vials containing 20 mL of dextrose 10% resulted in no visual changes and less than a 10% loss after 30 days of refrigeration at 10°C.1604
Clindamycin (Abbott) injection was diluted with sterile water for injection to a concentration of 15 mg/mL for use in minimizing measurement errors in pediatric dosing. The dilution was packaged in glass vials, and samples were stored at 22 and 4°C. The dilution remained visually free of particulate matter at both storage conditions throughout the study. No clindamycin loss occurred after 91 days at either 4 or 22°C.1714
Clindamycin phosphate is incompatible with natural rubber closures because of the extraction of crystalline particulate matter, primarily ß-sitosterol and stigmasterol. Simple cleaning procedures for the closures do not effectively remove the source of contamination. It is recommended that if clindamycin phosphate is repackaged in vials or disposable syringes, storage at room temperature should be limited to a few days.102
Central Venous Catheter
Clindamycin (Upjohn) 2 mg/mL in dextrose 5% was found to be compatible with the ARROWg+ard Blue Plus (Arrow International) chlorhexidine-bearing triple-lumen central catheter. Essentially complete delivery of the drug was found with little or no drug loss occurring. Furthermore, chlorhexidine delivered from the catheter remained at trace amounts with no substantial increase due to the delivery of the drug through the catheter.2335
Drugs in Syringe Compatibility
Y-Site Injection Compatibility (1:1 Mixture)
Additional Compatibility Information
Infusion Solutions
Manufacturers state that clindamycin phosphate demonstrated no inactivation or incompatibility in intravenous solutions containing sodium chloride, dextrose, and calcium or potassium and in solutions containing vitamin B complex in concentrations used clinically.3384; 3388
Other Drugs
Manufacturers state that clindamycin phosphate is physically incompatible with aminophylline, ampicillin sodium, barbiturates, calcium gluconate, magnesium sulfate, and phenytoin sodium, but that no incompatibility has been demonstrated with cephalothin, kanamycin, gentamicin, penicillin, and carbenicillin.3384; 3388
Peritoneal Dialysis Solutions
Clindamycin (Upjohn) 10 mg/L stability in peritoneal dialysis solutions (Dianeal 137 and PD-2) with heparin sodium 500 units/L was evaluated. Approximately 102 ± 9% activity remained after 24 hours at 25°C.1228
Clindamycin (Dalacin C Phosphate, Pfizer) 300 mg in 2 L of Dianeal PD-4 with dextrose 2.5% (Baxter) exhibited little to no loss of drug over 6 hours at 37°C.3108
For a list of references cited in the text of this monograph, search the monograph titled References.