DOSAGE AND ADMINISTRATION

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

Clindamycin phosphate IM administration should be used undiluted.

Clindamycin phosphate IV administration should be diluted (seeDilution 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):

600–1200 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:

1200–2700 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 (seeDilution 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	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 (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. Clindamycin should be dosed based on total body weight regardless of obesity. 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/m 2/day for serious infections and 450 mg/m 2/day for more severe infections.

Parenteral therapy may be changed to oral clindamycin palmitate hydrochloride granules 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 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	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. For current information regarding compatibilities of clindamycin phosphate under specific conditions, please contact Almaject Inc.

Physico-Chemical Stability of Diluted Solutions of Clindamycin Phosphate

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 Mini-Bag containers, 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 Mini-Bag containers, 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 Mini-Bag containers, 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 Mini-Bag containers demonstrated physical and chemical stability for at least eight weeks at -10°C.

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

HOW SUPPLIED

Each mL of Clindamycin Injection, USP contains clindamycin phosphate equivalent to 150 mg clindamycin, 0.5 mg disodium edetate, 9.45 mg benzyl alcohol added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid.

Clindamycin Injection, USP is supplied in single dose vials as follows:

NDC	Vial Size	Total Clindamycin Phosphate/vial
72611-634-25 (carton contains 25 vials of 72611-634-01)	2 mL	300 mg
72611-639-25 (carton contains 25 vials of 72611-639-01)	4 mL	600 mg
72611-642-25 (carton contains 25 vials of 72611-642-01)	6 mL	900 mg

Clindamycin Injection, USP is supplied as a Pharmacy Bulk Package as follows:

NDC	Vial Size	Total Clindamycin Phosphate/vial
72611-645-55 (carton contains 5 vials of 72611-645-11)	60 mL	9000 mg

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].