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CLEOCIN® Pediatric Dosage and Administration (clindamycin)

DOSAGE AND ADMINISTRATION

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

Concomitant administration of food does not adversely affect the absorption of clindamycin palmitate HCl contained in CLEOCIN PEDIATRIC Flavored Granules.

Serious infections: 8–12 mg/kg/day (4–6 mg/lb/day) divided into 3 or 4 equal doses.

Severe infections: 13–16 mg/kg/day (6.5–8 mg/lb/day) divided into 3 or 4 equal doses.

More severe infections: 17–25 mg/kg/day (8.5–12.5 mg/lb/day) divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, ½ teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose. Clindamycin should be dosed based on total body weight regardless of obesity.

Serious infections due to anaerobic bacteria are usually treated with CLEOCIN PHOSPHATE® Sterile Solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with CLEOCIN PEDIATRIC.

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

Reconstitution Instructions: When reconstituted with water as follows, each 5 mL (teaspoon) of solution contains clindamycin palmitate HCl equivalent to 75 mg clindamycin.

Reconstitute bottles of 100 mL with 75 mL of water. Add a large portion of the water and shake vigorously; add the remainder of the water and shake until the solution is uniform.

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

Do NOT refrigerate the reconstituted solution; when chilled, the solution may thicken and be difficult to pour. The solution is stable for 2 weeks at room temperature.

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