Cleocin (Clindamycin Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.

Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (eg, erythromycin).

Anaerobes:    Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tuboovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection.

Streptococci:    Serious respiratory tract infections; serious skin and soft tissue infections.

Staphylococci:    Serious respiratory tract infections; serious skin and soft tissue infections.

Pneumococci:    Serious respiratory tract infections.

Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.

In Vitro Susceptibility Testing:    A standardized disk testing procedure * is recommended for determining susceptibility of aerobic bacteria to clindamycin. A description is contained in the CLEOCIN^® Susceptibility Disk insert. Using this method, the laboratory can designate isolates as resistant, intermediate, or susceptible. Tube or agar dilution methods may be used for both anaerobic and aerobic bacteria. When the directions in the CLEOCIN^® Susceptibility Powder insert are followed, an MIC of 1.6 mcg/mL may be considered susceptible; MICs of 1.6 to 4.8 mcg/mL may be considered intermediate and MICs greater than 4.8 mcg/mL may be considered resistant.

CLEOCIN Susceptibility Disks 2 mcg. See package insert for use.

CLEOCIN Susceptibility Powder 20 mg. See package insert for use.

For anaerobic bacteria the minimal inhibitory concentration (MIC) of clindamycin can be determined by agar dilution and broth dilution (including microdilution) techniques. If MICs are not determined routinely, the disk broth method is recommended for routine use. THE KIRBY-BAUER DISK DIFFUSION METHOD AND ITS INTERPRETIVE STANDARDS ARE NOT RECOMMENDED FOR ANAEROBES.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLEOCIN HCl and other antibacterial drugs, CLEOCIN HCl should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

DOSAGE AND ADMINISTRATION

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

Adults:    Serious infections --150 to 300 mg every 6 hours. More severe infections --300 to 450 mg every 6 hours. Pediatric Patients: Serious infections --8 to 16 mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses. More severe infections --16 to 20 mg/kg/day (8 to 10 mg/lb/day) divided into three or four equal doses.

To avoid the possibility of esophageal irritation, CLEOCIN HCl Capsules should be taken with a full glass of water.

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 HCI Capsules.

In cases of (beta)-hemolytic streptococcal infections, treatment should continue for at least 10 days.

HOW SUPPLIED

CLEOCIN HCl Capsules are available in the following strengths, colors and sizes:

75 mg Green

Bottles of 100                             NDC 0009-0331-02

150 mg Light Blue and Green

Bottles of 16                                NDC 0009-0225-01

Bottles of 100                              NDC 0009-0225-02

Unit dose package of 100            NDC 0009-0225-03

300 mg Light Blue

Bottles of 16                                NDC 0009-0395-13

Bottles of 100                             NDC 0009-0395-14

Unit dose package of 100            NDC 0009-0395-02

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

ANIMAL TOXICOLOGY

One year oral toxicity studies in Spartan Sprague-Dawley rats and beagle dogs at dose levels up to 300 mg/kg/day (approximately 1.6 and 5.4 times the highest recommended adult human dose based on mg/m², respectively) have shown clindamycin to be well tolerated. No appreciable difference in pathological findings has been observed between groups of animals treated with clindamycin and comparable control groups. Rats receiving clindamycin hydrochloride at 600 mg/kg/day (approximately 3.2 times the highest recommended adult human dose based on mg/m²) for 6 months tolerated the drug well; however, dogs dosed at this level (approximately 10.8 times the highest recommended adult human dose based on mg/m²) vomited, would not eat, and lost weight.

Rx only