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Cautions

Contraindications

• Patients hypersensitive to clindamycin or lincomycin.

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible bacteria or fungi. Institute appropriate therapy if superinfection occurs.

Treatment with anti-infectives may permit overgrowth of clostridia. Consider CDAD if diarrhea develops and manage accordingly.

Some mild cases of CDAD may respond to discontinuance alone. Manage moderate to severe cases with fluid, electrolyte, and protein supplementation; appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) recommended if colitis is severe.

Patients with Meningitis

Do not use for the treatment of meningitis; clindamycin diffusion into CSF is inadequate for these infections.

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactoid reactions and erythema multiforme, sometimes resembling Stevens-Johnson syndrome, have been reported rarely.

Cleocin HCl^® 75- and 150-mg capsules contain the dye tartrazine (FD&C yellow No. 5), which may cause allergic reactions including bronchial asthma in susceptible individuals. Although the incidence of tartrazine sensitivity is low, it frequently occurs in patients who are sensitive to aspirin.

Prior to initiation of clindamycin, make careful inquiry regarding prior hypersensitivity to drugs and other allergens. Use with caution in atopic individuals.

General Precautions

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of clindamycin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.

Surgical procedures should be performed in conjunction with clindamycin therapy when indicated.

History of GI Disease

Use with caution in patients with a history of GI disease, particularly colitis. (See Superinfection/Clostridium difficile-associated Colitis under Cautions.)

Specific Populations

Pregnancy

Category B.

Lactation

Distributed into milk; discontinue nursing or the drug.

Pediatric Use

Monitor organ system functions when used in pediatric patients (birth to 16 years of age).

Each mL of clindamycin phosphate injection contains 9.45 mg of benzyl alcohol. A causal relationship not established, but use of injections preserved with benzyl alcohol has been associated with toxicity in neonates.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults.

Clinical experience indicates that C. difficile-associated diarrhea and colitis seen in association with anti-infectives may occur more frequently and be more severe in geriatric patients (>60 years of age). Geriatric patients receiving clindamycin should be carefully monitored for development of diarrhea.

Hepatic Impairment

Moderate to severe liver disease may result in prolonged clindamycin half-life, but accumulation may not occur.

Periodically monitor liver enzymes in patients with severe hepatic impairment.

Common Adverse Effects

GI effects (nausea, vomiting, diarrhea, abdominal pain, tenesmus); rash; local reactions (pain, induration, sterile abscess with IM and thrombophlebitis, erythema, pain and swelling with IV).

Drug Interactions

Specific Drugs