• 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, before selecting Clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., 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 tubo-ovarian 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.

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.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CLEOCIN HCl and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile. 

Because CLEOCIN HCl therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections.

C. difficile produces toxins A and B, which contribute to the development of CDAD. Hyper toxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

CLEOCIN HCl should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

CLEOCIN HCl should be prescribed with caution in atopic individuals.

Anaphylactic shock and anaphylactic reactions have been reported.

Severe hypersensitivity reactions, including severe skin reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens-Johnson syndrome (SJS), some with fatal outcome, have been reported.The use of CLEOCIN HCl occasionally results in overgrowth of nonsusceptible organisms—particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.

Cases of polyarthritis have been reported.

During prolonged therapy, periodic liver and kidney function tests and blood counts should be performed.

Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.

Inhibitors of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these isoenzymes may reduce plasma concentrations of clindamycin. In the presence of strong CYP3A4 inhibitors, monitor for adverse reactions. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness.

Clindamycin should be used during the first trimester of pregnancy only if clearly needed. There are no adequate and well controlled studies in pregnant women during the first trimester of pregnancy.

Clindamycin has the potential to cause adverse effects on the breastfed infant’s gastrointestinal flora. 

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• Acne. GoToSource

• Parasitic infections. GoToSource 

• Endocarditis. GoToSource

• Odontogenic abscesses and gingival inflammations. GoToSource

Pseudomembranous colitis (inflammation of inner lining of the colon). GoToSource

Anaphylactic shock (life-threatening allergic reaction). GoToSource

Clostridium difficile associated diarrhea (bacterium causing diarrhea). GoToSource

Liver damage. GoToSource

Drug rash with eosinophilia and systemic symptoms syndrome (severe skin reaction). GoToSource

Inflammatory bowel disease (disorders causing chronic inflammation of digestive tract). GoToSource

Neutropenia (low level of neutrophils, a type of white blood cell). GoToSource 

Maculopapular rash (skin rash), anorexia (loss of appetite), drug fever, urticaria (hves), polyarthritis (arthritis that affects more than four joints), monoarthritis (arthritis involving one joint at a time), leukopenia (low white blood cell count), agranulocytosis (body does not make enough granulocytes, a type of white blood cell), thrombocytopenic purpura (blood clots form in small blood vessels), oliguria (reduced urine volume), azotemia (high level of nitrogen waste products in blood) and proteinuria (excess proteins in urine). GoToSource

Esophagitis (inflammation of the esophagus). GoToSource

Lawsuits filed for death and colitis.