FDA approved Cleocin Hydrochloride (clindamycin) for Serious InfectionsFDA approved Cleocin Hydrochloride capsules to treat serious bacterial infections.

Not reported in label.

Clindamycin is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria. It is also indicated for serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Use should be reserved for penicillin-allergic patients or those for whom a penicillin is inappropriate. Specific infections include: anaerobic respiratory tract infections (empyema, anaerobic pneumonitis, lung abscess), serious skin and soft tissue infections, septicemia, intra-abdominal infections (peritonitis, intra-abdominal abscess), and female pelvic/genital tract infections (endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, postsurgical vaginal cuff infection). It is also used for serious respiratory and skin/soft tissue infections caused by streptococci and staphylococci, and serious respiratory infections due to pneumococci.

Administer capsules with a full glass of water (6 to 8 ounces, approximately 200 to 250 mL) and at least 30 minutes before lying down to reduce esophageal irritation. If significant diarrhea occurs, discontinue the drug.

Adults: Serious infections: 150 to 300 mg every 6 hours. More severe infections: 300 to 450 mg every 6 hours.

Pediatric patients (who can swallow capsules): Serious infections: 8 to 16 mg/kg/day divided into three or four equal doses. More severe infections: 16 to 20 mg/kg/day divided into three or four equal doses. Dose based on total body weight. Capsules are not suitable for children unable to swallow whole; use palmitate oral solution if exact mg/kg doses are needed.

For β-hemolytic streptococcal infections, continue treatment for at least 10 days.

Trial data not available in label.

Boxed warning: Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including clindamycin, and may range from mild diarrhea to fatal colitis. CDAD must be considered in all patients presenting with diarrhea after antibacterial use. If suspected or confirmed, discontinue ongoing antibacterial use not directed against C. difficile and institute appropriate management.

Other warnings: Anaphylactic and severe hypersensitivity reactions (including acute myocardial ischemia, toxic epidermal necrolysis, DRESS, Stevens-Johnson syndrome) have been reported; discontinue permanently if such reactions occur. Clindamycin is potentially nephrotoxic; monitor renal function in patients with pre-existing renal dysfunction or those on nephrotoxic drugs. Not for use in meningitis because it does not diffuse adequately into cerebrospinal fluid.

Contraindications: The label text is incomplete; however, based on standard labeling, contraindications include a history of hypersensitivity to clindamycin or lincomycin. (Note: The provided label text is truncated, so this is not fully reported.)

Clindamycin is reserved for penicillin-allergic patients or when penicillin is inappropriate, and the physician should consider less toxic alternatives (e.g., erythromycin) before selecting it. It is used for serious infections due to susceptible anaerobic bacteria, streptococci, staphylococci, and pneumococci. Because of the risk of CDAD, it should be used judiciously. For serious anaerobic infections, the sterile solution form is usually preferred, but capsules may be used in clinically appropriate circumstances.