Clostridium difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including clindamycin, and may range in severity from mild to life-threatening. Anti-infectives alter normal flora of the colon and may permit overgrowth of clostridia; a toxin produced by C. difficile is one primary cause of antibiotic-associated colitis.
It is important to consider a diagnosis of CDAD in patients who develop diarrhea subsequent to clindamycin treatment. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks after cessation of clindamycin therapy.
After a diagnosis of CDAD has been established, initiate therapeutic measures.
Mild cases usually respond to drug discontinuation alone.
In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an anti-infective clinically effective against CDAD. (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions.)
Because clindamycin has been associated with severe colitis (potentially fatal), it should be reserved for treatment of serious infections when less toxic anti-infectives are inappropriate.
Alternative for treatment of AOM† known or presumed to be caused by penicillin-resistant Streptococcus pneumoniae.
Not a first-line agent, but AAP and AAFP state clindamycin may be considered in individuals with penicillinhypersensitivity who may have AOM caused by penicillin-resistant S. pneumoniae.
Use of clindamycin also may be considered if AOM persists after treatment with amoxicillin and clavulanate or ceftriaxone and tympanocentesis is not available to make a bacteriologic diagnosis.
Bone and Joint Infections
Treatment of serious bone and joint infections (including acute hematogenous osteomyelitis) caused by susceptible Staphylococcus aureus.
Adjunct in the surgical treatment of chronic bone and joint infections caused by susceptible bacteria.
Gynecologic Infections
Treatment of serious gynecologic infections (e.g., endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, postsurgical vaginal cuff infection) caused by susceptible anaerobes.
Treatment of pelvic inflammatory disease (PID); used in conjunction with other anti-infectives. When a parenteral regimen is indicated for treatment of PID, IV clindamycin in conjunction with an IV or IM aminoglycoside (e.g., gentamicin) is one of the recommended regimens.
Intra-abdominal Infections
Treatment of serious intra-abdominal infections (e.g., peritonitis, intra-abdominal abscess) caused by susceptible anaerobes.
Pharyngitis and Tonsillitis
Alternative for treatment of pharyngitis and tonsillitis† caused by susceptible Streptococcus pyogenes (group A β-hemolytic streptococci) in patients who cannot receive β-lactam anti-infectives and have infections caused by macrolide-resistant S. pyogenes.
CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice for pharyngitis and tonsillitis; oral cephalosporins and oral macrolides are considered alternatives. Amoxicillin sometimes used instead of penicillin V, especially for young children.
Alternative for treatment of symptomatic patients who have multiple, recurrent episodes of pharyngitis known to be caused by S. pyogenes.
Consider that multiple, recurrent episodes of symptomatic pharyngitis within several months to years may indicate that the patient is a streptococcal carrier experiencing repeated episodes of nonstreptococcal pharyngitis (e.g., viral) pharyngitis; treatment not usually recommended for streptococcal pharyngeal carriers.
Respiratory Tract Infections
Treatment of serious respiratory tract infections (e.g., pneumonia, empyema, lung abscess) caused by susceptible anaerobes, S. pneumoniae, other streptococci, or S. aureus.
A drug of choice for treatment of community-acquired pneumonia (including aspiration pneumonia) when anaerobes are identified or suspected.
Septicemia
Treatment of serious septicemia caused by susceptible anaerobes, streptococci, or S. aureus.
Skin and Skin Structure Infections
Treatment of serious skin and skin structure infections caused by susceptible anaerobes, S. pyogenes, other streptococci, or staphylococci.
Actinomycosis
Treatment of actinomycosis† caused by Actinomyces israelii; follow-up treatment (6–12 months) after initial parenteral treatment (4–6 weeks) with penicillin G or ampicillin.
Anthrax
Alternative for treatment of anthrax†.
Component of multiple-drug parenteral regimens recommended for treatment of inhalational anthrax that occurs as the result of exposure to B. anthracis spores in the context of biologic warfare or bioterrorism. Initiate treatment with IV ciprofloxacin or doxycycline and 1 or 2 other anti-infective agents predicted to be effective (e.g., chloramphenicol, clindamycin, rifampin, vancomycin, clarithromycin, imipenem, penicillin, ampicillin); if meningitis is established or suspected, use IV ciprofloxacin (rather than doxycycline) and chloramphenicol, rifampin, or penicillin.
Babesiosis
Treatment of babesiosis† caused by Babesia microti.
Regimens of choice for babesiosis are clindamycin in conjunction with quinine or atovaquone in conjunction with azithromycin; the clindamycin and quinine regimen may be preferred for severe babesiosis. Also consider exchange transfusions in severely ill patients with high levels of parasitemia (>10%), significant hemolysis, or compromised renal, hepatic, or pulmonary function.
Bacillus cereus Infections
Treatment of invasive disease caused by Bacillus cereus†. Anti-infectives not usually indicated for gastroenteritis caused by B. cereus.
Bacterial Vaginosis
Treatment of bacterial vaginosis† (formerly called Haemophilusvaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in pregnant or nonpregnant women.
CDC recommends treatment of bacterial vaginosis in all symptomatic women (including pregnant women). In addition, asymptomatic pregnant women at high risk for complications of pregnancy should be screened (preferably at the first prenatal visit) and treatment initiated if needed.
Treatment recommendations for bacterial vaginosis in HIV-infected women are the same as those for women without HIV infection.
Regimens of choice in nonpregnant women are a 7-day regimen of oral metronidazole; a 5-day regimen of intravaginal metronidazole gel; or a 7-day regimen of intravaginal clindamycin cream; alternative regimens are a 7-day regimen of oral clindamycin or 3-day regimen of intravaginal clindamycin suppositories. The preferred regimens for pregnant women are a 7-day regimen of oral metronidazole or a 7-day regimen of oral clindamycin.
Regardless of regimen used, relapse or recurrence is common; an alternative regimen (e.g., oral therapy when topical was used initially) may be used in such situations.
Routine treatment of asymptomatic male sexual contacts of women who have relapsing or recurrent bacterial vaginosis not recommended.
Capnocytophaga Infections
Alternative to penicillin G for treatment of infections caused by Capnocytophaga canimorsus†.
Clostridium Infections
Alternative to penicillin G for treatment of clostridial myonecrosis (gas gangrene) caused by Clostridium perfringens or other Clostridium. Anti-infectives not usually indicated for gastroenteritis caused by C. perfringens.
Malaria
Treatment of uncomplicated malaria† caused by chloroquine-resistant Plasmodium falciparum or when the plasmodial species has not been identified. Used in conjunction with oral quinine; not effective alone.
CDC and others state treatments of choice for uncomplicated chloroquine-resistant P. falciparum malaria are a regimen of oral quinine in conjunction with doxycycline, tetracycline, or clindamycin or a regimen of atovaquone and proguanil. A regimen of quinine and doxycycline (or tetracycline) generally preferred over quinine and clindamycin, except for young children or pregnant women who should not receive tetracyclines.
Treatment of severe malaria caused by P. falciparum†; used in conjunction with IV quinidine gluconate initially and then with oral quinine when an oral regimen is tolerated.
Treatment of Pneumocystis jiroveci (formerly Pneumocystis carinii) pneumonia† (PCP); used in conjunction with primaquine. Designated an orphan drug by FDA for use in this condition.
Co-trimoxazole is initial drug of choice for treatment in most adults, adolescents, and children, including HIV-infected patients; a regimen of clindamycin and primaquine is an alternative for adults and adolescents with mild to moderately severe PCP who have had an inadequate response to co-trimoxazole or when co-trimoxazole is contraindicated or not tolerated.
Clindamycin in conjunction with primaquine has been used as an alternative for long-term suppressive or chronic maintenance therapy (secondary prophylaxis) of PCP†, but USPHS/IDSA states the regimen should only be considered for primary or secondary prophylaxis of PCP in unusual situations when the usually recommended agents (co-trimoxazole, dapsone, dapsone with pyrimethamine and leucovorin, aerosolized pentamidine, atovaquone) cannot be used.
Toxoplasmosis
Alternative for treatment of toxoplasmosis† in immunocompromised adults, adolescents, or children (including HIV-infected patients) who relapse or fail to respond to or are unable to tolerate the regimen of choice (pyrimethamine in conjunction with sulfadiazine and leucovorin). Clindamycin is used in conjunction with pyrimethamine and leucovorin and is the preferred alternative.
Alternative for long-term suppressive or chronic maintenance therapy (secondary prophylaxis) to prevent relapse of toxoplasmosis† in HIV-infected individuals who cannot receive the regimen of choice (sulfadiazine in conjunction with pyrimethamine and leucovorin). Clindamycin is used in conjunction with pyrimethamine and leucovorin. Consider that the clindamycin regimen may be less effective than the sulfadiazine regimen in preventing toxoplasmosis recurrence and that only the sulfadiazine regimen appears to provide protection against both toxoplasmosis and P. jiroveci.
Prevention of Bacterial Endocarditis
Alternative for prevention of α-hemolytic (viridans group) streptococcal bacterial endocarditis† in penicillin-allergic patients with certain cardiac conditions who are undergoing certain dental procedures (i.e., procedures that involve manipulation of gingival tissue, the periapical region of teeth, or perforation of oral mucosa) or certain invasive respiratory tract procedures (i.e., procedures involving incision or biopsy of respiratory mucosa).
Consult most recent AHA recommendations for information on which cardiac conditions are associated with the highest risk of adverse outcome from endocarditis and specific recommendations regarding use of prophylaxis to prevent endocarditis in these patients.
Prevention of Perinatal Group B Streptococcal Disease
Alternative to penicillin G or ampicillin for prevention of perinatal group B streptococcal (GBS) disease† in penicillin-allergic pregnant women at risk for anaphylaxis with a β-lactam anti-infective.
Intrapartum anti-infective prophylaxis to prevent early-onset neonatal GBS disease is administered to women identified as GBS carriers during routine prenatal GBS screening performed at 35–37 weeks during the current pregnancy and to women who have GBS bacteriuria during the current pregnancy, a previous infant with invasive GBS disease, unknown GBS status with delivery at <37 weeks gestation, amniotic membrane rupture for ≥18 hours, or intrapartum temperature of ≥38°C.
Penicillin G is the regimen of choice and ampicillin is the preferred alternative. Cefazolin can be used in penicillin-allergic women who do not have immediate-type penicillin hypersensitivity, but clindamycin or erythromycin should be used in penicillin-allergic women at high risk for anaphylaxis.
Consider that S. agalactiae (group B streptococci) with in vitro resistance to clindamycin and erythromycin has been reported with increasing frequency; perform in vitro susceptibility tests of clinical isolates obtained during GBS prenatal screening. GBS resistant to erythromycin often are resistant to clindamycin, although this may not be evident in results of in vitro testing. If in vitro susceptibility testing is not possible, results are unknown, or isolates are found to be resistant to erythromycin or clindamycin, vancomycin is recommended for intrapartum prophylaxis in penicillin-allergic women at high risk for anaphylaxis with β-lactams.
Perioperative Prophylaxis
Perioperative prophylaxis† to reduce the incidence of infections in patients undergoing clean, contaminated head and neck surgery. Regimens of choice are IV clindamycin (with or without gentamicin) or IV cefazolin.
Has been used for perioperative prophylaxis in patients undergoing nonperforated appendectomy†. Cephalosporins (cefazolin, cefoxitin) usually recommended for perioperative prophylaxis in patients undergoing GI procedures (e.g., esophageal and gastroduodenal surgery, biliary tract surgery, colorectal surgery, nonperforated appendectomy); clindamycin in conjunction with gentamicin, ciprofloxacin, levofloxacin, or aztreonam recommended in patients hypersensitive to cephalosporins.
Clindamycin in conjunction with gentamicin, ciprofloxacin, levofloxacin, or aztreonam recommended as an alternative to cephalosporins (cefazolin, cefoxitin) for perioperative prophylaxis in gynecologic and obstetric surgery (vaginal, abdominal, or laparoscopic hysterectomy)† in patients hypersensitive to cephalosporins (the preferred agents).
Clindamycin in conjunction with gentamicin, ciprofloxacin, levofloxacin, or aztreonam recommended for perioperative prophylaxis and postoperative treatment in contaminated or dirty surgery involving a perforated abdominal viscus† in patients hypersensitive to cephalosporins when cefoxitin (the preferred agent) cannot be used.
Dosage and Administration
Administration
Administer orally, IM, or by intermittent or continuous IV infusion. Do not administer by rapid IV injection.
In the treatment of serious anaerobic infections, parenteral route usually used initially and oral clindamycin substituted when warranted by patient's condition. In clinically appropriate circumstances, treatment may be initiated with oral clindamycin.
Single IM doses should not exceed 600 mg, and no more than 1.2 g should be administered by IV infusion in a 1-hour period.
Clindamycin phosphate ADD-Vantage® vials and the commercially available clindamycin phosphate injection in 5% dextrose should be used only for IV infusion.
For solution and drug compatibility information, see Compatibility under Stability.
Oral Administration
Clindamycin hydrochloride capsules and clindamycin palmitate hydrochloride oral solution can be administered without regard to food.
To avoid the possibility of esophageal irritation, administer clindamycin hydrochloride capsules with a full glass of water.
Reconstitution
Reconstitute clindamycin palmitate hydrochloride oral solution by adding 75 mL of water to the 100-mL bottle. A large portion of the water should be added initially and the bottle shaken vigorously; the remainder of the water should then be added and the bottle shaken until the solution is uniform. The resulting solution contains 75 mg of clindamycin/5 mL.
IV Infusion
Dilution
Prior to IV infusion, clindamycin phosphate injections (including ADD-Vantage® vials) must be diluted with a compatible IV solution to a concentration ≤18 mg/mL. (See Rate of Administration under Dosage and Administration.)
The clindamycin phosphate pharmacy bulk package is not intended for direct IV infusion; doses of the drug from the bulk package must be further diluted in a compatible IV infusion solution prior to administration. The bulk package is intended for use only under a laminar flow hood. Entry into the vial should be made using a sterile transfer set or other sterile dispensing device, and the contents dispensed in aliquots using appropriate technique; multiple entries with a syringe and needle are not recommended because of the increased risk of microbial and particulate contamination. After entry into the bulk package vial, the entire contents should be used promptly and any unused portion discarded within 24 hours after initial entry.
The commercially available clindamycin phosphate injections in 5% dextrose should not be used in series connections with other plastic containers, since such use could result in air embolism from residual air being drawn from the primary container before administration of fluid from the secondary container is complete.
Rate of Administration
By intermittent IV infusion over a period of at least 10–60 minutes and at a rate ≤30 mg/minute. No more than 1.2 g should be given by IV infusion in a single 1-hour period.
The manufacturers suggest that 300- or 600-mg doses be diluted in 50 mL of compatible diluent and infused over 10 or 20 minutes, respectively; 900-mg doses be diluted in 50–100 mL of diluent and infused over 30 minutes; or 1.2-g doses be diluted in 100 mL of diluent and infused over 40 minutes.
Alternatively, the initial dose can be given as a single rapid infusion over 30 minutes followed by continuous IV infusion (see Table).
Infusion Rates for Continuous IV Infusion
Target Serum Clindamycin Concentrations
Infusion Rate for Initial Dose
Maintenance Infusion Rate
>4 mcg/mL
10 mg/minute for 30 minutes
0.75 mg/minute
>5 mcg/mL
15 mg/minute for 30 minutes
1 mg/minute
>6 mcg/mL
20 mg/minute for 30 minutes
1.25 mg/minute
Dosage
Available as clindamycin hydrochloride, clindamycin palmitate hydrochloride, and clindamycin phosphate; dosage expressed in terms of clindamycin.
Pediatric Patients
General Dosage in Neonates
Oral
Oral Solution: Manufacturer recommends 8–12 mg/kg daily for serious infections, 13–16 mg/kg daily for severe infections, and 17–25 mg/kg daily for more severe infections. Daily dosage is given in 3 or 4 equally divided doses. In children weighing ≤10 kg, manufacturer recommends a minimum dosage of 37.5 mg 3 times daily.
Neonates <1 week of age: AAP recommends 5 mg/kg every 12 hours in those weighing ≤2 kg or 5 mg/kg every 8 hours in those weighing >2 kg.
Neonates 1–4 weeks of age: AAP recommends 5 mg/kg every 12 hours in those weighing <1.2 kg, 5 mg/kg every 8 hours in those weighing 1.2–2 kg, and 5–7.5 mg/kg every 6 hours in those weighing >2 kg.
IV or IM
Manufacturer recommends 15–20 mg/kg daily given in 3 or 4 equally divided doses. The lower dosage may be adequate for small, premature neonates.
Neonates <1 week of age: AAP recommends 5 mg/kg every 12 hours in those weighing ≤2 kg or 5 mg/kg every 8 hours in those weighing >2 kg.
Neonates 1–4 weeks of age: AAP recommends 5 mg/kg every 12 hours in those weighing <1.2 kg, 5 mg/kg every 8 hours in those weighing 1.2–2 kg, and 5–7.5 mg/kg every 6 hours in those weighing >2 kg.
General Dosage in Children 1 Month to 16 Years of Age
Oral
Capsules: Manufacturer recommends 8–16 mg/kg daily given in 3 or 4 equally divided doses for serious infections or 16–20 mg/kg daily given in 3 or 4 equally divided doses for more severe infections.
Oral Solution: Manufacturer recommends 8–12 mg/kg daily for serious infections, 13–16 mg/kg daily for severe infections, and 17–25 mg/kg daily for more severe infections. Daily dosage is given in 3 or 4 equally divided doses. In children weighing ≤10 kg, manufacturer recommends a minimum dosage of 37.5 mg 3 times daily.
AAP recommends 10–20 mg/kg daily given in 3 or 4 equally divided doses for mild to moderate infections. AAP states oral route inappropriate for severe infections.
IV or IM
Manufacturer recommends 20–40 mg/kg daily given in 3 or 4 equally divided doses. Alternatively, manufacturer recommends 350 mg/m2 daily for serious infections or 450 mg/m2 daily for more severe infections.
AAP recommends 15–25 mg/kg daily for mild to moderate infections and 25–40 mg/kg daily for severe infections. Daily dosage is given in 3 or 4 equally divided doses.
Acute Otitis Media (AOM)
Oral
30–40 mg/kg daily in 3 divided doses recommended by AAP and AAFP.†
Pharyngitis and Tonsillitis
Treatment of Symptomatic Patients with Multiple, Recurrent Episodes Known to Caused by Streptococcus pyogenes
Oral
20–30 mg/kg daily in 3 divided doses given for 10 days.†
Babesiosis
Oral
IDSA recommends 7–10 mg/kg (up to 600 mg) every 6–8 hours for 7–10 days; used in conjunction with oral quinine (8 mg/kg [up to 650 mg] every 8 hours for 7–10 days). Others recommend 20–40 mg/kg daily in 3 divided doses given for 7–10 days; used in conjunction with oral quinine sulfate (25 mg/kg daily in 3 divided doses for 7–10 days).†
IV
IDSA recommends 7–10 mg/kg (up to 600 mg) every 6–8 hours for 7–10 days; used in conjunction with oral quinine (8 mg/kg [up to 650 mg] every 8 hours for 7–10 days).†
Malaria
Treatment of Uncomplicated Chloroquine-resistant P. falciparum Malaria
Oral
20 mg/kg daily in 3 equally divided doses given for 7 days; used in conjunction with oral quinine sulfate (10 mg/kg 3 times daily given for 3 days if infection was acquired in Africa or South America or for 7 days if acquired in Southeast Asia).†
Treatment of Severe P. falciparum Malaria
Oral
20 mg/kg daily in 3 equally divided doses given for 7 days; used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.†
IV, then Oral
10-mg/kg IV loading dose followed by 5 mg/kg IV every 8 hours; when oral therapy is tolerated, switch to oral clindamycin 20 mg/kg daily in 3 divided doses and continue for a total duration of 7 days.†
Used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.†
Adolescents: 300–450 mg every 6–8 hours given for 21 days; used in conjunction with oral primaquine (15–30 mg once daily for 21 days).†
IV
Adolescents: 600–900 mg every 6–8 hours given for 21 days; used in conjunction with oral primaquine (15–30 mg once daily for 21 days).†
Toxoplasmosis
Treatment in Infants and Children
Oral or IV
5–7.5 mg/kg (up to 600 mg) 4 times daily; used in conjunction with oral pyrimethamine (2 mg/kg once daily for 3 days then 1 mg/kg once daily) and oral leucovorin (10–25 mg once daily).†
Continue acute treatment for ≥6 weeks; a longer duration may be appropriate if disease is extensive or response incomplete at 6 weeks.†
Treatment in Adolescents
Oral or IV
600 mg every 6 hours; used in conjunction with oral pyrimethamine (200-mg loading dose then 50–75 mg once daily) and oral leucovorin (10–20 mg once daily; higher dosage may be needed).†
Continue acute treatment for ≥6 weeks; longer duration may be appropriate if disease is extensive or response incomplete at 6 weeks.†
Prevention of Recurrence (Secondary Prophylaxis) in Infants and Children
Oral
20–30 mg/kg daily in 4 divided doses; used in conjunction with oral pyrimethamine (1 mg/kg or 15 mg/m2 once daily) and oral leucovorin (5 mg once every 3 days).†
Secondary prophylaxis against toxoplasmosis generally is continued for life. The safety of discontinuing secondary toxoplasmosis prophylaxis in HIV-infected infants and children receiving potent antiretroviral therapy has not been extensively studied.†
Prevention of Recurrence (Secondary Prophylaxis) in Adolescents
Oral
Dosage for secondary prophylaxis against toxoplasmosis in adolescents and criteria for initiation or discontinuance of such prophylaxis in this age group are the same as those recommended for adults. (See Adult Dosage under Dosage and Administration.)†
Prevention of Bacterial Endocarditis
Patients Undergoing Certain Dental or Respiratory Tract Procedures
Oral
20 mg/kg as a single dose given 30–60 minutes prior to the procedure.†
IM or IV
20 mg/kg as a single dose given 30–60 minutes prior to the procedure.†
Perioperative Prophylaxis
Head or Neck Surgery
IV
15 mg/kg given at induction of anesthesia (within 0.5–1 hour prior to incision); used with or without IV gentamicin. Additional intraoperative doses suggested every 3–6 hours for prolonged procedures (>4 hours) or if major blood loss occurs.†
Adults
General Adult Dosage
Serious Infections
Oral
150–300 mg every 6 hours.
IV or IM
600 mg to 1.2 g daily in 2–4 equally divided doses.
More Severe Infections
Oral
300–450 mg every 6 hours.
IV or IM
1.2–2.7 g daily in 2–4 equally divided doses.
For life-threatening infections, dosage may be increased up 4.8 g daily.
Gynecologic Infections
Pelvic Inflammatory Disease
IV, then Oral
Initially, 900 mg IV every 8 hours; used in conjunction with IV or IM gentamicin. After clinical improvement occurs, discontinue IV clindamycin and gentamicin and switch to oral clindamycin in a dosage of 450 mg 4 times daily to complete 14 days of therapy. Alternatively, oral doxycycline can be used to complete 14 days of therapy.
Pharyngitis and Tonsillitis
Treatment of Symptomatic Patients with Multiple, Recurrent Episodes Known to Caused by Streptococcus pyogenes
Oral
600 mg daily in 2–4 divided doses given for 10 days. IDSA states this dosage was not specifically studied in adults and was extrapolated from pediatric dosage recommendation.†
Anthrax
Treatment of Inhalational Anthrax
IV
900 mg every 8 hours.†
Used in multiple-drug regimens that initially include IV ciprofloxacin or IV doxycycline and 1 or 2 other anti-infectives predicted to be effective.†
Duration of treatment is 60 days if anthrax occurred as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.†
Babesiosis
Oral
600 mg 3 times daily given for 7–10 days recommended by IDSA and others; used in conjunction with oral quinine (650 mg every 6–8 hours for 7–10 days).†
IV
IDSA recommends 300–600 mg every 6 hours for 7–10 days; used in conjunction with oral quinine (650 mg every 6–8 hours for 7–10 days). Others recommend 1.2 g twice daily given for 7–10 days; used in conjunction with oral quinine (650 mg 3 times daily for 7–10 days).†
Bacterial Vaginosis
Treatment in Pregnant or Nonpregnant Women
Oral
300 mg twice daily given for 7 days.†
Malaria
Treatment of Uncomplicated Chloroquine-resistant P. falciparum Malaria
Oral
20 mg/kg daily in 3 equally divided doses given for 7 days; used in conjunction with oral quinine sulfate (650 mg 3 times daily given for 3 days if infection was acquired in Africa or South America or for 7 days if acquired in Southeast Asia).†
Treatment of Severe P. falciparum Malaria
Oral
20 mg/kg daily in 3 equally divided doses given for 7 days; used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.†
IV, then Oral
10-mg/kg IV loading dose followed by 5 mg/kg IV every 8 hours; when oral therapy is tolerated, switch to oral clindamycin 20 mg/kg daily in 3 divided doses and continue for a total duration of 7 days.†
Used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.†
300–450 mg every 6–8 hours given for 21 days; used in conjunction with oral primaquine (15–30 mg once daily for 21 days).†
IV
600–900 mg every 6–8 hours given for 21 days; used in conjunction with oral primaquine (15–30 mg once daily for 21 days).†
Toxoplasmosis
Treatment
Oral or IV
600 mg every 6 hours; used in conjunction with oral pyrimethamine (200-mg loading dose then 50–75 mg once daily) and oral leucovorin (10–20 mg once daily; higher dosage may be needed).†
Continue acute treatment for ≥6 weeks.†
Prevention of Recurrence (Secondary Prophylaxis)
Oral
300–450 mg every 6–8 hours; used in conjunction with oral pyrimethamine (25–50 mg once daily) and oral leucovorin (10–25 mg once daily).†
Initiate long-term suppressive therapy or chronic maintenance therapy (secondary prophylaxis) in all patients who have completed initial treatment of toxoplasmosis encephalitis (TE).†
Consideration can be given to discontinuing secondary prophylaxis in adults or adolescents who successfully completed initial treatment for TE, are asymptomatic with respect to TE, and have a sustained (≥6 months) increase in CD4+T-cell counts to >200/mm3.†
Reinitiate secondary prophylaxis if CD4+ T-cell count decreases to <200/mm3.†
Prevention of Bacterial Endocarditis
Patients Undergoing Certain Dental or Respiratory Tract Procedures
Oral
600 mg as a single dose given 30–60 minutes prior to the procedure.†
IM or IV
600 mg as a single dose given 30–60 minutes prior to the procedure.†
Prevention of Perinatal Group B Streptococcal Disease
Women at Risk Who Should Not Receive β-lactam Anti-infectives
IV
900 mg every 8 hours; initiate at time of labor or rupture of membranes and continue until delivery.†
Perioperative Prophylaxis
Head or Neck Surgery
IV
600–900 mg given at induction of anesthesia (within 0.5–1 hour prior to incision); used with or without IV gentamicin. Additional intraoperative doses suggested every 3–6 hours for prolonged procedures (>4 hours) or if major blood loss occurs.†
Special Populations
Hepatic Impairment
Dosage adjustments not necessary in those with mild or moderate hepatic impairment.
Renal Impairment
Dosage adjustments not necessary in those with mild or moderate renal impairment.
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).
Potential for enhanced neuromuscular blocking action
Use with caution in patients receiving neuromuscular blocking agents; closely monitor for prolonged neuromuscular blockade
Pharmacokinetics
Absorption
Bioavailability
Approximately 90% of an oral dose of clindamycin hydrochloride rapidly absorbed from GI tract; peak serum concentration attained within 45–60 minutes.
Prior to absorption, clindamycin palmitate hydrochloride is hydrolyzed in the GI tract to active clindamycin.
Clindamycin palmitate oral solution and clindamycin hydrochloride capsules are bioequivalent.
Following IM administration of clindamycin phosphate, peak serum concentrations occur within 3 hours in adults and 1 hour in children.
Food
Although peak plasma concentrations may be delayed, food does not have an appreciable effect on the extent of absorption of clindamycin hydrochloride capsules or clindamycin palmitate hydrochloride oral solution.
Distribution
Extent
Distributed into many body tissues and fluids.
Only small amounts of the drug diffuse into CSF.
Readily crosses the placenta and is distributed into milk.
Plasma Protein Binding
93%.
Elimination
Metabolism
Partially metabolized to bioactive and inactive metabolites.
Elimination Route
Excreted in urine, bile, and feces.
Half-life
2–3 hours in adults and children with normal renal function.
Serum half-life in neonates depends on gestational and chronologic age and body weight.
Special Populations
Serum half-life increased slightly in patients with markedly reduced renal or hepatic function.
Stability
Storage
Oral
Capsules
20–25°C.
For Solution
20–25°C. Following reconstitution, stable for 2 weeks at room temperature; do not refrigerate because solution will thicken.
Parenteral
Injection, for IV infusion
20–25°C; avoid temperatures >30°C.
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
May be bacteriostatic or bactericidal in action, depending on concentration attained at site of infection and susceptibility of the infecting organism.
Inhibits protein synthesis in susceptible organisms by reversibly binding to 50S ribosomal subunits.
Clindamycin palmitate hydrochloride and clindamycin phosphate are inactive until hydrolyzed in vivo to free clindamycin.
Spectrum of activity includes many gram-positive aerobic bacteria, some gram-negative aerobic bacteria, and many gram-positive and -negative anaerobic bacteria. Inactive against fungi and viruses.
Gram-positive aerobes: Active against Staphylococcus aureus (including penicillinase-producing strains), S. epidermidis (including penicillinase-producing strains), Streptococcus pneumoniae, and other streptococci. Also active in vitro against Arcanobacterium haemolyticum and Bacillus anthracis. Enterococci faecalis are resistant.
Gram-negative aerobes: Active against some strains of Corynebacterium diphtheriae, Haemophilus influenzae, and Neisseria gonorrhoeae. N. meningitidis and Enterobacteriaceae are resistant.
Anaerobes: Active against Actinomyces, Bacteroides, Eubacterium, Fusobacterium, Propionibacterium, Peptococcus, Peptostreptococcus, and Veillonella. Some strains of Clostridium perfringens are susceptible, but C. difficile and other Clostridium usually are resistant.
Active against Plasmodium.
Complete cross-resistance usually occurs between clindamycin and lincomycin.
Staphylococci resistant to erythromycins rapidly develop clindamycin resistance.
Importance of completing full course of therapy, even if feeling better after a few days.
Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with clindamycin or other antibacterials in the future.
Clindamycin hydrochloride capsules and clindamycin palmitate hydrochloride oral solution can be taken without regard to meals.
Take clindamycin hydrochloride capsules with a full glass of water to avoid the possibility of esophageal irritation.
Importance of discontinuing drug and informing clinician if significant diarrhea occurs.
Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, and any concomitant illnesses
Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.
Importance of advising patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Clindamycin Hydrochloride
Routes
Dosage Forms
Strengths
Brand Names
Manufacturer
Oral
Capsules
75 mg (of clindamycin)
Cleocin HCl® (with tartrazine)
Pfizer
150 mg (of clindamycin)*
Cleocin HCl® (with tartrazine)
Pfizer
300 mg (of clindamycin)
Cleocin HCl®
Pfizer
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
6 mg (of clindamycin) per mL (300 mg) in 5% Dextrose
Cleocin Phosphate® IV (Galaxy® [Baxter])
Pfizer
12 mg (of clindamycin) per mL (600 mg) in 5% Dextrose
Cleocin Phosphate® IV (Galaxy® [Baxter])
Pfizer
18 mg (of clindamycin) per mL (900 mg) in 5% Dextrose
Cleocin Phosphate® IV (Galaxy® [Baxter])
Pfizer
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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