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clindamycin hcl 150 mg capsule generic cleocin hcl

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Uses

Clindamycin is used for the treatment of certain serious infections caused by susceptible aerobic gram-positive bacteria (staphylococci, streptococci, pneumococci) and for the treatment of certain serious infections caused by susceptible anaerobic bacteria. Use of clindamycin generally should be reserved for the treatment of serious infections when less toxic anti-infectives cannot be used (e.g., penicillin-allergic patients or other patients for whom a penicillin is inappropriate). Because clindamycin has been associated with potentially fatal colitis (see Cautions: GI Effects), the manufacturer recommends that clinicians consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).

Certain infections may require incision and drainage or other indicated surgical procedures in addition to anti-infective treatment. Use of clindamycin does not eliminate the need for surgical procedures when indicated.

Because clindamycin does not distribute adequately into the CNS, the drug should not be used for the treatment of meningitis.

Gram-positive Aerobic Bacterial Infections

Clindamycin is used orally or parenterally for the treatment of serious respiratory tract infections caused by susceptible staphylococci, Streptococcus pneumoniae, or other streptococci or serious skin and skin structure infections caused by susceptible staphylococci, S. pneumoniae, or S. pyogenes (group A β-hemolytic streptococci; GAS). Clindamycin also is used parenterally for the treatment of septicemia caused by susceptible Staphylococcus aureus or streptococci, treatment of serious bone and joint infections (including acute hematogenous osteomyelitis) caused by susceptible S. aureus, and as adjunctive therapy in the surgical treatment of chronic bone and joint infections caused by susceptible bacteria. However, clindamycin generally should be reserved for use in penicillin-allergic or other patients when less toxic alternatives cannot be used.

Anaerobic Bacterial Infections

Clindamycin is used orally or parenterally for the treatment of serious lower respiratory tract infections (e.g., empyema, pneumonia, lung abscess), serious skin and skin structure infections, septicemia, intra-abdominal infections (e.g., peritonitis, intra-abdominal abscess), and gynecologic infections (e.g., endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, postsurgical vaginal cuff infections) caused by susceptible anaerobic bacteria. Parenteral clindamycin also is used for the treatment of serious bone and joint infections (including acute hematogenous osteomyelitis) caused by susceptible anaerobes and as adjunctive therapy in the surgical treatment of chronic bone and joint infections caused by susceptible bacteria. Although previously considered a drug of choice for the treatment of infections caused by Bacteroides, clindamycin is no longer routinely recommended for the treatment of intra-abdominal infections because of the increasing incidence of B. fragilis resistant to the drug. In the treatment of mixed aerobic-anaerobic bacterial infections (e.g., pelvic inflammatory disease), clindamycin has been used in conjunction with an IM or IV aminoglycoside.

Acute Otitis Media

Oral clindamycin is used as an alternative for the treatment of acute otitis media (AOM).

When anti-infective therapy is indicated for the treatment of AOM, the American Academy of Pediatrics (AAP) recommends high-dose amoxicillin or amoxicillin and clavulanate as the drug of first choice for initial treatment. These experts recommend certain cephalosporins (cefdinir, cefpodoxime, cefuroxime, ceftriaxone) as alternatives for initial treatment in penicillin-allergic patients who do not have a history of severe and/or recent penicillin-allergic reactions.

AAP states that clindamycin (with or without a third generation cephalosporin) is a possible alternative for the treatment of AOM in patients who fail to respond to initial treatment with first-line or preferred alternatives. When retreatment of AOM is indicated after failure of initial treatment, high-dose amoxicillin and clavulanate or IM ceftriaxone usually is recommended. Although clindamycin may be effective in infections caused by penicillin-resistant S. pneumoniae, the drug may not be effective against multidrug-resistant S. pneumoniae and usually is inactive against Haemophilus influenzae. If clindamycin is used for retreatment of AOM, concomitant use of an anti-infective active against H. influenzae and Moraxella catarrhalis (e.g., cefdinir, cefixime, cefuroxime) should be considered.

For additional information regarding treatment of AOM, including information on diagnosis and management strategies, anti-infectives for initial treatment, duration of initial treatment, and anti-infectives after initial treatment failure, .

Pharyngitis and Tonsillitis

Oral clindamycin is used as an alternative for the treatment of pharyngitis and tonsillitis caused by S. pyogenes (group A β-hemolytic streptococci; GAS). Although clindamycin usually is effective in eradicating S. pyogenes from the nasopharynx, it is reserved for use as an alternative in patients who cannot receive β-lactam anti-infectives. In addition, clindamycin is recommended as one of several possible alternatives for the treatment of symptomatic patients who failed to respond to initial penicillin treatment or have multiple, recurrent episodes of pharyngitis known to be caused by S. pyogenes.

Selection of an anti-infective for the treatment of S. pyogenes pharyngitis and tonsillitis should be based on the drug's spectrum of activity, bacteriologic and clinical efficacy, potential adverse effects, ease of administration, patient compliance, and cost. No regimen has been found to date that effectively eradicates group A β-hemolytic streptococci in 100% of patients.

Because the drugs have a narrow spectrum of activity, are inexpensive, and generally are effective with a low frequency of adverse effects, AAP, Infectious Diseases Society of America (IDSA), and American Heart Association (AHA) recommend a penicillin regimen (i.e., 10 days of oral penicillin V or oral amoxicillin or a single dose of IM penicillin G benzathine) as the treatment of choice for S. pyogenes pharyngitis and tonsillitis and prevention of initial attacks (primary prevention) of rheumatic fever. Other anti-infectives (e.g., oral cephalosporins, oral macrolides, oral clindamycin) are recommended as alternatives in penicillin-allergic patients.

Respiratory Tract Infections

Clindamycin is used for the treatment of serious respiratory tract infections (e.g., pneumonia, empyema, lung abscess) caused by susceptible S. aureus, S. pneumoniae, other streptococci, or anaerobes.

IDSA and American Thoracic Society (ATS) consider clindamycin an alternative agent for the treatment of community-acquired pneumonia (CAP) caused by S. pneumoniae or S. aureus (methicillin-susceptible strains) in adults. IDSA also considers clindamycin an alternative for the treatment of CAP caused by S. pneumoniae, S. pyogenes, or S. aureus in pediatric patients. For the treatment of pneumonia caused by methicillin-resistant S. aureus (MRSA; also known as oxacillin-resistant S. aureus or ORSA), IDSA states that clindamycin is one of several options, unless the strain is resistant to clindamycin.

For information regarding the treatment of CAP, including infections caused by MRSA, the current clinical practice guidelines from IDSA available at http://www.idsociety.org should be consulted.

Skin and Skin Structure Infections

Clindamycin is used for the treatment of serious skin and skin structure infections caused by susceptible staphylococci, S. pneumoniae, other streptococci, or anaerobes. Clindamycin is recommended as one of several options for the treatment of staphylococcal and streptococcal skin and skin structure infections, including those known or suspected to be caused by susceptible MRSA.

Clindamycin is used in conjunction with or as an alternative to penicillin G for the treatment of clostridial myonecrosis (gas gangrene) caused by Clostridium perfringens or other Clostridium.

Although the fixed combination of amoxicillin and clavulanate usually is the drug of choice for the treatment of infected human or animal (e.g., dog, cat, reptile) bite wounds, alternative regimens include clindamycin in conjunction with either an extended-spectrum cephalosporin or co-trimoxazole. Purulent bite wounds usually are polymicrobial and broad-spectrum anti-infective coverage is recommended. Nonpurulent infected bite wounds usually are caused by staphylococci and streptococci, but can be polymicrobial.

For information regarding the treatment of skin and skin structure infections, including infections caused by MRSA, the current clinical practice guidelines from IDSA available at http://www.idsociety.org should be consulted.

Actinomycosis

Clindamycin has been recommended as an alternative to penicillin G or ampicillin for the treatment of actinomycosis, including infections caused by Actinomyces israelii.

Anthrax

Although limited clinical data are available regarding use of clindamycin in the treatment of anthrax, clindamycin was included in a multiple-drug regimen that was effective for the treatment of several patients in the US who developed anthrax during September and October 2001 following exposure to an intentional release of anthrax spores (biologic warfare, bioterrorism). At least 2 patients were treated with a parenteral regimen of ciprofloxacin (400 mg every 8 hours), rifampin (300 mg every 12 hours), and clindamycin (900 mg every 8 hours).

Because of the rapid course of symptomatic inhalational anthrax and high mortality rate, prompt recognition of symptoms and early initiation of anti-infective therapy is essential. The US Centers for Disease Control and Prevention (CDC) and other experts (e.g., US Working Group on Civilian Biodefense) recommend that treatment of inhalational anthrax that occurs as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism should be initiated with a multiple-drug parenteral regimen that includes ciprofloxacin or doxycycline and 1 or 2 additional anti-infective agents predicted to be effective. Multiple-drug parenteral regimens also are recommended for the treatment of cutaneous anthrax if there are signs of systemic involvement, extensive edema, or lesions on the head and neck. Based on in vitro data, drugs that have been suggested as possibilities to augment ciprofloxacin or doxycycline in such multiple-drug regimens include chloramphenicol, clindamycin, rifampin, vancomycin, clarithromycin, imipenem, penicillin, or ampicillin. Strains of Bacillus anthracis that were associated with cases of inhalational or cutaneous anthrax that occurred in the US (Florida, New York, District of Columbia) during September and October 2001 following bioterrorism-related anthrax exposures were susceptible to clindamycin in vitro.

Based on in vitro data, clindamycin also has been suggested as a possible alternative for postexposure prophylaxis following a suspected or confirmed exposure to aerosolized anthrax spores (inhalational anthrax) when the drugs of choice (ciprofloxacin, doxycycline) are not tolerated or cannot be used.

For information on treatment of anthrax and recommendations for prophylaxis following exposure to anthrax spores,

Babesiosis

Oral or IV clindamycin is used in conjunction with oral quinine sulfate for the treatment of babesiosis caused by Babesia microti or other Babesia.

Although several species of Babesia can infect humans (e.g., B. microti, B. divergens, B. duncani, B. venatorum), B. microti is the most common cause of babesiosis in the US.B. microti is transmitted by Ixodes scapularis ticks, which also may be simultaneously infected with and transmit Borrelia burgdorferi (causative agent of Lyme disease) and Anaplasma phagocytophilum (causative agent of human granulocytotropic anaplasmosis [HGA, formerly known as human granulocytic ehrlichiosis]). Therefore, the possibility of coinfection with B. burgdorferi and/or A. phagocytophilum should be considered in patients who have severe or persistent symptoms despite appropriate anti-infective treatment for babesiosis.

IDSA states that all patients with active babesiosis (i.e., symptoms of viral-like infection and identification of babesial parasites in blood smears or by polymerase chain reaction [PCR] amplification of babesial DNA) should receive anti-infective treatment because of the risk of complications; however, symptomatic patients whose serum contains antibody to babesia but whose blood lacks identifiable babesial parasites on smear or babesial DNA by PCR should not receive treatment. In addition, these experts state that treatment is not generally recommended initially for asymptomatic individuals, regardless of the results of serologic examination, blood smears, or PCR, but should be considered if parasitemia persists for longer than 3 months.

When anti-infective treatment of babesiosis is indicated, IDSA and other clinicians recommend that either a regimen of clindamycin and quinine or a regimen of atovaquone and azithromycin be used. There is some evidence that, in patients with mild or moderate illness, the atovaquone and azithromycin regimen may be as effective and better tolerated than the clindamycin and quinine regimen. However, the clindamycin and quinine regimen generally is preferred for the treatment of severe babesiosis caused by M. microti and infections caused by M. divergens, B. duncani, B. divergens-like organisms, or B. venatorum. Patients with moderate to severe babesiosis should be monitored closely during treatment to ensure clinical improvement. Exchange transfusions have been used successfully in asplenic patients with life-threatening babesiosis and should be considered, especially in severely ill patients with high levels of parasitemia (10% or more), significant hemolysis, or compromised renal, hepatic, or pulmonary function.

Bacterial Vaginosis

Oral clindamycin is used in the treatment of bacterial vaginosis (formerly called Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). The drug also is used intravaginally as a vaginal cream or vaginal suppository for the treatment of bacterial vaginosis .

Bacterial vaginosis is a polymicrobial syndrome that can occur when normal hydrogen peroxide-producing Lactobacillus in the vagina are replaced by overgrowth of various anaerobic bacteria (e.g., Prevotella, Mobiluncus), Gardnerella vaginalis, Ureaplasma urealyticum, Mycoplasma hominis, Atopobium vaginae, or other bacteria. Treatment of bacterial vaginosis usually is recommended to relieve signs and symptoms of infection, regardless of pregnancy status.

For the treatment of bacterial vaginosis, CDC and other experts recommend a 7-day regimen of oral metronidazole (500 mg twice daily); a 5-day regimen of intravaginal metronidazole 0.75% gel; or a 7-day regimen of intravaginal clindamycin 2% cream. Alternative regimens include a 2-day regimen of oral tinidazole (2 g once daily); a 5-day regimen of oral tinidazole (1 g once daily); a 7-day regimen of oral clindamycin (300 mg twice daily); or a 3-day regimen of intravaginal clindamycin 100-mg suppositories. CDC and other clinicians state that the oral or intravaginal metronidazole or clindamycin regimens can be used to treat symptomatic bacterial vaginosis in pregnant women.

Regardless of the treatment regimen used, relapse or recurrence of bacterial vaginosis is common. Retreatment with the same regimen or an alternative regimen (e.g., oral therapy when topical therapy was used initially) can be effective for treating persistent or recurrent bacterial vaginosis after the first occurrence. Maintenance suppressive therapy with intravaginal metronidazole (0.75% gel twice weekly for 4-6 months) may reduce recurrences, but this benefit may not persist after suppressive therapy is discontinued.

Malaria

Treatment of Uncomplicated Malaria

Oral clindamycin is used in conjunction with oral quinine sulfate for the treatment of uncomplicated chloroquine-resistant Plasmodium falciparum malaria or when the plasmodial species has not been identified. Clindamycin is not effective when used alone for the treatment of malaria.

For the treatment of uncomplicated malaria caused by chloroquine-resistant P. falciparum or the treatment of uncomplicated malaria when the plasmodial species has not been identified, CDC and other clinicians recommend the fixed combination of atovaquone and proguanil hydrochloride (atovaquone/proguanil), the fixed combination of artemether and lumefantrine (artemether/lumefantrine), or a regimen that includes quinine sulfate in conjunction with doxycycline, tetracycline, or clindamycin. Although mefloquine is another option for treatment in these patients, CDC states that mefloquine should only be considered when other options cannot be used and is not recommended if malaria was acquired in Southeast Asia.

When a quinine sulfate regimen is used, concomitant doxycycline or tetracycline generally is preferable to concomitant clindamycin because more efficacy data exist regarding regimens that include tetracyclines. However, for pregnant women with uncomplicated malaria caused by chloroquine-resistant P. falciparum, a regimen of quinine sulfate and clindamycin is recommended. Although tetracyclines generally are contraindicated in pregnant women, in rare circumstances (e.g., if other treatment options are not available or are not tolerated) quinine sulfate may be used in conjunction with doxycycline or tetracycline if the benefits outweigh the risks.

Pediatric patients with uncomplicated malaria generally can receive the same treatment regimens recommended for adults using age- and weight-appropriate drugs and dosages. However, because doxycycline and tetracycline generally are contraindicated in children younger than 8 years of age, children in this age group with uncomplicated chloroquine-resistant P. falciparum malaria or when the plasmodial species has not been identified may receive a regimen of oral quinine sulfate alone for a full 7 days (regardless of geographic area where infection was acquired) or atovaquone/proguanil, artemether/lumefantrine, or a regimen of oral quinine sulfate in conjunction with oral clindamycin. Mefloquine should only be considered in these children when other options cannot be used and is not recommended if malaria was acquired in Southeast Asia. In rare circumstances when other treatment options are unavailable or are not tolerated, CDC states that doxycycline or tetracycline may be used in conjunction with quinine sulfate in children younger than 8 years of age if the benefits of tetracycline therapy outweigh the risks.

Treatment of Severe Malaria

Oral or IV clindamycin is used in conjunction with IV quinidine gluconate for the treatment of severe P. falciparum malaria in adults and children.

Patients with severe malaria require aggressive antimalarial treatment initiated as soon as possible after the diagnosis using a parenteral regimen. CDC recommends that severe malaria be treated with IV quinidine gluconate therapy in conjunction with a 7-day course of doxycycline, tetracycline, or clindamycin administered orally or IV as tolerated. After parasitemia is reduced to less than 1% and the patient can tolerate oral therapy, IV quinidine gluconate can be discontinued and oral quinine sulfate initiated to complete 3 or 7 days of total quinidine and quinine therapy as determined by the geographic origin of the infecting parasite (7 days if acquired in Southeast Asia or 3 days if acquired elsewhere).

Assistance with diagnosis or treatment of malaria is available by contacting the CDC Malaria Hotline at 770-488-7788 or 855-856-4713 from 9:00 a.m. to 5:00 p.m. Eastern Standard Time or the CDC Emergency Operation Center at 770-488-7100 after hours and on weekends and holidays.

Pelvic Inflammatory Disease

IV clindamycin used in conjunction with IV or IM gentamicin is one of several possible parenteral regimens for the treatment of acute pelvic inflammatory disease (PID) in adults and adolescents. PID is a polymicrobial infection most frequently caused by Neisseria gonorrhoeae and/or Chlamydia trachomatis; however, organisms that can be part of the normal vaginal flora (e.g., anaerobic bacteria, G. vaginalis, H. influenzae, enteric gram-negative bacilli, S. agalactiae) or mycoplasma (e.g., M. hominis, U. urealyticum) also may be involved. PID is treated with an empiric regimen that provides broad-spectrum coverage. The regimen should be effective against N. gonorrhoeae and C. trachomatis and also probably should be effective against anaerobes. In addition, women with PID often have bacterial vaginosis concurrently, a polymicrobial infection that can include anaerobes.(See Uses: Bacterial Vaginosis.)

The optimum regimen for the treatment of PID has not been identified. A variety of parenteral and oral regimens have been recommended by CDC and other clinicians. When a parenteral regimen is used, these experts recommend a regimen of IV cefotetan in conjunction with oral or IV doxycycline; IV cefoxitin in conjunction with oral or IV doxycycline; or IV clindamycin in conjunction with IM or IV gentamicin. The parenteral regimen should be continued until 24-48 hours after the patient improves clinically and then an oral regimen of either doxycycline (100 mg twice daily) or clindamycin (450 mg 4 times daily) is used to complete 14 days of therapy. If tubo-ovarian abscess is present, at least 24 hours of inpatient observation is recommended and use of oral clindamycin or oral metronidazole in addition to oral doxycycline is preferred for follow-up oral therapy since this provides more effective coverage against anaerobes than doxycycline alone.

Pneumocystis jirovecii Pneumonia

Treatment of Pneumocystis jirovecii Pneumonia

Clindamycin is used in conjunction with primaquine for the treatment of Pneumocystis jirovecii (formerly Pneumocystis carinii) pneumonia (PCP) in individuals with human immunodeficiency virus (HIV) infection. Clindamycin is designated an orphan drug by FDA for the treatment of PCP associated with acquired immunodeficiency syndrome (AIDS).

Co-trimoxazole is the drug of choice for the treatment of mild, moderate, or severe PCP, including PCP in HIV-infected adults, adolescents, and children. CDC, National Institutes of Health (NIH), and IDSA state that a regimen of primaquine and clindamycin is an alternative for the treatment of mild, moderate, or severe PCP in HIV-infected adults and adolescents who have had an inadequate response to co-trimoxazole or when co-trimoxazole is contraindicated or not tolerated. Although data are not available regarding use in children, CDC, NIH, IDSA, and AAP state that a regimen of primaquine and clindamycin also can be considered an alternative to co-trimoxazole for the treatment of PCP in HIV-infected children based on data in adults.

Results of clinical studies indicate that clindamycin administered IV (1.8-3.6 g given in 3 or 4 divided doses daily) or orally (1.2-3.6 g in 3 or 4 divided doses daily [in some cases oral clindamycin was administered after initial IV administration]) in conjunction with oral primaquine (15 or 30 mg daily) for a total 21 days of therapy is effective for the treatment of PCP in HIV-infected adults. Most patients exhibit clinical improvement within 2-7 days, and the combination generally appears to be well tolerated.

Prevention of Pneumocystis jirovecii Pneumonia

Co-trimoxazole is the drug of choice for prevention of initial episodes (primary prophylaxis) of PCP in HIV-infected adults, adolescents, and children. CDC, NIH, and IDSA state that a regimen of primaquine and clindamycin is not recommended for primary PCP prophylaxis because data are insufficient to determine efficacy of the regimen for such prophylaxis.

Although a regimen of clindamycin and primaquine has been used as an alternative to co-trimoxazole for long-term suppressive or chronic maintenance therapy (secondary prophylaxis) of PCP in a limited number of AIDS patients, this regimen is not included in CDC, NIH, IDSA, and AAP recommendations for secondary prophylaxis of PCP in HIV-infected adults, adolescents, or children. Co-trimoxazole is the drug of choice for secondary PCP prophylaxis in HIV-infected adults, adolescents, and children.

Toxoplasmosis

Treatment of Toxoplasmosis

Clindamycin is used in conjunction with pyrimethamine (and leucovorin) as an alternative for the treatment of toxoplasmosis caused by Toxoplasma gondii.

Pyrimethamine (and leucovorin) in conjunction with sulfadiazine is the regimen of choice for initial treatment of toxoplasmosis, including toxoplasmic encephalitis in HIV-infected adults, adolescents, and children. A regimen of pyrimethamine (and leucovorin) in conjunction with clindamycin is the preferred alternative in HIV-infected adults and adolescents who are unable to tolerate sulfadiazine or who failed to respond to an initial regimen of pyrimethamine and sulfadiazine. When a parenteral regimen is required for initial treatment of toxoplasmosis in severely ill adults or adolescents, some experts suggest parenteral co-trimoxazole or a regimen of oral pyrimethamine (and leucovorin) in conjunction with parenteral clindamycin.

Pyrimethamine (and leucovorin) in conjunction with sulfadiazine also is the regimen of choice for the treatment of congenital toxoplasmosis and the treatment of acquired CNS, ocular, or systemic toxoplasmosis in HIV-infected children. The preferred alternative for the treatment of toxoplasmosis in neonates or HIV-infected children with sulfonamide sensitivity is pyrimethamine (and leucovorin) in conjunction with clindamycin. Empiric treatment of congenital toxoplasmosis should be strongly considered in infants born to HIV-infected women who had symptomatic or asymptomatic toxoplasmosis during pregnancy, regardless of whether the mother received toxoplasmosis treatment during the pregnancy. Pregnant women with suspected or confirmed primary toxoplasmosis and neonates with possible or documented congenital toxoplasmosis should be managed in consultation with an appropriate infectious disease specialist.

Prevention of Recurrence of Toxoplasmosis

CDC, NIH, IDSA, and AAP state that HIV-infected adults, adolescents, and children who have completed initial treatment of T. gondii encephalitis should receive chronic maintenance therapy (secondary prophylaxis) to prevent relapse.

Pyrimethamine (and leucovorin) in conjunction with sulfadiazine is the regimen of choice for long-term suppressive or chronic maintenance therapy (secondary prophylaxis) of toxoplasmosis in HIV-infected adults, adolescents, and children. A regimen of pyrimethamine (and leucovorin) in conjunction with clindamycin is one of several alternatives for secondary prophylaxis of toxoplasmosis in HIV-infected adults, adolescents, and children who cannot tolerate sulfonamides.

CDC, NIH, and IDSA state that secondary prophylaxis against toxoplasmosis generally can be discontinued in HIV-infected adults and adolescents who have successfully completed initial therapy for toxoplasmic encephalitis, remain asymptomatic with respect to toxoplasmic encephalitis, and have CD4 T-cell counts that have remained greater than 200/mm for more than 6 months in response to antiretroviral therapy. Some experts recommend obtaining a magnetic resonance image (MRI) of the brain as part of the evaluation to determine whether discontinuance of secondary prophylaxis is appropriate. Secondary prophylaxis against toxoplasmosis should be reinitiated in HIV-infected adults and adolescents if CD4 T-cell counts decrease to less than 200/mm, regardless of plasma HIV viral load.

The safety of discontinuing secondary toxoplasmosis prophylaxis in HIV-infected children receiving potent antiretroviral therapy has not been extensively studied. However, based on data from adults, CDC, NIH, IDSA, and AAP state that discontinuance of secondary prophylaxis against toxoplasmosis can be considered in HIV-infected children 1 to less than 6 years of age who have completed toxoplasmosis treatment, have received more than 6 months of stable antiretroviral therapy, are asymptomatic with respect to toxoplasmosis, and have CD4 T-cell percentages that have remained greater than 15% for more than 6 consecutive months. In HIV-infected children 6 years of age or older who have received more than 6 months of antiretroviral therapy, consideration can be given to discontinuing secondary prophylaxis against toxoplasmosis if CD4 T-cell counts have remained greater than 200/mm for more than 6 consecutive months. Prophylaxis should be reinitiated in HIV-infected children if these parameters are not met.

Perioperative Prophylaxis

IV clindamycin is recommended as an alternative for perioperative prophylaxis to reduce the incidence of infections in patients undergoing certain clean, contaminated surgeries when the drugs of choice (e.g., cefazolin, cefuroxime, cefoxitin, cefotetan) cannot be used because the patient is hypersensitive to β-lactam anti-infectives.

Some experts state that clindamycin or vancomycin is a reasonable alternative for perioperative prophylaxis in patients allergic to β-lactam anti-infectives who are undergoing cardiac surgery (e.g., coronary artery bypass grafting, valve repairs, cardiac device implantation), neurosurgery (e.g., craniotomy, spinal and CSF-shunting procedures, intrathecal pump placement), orthopedic surgery (e.g., spinal procedures, hip fracture, internal fixation, total joint replacement), non-cardiac thoracic surgery (e.g., lobectomy, pneumonectomy, lung resection, thoracotomy), vascular surgery (e.g., arterial procedures involving a prosthesis, the abdominal aorta, or a groin incision), lower extremity amputation for ischemia, or certain transplant procedures (e.g., heart and/or lung). These experts state that clindamycin also is a reasonable alternative for perioperative prophylaxis in patients allergic to β-lactam anti-infectives who are undergoing head and neck surgery (e.g., incisions through oral or pharyngeal mucosa).

For procedures that might involve exposure to enteric gram-negative bacteria, some experts state that clindamycin or vancomycin used in conjunction with an aminoglycoside (e.g., amikacin, gentamicin, tobramycin), aztreonam, or a fluoroquinolone is a reasonable alternative in patients allergic to β-lactam anti-infectives. These procedures include certain GI and biliary tract procedures (e.g., esophageal or gastroduodenal procedures, appendectomy for uncomplicated appendicitis, surgery involving unobstructed small intestine, colorectal procedures), gynecologic and obstetric surgery (e.g., cesarean section, hysterectomy), urologic procedures involving an implanted prosthesis, and certain transplant procedures (e.g., liver, pancreas and/or kidney).

Prevention of Bacterial Endocarditis

Clindamycin is used as an alternative to amoxicillin or ampicillin for prevention of α-hemolytic (viridans group) streptococcal bacterial endocarditis in penicillin-allergic adults and children undergoing certain dental or upper respiratory tract procedures who have cardiac conditions that put them at highest risk of adverse outcomes from endocarditis.

The cardiac conditions identified by AHA as those associated with highest risk and for which endocarditis prophylaxis is reasonable are prosthetic cardiac valves or prosthetic material used for cardiac valve repair, previous infective endocarditis, cardiac valvulopathy after cardiac transplantation, and certain forms of congenital heart disease (i.e., unrepaired cyanotic congenital heart disease including palliative shunts and conduits; a completely repaired congenital heart defect where prosthetic material or device was placed by surgery or catheter intervention within the last 6 months; repaired congenital heart disease with residual defects at the site or adjacent to the site of a prosthetic patch or prosthetic device that inhibit endothelialization).

AHA states that anti-infective prophylaxis for prevention of α-hemolytic (viridans group) streptococcal bacterial endocarditis is reasonable for patients with the above cardiac risk factors if they are undergoing any dental procedures that involve manipulation of gingival tissue or the periapical region of teeth or perforation of the oral mucosa (e.g., biopsies, suture removal, placement of orthodontic bands). AHA states that anti-infective prophylaxis is not needed for routine anesthetic injections through noninfected tissue, dental radiographs, placement of removable prosthodontic or orthodontic appliances, adjustment of orthodontic appliances, placement of orthodontic brackets, shedding of deciduous teeth, or bleeding from trauma to the lips or oral mucosa.

AHA states that anti-infective prophylaxis for prevention of bacterial endocarditis also is reasonable for patients with these cardiac risk factors if they are undergoing invasive procedures of the respiratory tract that involve incision or biopsy of respiratory mucosa (e.g., tonsillectomy, adenoidectomy) and may be reasonable for such patients if they are undergoing surgical procedures that involve infected skin, skin structure, or musculoskeletal tissue. However, anti-infective prophylaxis solely to prevent infective endocarditis is no longer recommended by AHA for GI or genitourinary tract procedures.

For additional information on which cardiac conditions are associated with the highest risk of adverse outcomes from endocarditis and more specific information regarding use of prophylaxis to prevent endocarditis in these patients, the current recommendations published by AHA should be consulted.

Prevention of Perinatal Group B Streptococcal Disease

IV clindamycin is used as an alternative to parenteral penicillin G or ampicillin for prevention of perinatal group B streptococcal (GBS) disease in certain women who are hypersensitive to penicillins.

Pregnant women who are colonized with GBS in the genital or rectal areas can transmit GBS infection to their infants during labor and delivery, resulting in invasive neonatal infection that can be associated with substantial morbidity and mortality. Intrapartum anti-infective prophylaxis for prevention of early-onset neonatal GBS disease is administered selectively to women at high risk for transmitting GBS infection to their neonates. CDC and AAP recommend routine universal prenatal screening for GBS colonization (e.g., vaginal and rectal cultures) in all pregnant women at 35-37 weeks of gestation, unless GBS bacteriuria is known to be present during the current pregnancy or the woman had a previous infant with invasive GBS disease. Intrapartum anti-infective prophylaxis for prevention of perinatal GBS is indicated in pregnant women identified as GBS carriers during the routine prenatal GBS screening performed at 35-37 weeks during the current pregnancy, in women with GBS bacteriuria identified at any time during the current pregnancy, and in women who had a previous infant diagnosed with invasive GBS disease. Intrapartum anti-infective prophylaxis also is indicated in women with unknown GBS status at the time of onset of labor (i.e., culture not done, incomplete, or results unknown), if delivery is at less than 37 weeks of gestation, the duration of amniotic membrane rupture is 18 hours or longer, intrapartum temperature is 38°C or higher, or an intrapartum nucleic acid amplification test (NAAT) was positive for GBS.

When intrapartum anti-infective prophylaxis is indicated in the mother for prevention of GBS in the neonate, it should be initiated at the onset of labor or rupture of membranes. CDC, AAP, and others recommend penicillin G as the drug of choice and ampicillin as the preferred alternative for such prophylaxis. If intrapartum prophylaxis is indicated in a penicillin-allergic woman who is not at high risk for anaphylaxis (i.e., does not have a history of anaphylaxis, angioedema, respiratory distress, or urticaria after receiving a penicillin or cephalosporin), CDC, AAP, and others recommend IV cefazolin. If intrapartum prophylaxis is indicated in a penicillin-allergic woman who is at high risk for anaphylaxis (e.g., history of anaphylaxis, angioedema, respiratory distress, or urticaria after receiving a penicillin or cephalosporin), IV clindamycin is recommended if the GBS isolate is tested and found to be susceptible to clindamycin and erythromycin. GBS isolates susceptible to clindamycin but resistant to erythromycin in vitro should be evaluated for inducible clindamycin resistance. IV vancomycin can be used as an alternative in penicillin-allergic women if the GBS isolate is intrinsically resistant to clindamycin, demonstrates inducible resistance to clindamycin, or if susceptibility to clindamycin and erythromycin is unknown.

For additional information regarding prevention of perinatal group B streptococcal disease, the current guidelines from CDC or AAP should be consulted.

Topical Uses

For topical uses of clindamycin,

Dosage and Administration

Reconstitution and Administration

Clindamycin hydrochloride and clindamycin palmitate hydrochloride are administered orally.

Clindamycin phosphate is administered by IM injection or by intermittent or continuous IV infusion. Clindamycin phosphate should not be administered by rapid IV injection.

In the treatment of serious anaerobic infections, the parenteral route is usually used initially but may be switched to the oral route when warranted by the patient's condition. In clinically appropriate circumstances, the oral route may be used initially.

Oral Administration

Clindamycin hydrochloride capsules and clindamycin palmitate hydrochloride oral solution can be administered without regard to food.

Capsules

Clindamycin hydrochloride capsules should be administered orally with a full glass of water to avoid the possibility of esophageal irritation.

The capsules should be swallowed whole and are not suitable for use in pediatric patients who are unable to swallow capsules.

Oral Solution

Clindamycin palmitate hydrochloride powder (granules) for oral solution must be reconstituted by adding 75 mL of water to the 100-mL bottle. A large portion of the 75 mL 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 reconstituted oral solution contains 75 mg of clindamycin per 5 mL.

IM Injection

For IM injection, commercially available clindamycin phosphate solution containing 150 mg of clindamycin per mL is administered undiluted.

Single IM doses should not exceed 600 mg.

IV Infusion

Prior to IV infusion, commercially available clindamycin phosphate solution (including solutions provided in ADD-Vantage vials) must be diluted with a compatible IV solution to a concentration not exceeding 18 mg/mL.

Clindamycin phosphate usually is administered by intermittent IV infusion. As an alternative, clindamycin phosphate may be given by continuous IV infusion after the first dose of the drug has been given by rapid IV infusion.(See Table 1.)

Commercially available premixed solutions of clindamycin phosphate in 5% dextrose are administered only by IV infusion. Clindamycin phosphate in 5% dextrose injection should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit. Premixed solutions provided in flexible containers should be checked for minute leaks by firmly squeezing the bag. Premixed solutions should be discarded if the container seal is not intact or leaks are found or if the solution is not clear. Additives should not be introduced into containers of premixed solutions of clindamycin phosphate in 5% dextrose. Flexible containers 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 the fluid from the secondary container is complete.

Dilution

When commercially available clindamycin phosphate solution containing 150 mg of clindamycin per mL is used for IV infusion, the appropriate dose should be diluted in a compatible IV infusion solution and administered using the recommended rate of administration.(See Rate of Administration under Reconstitution and Administration: IV Infusion, in Dosage and Administration.)

Clindamycin phosphate solution provided in ADD-Vantage vials must be diluted prior to IV infusion according to the directions provided by the manufacturer. The ADD-Vantage vials are for IV infusion only.

Commercially available clindamycin phosphate pharmacy bulk packages are not intended for direct IV infusion; doses of the drug from the bulk package must be further diluted in a compatible IV infusion solution. The bulk package is intended for use only in a laminar flow hood. Entry into the bulk pharmacy 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. After entry into a pharmacy bulk package vial, the entire contents of the vial should be used promptly; any unused portion should be discarded within 24 hours after initial entry into the pharmacy bulk package vial.

Rate of Administration

Intermittent IV infusions of clindamycin phosphate solutions should be given over a period of at least 10-60 minutes and at a rate less than 30 mg/minute. No more than 1.2 g should be given by IV infusion in a single 1-hour period.

The manufacturer recommends that 300-mg doses should be diluted in 50 mL of compatible diluent and infused over 10 minutes; 600-mg doses should be diluted in 50 mL of diluent and infused over 20 minutes; 900-mg doses should be diluted in 50-100 mL of diluent and infused over 30 minutes; and 1.2-g doses should be diluted in 100 mL of diluent and infused over 40 minutes.

As an alternative to intermittent IV infusions, the manufacturer states that the drug can be given by continuous IV infusion in adults after an initial dose is given by IV infusion over 30 minutes.(See Table 1.)

Table 1. Infusion Rates for Continuous IV Infusion of Clindamycin Phosphate in Adults[139 ]
Target Serum Clindamycin Concentrations Infusion Rate for Initial Dose Maintenance Infusion Rate
Greater than 4 mcg/mL 10 mg/minute for 30 minutes 0.75 mg/minute
Greater than 5 mcg/mL 15 mg/minute for 30 minutes 1 mg/minute
Greater than 6 mcg/mL 20 mg/minute for 30 minutes 1.25 mg/minute

Dosage

Dosage of clindamycin hydrochloride, clindamycin palmitate hydrochloride, and clindamycin phosphate is expressed in terms of clindamycin.

Dosage and duration of treatment depend on the severity of the infection. If clindamycin is used in infections caused by Streptococcus pyogenes (group A β-hemolytic streptococci; GAS), therapy should be continued for at least 10 days. At least 6 weeks of therapy may be required for certain serious infections (e.g., osteomyelitis).

Oral Dosage

General Dosage for Neonates

When clindamycin oral solution is used in pediatric patients, the manufacturer recommends 8-12 mg/kg daily for the treatment of 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 pediatric patients weighing 10 kg or less, the manufacturer recommends a minimum clindamycin dosage of 37.5 mg 3 times daily.

When oral clindamycin is used in neonates 7 days of age or younger, the American Academy of Pediatrics (AAP) recommends a dosage of 5 mg/kg every 12 hours in those weighing 2 kg or less or 5 mg/kg every 8 hours in those weighing more than 2 kg.

In neonates 8-28 days of age, AAP recommends an oral clindamycin dosage of 5 mg/kg every 8 hours in those weighing 2 kg or less or 5 mg/kg every 6 hours in those weighing more than 2 kg. In extremely low-birthweight neonates (less than 1 kg), a dosage of 5 mg/kg every 12 hours can be considered until 2 weeks of age.

General Dosage for Infants and Children

When clindamycin capsules are used in pediatric patients able to swallow capsules, the manufacturer recommends 8-16 mg/kg daily given in 3 or 4 equally divided doses for the treatment of serious infections or 16-20 mg/kg daily given in 3 or 4 equally divided doses for more severe infections.

When the oral solution is used in pediatric patients, the manufacturer recommends 8-12 mg/kg daily for the treatment of 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 pediatric patients weighing 10 kg or less, the manufacturer recommends a minimum dosage of 37.5 mg 3 times daily.

When oral clindamycin is used in pediatric patients beyond the neonatal period, AAP recommends a dosage of 10-25 mg/kg daily given in 3 equally divided doses for the treatment of mild to moderate infections or 30-40 mg/kg daily given in 3 or 4 equally divided doses for the treatment of severe infections.

General Adult Dosage

The usual adult dosage of oral clindamycin is 150-300 mg every 6 hours for the treatment of serious infections or 300-450 mg every 6 hours for the treatment of more severe infections.

Acute Otitis Media

If oral clindamycin is used as an alternative for the treatment of acute otitis media (AOM) in children 6 months through 12 years of age, AAP recommends a dosage of 30-40 mg/kg daily given in 3 divided doses (with or without a third generation cephalosporin).(See Uses: Acute Otitis Media.)

Pharyngitis and Tonsillitis

If oral clindamycin is used as an alternative for the treatment of pharyngitis and tonsillitis caused by S. pyogenes (group A β-hemolytic streptococci; GAS) (see Uses: Pharyngitis and Tonsillitis), AAP recommends a dosage of 10 mg/kg 3 times daily (up to 900 mg daily) for 10 days. The Infectious Diseases Society of America (IDSA) recommends a dosage of 7 mg/kg (up to 300 mg) 3 times daily for 10 days. The American Heart Association (AHA) recommends a dosage of 20 mg/kg daily (up to 1.8 g daily) given in 3 divided doses for 10 days.

Although anti-infective treatment is not recommended for most individuals identified as chronic pharyngeal GAS carriers, AAP and IDSA state that oral clindamycin can be given in a dosage of 20-30 mg/kg daily in 3 equally divided doses (up to 300 mg per dose or up to 900 mg daily) for 10 days when treatment is indicated in such patients.

Respiratory Tract Infections

If oral clindamycin is used in adults for the treatment of healthcare-associated or community-acquired pneumonia (CAP) caused by susceptible methicillin-resistant Staphylococcus aureus (MRSA; also known as oxacillin-resistant S. aureus or ORSA), IDSA recommends a dosage of 600 mg 3 times daily for 7-21 days.

If oral clindamycin is used for the treatment of CAP caused by susceptible gram-positive bacteria (e.g., S. pneumoniae, S. pyogenes, S. aureus) in children older than 3 months of age, IDSA recommends a dosage of 30-40 mg/kg daily given in 3 or 4 divided doses.

Babesiosis

For the treatment of babesiosis caused by Babesia microti or other Babesia species, IDSA and other experts recommend that adults receive clindamycin in a dosage of 600 mg orally every 8 hours (or 300-600 mg IV every 6 hours) in conjunction with oral quinine sulfate (650 mg every 6 or 8 hours) given for 7-10 days.

For the treatment of babesiosis in pediatric patients, IDSA recommends an oral (or IV) clindamycin dosage of 7-10 mg/kg (up to 600 mg) every 6-8 hours in conjunction with oral quinine sulfate (8 mg/kg [up to 650 mg] every 8 hours) given for 7-10 days. Other clinicians recommend an oral (or IV) clindamycin dosage of 20-40 mg/kg (up to 600 mg) daily given in 3 or 4 divided doses for 7-10 days in conjunction with oral quinine sulfate (24 mg/kg daily given in 3 divided doses for 7-10 days).

Patients with mild to moderate babesiosis should have clinical improvement within 48 hours after treatment is initiated; symptoms should resolve completely within 3 months. Patients with severe babesiosis should receive IV clindamycin rather than oral clindamycin. Some patients may have persistent low-grade parasitemia for months after anti-infective treatment. Some experts suggest that anti-infective treatment in immunosuppressed patients should be continued for a minimum of 6 weeks and at least 2 weeks after the last positive smear. Regardless of the presence or absence of symptoms, IDSA suggests that retreatment be considered if babesial parasites or amplifiable babesial DNA is detected in blood 3 months or longer after initial treatment.

Bacterial Vaginosis

When oral clindamycin is used as an alternative for the treatment of bacterial vaginosis in symptomatic women, the US Centers for Disease Control and Prevention (CDC) and other clinicians recommend a dosage of 300 mg twice daily for 7 days.

Malaria

If clindamycin is used in conjunction with quinine sulfate for the treatment of uncomplicated malaria caused by chloroquine-resistant Plasmodium falciparum or when the plasmodial species has not been identified, CDC and other clinicians recommend that adults receive oral clindamycin in a dosage of 20 mg/kg daily in 3 equally divided doses given for 7 days in conjunction with oral quinine sulfate (650 mg 3 times daily given for 7 days if acquired in Southeast Asia or for 3 days if acquired elsewhere). Children with uncomplicated chloroquine-resistant P. falciparum malaria can receive oral clindamycin in a dosage of 20 mg/kg daily in 3 equally divided doses given for 7 days in conjunction with oral quinine sulfate (10 mg/kg 3 times daily given for 7 days if acquired in Southeast Asia or 3 days if acquired elsewhere).

If clindamycin is used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) for the treatment of severe malaria caused by P. falciparum and if the patient is intolerant of oral therapy, treatment may be initiated in adults and children with a 10-mg/kg loading dose of IV clindamycin followed by 5 mg/kg IV every 8 hours continued until treatment can be switched to oral clindamycin (given in dosages recommended for uncomplicated malaria). The total duration of clindamycin therapy should be 7 days.

Pneumocystis jirovecii Pneumonia

If a regimen of oral clindamycin and primaquine is used as an alternative for the treatment of mild to moderate Pneumocystis jirovecii pneumonia (PCP), CDC, National Institutes of Health (NIH), and IDSA recommend that adults and adolescents receive oral clindamycin in a dosage of 450 mg every 6 hours or 600 mg every 8 hours for 21 days in conjunction with oral primaquine (30 mg once daily for 21 days).

If a regimen of oral clindamycin and primaquine is used as an alternative for the treatment of moderate to severe PCP, CDC, NIH, and IDSA recommend that adults and adolescents receive oral clindamycin in a dosage of 450 mg every 6 hours or 600 mg every 8 hours for 21 days in conjunction with oral primaquine (30 mg once daily for 21 days).

Although data regarding use in children are not available, if a regimen of oral clindamycin and primaquine is used as an alternative for the treatment of PCP in pediatric patients, some clinicians recommend that oral clindamycin be given in a dosage of 10 mg/kg (up to 300-450 mg) every 6 hours for 21 days in conjunction with oral primaquine (0.3 mg/kg once daily [up to 30 mg daily] for 21 days).

Toxoplasmosis

For the treatment of toxoplasmosis caused by Toxoplasma gondii in HIV-infected adults and adolescents who cannot receive sulfadiazine or did not respond to an initial regimen, CDC, NIH, and IDSA recommend an oral (or IV) clindamycin dosage of 600 mg every 6 hours in conjunction with oral pyrimethamine (200-mg loading dose followed by 50 mg once daily in those weighing less than 60 kg or 75 mg once daily in those weighing 60 kg or more) and oral leucovorin (10-25 mg once daily; may be increased to 50 mg once or twice daily). Treatment should be continued for at least 6 weeks; a longer duration may be appropriate if disease is extensive or there is an incomplete response at 6 weeks.

For the treatment of congenital toxoplasmosis or the treatment of acquired CNS, ocular, or systemic toxoplasmosis in HIV-infected children who cannot receive sulfadiazine, CDC, NIH, and IDSA recommend an oral (or IV) clindamycin dosage of 5-7.5 mg/kg (up to 600 mg) 4 times daily in conjunction with oral pyrimethamine (2 mg/kg once daily for 2 days followed by 1 mg/kg once daily) and oral or IM leucovorin (10 mg with each pyrimethamine dose). Although optimal duration of treatment of congenital toxoplasmosis has not been determined, some clinicians recommend that the treatment regimen be continued for 12 months. In HIV-infected children with acquired CNS, ocular, or systemic toxoplasmosis, the treatment regimen should be continued for at least 6 weeks; a longer duration may be appropriate if disease is extensive or there is an incomplete response at 6 weeks.

For long-term suppressive therapy or chronic maintenance therapy (secondary prophylaxis) to prevent relapse of toxoplasmosis in HIV-infected patients when the regimen of first choice (pyrimethamine and sulfadiazine) cannot be used, CDC, NIH, and IDSA recommend that adults and adolescents receive oral clindamycin in a dosage of 600 mg every 8 hours with pyrimethamine (25-50 mg once daily) and leucovorin (10-25 mg once daily). For secondary prophylaxis in HIV-infected infants and children, CDC, NIH, IDSA, and AAP recommend an oral clindamycin dosage of 7-10 mg/kg 3 times daily with oral pyrimethamine (1 mg/kg or 15 mg/m [up to 25 mg] once daily) and oral leucovorin (5 mg once every 3 days). Long-term suppressive therapy for prophylaxis against relapse of toxoplasmosis in HIV-infected individuals generally can be discontinued if immune recovery has occurred as the result of potent antiretroviral therapy.(See Prevention of Recurrence of Toxoplasmosis under Uses: Toxoplasmosis.)

Prevention of Bacterial Endocarditis

When oral clindamycin is used as an alternative for prevention of bacterial endocarditis in penicillin-allergic patients with certain cardiac conditions who are undergoing certain dental procedures or certain other procedures (see Uses: Prevention of Bacterial Endocarditis), AHA recommends that adults receive a single 600-mg dose and that children receive a single 20-mg/kg dose of the drug 30-60 minutes before the procedure.

Parenteral Dosage

General Dosage for Neonates

The manufacturer recommends that neonates younger than 1 month of age receive IM or IV clindamycin in a dosage of 15-20 mg/kg daily given in 3 or 4 equally divided doses. The lower dosage may be adequate for small, premature neonates.

When IM or IV clindamycin is used in neonates 7 days of age or younger, AAP recommends 5 mg/kg every 12 hours in those weighing 2 kg or less or 5 mg/kg every 8 hours in those weighing more than 2 kg.

In neonates 8-28 days of age, AAP recommends an IM or IV clindamycin dosage of 5 mg/kg every 8 hours in those weighing 2 kg or less or 5 mg/kg every 6 hours in those weighing more than 2 kg. In extremely low-birthweight neonates (less than 1 kg), a dosage of 5 mg/kg every 12 hours can be considered until 2 weeks of age.

General Dosage for Infants and Children

The IM or IV dosage of clindamycin recommended by the manufacturer for infants and children 1 month of age or older is 20-40 mg/kg daily administered in 3 or 4 equally divided doses; the higher dosage should be used for more severe infections. Alternatively, the manufacturer states that these infants and children may receive 350 mg/m daily for the treatment of serious infections or 450 mg/m daily for the treatment of more severe infections.

In pediatric patients beyond the neonatal period, AAP recommends an IM or IV clindamycin dosage of 20-30 mg/kg daily given in 3 equally divided doses for the treatment of mild to moderate infections or 40 mg/kg daily given in 3 or 4 equally divided doses for the treatment of severe infections.

General Adult Dosage

The recommended adult dosage of IM or IV clindamycin is 600 mg to 1.2 g daily given in 2-4 equally divided doses for the treatment of serious infections or 1.2-2.7 g daily given in 2-4 equally divided doses for the treatment of more severe infections. In the treatment of life-threatening infections, adult IV dosage may be increased to a maximum of 4.8 g daily.

If continuous IV infusion of clindamycin is used to maintain serum clindamycin concentrations above 4-6 mcg/mL in adults, an initial dose is given by rapid IV infusion prior to continuous IV infusion.(See Table 1.)

Respiratory Tract Infections

If IV clindamycin is used in adults for the treatment of healthcare-associated pneumonia or CAP caused by susceptible methicillin-resistant S. aureus (MRSA), IDSA recommends a dosage of 600 mg 3 times daily for 7-21 days.

If parenteral clindamycin is used for the treatment of CAP caused by susceptible gram-positive bacteria (e.g., S. pneumoniae, S. pyogenes, S. aureus) in children older than 3 months of age, IDSA recommends a dosage of 40 mg/kg daily given in divided doses every 6-8 hours.

Anthrax

Although the optimum regimen for the treatment of inhalational anthrax remains to be established, several patients who developed inhalational anthrax in the context of an intentional release of anthrax spores (biologic warfare, bioterrorism) were treated successfully with a multiple-drug regimen that included IV clindamycin (900 mg every 8 hours), IV ciprofloxacin (400 mg every 8 hours), and IV rifampin (300 mg every 12 hours).(See Uses: Anthrax.)

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

For the treatment of babesiosis caused by B. microti or other Babesia species, IDSA and other experts recommend that adults receive clindamycin in a dosage of 300-600 mg IV every 6 hours (or 600 mg orally every 8 hours) in conjunction with oral quinine sulfate (650 mg every 6 or 8 hours) given for 7-10 days.

For the treatment of babesiosis in pediatric patients, IDSA recommends an IV (or oral) clindamycin dosage of 7-10 mg/kg (up to 600 mg) every 6-8 hours in conjunction with oral quinine sulfate (8 mg/kg [up to 650 mg] every 8 hours) given for 7-10 days. Other clinicians recommend an IV (or oral) clindamycin dosage of 20-40 mg/kg (up to 600 mg) daily given in 3 or 4 divided doses for 7-10 days in conjunction with oral quinine sulfate (24 mg/kg daily given in 3 divided doses for 7-10 days).

Patients with mild to moderate babesiosis should have clinical improvement within 48 hours after treatment is initiated; symptoms should resolve completely within 3 months. Patients with severe babesiosis should receive IV clindamycin rather than oral clindamycin. Some patients may have persistent low-grade parasitemia for months after anti-infective treatment. Some experts suggest that anti-infective treatment in immunosuppressed patients should be continued for a minimum of 6 weeks and at least 2 weeks after the last positive smear. Regardless of the presence or absence of symptoms, IDSA suggests that retreatment be considered if babesial parasites or amplifiable babesial DNA is detected in blood 3 months or longer after initial treatment.

Pelvic Inflammatory Disease

For the treatment of acute pelvic inflammatory disease (PID) when a parenteral regimen is indicated, adults and adolescents may receive 900 mg of clindamycin IV every 8 hours. Gentamicin sulfate should be administered concomitantly (initial IM or IV gentamicin dose of 2 mg/kg followed by 1.5 mg/kg every 8 hours; alternatively, 3-5 mg/kg of gentamicin can be given as a single daily dose). Both parenteral drugs can be discontinued 24-48 hours after there is clinical improvement and therapy continued with oral clindamycin in a dosage of 450 mg 4 times daily to complete 14 days of therapy. Alternatively, oral doxycycline (100 mg twice daily) can be given to complete 14 days of therapy.(See Uses: Pelvic Inflammatory Disease.)

Patients with PID who do not demonstrate substantial clinical improvement (e.g., defervescence; reduction in direct or rebound abdominal tenderness; reduction in uterine, adnexal, and cervical motion tenderness) within 72 hours of initiating parenteral or oral therapy usually require additional diagnostic tests and/or surgical intervention.

Pneumocystis jirovecii Pneumonia

If a regimen of IV clindamycin and oral primaquine is used as an alternative for the treatment of moderate to severe PCP, CDC, NIH, and IDSA recommend that adults and adolescents receive IV clindamycin in a dosage of 600 mg every 6 hours or 900 mg every 8 hours for 21 days in conjunction with oral primaquine (30 mg once daily for 21 days).

Although data regarding use in children are not available, if a regimen of IV clindamycin and oral primaquine is used as an alternative for the treatment of PCP in pediatric patients, some clinicians recommend that IV clindamycin be given in a dosage of 10 mg/kg (up to 600 mg) every 6 hours for 21 days in conjunction with oral primaquine (0.3 mg/kg once daily [up to 30 mg daily] for 21 days).

Toxoplasmosis

For the treatment of toxoplasmosis in HIV-infected adults and adolescents who cannot receive sulfadiazine or did not respond to an initial regimen, CDC, NIH, and IDSA recommend that adults and adolescents receive IV (or oral) clindamycin in a dosage of 600 mg every 6 hours in conjunction with oral pyrimethamine (200-mg loading dose followed by 50 mg once daily in those weighing less than 60 kg or 75 mg once daily in those weighing 60 kg or more) and oral leucovorin (10-25 mg once daily; may be increased to 50 mg once or twice daily).

For the treatment of congenital toxoplasmosis or the treatment of acquired CNS, ocular, or systemic toxoplasmosis in HIV-infected children, CDC, NIH, and IDSA recommend an IV (or oral) clindamycin dosage of 5-7.5 mg/kg (up to 600 mg) 4 times daily in conjunction with oral pyrimethamine (2 mg/kg once daily for 2 days followed by 1 mg/kg once daily) and oral or IM leucovorin (10 mg with each pyrimethamine dose). Although optimal duration of treatment has not been determined, some experts recommend that treatment of congenital toxoplasmosis be continued for 12 months. The treatment regimen should be continued for at least 6 weeks in HIV-infected children with acquired CNS, ocular, or systemic toxoplasmosis; a longer duration may be appropriate for extensive disease or if there is an incomplete response at 6 weeks.

Perioperative Prophylaxis

If clindamycin is used alone or in conjunction with another anti-infective for perioperative prophylaxis in patients undergoing certain surgeries when the drugs of choice cannot be used (see Uses: Perioperative Prophylaxis), some clinicians recommend that adults receive 900 mg of the drug and that pediatric patients receive 10 mg/kg of the drug given IV within 60 minutes prior to the initial incision.

During prolonged procedures, some clinicians suggest that additional intraoperative doses of clindamycin can be given every 6 hours for the duration of the procedure in patients with normal renal function. Postoperative doses of prophylactic anti-infectives generally are not recommended.

Prevention of Bacterial Endocarditis

When IM or IV clindamycin is used as an alternative for prevention of bacterial endocarditis in penicillin-allergic patients (or patients unable to take oral medication) with certain cardiac conditions who are undergoing certain dental procedures or certain other procedures (see Uses: Prevention of Bacterial Endocarditis), AHA recommends that adults receive a single 600-mg dose and that children receive a single 20-mg/kg dose of the drug given 30-60 minutes before the procedure.

Prevention of Perinatal Group B Streptococcal Disease

If clindamycin is used for intrapartum anti-infective prophylaxis for prevention of perinatal group B streptococcal (GBS) disease in women with penicillin hypersensitivity who should not receive a β-lactam anti-infective, CDC and AAP recommend that 900 mg of clindamycin be given IV at the time of onset of labor or rupture of membranes followed by 900 mg IV every 8 hours until delivery. Because S. agalactiae (group B streptococci; GBS) with resistance to clindamycin has been reported with increasing frequency, clinical isolates obtained during GBS prenatal screening should be tested for in vitro susceptibility to clindamycin whenever use of the drug is being considered for prevention of perinatal GBS disease.(See Uses: Prevention of Perinatal Group B Streptococcal Disease.)

Dosage in Renal and Hepatic Impairment

Renal Impairment

Dosage adjustments are not usually necessary in patients with renal impairment.

Hepatic Impairment

Dosage adjustments are not usually necessary in patients with hepatic impairment. However, because the plasma half-life of clindamycin may be prolonged, hepatic function should be monitored if the drug is used in those with severe hepatic impairment.

Cautions

GI Effects

Adverse GI effects frequently occur with oral, IM, or IV clindamycin and may be severe enough to necessitate discontinuance of the drug. Adverse GI effects reported in patients receiving clindamycin include nausea, vomiting, diarrhea, abdominal pain, and esophagitis. In addition, tenesmus, flatulence, bloating, anorexia, and weight loss have been reported.

An unpleasant or metallic taste has been reported in patients receiving oral clindamycin and also has been reported following IV administration of high doses of the drug.

Clostridium difficile-associated Diarrhea and Colitis

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.

C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) have been reported with nearly all anti-infectives, including clindamycin, and may range in severity from mild diarrhea to fatal colitis.C. difficile produces toxins A and B, which contribute to the development of CDAD; hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.(See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions: Precautions and Contraindications.)

Sensitivity and Dermatologic Reactions

Anaphylactic shock and anaphylactoid reactions with hypersensitivity have been reported in patients receiving clindamycin.

Other severe hypersensitivity reactions, including severe skin reactions such as toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens-Johnson syndrome, have been reported and have been fatal in some cases. Acute generalized exanthematous pustulosis and erythema multiforme also have been reported.

Generalized mild to moderate morbilliform-like (maculopapular) rash is the most frequently reported adverse reaction to clindamycin. Vesiculobullous rash, urticaria, pruritus, angioedema, and rare instances of exfoliative dermatitis also have been reported.

Local Effects

Thrombophlebitis, erythema, pain, and swelling have occurred with IV administration of clindamycin.

IM administration of clindamycin has caused pain, induration, and sterile abscess at the injection site. Reversible increases in serum creatine kinase (CK, creatine phosphokinase, CPK) concentrations have been reported.

Local reactions can be minimized by giving deep IM injections or avoiding prolonged use of indwelling IV catheters.

Other Adverse Effects

Cardiopulmonary arrest and hypotension have been reported when IV clindamycin was administered too rapidly.

Although renal damage has not been directly attributed to clindamycin, renal dysfunction manifested as azotemia, oliguria, and/or proteinuria has been observed in patients receiving clindamycin.

Transient neutropenia (leukopenia) and eosinophilia, agranulocytosis, and thrombocytopenia have been reported in patients receiving clindamycin; however, a causal relationship was not established.

Jaundice, abnormal liver function tests, polyarthritis, and vaginitis also have been reported.

Precautions and Contraindications

Clindamycin is contraindicated in patients hypersensitive to clindamycin or lincomycin.

Prior to initiation of clindamycin, the patient should be questioned regarding prior hypersensitivity to drugs and other allergens. Clindamycin should be used with caution in atopic individuals.

If an anaphylactic or severe hypersensitivity reaction occurs during clindamycin therapy, the drug should be permanently discontinued and appropriate therapy instituted as necessary.

Superinfection/Clostridium difficile-associated Diarrhea and Colitis

As with other anti-infectives, use of clindamycin may result in overgrowth of nonsusceptible organisms, especially yeasts. If superinfection occurs, appropriate therapy should be instituted.

Because CDAD has been reported with the use of nearly all anti-infectives, including clindamycin, it should be considered in the differential diagnosis in patients who develop diarrhea during or after clindamycin therapy. Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued. If CDAD is suspected or confirmed, anti-infective therapy not directed against C. difficile should be discontinued whenever possible. Patients should be managed with appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.

Patients should be advised that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued; however, it is important to contact a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.

Clindamycin should always be discontinued if clinically important diarrhea occurs. The drug should be used with caution in patients with a history of GI disease, particularly colitis.

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of clindamycin and other antibacterials, the drug should be used only for the treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria. When selecting or modifying anti-infective therapy, results of culture and in vitro susceptibility testing should be used. In the absence of such data, local epidemiology and susceptibility patterns should be considered when selecting anti-infectives for empiric therapy. Culture and susceptibility testing performed periodically during therapy provides information on the therapeutic effect of the anti-infective agent and the possible emergence of bacterial resistance.

Patients should be advised that antibacterials (including clindamycin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold). Patients also should be advised about the importance of completing the full course of therapy, even if feeling better after a few days, and that skipping doses or not completing 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.

Other Precautions and Contraindications

Some commercially available capsules of clindamycin hydrochloride (e.g., 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.

Because clindamycin does not distribute adequately into the CNS, the drug should not be used for the treatment of CNS infections.

During prolonged clindamycin therapy, liver and renal function tests and blood cell counts should be performed periodically.

If clindamycin is used in patients with hepatic impairment, dosage adjustments may not be necessary; however, liver enzymes should be monitored periodically when the drug is used in those with severe hepatic impairment.

Pediatric Precautions

When clindamycin is used in pediatric patients (birth to 16 years of age), organ system functions should be monitored.

Each mL of clindamycin phosphate injection contains 9.45 mg of benzyl alcohol. Although a causal relationship has not been established, administration of injections preserved with benzyl alcohol has been associated with toxicity in neonates, including potentially fatal ''gasping syndrome.'' Toxicity appears to have resulted from administration of large amounts (i.e., about 100-400 mg/kg daily) of benzyl alcohol in these neonates. Although the amounts of benzyl alcohol in recommended dosages of IM or IV clindamycin are substantially lower than amounts reported in association with ''gasping syndrome,'' the minimum amount of benzyl alcohol at which toxicity may occur is unknown. The risk of benzyl alcohol toxicity depends on the quantity administered and capacity of the liver and kidneys to detoxify the chemical. Premature and low-birthweight infants may be more likely to develop toxicity. Although use of drugs preserved with benzyl alcohol should be avoided in neonates whenever possible, the American Academy of Pediatrics (AAP) states that the presence of small amounts of the preservative in a commercially available injection should not proscribe its use when indicated in an infant.

Geriatric Precautions

Clinical studies of clindamycin did not include sufficient numbers of patients 65 years of age or older to determine whether geriatric patients respond differently than younger patients. Clinical experience indicates that C. difficile-associated diarrhea and colitis (see Cautions: GI Effects) seen in association with most anti-infectives may occur more frequently and be more severe in patients older than 60 years of age. Therefore, geriatric patients receiving clindamycin should be carefully monitored for the development of diarrhea (e.g., changes in bowel frequency).

Studies to date have not revealed any clinically important differences in the pharmacokinetics of oral or parenteral clindamycin between younger adults and geriatric patients with normal hepatic function and normal (age-adjusted) renal function. Dosage adjustments are not usually necessary if clindamycin is used in geriatric patients with normal hepatic function and normal (age-adjusted) renal function.

Mutagenicity and Carcinogenicity

Clindamycin was not mutagenic in a rat micronucleus test or the Ames Salmonella reversion test.

Long-term studies in animals have not been performed to date to evaluate the carcinogenic potential of clindamycin.

Pregnancy, Fertility, and Lactation

Pregnancy

Reproduction studies in rats and mice using oral or parenteral dosages of clindamycin up to 600 mg/kg daily (3.2 and 1.6 times, respectively, the maximum recommended human oral dosage or 2.1 and 1.1 times, respectively, the maximum recommended human parenteral dosage on a mg/m basis) have not revealed evidence of teratogenicity.

In clinical trials that included pregnant women, systemic clindamycin administered during the second and third trimesters was not associated with an increased frequency of congenital abnormalities. There are no adequate and well-controlled studies to date using clindamycin in pregnant women during the first trimester of pregnancy. Because animal reproduction studies are not always predictive of human response, clindamycin should be used during pregnancy only when clearly needed.

Clindamycin phosphate injection contains benzyl alcohol as a preservative; benzyl alcohol can cross the placenta.(See Cautions: Pediatric Precautions.)

Fertility

Fertility studies in rats treated with oral clindamycin doses up to 300 mg/kg daily (about 1.1-1.6 times the maximum recommended human dose on a mg/m basis) have not revealed evidence of impaired fertility or mating ability.

Lactation

Clindamycin is distributed into milk (see Pharmacokinetics: Distribution), and has the potential to cause adverse effects on the GI flora of breast-fed infants.

The manufacturer states that use of oral or IV clindamycin in the mother is not a reason to discontinue breast-feeding; however, it may be preferable to use an alternate anti-infective. If clindamycin is used in a breast-feeding mother, the infant should be monitored for possible adverse effects on GI flora, including diarrhea and candidiasis (thrush, diaper rash) or, rarely, blood in the stool indicating possible antibiotic-associated colitis. The benefits of breast-feeding and the importance of clindamycin to the woman should be considered along with potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.

Drug Interactions

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

In vitro studies indicate that clindamycin is a moderate inhibitor of cytochrome P-450 (CYP) isoenzyme 3A4 and does not inhibit CYP1A2, 2C9, 2C19, 2E1, or 2D6.

Clindamycin is a substrate of CYP3A4 and, to a lesser extent, CYP3A5. Concomitant use with CYP3A4 or 3A5 inhibitors may result in increased plasma concentrations of clindamycin, and concomitant use with CYP3A4 or 3A5 inducers may result in decreased plasma concentrations of clindamycin. If clindamycin is used concomitantly with a potent CYP3A4 inhibitor, the patient should be monitored for adverse effects. If clindamycin is used concomitantly with a potent CYP3A4 inducer (e.g., rifampin), the patient should be monitored for loss of clindamycin effectiveness.

Neuromuscular Blocking Agents

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the neuromuscular blocking action of other agents (e.g., ether, tubocurarine, pancuronium). Clindamycin should be used with caution in patients receiving such agents, and such patients should be observed for prolongation of neuromuscular blockade.

Pharmacokinetics

Absorption

Following oral administration of clindamycin hydrochloride, approximately 90% of the dose is rapidly absorbed from the GI tract. Following oral administration of a single 150-mg dose of clindamycin hydrochloride to healthy fasting adults, peak serum concentrations of clindamycin average 1.9-3.9 mcg/mL and are attained within 45-60 minutes; serum concentrations of clindamycin average 1.5 mcg/mL at 3 hours and 0.7 mcg/mL at 6 hours. Serum concentrations of clindamycin appear to be predictable, increasing linearly with increased doses.

Following oral administration of clindamycin palmitate hydrochloride oral solution, the drug is rapidly hydrolyzed in the GI tract to active clindamycin. Oral doses of clindamycin palmitate hydrochloride produce serum concentrations of clindamycin similar to those achieved with oral clindamycin hydrochloride. In a study in healthy children receiving 2, 3, or 4 mg/kg of clindamycin every 6 hours as the clindamycin palmitate hydrochloride oral solution, mean peak serum clindamycin concentrations were 1.24, 2.25, or 2.44 mcg/mL, respectively, 1 hour after the first dose. After the fifth dose, peak serum concentrations of the drug averaged 2.46, 2.98, or 3.79 mcg/mL, respectively.

Clindamycin is not inactivated by gastric acidity. Administration of clindamycin hydrochloride capsules or clindamycin palmitate hydrochloride oral solution with food does not appreciably affect absorption or serum concentrations of the drug. Accumulation in plasma does not occur following multiple oral doses, including in neonates and infants up to 6 months of age.

Following IM or IV administration, clindamycin phosphate is rapidly hydrolyzed in plasma to active clindamycin. Following IM administration of clindamycin phosphate, peak serum concentrations occur within 3 hours in adults and 1 hour in children. In healthy adult males, IM doses of 600 mg of clindamycin every 12 hours resulted in average peak serum clindamycin concentrations of 9 mcg/mL. IV doses of 600 mg of clindamycin infused over 30 minutes every 6 or 8 hours in healthy adult males resulted in average peak serum clindamycin concentrations of 11 mcg/mL and IV doses of 900 mg infused over 30 minutes every 8 hours resulted in average peak serum clindamycin concentrations of 14 mcg/mL. In a study in pediatric patients with infections, a single IM dose of 3-5 mg/kg resulted in average peak serum clindamycin concentrations of 4 mcg/mL and single IV or IM doses of 5-7 mg/kg resulted in average peak serum clindamycin concentrations of 10 or 8 mcg/mL, respectively.

Distribution

Clindamycin is widely distributed into body tissues and fluids, including saliva, ascites fluid, peritoneal fluid, pleural fluid, synovial fluid, bone, and bile. The concentration of clindamycin in synovial fluid and bone is reported to be 60-80% of concurrent serum concentrations of the drug; the degree of penetration does not appear to be affected by joint inflammation.

Clinically important concentrations of clindamycin are not attained in CSF, even in the presence of inflamed meninges.

Clindamycin readily crosses the placenta, and cord blood concentrations of the drug have been reported to be up to 50% of concurrent maternal blood concentrations.

Clindamycin is distributed into milk. Breast milk concentrations of 0.7-3.8 mcg/mL have been reported following clindamycin dosages of 150 mg orally to 600 mg IV. In one study in women who received oral clindamycin in a dosage of 150 mg 3 times daily, breast milk concentrations of the drug ranged from less than 0.5 to 3.1 mcg/mL.

At a concentration of 1 mcg/mL, clindamycin is approximately 93% bound to serum proteins.

Elimination

Clindamycin is partially metabolized to bioactive and inactive metabolites. In vitro studies indicate that clindamycin is predominantly metabolized by cytochrome P-450 (CYP) isoenzyme 3A4 and, to a lesser extent, by CYP3A5 to the major bioactive metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin.

The serum half-life of clindamycin is 2-3 hours in adults and children. In neonates, the serum half-life of clindamycin depends on gestational and chronologic age and body weight. Half-life of the drug reportedly averages 8.7 or 3.6 hours in premature or full-term neonates, respectively, and about 3 hours in infants 4 weeks to 1 year of age; serum half-life was longer in infants weighing less than 3.5 kg than in heavier infants.

Pharmacokinetic studies using IV clindamycin phosphate in healthy older adults (61-79 years of age) and younger adults (18-39 years of age) indicate that age alone does not alter clindamycin pharmacokinetics (clearance, elimination half-life, volume of distribution, area under the serum concentration-time curve [AUC]). Following oral administration of clindamycin hydrochloride, elimination half-life increased to approximately 4 hours (range: 3.4-5.1 hours) in geriatric patients compared with 3.2 hours (range: 2.1-4.2 hours) in younger adults. Following oral administration of clindamycin palmitate, the elimination half-life in geriatric adults was 4.5 hours.

The serum half-life of clindamycin is increased slightly in patients with markedly reduced renal or hepatic function.

Clindamycin sulfoxide and N-desmethylclindamycin are excreted in urine, bile, and feces. Approximately 10% of an oral dose of clindamycin is excreted in urine and 3.6% is excreted in feces as active drug and metabolites; the remainder is excreted as inactive metabolites.

Clindamycin is not appreciably removed by hemodialysis or peritoneal dialysis.

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