Clindamycin (Monograph)
Brand names: Cleocin HCL, Cleocin Pediatric, Cleocin Phosphate
Drug class: Lincomycins
Warning
- Diarrhea and Colitis
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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.121 126 139 Anti-infectives alter normal flora of the colon and may permit overgrowth of C. difficile.121 126 139
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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.121 126 139 Do not use for nonbacterial infections.121 126 139 (See Uses.)
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C. difficile produces toxins A and B which contribute to development of CDAD.121 126 139 Hypertoxin-producing strains cause increased morbidity and mortality since they may be refractory to anti-infectives and may require colectomy.121 126 139 CDAD must be considered in all patients who present with diarrhea following anti-infective use.121 126 139 Careful medical history is necessary since CDAD has been reported to occur 2 months or longer after administration of anti-infectives.121 126 139
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If CDAD is suspected or confirmed, ongoing anti-infective use not directed against C. difficile may need to be discontinued.121 126 139 Institute appropriate fluid and electrolyte management, protein supplementation, anti-infective treatment of C. difficile, and surgical evaluation as clinically indicated.121 126 139 (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis [CDAD] under Cautions.)
Introduction
Antibacterial; lincosamide antibiotic derived from lincomycin.121 126 139 140 141
Uses for Clindamycin
Acute Otitis Media (AOM)
Alternative for treatment of AOM† [off-label].499
When anti-infectives indicated, AAP recommends high-dose amoxicillin or amoxicillin and clavulanate as drugs of first choice for initial treatment of AOM; certain cephalosporins (cefdinir, cefpodoxime, cefuroxime, ceftriaxone) recommended as alternatives for initial treatment in penicillin-allergic patients without a history of severe and/or recent penicillin-allergic reactions.499
AAP states clindamycin (with or without a third generation cephalosporin) is a possible alternative for treatment of AOM in patients who fail to respond to initial treatment with first-line or preferred alternatives.499
May be effective in infections caused by penicillin-resistant Streptococcus pneumoniae; may not be effective against multidrug-resistant S. pneumoniae and usually inactive against Haemophilus influenzae.499 If used for retreatment of AOM, consider concomitant use of an anti-infective active against H. influenzae and Moraxella catarrhalis (e.g., cefdinir, cefixime, cefuroxime).499
Bone and Joint Infections
Treatment of serious bone and joint infections (including acute hematogenous osteomyelitis) caused by susceptible Staphylococcus aureus or anaerobes.139 590
Adjunct in the surgical treatment of chronic bone and joint infections caused by susceptible bacteria.139
Gynecologic Infections
Treatment of serious gynecologic infections (e.g., endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, postsurgical vaginal cuff infection) caused by susceptible anaerobes.121 126 139
Treatment of pelvic inflammatory disease (PID); used in conjunction with other anti-infectives.344 345 When a parenteral regimen is indicated for treatment of PID, IV clindamycin in conjunction with IV or IM gentamicin is one of several recommended regimens.344 345
Intra-abdominal Infections
Treatment of serious intra-abdominal infections (e.g., peritonitis, intra-abdominal abscess) caused by susceptible anaerobes.121 126 139
No longer routinely recommended for treatment of intra-abdominal infections because of increasing incidence of Bacteroides fragilis resistant to clindamycin.708
Pharyngitis and Tonsillitis
Alternative for treatment of pharyngitis and tonsillitis† [off-label] caused by susceptible S. pyogenes (group A β-hemolytic streptococci; GAS)135 149 292 375 580 in patients who cannot receive β-lactam anti-infectives.292 375 580
AAP, IDSA, and AHA recommend a penicillin regimen (10 days of oral penicillin V or oral amoxicillin or single dose of IM penicillin G benzathine) as treatment of choice for S. pyogenes pharyngitis and tonsillitis;292 375 580 other anti-infectives (oral cephalosporins, oral macrolides, oral clindamycin) recommended as alternatives in penicillin-allergic patients.292 375 580
Respiratory Tract Infections
Treatment of serious respiratory tract infections (e.g., pneumonia, empyema, lung abscess) caused by susceptible S. aureus, S. pneumoniae, other streptococci, or anaerobes.121 126 139 512 513 514
IDSA and ATS consider clindamycin an alternative for treatment of community-acquired pneumonia (CAP) caused by S. pneumoniae or S. aureus (methicillin-susceptible strains) in adults.512 IDSA also considers clindamycin an alternative for treatment of CAP caused by S. pneumoniae, S. pyogenes, or S. aureus in pediatric patients.513 For treatment of pneumonia caused by methicillin-resistant S. aureus (MRSA; also known as oxacillin-resistant S. aureus or ORSA), IDSA states clindamycin is one of several options, unless the strain is resistant to clindamycin.513 514
For information on treatment of CAP, consult current IDSA clinical practice guidelines available at [Web].512 513 514
Septicemia
Treatment of serious septicemia caused by S. aureus, streptococci, or anaerobes.121 126 139
Skin and Skin Structure Infections
Treatment of serious skin and skin structure infections caused by susceptible staphylococci, S. pneumoniae, other streptococci, or anaerobes.121 126 139 514 543 One of several preferred drugs for treatment of staphylococcal and streptococcal skin and skin structure infections, including those known or suspected to be caused by susceptible MRSA.514 543
Treatment of clostridial myonecrosis† [off-label] (gas gangrene) caused by Clostridium perfringens or other Clostridium; used in conjunction with or as alternative to penicillin G.197 292
Alternative for treatment of infected human or animal (e.g., dog, cat, reptile) bite wounds; used in conjunction with either an extended-spectrum cephalosporin or co-trimoxazole.292 543 Purulent bite wounds usually are polymicrobial and broad-spectrum anti-infective coverage recommended.292 543 Nonpurulent infected bite wounds usually caused by staphylococci and streptococci, but can be polymicrobial.543
For information on treatment of skin and skin structure infections, consult current IDSA clinical practice guidelines available at [Web].514 543
Actinomycosis
Alternative to penicillin G or ampicillin for treatment of actinomycosis† [off-label], including infections caused by Actinomyces israelii.197 292
Anthrax
Alternative for treatment of anthrax† [off-label].116 117 120
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.117 119 120 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);117 120 if meningitis is established or suspected, use IV ciprofloxacin (rather than doxycycline) and chloramphenicol, rifampin, or penicillin.117
Based on in vitro data, possible alternative for postexposure prophylaxis following a suspected or confirmed exposure to aerosolized anthrax spores† (inhalational anthrax) when drugs of choice (ciprofloxacin, doxycycline) not tolerated or cannot be used.118
Babesiosis
Treatment of babesiosis† caused by Babesia microti101 105 134 292 329 or other Babesia.134
Regimens of choice for babesiosis are clindamycin in conjunction with quinine or atovaquone in conjunction with azithromycin.111 134 292 329 Clindamycin and quinine regimen generally preferred for severe babesiosis caused by B. microti134 329 and infections caused by M. divergens, B. duncani, B. divergens-like organisms, or B. venatorum.134
Also consider exchange transfusions in severely ill patients with high levels of parasitemia (>10%), significant hemolysis, or compromised renal, hepatic, or pulmonary function.134 292 329
Bacterial Vaginosis
Treatment of bacterial vaginosis† (formerly called Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).180 181 182 194 196 203 344 345
CDC and others recommend treatment of bacterial vaginosis in all symptomatic women (including pregnant women).344 345
Regimens of choice are 7-day regimen of oral metronidazole; 5-day regimen of intravaginal metronidazole gel; or 7-day regimen of intravaginal clindamycin cream.344 345 Alternative regimens are 2- or 5-day regimen of oral tinidazole; 7-day regimen of oral clindamycin; or 3-day regimen of intravaginal clindamycin suppositories.344 345 Preferred regimens for pregnant women are the oral or intravaginal metronidazole or clindamycin regimens.344
Regardless of treatment regimen used, relapse or recurrence is common;188 192 193 194 195 344 345 retreatment with the same or an alternative regimen (e.g., oral therapy when topical was used initially) may be used in such situations.344
Malaria
Treatment of uncomplicated malaria† caused by chloroquine-resistant Plasmodium falciparum or when plasmodial species not identified.113 114 115 134 143 144 Used in conjunction with oral quinine; not effective alone.114 143 144
CDC and others state treatments of choice for uncomplicated chloroquine-resistant P. falciparum malaria or when plasmodial species not identified are the fixed combination of atovaquone and proguanil hydrochloride (atovaquone/proguanil); the fixed combination of artemether and lumefantrine (artemether/lumefantrine); or a regimen of oral quinine in conjunction with doxycycline, tetracycline, or clindamycin.134 143 144 When a quinine regimen used, concomitant doxycycline or tetracycline generally preferred over concomitant clindamycin (more efficacy data available regarding regimens that include a tetracycline);143 clindamycin preferred in young children or pregnant women who should not receive tetracyclines.113 115 134 143 144
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 tolerated.143 144 Severe malaria requires aggressive antimalarial treatment initiated as soon as possible after diagnosis.143 144
Assistance with diagnosis or treatment of malaria is available from 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 CDC Emergency Operation Center at 770-488-7100 after hours and on weekends and holidays.143 144
Pneumocystis jirovecii Pneumonia
Treatment of Pneumocystis jirovecii (formerly Pneumocystis carinii) pneumonia† (PCP); used in conjunction with primaquine.134 145 146 148 150 152 153 157 158 159 169 170 206 440 Designated an orphan drug by FDA for treatment of PCP associated with acquired immunodeficiency syndrome (AIDS).212
Co-trimoxazole is drug of choice for treatment of mild, moderate, or severe PCP, including PCP in HIV-infected adults, adolescents, and children.134 440 441 Regimen of primaquine and clindamycin is an alternative for 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.440 Although data not available regarding use in children, regimen of primaquine and clindamycin also can be considered an alternative to co-trimoxazole in HIV-infected children based on data in adults.441
Regimen of primaquine and clindamycin not recommended for prevention of initial episodes (primary prophylaxis) or long-term suppressive or chronic maintenance therapy (secondary prophylaxis) of PCP.440 441 Co-trimoxazole is drug of choice for primary and secondary prophylaxis of PCP in HIV-infected adults, adolescents, and children.440 441
Toxoplasmosis
Alternative for treatment of toxoplasmosis† caused by Toxoplasma gondii in immunocompromised adults, adolescents, and children (including HIV-infected patients);129 131 132 134 138 164 166 167 172 440 441 used in conjunction with pyrimethamine (and leucovorin).134 440 441 CDC, NIH, IDSA, and AAP recommend pyrimethamine (and leucovorin) used in conjunction with sulfadiazine as regimen of choice for initial treatment of toxoplasmosis in HIV-infected adults and adolescents, treatment of congenital toxoplasmosis, and treatment of acquired CNS, ocular, or systemic toxoplasmosis in HIV-infected children.440 441 Pyrimethamine (and leucovorin) used in conjunction with clindamycin is the preferred alternative in those unable to tolerate sulfadiazine or who fail to respond to initial regimen.440 441
Alternative for long-term suppressive or chronic maintenance therapy (secondary prophylaxis) to prevent relapse of toxoplasmosis† in HIV-infected adults, adolescents, and children who have completed treatment for the disease;440 441 used in conjunction with pyrimethamine and leucovorin.440 441 Pyrimethamine (and leucovorin) used in conjunction with sulfadiazine is regimen of choice for secondary prophylaxis. Pyrimethamine (and leucovorin) used in conjunction with clindamycin is one of several alternatives in those who cannot tolerate sulfonamides.440 441
Perioperative Prophylaxis
Alternative for perioperative prophylaxis† to reduce the incidence of infections in patients undergoing certain clean, contaminated surgeries when drugs of choice (e.g., cefazolin, cefuroxime, cefoxitin, cefotetan) cannot be used because of hypersensitivity to β-lactam anti-infectives.360 374
Experts state 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., CABG, 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).360 374 Clindamycin also a reasonable alternative for perioperative prophylaxis in such patients undergoing head and neck surgery (e.g., incisions through oral or pharyngeal mucosa).360 374
For procedures that might involve exposure to enteric gram-negative bacteria, 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.360 374 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).360 374
Prevention of Bacterial Endocarditis
Alternative to amoxicillin or ampicillin for prevention of α-hemolytic (viridans group) streptococcal bacterial endocarditis† in penicillin-allergic patients 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) who have certain cardiac conditions that put them at highest risk of adverse outcomes from endocarditis.451
Anti-infective prophylaxis solely for prevention of bacterial endocarditis no longer recommended by AHA for patients undergoing GU or GI procedures.451
Cardiac conditions identified by AHA as associated with highest risk of adverse outcomes from endocarditis: Prosthetic cardiac valves or prosthetic material used for cardiac valve repair, previous infective endocarditis, certain forms of congenital heart disease, and cardiac valvulopathy after cardiac transplantation.451
Consult most recent AHA recommendations for additional information on which cardiac conditions are associated with highest risk of adverse outcomes from endocarditis and specific recommendations regarding use of prophylaxis to prevent endocarditis in these patients.451
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 high risk for anaphylaxis if they receive a β-lactam anti-infective.292 359 362
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 of gestation 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 of gestation, amniotic membrane rupture for ≥18 hours, or intrapartum temperature of ≥38°C.292 359
Penicillin G is drug of choice and ampicillin is the preferred alternative for anti-infective prophylaxis of GBS.292 359 362 Cefazolin is recommended for GBS prophylaxis in penicillin-allergic women who do not have immediate-type penicillin hypersensitivity; clindamycin or, alternatively, vancomycin is recommended for such prophylaxis in penicillin-allergic women at high risk for anaphylaxis (e.g., history of anaphylaxis, angioedema, respiratory distress, or urticaria after receiving a penicillin or cephalosporin).292 359 362
Consider that S. agalactiae (group B streptococci; GBS) with in vitro resistance to clindamycin has been reported with increasing frequency;359 perform in vitro susceptibility tests of clinical isolates obtained during GBS prenatal screening.359 GBS isolates susceptible to clindamycin but resistant to erythromycin in vitro should be evaluated for inducible clindamycin resistance.359 If GBS isolate is intrinsically resistant to clindamycin, demonstrates inducible resistance to clindamycin, or if susceptibility to clindamycin and erythromycin are unknown, use vancomycin instead of clindamycin for GBS prophylaxis.292 359 362
Consult most recent CDC and AAP guidelines for additional information on prevention of perinatal GBS disease.359 362
Clindamycin Dosage and Administration
Administration
Administer orally,121 126 IM,139 or by intermittent or continuous IV infusion.139 Do not administer by rapid IV injection.139
In the treatment of serious anaerobic infections, parenteral route usually used initially but may be switched to oral route when warranted by patient’s condition.121 126 In clinically appropriate circumstances, oral route may be used initially.121 126
Clindamycin phosphate ADD-Vantage vials and commercially available premixed solutions of clindamycin phosphate in 5% dextrose should be used only for IV infusion.139
For solution and drug compatibility information, see Compatibility under Stability.
Oral Administration
Clindamycin hydrochloride capsules126 and clindamycin palmitate hydrochloride oral solution121 can be administered without regard to food.
To avoid the possibility of esophageal irritation, administer clindamycin hydrochloride capsules with a full glass of water.126 Swallow capsules whole;126 do not use in pediatric patients unable to swallow capsules.126
Reconstitution
Reconstitute clindamycin palmitate hydrochloride powder (granules) for oral solution by adding 75 mL of water to the 100-mL bottle.121 Add a large portion of the water initially and shake bottle vigorously; add remainder of the water and shake bottle until solution is uniform.121 The resulting oral solution contains 75 mg of clindamycin/5 mL.121
IM Injection
For IM injection, administer clindamycin phosphate solution containing 150 mg of clindamycin per mL undiluted.139
Single IM doses should not exceed 600 mg.139
IV Infusion
Prior to IV infusion, clindamycin phosphate solutions (including solutions provided in ADD-Vantage vials) must be diluted with a compatible IV solution to a concentration ≤18 mg/mL.139
Usually administered by intermittent IV infusion.139 Alternatively, may be given by continuous IV infusion in adults after first dose is given by rapid IV infusion.139 (See Table 1.)
Commercially available premixed solutions of clindamycin phosphate in 5% dextrose are administered only by IV infusion.139 Discard premixed solution if container seal is not intact or leaks are found or if the solution is not clear.139 Do not introduce additives into the container.139 Do not use flexible containers in series connections with other plastic containers; 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.139
Dilution
Clindamycin phosphate solution containing 150 mg of clindamycin per mL: Dilute appropriate dose in a compatible IV infusion solution and administer using the recommended rate of administration.139 (See Rate of Administration under Dosage and Administration.)
Clindamycin phosphate solution provided in ADD-Vantage vials: Dilute according to directions provided by the manufacturer.139 ADD-Vantage vials are for IV infusion only.139
Clindamycin phosphate pharmacy bulk package: Dilute in a compatible IV infusion solution;139 not intended for direct IV infusion.139 Bulk package is intended for use only under a laminar flow hood.139 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.139 After entry into the bulk package vial, use entire contents promptly; discard any unused portion within 24 hours after initial entry.139
Rate of Administration
Give intermittent IV infusions over a period of at least 10–60 minutes and at a rate ≤30 mg/minute.139 Give no more than 1.2 g by IV infusion in a single 1-hour period.139
Dilute 300-mg doses in 50 mL of compatible diluent and infuse over 10 minutes; dilute 600-mg doses in 50 mL of diluent and infuse over 20 minutes; dilute 900-mg doses in 50–100 mL of diluent and infuse over 30 minutes; dilute 1.2-g doses in 100 mL of diluent and infuse over 40 minutes.139
As an alternative to intermittent IV infusions in adults, the drug can be given by continuous IV infusion after an initial dose is given by IV infusion over 30 minutes.139 (See Table 1.)
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,126 clindamycin palmitate hydrochloride,121 and clindamycin phosphate;139 dosage expressed in terms of clindamycin.121 126 139
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.121 Give daily dosage in 3 or 4 equally divided doses.121 In children weighing ≤10 kg, manufacturer recommends a minimum dosage of 37.5 mg 3 times daily.121
Neonates ≤7 days 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.292
Neonates 8–28 days of age: AAP recommends 5 mg/kg every 8 hours in those weighing ≤2 kg or 5 mg/kg every 6 hours in those weighing >2 kg.292 In extremely low-birthweight neonates (<1 kg), consider 5 mg/kg every 12 hours until 2 weeks of age.292
IV or IM
Neonates <1 month of age: Manufacturer recommends 15–20 mg/kg daily given in 3 or 4 equally divided doses.139 The lower dosage may be adequate for small, premature neonates.139
Neonates ≤7 days 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.292
Neonates 8–28 days of age: AAP recommends 5 mg/kg every 8 hours in those weighing ≤2 kg or 5 mg/kg every 6 hours in those weighing >2 kg.292 In extremely low-birthweight neonates (<1 kg), consider 5 mg/kg every 12 hours until 2 weeks of age.292
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.126
Oral solution: Manufacturer recommends 8–12 mg/kg daily for serious infections, 13–16 mg/kg daily for severe infections, or 17–25 mg/kg daily for more severe infections.121 Give daily dosage in 3 or 4 equally divided doses.121 In children weighing ≤10 kg, manufacturer recommends a minimum dosage of 37.5 mg 3 times daily.121
AAP recommends 10–20 mg/kg daily given in 3 or 4 equally divided doses for mild to moderate infections or 30–40 mg/kg daily given in 3 or 4 equally divided doses for severe infections.292
IV or IM
Manufacturer recommends 20–40 mg/kg daily given in 3 or 4 equally divided doses;139 use the higher dosage for more severe infections.139 Alternatively, manufacturer recommends 350 mg/m2 daily for serious infections or 450 mg/m2 daily for more severe infections.139
AAP recommends 20–30 mg/kg daily given in 3 equally divided doses for mild to moderate infections or 40 mg/kg daily given in 3 or 4 equally divided doses for severe infections.292
Acute Otitis Media† (AOM)
Oral
Children 6 months through 12 years of age: 30–40 mg/kg daily in 3 divided doses recommended by AAP.499 Use with or without a third generation cephalosporin.499 (See Acute Otitis Media under Uses.)
Pharyngitis and Tonsillitis†
Oral
AAP recommends 10 mg/kg 3 times daily (up to 900 mg daily) for 10 days.292
IDSA recommends 7 mg/kg (up to 300 mg) 3 times daily for 10 days.580
AHA recommends 20 mg/kg daily (up to 1.8 g daily) in 3 divided doses given for 10 days.375
Respiratory Tract Infections
Oral
Children >3 months of age: IDSA recommends 30–40 mg/kg daily given in 3 or 4 divided doses.513
IM or IV
Children >3 months of age: IDSA recommends 40 mg/kg daily given in divided doses every 6–8 hours.513 514
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 sulfate (8 mg/kg [up to 650 mg] every 8 hours for 7–10 days).329 Others recommend 20–40 mg/kg (up to 600 mg) daily in 3 or 4 divided doses for 7–10 days; used in conjunction with oral quinine sulfate (24 mg/kg daily in 3 divided doses for 7–10 days).134
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 sulfate (8 mg/kg [up to 650 mg] every 8 hours for 7–10 days).329 Others recommend 20–40 mg/kg (up to 600 mg) daily in 3 or 4 divided doses for 7–10 days; used in conjunction with oral quinine sulfate (24 mg/kg daily in 3 divided doses for 7–10 days).134
Malaria†
Treatment of Uncomplicated Chloroquine-resistant P. falciparum Malaria†
Oral20 mg/kg daily in 3 equally divided doses given for 7 days;134 143 144 used 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).134 143 144
Treatment of Severe P. falciparum Malaria†
Oral20 mg/kg daily in 3 equally divided doses given for 7 days;143 144 used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.143 144
IV, then Oral10-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.143 144
Used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.143 144
Pneumocystis jirovecii Pneumonia†
Treatment of Mild to Moderate Infections†
OralChildren: 10 mg/kg (up to 300–450 mg) every 6 hours given for 21 days;441 used in conjunction with oral primaquine (0.3 mg/kg once daily [up to 30 mg daily] for 21 days).441
Adolescents: 450 mg every 6 hours or 600 mg every 8 hours given for 21 days;440 used in conjunction with oral primaquine (30 mg once daily for 21 days).440
IVChildren: 10 mg/kg (up to 600 mg) every 6 hours given for 21 days;441 used in conjunction with oral primaquine (0.3 mg/kg once daily [up to 30 mg daily] for 21 days).441
Adolescents: 600 mg every 6 hours or 900 mg every 8 hours given for 21 days;440 used in conjunction with oral primaquine (30 mg once daily for 21 days).440
Toxoplasmosis†
Congenital Toxoplasmosis†
Oral or IV5–7.5 mg/kg (up to 600 mg) 4 times daily;441 used 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).441
Optimal duration not determined;441 some experts recommend continuing treatment for 12 months.441
Treatment in Infants and Children†
Oral or IV5–7.5 mg/kg (up to 600 mg) 4 times daily;441 used 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).441
Continue acute treatment for ≥6 weeks; longer duration may be appropriate if disease is extensive or response incomplete at 6 weeks.441
Treatment in Adolescents†
Oral or IV600 mg every 6 hours;440 used in conjunction with oral pyrimethamine (200-mg loading dose followed by 50 mg once daily in those <60 kg or 75 mg once daily in those ≥60 kg) and oral leucovorin (10–25 mg once daily; may be increased to 50 mg once or twice daily).440
Continue acute treatment for ≥6 weeks; longer duration may be appropriate if disease is extensive or response incomplete at 6 weeks.440
Prevention of Recurrence (Secondary Prophylaxis) in Infants and Children†
Oral7–10 mg/kg 3 times daily; used in conjunction with oral pyrimethamine (1 mg/kg or 15 mg/m2 [up to 25 mg] once daily) and oral leucovorin (5 mg once every 3 days).441
Initiate long-term suppressive therapy or chronic maintenance therapy (secondary prophylaxis) in all patients after completion of acute treatment of toxoplasmosis.441
Safety of discontinuing secondary toxoplasmosis prophylaxis in HIV-infected infants and children receiving potent antiretroviral therapy not extensively studied.441 Consider discontinuing secondary prophylaxis in HIV-infected children 1 to <6 years of age who have completed toxoplasmosis acute treatment, have received >6 months of stable antiretroviral therapy, are asymptomatic with respect to toxoplasmosis, and have CD4+ T-cell percentages that have remained >15% for >6 consecutive months.441 In HIV-infected children ≥6 years of age who have received >6 months of antiretroviral therapy, consider discontinuing secondary prophylaxis if CD4+ T-cell counts have remained >200/mm3 for >6 consecutive months.441 Reinitiate secondary prophylaxis if these parameters not met.441
Prevention of Recurrence (Secondary Prophylaxis) in Adolescents†
OralDosage 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.440 (See Adult Dosage under Dosage and Administration.)
Perioperative Prophylaxis†
IV
10 mg/kg given within 60 minutes prior to incision.360 374 Used with or without another anti-infective.360 374 (See Perioperative Prophylaxis under Uses.)
May give additional intraoperative doses every 6 hours during prolonged procedures;360 postoperative doses generally not recommended.360
Prevention of Bacterial Endocarditis†
Patients Undergoing Certain Dental or Respiratory Tract Procedures†
Oral20 mg/kg as a single dose given 30–60 minutes prior to the procedure.451
IM or IV20 mg/kg as a single dose given 30–60 minutes prior to the procedure.451
Adults
General Adult Dosage
Serious Infections
Oral150–300 mg every 6 hours.126
IV or IM600 mg to 1.2 g daily in 2–4 equally divided doses.139
More Severe Infections
Oral300–450 mg every 6 hours.126
IV or IM1.2–2.7 g daily in 2–4 equally divided doses.139
For life-threatening infections, IV dosage may be increased up 4.8 g daily.139
Gynecologic Infections
Pelvic Inflammatory Disease
IV, then OralInitially, 900 mg IV every 8 hours;344 345 used in conjunction with IV or IM gentamicin.344 345 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.344 Alternatively, oral doxycycline can be used to complete 14 days of therapy.344 345
Pharyngitis and Tonsillitis†
Oral
IDSA recommends 7 mg/kg (up to 300 mg) 3 times daily for 10 days.580
AHA recommends 20 mg/kg daily (up to 1.8 g daily) in 3 divided doses given for 10 days.375
Respiratory Tract Infections
Oral
IDSA recommends 600 mg 3 times daily for 7–21 days.514
IV
IDSA recommends 600 mg 3 times daily for 7–21 days.514
Anthrax†
Treatment of Inhalational Anthrax†
IV900 mg every 8 hours.119
Used in multiple-drug regimens that initially include IV ciprofloxacin or IV doxycycline and 1 or 2 other anti-infectives predicted to be effective.116 117 119 120
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.117 120
Babesiosis†
Oral
IDSA and others recommend 600 mg every 8 hours given for 7–10 days;134 329 used in conjunction with oral quinine sulfate (650 mg every 6 or 8 hours for 7–10 days).134 329
IV
IDSA and others recommend 300–600 mg every 6 hours given for 7–10 days; used in conjunction with oral quinine sulfate (650 mg every 6 or 8 hours for 7–10 days).134 329
Bacterial Vaginosis†
Treatment in Pregnant or Nonpregnant Women†
Oral300 mg twice daily given for 7 days.344 345
Malaria†
Treatment of Uncomplicated Chloroquine-resistant P. falciparum Malaria†
Oral20 mg/kg daily in 3 equally divided doses given for 7 days;134 143 144 used in conjunction with oral quinine sulfate (650 mg 3 times daily given for 7 days if acquired in Southeast Asia or 3 days if acquired elsewhere).134 143 144
Treatment of Severe P. falciparum Malaria†
Oral20 mg/kg daily in 3 equally divided doses given for 7 days;134 143 144 used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.134 143 144
IV, then Oral10-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.143 144
Used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.143 144
Pneumocystis jirovecii Pneumonia†
Treatment of Mild to Moderate Infections†
Oral450 mg every 6 hours or 600 mg every 8 hours given for 21 days;440 used in conjunction with oral primaquine (30 mg once daily for 21 days).440
IV600 mg every 6 hours or 900 mg every 8 hours given for 21 days;440 used in conjunction with oral primaquine (30 mg once daily for 21 days).440
Toxoplasmosis†
Treatment†
Oral or IV600 mg every 6 hours;440 used in conjunction with oral pyrimethamine (200-mg loading dose followed by 50 mg once daily in those <60 kg or 75 mg once daily in those ≥60 kg) and oral leucovorin (10–25 mg once daily; may be increased to 50 mg once or twice daily).440
Continue acute treatment for ≥6 weeks; longer duration may be appropriate if disease is extensive or response incomplete at 6 weeks.440
Prevention of Recurrence (Secondary Prophylaxis)†
Oral600 mg every 8 hours;440 used in conjunction with oral pyrimethamine (25–50 mg once daily) and oral leucovorin (10–25 mg once daily).440
Initiate long-term suppressive therapy or chronic maintenance therapy (secondary prophylaxis) in all patients after completion of acute treatment of toxoplasmosis.440
Consider discontinuing secondary prophylaxis in HIV-infected adults or adolescents who have successfully completed initial treatment for toxoplasmosis, are asymptomatic with respect to toxoplasmosis, and have CD4+ T-cell counts that have remained >200/mm3 for ≥6 months.440
Reinitiate secondary prophylaxis if CD4+ T-cell count decreases to <200/mm3, regardless of plasma HIV viral load.440
Perioperative Prophylaxis†
IV
900 mg given within 60 minutes prior to incision.360 374 Used with or without another anti-infective.360 374 (See Perioperative Prophylaxis under Uses.)
May give additional intraoperative doses every 6 hours during prolonged procedures;360 postoperative doses generally not recommended.360
Prevention of Bacterial Endocarditis†
Patients Undergoing Certain Dental or Respiratory Tract Procedures†
Oral600 mg as a single dose given 30–60 minutes prior to the procedure.451
IM or IV600 mg as a single dose given 30–60 minutes prior to the procedure.451
Prevention of Perinatal Group B Streptococcal Disease†
Women at Risk Who Should Not Receive β-lactam Anti-infectives†
IV900 mg every 8 hours; initiate at time of labor or rupture of membranes and continue until delivery.359
Special Populations
Hepatic Impairment
Dosage adjustments not usually necessary.121 126 139 Monitor hepatic function if used in those with severe hepatic disease.121 126 139
Renal Impairment
Dosage adjustments not usually necessary.121 126 139
Geriatric Patients
Dosage adjustments not usually necessary if used in geriatric patients with normal hepatic function and normal (age-adjusted) renal function.121 126 139
Cautions for Clindamycin
Contraindications
Warnings/Precautions
Warnings
Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)
Possible emergence and overgrowth of nonsusceptible organisms, particularly yeasts.121 126 139 Institute appropriate therapy if superinfection occurs.121 126 139
Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.121 126 139 302 303 304 C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including clindamycin, and may range in severity from mild diarrhea to fatal colitis.121 126 139 302 303 304 C. difficile produces toxins A and B which contribute to development of CDAD;121 126 139 302 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.121 126 139
Consider CDAD if diarrhea develops during or after therapy and manage accordingly.121 126 139 302 303 304 Obtain careful medical history since CDAD may occur as late as ≥2 months after anti-infective therapy discontinued.121 126 139
If CDAD suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible.121 126 139 302 Initiate 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.121 126 139 302 303 304
Patients with Meningitis
Do not use for treatment of meningitis; clindamycin diffusion into CSF inadequate for treatment of CNS infections.121 126 139
Sensitivity Reactions
Anaphylactic shock and anaphylactoid reactions with hypersensitivity reported.121 126 139
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, reported and have been fatal in some cases.121 126 139 Acute generalized exanthematous pustulosis and erythema multiforme also reported.121 126 139
Generalized mild to moderate morbilliform-like (maculopapular) rash,121 126 139 vesiculobullous rash,121 126 urticaria,121 126 pruritus,121 126 angioedema,121 126 and rare instances of exfoliative dermatitis121 126 reported.
Some commercially available clindamycin capsules (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.126 Although the incidence of tartrazine sensitivity is low, it frequently occurs in patients sensitive to aspirin.126
Prior to initiation of clindamycin, make careful inquiry regarding prior hypersensitivity to drugs and other allergens.121 126 139 Use with caution in atopic individuals.121 126 139
If anaphylactic or severe hypersensitivity reactions occur, permanently discontinue clindamycin and institute appropriate therapy as necessary.121 126 139
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.121 126 139
When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.121 126 139 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.121 126 139
Surgical procedures should be performed in conjunction with clindamycin therapy when indicated.121 126 139
History of GI Disease
Use with caution in patients with a history of GI disease, particularly colitis.100 (See Superinfection/Clostridium difficile-associated Colitis under Cautions.)
Cardiovascular Effects
Rapid IV administration has caused cardiopulmonary arrest and hypotension.139
Laboratory Monitoring
Monitor liver function, renal function, and CBCs periodically during prolonged therapy.121 126 139
Specific Populations
Pregnancy
Reproduction studies in rats and mice have not revealed evidence of teratogenicity.121 126 139
In clinical trials that included pregnant women, systemic clindamycin administered during second and third trimesters was not associated with increased frequency of congenital abnormalities.126 139 No adequate and well-controlled studies to date using clindamycin in pregnant women during first trimester of pregnancy.121 126 139
Use during pregnancy only when clearly needed.121 126 139
Clindamycin phosphate injection contains benzyl alcohol as a preservative; benzyl alcohol can cross the placenta.139 (See Pediatric Use under Cautions.)
Lactation
Distributed into milk;100 121 126 139 potentially can cause adverse effects on GI flora of breast-fed infants.121 126 139
Manufacturer states clindamycin use in the mother is not a reason to discontinue breast-feeding; however, it may be preferable to use an alternate anti-infective.121 126 139
If used in a breast-feeding mother, monitor infant 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.121 126 139
Consider benefits of breast-feeding and importance of clindamycin to the woman; also consider potential adverse effects on breast-fed child from the drug or from the underlying maternal condition.121 126 139
Pediatric Use
Monitor organ system functions when used in pediatric patients (birth to 16 years of age).121 126 139
Each mL of clindamycin phosphate injection contains 9.45 mg of benzyl alcohol.139 Large amounts of benzyl alcohol (i.e., 100–400 mg/kg daily) have been associated with toxicity (potentially fatal “gasping syndrome”) in neonates.106 107 108 109 139 Although amount of benzyl alcohol in recommended IM or IV clindamycin dosages are substantially lower than amounts reported in association with “gasping syndrome,” minimum amount of benzyl alcohol at which toxicity may occur unknown.139 Risk of benzyl alcohol toxicity depends on quantity administered and capacity of liver and kidneys to detoxify the chemical.139 Premature and low-birthweight infants may be more likely to develop toxicity.139
Geriatric Use
Insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults.121 126 139
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).121 126 139 303 Carefully monitor geriatric patients for development of diarrhea (e.g., changes in bowel frequency).121 126 139
Hepatic Impairment
Moderate to severe liver disease may result in prolonged clindamycin half-life, but accumulation may not occur.121 126 139
Periodically monitor liver enzymes in patients with severe hepatic impairment.121 126 139
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).121 126 139
Drug Interactions
Substrate of CYP isoenzyme 3A4 and, to a lesser extent, CYP3A5.121 126 139
Moderate inhibitor of CYP3A4 in vitro; does not inhibit CYP1A2, 2C9, 2C19, 2E1, or 2D6.121 126 139
Drugs Affecting Hepatic Microsomal Enzymes
CYP3A4 or 3A5 inhibitors: Possible increased plasma concentrations of clindamycin.121 126 139 Monitor for adverse effects if used with potent CYP3A4 inhibitor.121 126 139
CYP3A4 or 3A5 inducers: Possible decreased plasma concentrations of clindamycin.121 126 139 Monitor for loss of clindamycin effectiveness if used with potent CYP3A4 inducer.121 126 139
Specific Drugs
Drug |
Interaction |
Comments |
---|---|---|
Neuromuscular blocking agents (tubocurarine, pancuronium) |
Potential for enhanced neuromuscular blocking action121 126 139 198 199 |
Use with caution in patients receiving neuromuscular blocking agents;121 126 139 198 199 closely monitor for prolonged neuromuscular blockade199 |
Rifampin |
Clindamycin Pharmacokinetics
Absorption
Bioavailability
Clindamycin hydrochloride capsules: Approximately 90% of an oral dose rapidly absorbed from GI tract;126 peak serum concentrations attained within 45 minutes.126
Clindamycin palmitate hydrochloride oral solution: Rapidly hydrolyzed in GI tract to active clindamycin.121
Clindamycin phosphate: Following IM or IV administration, rapidly hydrolyzed in plasma to active clindamycin.139
Following IM administration of clindamycin phosphate, peak serum concentrations occur within 3 hours in adults and 1 hour in children.139
Food
Administration of clindamycin hydrochloride capsules126 or clindamycin palmitate hydrochloride oral solution121 with food does not appreciably affect absorption121 or serum concentrations of the drug.126
Distribution
Extent
Widely distributed into body tissues and fluids,121 126 140 including saliva,140 ascites fluid,140 peritoneal fluid,140 pleural fluid,140 synovial fluid,140 bone,121 126 140 and bile.140
Clinically important concentrations not attained in CSF, even in the presence of inflamed meninges.121 126 139 140
Readily crosses the placenta;140 141 cord blood concentrations may be up to 50% of concurrent maternal blood concentrations.140
Distributed into milk.100 121 126 139 140
Plasma Protein Binding
93%.a
Elimination
Metabolism
Partially metabolized to bioactive and inactive metabolites.a
In vitro studies indicate clindamycin is predominantly metabolized by CYP3A4 and, to a lesser extent, by CYP3A5 to the major bioactive metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin.121 126 139
Elimination Route
Excreted in urine, bile, and feces.a
Approximately 10% of an oral dose excreted in urine and 3.6% excreted in feces as active drug and metabolites;121 126 remainder is excreted as inactive metabolites.121 126
Not appreciably removed by hemodialysis or peritoneal dialysis.121 126 139
Half-life
Adults and children: 2–3 hours.121 126 139
Geriatric adults: Approximately 4 hours (range: 3.4–5.1 hours) following oral administration.121 126 139
Neonates: Serum half-life depends on gestational and chronologic age and body weight.102 Reportedly averages 8.7 or 3.6 hours in premature or full-term neonates, respectively, and is about 3 hours in infants 4 weeks to 1 year of age.102
Special Populations
Pharmacokinetics after IV administration in healthy older adults (61–79 years of age) similar to younger adults (18–39 years of age).121 126 139
Serum half-life increased slightly in patients with markedly reduced renal or hepatic function.121 126 139
Stability
Storage
Oral
Capsules
20–25°C.126
For Solution
20–25°C.121 Following reconstitution, stable for 2 weeks at room temperature;121 do not refrigerate because solution will thicken.121
Parenteral
Solution, for IM or IV Use
20–25°C.139
Solution, for IV Infusion only
ADD-Vantage vials: 20–25°C.139
Pharmacy bulk package: 20–25°C.139 Discard unused portions within 24 hours after initial entry into the vial.139
Premixed solutions in 5% dextrose: Room temperature (25°C); avoid temperatures >30°C.139
Compatibility
Parenteral
Solution CompatibilityHID
Compatible |
---|
Amino acids 4.25%, dextrose 25% |
Dextrose 2.5% in Ringer’s injection, lactated |
Dextrose 5% in Ringer’s injection |
Dextrose 5% in sodium chloride 0.45 or 0.9% |
Dextrose 5 or 10% in water |
Isolyte M or P with dextrose 5% |
Normosol R |
Ringer’s injection, lactated |
Sodium chloride 0.9% |
Drug Compatibility
Compatible |
---|
Amikacin sulfate |
Ampicillin sodium |
Aztreonam |
Cefazolin sodium |
Cefepime HCl |
Cefotaxime sodium |
Cefoxitin sodium |
Ceftazidime |
Cefuroxime sodium |
Fluconazole |
Gentamicin sulfate |
Heparin sodium |
Hydrocortisone sodium succinate |
Methylprednisolone sodium succinate |
Metoclopramide HCl |
Potassium chloride |
Sodium bicarbonate |
Tobramycin sulfate |
Verapamil HCl |
Incompatible |
Aminophylline |
Ceftriaxone sodium |
Ciprofloxacin |
Gentamicin sulfate with cefazolin sodium |
Tramadol HCl |
Variable |
Ranitidine HCl |
Compatible |
---|
Acetaminophen |
Acyclovir sodium |
Amsacrine |
Amifostine |
Amiodarone HCl |
Amphotericin B cholesteryl sulfate complex |
Anakinra |
Anidulafungin |
Aztreonam |
Bivalirudin |
Cangrelor tetrasodium |
Ceftaroline fosamil |
Cisatracurium besylate |
Cloxacillin sodium |
Cyclophosphamide |
Dexmedetomidine HCl |
Diltiazem HCl |
Docetaxel |
Doxorubicin HCl liposome injection |
Enalaprilat |
Esmolol HCl |
Etoposide phosphate |
Fenoldopam mesylate |
Fludarabine phosphate |
Foscarnet sodium |
Gemcitabine HCl |
Granisetron HCl |
Heparin sodium |
Hetastarch in lactated electrolyte injection (Hextend) |
Hydromorphone HCl |
Hydroxyethyl starch 130/0.4 in sodium chloride 0.9% |
Labetalol HCl |
Levofloxacin |
Linezolid |
Magnesium sulfate |
Melphalan HCl |
Meperidine HCl |
Midazolam HCl |
Milrinone lactate |
Morphine sulfate |
Multivitamins |
Nicardipine HCl |
Ondansetron HCl |
Pemetrexed disodium |
Piperacillin sodium–tazobactam sodium |
Propofol |
Remifentanil HCl |
Sargramostim |
Tacrolimus |
Teniposide |
Theophylline |
Thiotepa |
Vinorelbine tartrate |
Zidovudine |
Incompatible |
Allopurinol sodium |
Azithromycin |
Caspofungin acetate |
Doxapram HCl |
Filgrastim |
Fluconazole |
Idarubicin HCl |
Oritavancin diphosphate |
Actions and Spectrum
-
Lincosamide antibiotic;140 141 semisynthetic derivative of lincomycin.121 126 139 140 140 141
-
Usually bacteriostatic in action, but may be bactericidal depending on concentration attained at site of infection and susceptibility of the infecting organism.a
-
Inhibits protein synthesis in susceptible bacteria by binding to 23S RNA of the 50S ribosomal subunits.121 126 139 140
-
Clindamycin palmitate hydrochloride and clindamycin phosphate are inactive until hydrolyzed in vivo to free clindamycin.a
-
Spectrum of activity includes many gram-positive aerobic and anaerobic bacteria and some gram-negative anaerobic bacteria.121 126 139 140 141 Generally inactive against most gram-negative aerobic bacteria.140
-
Gram-positive aerobes: Active in vitro against Staphylococcus aureus (methicillin-susceptible strains),121 126 139 140 141 S. epidermidis (methicillin-susceptible strains),121 126 139 141 Streptococcus pneumoniae (penicillin-susceptible strains),121 126 139 140 141 S. pyogenes (group A β-hemolytic streptococci; GAS),121 126 139 140 141 S. agalactiae (group B streptococci; GBS),121 126 139 S. anginosus,121 126 139 S. mitis,121 126 139 and S. oralis.121 126 139 Not active against Enterococcus faecalis or E. faecium.140
-
Anaerobes: Active in vitro against Actinomyces israelii,121 126 139 140 Clostridium clostridioforme,121 126 139 C. perfringens,121 126 139 Eggerthella lenta (previously known as Eubacterium lentum),121 126 139 Finegoldia anaerobius,121 126 139 Finegoldia magna,121 126 139 Fusobacterium necrophorum,121 126 139 F. nucleatum,121 126 139 Micromonas micros,121 126 139 Mobiluncus,173 176 177 Prevotella (P. disiens, P. intermedia, P. melaninogenica, P. vivia),121 126 139 140 173 Porphyromonas,140 173 and Propionibacterium acnes.121 126 139
-
Active in vitro and in vivo against Gardnerella vaginalis.140 173 178 179 180
-
Has in vitro activity against Toxoplasma gondii in infected human fibroblasts.141 Active against Plasmodium falciparum in vitro.140
-
Generally inactive against gram-negative aerobes, including Enterobacteriaceae,140 141 Pseudomonas,140 Acinetobacter,140 and most strains of Haemophilus influenzae140 141 and Neisseria.140 141
-
Resistance to clindamycin has been induced in vitro in staphylococci and has been reported in clinical isolates of S. aureus, especially methicillin-resistant S. aureus (MRSA; also known as oxacillin-resistant S. aureus or ORSA).141
-
S. agalactiae (group B streptococci; GBS) clinical isolates resistant to clindamycin reported with increasing frequency.140 292 359 GBS isolates that appear susceptible to clindamycin but resistant to erythromycin in vitro may have inducible resistance to clindamycin.359
-
Clinical isolates of Bacteroides fragilis with resistance or reduced susceptibility to clindamycin reported with increasing frequency.140 141
-
Resistance to clindamycin most frequently caused by modification of specific bases of the 23S ribosomal RNA.121 126 139
-
Complete cross-resistance usually occurs between clindamycin and lincomycin.121 126 139 141 Because of overlapping binding sites, partial cross-resistance reported between clindamycin and macrolides (e.g., erythromycin) and streptogramin B.121 126 139 140 141
Advice to Patients
-
Advise patients that antibacterials (including clindamycin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).121 126 139
-
Importance of completing full course of therapy, even if feeling better after a few days.121 126 139
-
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.121 126 139
-
Clindamycin hydrochloride capsules and clindamycin palmitate hydrochloride oral solution can be taken without regard to meals.121 126
-
Take clindamycin hydrochloride capsules with a full glass of water to avoid the possibility of esophageal irritation.126
-
Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.121 126 139 Importance of contacting 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.121 126 139
-
Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, and any concomitant illnesses.121 126 139
-
Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.121 126 139
-
Importance of advising patients of other important precautionary information.121 126 139 (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Oral |
Capsules |
75 mg (of clindamycin)* |
Cleocin HCl |
Pfizer |
Clindamycin Hydrochloride Capsules |
||||
150 mg (of clindamycin)* |
Cleocin HCl |
Pfizer |
||
Clindamycin Hydrochloride Capsules |
||||
300 mg (of clindamycin)* |
Cleocin HCl |
Pfizer |
||
Clindamycin Hydrochloride Capsules |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Oral |
For solution |
75 mg (of clindamycin) per 5 mL* |
Cleocin Pediatric |
Pfizer |
Clindamycin Palmitate Hydrochloride for Oral Solution |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Parenteral |
Injection |
150 mg (of clindamycin) per mL* |
Cleocin Phosphate |
Pfizer |
Clindamycin Phosphate Injection |
||||
9 g (150 mg/mL) (of clindamycin) pharmacy bulk package |
Cleocin Phosphate |
Pfizer |
||
Injection, for IV infusion only |
150 mg (of clindamycin) per mL (300 mg)* |
Cleocin Phosphate ADD-Vantage |
Pfizer |
|
Clindamycin Phosphate ADD-Vantage |
||||
150 mg (of clindamycin) per mL (600 and 900 mg)* |
Cleocin Phosphate ADD-Vantage |
Pfizer |
||
Clindamycin Phosphate ADD-Vantage |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Parenteral |
Injection, for IV infusion |
6 mg (of clindamycin) per mL (300 mg) in 5% Dextrose* |
Cleocin Phosphate IV |
Pfizer |
Clindamycin Phosphate in 5% Dextrose |
||||
12 mg (of clindamycin) per mL (600 mg) in 5% Dextrose* |
Cleocin Phosphate IV |
Pfizer |
||
Clindamycin Phosphate in 5% Dextrose |
||||
18 mg (of clindamycin) per mL (900 mg) in 5% Dextrose* |
Cleocin Phosphate IV |
Pfizer |
||
Clindamycin Phosphate in 5% Dextrose |
AHFS DI Essentials™. © Copyright 2024, Selected Revisions April 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
Only references cited for selected revisions after 1984 are available electronically.
100. Steen B, Rane A. Clindamycin passage into human milk. Br J Clin Pharmacol. 1982; 13:661-4. http://www.ncbi.nlm.nih.gov/pubmed/7082533?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=1402074&blobtype=pdf
101. Anon. Clindamycin and quinine treatment for Babesia microti infections. MMWR Morb Mortal Wkly Rep. 1983; 32:65-6,72. http://www.ncbi.nlm.nih.gov/pubmed/6405180?dopt=AbstractPlus
102. Bell MJ, Shackelford P, Smith R et al. Pharmacokinetics of clindamycin phosphate in the first year of life. J Pediatr. 1984; 105:482-6. http://www.ncbi.nlm.nih.gov/pubmed/6470871?dopt=AbstractPlus
103. The United States pharmacopeia, 21st rev, and The national formulary, 16th ed. Rockville, MD: The United States Pharmacopeial Convention, Inc; 1984:224-7,1449,1484.
105. Wittner M, Rowin KS, Tanowitz HB et al. Successful chemotherapy of transfusion babesiosis. Ann Intern Med. 1982; 96:601-4. http://www.ncbi.nlm.nih.gov/pubmed/7200341?dopt=AbstractPlus
106. American Academy of Pediatrics Committee on Fetus and Newborn and Committee on Drugs. Benzyl alcohol: toxic agent in neonatal units. Pediatrics. 1983; 72:356-8. http://www.ncbi.nlm.nih.gov/pubmed/6889041?dopt=AbstractPlus
107. Anon. Benzyl alcohol may be toxic to newborns. FDA Drug Bull. 1982; 12:10-1. http://www.ncbi.nlm.nih.gov/pubmed/7188569?dopt=AbstractPlus
108. Centers for Disease Control. Neonatal deaths associated with use of benzyl alcohol. MMWR Morb Mortal Wkly Rep. 1982; 31:290-1. http://www.ncbi.nlm.nih.gov/pubmed/6810084?dopt=AbstractPlus
109. Gershanik J, Boecler B, Ensley H et al. The gasping syndrome and benzyl alcohol poisoning. N Engl J Med. 1982; 307:1384-8. http://www.ncbi.nlm.nih.gov/pubmed/7133084?dopt=AbstractPlus
110. Carlson P, Kontiainen S, Renkonen OV. Antimicrobial susceptibility of Arcanobacterium haemolyticum. Antimicrob Agents Chemother. 1994; 38:142-3.
111. Krause PJ, Lepore T, Sikand VK et al. Atovaquone and azithromycin for the treatment of babesiosis. N Engl J Med. 2000; 343:1454-8. http://www.ncbi.nlm.nih.gov/pubmed/11078770?dopt=AbstractPlus
113. Pukrittayakamee S, Chantra A, Vanijanonta S et al. Therapeutic responses to quinine and clindamycin in multidrug-resistant falciparum malaria. Antimicrob Agents Chemother. 2000; 44:2395-8. http://www.ncbi.nlm.nih.gov/pubmed/10952585?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=90075&blobtype=pdf
114. Metzger W, Mordmuller B, Graninger W et al. High efficacy of short-term quinine-antibiotic combinations for treating adult malaria patients in an area in which malaria is hyperendemic. Antimicrob Agents Chemother. 1995; 39:245-6. http://www.ncbi.nlm.nih.gov/pubmed/7695315?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=162517&blobtype=pdf
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