Medication Guide App

Clindamycin Phosphate

Pronunciation

Class: Lincomycins
Note: This monograph also contains information on Clindamycin Hydrochloride
VA Class: AM350
CAS Number: 21462-39-5
Brands: Cleocin HCL, Cleocin Pediatric, Cleocin Phosphate

Warning(s)

  • Diarrhea and Colitis
  • 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 clostridia;121 126 139 a toxin produced by C. difficile is one primary cause of antibiotic-associated colitis.121 126 139

  • It is important to consider a diagnosis of CDAD in patients who develop diarrhea subsequent to clindamycin treatment.121 126 139 Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks after cessation of clindamycin therapy.121 126 139

  • After a diagnosis of CDAD has been established, initiate therapeutic measures.121 126 139

    Mild cases usually respond to drug discontinuation alone.121 126 139

    In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an anti-infective clinically effective against CDAD.121 126 139 (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions.)

  • Because clindamycin has been associated with severe colitis (potentially fatal), it should be reserved for treatment of serious infections when less toxic anti-infectives are inappropriate.121 126 139

  • Do not use for nonbacterial infections.121 126 139

Introduction

Antibacterial; broad-spectrum antibiotic derived from lincomycin.121 126 139

Uses for Clindamycin Phosphate

Acute Otitis Media (AOM)

Alternative for treatment of AOM known or presumed to be caused by penicillin-resistant Streptococcus pneumoniae.253

Not a first-line agent, but AAP and AAFP state clindamycin may be considered in individuals with penicillin hypersensitivity who may have AOM caused by penicillin-resistant S. pneumoniae.253

Use of clindamycin also may be considered if AOM persists after treatment with amoxicillin and clavulanate or ceftriaxone and tympanocentesis is not available to make a bacteriologic diagnosis.253

Bone and Joint Infections

Treatment of serious bone and joint infections (including acute hematogenous osteomyelitis) caused by susceptible Staphylococcus aureus.139

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.124 128 257 When a parenteral regimen is indicated for treatment of PID, IV clindamycin in conjunction with an IV or IM aminoglycoside (e.g., gentamicin) is one of the recommended regimens.124 128 257

Intra-abdominal Infections

Treatment of serious intra-abdominal infections (e.g., peritonitis, intra-abdominal abscess) caused by susceptible anaerobes.121 126 139

Pharyngitis and Tonsillitis

Alternative for treatment of pharyngitis and tonsillitis caused by susceptible Streptococcus pyogenes (group A β-hemolytic streptococci)120 122 135 144 149 in patients who cannot receive β-lactam anti-infectives and have infections caused by macrolide-resistant S. pyogenes.122

CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice for pharyngitis and tonsillitis;120 122 123 127 144 oral cephalosporins and oral macrolides are considered alternatives.120 122 123 127 144 Amoxicillin sometimes used instead of penicillin V, especially for young children.122 144

Alternative for treatment of symptomatic patients who have multiple, recurrent episodes of pharyngitis known to be caused by S. pyogenes.122 144

Consider that multiple, recurrent episodes of symptomatic pharyngitis within several months to years may indicate that the patient is a streptococcal carrier experiencing repeated episodes of nonstreptococcal pharyngitis (e.g., viral) pharyngitis; treatment not usually recommended for streptococcal pharyngeal carriers.122 144

Respiratory Tract Infections

Treatment of serious respiratory tract infections (e.g., pneumonia, empyema, lung abscess) caused by susceptible anaerobes, S. pneumoniae, other streptococci, or S. aureus.121 126 139 151

A drug of choice for treatment of community-acquired pneumonia (including aspiration pneumonia) when anaerobes are identified or suspected.151

Septicemia

Treatment of serious septicemia caused by susceptible anaerobes, streptococci, or S. aureus.121 126 139

Skin and Skin Structure Infections

Treatment of serious skin and skin structure infections caused by susceptible anaerobes, S. pyogenes, other streptococci, or staphylococci.120 121 126 139

Actinomycosis

Treatment of actinomycosis caused by Actinomyces israelii;120 144 follow-up treatment (6–12 months) after initial parenteral treatment (4–6 weeks) with penicillin G or ampicillin.144

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Anthrax

Alternative for treatment of anthrax.103 116 117

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.103 117 119 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);103 117 if meningitis is established or suspected, use IV ciprofloxacin (rather than doxycycline) and chloramphenicol, rifampin, or penicillin.117

Babesiosis

Treatment of babesiosis caused by Babesia microti.101 104 105 144

Regimens of choice for babesiosis are clindamycin in conjunction with quinine or atovaquone in conjunction with azithromycin;104 111 144 256 the clindamycin and quinine regimen may be preferred for severe babesiosis.256 Also consider exchange transfusions in severely ill patients with high levels of parasitemia (>10%), significant hemolysis, or compromised renal, hepatic, or pulmonary function.104 144 256

Bacillus cereus Infections

Treatment of invasive disease caused by Bacillus cereus.120 144 Anti-infectives not usually indicated for gastroenteritis caused by B. cereus.144

Bacterial Vaginosis

Treatment of bacterial vaginosis (formerly called Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in pregnant or nonpregnant women.124 128 180 181 182 183 194 196 203

CDC recommends treatment of bacterial vaginosis in all symptomatic women (including pregnant women).128 In addition, asymptomatic pregnant women at high risk for complications of pregnancy should be screened (preferably at the first prenatal visit) and treatment initiated if needed.128

Treatment recommendations for bacterial vaginosis in HIV-infected women are the same as those for women without HIV infection.128

Regimens of choice in nonpregnant women are a 7-day regimen of oral metronidazole; a 5-day regimen of intravaginal metronidazole gel; or a 7-day regimen of intravaginal clindamycin cream;124 128 alternative regimens are a 7-day regimen of oral clindamycin or 3-day regimen of intravaginal clindamycin suppositories.124 128 The preferred regimens for pregnant women are a 7-day regimen of oral metronidazole or a 7-day regimen of oral clindamycin.128

Regardless of regimen used, relapse or recurrence is common;128 189 192 193 194 195 197 an alternative regimen (e.g., oral therapy when topical was used initially) may be used in such situations.128 183

Routine treatment of asymptomatic male sexual contacts of women who have relapsing or recurrent bacterial vaginosis not recommended.128

Capnocytophaga Infections

Alternative to penicillin G for treatment of infections caused by Capnocytophaga canimorsus.120

Clostridium Infections

Alternative to penicillin G for treatment of clostridial myonecrosis (gas gangrene) caused by Clostridium perfringens or other Clostridium.120 144 Anti-infectives not usually indicated for gastroenteritis caused by C. perfringens.144

Malaria

Treatment of uncomplicated malaria caused by chloroquine-resistant Plasmodium falciparum or when the plasmodial species has not been identified.104 113 114 115 252 Used in conjunction with oral quinine; not effective alone.114 252

CDC and others state treatments of choice for uncomplicated chloroquine-resistant P. falciparum malaria are a regimen of oral quinine in conjunction with doxycycline, tetracycline, or clindamycin or a regimen of atovaquone and proguanil.114 252 A regimen of quinine and doxycycline (or tetracycline) generally preferred over quinine and clindamycin,252 except for young children or pregnant women who should not receive tetracyclines.104 113 115 252

Treatment of severe malaria caused by P. falciparum; used in conjunction with IV quinidine gluconate initially and then with oral quinine when an oral regimen is tolerated.252

Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia

Treatment of Pneumocystis jiroveci (formerly Pneumocystis carinii) pneumonia (PCP); used in conjunction with primaquine.104 145 146 148 150 152 153 155 157 158 159 169 170 204 205 206 254 Designated an orphan drug by FDA for use in this condition.212

Co-trimoxazole is initial drug of choice for treatment in most adults, adolescents, and children, including HIV-infected patients; a regimen of clindamycin and primaquine is an alternative for adults and adolescents with mild to moderately severe PCP who have had an inadequate response to co-trimoxazole or when co-trimoxazole is contraindicated or not tolerated.104 145 146 148 150 152 153 155 157 158 159 169 170 204 254

Clindamycin in conjunction with primaquine has been used as an alternative for long-term suppressive or chronic maintenance therapy (secondary prophylaxis) of PCP,150 159 but USPHS/IDSA states the regimen should only be considered for primary or secondary prophylaxis of PCP in unusual situations when the usually recommended agents (co-trimoxazole, dapsone, dapsone with pyrimethamine and leucovorin, aerosolized pentamidine, atovaquone) cannot be used.210

Toxoplasmosis

Alternative for treatment of toxoplasmosis in immunocompromised adults, adolescents, or children (including HIV-infected patients) who relapse or fail to respond to or are unable to tolerate the regimen of choice (pyrimethamine in conjunction with sulfadiazine and leucovorin).129 130 131 132 138 164 166 167 168 172 204 205 254 255 Clindamycin is used in conjunction with pyrimethamine and leucovorin and is the preferred alternative.163 164 166 172 204 205 254 255

Alternative for long-term suppressive or chronic maintenance therapy (secondary prophylaxis) to prevent relapse of toxoplasmosis in HIV-infected individuals who cannot receive the regimen of choice (sulfadiazine in conjunction with pyrimethamine and leucovorin).210 254 Clindamycin is used in conjunction with pyrimethamine and leucovorin.210 254 Consider that the clindamycin regimen may be less effective than the sulfadiazine regimen in preventing toxoplasmosis recurrence210 213 and that only the sulfadiazine regimen appears to provide protection against both toxoplasmosis and P. jiroveci.210

Prevention of Bacterial Endocarditis

Alternative for prevention of α-hemolytic (viridans group) streptococcal bacterial endocarditis in penicillin-allergic patients with certain cardiac conditions who are undergoing certain dental procedures (i.e., procedures that involve manipulation of gingival tissue, the periapical region of teeth, or perforation of oral mucosa) or certain invasive respiratory tract procedures (i.e., procedures involving incision or biopsy of respiratory mucosa).141

Consult most recent AHA recommendations for information on which cardiac conditions are associated with the highest risk of adverse outcome from endocarditis and specific recommendations regarding use of prophylaxis to prevent endocarditis in these patients.141

Prevention of Perinatal Group B Streptococcal Disease

Alternative to penicillin G or ampicillin for prevention of perinatal group B streptococcal (GBS) disease in penicillin-allergic pregnant women at risk for anaphylaxis with a β-lactam anti-infective.214 245

Intrapartum anti-infective prophylaxis to prevent early-onset neonatal GBS disease is administered to women identified as GBS carriers during routine prenatal GBS screening performed at 35–37 weeks during the current pregnancy and to women who have GBS bacteriuria during the current pregnancy, a previous infant with invasive GBS disease, unknown GBS status with delivery at <37 weeks gestation, amniotic membrane rupture for ≥18 hours, or intrapartum temperature of ≥38°C.214 245

Penicillin G is the regimen of choice and ampicillin is the preferred alternative.214 245 Cefazolin can be used in penicillin-allergic women who do not have immediate-type penicillin hypersensitivity, but clindamycin or erythromycin should be used in penicillin-allergic women at high risk for anaphylaxis.214

Consider that S. agalactiae (group B streptococci) with in vitro resistance to clindamycin and erythromycin has been reported with increasing frequency;214 perform in vitro susceptibility tests of clinical isolates obtained during GBS prenatal screening.214 GBS resistant to erythromycin often are resistant to clindamycin, although this may not be evident in results of in vitro testing.214 If in vitro susceptibility testing is not possible, results are unknown, or isolates are found to be resistant to erythromycin or clindamycin, vancomycin is recommended for intrapartum prophylaxis in penicillin-allergic women at high risk for anaphylaxis with β-lactams.214

Perioperative Prophylaxis

Perioperative prophylaxis to reduce the incidence of infections in patients undergoing clean, contaminated head and neck surgery.125 140 Regimens of choice are IV clindamycin (with or without gentamicin) or IV cefazolin.125 140

Has been used for perioperative prophylaxis in patients undergoing nonperforated appendectomy.140 Cephalosporins (cefazolin, cefoxitin) usually recommended for perioperative prophylaxis in patients undergoing GI procedures (e.g., esophageal and gastroduodenal surgery, biliary tract surgery, colorectal surgery, nonperforated appendectomy); 125 140 clindamycin in conjunction with gentamicin, ciprofloxacin, levofloxacin, or aztreonam recommended in patients hypersensitive to cephalosporins.125

Clindamycin in conjunction with gentamicin, ciprofloxacin, levofloxacin, or aztreonam recommended as an alternative to cephalosporins (cefazolin, cefoxitin) for perioperative prophylaxis in gynecologic and obstetric surgery (vaginal, abdominal, or laparoscopic hysterectomy) in patients hypersensitive to cephalosporins (the preferred agents).125

Clindamycin in conjunction with gentamicin, ciprofloxacin, levofloxacin, or aztreonam recommended for perioperative prophylaxis and postoperative treatment in contaminated or dirty surgery involving a perforated abdominal viscus in patients hypersensitive to cephalosporins when cefoxitin (the preferred agent) cannot be used.125

Clindamycin Phosphate 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 and oral clindamycin substituted when warranted by patient’s condition.121 126 In clinically appropriate circumstances, treatment may be initiated with oral clindamycin.121 126

Single IM doses should not exceed 600 mg, and no more than 1.2 g should be administered by IV infusion in a 1-hour period.139

Clindamycin phosphate ADD-Vantage vials and the commercially available clindamycin phosphate injection 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

Reconstitution

Reconstitute clindamycin palmitate hydrochloride oral solution by adding 75 mL of water to the 100-mL bottle.121 A large portion of the water should be added initially and the bottle shaken vigorously; the remainder of the water should then be added and the bottle shaken until the solution is uniform.121 The resulting solution contains 75 mg of clindamycin/5 mL.121

IV Infusion

Dilution

Prior to IV infusion, clindamycin phosphate injections (including ADD-Vantage vials) must be diluted with a compatible IV solution to a concentration ≤18 mg/mL.139 (See Rate of Administration under Dosage and Administration.)

The clindamycin phosphate pharmacy bulk package is not intended for direct IV infusion;139 doses of the drug from the bulk package must be further diluted in a compatible IV infusion solution prior to administration.139 The 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, the entire contents should be used promptly and any unused portion discarded within 24 hours after initial entry.139

The commercially available clindamycin phosphate injections in 5% dextrose should not be used in series connections with other plastic containers, since such use could result in air embolism from residual air being drawn from the primary container before administration of fluid from the secondary container is complete.139

Rate of Administration

By intermittent IV infusion over a period of at least 10–60 minutes139 and at a rate ≤30 mg/minute.139 No more than 1.2 g should be given by IV infusion in a single 1-hour period.139

The manufacturers suggest that 300- or 600-mg doses be diluted in 50 mL of compatible diluent and infused over 10 or 20 minutes, respectively; 900-mg doses be diluted in 50–100 mL of diluent and infused over 30 minutes; or 1.2-g doses be diluted in 100 mL of diluent and infused over 40 minutes.139

Alternatively, the initial dose can be given as a single rapid infusion over 30 minutes followed by continuous IV infusion (see Table).139

Infusion Rates for Continuous IV Infusion139

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 Daily dosage is given 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 <1 week of age: AAP recommends 5 mg/kg every 12 hours in those weighing ≤2 kg or 5 mg/kg every 8 hours in those weighing >2 kg.144

Neonates 1–4 weeks of age: AAP recommends 5 mg/kg every 12 hours in those weighing <1.2 kg, 5 mg/kg every 8 hours in those weighing 1.2–2 kg, and 5–7.5 mg/kg every 6 hours in those weighing >2 kg.144

IV or IM

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 <1 week of age: AAP recommends 5 mg/kg every 12 hours in those weighing ≤2 kg or 5 mg/kg every 8 hours in those weighing >2 kg.144

Neonates 1–4 weeks of age: AAP recommends 5 mg/kg every 12 hours in those weighing <1.2 kg, 5 mg/kg every 8 hours in those weighing 1.2–2 kg, and 5–7.5 mg/kg every 6 hours in those weighing >2 kg.144

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, and 17–25 mg/kg daily for more severe infections.121 Daily dosage is given 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.144 AAP states oral route inappropriate for severe infections.144

IV or IM

Manufacturer recommends 20–40 mg/kg daily given in 3 or 4 equally divided doses.139 Alternatively, manufacturer recommends 350 mg/m2 daily for serious infections or 450 mg/m2 daily for more severe infections.139

AAP recommends 15–25 mg/kg daily for mild to moderate infections and 25–40 mg/kg daily for severe infections.144 Daily dosage is given in 3 or 4 equally divided doses.144

Acute Otitis Media (AOM)
Oral

30–40 mg/kg daily in 3 divided doses recommended by AAP and AAFP.253

Pharyngitis and Tonsillitis
Treatment of Symptomatic Patients with Multiple, Recurrent Episodes Known to Caused by Streptococcus pyogenes
Oral

20–30 mg/kg daily in 3 divided doses given for 10 days.122

Babesiosis
Oral

IDSA recommends 7–10 mg/kg (up to 600 mg) every 6–8 hours for 7–10 days; used in conjunction with oral quinine (8 mg/kg [up to 650 mg] every 8 hours for 7–10 days).256 Others recommend 20–40 mg/kg daily in 3 divided doses given for 7–10 days;104 used in conjunction with oral quinine sulfate (25 mg/kg daily in 3 divided doses for 7–10 days).104 111 144

IV

IDSA recommends 7–10 mg/kg (up to 600 mg) every 6–8 hours for 7–10 days; used in conjunction with oral quinine (8 mg/kg [up to 650 mg] every 8 hours for 7–10 days).256

Malaria
Treatment of Uncomplicated Chloroquine-resistant P. falciparum Malaria
Oral

20 mg/kg daily in 3 equally divided doses given for 7 days;104 252 used in conjunction with oral quinine sulfate (10 mg/kg 3 times daily given for 3 days if infection was acquired in Africa or South America or for 7 days if acquired in Southeast Asia).104 252

Treatment of Severe P. falciparum Malaria
Oral

20 mg/kg daily in 3 equally divided doses given for 7 days;252 used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.252

IV, then Oral

10-mg/kg IV loading dose followed by 5 mg/kg IV every 8 hours; when oral therapy is tolerated, switch to oral clindamycin 20 mg/kg daily in 3 divided doses and continue for a total duration of 7 days.252

Used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.252

Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia
Treatment of Mild to Moderate Infections
Oral

Adolescents: 300–450 mg every 6–8 hours given for 21 days;104 254 used in conjunction with oral primaquine (15–30 mg once daily for 21 days).104 254

IV

Adolescents: 600–900 mg every 6–8 hours given for 21 days;104 254 used in conjunction with oral primaquine (15–30 mg once daily for 21 days).104 254

Toxoplasmosis
Treatment in Infants and Children
Oral or IV

5–7.5 mg/kg (up to 600 mg) 4 times daily;255 used in conjunction with oral pyrimethamine (2 mg/kg once daily for 3 days then 1 mg/kg once daily) and oral leucovorin (10–25 mg once daily).255

Continue acute treatment for ≥6 weeks; a longer duration may be appropriate if disease is extensive or response incomplete at 6 weeks.255

Treatment in Adolescents
Oral or IV

600 mg every 6 hours;254 used in conjunction with oral pyrimethamine (200-mg loading dose then 50–75 mg once daily) and oral leucovorin (10–20 mg once daily; higher dosage may be needed).254

Continue acute treatment for ≥6 weeks; longer duration may be appropriate if disease is extensive or response incomplete at 6 weeks.254

Prevention of Recurrence (Secondary Prophylaxis) in Infants and Children
Oral

20–30 mg/kg daily in 4 divided doses;210 used in conjunction with oral pyrimethamine (1 mg/kg or 15 mg/m2 once daily) and oral leucovorin (5 mg once every 3 days).210

Secondary prophylaxis against toxoplasmosis generally is continued for life.210 The safety of discontinuing secondary toxoplasmosis prophylaxis in HIV-infected infants and children receiving potent antiretroviral therapy has not been extensively studied.210

Prevention of Recurrence (Secondary Prophylaxis) in Adolescents
Oral

Dosage for secondary prophylaxis against toxoplasmosis in adolescents and criteria for initiation or discontinuance of such prophylaxis in this age group are the same as those recommended for adults.210 (See Adult Dosage under Dosage and Administration.)

Prevention of Bacterial Endocarditis
Patients Undergoing Certain Dental or Respiratory Tract Procedures
Oral

20 mg/kg as a single dose given 30–60 minutes prior to the procedure.141

IM or IV

20 mg/kg as a single dose given 30–60 minutes prior to the procedure.141

Perioperative Prophylaxis
Head or Neck Surgery
IV

15 mg/kg given at induction of anesthesia (within 0.5–1 hour prior to incision); used with or without IV gentamicin.140 Additional intraoperative doses suggested every 3–6 hours for prolonged procedures (>4 hours) or if major blood loss occurs.125

Adults

General Adult Dosage
Serious Infections
Oral

150–300 mg every 6 hours.126

IV or IM

600 mg to 1.2 g daily in 2–4 equally divided doses.139

More Severe Infections
Oral

300–450 mg every 6 hours.126

IV or IM

1.2–2.7 g daily in 2–4 equally divided doses.139

For life-threatening infections, dosage may be increased up 4.8 g daily.139

Gynecologic Infections
Pelvic Inflammatory Disease
IV, then Oral

Initially, 900 mg IV every 8 hours;124 128 257 used in conjunction with IV or IM gentamicin.124 128 257 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.128 Alternatively, oral doxycycline can be used to complete 14 days of therapy.124 128

Pharyngitis and Tonsillitis
Treatment of Symptomatic Patients with Multiple, Recurrent Episodes Known to Caused by Streptococcus pyogenes
Oral

600 mg daily in 2–4 divided doses given for 10 days.122 IDSA states this dosage was not specifically studied in adults and was extrapolated from pediatric dosage recommendation.122

Anthrax
Treatment of Inhalational Anthrax
IV

900 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.103 116 117 119

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.103 117

Babesiosis
Oral

600 mg 3 times daily given for 7–10 days recommended by IDSA and others;104 256 used in conjunction with oral quinine (650 mg every 6–8 hours for 7–10 days).104 111 256

IV

IDSA recommends 300–600 mg every 6 hours for 7–10 days; used in conjunction with oral quinine (650 mg every 6–8 hours for 7–10 days).256 Others recommend 1.2 g twice daily given for 7–10 days;104 used in conjunction with oral quinine (650 mg 3 times daily for 7–10 days).104 111

Bacterial Vaginosis
Treatment in Pregnant or Nonpregnant Women
Oral

300 mg twice daily given for 7 days.124 128 180 183 193 196 197

Malaria
Treatment of Uncomplicated Chloroquine-resistant P. falciparum Malaria
Oral

20 mg/kg daily in 3 equally divided doses given for 7 days;104 252 used in conjunction with oral quinine sulfate (650 mg 3 times daily given for 3 days if infection was acquired in Africa or South America or for 7 days if acquired in Southeast Asia).104 252

Treatment of Severe P. falciparum Malaria
Oral

20 mg/kg daily in 3 equally divided doses given for 7 days;104 252 used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.104 252

IV, then Oral

10-mg/kg IV loading dose followed by 5 mg/kg IV every 8 hours; when oral therapy is tolerated, switch to oral clindamycin 20 mg/kg daily in 3 divided doses and continue for a total duration of 7 days.252

Used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.252

Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia
Treatment of Mild to Moderate Infections
Oral

300–450 mg every 6–8 hours given for 21 days;104 254 used in conjunction with oral primaquine (15–30 mg once daily for 21 days).104 254

IV

600–900 mg every 6–8 hours given for 21 days;104 254 used in conjunction with oral primaquine (15–30 mg once daily for 21 days).104 254

Toxoplasmosis
Treatment
Oral or IV

600 mg every 6 hours;254 used in conjunction with oral pyrimethamine (200-mg loading dose then 50–75 mg once daily) and oral leucovorin (10–20 mg once daily; higher dosage may be needed).254

Continue acute treatment for ≥6 weeks.254

Prevention of Recurrence (Secondary Prophylaxis)
Oral

300–450 mg every 6–8 hours;210 254 used in conjunction with oral pyrimethamine (25–50 mg once daily) and oral leucovorin (10–25 mg once daily).210 254

Initiate long-term suppressive therapy or chronic maintenance therapy (secondary prophylaxis) in all patients who have completed initial treatment of toxoplasmosis encephalitis (TE).210

Consideration can be given to discontinuing secondary prophylaxis in adults or adolescents who successfully completed initial treatment for TE, are asymptomatic with respect to TE, and have a sustained (≥6 months) increase in CD4+ T-cell counts to >200/mm3.210 254

Reinitiate secondary prophylaxis if CD4+ T-cell count decreases to <200/mm3.210 254

Prevention of Bacterial Endocarditis
Patients Undergoing Certain Dental or Respiratory Tract Procedures
Oral

600 mg as a single dose given 30–60 minutes prior to the procedure.141

IM or IV

600 mg as a single dose given 30–60 minutes prior to the procedure.141

Prevention of Perinatal Group B Streptococcal Disease
Women at Risk Who Should Not Receive β-lactam Anti-infectives
IV

900 mg every 8 hours; initiate at time of labor or rupture of membranes and continue until delivery.214

Perioperative Prophylaxis
Head or Neck Surgery
IV

600–900 mg given at induction of anesthesia (within 0.5–1 hour prior to incision); used with or without IV gentamicin.125 140 Additional intraoperative doses suggested every 3–6 hours for prolonged procedures (>4 hours) or if major blood loss occurs.125

Special Populations

Hepatic Impairment

Dosage adjustments not necessary in those with mild or moderate hepatic impairment.126 139

Renal Impairment

Dosage adjustments not necessary in those with mild or moderate renal impairment.126 139

Cautions for Clindamycin Phosphate

Contraindications

  • Patients hypersensitive to clindamycin or lincomycin.121 126 139

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.121 126 139 Institute appropriate therapy if superinfection occurs.121 126 139

Treatment with anti-infectives may permit overgrowth of clostridia.121 126 139 Consider CDAD if diarrhea develops and manage accordingly.121 126 139

Some mild cases of CDAD may respond to discontinuance alone.121 126 139 238 239 240 241 242 Manage moderate to severe cases with fluid, electrolyte, and protein supplementation; appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) recommended if colitis is severe.121 126 139 238 239 240 241 242

Patients with Meningitis

Do not use for the treatment of meningitis; clindamycin diffusion into CSF is inadequate for these infections.121 126 139

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactoid reactions and erythema multiforme, sometimes resembling Stevens-Johnson syndrome, have been reported rarely.121 126 139

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 who are 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

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.)

Specific Populations

Pregnancy

Category B.121 126 139

Lactation

Distributed into milk;121 126 139 discontinue nursing or the drug.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 A causal relationship not established, but use of injections preserved with benzyl alcohol has been associated with toxicity in neonates.107 108

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults.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).126 139 240 Geriatric patients receiving clindamycin should be carefully monitored for development of diarrhea.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

Interactions for Clindamycin Phosphate

Specific Drugs

Drug

Interaction

Comments

Aminoglycosides

In vitro evidence of antagonismd

Some suggest avoid concomitant use, but in vivo antagonism has not been confirmedd

Erythromycin

In vitro evidence of antagonism121 126 139

Avoid concomitant use121 126 139

Neuromuscular blocking agents (tubocurarine, pancuronium)

Potential for enhanced neuromuscular blocking action126 139 162 175 198 199

Use with caution in patients receiving neuromuscular blocking agents;126 139 162 175 198 199 closely monitor for prolonged neuromuscular blockade199

Clindamycin Phosphate Pharmacokinetics

Absorption

Bioavailability

Approximately 90% of an oral dose of clindamycin hydrochloride rapidly absorbed from GI tract;126 peak serum concentration attained within 45–60 minutes.126 d

Prior to absorption, clindamycin palmitate hydrochloride is hydrolyzed in the GI tract to active clindamycin.d

Clindamycin palmitate oral solution and clindamycin hydrochloride capsules are bioequivalent.d

Following IM administration of clindamycin phosphate, peak serum concentrations occur within 3 hours in adults and 1 hour in children.d

Food

Although peak plasma concentrations may be delayed, food does not have an appreciable effect on the extent of absorption of clindamycin hydrochloride capsules126 or clindamycin palmitate hydrochloride oral solution.121

Distribution

Extent

Distributed into many body tissues and fluids.d

Only small amounts of the drug diffuse into CSF.d

Readily crosses the placentad and is distributed into milk.100

Plasma Protein Binding

93%.d

Elimination

Metabolism

Partially metabolized to bioactive and inactive metabolites.d

Elimination Route

Excreted in urine, bile, and feces.d

Half-life

2–3 hours in adults and children with normal renal function.d

Serum half-life in neonates depends on gestational and chronologic age and body weight.102

Special Populations

Serum half-life increased slightly in patients with markedly reduced renal or hepatic function.d

Stability

Storage

Oral

Capsules

20–25°C.126

For Solution

20–25°C.121 Following reconstitution, stable for 2 weeks at room temperature; do not refrigerate because solution will thicken.121

Parenteral

Injection, for IV infusion

20–25°C;139 avoid temperatures >30°C.139

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

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
Admixture CompatibilityHID

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

Variable

Ranitidine HCl

Y-Site CompatibilityHID

Compatible

Acyclovir sodium

Amifostine

Amiodarone HCl

Amphotericin B cholesteryl sulfate complex

Anakinra

Anidulafungin

Aztreonam

Bivalirudin

Ceftaroline fosamil

Cisatracurium besylate

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

Actions and Spectrum

  • May be bacteriostatic or bactericidal in action, depending on concentration attained at site of infection and susceptibility of the infecting organism.d

  • Inhibits protein synthesis in susceptible organisms by reversibly binding to 50S ribosomal subunits.d

  • Clindamycin palmitate hydrochloride and clindamycin phosphate are inactive until hydrolyzed in vivo to free clindamycin.d

  • Spectrum of activity includes many gram-positive aerobic bacteria, some gram-negative aerobic bacteria, and many gram-positive and -negative anaerobic bacteria.d Inactive against fungi and viruses.d

  • Gram-positive aerobes: Active against Staphylococcus aureus (including penicillinase-producing strains), S. epidermidis (including penicillinase-producing strains), Streptococcus pneumoniae, and other streptococci.121 126 139 d Also active in vitro against Arcanobacterium haemolyticum110 and Bacillus anthracis.103 Enterococci faecalis are resistant.121 126 139 d

  • Gram-negative aerobes: Active against some strains of Corynebacterium diphtheriae, Haemophilus influenzae, and Neisseria gonorrhoeae.d N. meningitidis and Enterobacteriaceae are resistant.d

  • Anaerobes: Active against Actinomyces, Bacteroides, Eubacterium, Fusobacterium, Propionibacterium, Peptococcus, Peptostreptococcus, and Veillonella.d Some strains of Clostridium perfringens are susceptible, but C. difficile and other Clostridium usually are resistant.121 126 139 d

  • Active against Plasmodium.121 126 139 d

  • Complete cross-resistance usually occurs between clindamycin and lincomycin.121 126 139 d

  • Staphylococci resistant to erythromycins rapidly develop clindamycin resistance.121 126 139 d

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

  • Importance of discontinuing drug and informing clinician if significant diarrhea occurs.121 126 139

  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, and any concomitant illnesses

  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.

  • Importance of advising patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Clindamycin Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

75 mg (of clindamycin)

Cleocin HCl

Pfizer

150 mg (of clindamycin)*

Cleocin HCl

Pfizer

300 mg (of clindamycin)

Cleocin HCl

Pfizer

Clindamycin Palmitate Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For solution

75 mg (of clindamycin) per 5 mL

Cleocin Pediatric

Pfizer

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Clindamycin Phosphate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection

150 mg (of clindamycin) per mL*

Cleocin Phosphate

Pfizer

9 g (150 mg/mL) (of clindamycin) pharmacy bulk package

Cleocin Phosphate

Pfizer

Clindamycin Phosphate Injection

Injection, for IV infusion only

150 mg (of clindamycin) per mL (300 mg)

Clindamycin Phosphate ADD-Vantage

150 mg (of clindamycin) per mL (600 and 900 mg)

Cleocin Phosphate ADD-Vantage

Pfizer

Clindamycin Phosphate ADD-Vantage

Clindamycin Phosphate in Dextrose

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 (Galaxy [Baxter])

Pfizer

12 mg (of clindamycin) per mL (600 mg) in 5% Dextrose

Cleocin Phosphate IV (Galaxy [Baxter])

Pfizer

18 mg (of clindamycin) per mL (900 mg) in 5% Dextrose

Cleocin Phosphate IV (Galaxy [Baxter])

Pfizer

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Cleocin 150MG Capsules (PFIZER U.S.): 30/$127.04 or 90/$355.55

Cleocin 75MG/5ML Solution (PFIZER U.S.): 100/$78.70 or 300/$198.46

Clindamycin HCl 150MG Capsules (GREENSTONE): 30/$24.99 or 90/$69.97

Clindamycin HCl 300MG Capsules (WATSON LABS): 30/$79.99 or 90/$238.99

Clindamycin Phosphate 600MG/4ML Solution (HOSPIRA): 4/$13.99 or 12/$20.42

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions June 19, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† 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.

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