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Clindamycin (Systemic)

Medically reviewed on Sep 10, 2018

Pronunciation

(klin da MYE sin)

Index Terms

  • Clindamycin HCl
  • Clindamycin Hydrochloride
  • Clindamycin Palmitate
  • Clindamycin Palmitate HCl

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral, as hydrochloride [strength expressed as base]:

Cleocin: 75 mg, 150 mg [contains brilliant blue fcf (fd&c blue #1), tartrazine (fd&c yellow #5)]

Cleocin: 300 mg [contains brilliant blue fcf (fd&c blue #1)]

Generic: 75 mg, 150 mg, 300 mg

Kit, Injection, as phosphate [strength expressed as base]:

CLIN Single Use: 300 mg/2 mL [contains benzyl alcohol, edetate disodium]

Solution, Injection, as phosphate [strength expressed as base]:

Cleocin Phosphate: 300 mg/2 mL (2 mL) [contains benzyl alcohol]

Cleocin Phosphate: 300 mg/2 mL (2 mL); 600 mg/4 mL (4 mL) [contains benzyl alcohol, edetate disodium]

Cleocin Phosphate: 900 mg/6 mL (6 mL) [contains benzyl alcohol]

Cleocin Phosphate: 900 mg/6 mL (6 mL); 9 g/60 mL (60 mL) [contains benzyl alcohol, edetate disodium]

Generic: 300 mg/2 mL (2 mL); 600 mg/4 mL (4 mL); 900 mg/6 mL (6 mL); 9000 mg/60 mL (60 mL); 9 g/60 mL (60 mL)

Solution, Intravenous, as phosphate [strength expressed as base]:

Cleocin in D5W: 300 mg/50 mL (50 mL) [contains benzyl alcohol, edetate disodium]

Cleocin in D5W: 300 mg/50 mL (50 mL) [contains edetate disodium]

Cleocin in D5W: 600 mg/50 mL (50 mL) [contains benzyl alcohol, edetate disodium]

Cleocin in D5W: 600 mg/50 mL (50 mL [DSC]) [contains edetate disodium]

Cleocin in D5W: 900 mg/50 mL (50 mL) [contains benzyl alcohol, edetate disodium]

Cleocin in D5W: 900 mg/50 mL (50 mL [DSC]) [contains edetate disodium]

Cleocin Phosphate: 300 mg/2 mL (2 mL); 600 mg/4 mL (4 mL); 900 mg/6 mL (6 mL) [contains benzyl alcohol, edetate disodium]

Generic: 300 mg/50 mL (50 mL); 600 mg/50 mL (50 mL); 900 mg/50 mL (50 mL); 150 mg/mL (2 mL); 300 mg/2 mL (2 mL); 600 mg/4 mL (4 mL); 900 mg/6 mL (6 mL); 300 mg/50 mL in NaCl 0.9% (50 mL); 600 mg/50 mL in NaCl 0.9% (50 mL); 900 mg/50 mL in NaCl 0.9% (50 mL)

Solution Reconstituted, Oral, as palmitate hydrochloride [strength expressed as base]:

Cleocin: 75 mg/5 mL (100 mL) [contains ethylparaben]

Generic: 75 mg/5 mL (100 mL)

Brand Names: U.S.

  • Cleocin
  • Cleocin in D5W
  • Cleocin Phosphate
  • CLIN Single Use

Pharmacologic Category

  • Antibiotic, Lincosamide

Pharmacology

Reversibly binds to 50S ribosomal subunits preventing peptide bond formation thus inhibiting bacterial protein synthesis; bacteriostatic or bactericidal depending on drug concentration, infection site, and organism

Absorption

Oral, hydrochloride: Rapid (90%); clindamycin palmitate must be hydrolyzed in the GI tract before it is active

Distribution

Distributed in body fluids and tissues; no significant levels in CSF, even with inflamed meninges

Metabolism

Biologically inactive clindamycin phosphate (intravenous formulation) is rapidly converted to active clindamycin. Clindamycin is metabolized predominantly by CYP3A4, with minor contribution by CYP3A5, to form clindamycin sulfoxide (major metabolite) and N-desmethylclindamycin (minor metabolite)

Excretion

Urine (~10%) and feces (3.6%) as active drug and metabolites

Time to Peak

Serum: Oral: Within 60 minutes; IM: 1 to 3 hours

Half-Life Elimination

Neonates: Premature: 8.7 hours; Full-term: 3.6 hours; Infants 1 month to 1 year: 3 hours; Children: ~2.5 hours; Adults: 3 hours; Elderly (oral) ~4 hours (range: 3.4 to 5.1 hours)

Protein Binding

94%

Use: Labeled Indications

Bone and joint infections: Treatment of bone and joint infections, including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections caused by susceptible organisms.

Gynecological infections: Treatment of gynecologic infections, including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes.

Intra-abdominal infections: Treatment of intra-abdominal infections, including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms.

Lower respiratory tract infections: Treatment of lower respiratory tract infections, including pneumonia, empyema, and lung abscess caused by susceptible anaerobes, Streptococcus pneumoniae, other streptococci (except Enterococcus faecalis), and S. aureus.

Septicemia: Treatment of septicemia caused by S. aureus, streptococci (except E. faecalis), and susceptible anaerobes.

Skin and skin structure infections: Treatment of skin and skin structure infections caused by Streptococcus pyogenes, S. aureus, and susceptible anaerobes.

Off Label Uses

Acute bacterial rhinosinusitis (children)

Based on the Infectious Diseases Society of America (IDSA) guidelines for acute bacterial rhinosinusitis (ABRS) in children and adults, clindamycin (in combination with a third-generation cephalosporin) is an effective and recommended therapy for the treatment of ABRS.

Acute otitis media (children)

According to American Academy of Pediatrics (AAP) guidelines on the management of acute otitis media, when an antibiotic is considered necessary, amoxicillin should be prescribed for most children. Oral clindamycin is an alternative option in children with an infection known or presumed to be caused by penicillin-resistant Streptococcus pneumoniae. In addition, clindamycin is recommended as an alternative treatment in patients who have failed initial or second courses of antibiotic therapy.

Anthrax

Based on the Centers for Disease Control and Prevention (CDC) expert panel meetings on prevention and treatment of anthrax in adults and recommendations from the American Academy of Pediatrics (AAP) for pediatric anthrax clinical management, clindamycin is an effective and acceptable alternative for postexposure prophylaxis or treatment of cutaneous anthrax; it is also a first-line option, in combination with other antimicrobials, for the treatment of systemic anthrax. Alternative regimens have also been suggested for other patient populations with anthrax, including injectable drug users who develop injectional anthrax [Hicks 2012].

Babesiosis

Based on the IDSA guidelines for the clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis, clindamycin (in combination with quinine) is an effective and recommended option for the treatment of babesiosis.

Bacterial vaginosis

Based on the CDC sexually transmitted diseases treatment guidelines, oral clindamycin is an effective and recommended alternative agent for patients with bacterial vaginosis.

Bite wounds, prophylaxis or treatment (animal or human bites)

Based on the IDSA guidelines for the diagnosis and management of skin and soft tissue infections (SSTIs), clindamycin, in combination with a second- or third-generation cephalosporin, levofloxacin, or sulfamethoxazole and trimethoprim, is an effective and recommended alternative for treatment of animal bite wounds.

Community-acquired pneumonia (CAP) (children)

Following clinical guideline recommendations on the management of CAP reduces the incidence of morbidity and mortality related to pneumonia. Clindamycin is the preferred oral option for treatment of CAP caused by MRSA and should be added to empiric beta-lactam therapy when Staphylococcus aureus is suspected. It can be used for pathogen-directed therapy aimed at penicillin-resistant S. pneumoniae, group A streptococcus (GAS), or methicillin-susceptible S. aureus (MSSA) in children older than 3 months of age. Clindamycin has been associated with severe, fatal colitis.

Diabetic foot infection, mild to moderate

Based on the IDSA guidelines for the diagnosis and treatment of diabetic foot infections, clindamycin is an effective and recommended alternative treatment option for mild diabetic foot infection due to S. aureus or Streptococcus spp and, in combination with ciprofloxacin or levofloxacin, for moderate diabetic foot infection

Endocarditis, prophylaxis (dental or invasive respiratory tract procedures) (alternative agent for penicillin-allergic patients)

Based on the American Heart Association (AHA) guidelines for the prevention of infective endocarditis, clindamycin is an effective and recommended alternative agent for the prevention of infective endocarditis associated with dental or respiratory tract procedures in patients with certain cardiac conditions who are allergic to penicillins or ampicillin.

Group B streptococci, maternal prophylaxis for prevention of neonatal disease

Based on the CDC guidelines for the prevention of perinatal group B streptococcal disease (GBS), the use of clindamycin is effective and recommended in patients at high risk for anaphylaxis due to penicillin allergy if the GBS isolate is sensitive to clindamycin and erythromycin or if testing for inducible clindamycin resistance is negative when the isolate is resistant to erythromycin.

Hidradenitis suppurativa

Data from a prospective, observational cohort study and a retrospective cohort study suggest that clindamycin, in combination with rifampin, may be beneficial for the treatment of hidradenitis suppurativa [Dessinioti 2016], [Gener 2009]. Based on the European S1 guideline on hidradenitis suppurativa/acne inversa, clindamycin, in combination with rifampin, is an effective and recommended agent for the treatment of hidradenitis suppurativa.

Malaria

Based on the CDC guidelines for the treatment of malaria, clindamycin, in combination with quinidine or quinine, is effective and recommended for the treatment of malaria.

Neutropenic fever, empiric therapy for low-risk cancer patients (alternative agent for penicillin-allergic patients)

Data from a prospective, randomized, open-label study support the use of clindamycin (in combination with ciprofloxacin) for the outpatient management of neutropenic fever in low-risk cancer patients [Rubenstein 1993]. Based on the IDSA guidelines for the use of antimicrobial agents in neutropenic patients with cancer and the American Society of Clinical Oncology (ASCO) and IDSA guidelines for the outpatient management of fever and neutropenia in adults treated for malignancy, clindamycin (in combination with ciprofloxacin) is an effective and recommended agent for the management of neutropenic fever in low-risk cancer patients.

Odontogenic infection

Data from two randomized, prospective, blinded (one single-blind, one double-blind) studies support the use of clindamycin for the treatment of odontogenic infections [Cachovan 2011], [Tancawan 2015].

Perioperative prophylaxis

Based on the American Society of Health-System Pharmacists (ASHP) clinical practice guidelines for antimicrobial prophylaxis in surgery, clindamycin, given as an alternative antibiotic in patients with beta-lactam allergy requiring surgical prophylaxis, is effective and recommended for a number of surgical procedures.

Pneumocystis jiroveci pneumonia (PCP), treatment (adolescents and adults)

Based on the US Department of Health and Human Services (HHS) guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents, clindamycin (with primaquine) is an effective and recommended alternative regimen for the treatment of PCP in HIV-infected adolescents and adults.

Pneumonia due to methicillin-resistant Staphylococcus aureus (MRSA)

Based on the IDSA guidelines for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children, clindamycin is effective and recommended in the treatment of community-acquired MRSA pneumonia.

Postpartum endometritis

Data from a prospective, randomized study as well as a meta-analysis of randomized studies support the use of clindamycin (in combination with gentamicin) for the treatment of postpartum endometritis [Gall 1996], [Mackeen 2015]. Clinical experience also suggests the utility of clindamycin (in combination with gentamicin) for the treatment of postpartum endometritis [ACOG 1998].

Prosthetic joint infection

Data from a retrospective review suggest that clindamycin may be beneficial for the treatment of prosthetic joint infection caused by beta-hemolytic streptococci [Sendi 2011]. Clinical experience also suggests the utility of clindamycin as an alternative agent in the treatment of prosthetic joint infection caused by beta-hemolytic streptococci [Berbari 2018].

Based on the IDSA guidelines for the management of prosthetic joint infection, clindamycin is an effective and recommended alternative agent for the treatment of prosthetic joint infection due to Cutibacterium acnes.

Streptococcal (group A) pharyngitis and chronic carriage (adults)

Based on the IDSA guidelines for the diagnosis and management of group A streptococcal pharyngitis, clindamycin is an effective and recommended alternative agent for the treatment of streptococcal pharyngitis and an option for treatment of chronic GAS carriage.

Toxoplasma gondii encephalitis and pneumonitis (treatment/long-term maintenance)

Based on the US Department of Health and Human Services (HHS) guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents and the American Society of Transplantation Infectious Diseases Community of Practice guidelines on parasitic infections in solid organ transplantation, clindamycin (with pyrimethamine and leucovorin) is an effective and recommended alternative regimen for the treatment and long-term maintenance therapy of Toxoplasma gondii encephalitis and pneumonitis.

Contraindications

Hypersensitivity to clindamycin, lincomycin, or any component of the formulation.

Canadian labeling: Additional contraindications (not in US labeling): Oral clindamycin: Infants <30 days of age.

Dosing: Adult

Usual dose:

Oral: 600 to 1,800 mg/day in 2 to 4 divided doses; up to 2,400 mg/day in 4 divided doses may be given for severe infections

IM, IV: 600 to 2,700 mg/day in 2 to 4 divided doses; according to the manufacturer, up to 4,800 mg/day IV (in divided doses) has been used in life-threatening infections; however, data supporting this dose are lacking; maximum: 600 mg/dose IM

Anthrax (off-label use): Note: Consult public health officials for event-specific recommendations.

Inhalational exposure postexposure prophylaxis (alternative agent): Oral: 600 mg every 8 hours for 60 days. Note: Anthrax vaccine should also be administered to exposed individuals (CDC [Hendricks 2014]).

Cutaneous, without systemic involvement, empiric therapy (alternative agent): Oral: 600 mg every 8 hours for 60 days following biological weapon-related event; duration is 7 to 10 days after naturally acquired infection. Note: Patients with cutaneous lesions of the head or neck or extensive edema should be treated for systemic involvement (CDC [Hendricks 2014]).

Systemic, meningitis excluded: IV: 900 mg every 8 hours in combination with other appropriate agents for at least 2 weeks or until clinically stable, whichever is longer (CDC [Hendricks 2014]).

Meningitis (alternative agent): IV: 900 mg every 8 hours in combination with other appropriate agents for at least 2 to 3 weeks or until clinically stable, whichever is longer (CDC [Hendricks 2014]).

Note: Following the course of IV combination therapy for systemic anthrax infection (including meningitis), patients exposed to aerosolized spores require oral monotherapy to complete a total antimicrobial course of 60 days (CDC [Hendricks 2014]).

Babesiosis (off-label use):

Mild to moderate disease: Oral: 600 mg every 8 hours in combination with quinine for 7 to 10 days (IDSA [Wormser 2006])

Severe disease: IV: 600 mg every 6 hours for 7 to 10 days in combination with quinine (IDSA [Wormser 2006]; Krause 2018); patients with persistent or relapsing infection require at least 6 weeks of treatment, including for 2 weeks after resolution of parasitemia (Krause 2008). Clindamycin can be given orally once symptoms have abated and parasitemia is reduced (Krause 2018; Sanchez 2016).

Bacterial vaginosis (alternative agent) (off-label use): Oral: 300 mg twice daily for 7 days (CDC [Workowski 2015])

Bite wounds, prophylaxis or treatment, animal or human bites (alternative agent) (off-label use): Note: For animal bites, use in combination with an appropriate agent for Pasteurella multocida. For human bites, use in combination with an appropriate agent for Eikenella corrodens (IDSA [Stevens 2014]).

Oral: 300 to 450 mg 3 times daily (Baddour 2018; IDSA [Stevens 2014])

IV: 600 mg every 6 to 8 hours (IDSA [Stevens 2014]). Note: In selected patients with high-risk wounds, some experts recommend parenteral therapy be given initially until infection is resolving, followed by oral therapy (Harper 2018).

Note: For prophylaxis, duration is 3 to 5 days (IDSA [Stevens 2014]); for treatment of established infection, duration varies based on patient-specific factors (Harper 2018).

Diabetic foot infection, mild to moderate (alternative agent) (off-label use): Oral: 300 to 450 mg every 6 to 8 hours (Bader 2008; IDSA [Lipsky 2012]; Lipsky 1990; Weintrob 2018). Note: May be used alone for empiric therapy of mild infections; if there are risk factors for gram-negative bacilli, must be used in combination with other appropriate agents. Duration of therapy should be tailored to individual clinical circumstances; most patients respond to 1 to 2 weeks of therapy (IDSA [Lipsky 2012]; Weintrob 2018).

Endocarditis, prophylaxis (dental or invasive respiratory tract procedures) (alternative agent for penicillin-allergic patients) (off-label use):

Oral: 600 mg as a single dose 30 to 60 minutes prior to procedure (AHA [Wilson 2007])

IM, IV: 600 mg as a single dose 30 to 60 minutes before procedure (only if unable to tolerate or absorb oral therapy) (AHA [Wilson 2007])

Note: Only recommended for patients with cardiac conditions associated with the highest risk of an adverse outcome from endocarditis and who are undergoing a procedure likely to result in bacteremia with an organism that has the potential ability to cause endocarditis.

Group B streptococci, maternal prophylaxis for prevention of neonatal disease (alternative agent) (off-label use): IV: 900 mg every 8 hours until delivery. Note: Reserve for penicillin-allergic patients at high risk for anaphylaxis (CDC [Verani 2010]).

Hidradenitis suppurativa (off-label use): Oral: 300 mg twice daily in combination with rifampin for 10 to 12 weeks (Dessinioti 2016; Gener 2009; Gulliver 2016; Zouboulis 2015)

Malaria (off-label use):

Uncomplicated malaria, treatment, chloroquine-resistant or unknown resistance (alternative agent): Oral: 20 mg/kg/day in divided doses every 8 hours for 7 days in combination with quinine sulfate. Note: Quinine sulfate duration is region specific (CDC 2013).

Severe malaria, treatment: IV: Loading dose: 10 mg/kg followed by 5 mg/kg every 8 hours in combination with IV quinidine gluconate; may switch to oral therapy (clindamycin plus quinine sulfate) when tolerated. Note: Duration of clindamycin is 7 days. Quinine sulfate duration is region specific (CDC 2013).

Neutropenic fever, empiric therapy for low-risk cancer patients (alternative agent for penicillin-allergic patients) (off-label use): Oral: 600 mg every 8 hours (Rubenstein 1993); some experts recommend 300 mg every 6 hours (Bow 2018) (data on appropriate dose are limited). Use in combination with oral ciprofloxacin; continue until afebrile and neutropenia has resolved. Note: Avoid in patients who have received fluoroquinolone prophylaxis. Administer first dose in the health care setting (after blood cultures are drawn); observe patient for ≥4 hours before discharge (ASCO/IDSA [Taplitz 2018]; IDSA [Freifeld 2011]).

Odontogenic infection (alternative agent for penicillin-allergic patients) (off-label use):

IV: 600 mg every 8 hours until improved, then transition to oral clindamycin (Bhagania 2018; Chow 2018).

Oral (initial therapy for mild infection or step-down after parenteral treatment): 450 mg every 8 hours to complete a 7- to 14-day course (Chow 2018); doses in the literature varied from 150 mg every 6 hours (Tancawan 2015) to 300 mg every 6 hours (Cachovan 2011) to 600 mg every 8 hours (Bhagania 2018).

Osteomyelitis:

Osteomyelitis due to MRSA (alternative agent): IV, Oral: 600 mg 3 times daily for a minimum of 8 weeks; some experts combine with rifampin (IDSA [Liu 2011]).

Osteomyelitis, native vertebral due to staphylococci, methicillin-susceptible (alternative agent):

IV: 600 to 900 mg every 8 hours for 6 weeks (IDSA [Berbari 2015])

Oral: 300 to 450 mg 4 times daily (IDSA [Berbari 2015]) or 600 mg 3 times daily (IDSA [Liu 2011]) for 6 weeks (IDSA [Berbari 2015]).

Osteomyelitis, native vertebral due to Cutibacterium acnes (alternative agent): IV: 600 to 900 mg every 8 hours for 6 weeks (IDSA [Berbari 2015])

Pelvic inflammatory disease, severe: IV: 900 mg every 8 hours with gentamicin; after 24 to 48 hours of sustained clinical improvement, transition to clindamycin 450 mg orally 4 times daily (or oral doxycycline) to complete 14 days of therapy. Note: If tubo-ovarian abscess is present, oral clindamycin should be given in combination with doxycycline to complete at least 14 days of therapy rather than giving doxycycline alone (CDC [Workowski 2015]).

Perioperative prophylaxis (in combination with other appropriate agents when coverage for MRSA is indicated or for gram-positive coverage in patients unable to tolerate cephalosporins) (off-label use): IV: 900 mg started within 60 minutes prior to initial surgical incision. Clindamycin doses may be repeated intraoperatively at 6-hour intervals if procedure is lengthy or if there is excessive blood loss (ASHP/IDSA/SIS/SHEA [Bratzler 2013]). In cases where an extension of prophylaxis is warranted postoperatively, total duration should be ≤24 hours (Anderson 2014; ASHP/IDSA/SIS/SHEA [Bratzler 2013]). For clean and clean-contaminated procedures, continued prophylactic antibiotics beyond surgical incision closure is not recommended, even in the presence of a drain (CDC [Berríos-Torres 2017]).

Pneumocystis jiroveci pneumonia (PCP), treatment (alternative agent) (off-label use):

Mild to moderate disease: Oral: 450 mg every 6 hours or 600 mg every 8 hours with primaquine for 21 days (HHS [OI adult 2017])

Severe disease: IV: 600 mg every 6 hours or 900 mg every 8 hours with primaquine for 21 days; following clinical improvement, clindamycin can be given orally at 450 mg every 6 hours or 600 mg every 8 hours (HHS [OI adult 2017]; Thomas 2018).

Note: Patients with moderate or severe infection (PaO2 <70 mm Hg at room air or alveolar-arterial oxygen gradient ≥35 mm Hg) should receive adjunctive glucocorticoids (HHS [OI adult 2017]).

Pneumonia due to MRSA (alternative agent) (off-label use): Oral, IV: 600 mg 3 times daily for 7 to 21 days (IDSA [Liu 2011])

Postpartum endometritis (off-label use): IV: 900 mg every 8 hours plus gentamicin (ACOG 1998; Gall 1996). Treat until the patient is clinically improved (no fundal tenderness) and afebrile for 24 to 48 hours (ACOG 1998; Chen 2018).

Prosthetic joint infection (alternative agent for penicillin allergy) (off-label use):

Beta-hemolytic streptococci, treatment: IV: 900 mg every 8 hours (Berbari 2018)

Cutibacterium acnes, treatment:

IV: 600 to 900 mg every 8 hours for 4 to 6 weeks (IDSA [Osmon 2013])

Oral: 300 to 450 mg every 6 hours (IDSA [Osmon 2013]), following at least 2 weeks of parenteral therapy (Kanafani 2018)

Septic arthritis due to Staphylococcus aureus (including MRSA) (alternative agent): Oral, IV: 600 mg 3 times daily for 3 to 4 weeks (Goldenberg 2018; IDSA [Liu 2011]). Note: A longer course of parenteral therapy (up to 4 weeks) may be required in the setting of concomitant bacteremia and arthritis (Goldenberg 2018).

Skin and soft tissue infections:

Impetigo or ecthyma if MRSA is suspected or confirmed (alternative agent): Oral: 300 to 450 mg 4 times daily for 7 days (IDSA [Stevens 2014)

Nonpurulent cellulitis or erysipelas due to beta-hemolytic streptococci or Staphylococcus aureus (including MRSA), empiric or pathogen-directed therapy (alternative agent):

Oral: 300 to 450 mg 4 times daily

IV: 600 mg to 900 mg every 8 hours

Note: Transition to oral therapy once improving; treat for at least 5 days but may extend to 14 days depending on severity and clinical response (IDSA [Stevens 2014]; Spelman 2018).

Purulent cellulitis or abscess due to Staphylococcus aureus (including MRSA) or beta-hemolytic streptococci (alternative agent):

Oral: 300 to 450 mg 4 times daily. Treat for 5 to 14 days depending on severity and clinical response.

Note: Systemic antibiotics only indicated for certain instances (eg, immunocompromised patients, signs of systemic infection, large or multiple abscess, indwelling device, high risk for adverse outcome with endocarditis). If at risk for gram-negative bacilli, use in combination with an appropriate agent (IDSA [Stevens 2014]; Spelman 2018).

Necrotizing soft tissue infections (alternative agent): IV: 600 to 900 mg every 8 hours as part of an appropriate combination regimen. Note: Antibiotic therapy must be used in conjunction with early and aggressive surgical exploration and debridement of necrotic tissue and hemodynamic support (IDSA [Stevens 2014]; Stevens 2018a).

Streptococcus (group A):

Pharyngitis (alternative agent for penicillin-allergic patients) (off-label use): Oral: 300 mg 3 times daily for 10 days (IDSA [Shulman 2012])

Chronic carriage (off-label use): Oral: 300 mg 3 times daily for 10 days. Note: Most individuals with chronic carriage do not require antimicrobial treatment (IDSA [Shulman 2012])

Toxic shock syndrome (empiric therapy): IV: 900 mg every 8 hours as part of an appropriate combination regimen (Lappin 2009; Wong 2013). Duration of therapy varies based on causative organism and response to therapy; treat patients who are bacteremic for at least 14 days (Stevens 2018b).

Toxoplasma gondii encephalitis and pneumonitis (alternative agent) (off-label use):

Initial treatment: Oral, IV: 600 mg every 6 hours in combination with pyrimethamine and leucovorin. Continue therapy for at least 6 weeks; longer duration may be required if incomplete response or extensive disease; after completion of acute therapy, all patients should receive long-term maintenance therapy (HHS [OI adult 2017]; Schwartz 2013).

Long-term maintenance therapy: Oral: 600 mg every 8 hours in combination with pyrimethamine and leucovorin (HHS [OI adult 2017]; Schwartz 2013); in HIV-infected patients, may discontinue when asymptomatic with a CD4 count >200 cells/mm3 and an undetectable HIV viral load for >6 months in response to ART (HHS [OI adult 2017])

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Usual dose:

Neonates: IM, IV: Manufacturer’s labeling: 15 to 20 mg/kg/day divided every 6 to 8 hours.

Infants, Children, and Adolescents:

Oral: 8 to 40 mg/kg/day in 3 to 4 divided doses; Manufacturer’s labeling: 8 to 20 mg/kg/day (as hydrochloride) or 8 to 25 mg/kg/day (as palmitate) in 3 to 4 divided doses; minimum dose of palmitate: 37.5 mg 3 times daily

IM, IV: Manufacturer’s labeling: 20 to 40 mg/kg/day or 350 to 450 mg/m2/day in 3 to 4 divided doses

Acute bacterial rhinosinusitis (off-label use): Oral: 30 to 40 mg/kg/day divided every 8 hours with concomitant cefixime or cefpodoxime for 10 to 14 days. Note: Recommended in patients with non-type I penicillin allergy, after failure of initial therapy or in patients at risk for antibiotic resistance (eg, daycare attendance, age <2 years, recent hospitalization, antibiotic use within the past month) (IDSA [Chow 2012]).

Acute otitis media (off-label use): Oral: 30 to 40 mg/kg/day in 3 divided doses for 5 to 10 days. Use with or without concomitant third-generation cephalosporin for failure of initial antibiotic therapy; use with a third-generation cephalosporin is recommended for failure of a second course of antibiotics. Duration depends upon illness severity and patient age: Severe illness or <2 years: 10 days; 2 to 5 years: 7 days; children ≥6 years: 5 to 7 days (Lieberthal 2013).

Anthrax (off-label use) (AAP [Bradley 2014]):

Postexposure prophylaxis: Oral: 30 mg/kg/day divided every 8 hours for 60 days after exposure (maximum: 900 mg/dose)

Cutaneous, treatment: Oral: 30 mg/kg/day divided every 8 hours for 7 to 10 days after naturally acquired infection; up to 60 days following biological weapon related event (maximum: 900 mg/dose)

Systemic, treatment: IV: 40 mg/kg/day divided every 8 hours for ≥14 days (maximum: 900 mg/dose); use in combination with a bactericidal antimicrobial (eg, fluoroquinolone, penicillin G); if meningitis is suspected or cannot be ruled out, use in combination with 2 bactericidal antimicrobials (eg, fluoroquinolone and beta-lactam or glycopeptide). Continue with prophylaxis therapy for up to 60 days from onset of illness.

Babesiosis (off-label use): Oral: 20 to 40 mg/kg/day divided every 8 hours for 7 to 10 days plus quinine (Red Book [AAP 2015])

Impetigo: Oral: 20 mg/kg/day divided every 8 hours for 7 days, depending on response (IDSA [Stevens 2014])

Malaria, severe (off-label use): IV: Load: 10 mg/kg followed by 15 mg/kg/day divided every 8 hours plus IV quinidine gluconate; switch to oral therapy (clindamycin plus quinine) when able for total clindamycin treatment duration of 7 days (Note: Quinine duration is region specific, consult CDC for current recommendations) (CDC 2013)

Malaria, uncomplicated treatment (off-label use): Oral: 20 mg/kg/day divided every 8 hours for 7 days plus quinine (CDC 2013)

Osteomyelitis due to MRSA (off-label use): IV, Oral: 10 to 13 mg/kg/dose every 6 to 8 hours for a minimum of 4 to 6 weeks (maximum: 40 mg/kg/day) (IDSA [Liu 2011])

Pharyngitis, group A streptococci (IDSA recommendations): Oral:

Acute treatment in penicillin-allergic patients: 21 mg/kg/day divided every 8 hours (maximum: 300 mg per dose) for 10 days (IDSA [Shulman 2012])

Chronic carrier treatment: 20 to 30 mg/kg/day divided every 8 hours (maximum: 300 mg per dose) for 10 days (IDSA [Shulman 2012])

Pneumocystis pneumonia (PCP) in HIV-infected patients (alternative to preferred therapy) (off-label use): Adolescents: Refer to adult dosing.

Pneumonia:

Community-acquired pneumonia (CAP) (IDSA/PIDS [Bradley 2011]): Infants >3 months and Children: Note: In children ≥5 years, a macrolide antibiotic should be added if atypical pneumonia cannot be ruled out.

Group A Streptococcus:

Moderate to severe infection (alternative to ampicillin/penicillin): IV: 40 mg/kg/day divided every 6 to 8 hours

Mild infection, step-down therapy (alternative to amoxicillin/penicillin): Oral: 40 mg/kg/day divided every 8 hours

Presumed bacterial (in addition to recommended antibiotic therapy), S. pneumoniae moderate to severe (MICs to penicillin ≤2.0 mcg/mL) (alternative to ampicillin/penicillin): IV: 40 mg/kg/day divided every 6 to 8 hours

S. pneumoniae:

Moderate to severe infection (MICs to penicillin ≥4.0 mcg/mL) (alternative to ceftriaxone): IV: 40 mg/kg/day divided every 6 to 8 hours

Mild infection, step-down therapy (MICs to penicillin ≥4.0 mcg/mL) (alternative to levofloxacin or linezolid): Oral: 30 to 40 mg/kg/day divided every 8 hours

S. aureus (methicillin-susceptible):

Moderate to severe infection (alternative to cefazolin or oxacillin): IV: 40 mg/kg/day divided every 6 to 8 hours

Mild infection, step-down therapy (alternative to cephalexin): Oral: 30 to 40 mg/kg/day divided every 6 to 8 hours

S. aureus (methicillin-resistant/clindamycin-susceptible):

Moderate to severe infection (preferred): IV: 40 mg/kg/day divided every 6 to 8 hours; recommended duration: 7 to 21 days (IDSA [Liu 2011])

Mild infection, step-down therapy (preferred): Oral: 30 to 40 mg/kg/day divided every 6 to 8 hours; recommended duration: 7 to 21 days (IDSA [Liu 2011])

Health care-associated pneumonia (HAP) (methicillin-resistant/clindamycin-susceptible): Children: Oral, IV: 30 to 40 mg/kg/day divided every 6 to 8 hours for 7 to 21 days (IDSA [Liu 2011])

Prophylaxis against infective endocarditis (off-label use):

Oral: 20 mg/kg 30 to 60 minutes before procedure (Wilson 2007)

IM, IV: 20 mg/kg 30 to 60 minutes before procedure. Intramuscular injections should be avoided in patients who are receiving anticoagulant therapy. In these circumstances, orally administered regimens should be given whenever possible. Intravenously administered antibiotics should be used for patients who are unable to tolerate or absorb oral medications (Wilson 2007).

Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA.

Septic arthritis due to MRSA (off-label use): IV, Oral: 10 to 13 mg/kg/dose every 6 to 8 hours for minimum of 3 to 4 weeks (maximum: 40 mg/kg/day) (IDSA [Liu 2011])

Skin and soft tissue infections due to MSSA:

Oral: 25 to 30 mg/kg/day divided every 8 hours for 7 to 14 days (IDSA [Stevens 2014])

IV: 25 to 40 mg/kg/day divided every 8 hours for 7 to 14 days (IDSA [Stevens 2014])

Skin and soft tissue infections due to MRSA (off-label use):

Oral: 30 to 40 mg/kg/day divided every 8 hours for 7 to 14 days (IDSA [Stevens 2014])

IV: 25 to 40 mg/kg/day divided every 8 hours for 7 to 14 days (IDSA [Stevens 2014])

Complicated infections: Oral, IV: 10 to 13 mg/kg/dose every 6 to 8 hours for 7 to 14 days (maximum: 40 mg/kg/day) (IDSA [Liu 2011])

Cellulitis: Oral: 10 to 13 mg/kg/dose every 6 to 8 hours for 5 to 10 days (maximum: 40 mg/kg/day) (IDSA [Liu 2011])

Skin and soft tissue necrotizing infections (off-label use): IV: 10 to 13 mg/kg/dose every 8 hours, in combination with cefotaxime for empiric therapy of polymicrobial infections or in combination with penicillin IV for the treatment of group A streptococcal or Clostridium species necrotizing infections. May give as monotherapy for MSSA. Continue until further debridement is not necessary, patient has clinically improved, and patient is afebrile for 48 to 72 hours (IDSA [Stevens 2014])

Streptococcal skin infections: IV: 10 to 13 mg/kg/dose every 8 hours (IDSA [Stevens 2014])

Surgical (perioperative) prophylaxis (off-label use): IV: 10 mg/kg within 60 minutes prior to surgical incision. Doses may be repeated in 6 hours if procedure is lengthy (maximum single dose: 900 mg) (Bratzler 2013).

Toxoplasma gondii encephalitis in HIV-exposed/-positive patients (off-label use):

Children:

Treatment: IV, Oral: 5 to 7.5 mg/kg/dose (maximum dose: 600 mg) every 6 hours (plus pyrimethamine and leucovorin) (HHS [pediatric] 2016).

Secondary prevention: Oral: 7 to 10 mg/kg/dose (maximum dose: 600 mg) every 8 hours (plus pyrimethamine and leucovorin) (HHS [pediatric] 2016).

Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

Mild to severe impairment: No dosage adjustment necessary

End-stage renal disease (ESRD) on hemodialysis or peritoneal dialysis: Not removed from serum (eg, poorly dialyzed); no supplemental dose or dosage adjustment necessary (Aronoff 2007).

Continuous renal replacement therapy (CRRT) (eg, CVVH, CVVHD, CVVHDF): No supplemental dose or dosage adjustment necessary (Heintz 2009).

Dosing: Hepatic Impairment

Mild impairment: There are no dosage adjustments provided in the manufacturer's labeling.

Moderate to severe impairment: There are no dosage adjustments provided in the manufacturer's labeling; in studies of patients with moderate or severe liver disease, half-life is prolonged, however, when administered on an every 8 hour schedule, accumulation should rarely occur. In severe liver disease, use caution and monitor liver enzymes periodically during therapy.

Reconstitution

Injection: Never administer undiluted as bolus. For IV infusion, dilute vials with 50 to 100 mL of compatible diluent (eg, D5W, NS); concentration of clindamycin for IV infusion should not exceed 18 mg/mL.

Oral solution: Reconstitute bottles of 100 mL with 75 mL of water. Add a large portion of the water and shake vigorously; add the remainder of the water and shake until the solution is uniform. When reconstituted with water, each 5 mL of solution contains clindamycin palmitate hydrochloride equivalent to clindamycin 75 mg.

Administration

IM: Deep IM sites, rotate sites; do not exceed 600 mg in a single injection.

IV: Never administer undiluted as bolus; administer by IV intermittent infusion over at least 10 to 60 minutes, at a maximum rate of 30 mg/minute (do not exceed 1,200 mg/hour).

Oral: Capsule should be taken with a full glass of water to avoid esophageal irritation; shake oral solution well before use; may administer with or without meals.

Storage

Oral: Store at 20°C to 25°C (68°F to 77°F). Do not refrigerate the reconstituted oral solution (it will thicken); the solution is stable for 2 weeks at room temperature.

IV: Store intact vials and premixed bags at 20°C to 25°C (68°F to 77°F). Infusion solution in NS or D5W solution is stable for 16 days at room temperature, 32 days refrigerated, or 8 weeks frozen. After initial use, discard any unused portion of vial after 24 hours.

Drug Interactions

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Avoid combination

CYP3A4 Inducers (Strong): May decrease the serum concentration of Clindamycin (Systemic). Refer to the specific clindamycin (systemic) - rifampin drug interaction monograph for information concerning that combination. Exceptions: RifAMPin. Monitor therapy

Kaolin: May decrease the absorption of Lincosamide Antibiotics. Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Mecamylamine: Lincosamide Antibiotics may enhance the neuromuscular-blocking effect of Mecamylamine. Avoid combination

Neuromuscular-Blocking Agents: Lincosamide Antibiotics may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

Adverse Reactions

Frequency not defined.

Cardiovascular: Hypotension (rare; IV administration), thrombophlebitis (IV)

Central nervous system: Metallic taste (IV)

Dermatologic: Acute generalized exanthematous pustulosis, erythema multiforme (rare), exfoliative dermatitis (rare), maculopapular rash, pruritus, skin rash, Stevens-Johnson syndrome (rare), toxic epidermal necrolysis, urticaria, vesiculobullous dermatitis

Gastrointestinal: Abdominal pain, antibiotic-associated colitis, Clostridium difficile associated diarrhea, diarrhea, esophageal ulcer, esophagitis, nausea, pseudomembranous colitis, unpleasant taste (IV), vomiting

Genitourinary: Azotemia, oliguria, proteinuria, vaginitis

Hematologic & oncologic: Agranulocytosis, eosinophilia (transient), neutropenia (transient), thrombocytopenia

Hepatic: Abnormal hepatic function tests, jaundice

Hypersensitivity: Anaphylactic shock, anaphylactoid reaction (rare), anaphylaxis, angioedema, hypersensitivity reaction

Immunologic: DRESS syndrome

Local: Abscess at injection site (IM), induration at injection site (IM), irritation at injection site (IM), pain at injection site (IM)

Neuromuscular & skeletal: Polyarthritis (rare)

Renal: Renal insufficiency (rare)

ALERT: U.S. Boxed Warning

Colitis:

Clostridium difficileassociated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile.

Because clindamycin therapy has been associated with severe colitis, which may end fatally, reserve it for serious infections for which less toxic antimicrobial agents are inappropriate. Do not use clindamycin in patients with nonbacterial infections, such as most upper respiratory tract infections.

C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Institute appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation as clinically indicated.

Warnings/Precautions

Concerns related to adverse effects:

• Colitis: [US Boxed Warning]: Can cause severe and possibly fatal colitis. Should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. C. difficile-associated diarrhea (CDAD) must be considered in all patients who present with diarrhea following antibiotic use. CDAD has been observed >2 months postantibiotic treatment. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Institute appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation as clinically indicated.

• Hypersensitivity: Severe hypersensitivity reactions, including severe skin reactions (eg, drug reaction with eosinophilia and systemic symptoms [DRESS], Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN]), some fatal, and anaphylactic reactions, including anaphylactic shock, have been reported. Permanently discontinue treatment and institute appropriate therapy if these reactions occur.

• Superinfection: Use may result in overgrowth of nonsusceptible organisms, particularly yeast. Should superinfection occur, appropriate measures should be taken as indicated by the clinical situation.

Disease-related concerns:

• GI disease: Use with caution in patients with a history of GI disease, particularly colitis.

• Hepatic impairment: Use with caution in patients with moderate to severe liver disease, however, when administered at every-8-hour intervals, drug accumulation is rare. Monitor hepatic enzymes periodically as dosage adjustments may be necessary in patients with severe liver disease.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Atopic patients: Use with caution in atopic patients.

• Elderly: A subgroup of older patients with associated severe illness may tolerate diarrhea less well. Monitor carefully for changes in bowel frequency.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

• Tartrazine: Some products may contain tartrazine (FD&C yellow no. 5), which may cause allergic reactions in certain individuals. Allergy is frequently seen in patients who also have an aspirin hypersensitivity.

Other warnings/precautions:

• Administration (IV): Do not inject IV undiluted as a bolus. Product should be diluted in compatible fluid and infused over 10 to 60 minutes.

• Appropriate use: Not appropriate for use in the treatment of meningitis due to inadequate penetration into the CSF.

Monitoring Parameters

Observe for changes in bowel frequency. Monitor for colitis and resolution of symptoms. In severe liver disease monitor liver function tests periodically; during prolonged therapy monitor CBC, liver and renal function tests periodically.

Pregnancy Considerations

Clindamycin crosses the placenta and can be detected in the cord blood and fetal tissue (Philipson 1973; Weinstein 1976). Clindamycin injection contains benzyl alcohol which may also cross the placenta. Clindamycin pharmacokinetics are not affected by pregnancy (Philipson 1976; Weinstein 1976). Clindamycin is recommended for use in pregnant women for the prophylaxis of group B streptococcal disease in newborns (alternative therapy) (ACOG 485, 2011); prophylaxis and treatment of Toxoplasma gondii encephalitis (alternative therapy), or Pneumocystis pneumonia (PCP) (alternative therapy) (HHS [OI adult 2015]); bacterial vaginosis (CDC [Workowski 2015]); anthrax (Meaney-Delman 2014); or malaria (CDC 2013). Clindamycin is also one of the antibiotics recommended for prophylactic use prior to cesarean delivery and may be used in certain situations prior to vaginal delivery in women at high risk for endocarditis (ACOG 120, 2011).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience abdominal pain, nausea, vomiting, or diarrhea. Have patient report immediately to prescriber signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools), injection site pain or irritation, joint pain, joint edema, urinary retention, change in amount of urine passed, jaundice, vaginitis, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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