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Clindamycin (Systemic)

Pronunciation

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); 600 mg/50 mL (50 mL); 900 mg/50 mL (50 mL) [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 [DSC]); 600 mg/4 mL (4 mL [DSC]); 900 mg/6 mL (6 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

Clindamycin phosphate is converted to clindamycin HCl (active)

Excretion

Urine (10%) and feces (~4%) 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 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 anaerobes.

Use: Unlabeled

May be useful in PCP; alternate treatment for toxoplasmosis; bacterial vaginosis (oral); alternate treatment for MRSA infections; alternate antibiotic for prophylaxis of infective endocarditis in patients who are allergic to penicillin and undergoing surgical or dental procedures (ACC/AHA guidelines); group B streptococcus (GBS) infection (maternal use for neonatal prophylaxis in penicillin-allergic women); treatment of severe or uncomplicated malaria; treatment of babesiosis; treatment of acute bacterial rhinosinusitis (ABRS) (pediatric) (in combination with a third-generation cephalosporin); chronic oral antimicrobial suppression of prosthetic joint infection

Contraindications

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

Dosing: Adult

Usual dose:

Oral: 150 to 450 mg/dose every 6 hours

IM, IV: 600 to 2,700 mg daily in 2 to 4 divided doses; up to 4,800 mg IV daily may be used in life-threatening infections (maximum: 600 mg/dose IM)

Amnionitis: IV: 450 to 900 mg every 8 hours

Anthrax (off-label use) (Hendricks 2014):

Postexposure prophylaxis: Oral: 600 mg every 8 hours for 60 days after exposure

Cutaneous, treatment: Oral: 600 mg every 8 hours for 7 to 10 days after naturally acquired infection; 60 days following biological weapon related event

Systemic, treatment: IV: 900 mg every 8 hours; 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). Duration of therapy is 2 weeks when meningitis has been excluded; ≥ 2 to 3 weeks for possible/confirmed meningitis. Patients exposed to aerosolized spores require prophylaxis to complete an antimicrobial course of 60 days from illness onset.

Injectional: IV: 600 mg every 8 hours in combination with ciprofloxacin and other antibiotics (eg, a 5-drug combination) (Hicks 2012)

Babesiosis (off-label use):

Oral: 600 mg 3 times daily for 7 to 10 days with quinine (Vannier 2012; Wormser 2006)

IV: 300 to 600 mg every 6 hours for 7 to 10 days with quinine (Vannier 2012; Wormser 2006)

Note: Relapsing infection may require at least 6 weeks of therapy (Vannier 2012)

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

Bite wounds (animal) (off-label use):

Oral: 300 mg 3 times daily; in combination with a second- or third-generation cephalosporin, levofloxacin, or sulfamethoxazole and trimethoprim (IDSA [Stevens 2014])

IV: 600 mg every 6 to 8 hours; in combination with a second- or third-generation cephalosporin, levofloxacin, or sulfamethoxazole and trimethoprim (IDSA [Stevens 2014])

Gangrenous pyomyositis: IV: 900 mg every 8 hours with penicillin G (Brook, 1999; Hassel 2004; Wong 2013)

Group B streptococcus (neonatal prophylaxis) (off-label use): IV: 900 mg every 8 hours until delivery (CDC 2010)

Impetigo: Oral: 300 to 450 mg 4 times daily 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: 600 mg 3 times daily for a minimum of 8 weeks (some experts combine with rifampin) (Liu 2011)

Pelvic inflammatory disease: IV: 900 mg every 8 hours with gentamicin (conventional or single daily dosing); transition from parenteral to clindamycin 450 mg orally 4 times daily (or oral doxycycline) can usually be initiated after 24 to 48 hours of clinical improvement to complete 14 days of total therapy. If tubo-ovarian abscess is present, oral clindamycin in combination with doxycycline is a preferred regimen to complete 14 days of therapy (CDC [Workowski 2015]).

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 (Shulman 2012)

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

Pneumocystis pneumonia (PCP) in HIV-infected patients (alternative to preferred therapy) (off-label use):

IV: 600 mg every 6 hours or 900 mg every 8 hours with primaquine for 21 days (HHS [OI adult 2015])

Oral: 450 mg every 6 hours or 600 mg every 8 hours with primaquine for 21 days (HHS [OI adult 2015])

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

Prophylaxis against infective endocarditis (off-label use):

Oral: 600 mg 30 to 60 minutes before procedure with no follow-up dose needed (Wilson 2007)

IM, IV: 600 mg 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.

Prophylaxis in total joint replacement patients undergoing dental procedures which produce bacteremia (off-label use): Note: In general, patients with prosthetic joint implants do not require prophylactic antibiotics prior to dental procedures. In planning an invasive oral procedure, dental consultation with the patient's orthopedic surgeon may be advised to review the risks of infection (Sollecito 2015).

Oral: 600 mg 1 hour prior to procedure (ADA 2003)

IV: 600 mg 1 hour prior to procedure (for patients unable to take oral medication) (ADA 2003)

Prosthetic joint infection:

Chronic antimicrobial suppression, Staphylococci (oxacillin-susceptible) (alternative to cephalexin or cefadroxil) (off-label use): Oral: 300 mg every 6 hours (Osmon 2013)

Propionibacterium acnes, treatment (alternative to penicillin G or ceftriaxone):

Oral: 300 to 450 mg every 6 hours for 4 to 6 weeks (Osmon 2013)

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

Septic arthritis due to MRSA (off-label use): IV, Oral: 600 mg 3 times daily for 3 to 4 weeks (Liu 2011)

Skin and soft tissue infections due to MSSA:

Oral: 300 to 450 mg 4 times daily for 7 to 14 days (IDSA [Stevens 2014])

IV: 600 mg every 8 hours for 7 to 14 days (IDSA [Stevens 2014])

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

Oral: 300 to 450 mg 4 times daily for 7 to 14 days (IDSA [Stevens 2014])

IV: 600 mg every 8 hours for 7 to 14 days (IDSA [Stevens 2014])

Complicated infections: IV, Oral: 600 mg 3 times daily for 7 to 14 days (IDSA [Liu 2011])

Cellulitis: Oral: 300 to 450 mg 3 times daily for 5 to 10 days (Liu 2011)

Skin and soft tissue necrotizing infections (off-label use): IV: 600 to 900 mg 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: 600 to 900 mg every 8 hours (IDSA [Stevens 2014])

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

Toxic shock syndrome: IV: 900 mg every 8 hours with additional concomitant therapy (Lappin 2009; Wong 2013)

Toxoplasma gondii encephalitis in HIV-infected patients (off label use):

Treatment (alternative to preferred regimen): IV, Oral: 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 (HHS [OI adult 2015]).

Chronic maintenance therapy (alternative to preferred regimen): Oral: 600 mg every 8 hours in combination with pyrimethamine and leucovorin; may discontinue when asymptomatic and CD4 count >200 cells/mm3 for 6 months in response to ART (HHS [OI adult 2015])

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) (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) (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 divided every 8 hours for 7 to 10 days plus quinine (Medical Letter 2007)

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) (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 (Shulman 2012).

Chronic carrier treatment: 20 to 30 mg/kg/day divided every 8 hours (maximum: 300 mg per dose) for 10 days (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 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 (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 (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 (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) (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) (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) (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) (DHHS [OI Children 2013])

Secondary prevention: Oral: 7 to 10 mg/kg/dose (maximum dose: 600 mg) every 8 hours (plus pyrimethamine and leucovorin) (DHHS [OI Children 2013])

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

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

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

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 10-60 minutes, at a maximum rate of 30 mg/minute (do not exceed 1200 mg/hour).

Oral: Administer with a full glass of water to minimize esophageal ulceration; give around-the-clock to promote less variation in peak and trough serum levels. Coadministration with food does not adversely affect the absorption of clindamycin-flavored granules.

Compatibility

Stable in D5R, D51/2NS, D5NS, D5W, D10W, LR, NS; variable stability (consult detailed reference) in peritoneal dialysis solutions.

Y-site administration: Incompatible with allopurinol, azithromycin, caspofungin, doxapram, filgrastim, idarubicin, pantoprazole.

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. Avoid combination

Erythromycin (Systemic): Lincosamide Antibiotics may diminish the therapeutic effect of Erythromycin (Systemic). Avoid combination

Kaolin: May decrease the absorption of Lincosamide Antibiotics. Consider therapy modification

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 difficile–associated 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, have been reported; permanently discontinue treatment if these reactions occur. Serious anaphylactoid or anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen and IV corticosteroids should also be administered as indicated.

• 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 Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. 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 (stomach pain or cramps, very loose 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.

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