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Product Name
:
CLINDO (cap)
Chemical Name
:
Clindamycin (HCl)
Therapeutic Category
:
Antimicrobial
Pharmacologic Category
:
Antibiotic, Lincosamide
Pharmaceutical Form
:
Capsules
Composition
:
Clindamycin (HCl) 75mg / 150mg / 300mg
Monitoring Parameters
Dosing
 
Dosing: Adult
Usual dose:
Oral: 150-450 mg/dose every 6-8 hours; maximum dose: 1.8 g/day
I.M., I.V.: 1.2-2.7 g/day in 2-4 divided doses; maximum dose: 4.8 g/day
Amnionitis: I.V.: 450-900 mg every 8 hours
Anthrax (unlabeled use): I.V.: 900 mg every 8 hours with ciprofloxacin or doxycycline
Babesiosis (unlabeled use):
Oral: 600 mg 3 times/day for 7-10 days with quinine (Medical Letter, 2007)
I.V.: 1.2 g twice daily for 7-10 days with quinine (Medical Letter, 2007)
Bacterial vaginosis (unlabeled use): Oral: 300 mg twice daily for 7 days (CDC, 2010)
Bite wounds (canine): Oral: 300 mg 4 times/day with a fluoroquinolone
Cellulitis due to MRSA (unlabeled use): Oral: 300-450 mg 3 times/day for 5-10 days (Liu, 2011)
Complicated skin/soft tissue infection due to MRSA (unlabeled use): I.V., Oral: 600 mg 3 times/day for 7-14 days (Liu, 2011)
Gangrenous pyomyositis: I.V.: 900 mg every 8 hours with penicillin G
Group B streptococcus (neonatal prophylaxis): I.V.: 900 mg every 8 hours until delivery
Malaria, severe (unlabeled use) : I.V.: Load: 10 mg/kg followed by 15 mg/kg/day divided every 8 hours plus I.V. 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, 2009)
Malaria, uncomplicated treatment (unlabeled use): Oral: 20 mg/kg/day divided every 8 hours for 7 days plus quinine (CDC, 2009)
Orofacial/parapharyngeal space infections:
Oral: 150-450 mg every 6 hours for at least 7 days; maximum dose: 1.8 g/day
I.V.: 600-900 mg every 8 hours
Osteomyelitis due to MRSA (unlabeled use): I.V., Oral: 600 mg 3 times/day for a minimum of 8 weeks (some experts combine with rifampin) (Liu, 2011)
Pelvic inflammatory disease: I.V.: 900 mg every 8 hours with gentamicin (conventional or single daily dosing); 24 hours after clinical improvement may convert to oral doxycycline 100 mg twice daily or clindamycin 450 mg 4 times/day to complete 14 days of total therapy. Avoid doxycycline if tubo-ovarian abscess is present. (CDC, 2010)
Pneumocystis jirovecii pneumonia (unlabeled use):
I.V.: 600-900 mg every 6-8 hours with primaquine for 21 days (CDC, 2009)
Oral: 300-450 mg every 6-8 hours with primaquine for 21 days (CDC, 2009)
Pneumonia due to MRSA (unlabeled use): I.V., Oral: 600 mg 3 times/day for 7-21 days (Liu, 2011)
Prophylaxis against infective endocarditis (unlabeled use):
Oral: 600 mg 30-60 minutes before procedure with no follow-up dose needed (Wilson, 2007)
I.M., I.V.: 600 mg 30-60 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 (unlabeled use):
Oral: 600 mg 1 hour prior to procedure (ADA, 2003)
I.V.: 600 mg 1 hour prior to procedure (for patients unable to take oral medication) (ADA, 2003)
Septic arthritis due to MRSA (unlabeled use): I.V., Oral: 600 mg 3 times/day for 3-4 weeks (Liu, 2011)
Toxic shock syndrome: I.V.: 900 mg every 8 hours with penicillin G or ceftriaxone
Toxoplasmosis (HIV-exposed/positive; secondary prevention [unlabeled use]): Oral: 600 mg every 8 hours (with pyrimethamine and leucovorin calcium) (CDC, 2009)

Dosing: Pediatric
Usual dose:
Infants and Children:
Oral: 8–40 mg/kg/day in 3-4 divided doses; Manufacturer’s labeling: 8-20 mg/kg/day (as hydrochloride) or 8-25 mg/kg/day (as palmitate) in 3-4 divided doses; minimum dose of palmitate: 37.5 mg 3 times/day
I.M., I.V.: Manufacturer’s labeling: 20-40 mg/kg/day in 3-4 divided doses
Anthrax (unlabeled use): I.V.: 7.5 mg/kg every 6 hours
Babesiosis (unlabeled use): Oral: 20-40 mg/kg divided every 8 hours for 7-10 days plus quinine (Medical Letter, 2007)
Cellulitis due to MRSA (unlabeled use): Oral: 10-13 mg/kg/dose every 6-8 hours for 5-10 days (maximum: 40 mg/kg/day) (Liu, 2011)
Complicated skin/soft tissue infection due to MRSA (unlabeled use): I.V., Oral: 10-13 mg/kg/dose every 6-8 hours for 7-14 days (maximum: 40 mg/kg/day) (Liu, 2011)
Malaria, severe (unlabeled use) : I.V.: Load: 10 mg/kg followed by 15 mg/kg/day divided every 8 hours plus I.V. 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, 2009)
Malaria, uncomplicated treatment (unlabeled use): Oral: 20 mg/kg/day divided every 8 hours for 7 days plus quinine (CDC, 2009)
Osteomyelitis due to MRSA (unlabeled use): I.V., Oral: 10-13 mg/kg/dose every 6-8 hours for a minimum of 4-6 weeks (maximum: 40 mg/kg/day) (Liu, 2011)
Pneumonia due to MRSA (unlabeled use): I.V., Oral: 10-13 mg/kg/dose every 6-8 hours for 7-21 days (maximum: 40 mg/kg/day) (Liu, 2011)
Prophylaxis against infective endocarditis (unlabeled use):
Oral: 20 mg/kg 30-60 minutes before procedure (Wilson, 2007)
I.M., I.V.: 20 mg/kg 30-60 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 (unlabeled use): I.V., Oral: 10-13 mg/kg/dose every 6-8 hours for minimum of 3-4 weeks (maximum: 40 mg/kg/day) (Liu, 2011)
Toxoplasmosis (HIV-exposed/-positive; secondary prevention [unlabeled use]): Oral: 20-30 mg/kg/day divided every 6-8 hours (plus pyrimethamine and leucovorin calcium) (CDC, 2009)
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment
No dosage adjustment required in renal impairment.
Poorly dialyzed; no supplemental dose or dosage adjustment necessary, including patients on intermittent hemodialysis, peritoneal dialysis, or continuous renal replacement therapy (eg, CVVHD).
Dosing: Hepatic Impairment
Systemic use: No adjustment required. Use caution with severe hepatic impairment.
Use
 
Treatment of susceptible bacterial infections, mainly those caused by anaerobes, streptococci, pneumococci, and staphylococci; pelvic inflammatory disease (I.V.)
Use - Unlabeled/Investigational
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); treatment of severe or uncomplicated malaria; treatment of babesiosis
Adverse Reactions
 
Frequency not defined.
Cardiovascular: Cardiac arrest (rare; I.V. administration), hypotension (rare; I.V. administration)
Dermatologic: Erythema multiforme (rare), exfoliative dermatitis (rare), pruritus, rash, Stevens-Johnson syndrome (rare), urticaria
Gastrointestinal: Abdominal pain, diarrhea, esophagitis, nausea, pseudomembranous colitis, vomiting
Genitourinary: Vaginitis
Hematologic: Agranulocytosis, eosinophilia (transient), neutropenia (transient), thrombocytopenia
Hepatic: Jaundice, liver function test abnormalities
Local: Induration/pain/sterile abscess (I.M.), thrombophlebitis (I.V.)
Neuromuscular & skeletal: Polyarthritis (rare)
Renal: Renal dysfunction (rare)
Miscellaneous: Anaphylactoid reactions (rare)
Contraindications
 
Hypersensitivity to clindamycin, lincomycin, or any component of the formulation
Warnings / Precautions Drug
 
Boxed warnings:
• Colitis: See “Concerns related to adverse effects” below.
Concerns related to adverse effects:
• Colitis: [U.S. Boxed Warning]: Can cause severe and possibly fatal colitis. Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment. Use with caution in patients with a history of gastrointestinal disease. Discontinue drug if significant diarrhea, abdominal cramps, or passage of blood and mucus occurs.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment; monitor hepatic enzymes periodically as dosage adjustments may be necessary in patients with severe impairment.
Special populations:
• Atopic patients: Use with caution in atopic patients.
Dosage form specific issues:
• Benzyl alcohol: Some products may contain benzyl alcohol which has been associated with "gasping syndrome" in neonates.
• Tartrazine: Some products may contain tartrazine, which may cause allergic reactions in certain individuals.
Other warnings/precautions:
• Appropriate use: Not appropriate for use in the treatment of meningitis due to inadequate penetration into the CSF.
Interactions
 
BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination
Erythromycin: May diminish the therapeutic effect of Lincosamide Antibiotics. Risk X: Avoid combination
Erythromycin (Systemic): Lincosamide Antibiotics may diminish the therapeutic effect of Erythromycin (Systemic). Risk X: Avoid combination
Kaolin: May decrease the absorption of Lincosamide Antibiotics. Risk D: Consider therapy modification
Neuromuscular-Blocking Agents: Lincosamide Antibiotics may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy
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 24 hours after cessation of antibacterial agents. Risk D: Consider therapy modification
Pregnancy
 
B
Pregnancy Implications
Because adverse effects were not observed in animals, clindamycin is classified as pregnancy category B. Clindamycin crosses the placenta throughout pregnancy and at term, but use during pregnancy has not been shown to cause adverse fetal effects. Clindamycin pharmacokinetics are not affected by pregnancy. Clindamycin therapy is recommended in certain pregnant patients for prophylaxis of group B streptococcal disease in newborns, prophylaxis and treatment of Toxoplasma gondii encephalitis, or for the treatment of Pneumocystis pneumonia (PCP), bacterial vaginosis, or malaria.
Lactation
 
Enters breast milk/not recommended (AAP rates “compatible”; AAP 2001 update pending)
Breast-Feeding Considerations
Small amounts of clindamycin transfer to human milk. The manufacturer does not recommend the use of clindamycin during breast-feeding. Nondose-related effects could include modification of bowel flora. There has been one published case of bloody stools in a nursing infant, but a causal relationship was not proven.
Mechanism of Action
 
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
Pharmacodynamics / Kinetics
 
Absorption: Oral, hydrochloride: Rapid (90%)
Distribution: High concentrations in bone and urine; no significant levels in CSF, even with inflamed meninges
Vd: ~2 L/kg
Metabolism: Hepatic; forms metabolites (variable activity); Clindamycin phosphate is converted to clindamycin HCl (active)
Half-life elimination: Neonates: Premature: 8.7 hours; Full-term: 3.6 hours; Children: ~2 hours; Adults: ~2-3 hours; Elderly 4 hours (range 3.4-5.1 hours)
Time to peak, serum: Oral: Within 60 minutes; I.M.: 1-3 hours
Excretion: Urine (10%) and feces (~4%) as active drug and metabolites
 
   
 
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