Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Clindamycin

Generic name
Clindamycin
Brand name
ATC Code
J01FF01

Pharmacokinetics in children

The bioavailability of clindamycin is high, so the same oral dose gives virtually the same levels as after intravenous administration. The following kinetic parameters have been observed (Bell 1984, Gonzalez 2014, Gonzalez 2016):

  Cmax (µg/ml)
20 mg/kg/day
IV ss		 Cl (l/hour/kg) V (l/kg) t½ (hours)
PMA < 40 weeks 10.92 0.11-0.24 0.9-1.03 3.9-5.9
PMA > 40 weeks 10.45-12.69 0.20-0.31 0.9-1.9 2.1-3.6

 

 In the study by Smith in 2017, the following kinetic parameters were found in children with a healthy weight (n=144) and children with obesity (n=76):

  t½ (hours) t½ (hours) Cl (l/hour/kg) Cl (l/hour/kg) Vd (l/kg) Vd (l/kg)
  Non-obese Obese Non-obese Obese Non-obese Obese
2-6 years 2.41 2.15 0.23 0.28 0.81 0.86
7-12 years 2.15 3.03 0.33 0.22 0.90 1.03
> 12 years 2.84 3.55 0.23 0.18 0.89 0.89

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

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Available formulations

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Dosages

Bacterial infections
  • Oral
    • 1 month up to 18 years
      [16] [17]
      • (Clindamycine base) 8 - 25 mg/kg/day in 3 - 4 doses. Max: 1.8 g/day.
Severe bacterial infections
  • Intravenous
    • < 1 week and weight at birth < 2000 g
      • (Clindamycine base) 10 mg/kg/day in 2 doses.
    • < 1 week and weight at birth ≥ 2000 g
      • (Clindamycine base) 15 mg/kg/day in 3 doses.
    • 1 week up to 4 weeks and weight at birth < 2000 g
      • (Clindamycine base) 10 mg/kg/day in 2 doses.
    • 1 week up to 4 weeks and weight at birth ≥ 2000 g
      • (Clindamycine base) 20 mg/kg/day in 4 doses.
    • 1 month up to 18 years
      • (Clindamycine base) 40 mg/kg/day in 3 - 4 doses. Max: 4.8 g/day.
  • Oral
Perioperative prophylaxis
  • Intravenous
    • 1 month up to 18 years and < 60 kg
      [19] [20] [22] [23]
      • (Clindamycine base) 10 mg/kg/dose if the procedure takes longer than 8 hours, a second dose should be given..
    • ≥ 60 kg
      • (Clindamycine base) 600 mg/dose if the procedure takes longer than 8 hours, a second dose should be given.. A maximum of 900 mg/dose should be observed in obese children (Smith 2017)..
Endocarditis prophylaxis in hypersensitivity to penicillin or treatment with penicillin in the 7 days before the procedure
  • Oral
    • 1 month up to 18 years
      [9]
      • (Clindamycine base): 30-60 minutes before the procedure 20 mg/kg/dose, once only. Max single dose: 600 mg/dose.
  • Intravenous
    • 1 month up to 18 years
      [9]
      • (Clindamycine base): 30-60 minutes before the procedure 20 mg/kg/dose, once only. Max single dose: 600 mg/dose.
Treatment of uncomplicated malaria
  • Oral
    • 1 month up to 8 years
      [13]
      • (Clindamycine base): In combination with quinine: 16 mg/kg/day in 3 - 4 doses.

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Clindamycin can cause severe diarrhoea, colitis and pseudomembranous colitis, caused by the toxins of Clostridium difficile. Hypotension and cardiac arrest can also occur as a result of administering it too rapidly.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Clindamycin does not penetrate the central nervous system well. High doses are indicated in opportunistic infections. Watch out for pseudomembranous colitis. Adjust dose in children with reduced hepatic function. In children aged less than one year and in long-term use (> 3 weeks), check the hepatic function, renal function and blood counts regularly.

The liquid for injection contains benzyl alcohol: be careful when using in premature infants and neonates.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Macrolides
J01FA10
J01FA09

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References

  1. Hartwig NC, et al, Vademecum pediatrische antimicrobiële therapie, 2005
  2. Bell MJ, et al, Pharmacokinetics of clindamycin phosphate in the first year of life, J Pediatr, 1984, 105, 482-6
  3. Faix RG, et al, A randomized, controlled trial of parenteral clindamycin in neonatal necrotizing enterocolitis, J Pediatr, 1988, 112, 271-7
  4. Frank AL, et al, Clindamycin treatment of methicillin-resistant Staphylococcus aureus infections in children, Pediatr Infect Dis J, 2002, 21, 530–534
  5. Jacobson SJ, et al, A randomized controlled trial of penicillin vs clindamycin for the treatment of aspiration pneumonia in children., Arch Pediatr Adolesc Med, 1997, 151, 701-4
  6. Kaplan SL., Treatment of community-associated methicillin-resistant Staphylococcus aureus infections, Pediatr Infect Dis J, 2005, 24, 457-8
  7. Peltola H, et al, Simplified treatment of acute staphylococcal osteomyelitis of childhood. The Finnish Study Group., Pediatrics, 1997, 99, 846-50
  8. Tanz RR, et al, Clindamycin treatment of chronic pharyngeal carriage of group A streptococci., J Pediatr, 1991, 119, 123-8
  9. Endocarditis Profylaxe Commissie Nederlandse Hartstichting, Preventie bacteriele endocarditis, Herziening augustus 2008
  10. Cohen R, et al, Pharmacokinetics and pharmacodynamics of antimicrobial therapy used in child osteoarticular infections., Arch Pediatr., 2007, 14, S122-7
  11. Ecury-Goosssen GM, et al, Sequential intravenous-oral antibiotic therapy for neonatal osteomyelitis, Pediatr Infect Dis J, 2009, 28, 72-3
  12. Hyun DY, et al, Trimethoprim-sulfamethoxazole or clindamycin for treatment of community-acquired me thicillin-resistant Staphylococcus aureus skin and soft tissue infections, Pediatr Infect Dis J, 2009, 28, 57-9
  13. LCR, Malariabulletin 2016
  14. Liu C et al. , Clinical practice guidelines by the infectious diseases society of america for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. , Clin Infect Dis., 2011, Feb 1;52(3), e18-55
  15. Bradley JS et al. , The management of community-acquired pneumonia in infants and children older than 3 months of age: clinical practice guidelines by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America., Clin Infect Dis., 2011 , Oct;53(7):, e25-76
  16. Stevens DL et al. , Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America., Clin Infect Dis. , 2014 , Jul 15;59(2):, e10-52
  17. Pfizer BV. , SmPC Dalacin (RVG 06354) 20-5-2016., www.geneesmiddeleninformatiebank.nl
  18. Martínez-Aguilar G et al. , Clindamycin treatment of invasive infections caused by community-acquired, methicillin-resistant and methicillin-susceptible Staphylococcus aureus in children., Pediatr Infect Dis J. , 2003 , Jul;22(7):, 593-8
  19. Gonzalez D et al. , Use of opportunistic clinical data and a population pharmacokinetic model to support dosing of clindamycin for premature infants to adolescents., Clin Pharmacol Ther. , 2014 , Oct;96(4):, 429-37
  20. Gonzalez D et al. , Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants., Antimicrob Agents Chemother. , 2016 , Apr 22;60(5):, 2888-94
  21. Erickson CM et al., Sequential Parenteral to Oral Clindamycin Dosing in Pediatric Musculoskeletal Infection: A Retrospective Review of 30 mg/kg/d Versus 40 mg/kg/d., Pediatr Infect Dis J. , 2016 , Oct;35(10):, 1092-6
  22. Smith MJ et al, Pharmacokinetics of Clindamycin in Obese and Nonobese Children, Antimicrob Agents Chemother, 2017, Mar 24;61(4)
  23. Bratzler DW et al. , Clinical practice guidelines for antimicrobial prophylaxis in surgery., Surg Infect (Larchmt). , 2013, Feb;14(1), 73-156
  24. CNP Pharma, Clindasol® 600 mg Filmtabletten (48537.00.00), 02/2018
  25. CNP Pharma, Clindasol® 150/300 mg Filmtabletten (42725.00.01 / 42725.01.01), 02/2018
  26. Hexal, SmPC ClindaHEXAL® Filmtabletten (58763.00.00 / 58763.01.00), 03/2016
  27. Hexal, SmPC ClindaHEXAL® Hartkapseln (6063302.00.00 / 32127.00.00), 08/2017
  28. Ratiopharm, SmPC Clindamycin-ratiopharm® 600 mg Filmtabletten (42727.00.01), 04/2014
  29. Ratiopharm, SmPC Clindamycin-ratiopharm® 150/300 mg Hartkapseln (33387.00.01 / 33387.01.01), 04/2014
  30. Pfizer, SmPC Sobelin® 150/300 mg (6888.01.00/6888.01.00), 04/2017
  31. Pfizer, SmPC Sobelin® Granulat (6888.00.01), 04/2017
  32. Chephasaar, Clinda-saar® 150/300/600 mg Filmtablette / Clinda-saar® 600/900 mg Injektionslösung, 08/2015
  33. Hikma, SmPC Clindamycin Hikma 150mg/ml (42472.01.00), 06/2014
  34. Ratiopharm, SmPC Clindamycin-ratiopharm® Injektionslösung (33387.00.00 / 33387.01.00), 12/2017
  35. Pfizer, SmPC Sobelin® Solubile 600 mg/4 ml Injektionslösung (6892.01.00), 05/2018
  36. MMI, Gelbe Liste Online, 24/04/2018

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Changes

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