Chloramphenicol (eye)

Generic name
Chloramphenicol (eye)
Brand name
ATC Code
S01AA01
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Chloramphenicol (eye)

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

In the study by Trope (1979), no chloramphenicol was found in the urine of 5 children (2-8 years) after administration in the eye. There may possibly be absorption after prolonged use.

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

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Eye infections (not trachoma)
  • Ocular
    • Gestational age ≥ 32 weeks

      • Drops: 0.5%: 4-6x daily 1 drop
        Eye ointment: 1%: one line of ointment (0,5-1 cm) for the night (as an addition to the treatment with eye drops during the day).

      • Duration of treatment:

        Treat until at least 48 hours after the symptoms disappear. Maximum duration of treatment 14 days. Treat both eyes.

    • Term neonate

      • Drops: 0.5%: 4-6x daily 1 drop
        Eye ointment: 1%: one line of ointment (0,5-1 cm) for the night (as an addition to the treatment with eye drops during the day).

      • Duration of treatment:

        Treat until at least 48 hours after the symptoms disappear. Maximum duration of treatment 14 days. Treat both eyes.

    • 1 month up to 18 years

      • Drops: 0.4 or 0.5%: 4-12 times daily 1 drop (every 2-6 hours)
        Eye ointment: 1%: one line of ointment (1 cm) for the night (as an addition to the treatment with eye drops during the day). As monotherapy: a line of ointment 1 cm long, 2-4x daily. 

      • Duration of treatment:

        Treat until at least 48 hours after the symptoms disappear. Maximum duration of treatment 14 days. Treat both eyes.

      • Directions for administration:

        Ointment: apply to the inside of the lower eyelid.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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

Stinging and burning sensation in the eyes, swollen eyelids, irritation, watery eyes.
Using chloramphenicol in the eye does not give levels that are high enough to explain dose-related bone marrow toxicity (aplastic anaemia). [Walker 1998]
 

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

The use of drops is preferred above the use of monotherapy with salve in children because the drops have a thinning effect. Additionally, the salve is difficult to apply in children because of its very firm consistency.

Grey baby syndrome has been described with systemic administration of chloramphenicol in infants. These effects are unlikely to occur following ocular exposure, as systemic absorption after ocular application is limited. 

The eye drops contain boron. This can reduce future fertility. Only use the drops in children < 2 years after careful consideration if no alternative therapy is available.

Interactions

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

ANTIINFECTIVES

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Antibiotics
S01AA26
S01AA13
S01AA11
S01AA24
S01AA20
S01AA12
Antivirals
S01AD03
ANTIBIOTICS
S01AA26
S01AA13
S01AA11
S01AA24
S01AA20
S01AA12
ANTIVIRALS
S01AD03
Fluoroquinolones
S01AE07
S01AE01

References

  1. Rose PW, et al, Chloramphenicol treatment for acute infective conjunctivitis in children in primary care: a randomised double-blind placebo-controlled trial, Lancet., 2005, Jul 2-8;366(9479), 37-43
  2. Normann EK et al, Treatment of acute neonatal bacterial conjunctivitis: a comparison of fucidic acid to chloramphenicol eye drops, Acta Ophthalmol Scand, 2002, Apr;80(2), 183-7
  3. Walker S, Lack of evidence for systemic toxicity following topical chloramphenicol use, Eye (Lond)., 1998, 12 ( Pt 5):, 875-9
  4. Wiholm BE et al, Relation of aplastic anaemia to use of chloramphenicol eye drops in two international case-control studies, BMJ., 1998, Feb 28;316(7132), 666
  5. Sandström I, Treatment of neonatal conjunctivitis, Arch Ophthalmol, 1987, Jul;105(7), 925-8
  6. Trope GE, et al, Systemic absorption of topically applied chloramphenicol eyedrops, Br J Ophthalmol, 1979 , Oct;63(10), 690-1
  7. Lam RF et al, Topical chloramfenicol for eye infections, HKMJ, 2002, 8, 44-7
  8. Teva Nederland BV, Chlooramfenicol 10 mg/g, oogzalf (RVG 57557) 11-11-2020, www.geneesmiddeleninformatiebank.nl
  9. Teva Nederland BV, Chlooramfenicol 5 mg/ml , oogdruppels (RVG 01767) 26-09-2017, www.geneesmiddeleninformatiebank.nl
  10. Trope GE, et al, Systemic absorption of topically applied chloramphenicol eyedrops, Br J Ophthalmol, 1979, Oct;63(10), 690-1

Changes

Therapeutic Drug Monitoring


Overdose