Chloramphenicol

Registered South African indications: 

• Local treatment of acute eye infections caused by susceptible organisms (opd)
• Superficial infections of the eye and eyelid, including conjunctivitis, uveitis, corneitis, blepharitis and trachoma (eyo)

Contraindications

South African recommendations

Eye drops

• History of hypersensitivity to chloramphenicol or any of the excipients
• Known personal or family history of blood dyscrasias including aplastic anaemia
• Pregnancy
• Lactation
• Porphyria

Eye ointment

• Hypersensitivity to chloramphenicol or to any of the excipients
• Known personal or family history of blood dyscrasias including aplastic anaemia

Recommendations in other jurisdictions

• Hypersensitivity to the active substance or to any of the excipients
• Myelosuppression during previous exposure to chloramphenicol
• Family or personal history of blood dyscrasias including aplastic anaemia

Cautions

• Pregnancy (eyo) (South African recommendations)
• Pregnancy (Recommendations in other jurisdictions) 
• Breastfeeding (eyo) (South African recommendations)
• Breastfeeding (Recommendations in other jurisdictions)
• Renal impairment
• Hepatic impairment
• Severe infections
• Newborn infants
• Prolonged use
• Concomitant use of contact lenses

Forms avail. in SA and covered in this monograph: opd, eyo

Dosages below include:

• South African Standard Treatment Guidelines indications and dosages
• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guidelines indications and dosages

Corneal ulcer
Eye injury
- Chemical burn 

• Ophthalmic (eyo): Apply to affected eye(s), 6hrly
  (STG, PHC 2020)

Eye injury - blunt or penetrating
- Deep corneal/ scleral injuries

• Ophthalmic (eyo): Apply to affected eye(s), immediately (and refer)
  (STG, PHC 2020)

Bacterial conjunctivitis
- During the day

• Ophthalmic (eyo): Apply to affected eye(s), 6hrly; Treatment duration: 7 days
  (STG, Adult 2019; PHC 2020)

Antibiotic prophylaxis for ophthalmic surgery

• Ophthalmic (opd): 1 drop into each eye(s), 2-4hrly for 24hrs before surgery
  (STG, Adult 2019)

Snake venom in the eye (Additional agent required)

• Ophthalmic (eyo): Apply to affected eye(s), and cover with an eye patch
  (STG, Adult 2019)

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South African registered indications and dosages

Local treatment of acute eye infections caused by susceptible organisms

• Ophthalmic (opd): 1-2 drops to affected eye(s), up to 4hrly or more frequently if required; Max duration: 10-14 days

- Severe infections

• Ophthalmic (opd): Initial: 1-2 drops, every 15-20min; Reducing the frequency of instillation gradually as the infection is controlled; Max duration: 10-14 days

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Chloramphenicol eye drops are ocular use only

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Superficial infections of the eye and eyelid, including conjunctivitis, uveitis, corneitis, blepharitis and trachoma
- Eye infections

• Ophthalmic (eyo): Apply a small quantity, 6hrly into the corner of the affected eye(s) by drawing down the lower lid and massaging gently over the eye surface

- Eyelid infections

• Ophthalmic (eyo): Apply to the affected area, 6hrly with the fingertip

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Chloramphenicol ointment is for ophthalmic use only

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Indications and dosages registered in other jurisdictions

Acute bacterial conjunctivitis

• Ophthalmic (opd): 1 drop into affected eye(s), 2hrly for the first 48hrs; Then: 4hrly thereafter; Treatment duration: 5 days

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To be used during waking hours only. Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute following instillation of the drops

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Patients should wash their hands before use and avoid allowing the tip of the container to come into contact with the eye or surrounding structures as this could cause injury to the eye. Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions

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Considerations should be given to official guidance on the appropriate use of antibacterial agents

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• Ophthalmic (eyo): Apply a small quantity (~1cm) into the affected eye(s), at night if eye drops are used during the day OR 6-8hrly if ointment used alone; Treatment duration: 5 days even if symptoms improve

Paed. forms avail. in SA and covered in this monograph: opd, eyo

Dosages below include:

• South African Standard Treatment Guidelines indications and dosages
• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guidelines indications and dosages

Bacterial conjunctivitis 
Conjunctivitis of the newborn
- Sticky eye(s) without purulent discharge

• Ophthalmic (eyo): Apply to affected eye(s), 6hrly; Treatment duration: 7 days
  (STG, PHC 2020)

Neonatal conjunctivitis prophylaxis

• Ophthalmic (eyo): Apply to eyes after birth
  (STG, PHC 2023)

Measles
- Purulent conjunctivitis

• Ophthalmic (eyo): Apply to affected eye (into lower conjunctival sac), 8hrly
  (STG, PHC 2023)

- Conjunctivitis

• Ophthalmic (eyo): Apply to affected eye, 6hrly; Treatment duration: 5 days
  (STG, Paed. 2017)

Antibiotic prophylaxis for ophthalmic surgery

• Ophthalmic (opd): 1 drop into the affected eye(s), every 5-15min, for a total of 5 doses in the hour before starting the procedure
  (STG, Paed. 2023)

Non-penetrating eye injury
- Corneal injury (Additional agent required)

• Ophthalmic (eyo): Apply to affected eye, 8hrly; Treatment duration: 5-10 days
  (STG, Paed. 2023)

Complicated eye infection - severe
- During the day

• Ophthalmic (opd): 1 drop into the affected eye(s), 4-6hrly
  (STG, Paed. 2023)

- At night

• Ophthalmic (eyo): Apply to affected eye at night
  (STG, Paed. 2023)

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South African registered indications and dosages

Local treatment of acute eye infections caused by susceptible organisms (opd)

• See adult dosage; Dosage adjustment may be necessary in newborn infants because of reduced systemic elimination due to immature metabolism and the risk of dose-related adverse effects

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No information available for ointment use in children

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Indications and dosages registered in other jurisdictions

Acute bacterial conjunctivitis

Younger than 2 years

• Not established for use

2 years and older

• See adult dosage

Pregnancy

South African recommendations

• Contraindicated (opd)
• The safety of chloramphenicol in pregnancy has not been established
   
• Caution (eyo)
• The safety of chloramphenicol in pregnancy has not been established
• Chloramphenicol may be absorbed systemically following the use of eye ointment and may cross the placenta

Recommendations in other jurisdictions

• Caution; not recommended (opd)
• The safety of chloramphenicol in pregnancy has not been established. Not recommended for use during pregnancy
   
• Caution (eyo)
• The safety of chloramphenicol in pregnancy has not been established. Therefore, use only when considered essential

Breastfeeding 

South African recommendations

• Contraindicated (opd)
• Chloramphenicol may be absorbed systemically following the use of eye drops and may cross the placenta and appear in breast milk. Therefore this product is not recommended for use during breastfeeding
   
• Caution (eyo)
• Chloramphenicol may appear in breast milk

Recommendations in other jurisdictions

• Caution; not recommended (opd)
• The safety of chloramphenicol in lactation has not been established. Chloramphenicol may appear in breast milk, use of the product during lactation should be avoided
   
• Caution (eyo)
• The safety of chloramphenicol in lactation has not been established. Therefore, use only when considered essential

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

South African recommendations

• Contraindicated 

Recommendations in other jurisdictions

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Skin and Subcutaneous Tissue Disorders

• Pale skin
• Pruritis
• Urticaria
• Vesicular and maculopapular dermatitis

Immune, Blood and Lymphatic System Disorders

• Bone marrow depression
• Aplastic anaemia
• Blood disorders
• Hypersensitivity reactions
• Anaphylaxis
• Angioedema
• Fever

Sensory Disorders

• Local sensitivity reactions
  - Transient irritation
  - Burning
  - Stinging
  - Itching

• Chymotrysin

Chloramphenicol acts on an intracellular level by reversibly binding to the 50S subunit of bacterial ribosomes. This prevents amino acids being transferred to peptide chains resulting in the inhibition of protein synthesis.

Eye ointment (per g) 10mg

• Chloramex 3.5G (Pharmacare) 
• Chlorcol (Adcock)
• Chlornicol (Thebe)
• Chlorophen (Caps Pharmaceuticals)

Eye drops (per 0.5ml) 2.5mg

• Minims Chloramphenicol 0.5% (Soflens) originator

Eye drops (per ml) 5mg

• Optiphen 0.5% Eye Drops (Gen-Eye)

Also available in the following forms: Capsule and injection.

COMBINATION PREPARATIONS

Dexamethasone/ Chloramphenicol

Eye drops (per ml) 1mg/5mg

• Spersadex Comp eye drop (Adcock) originator