Chloramphenicol/ Naphazoline/ Neomycin

Registered South African indications:

• Ocular infections
• Ear infections
• Nose infections

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Chloramphenicol
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• History of bone marrow suppression with previous administration with chloramphenicol

Cautions

• Pregnancy
• Breastfeeding
• Severe infections
• Neonates
• Children
• Prolonged use
• Concomitant use of contact lenses

Naphazoline
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Glaucoma
• Corneal damage
• Acute iritis
• Eye surgery

Cautions

• Pregnancy
• Breastfeeding
• Pre-exisiting red eye condition
• Hypertension
• Diabetes mellitus
• Hyperthyroidism
• Cardiovascular abnormalities
• Arteriosclerosis
• Concomitant use of soft contact lenses

Neomycin
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Pregnancy 

Cautions 

• Breastfeeding 
• Elderly
• Prolonged use
• Concomitant use of contact lenses

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

Ocular infections
- Blepharitis
- Conjunctivitis
Ear infections
Nose infection
- Caused by sensitive orgnisms and decongestant action needed

Chloramphenicol/ Naphazoline/ Neomycin
2/0.5/5 (mg/ml)

• Ophthalmic (opd): 1-2 drops into affected eye(s), 2hrly; Treatment duration: 5 days
• Otic (dro): 1-2 drops into affected ear(s), 2hrly; Treatment duration: 5 days
• Nasal (dro): 1-2 drops into affected nare(s), 2hrly; Treatment duration: 5 days

No information available

Recommendations for this combination product as per highest risk category when comparing individual active ingredients

Pregnancy

• FDA Pregnancy Category D (Neomycin)

Breastfeeding

• Caution; not recommended (Chloramphenicol)

Renal Impairment

• No dose adjustment recommended (Chloramphenicol, Naphazoline, Neomycin)

Hepatic Impairment

• No dose adjustment recommended (Chloramphenicol, Naphazoline, Neomycin)

Elderly

• Caution; no information available (Neomycin)

Drugs in Sport

• Permitted - No warning

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Chloramphenicol
Skin and Subcutaneous Tissue Disorders

• Pruritis
• Dermatitis
• Localised sensitivity reactions
• Urticaria

Immune, Blood and Lymphatic System Disorders

• Bone marrow depression
• Aplastic anaemia
• Anaphylaxis
• Angioneurotic oedema
• Fever

Naphazoline
Sensory Disorders

• Mydriasis (mild)
• Blurred vision
• Eye discomfort
• Eye irritation
• Eye redness
• Increased intraocular pressure
• Increased lacrimation
• Punctate keratitis

Neomycin
Central Nervous System Disorders

• Headache 

Genitourinary Disorders

• Nephrotoxicity 

Skin and Subcutaneous Tissue Disorders

• Dermatitis 
• Itching 

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity 

Sensory Disorders

• Ocular discomfort
• Keratitis
• Eye irritation
• Ototoxicity 

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Chloramphenicol

• Chymotrysin

Naphazoline

• Other ocular agents
• Halothane

Neomycin

• No information available

None routine. Specific cases may require

• Ophthalmic examination
• Full blood count

Chloramphenicol
Chloramphenicol acts on an intracellular level by reversibly binding to the L16 protein of the 50S subunit of bacterial ribosomes. This prevents peptide bond formation and thus ultimately inhibits protein synthesis.

Naphazoline
Naphazoline is an alpha-adrenoreceptor agonist which causes arteriolar vasoconstriction.

Neomycin
Neomycin is an aminoglycoside antibiotic which acts by binding to a specific protein on the 30S ribosomal subunit of the microbe. This results in faulty alignment or recognition with respect to mRNA and probably tRNA during initiation of microbial peptide chain formation. The mRNA is misread on the recognition region of the ribosome, resulting in the wrong amino acid being inserted into the peptide. This result in production of non-functional peptide chains.

COMBINATION PREPARATIONS

Chloramphenicol/ Naphazoline/ Neomycin

Ear/Eye/Nose drops (per ml) 2mg/0.5mg/5mg

• Covomycin (Adcock) originator