Chloramphenicol/ Dexamethasone

Registered South African indications:

• Acute purulent conjunctivitis
• Inflammation of the cornea
• Corneal ulceration
• Keratitis disciformis
• Post-herpetic keratitis
• Allergic conjunctivitis
• Allergic blepharitis
• Iritis
• Iridocyclitis

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
• Renal impairment
• Hepatic impairment
• Severe infections
• Neonates
• Children
• Prolonged use
• Concomitant use of contact lenses

Dexamethasone
Contraindications

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

Caution

• Pregnancy
• Breastfeeding
• Concomitant use of contact lenses
• Diseases causing thinning of cornea/sclera
• Glaucoma

Additional contraindications for this combination product

• Herpes simplex cornealis
• Tubercular processes involving the conjunctiva, the cornea and anterior uvea

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

Acute purulent conjunctivitis
Inflammation of the cornea
Corneal ulceration
Keratitis disciformis
Post-herpetic keratitis
Allergic conjunctivitis
Allergic blepharitis
Iritis
Iridocyclitis

Chloramphenicol/ Dexamethasone
5/1 (mg/ml)

• Ophthalmic (opd): Apply 1 drop into affected eye(s), 6-24hrly

No information available

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

Pregnancy

• Caution (Chloramphenicol, Dexamethasone)
• Refer to the single agent monograph for Chloramphenicol
• Refer to the single agent monograph for Dexamethasone

Breastfeeding

• Caution; not recommended (Chloramphenicol, Dexamethasone)
• Refer to the single agent monograph for Chloramphenicol
• Refer to the single agent monograph for Dexamethasone

Renal Impairment

• Caution; no dose adjustment recommended (Chloramphenicol)

Hepatic Impairment

• Caution; no dose adjustment recommended (Chloramphenicol)

Elderly

• No dose adjustment recommended (Chloramphenicol, Dexamethasone)

Porphyria Information

• Not yet classified (NC) 

Drugs in Sport

• Permitted - No warnings

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

Dexamethasone
Central Nervous System Disorders

• Disgeusia
• Dizziness
• Headache

Cardiovascular System Disorders

• Hypertension
• Aneurysm

Respiratory System Disorders

• Bronchitis

Immune Blood and Lymphatic System Disorders

• Hypersensitivity

Sensory Disorders

• Keratitis
• Conjunctivitis
• Keratoconjunctivitis sicca
• Corneal staining
• Photophobia
• Blurred vision 
• Eye pruritus
• Foreign body sensation in eyes
• Lacrimation increased
• Eyelid margin crusting
• Ocular hyperaemia
• Increased intraocular pressure 
• Reduced visual acuity 
• Corneal erosion
• Eyelid ptosis
• Eye pain
• Mydriasis

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

Chloramphenicol

• Chymotrysin

Dexamethasone

• CYP3A inhibitors
• Topical non-steroidal anti-inflammatory drugs
• Phenytoin
• Phenobarbitone
• Ephedrine
• Rifampicin
• Anticholinergics

• Intraocular pressure

Specific cases may require

• Full blood count

Dexamethasone

• In patients who have received more than physiological doses of systemic corticosteroids (approximately 1 mg dexamethasone) for greater than 3 weeks, withdrawal should not be abrupt

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 inhbits protein synthesis.

Dexamethasone
Suppresses inflammation by inhibiting oedema, fibrin deposition, capillary leakage, and phagocytic migration during the inflammatory response. Glucocorticoids inhibit vascular endothelial growth factor, a potent promoter of vascular permeability.

COMBINATION PREPARATIONS

Chloramphenicol/ Dexamethasone

Eye drop (per ml) 5mg/1mg

• Spersadex Comp (Adcock) originator