Dexamethasone

Registered South African indications:

• Inflammatory conditions of the eye
• Inflammatory conditions of the external auditory meatus

Contraindication

• Hypersensitivity to the active ingredient or any of its excipients
• Infections

Caution

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

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

Non-infective inflammatory conditions of the eye

• Ophthalmic (opd): Initial: 1-2 drops into affected eye(s), 1hrly until adequate response; Maintenance: 1-2 drops into affected eye(s), 6-8hrly

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Nasolacrimal occlusion or gently closing the eyelid after admin. is recommended

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Should not be used for longer than one week except under ophthalmic supervision

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Steroid responsive inflammatory conditions of the external auditory meatus
- Allergic otitis
- Purulent and non-purulent infective otitis externa 

• Otic (dro): 3-4 drops into affected ear(s), 6-12hrly

Not established for use in children below 2 years

Pregnancy

• Caution
• Insufficient data are available on the use of dexamethasone eye drops/solution in human pregnancy to assess possible harmful effects. Corticosteroids cross the placenta. Teratogenic effects have been observed in animals. However, there is no evidence to date that teratogenic effects are induced in humans. After systemic use of corticosteroids, at higher doses, effects on the unborn/neonate (intrauterine growth inhibition, inhibition of the function of the adrenal cortex) have been reported. However, these effects have not been reported for ocular use
• Insufficient data are available on the use of dexamethasone eye drops/solution in human pregnancy to assess possible harmful effects.  As a precautionary measure, it is preferable to avoid the use of dexamethasone eye drops/solution during pregnancy

Breastfeeding 

• Caution; not recommended
• It is not known whether this medicine is excreted in breast milk. However, the total dose of dexamethasone is low. Dexamethasone eye drops/solution can be used during breastfeeding

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

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

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

Intraocular pressure

Dexamethasone eye drops - EML (Hospital)

Dexamethasone ear drops - Non-EML

• 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

 

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.

Eye/Ear drops (per 100ml) 0.1g

• Maxidex (Alcon) originator

Eye drops (per 100ml) 0.1g

• Spersadex 0.1% (Adcock) originator

Also available in the following forms: Injection and implant.

COMBINATION PREPARATIONS

Chloramphenicol/ Dexamethasone

Eye drops (per ml) 5mg/1mg

• Spersadex Comp (Adcock) originator

Chloramphenicol/ Dexamethasone/ Neomycin

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

• Covomycin D (Adcock) originator

Polymyxin B/ Dexamethasone/ Neomycin

Eye drops (per ml) 6000iu/1mg/3500iu

• Maxitrol (Alcon) originator

Eye ointment (per ml) 6000iu/1mg/3500iu

• Maxitrol Ointment (Alcon) originator

Dexamethasone/ Framycetin

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

• Sofradex Ear/Eye (Sanofi)

Dexamethasone/ Tobramycin

Eye ointment (per ml) 1mg/0.3%

• Tobradex Eye Ointment (Alcon) originator

Eye drops (per ml) 1mg/0.3%

• Tobradex Eye Drops (Alcon) originator