Drug formEye ointments
ATC subcategoryGlucocorticoids for use in ophthalmology
Each gram of Hydrocortisone, 0.5% eye ointment contains:
active ingredient: Hydrocortisone acetate – 5 mg
excipients: Methylparaben-2mg, Petrolatum ophthalmic to 1000 mg.
Corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.Short-acting glucocorticoid that depresses formation, release, and activity of endogenous mediators of inflammation including prostaglandins, kinins, histamine, liposomal enzymes, and complement system.
Hydrocortisone is a corticosteroid with both glucocorticoid and to a lesser extent mineralocorticoid activity. As cortisol it is the most important of the predominantly glucocorticoid steroids secreted by the adrenal cortex. Hydrocortisone is used, usually with a more potent mineralocorticoid, for replacement therapy in adrenocortical insufficiency. It may also be used for its glucocorticoid properties in other conditions for which corticosteroid therapy is indicated but drugs with fewer mineralocorticoid effects tend to be preferred for the long-term systemic therapy of auto-immune and inflammatory disease.
Apply a small amount into the conjunctival sac 2-3 times daily for 2 weeks or until a satisfactory response occurs.
For ocular use only. Prolonged use of topical ophthalmic corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, reduced visual acuity, visual field defects and posterior subcapsular cataract formation. In patients receiving prolonged ophthalmic corticosteroid therapy, intraocular pressure and the lens should be checked routinely and frequently, particularly in patients with a history or presence of glaucoma. Topical corticosteroids should not be used for longer than one week except under ophthalmic supervision, with regular checks of intraocular pressure. Corticosteroids may reduce resistance to and aid in the establishment of bacterial, viral and fungal infections and mask the clinical signs of infections, preventing recognition of ineffectiveness of the antibiotic. In such cases antibiotic therapy is mandatory. Fungal infection should be suspected in patients with persistent corneal ulceration who have been or are receiving these drugs, and corticosteroids therapy should be discontinued if fungal infection occurs. Topical ophthalmic corticosteroids may slow corneal wound healing. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. Contact lens wear is not recommended during treatment of an ocular inflammation. There is no evidence of safety in use in children under two years of age.
Effects on ability to drive and use machines
– May cause transient blurring of vision on instillation or sensitivity to bright light. Warn patients not to drive or use hazardous machinery if vision is not clear.
Long-term intensive topical use may lead to systemic effects.An ocular overdose of Hydrocortisone can be flushed from the eye(s) with lukewarm water.
Safety for use in pregnancy and lactation has not been established. Animal studies suggest some adverse effects following use of topical corticosteroids. The product should only be used if considered essential by the physician
No interaction studies have been performed.If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.
3 g of ointment for local use is filled into collapsed ophthalmic aluminum tubes (inside package). The tubes are packed and inserted with the leaflet into cardboard boxes (outer package).
2 years. Do not use after the expiration date.
To be dispensed with prescription.
Store in a cool and dry place from 50 to 15°C , out of the reach of children. Protect from light.