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Hydrocortisone, 0.5 % eye ointment

Drug formEye ointments

ATC categoryOphthalmology

ATC subcategoryGlucocorticoids for use in ophthalmology

Brand nameHydrocortisone

Generic nameHydrocortisone

Composition

Each gram of Hydrocortisone, 0.5% eye ointment contains:

active ingredient: Hydrocortisone acetate – 5 mg

excipients: Methylparaben-2mg, Petrolatum ophthalmic to 1000 mg.

Pharmacological group and ATC code
Corticosteroids. S01BA02.

Pharmacology

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.

Pharmacokinetics
Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects. Hydrocortisone is metabolised in the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone. Hydrocortisone readily crosses the placenta. Metabolism is similar to other corticosteroids. Intraocular penetration occurs and contributes to the effectiveness of hydrocortisone in anterior segment inflammatory disease.

Uses and Administration
Indicated for treatment of steroid responsive inflammatory conditions of the conjunctiva, cornea and anterior segment of the eye such as: anterior uveitis, iritis, cyclitis, allergic and vernal conjunctivitis, superficial punctate keratitis and non-specific superficial keratitis. Also indicated for the treatment of corneal injury from chemical, radiation or thermal burns or following penetration by foreign bodies. Indicated for post-operative use to reduce inflammatory reactions and suppress graft reaction.

Apply a small amount into the conjunctival sac 2-3 times daily for 2 weeks or until a satisfactory response occurs.

Precautions

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.

Overdosage

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.

Contraindications
• Vaccinia, varicella, or other viral diseases of cornea and conjunctiva
• Ocular herpes simplex
• Fungal diseases of ocular structures
• Mycobacterial ocular infections
• Acute, untreated purulent bacterial infections
• Hypersensitivity to hydrocortisone or to any of the excipients.

Adverse effects
Apply a small amount into the conjunctival sac 3-4 times daily for 3-4 days or until a satisfactory response occurs. Continued use of corticosteroids may increase intraocular pressure. Intensive or prolonged use of corticosteroids may lead to the formation of cataracts. Viral and fungal infections may be exacerbated by corticosteroids. Topical corticosteroids may induce scleral or corneal perforation.

Pregnancy and Breast feeding

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

Drug interactions

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.

Presentation

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).

Expiry date

2 years. Do not use after the expiration date.

Prescription status

To be dispensed with prescription.

Storage conditions

Store in a cool and dry place from 50 to 15°C , out of the reach of children. Protect from light.