SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Hydrocortisone Eye Drops 1% BPC 1973

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Hydrocortisone Acetate BP 1.0% w/v

3 PHARMACEUTICAL FORM

Eye Drops

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the treatment of non-infected inflammatory conditions, such as anterior uveitis, iritis, cyclitis, allergic and vernal conjunctivitis, superficial punctate keratitis and nonspecific superficial keratitis.

For the treatment of corneal injury following ocular trauma such as chemical, radiation or thermal burns or following penetration by foreign bodies.

Used post-operatively to reduce inflammatory reactions and suppress graft reaction.

Also indicated to treat herpes zoster keratitis in conjunction with appropriate antiviral cover. Its use requires considerable experience in this area.

4.2. Posology and Method of Administration

The route of administration is topical.

Adults, children and the elderly.

The frequency of instillation of drops and the duration of treatment will vary depending on the severity of the underlying condition and response to treatment.

Severe inflammation requires one or two drops instilled into the eye every 30 to 60 minutes until a satisfactory response occurs. Subconjunctival or systemic steroid therapy should be considered if there is no response. When a favourable response has been observed reduce the dosage toward one drop every four hours.

4.3. Contra-indications

Should not be used for the treatment of an undiagnosed red eye.

Should not be used in patients with raised intra-ocular pressure.

Herpes simplex and other viral diseases of the cornea and conjunctivitis. Fungal diseases, ocular tuberculosis and purulent infections.

Hypersensitivity to any of the constituents of the preparation.

Should not be used with soft contact lenses.

4.4. Special Warnings and Precautions for Use

Check the intraocular pressure and lens frequently during the use of this preparation because there is a risk of “steroid glaucoma” and cataract formation.

Frequent slit-lamp examination is essential to avoid the risk of enhancement of herpetic corneal disease

Topical steroids may mask or enhance the activity of acute purulent eye infections. In such cases, antibiotic therapy is mandatory.

Persistent corneal ulceration following long term topical steroid use may be due to fungal invasion.

Topical corticosteroid preparations are not effective in mustard gas keratitis or Sjogren’s kerato-conjunctivitis.

4.5. Interactions with other Medicaments and other forms of Interaction

None relevant to topical use.

4.6. Pregnancy and Lactation

Should not be used in pregnancy unless considered essential.

4.7. Effects on Ability to Drive and Use Machines

The use of these eye drops may cause a transient blurring of vision and stinging on instillation. Do not drive or operate machinery until vision is clear. Some patients may experience sensitivity to bright lights.

Care should be taken in driving and in the use of hazardous machinery if vision is affected.

4.8. Undesirable Effects

Topical steroid application may result in a serious rise in intra-ocular pressure in a small percentage of patients. A family history of glaucoma is significant. A milder rise may be experienced in a greater number of patients if treatment is continued for longer than a few weeks.

Intensive and prolonged use of topical corticosteroids has been reported to lead to the formation of cataracts. Thinning of the cornea leading to perforation has also occurred.

Viral and fungal infections may get worse and their symptoms masked by topical corticosteroid usage

In cases of infection by the herpes simplex virus which produces a dendritic ulcer, treatment with corticosteroids will aggravate this condition with a significant chance of loss of vision or even the loss of the eye.

Transient stinging or burning may occur on instillation of the drops.

Systemic effects of hydrocortisone may occur with extensive use.

This medicinal product contains thiomersal as (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur

4.9. Overdose

Long term intensive topical use may lead to systemic effects. Oral ingestion of the contents of one bottle (up to 10ml) is unlikely to lead to any serious adverse effects.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Hydrocortisone belongs to the corticosteroid group of medicines.

Corticosteroids are used for replacement therapy in adrenal insufficiency and are also given for their palliative anti-inflammatory and immunosuppressant effects in a wide variety of disorders.

High doses may be needed for emergencies but in general the lowest effective dose should be given for the shortest possible time; local administration is preferable. Withdrawal of systemic treatment should be gradual because of abrupt cessation of corticosteroids may precipitate acute adrenal insufficiency. To prevent adrenal insufficiency resulting from increased corticosteroid requirements during periods of stress or trauma, it may be necessary to increase the dose.

Adverse effects of corticosteroids mainly result from an excessive action on electrolyte balance, metabolism, and tissue repair and an inhibitory effect on secretion of corticotrophin. Susceptibility to all kinds of infection may be increased and there may be growth retardation in children.

5.2. Pharmacokinetic Properties

Absorption

Corticosteroids are well absorbed from the sites of local action. When administered by topical application, sufficient corticosteroid may be absorbed to give systemic effects.

Hydrocortisone is readily absorbed from the gastro-intestinal tract and peak blood concentrations are attained in about one hour. The biological half life is about 100 minutes. It is more than 90% bound to plasma proteins.

Absorption of hydrocortisone acetate after intra-muscular or soft tissue injection is also slow.

Distribution

Corticosteroids are rapidly distributed to all body tissues. They cross the placenta and may be excreted in small amounts in breast milk. Most corticosteroids in the circulation are extensively bound to plasma proteins, mainly to globulin and less so to albumin.

The corticosteroid-binding globulin has high affinity but low binding capacity, while the albumin has low affinity but large binding capacity. The synthetic corticosteroids are less extensively protein bound than hydrocortisone. They also tend to have longer half lives.

Elimination

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.

Topical corticosteroids should normally only be prescribed under expert supervision, they should not be prescribed for undiagnosed “red eye”. There are two main dangers from topical corticosteroids. First the red eye may be caused by herpes simplex virus which produces a dendritic ulcer; corticosteroids aggravate the condition which may lead to loss of vision or even loss of the eye. Second a “steroid glaucoma” may be produced after a few weeks treatment, in patients predisposed to chronic simple glaucoma. Use of combination product containing a corticosteroid with an anti-infective is rarely justified.

The therapeutic effects of systemically administered corticosteroids are decreased by the concurrent use of phenobarbitone (and probably other barbitutes) because the loss of these corticosteroids from the body is increased. An increase in the corticosteroid dosage may be needed.

Amphotericin and hydrocortisone can cause potassium loss as well as salt and water retention which can have adverse effects on cardiac function.

Prolonged use of glucosteroids may cause a diabetic like syndrome associated with increased resistance to insulin and a decrease in the tolerance to glucose. Hydrocortisone may increase the renal excretion of aspirin and result in decreased salicylic levels during concurrent therapy but the clinical significance of this interaction has not been established.

5.3. Preclinical Safety Data

None available.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sodium acid phosphate BP

Sodium phosphate BP Sodium Carboxymethylcellulose BPC Disodium edetate BP Thiomersal BP

Benzalkonium chloride solution BP Propylene glycol BP Purified water BP

6.2. Incompatibilities

None relevant to topical ocular use.

Shelf Life

DATE OF REVISION OF THE TEXT

November 2000