MAXIDEX 0.1% w/v, eye drops, suspension

Dexamethasone 0.1% w/v

For excipients, see 6.1.

Eye drops, suspension.

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, herpes zoster keratitis, 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.

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

Severe inflammations require one to two drops instilled into the eye every thirty to sixty 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 towards one drop every four hours.

Herpes simplex and other viral diseases of the cornea and conjunctiva, fungal disease, ocular tuberculosis, untreated purulent infections and hypersensitivity to any component of the preparation. Patients with soft contact lenses should not use this preparation.

Topical corticosteroids should never be given for an undiagnosed red eye as inappropriate use is potentially blinding.

Because of the risk of "steroid glaucoma" and cataract formation the intraocular pressure and the lens must be checked frequently during use of this preparation.

To avoid the risk of enhancement of herpetic corneal disease, frequent slit-lamp examination is essential.

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 corticosteroids are not effective in mustard gas keratitis or Sjogren's keratoconjunctivitis.

None relevant to topical use.

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human pregnancy.

May cause transient stinging on instillation or sensitivity to bright light. Warn patients not to drive or use hazardous machinery if vision is not clear.

Topical steroid use may result in increased intraocular pressure leading to optic nerve damage, reduced visual acuity and visual field defects.

Intensive or prolonged use of topical corticosteroids may lead to the formation of posterior subcapsular cataracts. In those diseases causing thinning of the cornea or sclera, perforation of the globe may occur. Viral and fungal infections may be exacerbated by steroids. Transient stinging or burning may occur on instillation of the drops. Systemic side effects may occur with extensive use.

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

Pharmacotherapeutic Group: Ophthalmologicals: Anti-inflammatory Agents

ATC Code S01B A01

Dexamethasone has been demonstrated by animal and human studies based on oral application to possess approximately six to seven times the potency of prednisolone and at least 30 times the potency of cortisone. The potency of the compound is accomplished by the addition of a methyl radical and a fluorine atom to the prednisolone radical.

Dexamethasone is absorbed rapidly after oral administration with a half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects. In plasma dexamethasone protein binding is less than for most other corticosteroids. Corticosteroids diffuse into tissue fluids and cerebrospinal fluid but transplacental diffusion in significant amounts has not been demonstrated. Corticosteroids are metabilised in the liver the kidney and excrete in the urine. Metabolism is similar to other corticosteroids. Intraocular penetration occurs in significant amounts and contributes to the effectiveness of dexamethasone in anterior segment inflammatory disease.

There are no preclinical data of relevance to the presciber which are additional to that already included in other sections of the SPC.

Disodium phosphate anhydrous

Polysorbate 80

Disodium edetate

Sodium chloride

Benzalkonium chloride

Hypromellose

Citric acid

Purified water

None known

36 months (unopened), 1 month (after first opening)

Do not store above 25°C.. Do not refrigerate or freeze. Keep container tightly closed. Discard 1 month after first opening. Store in the original package.

Drop-Tainer - 5ml and 10ml Natural Low Density Polyethylene Bottles and Plugs.

Polystyrene or Polypropylene cap.

Do not touch dropper tip to any surface as this may contaminate the contents.

If the drop of medication is not retained in the eye upon dosing for any reason then instill another drop.

Alcon Laboratories (UK) Ltd.,

Pentagon Park,

Boundary Way,

Hemel Hempstead,

HP2 7UD.

PL 0649/5914R

October 2002

August 2004