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.

Adults, adolescents, and children (above 2 years of age)

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.

Paediatric patients

The safety and efficacy of this product has not been established in children below 2 years of age.

• Vaccinia, varicella, or other viral diseases of cornea and conjunctiva (except herpes zoster keratitis)

• Ocular herpes simplex

• Fungal diseases of ocular structures

• Mycobacterial ocular infections

• Acute, untreated purulent bacterial infections

• Hypersensitivity to dexamethasone or to any of the excipients.

• 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.

• Additionally, this product contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to application of MAXIDEX and wait at least 15 minutes before reinsertion.

• There is no evidence of safety in use in children under two years of age.

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.

Pregnancy

There are no or limited amount of data from the use of MAXIDEX in pregnant woman. Studies in animals have shown reproductive toxicity (see section 5.3). Even though, the maximum daily dose (2x 30μl drops x 4 times per day = about 0.240 mg/day dexamethasone) following topical application is much lower than a standard systemic anti-inflammatory dose of about 0.5 to 10mg daily.

MAXIDEX is not recommended during pregnancy unless the clinical condition of the woman requires treatment with MAXIDEX.

Lactation

Systemically administered corticosteroids appear in human milk in quantities that could affect the child being breastfed. However, when instilled topically, systemic exposure is low. It is unknown whether MAXIDEX is excreted in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from MAXIDEX therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

MAXIDEX has no or negligible influence on the ability to drive and use machines. As with any topical ophthalmic medicinal product, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs upon instillation, the patient must wait until the vision clears before driving or using machinery.

Summary of the safety profile

In clinical trials, the most common adverse reaction was ocular discomfort.

Tabulated list of adverse reactions

The following adverse reactions are classified according to the following convention:

very common ( 1/10), common ( 1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions have been observed during clinical trials and post-marketing experience with Maxidex.

Description of selected adverse reactions

Prolonged topical ophthalmic corticosteroids may result in increased intraocular pressure with damage to the optic nerve, reduced visual acuity and visual field defects, and to posterior subcapsular cataract formation (see section 4.4).

Due to the corticosteroid component, in diseases causing thinning of the cornea or sclera there is a higher risk for perforation especially after long treatments (see section 4.4).

Corticosteroids may reduce resistance to and aid in the establishment of infections (see section 4.4).

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.

An ocular overdose of Maxidex can be flushed from the eye(s) with lukewarm water.

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.

Repeat dose topical ocular safety studies with dexamethasone in rabbits have shown systemic corticosteroid effects. Such effects are considered to be unlikely when MAXIDEX is used as recommended.

Dexamethasone was clastogenic in the in vitro human lymphocyte assay and in vivo in the mouse micronucleus assay at doses in excess of those obtained following topical application. Conventional carcinogenicity studies with MAXIDEX have not been performed.

Dexamethasone has been found to be teratogenic in animal models. Dexamethasone induced abnormalities of foetal development including cleft palate, intra-uterine growth retardation and affects on brain growth and development.

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

Sodium phosphate

Polysorbate 80

Disodium edetate

Sodium chloride

Benzalkonium chloride

Hypromellose

Citric acid

Purified water

None known

20 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

28/09/1990 / 17/09/2003

20/07/2010