DROPODEX Eye drops, solution Ref.[6774] Active ingredients: Dexamethasone

For ocular use only. Not for injection into the eye.

Care should be taken to ensure that the eye is not infected before Dropodex 0.1% w/v Eye Drops are used.

In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids.

Caution is also necessary when used in conjunction with antiviral therapy in the treatment of stromal keratitis or uveitis and use of periodic slit-lamp microscopy.

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.

This medicinal product contains phosphates which may lead to corneal deposits or corneal opacity when topically administered. It should be used with caution in patients presenting with compromised cornea and in instances where the patient is receiving polypharmacy with other phosphate-containing eye medications (see section 4.5).

Topical corticosteroids should not be used for longer than one week except under ophthalmic supervision. 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. The dose of anti-glaucoma medication may need to be adjusted in these patients. Prolonged use may also increase the hazard of secondary ocular infections. Topical ophthalmic corticosteroids may slow corneal wound healing.

Cushing’s syndrome and/or adrenal suppression associated with systemic absorption of ophthalmic dexamethasone may occur after intensive or long-term continuous therapy in predisposed patients, including children and patients treated with CYP3A4 inhibitors (including ritonavir and cobicistat). In these cases, treatment should be progressively discontinued.

Contact lenses should not be worn during treatment with corticosteroid eye drops due to increased risk of infection.

Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)

Paediatric population

In children, long-term, continuous corticosteroid therapy should be avoided due to possible adrenal suppression.

The risk of increased intraocular pressure associated with prolonged corticosteroid therapy may be more likely to occur with concomitant use of anticholinergics, especially atropine and related compounds, in patients predisposed to acute angle closure.

The risk of corneal deposits or corneal opacity may be more likely to occur in patients presenting with compromised cornea and receiving polypharmacy with other phosphate-containing eye medications.

The following drug interactions are possible, but are unlikely to be of clinical significance, following the use of Dropodex 0.1% w/v Eye Drops in the eye:

The therapeutic efficacy of dexamethasone may be reduced by phenytoin, phenobarbitone, ephedrine and rifampicin.

Glucocorticoids may increase the need for salicylates as plasma salicylate clearance is increased.

CYP3A4 inhibitors (including ritanovir and cobicistat) may decrease dexamethasone clearance resulting in increased effects and adrenal suppression/Cushing’s syndrome. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid effects.

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 dexamethasone eye drops in pregnant women. Studies in animals have shown that topically applied steroids can be absorbed systemically and can cause abnormalities of foetal development in pregnant animals (see section 5.3). Although the relevance of these findings to human beings has not been established, the use of Dropodex 0.1% w/v Eye Drops during pregnancy should be avoided.

Breastfeeding

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 dexamethasone is excreted in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from dexamethasone therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Dropodex 0.1% w/v Eye Drops have no or negligible influence on the ability to drive and use machines; however, instillation of eye drops may cause transient blurring of vision. Warn patients not to drive or operate hazardous machinery until vision is clear.

The following undesirable effects 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 <1/1000), very rare (<1/10,000), or not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in decreasing order of seriousness.

Endocrine disorders

Not known (cannot be estimated from the available data): Cushing’s syndrome, adrenal suppression (see section 4.4)

Ocular disorders

Very common (>1/10): intraocular pressure increased (after 2 weeks of treatment).

Common (>1/100, <1/10): ocular discomfort after instillation, irritation, burning, eye pruritus and blurred vision. These symptoms are mild and transient with no consequences.

Uncommon (>1/1,000, <1/100): signs and symptoms of allergic or hypersensitive reactions can occur. The following corticoid specific undesirable effects can occur: delay in healing, risk of posterior subcapsular cataract formation, opportunist infections and glaucoma.

Very rare (<1/10,000, including isolated reports): conjunctivitis, eyelid oedema, corticoid-induced uveitis, keratitis, corneal thinning, corneal oedema and ulcerations. Cases of corneal calcification have been reported in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas. Due to the steroid component, in diseases causing thinning of the cornea or sclera, there is a higher risk for perforation especially after topical long treatments.

General disorders and administration site conditions

Uncommon (>1/1,000, <1/100): after long treatment posology, systemic absorption can occur with an inhibition of the adrenal function.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.

None known. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.