Please refer to Summary of Product Characteristics before prescribing. Further information about this product can be requested from the Marketing Authorisation Holder or may be found in the Summary of Product Characteristics.
Contains: Dexamethasone sodium phosphate Ph Eur 0.1% w/v.
Main Indications, Dosage and Administration: Non-infected, steroid responsive, inflammatory conditions of the eye. Adults and the elderly One or two drops should be applied topically to the eye up to six times a day. Note: In severe conditions the treatment may be initiated with 1 or 2 drops every hour, the dosage should then be gradually reduced as the inflammation subsides. Paediatric population: At the discretion of the physician.
Contraindications, Precautions and Warnings: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC. Eye infections not controlled by appropriate anti-infectious treatment, such as: herpes simplex and other viral diseases of the cornea and conjunctiva, ocular fungal disease, ocular bacterial infections, ocular tuberculosis, untreated purulent infections. Corneal damage or ulcerous processes of the cornea. Patients with a pre-existing eye infection should only receive dexamethasone eye drops while using simultaneously specific anti-infective therapy.
In children, long-term, continuous corticosteroid therapy should be avoided due to possible adrenal suppression. Care should be taken to ensure that the eye is not infected before Minims Dexamethasone is used. These drops should be used cautiously in patients with glaucoma and should be considered carefully in patients with a family history of this disease. 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 of the SmPC). Topical corticosteroids should not be used for longer than 10 days except under ophthalmic supervision, as prolonged application to the eye of preparations containing corticosteroids has caused increased intraocular pressure and corneal damage. 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. Cushing’s syndrome and/or adrenal suppression associated with systemic absorption of ocular 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. Fungal infections of the cornea may occur under long-term local corticosteroid treatment. Therefore, in case of persistent corneal ulcers, the possibility of a fungal infection under corticoid treatment should be considered. If suspicion is present, samples should be taken. If symptoms do not improve within 2 days, a discontinuation of corticosteroid therapy should be considered.
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). Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
As any other corticosteroid, dexamethasone may affect the body's immune defence due to its protein catabolic nature and thus increase the hazard of secondary ocular infections. In these cases, treatment with dexamethasone should be discontinued until the infection is controlled effectively by an antibiotic therapy unless inflammation has been so violent that an anti-inflammatory treatment is mandatory.
Interactions: 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. 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. Concomitant use of topical steroids and topical NSAIDs may increase the potential for corneal healing problems. The following drug interactions are possible, but are unlikely to be of clinical significance, following the use of Minims Dexamethasone sodium phosphate 0.1% w/v Eye Drops, solution 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 ritonavir 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.
Fertility, Pregnancy and lactation: See section 4.6 of the SmPC for detailed advice.
Undesirable effects: Infections and infestations: Not known: Infection masked, Secondary infection. Immune system disorders: Not known: Hypersensitivity. Endocrine disorders: Not known: Adrenal suppression, Cushing’s syndrome. Eye disorders: Not known: Cataract (with long-term use), Eye irritation, Eyelid ptosis, Eye pain, Keratitis, Mydriasis, Ulcerative keratitis, Vision blurred, Visual acuity reduced. Rare: Cataract subcapsular, Lacrimation increased, Ocular hyperaemia, Eye stinging, Eye burning. General disorders and administration site complications: Not known: Impaired healing. Investigations: Not known: Blood glucose increased (in diabetics), Intraocular pressure increased (with long term use). Injury, poisoning and procedural complications: Not known: Open globe injury, Optic nerve injury.
Note: Fungal infections of the cornea may occur under long-term topical corticosteroid treatment. Therefore, in case of persistent corneal ulcers, the possibility of a fungal infection under corticoid treatment should be considered. If suspicion is present, samples should be taken. If symptoms do not improve within 2 days, a discontinuation of corticosteroid therapy should be considered. Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Legal Category: POM.
UK PL No: 03468/0072. Basic NHS Price: £ 11.46
Marketing Authorisation Holder: Bausch & Lomb UK Limited, Bausch & Lomb House 106 London Road, Kingston-Upon-Thames, Surrey, UK, KT2 6TN
Date of Revision: June 2024
Exemption Level: Not Available For Optometry Use
Evocative Code: DSP 0.1
PIP Code: 247-9442
United Kingdom (UK)
