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Dexamethasone ocular preservative-free

Presentation

Eye drops containing dexamethasone (preservative-free).

Drugs List

  • DEXAFREE 1mg/ml eye drops 0.4ml unit dose
  • dexamethasone sodium phosphate 0.1% eye drops preservative-free
  • dexamethasone sodium phosphate 0.1% eye drops preservative-free 0.3ml unit dose
  • dexamethasone sodium phosphate 0.1% eye drops preservative-free 0.4ml unit dose
  • dexamethasone sodium phosphate 0.1% eye drops preservative-free 0.5ml unit dose
  • DROPODEX 0.1% eye drops 0.4ml unit dose
  • EYTHALM 1mg/ml eye drops
  • MINIMS DEXAMETHASONE 0.1% eye drops 0.5ml unit dose
  • Therapeutic Indications

    Uses

    Eye - non-infected inflammatory conditions

    Dosage

    Dose regimens vary according to brand.

    Adults

    Moderate inflammation
    Instil 1 drop every four to six hours.

    Severe inflammation
    Instil 1 to 2 drops every 60 minutes until a satisfactory response occurs. When this is obtained, reduce the dose towards 1 drop every four hours.
    Consider subconjunctival or systemic steroid therapy if there is no response.

    Children

    Children 2-18 years
    Moderate inflammation
    Instil 1 drop every four to six hours.

    Severe inflammation
    Instil 1 to 2 drops every 60 minutes until a satisfactory response occurs. When this is obtained, reduce the dose towards 1 drop every four hours.
    Consider subconjunctival or systemic steroid therapy if there is no response.

    Children under 2 years (unlicensed)
    Moderate inflammation
    Instil 1 drop every four to six hours.

    Severe inflammation
    Instil 1 drop every 60 minutes until a satisfactory response occurs. When this is obtained, reduce the dose towards 1 drop every four hours.
    Consider subconjunctival or systemic steroid therapy if there is no response.

    Contraindications

    Wearing of contact lenses
    History of herpes simplex keratitis
    Ocular infection
    Undiagnosed red eye

    Precautions and Warnings

    Children under 18 years
    Family history of glaucoma
    Breastfeeding
    Corneal damage
    Diabetes mellitus
    Glaucoma
    Pregnancy

    Diabetes mellitus: May increase risk of glaucoma and cataracts
    May mask symptoms or signs of infections
    Advise patient blurred vision may affect ability to drive/operate machinery
    Exclude bacterial infection before treatment
    Exclude fungal infection before treatment
    Exclude tubercular infection before treatment
    Exclude viral infection before treatment
    Not all available brands are licensed for all age groups
    Treat and control infections prior to commencing therapy
    Some formulations may contain traces of silver - risk of hypersensitivity
    Administer other ophthalmic products at least 15 minutes apart
    To reduce systemic absorption compress lacrimal sac during administration
    Check ocular lens frequently - risk of cataract formation
    Monitor intraocular pressure frequently - risk of steroid glaucoma
    Perform eye tests in any patient with vision change/ophthalmologic symptoms
    Possible systemic absorption of steroid
    Prolonged or high dose may lead to adrenal suppression
    Contains phosphate: Risk of calcification in existing notable cornea damage
    May cause perforation of eye in disorders that thin the sclera or cornea
    Prolonged use may cause raised intraocular pressure
    Prolonged use may result in ocular infections
    Treatment may adversely affect wound healing
    Advise patient to avoid touching the eye/other surfaces with container tip
    Contact lenses should not be worn during treatment

    Pregnancy and Lactation

    Pregnancy

    Use dexamethasone eye drops with caution during pregnancy.

    The manufacturers note that it is preferable to avoid the use of these eye drops during pregnancy.

    There is limited data from the use of these eye drops in pregnant women. Most information available relates to use of systemically administered corticosteroids. Dexamethasone crosses the placenta to the foetus but toxicity in the foetus and newborn following its use is rare.

    Lactation

    Use dexamethasone eye drops with caution during breastfeeding.

    The manufacturer recommends avoiding the use of dexamethasone eye drops during breastfeeding. Little data is available on the transfer of dexamethasone into human milk but it is likely to be extremely low when instilled topically. Effects on exposed infants are unknown.

    Side Effects

    Adrenal suppression
    Allergic reaction
    Blurred vision (transient)
    Burning and stinging of the eyes
    Conjunctivitis
    Corneal deposits
    Corneal oedema
    Corneal opacities
    Corneal perforation
    Corneal thinning
    Corneal ulcer
    Crystalline keratopathy
    Cushing's syndrome
    Dysgeusia
    Eye infection
    Eyelid oedema
    Facial oedema
    Glaucoma
    Hypersensitivity reactions
    Impaired healing
    Increased intra-ocular pressure
    Increased lacrimation
    Keratitis
    Mydriasis
    Ocular discomfort
    Ocular irritation
    Ocular itching
    Ocular pain
    Ocular pruritus
    Opportunistic infections
    Optic nerve damage
    Perforation of the ocular globe
    Photophobia
    Ptosis
    Reddening of eyes
    Reduced visual acuity
    Scleral thinning
    Subcapsular cataract
    Systemic effects (on prolonged use)
    Uveitis
    Visual field defects

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: October 2022

    Reference Sources

    Summary of Product Characteristics: Dexamethasone phosphate 1mg/ml, eye drops, solution in single-dose container. Kent Pharma (UK) Ltd. Revised June 2020.

    Summary of Product Characteristics: Dexafree 1mg/ml, eye drops, solution in single-dose container. Thea Pharmaceuticals Ltd. Revised August 2018.

    Summary of Product Characteristics: Dropodex 0.1% w/v Eye Drops, solution. Rayner Pharmaceuticals Ltd. Revised August 2022.

    Summary of Product Characteristics: Eythalm 1mg/ml eye drops, solution. Aspire Pharma Ltd. Revised September 2021.

    Summary of Product Characteristics: Minims Dexamethasone sodium phosphate 0.1% w/v eye drops. Bausch & Lomb U.K. Ltd. Revised October 2022.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 21 October 2022

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.