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Dexamethasone ocular preservative containing

Presentation

Eye drops containing dexamethasone (preservative containing).

Drugs List

  • dexamethasone 0.1% eye drops
  • MAXIDEX 0.1% eye drops
  • Therapeutic Indications

    Uses

    Eye - non-infected inflammatory conditions

    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 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.

    Dosage

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

    Adults

    Severe inflammation
    Instil 1 to 2 drops into the eye every 30 to 60 minutes.

    Subconjunctival or systemic steroid therapy should be considered if there is no response. When a favourable response has been observed reduce the dosage towards 1 drop every 4 hours.

    Children

    Severe inflammation
    Children aged 2 years and older
    Instil 1 to 2 drops into the eye every 30 to 60 minutes.

    Subconjunctival or systemic steroid therapy should be considered if there is no response. When a favourable response has been observed reduce the dosage towards 1 drop every 4 hours.

    Contraindications

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

    Precautions and Warnings

    Children under 2 years
    Family history of diabetes mellitus
    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 viral infection before treatment
    Not all available brands are licensed for all age groups
    Treat and control infections prior to commencing therapy
    Contains benzalkonium chloride. Not to be used with soft contact lenses
    Contains polysorbate
    In combined therapy, administer eye products at least five 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
    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
    Remove contact lenses before use and re-insert 15 minutes after use

    Prolonged use 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.

    Pregnancy and Lactation

    Pregnancy

    Use dexamethasone with caution during pregnancy.

    The manufacturer does not recommend using dexamethasone during pregnancy. At the time of writing there is limited data regarding the use of dexamethasone eye drops in pregnant women. Prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation. Infants of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism. Animal studies have shown reproductive toxicity.

    Lactation

    Use dexamethasone with caution during breastfeeding.

    The manufacturer advises that the patient either discontinues dexamethasone or discontinues breastfeeding. The presence of dexamethasone in human breast milk is unknown. It is unlikely that the amount of dexamethasone in human milk would be capable of producing clinical effects in the infant following maternal use of the product. Effects on exposed infants are unknown.

    Side Effects

    Abnormal sensation in eye
    Adrenal suppression
    Blurred vision (transient)
    Conjunctivitis
    Corneal deposits
    Corneal erosion
    Corneal perforation
    Corneal staining
    Corneal thinning
    Corneal ulcer
    Cushing's syndrome
    Dizziness
    Dry eyes
    Dysgeusia
    Eye infection
    Glaucoma
    Headache
    Hypersensitivity reactions
    Impaired healing
    Increased intra-ocular pressure
    Increased lacrimation
    Keratitis
    Lid margin crusting
    Mydriasis
    Ocular discomfort
    Ocular hyperaemia
    Ocular irritation
    Ocular pain
    Ocular pruritus
    Opportunistic infections
    Optic nerve damage
    Perforation of the ocular globe
    Photophobia
    Ptosis
    Reduced visual acuity
    Scleral thinning
    Sensation of foreign body in eye
    Subcapsular cataract
    Systemic effects (on prolonged use)
    Ulcerative keratitis
    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: Maxidex 0.1% eye drops. Novartis Pharmaceuticals UK Ltd. Revised October 2022.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 12 October 2022

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