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Propamidine isetionate

Presentation

Eye drops containing propamidine isetionate with preservative.

Drugs List

  • BROLENE 0.1% eye drops
  • GOLDEN EYE PROPAMIDINE ISETIONATE 0.1% eye drops
  • propamidine 0.1% eye drops
  • Therapeutic Indications

    Uses

    Propamidine isetionate is an aromatic diamidine disinfectant which is active against Gram-positive non-spore forming organisms and has antifungal properties.

    It is used for the treatment of minor eye infections such as conjunctivitis and blepharitis.

    Unlicensed Uses

    Acanthamoeba keratitis.

    Dosage

    Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following instillation of drops. It is especially advisable in children.

    Contact lenses should not be worn during the course of treatment.

    Avoid contact of the container with the eye or other surfaces as contamination may occur.

    Leave an interval of at least 5 minutes between instilling another ophthalmic medication and this one.

    Discard 4 weeks after first opening.

    Adults

    Instil one drop or two drops into the affected eye(s) up to four times a day. If no improvement after two days seek medical advice.

    Elderly

    As for adults.

    Children

    As for adults.

    Additional Dosage Information

    The optimal dosage regime for Acanthamoeba keratitis has not been established. Other antibiotics may be required concurrently.

    Administration

    For ocular administration.

    Contraindications

    Wearing of contact lenses.

    Hypersensitivity to benzalkonium chloride.

    Precautions and Warnings

    If the vision or symptoms worsen, or if there is no significant improvement in 2 days, discontinue treatment and consult a doctor.

    Discontinue if hypersensitivity reactions occur.

    Solution contains benzalkonium chloride and should not be used where soft or hard contact lenses are worn.

    Pregnancy and Lactation

    Pregnancy

    The safety of this drug for use during pregnancy has not been established. It should only be used during pregnancy under the advice of a physician.

    Lactation

    The safety of this drug for use during breastfeeding has not been established. It should only be used during breastfeeding under the advice of a physician.

    Effects on Ability to Drive and Operate Machinery

    Instillation of the eye drops may cause blurring of vision. Driving or operating harzadous machinery should be delayed until vision has cleared.

    Counselling

    Advise patient to wash their hands prior to use.

    Advise patient to avoid wearing hard or soft contact lenses during treatment.

    Advise patient to avoid contact of the container with eye or other surfaces as contamination leading to ophthalmic infection may occur.

    Advise patient to compress the lacrimal sac during administration and for one minute afterwards.

    Advise patient that eye drops may cause transient blurring of vision after instillation and to avoid driving or operating machinery until vision is clear

    Advise patient to leave an interval of at least 5 minutes between instilling another ophthalmic medication and this one.

    Advise patient to discard 4 weeks after first opening.

    Side Effects

    Hypersensitivity reactions

    Blurred vision (transient)

    Ocular pain

    Ocular irritation

    Burning and stinging of the eyes

    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 (https://www.toxbase.org/).

    Shelf Life and Storage

    Store below 25 degrees C.

    Once opened discard any unused contents after 28 days.

    Further Information

    Last Full Review Date: February 2011.

    Reference Sources

    British National Formulary, 60th Edition (2010) Pharmaceutical Press, London.

    BNF for Children (2010-2011) Pharmaceutical Press, London.

    Martindale: The Complete Drug Reference, 36th edition (2009) ed. Sweetman, S. Pharmaceutical Press, London.

    Summary of Product Characteristics: Brolene Eye Drops, Sanofi, revised March 2021.

    Summary of Product Characteristics: Golden Eye 0.1% Eye Drops, Typharm Ltd, revised December 2006.

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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.