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Presentation

Eye drops containing 1mg/ml olopatadine (as olopatadine hydrochloride)

Drugs List

  • olopatadine 1mg/ml eye drops
  • OPATANOL 1mg/ml eye drops
  • Dosage

    Wash hands prior to use.

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

    To reduce systemic absorption compress the lacrimal sac during administration and for one minute afterwards.

    Leave an interval of at least 5 minutes before instilling another ophthalmic medication.

    Soft contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes.

    Discard 4 weeks after first opening.

    Adults

    Instil one drop in the affected eye(s) twice daily, for up to four months if necessary.

    Elderly

    Instil one drop in the affected eye(s) twice daily, for up to four months if necessary.

    Children

    Aged under 3 years:
    Contraindicated.

    Aged 3 years and older :
    Instil one drop in the affected eye(s) twice daily, for up to four months if necessary.

    Adolescents

    Instil one drop in the affected eye(s) twice daily, for up to four months if necessary.

    Patients with Renal Impairment

    No dosage adjustment is necessary.

    Although increased plasma levels have been seen in patients with severe renal impairment after oral dosing, no dose adjustment is required for the eye drops because low plasma levels are achieved after ocular administration.

    Patients with Hepatic Impairment

    No dosage adjustment is necessary.

    Administration

    For ocular administration.

    Contraindications

    Children aged under 3 years.

    Precautions and Warnings

    Application may cause transient blurring of vision; patients should avoid driving or operating machinery until vision is clear.

    Although used topically, some systemic absorption will occur. If serious hypersensitivity reactions occur, discontinue use.

    Contains benzalkonium chloride which has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Monitor patients with dry eyes or if the cornea is compromised, particularly if the eye drops are used frequently or over a prolonged period. Benzalkonium also affects soft contact lenses.

    Contains benzalkonium chloride. Soft contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes.

    Pregnancy (see Pregnancy)

    Breastfeeding (see Lactation)

    Pregnancy and Lactation

    Pregnancy

    Use with caution during pregnancy.

    At the time of writing there is no published experienced concerning the use of olopatadine during pregnancy. It is not known if olopatadine crosses the human placenta. Animal studies do not indicate direct or indirect harmful effects on the pregnancy, foetus, parturition or on postnatal development. Briggs concludes that as ocular use results in very low plasma concentrations, the risk to the foetus is negligible (Briggs 2011).

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Lactation

    Use with caution during breastfeeding.

    At the time of writing there is no published experienced concerning the use of olopatadine during breastfeeding. Olopatadine has been found in the milk of nursing rats following oral administration. Studies have shown reduced growth of nursing pups of dams receiving systemic doses in excess of the maximum recommended dose for human ocular use. It is not known whether topical use in humans could result in sufficient systemic absorption to produce detectable quantities in human milk. Maternal milk levels are likely to be very low, therefore the risk to the nursing infants is likely to be negligible. Schaefer considers that generally antihistamine eye drops may be used for the appropriate indications (Schaefer 2007).

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Drug excreted in breast milk? - Unknown, but if present levels are likely to be very low.

    Counselling

    Advise patient to wash their hands prior to use.

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

    Advise patients to leave an interval of at least 5 minutes before instilling another ophthalmic medication.

    Advise patient to compress the lacrimal sac during administration and for one minute afterwards, to reduce systemic absorption.

    Advise patient to remove soft contact lenses before instillation of the eye drops and re-insert them after 15 minutes.

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

    Advise patient to discard eye drops 4 weeks after first opening.

    Side Effects

    Blurred vision (transient)
    Rhinitis
    Headache
    Dysgeusia
    Dizziness
    Hypoaesthesia
    Ocular pain
    Ocular irritation
    Dry eyes
    Abnormal sensation in eye
    Corneal erosion
    Corneal epithelium disorder
    Superficial punctate keratitis
    Keratitis
    Corneal staining
    Ocular discharge
    Photophobia
    Reduced visual acuity
    Blepharospasm
    Ocular discomfort
    Ocular pruritus
    Conjunctival follicles
    Conjunctivitis
    Sensation of foreign body in eye
    Increased lacrimation
    Eyelid pruritus
    Eyelid erythema
    Eyelid oedema
    Eyelid reaction
    Conjunctival hyperaemia
    Ocular hyperaemia
    Nasal dryness
    Subcutaneous tissue disorders
    Contact dermatitis
    Skin burning sensation
    Dry skin
    Fatigue
    Corneal oedema
    Ocular oedema
    Mydriasis
    Visual disturbances
    Lid margin crusting
    Hypersensitivity reactions
    Dyspnoea
    Somnolence
    Facial swelling
    Dermatitis
    Erythema
    Nausea
    Vomiting
    Sinusitis
    Asthenia
    Malaise

    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 ).

    Reference Sources

    British National Formulary, 63rd Edition (2012) Pharmaceutical Press, London.

    BNF for Children (2011-2012) Pharmaceutical Press, London.

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Summary of Product Characteristics: Opatanol 1mg/ml eye drops solution. Alcon Laboratories UK Limited. Revised September 2010

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
    Olopatadine. Last revised: February 12, 2010
    Last accessed: April 24, 2012

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