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Xylometazoline hydrochloride with antazoline sulfate ocular

Presentation

Eye drops containing xylometazoline hydrochloride and antazoline sulfate (preservative containing and preservative-free)

Drugs List

  • antazoline 0.5% and xylometazoline 0.05% eye drops
  • OTRIVINE ANTISTIN eye drops
  • Therapeutic Indications

    Uses

    Conjunctivitis - allergic

    Dosage

    Xylometazoline hydrochloride and antazoline sulfate eye drops should be used for a maximum of 7 days.

    Adults

    Instil one or two drops into the affected eye(s) 2 to 3 times a day.

    Elderly

    Instil one or two drops into the affected eye(s) 2 to 3 times a day.

    Children

    Children aged 12 to 18 years
    Instil one or two drops into the affected eye(s) 2 to 3 times a day.

    Contraindications

    Children under 12 years
    Wearing of contact lenses
    Narrow angle glaucoma

    Precautions and Warnings

    Elderly
    Within 2 weeks of discontinuing MAOIs
    Benign prostatic hyperplasia
    Breastfeeding
    Cardiac disorder
    Diabetes mellitus
    Hypertension
    Hyperthyroidism
    Phaeochromocytoma
    Pregnancy
    Urinary retention

    Advise patient blurred vision may affect ability to drive/operate machinery
    Avoid within 2 weeks of discontinuing a MAOI
    Contains benzalkonium chloride
    In combined therapy, administer eye products at least five minutes apart
    To reduce systemic absorption compress lacrimal sac during administration
    Prolonged use may lead to rebound ocular hyperaemia
    If no significant improvement in 2 days, discontinue and contact GP
    Do not use for more than seven days
    Advise patient to avoid touching the eye/other surfaces with container tip

    Pregnancy and Lactation

    Pregnancy

    Use xylometazoline hydrochloride with antazoline sulfate with caution in pregnancy.

    The safety of ocular application of xylometazoline hydrochloride and antazoline sulfate has not been studied during pregnancy. A small degree of systemic absorption may occur. Xylometazoline is a direct acting sympathomimetic with alpha-adrenergic activity and is employed as a vasoconstrictor. Antazoline is employed as an anti-histamine. Nasal preparations using xylometazoline have been used during pregnancy without any reported risk to the foetus. There is a possibility of reduced circulation to the foetus as a result of systemic vasoconstriction.

    Although there is no evidence that these substances given by ocular application are harmful in pregnancy, there use should be avoided unless judged essential.

    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 to 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 xylometazoline hydrochloride with antazoline sulfate with caution in breastfeeding.

    Following administration of xylometazoline hydrochloride and antazoline sulfate topically to the eye, a small degree of systemic absorption may occur.

    It is not known if the active ingredients are excreted in milk, although levels are unlikely to be high enough to affect the infant in therapeutic doses. However, due to the increased sensitivity of neonates and premature infants to antihistamine, the manufacturer advises that it is safer to avoid breastfeeding for 48 hours after administration.

    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

    Side Effects

    Allergic reaction
    Arrhythmias
    Blurred vision
    Dizziness
    Drowsiness
    Headache
    Hyperaemia
    Hypertension
    Insomnia
    Mydriasis
    Nausea
    Nervousness
    Ocular irritation
    Oedema at application site
    Paleness at application site
    Palpitations
    Pruritus
    Rash
    Stinging
    Sweating
    Tachycardia

    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: April 2015.

    Reference Sources

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

    Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on D21 April 2015.

    Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications Accessed on 21 April 2015].

    Summary of Product Characteristics: Otrivine Antistin Eye Drops. Spectrum Thea. Revised January 2015.

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