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Azelastine nasal

Updated 2 Feb 2023 | Nasal allergy


Nasal spray containing azelastine hydrochloride

Drugs List

  • azelastine 0.1% nasal spray
  • RHINOLAST 0.1% nasal spray
  • Therapeutic Indications


    Allergic rhinitis - perennial and seasonal



    One spray (0.14 ml) in each nostril twice a day.


    One spray (0.14 ml) in each nostril twice a day.


    Children over 6 years
    One spray (0.14 ml) in each nostril twice a day.


    Children under 6 years

    Precautions and Warnings


    Pregnancy and Lactation


    Use azelastine nasal spray with caution in pregnancy.

    There are no reports on the use of azelastine in human pregnancy and it is not known if it crosses the human placenta. Animal data indicates that the risk to the embryo/foetus is low.

    Due to the nasal route of administration and the low dose administered, minimal systemic exposure can be expected.

    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 ( ) or if this is unavailable at the backup site ( ).


    Use azelastine nasal spray with caution in breastfeeding.

    There are no reports on the use of azelastine in human breastfeeding. After nasal use, the systemic bioavailability is only about 40% and it is doubtful if clinically significant amounts will be excreted into milk.

    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

    Side Effects

    Bitter taste
    Hypersensitivity reactions
    Irritation of nasal mucosa


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: December 2016

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Summary of Product Characteristics: Rhinolast Nasal Spray. Meda Pharmaceuticals Ltd. Revised January 2014.

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