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Nicotine nasal spray

Updated 2 Feb 2023 | Smoking cessation


Nasal spray containing 10mg/ml nicotine. Each spray delivers 0.5mg nicotine

Drugs List

  • NICORETTE 500microgram nasal spray
  • nicotine 500microgram nasal spray
  • Therapeutic Indications


    Relief of nicotine withdrawal symptoms associated with smoking cessation


    Patients should make every effort to stop smoking completely during therapy.

    Frequency of administration depends on previous smoking habit and the level of nicotine dependence.

    Advice and support normally improve the success rate.

    The nasal spray must only be used with other nicotine replacement therapy products under the advice of a healthcare professional.

    Duration of treatment should not be longer than 3 months. The National Institute for Clinical Excellence (NICE) has recommended that nicotine replacement therapy should be prescribed only for patients who agree to a quit date. Ensure the patient has nicotine replacement therapy ready to start before the quit date (NICE).


    Initially the spray should be used to treat craving as required, up to a maximum of one spray to each nostril twice per hour. The daily limit of use is 64 sprays which is the equivalent of two sprays to each nostril every hour for 16 hours.

    The three month course should consist of eight weeks using the spray as required subject to the limits above; then halve the dose over next two weeks and finally reduce the dose to zero by the end of the last two weeks. Spraying into a single nostril during the last four weeks of the three month course may be helpful.

    Patients who continue to use the nasal spray after 9 months should seek additional help and advice from a healthcare professional.


    Children and Adolescents aged 12-18 years
    As adult dosage. However, treatment should be limited to 12 weeks. If a longer treatment period is required, patients should be advised to seek the advice of a healthcare professional.


    Children under 12 years
    Non smokers
    Occasional tobacco smokers

    Precautions and Warnings

    Children aged 12 to 18 years
    Cardiac arrhythmias
    Cardiac failure
    Cerebrovascular disorder
    Diabetes mellitus
    Haemodynamic instability
    History of cerebrovascular accident
    History of myocardial infarction
    Moderate hepatic impairment
    Occlusive peripheral arterial disease
    Peptic ulcer
    Severe renal impairment
    Ulcerative stomatitis
    Uncontrolled hypertension

    Advise patient not to use whilst driving or operating machinery
    Contains hydroxybenzoate
    Diabetic control may need adjustment
    Monitor patients with cardiovascular conditions
    Advise patient to report worsening nasal disorders to doctor
    Stopping smoking may lead to raised levels of drugs metabolised by CYP 1A2
    Treatment should be limited to 3 months
    Nasal irritation may be unpleasant for the first few days
    Seek professional advice if use continues beyond 9 months

    Pregnancy and Lactation


    Complete cessation of nicotine consumption should always be recommended in preference to nicotine replacement therapy (NRT). However, NRT may be recommended for women unable to quit on their own, as this is preferable to continued smoking. The decision to use NRT should be made as early in the pregnancy as possible, with an aim of discontinuing use during a successful quit attempt as early as possible, preferably within 8 to 10 weeks (Briggs et al).

    Smoking in pregnant women can cause spontaneous abortion, inter-uterine growth retardation, premature birth, still birth and neonatal death. The risk of these effects appears to correlate with the extent of tobacco exposure; growth problems are less common if smoking cessation occurs in the first trimester. Stopping smoking as early as possible is therefore the single most effective intervention for improving the health of both the pregnant smoker and her baby. No invasive diagnostics are indicated in the case of heavy smoking during pregnancy (Schaefer et al, Lee et al).

    Nicotine passes to the foetus, where it affects breathing movements, and has a dose-dependent effect on the placental/foetal circulation. However, the risk of nicotine to the foetus is lower with NRT than with tobacco smoking since the maximal plasma nicotine levels are lower, and there is no additional risk from polycyclic hydrocarbons and carbon monoxide. Intermittent dosing preparations i.e. lozenges, gum, inhalators or nasal spray may be preferable to patches as they provide a lower daily dose of nicotine. However, if the woman suffers from nausea and/or vomiting during pregnancy, patches may be preferred, but should be removed before going to bed.


    Nicotine and its main metabolites (e.g. cotinine) pass readily into breast milk, and are detectable in the serum of breastfed infants (Schaefer et al, Lee et al and Hale et al).

    If the infant is exposed to nicotine through the breast milk, the amount is relatively small and less hazardous than the second-hand smoke they would be exposed to from a smoking mother.

    Possible adverse effects in infants exposed to nicotine laden breast milk include vomiting, diarrhoea, tachycardia, restlessness and colic. Infants exposed to passive smoking are believed to be more susceptible to respiratory tract infections. Passive smoking is a major risk factor for sudden infant death syndrome. There is some evidence to suggest that nicotine decreases basal prolactin production in women, and therefore reduces volume of milk produced (Lee et al, Hale et al).

    Intermittent preparations i.e. lozenges, gum, inhalators, nasal spray are generally considered preferable for a breastfeeding mother, as these allow the mother to minimise the amount of nicotine found in the breast milk and permit feeding when levels are at their lowest.

    Ideally, NRT should be used immediately after a feed in order to allow the maximum time to elapse before the next feed. Whilst patches do not allow this flexibility, they are still preferable to the combination of continued smoking and formula feeding, and have no significant effect on milk intake by the infant (Schaefer et al).

    Side Effects

    Anaphylactic reaction
    Aphthous ulcers
    Atrial fibrillation
    Chest discomfort
    Chest pain
    Decrease in heart rate
    Depressed mood
    Gastro-intestinal disturbances
    Gingival bleeding
    Hypersensitivity reactions
    Impaired concentration
    Increased appetite
    Irritation of nasal mucosa
    Nasal discomfort
    Oropharyngeal irritation
    Oropharyngeal pain
    Runny nose
    Sleep disturbances
    Sore nose
    Throat irritation
    Vivid dreams
    Watering eyes
    Weight gain


    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: February 2020

    Reference Sources

    Summary of Product Characteristics: Nicorette nasal spray. McNeil Ltd. Revised December 2019

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

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

    Medications and Mother's Milk, 16th edition (2014) Hale, T.W. Hale Publishing, Texas.

    NICE guideline 92 (NG92) - Stop smoking interventions and services, March 2018.
    Available at
    Last accessed 11/02/2020

    Therapeutics in Pregnancy and Lactation (2000) Lee, A., Inch, S. and Finnigan, D. Radcliffe Medical Press, Oxon.

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