Drugs List

Therapeutic Indications

Uses

Relief of nicotine withdrawal symptoms associated with smoking cessation

Contraindications

Children under 12 years
Non smokers
Occasional tobacco smokers

Precautions and Warnings

Children aged 12 to 18 years
Angina
Breastfeeding
Bronchospasm
Cardiac arrhythmias
Cardiac failure
Cerebrovascular disorder
Diabetes mellitus
Gastritis
Haemodynamic instability
History of cerebrovascular accident
History of myocardial infarction
Hyperthyroidism
Moderate hepatic impairment
Occlusive peripheral arterial disease
Oesophagitis
Peptic ulcer
Phaeochromocytoma
Pregnancy
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

Pregnancy

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.

Lactation

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

Aggression
Anaphylactic reaction
Angioedema
Anxiety
Aphthous ulcers
Asthenia
Atrial fibrillation
Chest discomfort
Chest pain
Constipation
Cough
Decrease in heart rate
Dependence
Depressed mood
Dizziness
Dysphoria
Dyspnoea
Epistaxis
Erythema
Faintness
Fatigue
Flushing
Gastro-intestinal disturbances
Gingival bleeding
Headache
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Impaired concentration
Increased appetite
Insomnia
Irritability
Irritation of nasal mucosa
Malaise
Nasal discomfort
Nasopharyngitis
Nausea
Oropharyngeal irritation
Oropharyngeal pain
Palpitations
Paraesthesia
Presyncope
Pruritus
Rash
Restlessness
Runny nose
Sleep disturbances
Sneezing
Sore nose
Tachycardia
Throat irritation
Urticaria
Vivid dreams
Vomiting
Watering eyes
Weight gain

Presentation

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

Drugs List

Therapeutic Indications

Uses

Relief of nicotine withdrawal symptoms associated with smoking cessation

Dosage

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).

Adults

Children

Contraindications

Children under 12 years
Non smokers
Occasional tobacco smokers

Precautions and Warnings

Children aged 12 to 18 years
Angina
Breastfeeding
Bronchospasm
Cardiac arrhythmias
Cardiac failure
Cerebrovascular disorder
Diabetes mellitus
Gastritis
Haemodynamic instability
History of cerebrovascular accident
History of myocardial infarction
Hyperthyroidism
Moderate hepatic impairment
Occlusive peripheral arterial disease
Oesophagitis
Peptic ulcer
Phaeochromocytoma
Pregnancy
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

Pregnancy

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.

Lactation

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

Aggression
Anaphylactic reaction
Angioedema
Anxiety
Aphthous ulcers
Asthenia
Atrial fibrillation
Chest discomfort
Chest pain
Constipation
Cough
Decrease in heart rate
Dependence
Depressed mood
Dizziness
Dysphoria
Dyspnoea
Epistaxis
Erythema
Faintness
Fatigue
Flushing
Gastro-intestinal disturbances
Gingival bleeding
Headache
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Impaired concentration
Increased appetite
Insomnia
Irritability
Irritation of nasal mucosa
Malaise
Nasal discomfort
Nasopharyngitis
Nausea
Oropharyngeal irritation
Oropharyngeal pain
Palpitations
Paraesthesia
Presyncope
Pruritus
Rash
Restlessness
Runny nose
Sleep disturbances
Sneezing
Sore nose
Tachycardia
Throat irritation
Urticaria
Vivid dreams
Vomiting
Watering eyes
Weight gain

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/ ) or, if this is unavailable, at the backup site ( www.toxbasebackup.org ).

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 www.nice.org.uk/guidance/ng92
Last accessed 11/02/2020

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