Drugs List

Therapeutic Indications

Uses

Relief of nicotine withdrawal symptoms associated with smoking cessation

Contraindications

Children under 12 years

Precautions and Warnings

Breastfeeding
Cerebrovascular accident
Diabetes mellitus
Gastritis
History of seizures
Moderate hepatic impairment
Oesophagitis
Peptic ulcer
Phaeochromocytoma
Pregnancy
Recent myocardial infarction
Serious cardiac arrhythmias
Severe renal impairment
Uncontrolled hypertension
Uncontrolled hyperthyroidism
Unstable angina

Contains alcohol
Contains butylated hydroxytoluene - May irritate skin/eyes/mucous membranes
Contains propylene glycol
Advise patient to avoid spraying this preparation into or near the eyes
Do not inhale the spray
Minimise swallowing which inactivates nicotine + may increase side effects
Diabetic control may need adjustment
Monitor blood glucose closely in patients with diabetes mellitus
Monitor patients with cardiovascular conditions
Stopping smoking may lead to raised levels of drugs metabolised by CYP 1A2

Any risks associated with nicotine replacement therapy are generally outweighed by the dangers of continued smoking.

Nicotine mouthspray is not recommended in patients hospitalised as a result of myocardial infarction, unstable or worsening angina (including Prinzmetal's angina), severe dysrhythmia or cerebrovascular accident that are haemodynamically unstable and/or have uncontrolled hypertension. Non-pharmacological interventions should be used instead however if this fails, nicotine mouthspray may be considered under close medical supervision.

Transferred dependence has been reported rarely but is considered less harmful and easier to break than smoking dependence. Patients that have managed to quit smoking but have difficulty discontinuing the nicotine mouthspray should contact their doctor or pharmacist for advice.

Smoking cessation itself can cause a number of symptoms independent of the use of nicotine replacement therapy. These include dysphoria, depressed mood, insomnia, irritability, frustration, anger, anxiety, difficulty concentrating, restlessness, impatience, decreased heart rate, increased appetite, weight gain, apthous ulcer, cough, nasopharyngitis, dizziness, presyncopal symptoms, constipation and gingival bleeding.

Patients with a history of epilepsy should consider the potential risks and benefits of nicotine due to reports of convulsions associated with nicotine.

Pregnancy and Lactation

Pregnancy

Use nicotine mouthspray with caution during pregnancy.

Non-pharmacological interventions are preferred however the additional use of nicotine replacement therapy (NRT) may be considered in patients that are unlikely to be successful without pharmacological support. Complete cessation will have the best outcome on improving the health of both the mother and baby. Where this cannot be achieved, the manufacturer states that nicotine mouthspray can be used as an alternative to smoking.

The risks associated with NRT use are considered lower than continued use of tobacco smoking. Available human pregnancy data indicates no increased risk of spontaneous abortion, intrauterine death, neonatal complications or neurodevelopment impairment. There is currently no evidence that NRT increases the overall risk of congenital anomaly or major malformation however current data is limited.

Whilst an increased risk of preterm delivery and low birth weight in comparison to non-smokers has been reported, specific studies comparing those attempting cessation with and without NRT have failed to identify an adverse effect on foetal growth or gestational age.

No variation in the risk of adverse effects have been identified between different formulations of NRT. Intermittent dose forms such as the nicotine mouthspray are preferred due to the potential for nicotine-free periods. Liquorice-flavoured products should be avoided.

Lactation

Use nicotine mouthspray with caution during breastfeeding.

Smoking cessation should be encouraged in all mothers regardless of whether they are breastfeeding.

Human data regarding the use of nicotine replacement therapy (NRT) when breastfeeding is limited. Whilst nicotine is transferred into breast milk, the quantities are relatively small and are considered less hazardous than exposure to second hand smoke. Intermittent NRT such as the nicotine mouthspray may allow timing of doses to the period immediately following a feed thus minimising the quantity of nicotine ingested by the infant.

Side Effects

Abdominal pain
Anaphylactic reaction
Angioedema
Asthenia
Atrial arrhythmia
Atrial fibrillation
Blurred vision
Bronchospasm
Burning sensation
Chest discomfort
Chest pain
Cough
Dependence
Diarrhoea
Dizziness
Dream abnormalities
Dry mouth
Dry skin
Dry throat
Dysgeusia
Dyspepsia
Dysphagia
Dysphonia
Dyspnoea
Eructation
Erythema
Fatigue
Flatulence
Flushing
Gastro-intestinal discomfort
Gingivitis
Glossitis
Headache
Hiccups
Hyperhidrosis
Hypersalivation
Hypersensitivity reactions
Hypertension
Increased lacrimation
Jaw pain
Lip pain
Malaise
Musculoskeletal pain
Nasal congestion
Nausea
Oral hypoaesthesia
Oral mucosal blistering
Oral paraesthesia
Oropharyngeal pain
Palpitations
Paraesthesia
Pruritus
Rash
Retching
Rhinorrhoea
Seizures
Sneezing
Stiffness
Stomatitis
Tachycardia
Throat irritation
Throat tightness
Tooth ache
Urticaria
Vomiting

Presentation

Oromucosal spray containing nicotine.

Drugs List

Therapeutic Indications

Uses

Relief of nicotine withdrawal symptoms associated with smoking cessation

Dosage

Adults

Children

Contraindications

Children under 12 years

Precautions and Warnings

Breastfeeding
Cerebrovascular accident
Diabetes mellitus
Gastritis
History of seizures
Moderate hepatic impairment
Oesophagitis
Peptic ulcer
Phaeochromocytoma
Pregnancy
Recent myocardial infarction
Serious cardiac arrhythmias
Severe renal impairment
Uncontrolled hypertension
Uncontrolled hyperthyroidism
Unstable angina

Contains alcohol
Contains butylated hydroxytoluene - May irritate skin/eyes/mucous membranes
Contains propylene glycol
Advise patient to avoid spraying this preparation into or near the eyes
Do not inhale the spray
Minimise swallowing which inactivates nicotine + may increase side effects
Diabetic control may need adjustment
Monitor blood glucose closely in patients with diabetes mellitus
Monitor patients with cardiovascular conditions
Stopping smoking may lead to raised levels of drugs metabolised by CYP 1A2

Any risks associated with nicotine replacement therapy are generally outweighed by the dangers of continued smoking.

Nicotine mouthspray is not recommended in patients hospitalised as a result of myocardial infarction, unstable or worsening angina (including Prinzmetal's angina), severe dysrhythmia or cerebrovascular accident that are haemodynamically unstable and/or have uncontrolled hypertension. Non-pharmacological interventions should be used instead however if this fails, nicotine mouthspray may be considered under close medical supervision.

Transferred dependence has been reported rarely but is considered less harmful and easier to break than smoking dependence. Patients that have managed to quit smoking but have difficulty discontinuing the nicotine mouthspray should contact their doctor or pharmacist for advice.

Smoking cessation itself can cause a number of symptoms independent of the use of nicotine replacement therapy. These include dysphoria, depressed mood, insomnia, irritability, frustration, anger, anxiety, difficulty concentrating, restlessness, impatience, decreased heart rate, increased appetite, weight gain, apthous ulcer, cough, nasopharyngitis, dizziness, presyncopal symptoms, constipation and gingival bleeding.

Patients with a history of epilepsy should consider the potential risks and benefits of nicotine due to reports of convulsions associated with nicotine.

Pregnancy and Lactation

Pregnancy

Use nicotine mouthspray with caution during pregnancy.

Non-pharmacological interventions are preferred however the additional use of nicotine replacement therapy (NRT) may be considered in patients that are unlikely to be successful without pharmacological support. Complete cessation will have the best outcome on improving the health of both the mother and baby. Where this cannot be achieved, the manufacturer states that nicotine mouthspray can be used as an alternative to smoking.

The risks associated with NRT use are considered lower than continued use of tobacco smoking. Available human pregnancy data indicates no increased risk of spontaneous abortion, intrauterine death, neonatal complications or neurodevelopment impairment. There is currently no evidence that NRT increases the overall risk of congenital anomaly or major malformation however current data is limited.

Whilst an increased risk of preterm delivery and low birth weight in comparison to non-smokers has been reported, specific studies comparing those attempting cessation with and without NRT have failed to identify an adverse effect on foetal growth or gestational age.

No variation in the risk of adverse effects have been identified between different formulations of NRT. Intermittent dose forms such as the nicotine mouthspray are preferred due to the potential for nicotine-free periods. Liquorice-flavoured products should be avoided.

Lactation

Use nicotine mouthspray with caution during breastfeeding.

Smoking cessation should be encouraged in all mothers regardless of whether they are breastfeeding.

Human data regarding the use of nicotine replacement therapy (NRT) when breastfeeding is limited. Whilst nicotine is transferred into breast milk, the quantities are relatively small and are considered less hazardous than exposure to second hand smoke. Intermittent NRT such as the nicotine mouthspray may allow timing of doses to the period immediately following a feed thus minimising the quantity of nicotine ingested by the infant.

Counselling

Advise patient to release the spray into the mouth, avoiding contact with the lips. The patient should not inhale during administration and should minimise swallowing for a few seconds afterwards. Avoid spraying the eye area. The spray must be primed before initial use or if it hasn't been used for 2 or more days.

Advise patient behavioural therapy, advice and support will improve their success rate.

Advise patient to keep all nicotine replacement therapy (NRT) products out of the reach and sight of children as exposure can cause severe toxicity which may be fatal.

Advise patients with diabetes that increased blood glucose monitoring may be required.

Side Effects

Abdominal pain
Anaphylactic reaction
Angioedema
Asthenia
Atrial arrhythmia
Atrial fibrillation
Blurred vision
Bronchospasm
Burning sensation
Chest discomfort
Chest pain
Cough
Dependence
Diarrhoea
Dizziness
Dream abnormalities
Dry mouth
Dry skin
Dry throat
Dysgeusia
Dyspepsia
Dysphagia
Dysphonia
Dyspnoea
Eructation
Erythema
Fatigue
Flatulence
Flushing
Gastro-intestinal discomfort
Gingivitis
Glossitis
Headache
Hiccups
Hyperhidrosis
Hypersalivation
Hypersensitivity reactions
Hypertension
Increased lacrimation
Jaw pain
Lip pain
Malaise
Musculoskeletal pain
Nasal congestion
Nausea
Oral hypoaesthesia
Oral mucosal blistering
Oral paraesthesia
Oropharyngeal pain
Palpitations
Paraesthesia
Pruritus
Rash
Retching
Rhinorrhoea
Seizures
Sneezing
Stiffness
Stomatitis
Tachycardia
Throat irritation
Throat tightness
Tooth ache
Urticaria
Vomiting

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: May 2021

Reference Sources

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. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Nicorette QuickMist 1mg/spray mouthspray. McNeil Products Ltd. Revised December 2020.
Summary of Product Characteristics: Nicorette QuickMist Cool Berry 1mg/spray mouthspray. McNeil Products Ltd. Revised October 2020.
Summary of Product Characteristics: Nicorette QuickMist SmartTrack 1mg/spray mouthspray. McNeil Products Ltd. Revised June 2021.

UK teratology information service (uktis)
Available at: https://www.uktis.org/index.html
Tobacco and NRT use in pregnancy. Last revised: August 2018
Last accessed: 12 May 2021