Nicotine oral and oromucosal
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of nicotine.
Drugs List
Therapeutic Indications
Uses
Relief of nicotine withdrawal symptoms associated with smoking cessation
Dosage
Dosage should be adjusted according to patient requirement within the maximum limit.
Patients should be committed to stopping smoking before initiation of therapy and should make every effort to stop smoking completely during treatment.
Behavioural therapy, advice and support will improve the success rate.
Adults
The treatment duration is individual. Normally treatment should continue for at least 3 months to break the habit of smoking. After three months, the user should gradually cut down the number of pieces used each day until they have stopped using the product. Treatment should be discontinued when the dose has been reduced to 1 to 2 pieces per day. Treatment beyond 6 months is generally not recommended, however some patients may need treatment for longer to avoid returning to smoking.
Chewing gum
Smoking Cessation
One piece of chewing gum to be chewed when the user feels the urge to smoke. Normal dose 8 to 12 pieces per day up to a maximum of 25 pieces of 2 mg chewing gum and up to 15 pieces of 4 mg chewing gum.
The 4 mg gum may be suitable for heavy smokers who have more than 20 cigarettes per day or who smoke their first cigarette within 30 minutes of waking.
The 2 mg gum may be suitable for lighter smokers who have less than 20 cigarettes per day or who smoke their first cigarette at least 30 minutes after waking. The 2 mg gum may also be useful to help patients withdrawing from using 4 mg gum.
Smoking Reduction
Chewing gum should be used between smoking episodes to prolong smoke-free intervals. If a reduction in the number of cigarettes smoked daily has not been achieved within 6 weeks, professional advice should be sought.
A quit attempt should be made as soon as the patient feels ready, but not later than 6 months after initiating treatment. If a quit attempt has not been made within 9 months, patients should consult their doctor.
During a quit attempt, the dosage for smoking cessation above should be followed.
Temporary abstinence
Chewing gum should be used during a strong urge to smoke to control withdrawal symptoms including cravings. Users should not take more than 15 pieces of gum per day, and should be encouraged to stop smoking completely as soon as possible.
If no complete quit attempt has been made within 6 months, advice and help should be sort from a healthcare professional.
Lozenge
Dose varies with brand - see manufacturers' literature for specific dosage information.
Orodispersible Film
Abrupt smoking cessation
Weeks 1 to 6: 1 nicotine film every 1 to 2 hours (minimum of 9 films per day, do not exceed 15 films per day)
Weeks 7 to 9: 1 nicotine film every 2 to 4 hours
Weeks 10 to 12: 1 nicotine film every 4 to 8 hours.
Gradual smoking cessation (for smokers who are unwilling or unable to quit abruptly)
Use a nicotine film whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible.
Do not exceed 15 films per day.
When the number of cigarettes has been reduced to a level from which the user feels able to quit completely, then start on the schedule for "abrupt cessation" as given above.
Smoking Reduction (for smokers who wish to cut down with no immediate plans to quit)
Use a nicotine film whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible.
Do not exceed 15 films per day.
If no complete quit attempt has been made within 6 months, advice and help should be sort from a healthcare professional.
Temporary Abstinence
Use a nicotine film every 1 to 2 hours to control troublesome withdrawal symptoms including craving.
Do not exceed 15 films per day.
If no complete quit attempt has been made within 6 months, advice and help should be sort from a healthcare professional.
Sublingual tablet
Smoking Cessation
The initial dose is based on the individual's nicotine dependence. The tablet is used sublingually with a recommended dose of one tablet per hour or for heavy smokers (smoking more than 20 cigarettes per day), two tablets per hour. Increasing to two tablets per hour may be considered for patients who fail to stop smoking with the one tablet per hour regimen or for those whose nicotine withdrawal symptoms remain so strong as to foresee a relapse.
Most smokers require 8 to 12 or 16 to 24 tablets per day, not to exceed 40 tablets. The duration of treatment is individual, but at least three months of treatment is recommended. The nicotine dose should then be gradually reduced, by decreasing the total number of tablets used per day. The treatment should be stopped when the daily consumption is down to one or two tablets. Treatment with nicotine sublingual tablets beyond six months is not generally recommended, and patients who use the tablets beyond 9 months are recommended to seek additional help and advice from a healthcare professional.
Smoking Reduction
The sublingual tablet can be used between smoking episodes to manage the urge to smoke, to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. If a reduction in the number of cigarettes per day has not been achieved after 6 weeks, advice should be sought from a healthcare professional.
A quit attempt should be made as soon as the patient feels ready, but not later than 6 months after initiating treatment. If a quit attempt has not been made within 9 months, patients should consult their doctor.
During a quit attempt, the dosage for smoking cessation above should be followed.
Children
Children 12 to 17 years
Chewing gum
Chewing gum should be used during a strong urge to smoke to control withdrawal symptoms including cravings. Users should not take more than 15 pieces of gum per day, and should be encouraged to stop smoking completely as soon as possible.
If no complete quit attempt has been made within 6 months, advice and help should be sort from a healthcare professional.
Lozenge
Dose varies with brand - see manufacturers' literature for specific dosage information.
Orodispersible Film
Abrupt smoking cessation
Weeks 1 to 6: 1 nicotine film every 1 to 2 hours (minimum of 9 films per day, do not exceed 15 films per day)
Weeks 7 to 9: 1 nicotine film every 2 to 4 hours
Weeks 10 to 12: 1 nicotine film every 4 to 8 hours.
Gradual smoking cessation (for smokers who are unwilling or unable to quit abruptly)
Use a nicotine film whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible.
Do not exceed 15 films per day.
When the number of cigarettes has been reduced to a level from which the user feels able to quit completely, then start on the schedule for "abrupt cessation" as given above.
Smoking Reduction (for smokers who wish to cut down with no immediate plans to quit)
Use a nicotine film whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible.
Do not exceed 15 films per day.
If no complete quit attempt has been made within 6 months, advice and help should be sort from a healthcare professional.
Temporary Abstinence
Use a nicotine film every 1 to 2 hours to control troublesome withdrawal symptoms including craving.
Do not exceed 15 films per day.
If no complete quit attempt has been made within 6 months, advice and help should be sort from a healthcare professional.
Sublingual tablet
Smoking Cessation
The initial dose is based on the individual's nicotine dependence. The tablet is used sublingually with a recommended dose of one tablet per hour or for heavy smokers (smoking more than 20 cigarettes per day), two tablets per hour. Increasing to two tablets per hour may be considered for patients who fail to stop smoking with the one tablet per hour regimen or for those whose nicotine withdrawal symptoms remain so strong as to foresee a relapse.
Most smokers require 8 to 12 or 16 to 24 tablets per day, not to exceed 40 tablets. The duration of treatment is individual, but at least three months of treatment is recommended. The nicotine dose should then be gradually reduced, by decreasing the total number of tablets used per day. The treatment should be stopped when the daily consumption is down to one or two tablets. Treatment with nicotine sublingual tablets beyond six months is not generally recommended, and patients who use the tablets beyond 9 months are recommended to seek additional help and advice from a healthcare professional.
Smoking Reduction
The sublingual tablet can be used between smoking episodes to manage the urge to smoke, to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. If a reduction in the number of cigarettes per day has not been achieved after 6 weeks, advice should be sought from a healthcare professional.
A quit attempt should be made as soon as the patient feels ready, but not later than 6 months after initiating treatment. If a quit attempt has not been made within 9 months, patients should consult their doctor.
During a quit attempt, the dosage for smoking cessation above should be followed.
Children under 12 years
No brands are recommended for children under 12 years of age.
Contraindications
Children under 12 years
Precautions and Warnings
Children aged 12 to 18 years
Oropharyngeal inflammation
Angina
Breastfeeding
Cardiac arrhythmias
Cerebrovascular disorder
Diabetes mellitus
Gastritis
Hereditary fructose intolerance
History of cerebrovascular accident
History of myocardial infarction
Hypertension
Hyperthyroidism
Moderate hepatic impairment
Occlusive peripheral arterial disease
Oesophagitis
Peptic ulcer
Phaeochromocytoma
Phenylketonuria
Pregnancy
Seizures
Severe cardiovascular disorder
Severe renal impairment
Sodium content of formulation may be significant
Some formulations contain aspartame - caution in phenylketonuria
Advise ability to drive/operate machinery may be affected by side effects
Not all available brands are licensed for all indications
May contain polysorbate
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain butylated hydroxy toluene (E321)
Some formulations contain maltitol
Pregnancy: Advise pregnant women to avoid liquorice flavoured products
Avoid coffee, acid or soft drinks for 15 mins prior to administration
Minimise swallowing which inactivates nicotine + may increase side effects
Diabetic control may need adjustment
Monitor antiepileptic drug treatment
Monitor patients with cardiovascular conditions
May increase risk of seizure
Patient should be made aware of possible adverse effects on mood/behaviour
Stopping smoking may lead to raised levels of drugs metabolised by CYP 1A2
Denture wearers should be advised that chewing gum may damage dentures
Seek professional advice if use continues beyond 9 months
Pregnancy and Lactation
Pregnancy
Use oral nicotine with caution in 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 2 to 3 months.
Smoking in pregnant women can cause intrauterine growth retardation, premature birth and still birth. 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).
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 during pregnancy, patches may be preferred, but should be removed before going to bed. Liquorice-flavoured products should be avoided.
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 oral nicotine with caution in breastfeeding.
Nicotine and its metabolite (cotinine) pass readily into breast milk, and are detectable in the serum of breastfed infants.
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.
Maternal nicotine plasma concentrations after using nicotine gum are variable depending on the vigour of chewing and number of pieces chewed daily, but can be similar to those attained after smoking.
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. Maternal 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.
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. 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.
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
Counselling
Behavioural therapy, advice and support will improve the success rate.
Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as nicotine can affect carbohydrate metabolism.
Ability to drive or operate machinery may be affected by side effects.
Side Effects
Aggression
Allergic reaction
Angioedema
Anxiety
Aphthous ulcers
Asthenia
Atrial fibrillation
Belching
Blurred vision
Burning sensation
Changes in mood
Constipation
Cough
Decrease in heart rate
Decreased appetite
Depression
Diarrhoea
Dizziness
Dry mouth
Dry throat
Dyspepsia
Dysphagia
Dyspnoea
Epistaxis
Erythema
Faintness
Fatigue
Flatulence
Gastro-intestinal symptoms
Gastroesophageal reflux
Gastrointestinal disorder
Headache
Heartburn
Hiccups
Hot flushes
Hyperhidrosis
Hypersalivation
Hypersensitivity reactions including anaphylaxis
Impaired concentration
Increased appetite
Increased lacrimation
Indigestion
Influenza-like symptoms
Insomnia
Irritability
Jaw pain
Lethargy
Malaise
Mouth irritation
Nasal congestion
Nausea
Nocturia
Oesophagitis
Oral hypoaesthesia
Oral mucosal blistering
Oral paraesthesia
Pain
Palpitations
Pharyngitis
Pruritus
Rash
Restlessness
Retching
Rhinitis
Seizures
Sleep disturbances
Sneezing
Sore mouth
Sore throat
Stomatitis
Tachycardia
Taste disturbances
Throat irritation
Throat tightness
Tongue swelling
Upper abdominal pain
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: July 2013
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.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
Summary of Product Characteristics: Nicotinell Mint 1 mg lozenge. Novartis Consumer Health. Revised November 2010.
Summary of Product Characteristics: Nicotinell Mint 2 mg lozenge. Novartis Consumer Health. Revised November 2010.
Summary of Product Characteristics: Nicotinell Mint 2 mg medicated chewing gum. Novartis Consumer Health. Revised April 2013.
Summary of Product Characteristics: Nicotinell Mint 4 mg medicated chewing gum. Novartis Consumer Health. Revised April 2013.
Summary of Product Characteristics: Nicotinell fruit 2 mg medicated chewing gum. Novartis Consumer Health. Revised May 2012.
Summary of Product Characteristics: Nicotinell fruit 4 mg medicated chewing gum. Novartis Consumer Health. Revised May 2012.
Summary of Product Characteristics: Nicotinell Classic 2 mg medicated chewing gum. Novartis Consumer Health. Revised May 2012.
Summary of Product Characteristics: Nicotinell Classic 4 mg medicated chewing gum. Novartis Consumer Health. Revised May 2012.
Summary of Product Characteristics: Nicotinell Liquorice 2 mg chewing gum. Novartis Consumer Health. Revised June 2012.
Summary of Product Characteristics: Nicotinell Liquorice 4 mg chewing gum. Novartis Consumer Health. Revised June 2012.
Summary of Product Characteristics: Nicotinell Icemint 2 mg chewing gum. Novartis Consumer Health. Revised February 2011.
Summary of Product Characteristics: Nicotinell Icemint 4 mg chewing gum. Novartis Consumer Health. Revised February 2011.
Summary of Product Characteristics: Nicotinell Support Icemint 2 mg chewing gum. Novartis Consumer Health. Revised June 2014.
Summary of Product Characteristics: Nicotinell Support Icemint 4 mg chewing gum. Novartis Consumer Health. Revised June 2014.
Summary of Product Characteristics: Nicorette Microtab 2 mg. McNeil Products Ltd. Revised July 2009.
Summary of Product Characteristics: Nicorette Microtab Lemon 2 mg. McNeil Products Ltd. Revised June 2009.
Summary of Product Characteristics: Nicorette 2 mg gum. McNeil Products Ltd. Revised January 2008.
Summary of Product Characteristics: Nicorette 4 mg gum. McNeil Products Ltd. Revised June 2010.
Summary of Product Characteristics: Nicorette Fruitfusion 2 mg gum. McNeil Products Ltd. Revised June 2013.
Summary of Product Characteristics: Nicorette Fruitfusion 4 mg gum. McNeil Products Ltd. Revised June 2013.
Summary of Product Characteristics: Nicorette Cools 2 mg gum. McNeil Products Ltd. Revised February 2012.
Summary of Product Characteristics: Nicorette Cools 4 mg gum. McNeil Products Ltd. Revised February 2012.
Summary of Product Characteristics: Nicorette Mint 2 mg gum. McNeil Products Ltd. Revised January 2008.
Summary of Product Characteristics: Nicorette Mint 4 mg gum. McNeil Products Ltd. Revised January 2008.
Summary of Product Characteristics: Nicorette Icy White 2 mg gum. McNeil Products Ltd. Revised August 2012.
Summary of Product Characteristics: Nicorette Icy White 4 mg gum. McNeil Products Ltd. Revised August 2012.
Summary of Product Characteristics: NiQuitin 2 mg Mint lozenge. GlaxoSmithKline Consumer Healthcare. Revised March 2013.
Summary of Product Characteristics: NiQuitin 4 mg Mint lozenge. GlaxoSmithKline Consumer Healthcare. Revised March 2014.
Summary of Product Characteristics: NiQuitin 2 mg lozenges. GlaxoSmithKline Consumer Healthcare. Revised March 2014.
Summary of Product Characteristics: NiQuitin 4 mg lozenges. GlaxoSmithKline Consumer Healthcare. Revised March 2014.
Summary of Product Characteristics: NiQuitin Minis Cherry 1.5 mg lozenge. GlaxoSmithKline Consumer Healthcare. Revised March 2014.
Summary of Product Characteristics: NiQuitin Minis Mint 1.5 mg lozenge. GlaxoSmithKline Consumer Healthcare. Revised March 2014.
Summary of Product Characteristics: NiQuitin Minis Orange 1.5 mg lozenge. GlaxoSmithKline Consumer Healthcare. Revised March 2014.
Summary of Product Characteristics: NiQuitin Minis Mint 4 mg lozenge. GlaxoSmithKline Consumer Healthcare. Revised March 2014.
Summary of Product Characteristics: NiQuitin Mint gum 2 mg. GlaxoSmithKline Consumer Healthcare. Revised March 2014.
Summary of Product Characteristics: NiQuitin Mint gum 4 mg. GlaxoSmithKline Consumer Healthcare. Revised September 2013.
Summary of Product Characteristics: NiQuitin Strips Mint 2.5 mg Oral Film. GlaxoSmithKline Consumer Healthcare. Revised March 2014.
Summary of Product Characteristics: NiQuitin Extra Fresh Mint 2 mg Medicated Chewing Gum. Omega Pharma. Revised April 2016.
Summary of Product Characteristics: NiQuitin Extra Fresh Mint 4 mg Medicated Chewing Gum. Omega Pharma. Revised April 2016.
Therapeutics in Pregnancy and Lactation (2000) Lee, A., Inch, S. and Finnigan, D. Radcliffe Medical Press, Abingdon.
Clinical Knowledge Summaries - Smoking cessation - Management - Prescribing information
Available at:https://cks.nice.org.uk/smoking-cessation (last revised October 2012)
Last accessed: 24 September, 2014
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 24 September 2014
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