Drugs List

Therapeutic Indications

Uses

For the relief and/or prevention of craving and nicotine withdrawal symptoms, as an aid to smoking cessation or as part of a programme to reduce smoking prior to quitting completely, to assist smokers who are unwilling or unable to smoke, and as as safer alternative to smoking for smokers and those around them.

Administration

For inhalation

The number, frequency, puffing/inhalation time and technique vary individually.

10mg cartridges
Each cartridge can be used for approximately four 5-minute sessions, with each cartridge lasting approximately 20 minutes of intense use.

15mg cartridges
Each cartridge can be used for approximately eight 5-minute sessions, with each cartridge lasting approximately 40 minutes of intense use.

Contraindications

Children under 12 years of age

Precautions and Warnings

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

Behavioural therapy, advice and support will improve the success rate.

Dependant smokers hospitalised for myocardial infarction, severe dysrhythmia or cerebrovascular accident and who are considered haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails then nicotine replacement therapy may be considered under medical supervision.

Use with caution in the following conditions:
Hypertension
Angina
Cerebrovascular disease
Occlusive peripheral arterial disease
Hyperthyroidism
Phaeochromocytoma
Diabetes mellitus - treatment may alter carbohydrate metabolism, therefore monitor blood glucose levels carefully.
Severe renal impairment (see Dosage - Renal impairment )
Moderate hepatic impairment (see Dosage - Hepatic impairment )

Gastro-intestinal disease - Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and oral nicotine replacement preparations should be used with caution in these conditions.

Use with caution in patients with obstructive lung disease, chronic throat disease or bronchospastic disease. Alternative preparations may better suited to these patients.

Pregnancy (see Pregnancy section)

Breastfeeding (see Lactation section)

The manufacturer recommends that the treatment should be for no longer than 12 weeks. After 12 weeks if the patient feels unable to quit or is not ready to quit medical help should be sought.

Patients who smoke or use other nicotine products during treatment have an increased risk of adverse events due to increased plasma nicotine levels.

Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine must not be left where they might inadvertently be handled, ingested or misused by children

The by-products of smoking cause the induction of metabolism of certain drugs. When smoking is stopped, the rate of metabolism of these drugs may reduce leading to raised blood levels and possible toxicity. This may be significant for drugs with a narrow therapeutic window e.g. theophylline, clozapine and ropinirole.

Use at room temperature between 15 - 30 degrees C

Advise patients to rinse empty mouthpiece in water several times a week.

Contains some small parts which are a potential choking hazard. Unused cartridges should remain in the cartridge tray to minimise risk of swallowing.

The possibility of transferred dependence is rare, and should it occur, is both less harmful and easier to break than smoking dependence.

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 2-3 months.

Smoking in pregnant women can cause inter-uterine 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.

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 14-17 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 at https://www.toxbase.org/

Lactation

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.

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 of the amount of nicotine found 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

Side Effects

Cough
Headache
Throat irritation
Rhinitis
Pharyngitis
Stomatitis
Dyspepsia
Anxiety
Nausea
Sinusitis
Dry mouth
Chest pain
Pain
Allergic reaction
Depression
Vomiting
Hiccups
Dependence
Palpitations
Dizziness
Sleeplessness
Aphthous ulcers
Influenza-like symptoms
Gastro-intestinal disturbances
Changes of blood pressure
Irritability
Impaired concentration
Atrial fibrillation
Nasal congestion
Aggression
Restlessness
Decrease in heart rate
Increased appetite
Weight gain
Myalgia
Somnolence
Dysmenorrhoea
Dysphoria
Mood changes
Sleep disturbances
Faintness
Mouth irritation

Presentation

Inhalation cartridges each containing 10mg nicotine
Inhalation cartridges each containing 15mg nicotine

Drugs List

Therapeutic Indications

Uses

For the relief and/or prevention of craving and nicotine withdrawal symptoms, as an aid to smoking cessation or as part of a programme to reduce smoking prior to quitting completely, to assist smokers who are unwilling or unable to smoke, and as as safer alternative to smoking for smokers and those around them.

Dosage

Behavioural therapy, advice and support will improve the success rate.

Adults

Elderly

Children

Adolescents

Patients with Renal Impairment

Patients with Hepatic Impairment

Administration

For inhalation

The number, frequency, puffing/inhalation time and technique vary individually.

10mg cartridges
Each cartridge can be used for approximately four 5-minute sessions, with each cartridge lasting approximately 20 minutes of intense use.

15mg cartridges
Each cartridge can be used for approximately eight 5-minute sessions, with each cartridge lasting approximately 40 minutes of intense use.

Contraindications

Children under 12 years of age

Precautions and Warnings

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

Behavioural therapy, advice and support will improve the success rate.

Dependant smokers hospitalised for myocardial infarction, severe dysrhythmia or cerebrovascular accident and who are considered haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails then nicotine replacement therapy may be considered under medical supervision.

Use with caution in the following conditions:
Hypertension
Angina
Cerebrovascular disease
Occlusive peripheral arterial disease
Hyperthyroidism
Phaeochromocytoma
Diabetes mellitus - treatment may alter carbohydrate metabolism, therefore monitor blood glucose levels carefully.
Severe renal impairment (see Dosage - Renal impairment )
Moderate hepatic impairment (see Dosage - Hepatic impairment )

Gastro-intestinal disease - Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and oral nicotine replacement preparations should be used with caution in these conditions.

Use with caution in patients with obstructive lung disease, chronic throat disease or bronchospastic disease. Alternative preparations may better suited to these patients.

Pregnancy (see Pregnancy section)

Breastfeeding (see Lactation section)

The manufacturer recommends that the treatment should be for no longer than 12 weeks. After 12 weeks if the patient feels unable to quit or is not ready to quit medical help should be sought.

Patients who smoke or use other nicotine products during treatment have an increased risk of adverse events due to increased plasma nicotine levels.

Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine must not be left where they might inadvertently be handled, ingested or misused by children

The by-products of smoking cause the induction of metabolism of certain drugs. When smoking is stopped, the rate of metabolism of these drugs may reduce leading to raised blood levels and possible toxicity. This may be significant for drugs with a narrow therapeutic window e.g. theophylline, clozapine and ropinirole.

Use at room temperature between 15 - 30 degrees C

Advise patients to rinse empty mouthpiece in water several times a week.

Contains some small parts which are a potential choking hazard. Unused cartridges should remain in the cartridge tray to minimise risk of swallowing.

The possibility of transferred dependence is rare, and should it occur, is both less harmful and easier to break than smoking dependence.

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 2-3 months.

Smoking in pregnant women can cause inter-uterine 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.

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 14-17 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 at https://www.toxbase.org/

Lactation

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.

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 of the amount of nicotine found 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.

Products contain quantities of nicotine that could be harmful to small children. They must not be left where they might inadvertently be handled, ingested or misused by children.

Advise patients to use inhaler at room temperature between 15 and 30 degrees C and to rinse mouthpiece in water several times a week.

Patients should be warned that they may experience increased adverse effects, including cardiovascular effects, if they continue smoking during therapy.

Advise patients the some side effects or changes in behaviour may effect the ability to drive or operate machinery.

Side Effects

Cough
Headache
Throat irritation
Rhinitis
Pharyngitis
Stomatitis
Dyspepsia
Anxiety
Nausea
Sinusitis
Dry mouth
Chest pain
Pain
Allergic reaction
Depression
Vomiting
Hiccups
Dependence
Palpitations
Dizziness
Sleeplessness
Aphthous ulcers
Influenza-like symptoms
Gastro-intestinal disturbances
Changes of blood pressure
Irritability
Impaired concentration
Atrial fibrillation
Nasal congestion
Aggression
Restlessness
Decrease in heart rate
Increased appetite
Weight gain
Myalgia
Somnolence
Dysmenorrhoea
Dysphoria
Mood changes
Sleep disturbances
Faintness
Mouth irritation

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 2011

Reference Sources

British National Formulary, 61st Edition (2011) Pharmaceutical Press, London.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

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

Summary of Product Characteristics: Nicorette Inhalator. Mc Neil Products Ltd. Revised January 2010
Summary of Product Characteristics: Nicorette 15mg Inhalator. Mc Neil Products Ltd. Revised July 2011

Clinical Knowledge Summaries - Smoking cessation - Management - Prescribing information
Available at: https://cks.library.nhs.uk/smoking_cessation
Last accessed: March 14, 2011

NICE clinical guideline 62 - Antenatal care, March 2008
Available at www.nice.org.uk/nicemedia/pdf/CG062NICEguideline.pdf
Last accessed March 14, 2011.