Drugs List

Therapeutic Indications

Uses

Relief of nicotine withdrawal symptoms associated with smoking cessation

Administration

Patches should be applied, upon waking, to clean, dry, non-hairy skin sites, avoiding any skin which is red or irritated and removed after 16 or 24 hours as directed by individual manufacturer.

Contraindications

Children under 12 years

Precautions and Warnings

Children aged 12 to 18 years
Oropharyngeal inflammation
Angina
Breastfeeding
Cardiac arrhythmias
Cerebrovascular disorder
Dermatosis
Diabetes mellitus
Gastritis
Gastrointestinal ulcer
Haemodynamic instability
History of cerebrovascular accident
History of myocardial infarction
Moderate hepatic impairment
Oesophagitis
Phaeochromocytoma
Pregnancy
Seizures
Severe cardiovascular disorder
Severe renal impairment
Uncontrolled hypertension
Uncontrolled hyperthyroidism

Avoid administration to eczematous or inflamed skin
Discard used patches safely - fold with adhesive edges together
Remove metal containing patch prior to MRI scan
Remove patch before cardioversion, defibrillation or diathermy
Rotate application sites. Allow 7 days before applying patch to same site
Diabetic control may need adjustment
Monitor antiepileptic drug treatment
Monitor patients with cardiovascular conditions
Review treatment after 3 months - beware dependence
May increase risk of seizure
Discontinue if severe skin reaction occurs
Suspend or discontinue therapy if cardiovascular symptoms increase
Stopping smoking may lead to raised levels of drugs metabolised by CYP 1A2
Seek professional advice if use continues beyond 6 months

The pre-cessation regimen should not be used in patients with cardiovascular disease without evaluation by a healthcare professional.

Doses of therapeutic nicotine can produce severe toxicity in small children that may be fatal.

Pregnancy and Lactation

Pregnancy

Use nicotine patches with caution during 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

Use nicotine patches with caution during breastfeeding.

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 of 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
Agitation
Allergic dermatitis
Allergic reaction
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Anxiety
Aphthous ulcers
Application site reaction
Arrhythmias
Arthralgia
Arthritis
Asthenia
Atrial fibrillation
Blood pressure changes
Blurred vision
Burning sensation (local)
Changes in mood
Chest discomfort
Chest pain
Confusion
Constipation
Contact dermatitis
Cough
Cutaneous vasculitis
Decrease in heart rate
Dependence
Depression
Diarrhoea
Dizziness
Drowsiness
Dry mouth
Dysgeusia
Dyspepsia
Dyspnoea
Erythema
Faintness
Fatigue
Flatulence
Flushing
Gastro-intestinal symptoms
General discomfort
Headache
Hot flushes
Hyperhidrosis
Hypersensitivity reactions including anaphylaxis
Hypertension
Impaired concentration
Increased appetite
Increased sweating
Influenza-like symptoms
Insomnia
Irritability
Itching
Limb pain
Malaise
Motor disturbances
Muscular cramps
Myalgia
Nausea
Nervousness
Oedema
Pain
Palpitations
Paraesthesia
Pharyngitis
Photosensitivity
Pruritus
Rash
Restlessness
Seizures
Skin discolouration
Sleep disturbances
Somnolence
Tachycardia
Tremor
Upper respiratory tract infection
Urticaria
Vesicles
Vivid dreams
Vomiting
Weight changes

Presentation

Transdermal patches containing nicotine.

Drugs List

Therapeutic Indications

Uses

Relief of nicotine withdrawal symptoms associated with smoking cessation

Dosage

Adults

Children

Additional Dosage Information

Administration

Patches should be applied, upon waking, to clean, dry, non-hairy skin sites, avoiding any skin which is red or irritated and removed after 16 or 24 hours as directed by individual manufacturer.

Contraindications

Children under 12 years

Precautions and Warnings

Children aged 12 to 18 years
Oropharyngeal inflammation
Angina
Breastfeeding
Cardiac arrhythmias
Cerebrovascular disorder
Dermatosis
Diabetes mellitus
Gastritis
Gastrointestinal ulcer
Haemodynamic instability
History of cerebrovascular accident
History of myocardial infarction
Moderate hepatic impairment
Oesophagitis
Phaeochromocytoma
Pregnancy
Seizures
Severe cardiovascular disorder
Severe renal impairment
Uncontrolled hypertension
Uncontrolled hyperthyroidism

Avoid administration to eczematous or inflamed skin
Discard used patches safely - fold with adhesive edges together
Remove metal containing patch prior to MRI scan
Remove patch before cardioversion, defibrillation or diathermy
Rotate application sites. Allow 7 days before applying patch to same site
Diabetic control may need adjustment
Monitor antiepileptic drug treatment
Monitor patients with cardiovascular conditions
Review treatment after 3 months - beware dependence
May increase risk of seizure
Discontinue if severe skin reaction occurs
Suspend or discontinue therapy if cardiovascular symptoms increase
Stopping smoking may lead to raised levels of drugs metabolised by CYP 1A2
Seek professional advice if use continues beyond 6 months

The pre-cessation regimen should not be used in patients with cardiovascular disease without evaluation by a healthcare professional.

Doses of therapeutic nicotine can produce severe toxicity in small children that may be fatal.

Pregnancy and Lactation

Pregnancy

Use nicotine patches with caution during 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

Use nicotine patches with caution during breastfeeding.

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 of 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).

Counselling

Patients should be advised to avoid application to eczematous, inflamed or broken skin.

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.

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

Patients should be advised that patches 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.

After handling, wash hands with water alone as soap could increase nicotine absorption.

Side Effects

Aggression
Agitation
Allergic dermatitis
Allergic reaction
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Anxiety
Aphthous ulcers
Application site reaction
Arrhythmias
Arthralgia
Arthritis
Asthenia
Atrial fibrillation
Blood pressure changes
Blurred vision
Burning sensation (local)
Changes in mood
Chest discomfort
Chest pain
Confusion
Constipation
Contact dermatitis
Cough
Cutaneous vasculitis
Decrease in heart rate
Dependence
Depression
Diarrhoea
Dizziness
Drowsiness
Dry mouth
Dysgeusia
Dyspepsia
Dyspnoea
Erythema
Faintness
Fatigue
Flatulence
Flushing
Gastro-intestinal symptoms
General discomfort
Headache
Hot flushes
Hyperhidrosis
Hypersensitivity reactions including anaphylaxis
Hypertension
Impaired concentration
Increased appetite
Increased sweating
Influenza-like symptoms
Insomnia
Irritability
Itching
Limb pain
Malaise
Motor disturbances
Muscular cramps
Myalgia
Nausea
Nervousness
Oedema
Pain
Palpitations
Paraesthesia
Pharyngitis
Photosensitivity
Pruritus
Rash
Restlessness
Seizures
Skin discolouration
Sleep disturbances
Somnolence
Tachycardia
Tremor
Upper respiratory tract infection
Urticaria
Vesicles
Vivid dreams
Vomiting
Weight changes

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: March 2020

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. and Yaffe, S. Wolters Kluwer Health, Philadelphia.

Medications and Mothers' Milk, 16th Edition (2014) Hale, T. Hale Publishing, Texas.

Summary of Product Characteristics: Nicotinell TTS 10. Novartis Consumer Health. Revised July 2019.
Summary of Product Characteristics: Nicotinell TTS 20. Novartis Consumer Health. Revised July 2019.
Summary of Product Characteristics: Nicotinell TTS 30. Novartis Consumer Health. Revised July 2019.

Summary of Product Characteristics: NiQuitin Clear 7 mg. Omega Pharma Ltd. Revised October 2018.
Summary of Product Characteristics: NiQuitin Clear 14 mg. Omega Pharma Ltd. Revised October 2018.
Summary of Product Characteristics: NiQuitin Clear 21 mg. Omega Pharma Ltd. Revised October 2018.
Summary of Product Characteristics: NiQuitin Pre-Quit Clear 21mg patch. Omega Pharma Ltd. Revised June 2020.

Summary of Product Characteristics: NiQuitin 7 mg transdermal patches. GlaxoSmithKline Consumer Health. Revised October 2019.
Summary of Product Characteristics: NiQuitin 14 mg transdermal patches. GlaxoSmithKline Consumer Health. Revised October 2018.
Summary of Product Characteristics: NiQuitin 21 mg transdermal patches. GlaxoSmithKline Consumer Health. Revised October 2018.

Summary of Product Characteristics: Nicorette Invisi 10 mg Patch. McNeil Ltd. Revised March 2019.
Summary of Product Characteristics: Nicorette Invisi 15 mg Patch. McNeil Ltd. Revised March 2019.
Summary of Product Characteristics: Nicorette Invisi 25 mg Patch. McNeil Ltd. Revised March 2019.