- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Transdermal patches containing nicotine.
Relief of nicotine withdrawal symptoms associated with smoking cessation
The treatment duration is individual and varies with manufacturer (see manufacturers information).
The strength of patch used should reflect the number of cigarettes smoked.
In general high strength patches are used at the start of the treatment programme for those who smoke ten or more cigarettes a day.
Lower strength patches should be used for those who smoke less than ten cigarettes a day or those reducing dose after being on higher strength patches.
Normally treatment should continue for at least 10 to 12 weeks to break the habit of smoking. A slower reduction may be required.
Manufacturers of brands licensed for use in adolescents (children over 12 years of age) recommend using the doses and method used for adults. Treatment should be limited to 10 to 12 weeks (depending on brand used), and advice sought from a healthcare professional if longer treatment is required. See manufacturers' literature for specific dosage information.
Additional Dosage Information
Dosage should be reduced if adverse reactions occur. The dosage must not be adjusted by cutting a patch.
If patient is unwilling or unable to quit abruptly then high strength patches may be used and the patient may smoke when needed for 2 to 4 weeks. Normal treatment programme should be resumed after this period without smoking.
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.
Children under 12 years
Precautions and Warnings
Children aged 12 to 18 years
History of cerebrovascular accident
History of myocardial infarction
Moderate hepatic impairment
Severe cardiovascular disorder
Severe renal impairment
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
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.
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).
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.
Application site reaction
Blood pressure changes
Burning sensation (local)
Changes in mood
Decrease in heart rate
Hypersensitivity reactions including anaphylaxis
Upper respiratory tract infection
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 ).
Last Full Review Date: March 2020
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.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.