Nicotine replacement therapy (NRT) Pregnancy: Women who are pregnant should first be advised to stop smoking without the assistance of nicotine replacement therapy, as stopping smoking is the single most effective intervention. If the mother cannot, or is unlikely to, quit without pharmacological support, NRT may be used as the risk to the foetus is lower than that expected with smoking tobacco; it should only be used if the expected benefits to the mother outweigh the potential risks to the foetus. Intermittent dose forms are preferable because of the potential for nicotine-free periods. Lactation: nicotine is excreted in breast milk and NRT should be avoided during breast-feeding; if smoking withdrawal is not achieved, intermittent oral forms may be considered as they minimise the amount of nicotine in breast milk.

Nicotine

Brand names: NicoRette, Niquitin, Nicabate, Nicotinell

Nicotine replacement therapy (NRT) supplies nicotine without the harmful tar and combustion products of tobacco, supporting smoking cessation and harm reduction. It is available as patches, gum, lozenges, an inhalator, a nasal or mouth spray, and other oral forms.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Nicotine 2 mg medicated chewing gum: one piece of gum to be chewed when the user feels the urge to smoke. Normally 8-12 pieces per day can be used

Route: Oromucosal (buccal) — chew one piece until the taste becomes strong, rest the gum between the gum and cheek, resume chewing when the taste fades, and repeat the routine for 30 minutes

Frequency: As required when the urge to smoke occurs; do not use more than 1 piece of gum per hour. Dosage frequency should be adjusted to individual requirements within the stated maximum

Max: Maximum 24 pieces per day; no more than 1 piece of gum per hour

FORMULATION CAVEAT — the UK SPC retrieved is for Nicotinell fruit 2 mg medicated chewing gum only. Other nicotine replacement forms (patches, lozenges, inhalators, sprays) have their own SPCs, which were NOT fetched; do not extrapolate this regimen to them. STRENGTH SELECTION (SPC table): less than 20 cigarettes/day (low to moderate dependency) — low dose forms preferable (2 mg gum); 20 to 30 cigarettes/day (moderate to strong) — 2 mg or 4 mg gum acceptable depending on patient characteristics and preference; over 30 cigarettes/day (strong to very strong) — high dose forms preferable (4 mg gum). If an adverse event is noted when a high dose form is initiated, it should be replaced by the lower dosage form. DURATION: treatment time is individual but should normally continue for at least 3 months; after three months the user should gradually cut down the number of pieces chewed each day, and treatment should be discontinued when the dose has been reduced to 1-2 pieces per day. Nicotine gum should not be used for more than 12 months unless the potential benefit outweighs the potential risk. Acidic beverages such as coffee or soda may decrease buccal absorption and should be avoided for 15 minutes before chewing the gum. PAEDIATRIC/ADOLESCENT: the adult recommendation can be used for adolescents aged 12-17 years (not weight-based, so paedDose is null); data are limited, so medical advice should be obtained if use beyond 12 weeks is necessary, use should only occur when the benefits of abstinence outweigh the risks of continued smoking, and adolescents should not quit with a combination NRT regimen. Not recommended for children under 12 years. Doses of nicotine tolerated by adults and adolescent smokers can produce severe, potentially fatal toxicity in small children — keep out of sight and reach of children and dispose of gum with care. US OTC labelling cross-check (nicotine polacrilex lozenge, a different formulation): 2 mg if the first cigarette is smoked more than 30 minutes after waking, 4 mg if within 30 minutes; weeks 1-6 one lozenge every 1-2 hours, weeks 7-9 every 2-4 hours, weeks 10-12 every 4-8 hours; do not use more than 5 lozenges in 6 hours or more than 20 lozenges per day.

Dose adjustments

Renal

Use with caution in patients with moderate to severe renal impairment (and in moderate to severe hepatic impairment) as the clearance of nicotine or its metabolites may be decreased, with the potential for increased adverse effects.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

US labelling (FDA)

Reference — US labelling, may differ from UK

Directions 2 mg : if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you. before using this product, read the enclosed User’s Guide for complete directions and other important information begin using the lozenge on your quit day if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours nicotine lozenge is a medicine and …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2024-07-04. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

Hypersensitivity to nicotine or any of the components of the gum
Should not be used by non-smokers or occasional smokers

Side effects

Gastrointestinal (common) — salivary hypersecretion, stomatitis, oral pain and discomfort, hiccups, nausea, vomiting, dyspepsia, upper abdominal pain, diarrhoea, dry mouth, constipation, flatulence; throat irritation and heartburn may occur at the start of treatment
Nervous system/psychiatric (common) — headache, dizziness, insomnia; seizures (not known); these symptoms may also relate to smoking-cessation withdrawal or insufficient nicotine administration
Jaw muscle ache (common), a non dose-dependent effect of chewing
Cardiac — palpitations (uncommon), atrial arrhythmia (rare)
Skin/immune — erythema and urticaria (uncommon); hypersensitivity, angioneurotic oedema and anaphylactic reactions reported. The gum may stick to and, rarely, damage dentures and dental appliances

Clinical monograph

How it works

It provides a controlled dose of nicotine that stimulates nicotinic acetylcholine receptors, easing withdrawal symptoms and cravings while the person breaks the behavioural habit of smoking.

Prescribing in practice

NRT is far safer than continued smoking and can be used in cardiovascular disease and in pregnancy where it supports quitting.
Combining a long-acting patch with a faster-acting form (such as gum, lozenge, inhalator or spray) controls breakthrough cravings better than a single product.
Local irritation, nausea, palpitations, headache and sleep disturbance with vivid dreams can occur; removing the patch at night helps if dreams are troublesome.

Monitoring

Routine biochemical monitoring is not required; review the person's progress, craving control, side effects and whether the product type or combination needs adjusting.

Counselling the patient

Stop smoking completely while using NRT, and use a fast-acting form whenever cravings break through.
If you get vivid dreams or poor sleep, take the patch off at night and reapply in the morning.
Mild skin irritation, hiccups or a sore mouth/throat can occur; rotate patch sites and report anything troublesome.

Evidence & guidelines

Recommended for smoking cessation by NICE (NG209).

Reference: NICE NG209; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways