Nicotine replacement therapy for tobacco dependence
Brand names: Nicorette, Nicotinell, NiQuitin, Nicabate
Updated · Methodology
First line
First-line for smoking cessation per NG209 (2021) and 2021. Combining long-acting (patch 14 or 21 mg over 24 or 16 hours) and short-acting (gum 2 or 4 mg as needed, lozenge, nasal or oral spray) raises efficacy over monotherapy. Course 8–12 weeks with gradual dose reduction. Efficacy comparable to bupropion and varenicline; combined with behavioral support – best outcomes.
Sources
ICD-10: F17 · ICD-11: 6C4A.2
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Nicotine in patches, gum, and snus is taken by healthy non-smoking adults as a cognitive enhancer for concentration. 2021 limits nicotine replacement therapy to patients with tobacco dependence for smoking cessation. Nicotine is a highly addictive substance that can produce dependence even in non-smokers, sometimes quickly. Use carries risks of nicotine dependence, elevated blood pressure, increased heart rate, headache, and nausea. In young adults nicotine disrupts prefrontal cortex development. If nicotine is being taken for concentration, consider seeking a second opinion: attention problems usually have other causes (sleep deprivation, ADHD, anxiety) treated per diagnosis.
An agonist of nicotinic acetylcholine receptors (nAChR), preferentially α4β2 in the CNS. Nicotine replacement therapy (NRT) delivers controlled nicotine via patches, gum, lozenges, spray – without harmful tobacco smoke components (tar, carbon monoxide, carcinogens). Reduces withdrawal severity and cravings. Smoking cessation effect confirmed in over 50 RCTs (Cochrane 2018, RR 1.55 vs placebo).
AEMPS summary of product characteristics (section 4.6): nicotine reaches the fetus and affects its breathing movements and circulation, and the effect on circulation is dose-dependent. In animal studies, nicotine was toxic to both mother and fetus and delayed pre- and postnatal growth and postnatal development of the central nervous system. Pregnant smokers are always advised to stop using tobacco completely without nicotine replacement therapy, ideally before the third trimester, when nicotine has haemodynamic effects that may affect the fetus near delivery. For pregnant smokers who have not managed to quit, continued smoking may carry a greater risk to the fetus than nicotine replacement within a controlled cessation programme. Even so, a highly dependent pregnant smoker uses this treatment only if a doctor recommends it.
Nicotine passes into milk. NRT is preferred over active smoking. Defer breastfeeding for 2–3 hours after fast-acting forms (gum, lozenges, spray).
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Verbatim lines from the interaction sections, in the language of the label
«DESCRIPCIÓN DEL EFECTO: Estradiol (anticonceptivos orales)»AEMPS, section 4.5 · Open on CIMA
«DESCRIPCIÓN DEL EFECTO: Benzodiazepinas (diazepam, clordiazepóxido, oxazepam desmetildiazepam)»AEMPS, section 4.5 · Open on CIMA
«DESCRIPCIÓN DEL EFECTO: Bloqueantes beta adrenérgicos»AEMPS, section 4.5 · Open on CIMA
«La concentración plasmática de otros productos metabolizados en parte por CYP1A2, por ejemplo; cafeína, imipramina, olanzapina, clomipramina y fluvoxamina pueden aumentar cuando se deja de fumar.»AEMPS, section 4.5 · Open on CIMA
«Fumar (no la nicotina) se asocia con un aumento en la actividad de la enzima CYP1A2. Después de dejar de fumar, puede ocurrir que se reduzca el aclaramiento de sustratos de esta enzima. Esto puede…»AEMPS, section 4.5 · Open on CIMA
«DESCRIPCIÓN DEL EFECTO: Benzodiazepinas (diazepam, clordiazepóxido, oxazepam desmetildiazepam)»AEMPS, section 4.5 · Open on CIMA
«DESCRIPCIÓN DEL EFECTO: Puede reducir el efecto diurético»AEMPS, section 4.5 · Open on CIMA
«DESCRIPCIÓN DEL EFECTO: Estradiol (anticonceptivos orales)»AEMPS, section 4.5 · Open on CIMA
«Datos limitados indican que el metabolismo de flecainida y pentazocina pueden ser inducidos por el hecho de fumar.»AEMPS, section 4.5 · Open on CIMA
«La concentración plasmática de otros productos metabolizados en parte por CYP1A2, por ejemplo; cafeína, imipramina, olanzapina, clomipramina y fluvoxamina pueden aumentar cuando se deja de fumar.»AEMPS, section 4.5 · Open on CIMA
«DESCRIPCIÓN DEL EFECTO: Furosemida»AEMPS, section 4.5 · Open on CIMA
«DESCRIPCIÓN DEL EFECTO: Insulina»AEMPS, section 4.5 · Open on CIMA
«DESCRIPCIÓN DEL EFECTO: Insulina»AEMPS, section 4.5 · Open on CIMA
«DESCRIPCIÓN DEL EFECTO: Clorazepato, lidocaína (vía oral)»AEMPS, section 4.5 · Open on CIMA
«La concentración plasmática de otros productos metabolizados en parte por CYP1A2, por ejemplo; cafeína, imipramina, olanzapina, clomipramina y fluvoxamina pueden aumentar cuando se deja de fumar.»AEMPS, section 4.5 · Open on CIMA
«DESCRIPCIÓN DEL EFECTO: Opiáceos (dextropropoxifeno, pentazocina)»AEMPS, section 4.5 · Open on CIMA
«DESCRIPCIÓN DEL EFECTO: Cafeína, clozapina, fluvoxamina, olanzapina, tacrina, teofilina, paracetamol, warfarina, vitamina B12»AEMPS, section 4.5 · Open on CIMA
«DESCRIPCIÓN DEL EFECTO: Propranolol»AEMPS, section 4.5 · Open on CIMA
«Fumar (no la nicotina) se asocia con un aumento en la actividad de la enzima CYP1A2. Después de dejar de fumar, puede ocurrir que se reduzca el aclaramiento de sustratos de esta enzima. Esto puede…»AEMPS, section 4.5 · Open on CIMA
«Fumar (no la nicotina) se asocia con un aumento en la actividad de la enzima CYP1A2. Después de dejar de fumar, puede ocurrir que se reduzca el aclaramiento de sustratos de esta enzima. Esto puede…»AEMPS, section 4.5 · Open on CIMA
«DESCRIPCIÓN DEL EFECTO: Cafeína, clozapina, fluvoxamina, olanzapina, tacrina, teofilina, paracetamol, warfarina, vitamina B12»AEMPS, section 4.5 · Open on CIMA
«Pacientes con insuficiencia cardiaca: Eletriptán no debe administrarse sin una evaluación previa en pacientes con una posible enfermedad cardiaca no diagnosticada ni en pacientes con riesgo de…»AEMPS, section 4.4 · Open on CIMA
«Al igual que otros agonistas del receptor 5-HT 1 , frovatriptán no debe administrarse a pacientes con riesgo de cardiopatía isquémica (CAD), incluidos los pacientes con hábito tabáquico o pacientes…»AEMPS, section 4.4 · Open on CIMA
«Sumatriptán no se debe administrar a pacientes con factores de riesgo de enfermedad isquémica cardiaca incluyendo aquellos pacientes que fuman grandes cantidades de tabaco al dia o los que usan…»AEMPS, section 4.4 · Open on CIMA
«Otra información sobre interacciones: El uso concomitante de bupropión y un Sistema Transdérmico de Nicotina (STN) puede provocar elevaciones de la presión arterial.»AEMPS, section 4.5 · Open on CIMA
«DRUG INTERACTIONS: Beta Blockers/FDA, section 7 · Open on DailyMed
«CYP 3A4 Inhibitors (e.g., Macrolide Antibiotics and Protease inhibitors): Ergomar ® Sublingual Tablets (Ergotamine Tartrate Sublingual Tablets USP) should not be administered with other…»FDA, section 7 · Open on DailyMed
«Otros principios activos, como cimetidina, ranitidina, procainamida, quinidina, quinina y nicotina, que utilizan el mismo sistema de transporte catiónico renal que la amantadina, posiblemente también…»AEMPS, section 4.5 · Open on CIMA
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Nicotine is evaluated for the following indications with varying evidence strength: Smoking cessation (evidence tier A), Memory and concentration enhancement (evidence tier F). See the full indication matrix with dosing and citations above on this page.
Common side effects of Nicotine (≥ 1 in 100): Skin irritation under the patch, Nausea, Headache, Insomnia and vivid dreams, Oral mucosa irritation (gum and lozenges), Cough (nasal spray). See the Safety section for uncommon and serious reactions.
AEMPS summary of product characteristics (section 4.6): nicotine reaches the fetus and affects its breathing movements and circulation, and the effect on circulation is dose-dependent. In animal studies, nicotine was toxic to both mother and fetus and delayed pre- and postnatal growth and postnatal development of the central nervous system. Pregnant smokers are always advised to stop using tobacco completely without nicotine replacement therapy, ideally before the third trimester, when nicotine has haemodynamic effects that may affect the fetus near delivery. For pregnant smokers who have not managed to quit, continued smoking may carry a greater risk to the fetus than nicotine replacement within a controlled cessation programme. Even so, a highly dependent pregnant smoker uses this treatment only if a doctor recommends it.
Nicotine passes into milk. NRT is preferred over active smoking. Defer breastfeeding for 2–3 hours after fast-acting forms (gum, lozenges, spray).
Nicotine is contraindicated in: Hypersensitivity to nicotine or excipients; Age under 12; Pregnancy – with caution (preferable in non-smoking pregnant patients); Acute MI (first 2 weeks); Unstable angina. Full list in the Safety section.
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