Nicorette is the brand name of a number of products for nicotine replacement therapy (NRT) that contain nicotine polacrilex. Developed in the late 1970s in Sweden by AB Leo in the form of a chewing gum, Nicorette was the first nicotine replacement product on the market. The product range encompasses chewing gum, lozenges, patches of two kinds (transparent and non-transparent), oral spray (Nicorette QuickMist), inhalator, sublingual tablets (Nicorette Microtab) and nasal spray. Nicotine replacement products including gum and transdermal patches are on the World Health Organization's List of Essential Medicines. In April 2024, nicotine gum and patch products manufactured by Kenvue (marketed in many countries under the Nicorette brand) became the first nicotine replacement therapies to receive WHO prequalification, allowing their procurement through global health organizations and initiatives. The brand name "Nicorette" comes from "nicotine" and Swedish: rette, "right way". The brand is owned by Kenvue outside of the US, and Haleon in the US.
Medical uses Nicorette products are indicated for the relief of withdrawal symptoms associated with nicotine withdrawal and to aid in smoking cessation. It is suggested that Nicorette products should be used in "conjunction with a behavioural support programme". The World Health Organization released its first clinical treatment guideline for tobacco cessation in adults in 2024, recommending pharmacotherapy including nicotine replacement therapy alongside behavioral support. Prior to 2005, nicotine products in Britain were only licensed to "assist smokers who were making an immediate and complete quit attempt". Following advice from a working group set up by the Committee on Safety of Medicines (since 2005, the Commission on Human Medicines) the Medicines and Healthcare products Regulatory Agency (MHRA) concluded that nicotine replacement therapy products should be used also by those who are unable to stop abruptly. Nicorette products in the UK are indicated to:
relieve craving (the urge to smoke), relieve withdrawal symptoms (irritability, impatience; difficulty in concentrating), improve the likelihood of a successful abrupt quit attempt, reduce the amount smoked in those not immediately motivated to quit. The products are intended for adults and children over 12 years of age as well as pregnant and lactating women (it has been concluded that "the use of NRT in pregnancy does not give undue concern and any harm caused by nicotine replacement must be compared with that caused by continued smoking – which is extremely harmful to both the woman and her child".) Nicorette, like all other nicotine replacement therapy products, are most beneficial for heavy smokers (more than 15 cigarettes per day). There are not enough studies to show that nicotine replacement therapy helps those who smoke fewer than 10 cigarettes per day.
Contraindications The typical contraindication (reason to not use) for Nicorette products is hypersensitivity to nicotine. Cardiovascular disease was considered to be a contraindication to nicotine replacement therapy products. However, in 2003, the French Agency for the Safety of Health Products (AFSSAPS) removed all cardiovascular and cerebrovascular disease contraindications. In 2005, the UK Medicines and Healthcare products Regulatory Agency followed suit. The rationale is that the benefit of nicotine replacement therapy outweighs the risks of nicotine medication, even in smokers with cardiovascular disease. In 2013, the US Food and Drug Administration (FDA) stated that the contraindication concerning usage of nicotine replacement therapy products while smoking is no longer valid. The FDA approved labeling for Nicorette products with a warning concerning pregnancy and breastfeeding: "This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known". The FDA suggests not using Nicorette products if the patient continues to smoke, or use chewing tobacco, snuff or other nicotine-containing products. The FDA advises consulting a doctor before using the product if the patient previously had:
heart disease, recent heart attack, or irregular heartbeat, high blood pressure, taken a prescription medicine for depression or asthma. Specific contraindications listed by the FDA for various formats include sodium-restricted diet, stomach ulcer of diabetes (for gums and lozenges), or an allergy to adhesive tape or skin problems (for patches). The FDA suggests stopping use of Nicorette products in cases of irregular heartbeat or palpitations, symptoms of nicotine overdose (nausea, vomiting, dizziness, weakness, and rapid heartbeat) or skin redness caused by the patch.
Formats
Gum
Nicorette chewing gum releases nicotine while chewing. Nicotine then is absorbed across the oral mucosa into the systemic circulation. Patients are advised to chew the gum slowly and intermittently to avoid the risk of releasing too much nicotine. It is also suggested not to eat or drink while chewing since foods and beverages can reduce nicotine absorption. Nicorette chewing gum is available in two strengths: 2 mg/piece and 4 mg/piece. Dosing would depend on the degree of nicotine dependence: light smokers should use 2 mg gum, heavy smokers (more than 25 cigarettes a day) should use 4 mg gum. Patients should chew gum once they feel the craving. FDA limits maximum daily amount of 2 mg gum pieces to 24 pieces.
Patch The patches provide slow absorption of nicotine into blood within the day and work for 16 hours. They are usually applied in the morning and removed at bedtime. The patch supports smoking cessation within 12 week programme: 25 mg patch (25 mg nicotine over 16 hours) for eight weeks (Step 1), 15 mg patch for two weeks (Step 2), 10 mg patch for the last two weeks (Step 3). Light smokers (less than 10 cigarettes per day) were recommended to start at Step 2 (15 mg) for eight weeks and reduce the dose to 10 mg for the last four weeks.
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