Nicotine gum

Nicotine gum is a type of chewing gum that delivers nicotine to the body. It is used as an aid in nicotine replacement therapy (NRT), a process for smoking cessation and quitting smokeless tobacco. The nicotine is delivered to the bloodstream via absorption by the tissues of the mouth.

It is available over-the-counter in Europe, the US and elsewhere. The pieces are usually available in individual foil packages and come in various flavors. Nicotine content is usually either 2 or 4 mg of nicotine, roughly the nicotine content of one sixth to one third of a cigarette, with the appropriate content and dosage depending on the smoking habits of the user. Popular brands include Nicotex, Nicorette, Nicogum, Nicotinell and Zonnic.

Alternative nicotine replacement products include the nicotine patch, nicotine pastilles/lozenges and the nicotine inhaler.

Nicotine replacement products including gum and transdermal patches are on the World Health Organization's List of Essential Medicines.[1]

Medical uses

Nicotine gum can be used in combination with long acting nicotine replacement therapy formulations such as the nicotine patch. It has been shown that combination therapy is more effective than use of a single agent for tobacco cessation.[2] Nicotine absorption from chewing gum is much lower than during smoking. In addition, extraction of nicotine is incomplete, averaging 53% and 72% for 2 mg and 4 mg gum, respectively, and it varies among individuals.[3] It is important to recognize that tobacco cessation is treatment of nicotine addiction. As with other types of addiction, pharmacological therapy is not the only component in treating addiction. Behavioral habits must also be treated, and modifications to these behaviors along with pharmacological therapies can greatly impact and improve chances of successful tobacco cessation.[4]

Dosing

Although there are many brands of nicotine gum available, they are dosed in a similar manner. Light smokers, those who smoke less than 15 cigarettes per day, should use the 2 mg gum. Heavy smokers (≥ 23 cig/day)[5] should use the 4 mg. The size of nicotine gum is the same for both strengths. [5] The dosing regimen[6] provided by the Nicorette gum label is as follows:

Week Pieces of gum
Weeks 1 – 6 1 piece every 1–2 hours
Weeks 7 – 9 1 piece every 2–4 hours
Weeks 10 – 12 1 piece every 4–8 hours

Users should not use more than 24 pieces of gum per day.[6]

Directions for use:

  • Users are directed to chew the gum until it softens and produces a tingling sensation or "peppery" taste.
  • The gum is then "parked," or tucked, in between the cheek and gums.
  • When the tingling ends the gum is chewed again until it returns, and is then re-parked in a new location.[7]
  • These steps are repeated until the gum is depleted of nicotine (about 30 minutes) or the craving dissipates.

Cautions:

  • The gum should not be used for longer than 12 weeks.[6]
  • Nicotine gum should not be used less than 15 minutes after eating or drinking, as doing so will reduce absorption.
  • Do not smoke while using nicotine gum to avoid nicotine overdose.[8]

Side effects
Further information: Nicotine § Side effects

Nicotine is a vasoconstrictor; it constricts arteries, which increases the resistance against which the heart has to pump blood, effectively making it harder for the heart to pump blood through the body. The result is enhanced shear stress on vessel walls, and repeated nicotine exposure contributes to accelerated health problems that are a function of chronic vascular injury such as coronary artery disease, acute cardiac ischemic events, and hypertension[9] Studies have shown that nicotine exposure contributes to stroke, peptic ulcer disease, and esophageal reflux.[9] Nicotine may also cause wounds to heal more slowly and may be associated with reproductive toxicity.[9]

Nicotine gum requires frequent periods of chewing throughout the day which can lead to jaw soreness.[10] People with dental problems should also be cautious from the effects of constant gum chewing and should consult their dentist before using the nicotine gum.[10]

Muscle control

Two unpleasant symptoms which affect some new users and existing users who make excessive use of nicotine gum, are hiccups[11] and a perceived constriction of the throat muscles, as accidental swallowing of saliva containing high amounts of nicotine may cause irritation.

Special populations

Birth defects

Women who use nicotine gum and patches during the early stages of pregnancy face an increased risk of having babies with birth defects according to a 2006 study that looked at about 77,000 pregnant women in Denmark. The study found that women who used nicotine-replacement therapy in the first 12 weeks of pregnancy had a greater risk of having babies with birth defects than women who did not.[12]

Breastfeeding

No studies have been done to show the effects of nicotine gum on breast-feeding. The nicotine from gum will end up in the breast milk. Animal models have shown that nicotine may increase the likelihood of infant death syndrome. It is generally not recommended that breast-feeding mothers use any nicotine products.[13]

Temporomandibular joint disease (TMJ)

Because this medication requires frequent periods of chewing throughout the day, people who have Temporomandibular joint disease should avoid using this medication as it will exacerbate their disease.[10]

Storage and disposal

The nicotine gum should be kept tightly closed in a dry cool place and out of reach of children and pets. Used nicotine gum must be wrapped in paper and put in the trash can. When the medication is no longer needed, do not flush it down the toilet and return it to pharmacies through mail-back service. In case of limited access to mail-back program, see FDA's Safe Disposal of Medicines website for further instructions.[8]

Availability

Various policies exist worldwide as to the accessibility of these medications. Originally (in the 1980s) gum was sold only by prescription.

In most of the EU and the US, nicotine gum is currently available at pharmacies over-the-counter subject to the same restrictions on underage purchases as tobacco. Depending upon jurisdiction and pharmacy the purchaser may be directed to the pharmacist, or nicotine gum may be purchased off-the-shelf. If sold where tobacco products are also sold, the display of the nicotine therapy products may be adjacent to the tobacco display.

Although nicotine gum can be purchased over the counter, in efforts to promote and support tobacco cessation the FDA has approved the nicotine gum, as well as other NRT agents and two other cessation agents: Varenicline and bupropion, for a tobacco cessation indication. This reduces the cost to many U.S. consumers whose health insurance plans cover or have discounts for prescription but not over-the-counter drugs.[14]

In New Zealand (and now Australia) nicotine gum and patches are classified General Sale and can be sold in outlets other than pharmacies, e.g. petrol stations and supermarkets. This has resulted in a steep fall in the retail price, particularly from online New Zealand stores.

This trend away from only being sold over the counter (S3) at pharmacies also followed in Australia with sharp price falls in the last year[ref=2010] and wide availability. Nicotine gum, lozenges and similar preparations can be now readily found on the shelf in the medicinal aisle of most major chain supermarkets and can be purchased alongside other grocery items.

In the United Kingdom many NRT products are available in shops, supermarkets, petrol stations and even schools, although an age limit of 12 is required. Own-brand NRT products are available from some pharmacy chains. The National Health Service (NHS) provides NRT at a discounted price or free of charge. Nicotinell was one of the biggest selling branded over-the-counter medications sold in Great Britain in 2016, with sales of £31.2 million.[15]

In Hong Kong the large chain pharmacist shops usually, but not always, require the purchaser of the stronger therapy (4 mg dose) to sign a register with passport number or Hong Kong ID.

Country Availability Restrictions
USA OTC 18 years of age, even though the US tobacco age is 21, nicotine replacement therapies are not controlled as tobacco products
Europe OTC Same as purchasing tobacco
New Zealand OTC and General Stores None
Australia OTC and General Stores None
Hong Kong Pharmacies Strong therapy purchase requires ID
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See also

References
  1. World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
  2. Hollands, Gareth J.; Naughton, Felix; Farley, Amanda; Lindson, Nicola; Aveyard, Paul (August 16, 2019). "Interventions to increase adherence to medications for tobacco dependence". The Cochrane Database of Systematic Reviews. 8: CD009164. doi:10.1002/14651858.CD009164.pub3. ISSN 1469-493X. PMC 6699660. PMID 31425618.
  3. Benowitz, Neal L.; Jacob, Peyton; Savanapridi, Chin (1987). "Determinants of nicotine intake while chewing nicotine polacrilex gum". Clinical Pharmacology and Therapeutics. 41 (4): 467–473. doi:10.1038/clpt.1987.58. PMID 3829583.
  4. CDCTobaccoFree (2019-06-04). "Learn About Nicotine Replacement Therapy". Centers for Disease Control and Prevention. Retrieved 2019-11-19.
  5. Schane, Rebecca E.; Ling, Pamela M.; Glantz, Stanton A. (6 April 2010). "Health Effects of Light and Intermittent Smoking: A Review". Circulation. 121 (13): 1518–1522. doi:10.1161/CIRCULATIONAHA.109.904235. PMC 2865193. PMID 20368531.
  6. aceessdata.fda.gov (October 23, 2019). "Nicorette Gum label" (PDF). Nicorette Gum labeling-FDA. Retrieved October 23, 2019.
  7. "Nicabate Gum". Nicabate.com.au. GlaxoSmithKline. Archived from the original on 29 November 2014. Retrieved 20 November 2014.
  8. "Nicotine Gum: MedlinePlus Drug Information". medlineplus.gov.
  9. Wollscheid, Kristine (2009). "Electronic Cigarettes: Safety Concerns and Regulatory Issues". American Journal of Health-System Pharmacy. 66 (19): 1740–2. doi:10.2146/ajhp090127. PMID 19767381.
  10. "Nicotine Gum (Nicorette): Side Effects, Dosages, Treatment, Interactions, Warnings". RxList. Retrieved 2019-11-11.
  11. Einarson TR, Einarson A., "Hiccups following nicotine gum use", Ann Pharmacother., 1997 Oct;31(10):1263-4. PMID 9337460
  12. Morales-Suárez-Varela et al. Smoking habits, nicotine use, and congenital malformations. Obstetrics & Gynecology, 107, 51–57, 2006.
  13. "Nicotine", Drugs and Lactation Database (LactMed), National Library of Medicine (US), 2006, PMID 30000646, retrieved 2019-10-24
  14. "III. Cessation Interventions" (PDF). Best Practices for Comprehensive Tobacco Control Programs. Center for Disease Control.
  15. "A breakdown of the over-the-counter medicines market in Britain in 2016". Pharmaceutical Journal. 28 April 2017. Retrieved 29 May 2017.
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