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Characteristics
Each piece of Nicorette® Gum contains 2 mg or 4 mg of nicotine
bound to an ion-exchange resin, which permits slow release of nicotine,
and an alkaline hydrocarbonate buffer, which increases the oral absorption
of nicotine by increasing salivary pH to 8.5. The chewing gum formulation
of Nicorette® provides readily absorbed nicotine and some oral gratification. |
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Pharmacokinetics
Depending on the rate and intensity of chewing and the amount of
saliva produced, approximately 75% of the nicotine contained in Nicorette®
Gum is released during 30 minutes of chewing. Individuals generally chew
fewer pieces of Nicorette® Gum than the number of cigarettes they smoke,
and thus plasma nicotine concentrations attained are approximately one-third
(2 mg dose) and two-thirds (4 mg dose) of those achieved by smoking.
However, chewing Nicorette® 4 mg gum on an hourly basis may result in
plasma nicotine concentrations comparable to those attained by smoking.
There is little risk of transferred dependence because there are no pronounced
peaks in blood nicotine concentration.
Clinical efficiency
Craving and withdrawal symptoms
Studies have shown that Nicorette® Gum reduces the incidence and severity
of tobacco withdrawal symptoms, such as irritability, anger and impatience,
more effectively than placebo. Nicorette® Gum has also been shown to markedly
reduce the incidence and severity of hunger, which may persist for several
weeks or months after quitting.
Cessation rates
A meta-analysis of 48 studies that compared smoking cessation rates
with nicotine gum or placebo reported that 18% of subjects using nicotine chewing
gum were abstinent at 12 months, compared to 11% in the group using placebo gum.
The odds ratio of abstinence for nicotine gum was 1.63 compared to placebo. Trials
that directly compared the 2 mg versus 4 mg gum in highly dependent smokers found
a significant benefit in favour of the 4 mg strength (odds ratio 2.67, 95% confidence
interval 1.69 to 4.22).
Safety
Nicorette® Gum used at the recommended dose has not been found to cause any
serious adverse events. Nicotine from the gum may sometimes cause slight throat
irritation and increased salivation at commencement of treatment. Excessive swallowing
of dissolved nicotine may cause hiccups. The most frequently reported adverse
events are gastrointestinal disturbances (including nausea and vomiting, borborygmus
and hiccups), headache, dizziness, and local adverse events (sore mouth or throat
and jaw ache). Less frequent adverse events include palpitations, erythema and
urticaria. |
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