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Characteristics
Nicorette® Patch is an adhesive, square, matt beige patch. It
is available in three strengths that deliver 15, 10 and 5 mg of nicotine,
respectively, per 16-hour application period. When the patch is applied
to the skin, nicotine is slowly released and absorbed through the
skin without producing the high and rapid peaks in arterial nicotine
concentrations that are seen following cigarette smoking.
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Pharmacokinetics
Pharmacokinetic studies have shown that approximately 15 mg of nicotine
is released from the 30 cm² patch over 16 hours. The mean bioavailability
of nicotine released from the Nicorette® Patch is close to 100%. The
maximum plasma concentration (Cmax) of nicotine after application of
a 15 mg patch is between 8 and 15 mg/ml and the time to reach Cmax (tmax)
is approximately 6–10 hours.
Clinical efficacy
Craving and withdrawal symptoms
In placebo-controlled studies, Nicorette® Patch 15 mg significantly reduced
craving for cigarettes and tobacco withdrawal symptoms.
Abstinence rates
Abstinence rates achieved with Nicorette® Patch in randomised, double-blind,
placebo-controlled studies were significantly greater than those achieved with
placebo. A general practice study involving 1 200 smokers reported that 3 weeks
after quitting, twice as many subjects in the Nicorette® Patch group compared
with the placebo group were abstinent; this advantage was still apparent at 1
year.
Meta-analysis of the results from five placebo controlled trials shows the Odds
Ratio for 12-month abstinence with the Nicorette® Patch to be 1.72.
Safety
In clinical trials, Nicorette® Patch used at the recommended dose has not
been shown to cause any serious adverse reactions.
Local adverse events associated with patch use may include mild to moderate erythema,
oedema and itching. The most frequently reported systemic adverse events are
nausea, vomiting, gastrointestinal discomfort and headache; these are generally
mild and transient. |
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