Nicotine Nasal Spray Adverse Events Associated with NRT

11.1.9.5 Nicotine Sublingual Tablet

The฀nicotine฀sublingual฀tablet฀may฀cause฀irritation฀or฀soreness฀in฀the฀mouth฀or฀throat,฀hic- cups,฀ nausea,฀ gastrointestinal฀ discomfort,฀ dry฀ mouth฀ or฀ cough฀ [66,฀ 67] .฀ Most฀ AEs฀ are฀ generally฀mild฀and฀occur฀soon฀after฀commencing฀treatment,฀and฀the฀incidence฀diminishes฀ as฀treatment฀continues.฀Use฀of฀nicotine฀sublingual฀tablets฀for฀6฀months฀has฀no฀adverse฀ effect฀on฀the฀oral฀mucosa฀or฀the฀loor฀of฀the฀mouth฀ [67] .

11.1.9.6 Nicotine Lozenge

The฀nicotine฀lozenge฀was฀tested฀in฀one฀study฀with฀1,818฀smokers฀ [11] .฀61.8฀of฀partici- pants฀reported฀one฀or฀more฀adverse฀effects฀during฀6฀months.฀Severe฀adverse฀effects฀were฀ experienced฀by฀17฀of฀the฀participants฀headache,฀diarrhoea,฀latulence,฀heartburn,฀hiccup,฀ nausea,฀coughing.฀However,฀detailed฀information฀about฀the฀frequency฀of฀adverse฀effects฀ will฀be฀available,฀if฀larger฀treatment฀numbers฀are฀reached.

11.1.10 Withdrawal Symptoms

Withdrawal฀symptoms฀vary฀in฀severity฀from฀person฀to฀person฀and฀may฀last฀for฀several฀ weeks฀to฀months.฀Like฀alcoholics,฀many฀ex-smokers฀are฀severely฀at฀risk฀because฀the฀least฀ cause฀going฀to฀a฀restaurant฀and฀having฀an฀alcoholic฀drink,฀meeting฀up฀with฀smokers,฀stress฀ situations฀may฀trigger฀a฀return฀to฀smoking.฀Many฀smokers,฀however,฀“merely”฀miss฀the฀ manual฀cues฀associated฀with฀the฀activity฀of฀smoking.฀Withdrawal฀symptoms฀are฀commonly฀ misinterpreted฀as฀AEs฀of฀nicotine฀products฀Table฀ 11.4 ,฀especially฀where฀the฀symptoms฀ are฀of฀a฀psychological฀nature. Very฀rarely฀a฀drug-induced฀dependence฀reaction฀may฀also฀develop฀during฀the฀course฀of฀ smoking฀cessation฀therapy฀with฀nicotine฀preparations.฀In฀these฀circumstances,฀ex-smokers฀ become฀dependent฀on฀the฀nicotine฀preparations฀themselves฀nasal฀spray฀฀chewing฀gum฀ and฀then฀frequently฀continue฀to฀use฀these฀products฀over฀a฀period฀of฀months.

11.1.11 Drug Interactions During Smoking Cessation

No฀systematic฀studies฀have฀been฀conducted฀on฀interactions฀between฀nicotine฀and฀other฀ concurrently฀administered฀medication.฀The฀metabolic฀processes฀in฀the฀liver฀are฀stimulated฀ principally฀by฀the฀combustion฀products฀of฀tobacco฀and฀not฀by฀nicotine.฀Tobacco฀smoke฀ induces฀the฀cytochrome฀P450฀enzymes฀CYP1A1,฀CYP1A2฀and฀possibly฀CYP2E1฀ [68] .฀ Smokers฀therefore฀metabolise฀various฀drugs฀more฀rapidly,฀and฀the฀converse฀of฀this฀situa- tion฀is฀that฀during฀smoking฀cessation฀the฀activity฀of฀the฀drugs฀in฀question฀may฀be฀increased฀