NICORETTE INHALATOR 42

NICORETTE INHALATOR
Strength: 10mg
Pack Quantity: 42

Nicorette Inhalator is indicated for the relief of nicotine withdrawal symptoms as an aid to smoking cessation in adults and children over 12 years of age.  It is also indicated in pregnant and lactating women

In smokers currently unable or not ready to stop smoking abruptly, the inhalator may also be used as part of a programme to reduce smoking prior to stopping completely. 

Nicorette Inhalator should be used whenever the urge to smoke is felt, up to a maximum usage of 12 cartridges per day.  The more the subject is able to use the inhalator, the easier it will be to stay smoke-free.  Each cartridge can be used for approximately 4 sessions, with each cartridge lasting approximately 20 minutes. 

Any spare cartridges should be retained, as craving may suddenly occur. 

Behavioural therapy, advice and support will normally improve the success rate. 


Smoking cessation

Adults (over 18 years of age)

In the treatment of nicotine dependence, a course not exceeding 12 weeks is suggested.  The patient should make every effort to stopping smoking completely during treatment with Nicorette Inhalator. 

a) For up to 8 weeks the patient uses not less than six and not more than 12 cartridges each day, to relieve craving. 

b) Over the following two weeks the aim is to reduce the number of cartridges used by half, and over the next two weeks to reduce the number to zero by the last day. 

Adults who use NRT beyond 9 months for smoking cessation are recommended to seek additional help and advice from a healthcare professional. 


Adolescents (12 to 18 years)

The dose and method of use are as for adults however as data are limited in this age group, the recommended treatment duration is 12 weeks.  If longer treatment is required, advice from a healthcare professional should be sought. 


Smoking reduction

Adults (over 18 years of age)

Use the Inhalator between smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as possible.  If a reduction in number of cigarettes per day has not been achieved after 6 weeks, professional advice should be sought. 

A quit attempt should be made as soon the smoker feels ready, but not later than 6 months after start of treatment.  If a quit attempt cannot be made within 9 months after starting treatment, professional advice should be sought. 

When making a quit attempt the smoking cessation instructions above can be followed. 


Adolescents (12 to 18 years)

Where adolescents are motivated to stop smoking abruptly, smoking cessation should be recommended.  However, smoking reduction can be considered where adolescents are not ready or able to stop smoking abruptly.  As data are limited in this age group, and the recommended duration of NRT is 12 weeks, adolescents should consult a healthcare professional before starting the 'smoking reduction prior to stopping' regimen. 

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Use the Inhalator between smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as possible.  If a reduction in number of cigarettes per day has not been achieved after 6 weeks, professional advice should be sought. 

A quit attempt should be made as soon the smoker feels ready, but not later than 6 months after start of treatment.  If a quit attempt cannot be made within 9 months after starting treatment, professional advice should be sought. 

When making a quit attempt the smoking cessation instructions for adolescents (12 to 18 years) given above can be followed. 


Method of administration

The cartridge is inserted into the mouthpiece according to the instructions.  The patient draws air into the mouth through the mouthpiece: there is a greater effort needed than with a cigarette.  The patient may find deep drawing or short sucks on the mouthpiece most effective ' patients soon find a favoured technique, Nicotine vapour passing through the mouth is absorbed by the buccal mucosa: little reaches the lungs.  After about 20 minutes of intense use the maximal dose is achieved and it is about then that the nicotine amounts released from the cartridge begin the fall away, such that the cartridge is rejected by the user. 

1.  Remove the sealed tray and the mouthpiece from the carton box. 

2.  Peel back the foil from the tray. 

3.  Separate the mouthpiece by twisting the two halves until the two marks line up.  The mouthpiece can now be pulled apart. 

4.  Take a cartridge and push it firmly into the bottom of the mouthpiece until the seal breaks. 

5.  Push the other part of the mouthpiece back into place over the cartridge.  Line up the marks and push the top and bottom together firmly to break the top seal of the cartridge. 

6.  Twist to lock: the product is ready for use. 

7.  Grip the mouthpiece with the lips. 

As air is inhaled, the nicotine is vaporised and absorbed in the mouth. 

The actual time that the cartridge is active depends on the intensity of use. 

The number, frequency, puffing/inhalation time and technique vary individually.  Studies show that different inhalation techniques give similar effects: deep inhalation (the cigarette smoker's way) or shallow puffing (the pipe smoker's way).  The amount of nicotine from a puff is less than that from a cigarette. 

To compensate for less nicotine delivery from a puff it is necessary to inhale more often than when smoking a cigarette, i.e.  use the Nicorette Inhalator for longer periods at a time.  After using a few cartridges the patient will have found a method that suits him/her and gives the best effect. 

This product works best at room temperature.  In cold conditions (below 15°C) the nicotine evaporates less readily and it will be necessary to inhale more frequently, whilst in warm conditions (above 30°C) nicotine will evaporate more readily and inhalation should be less frequent to avoid overdose. 

The empty mouthpiece should be rinsed in water several times a week. 


Lung Disease

Patients with obstructive lung disease may find use of the Inhalator difficult.  Nicotine Gum, Patch, Nasal Spray or Sublingual tablet may be preferred in such cases. 


Any risks that may be associated with NRT are substantially outweighed by the well established dangers of continued smoking. 

Underlying cardiovascular disease: In stable cardiovascular disease Nicorette Inhalator presents a lesser hazard than continuing to smoke.  However dependent smokers currently hospitalised as a result of myocardial infarction, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions.  If this fails, Nicorette Inhalator may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision. 

Diabetes mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism. 

GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and oral NRT preparations should be used with caution in these conditions.  Ulcerative stomatitis has been reported. 

Renal or hepatic impairment: Nicorette Inhalator should be used with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects. 

Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal.  Products containing nicotine should not be left where they may be misused, handled or ingested by children. 

Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines, Nicorette Inhalator should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma. 

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence. 

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1).  When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs.  This is of potential clinical importance for products with a narrow therapeutic window, e.g.  theophylline, clozapine and ropinirole. 

Nicorette Inhalator should be used with caution in patients with chronic throat disease and bronchospastic disease. 

Potential choking hazard: This product contains some small parts.  Any unused cartridges should remain in the cartridge tray to minimise the risk of swallowing.