NiQuitin Mint Gum is indicated for the relief of nicotine withdrawal symptoms. Permanent cessation of tobacco use is the eventual objective. NiQuitin Mint Gum can be used:
• for smoking cessation (abrupt and gradual).
• as an aid for smokers during temporary abstinence.
NiQuitin Mint Gum should preferably be used in conjunction with a behavioural support programme.
Directions for use:
NiQuitin Mint Gum should be chewed slowly according to the instructions.
NiQuitin 4 mg Mint Gum is suitable for smokers who have their first cigarette of the day within 30 minutes of waking up.
Behavioural therapy, advice and support will normally improve the success rate.
The chewing gums should be used whenever there is an urge to smoke according to the “chew and rest” technique described on the pack. After about 30 minutes of such use, the gum will be exhausted. Not more than 15 pieces of the chewing gum may be used each day. Absorption of nicotine is through the buccal mucosa, any nicotine which is swallowed being destroyed by the liver.
Adults (18 years and over)
Abrupt cessation of smoking:
Users should make every effort to stop smoking completely during treatment with NiQuitin Mint Gum.
NiQuitin Mint Gum should be chewed as directed whenever there is an urge to smoke to maintain complete abstinence from smoking.
Sufficient gums should be used each day, usually 812, up to a maximum of 15.
Continue use for up to three months to break the habit of smoking, then gradually reduce gum use. When daily use is 12 gums, use should be stopped. Any spare gum should be retained, as craving may suddenly return.
Those who use the gum beyond 9 months are recommended to seek additional help and advice from a healthcare professional.
For those using the 4 mg gum, the 2 mg gum will be helpful during withdrawal from treatment. Gradual cessation of smoking:
For smokers who are unwilling or unable to quit abruptly. Use a piece of gum whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. The number of pieces of gum a day is variable and depends on the patients needs. Nonetheless it should not exceed 15 pieces per day.
If a reduction in cigarette consumption has not been achieved after 6 weeks of treatment, a healthcare professional should be consulted.
Reduced tobacco consumption should lead to complete cessation of smoking. This should be attempted as soon as possible. When the number of cigarettes has been reduced to a level from which the user feels able to quit completely, then start on the schedule for “abrupt cessation” as given above.
If an attempt to stop smoking completely has not been started within 6 months after the beginning of treatment, it is recommended to consult a healthcare professional.
Temporary abstinence:
Use a piece of gum whenever there is a strong urge to smoke to control troublesome withdrawal symptoms including cravings. Users should not take more than 15 pieces of gum per day.
Users should be encouraged to stop smoking completely as soon as possible.
If users are still feeling the need to use gum on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.
Adolescents and children
Adolescents (12 to 17 years) should follow the above usage advice for abrupt cessation of smoking, but as data are limited, duration of NRT in this age group is restricted to 12 weeks. If longer treatment is required, or where adolescents are unwilling or unable to quit smoking abruptly, advice from a healthcare professional should be sought.
NiQuitin Mint Gum is not recommended for use in children under 12 years of age.
The risks associated with the use of NRT are substantially outweighed in virtually all circumstances by the well established dangers of continued smoking.
Patients hospitalised for MI, severe dysrhythmia or CVA who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, NiQuitin Mint Gum may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision. Once patients are discharged from hospital they can use NRT as normal.
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.
Allergic reactions: susceptibility to angioedema and urticaria.
A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions:
•Renal and hepatic impairment: Use 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.
•Phaeochromocytoma and uncontrolled hyperthyroidism: Use with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma as nicotine causes release of catecholamines.
•GI Disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.
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. NiQuitin Mint Gum should be disposed of with care.
Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops this may result in a slower metabolism and a consequent rise in blood levels of such drugs.
Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.
Smokers who wear dentures may experience difficulty in chewing NiQuitin Mint Gum.
Pregnancy
Smoking during pregnancy is associated with risks such as intra-uterine growth retardation, premature birth or stillbirth. Stopping smoking is the single most effective intervention for improving the health of both pregnant smoker and her baby. The earlier abstinence is achieved the better.
Ideally smoking cessation during pregnancy should be achieved without NRT. However for women unable to quit on their own, NRT may be recommended to assist a quit attempt. The risk of using NRT to the fetus is lower than that expected with tobacco smoking, due to lower maximal plasma nicotine concentration and no additional exposure to polycyclic hydrocarbons and carbon monoxide.
However, as nicotine passes to the fetus affecting breathing movements and has a dose dependent effect on placental/fetal circulation, the decision to use NRT should be made as early on in the pregnancy as possible. The aim should be to use NRT for only 2-3 months.
Intermittent dosing products may be preferable as these usually provide a lower daily dose of nicotine than patches. However patches may be preferred if the woman is suffering from nausea during pregnancy. If patches are used they should be removed before going to bed.
Lactation
Nicotine from smoking and NRT is found in breast milk. However the amount of nicotine the infant is exposed to from NRT is relatively small and less hazardous than the second-hand smoke they would otherwise be exposed to.
Using intermittent dose NRT preparations, compared with patches, may minimize the amount of nicotine in the breast milk as the time between administrations of NRT and feeding can be more easily prolonged.
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