HABITROL(r) Nicotine Chewing Gum 2 mg, 4 mg
HABITROL chewing gum contains 2mg or 4mg of nicotine as a nicotine resin in a chewing gum formulation. Gum pieces are rectangular in shape and available in, fruit, mint, liquorice and classic flavours
Nicotine gum mimics the pharmacological effects of nicotine from smoking and may therefore be used to help provide relief from nicotine withdrawal symptoms. In addition to effects on the central nervous system, nicotine produces haemodynamic effects such as increased heart rate and systolic blood pressure.
When the gum is chewed, nicotine is steadily released into the mouth and is rapidly absorbed through the buccal mucosa. A proportion, by the swallowing of nicotine containing saliva, reaches the stomach and intestine where it is inactivated. The peak plasma concentration after a single dose of the 2 mg gum is approximately 6.4 nanograms per ml. For the 4 mg chewing gum, it has been calculated that the nicotine peak plasma concentration after a single dose is approximately 9.3 nanograms per mL (after approximately 60 minutes). After 45 minutes average plasma concentration of nicotine when smoking a cigarette is 15-30 nanograms per mL. Nicotine crosses the blood-brain barrier the placenta, and is detectable in breast milk. Nicotine is eliminated mainly via hepatic metabolism, small amounts being eliminated in unchanged form via the kidneys. The plasma half-life is approximately three hours.
HABITROL nicotine chewing gum treatment is indicated for the relief of nicotine withdrawal symptoms, in nicotine dependency as an aid to smoking cessation. It may be used as part of a smoking reduction strategy by smokers who are unable or not ready to stop smoking abruptly as a step towards stopping completely. May be used by smokers who are unable or not ready to quit on occasions when they want to temporarily abstain from smoking.
The patient should be advised to stop smoking completely during treatment with HABITROL chewing gum. The strength of HABITROL nicotine chewing gum should be chosen according to the smoker's tobacco dependence. Highly dependent smokers, as well as smokers who have failed to quit when using the 2 mg gum, should use the 4 mg strength. Otherwise, the 2 mg strength should be used. One piece of gum should be chewed slowly when the user feels the urge to smoke. Normally, 8-12 of the 2 mg pieces or 4-6 of the 4 mg pieces per day, up to a maximum of 20 pieces per day for the 2 mg gum and 10 pieces for the 4 mg gum.
Concomitant use of acidic beverages such as coffee or soft drinks may interfere with the buccal absorption of nicotine. Acidic beverages should be avoided for 15 minutes prior to chewing the gum. One piece of gum should be chewed until the taste becomes strong. The chewing gum should be rested between the gum and cheek. When the taste fades, chewing should commence again. The chewing routine should be repeated for 30 minutes. After three months, the user should gradually cut down the number of pieces chewed each day until only 1-2 pieces of gum per day are required, at which time they should stop using the product. This process may take 6 months from the start of treatment. Counselling may help smokers to quit. Those using NRT for more than 9 months should seek advice from a healthcare professional.
For smokers who are unwilling or unable to suddenly quit, HABITROL chewing gum may be used whenever there is an intense desire to smoke to help reduce the number of cigarettes smoked, before stopping smoking completely. The smoker should attempt a reduction in cigarette consumption as soon as possible. Consult a healthcare professional if the number of cigarettes smoked has not been reduced in 6 weeks. Once the number of cigarettes has been reduced to a point where the smokers can quit completely, then the HABITROL program should be followed. Consult a healthcare professional if an attempt to stop smoking completely has not commenced within 6-9 months of beginning treatment.
Smokers who are unable or not ready to quit may use the gum on occasions when they want to temporarily abstain from smoking. For example in smoke-free areas, at their place of work, on a plane or in other situations where they cannot or choose not to smoke, and there is an urge to smoke. Refer to 'Dosage and Administration' to select the most appropriate gum strength based on daily cigarette consumption.
If smokers have previously relapsed with use of one form of nicotine replacement therapy (NRT), combination therapy could be beneficial. Smokers who experience breakthrough cravings or have difficulty controlling cravings using one form of NRT alone could combine the use of HABITROL Patch Step 1 with another form of NRT such as HABITROL chewing gum 2 mg. HABITROL chewing gum 4 mg should not be used with HABITROL Patches. When using HABITROL Patch Step 1 in addition of HABITROL chewing gum 2 mg, it is recommended that 4 to 12 pieces are used each day. Most people will use 5 to 6 pieces. Do not exceed 12 pieces a day. Combination therapy should be used for 12 weeks, after which one of the two following programs should be followed: Stop use of HABITROL Patch and gradually reduce the number of gums used until they are no longer needed. Continue with HABITROL Patch Step 2 for 3-4 weeks, then HABITROL Patch Step 3 for a further 3-4 weeks while maintaining the number of HABITROL chewing gum 2 mg that is used each day. After use of patches is ceased, gradually reduce the number of gums used until they are no longer needed.
Children aged 12 to 17 years should only use HABITROL chewing gum under the advice of a healthcare professional. Treatment should not exceed 12 weeks without consultation with a healthcare professional, who should reassess the person for their commitment to quitting smoking and the likely benefit of continued treatment, before recommending use of NRT in this age group beyond 12 weeks. Treatment should not be extended by more than a further 4 weeks in this case. Do not use in children under 12 years.
HABITROL chewing gum should not be used by non-smokers, children under 12 years, occasional smokers or those with known hypersensitivity to nicotine or any of the excipients in the formulation.
Nicotine is a toxic and addictive drug and milligram doses are potentially fatal if rapidly absorbed. For any smoker, with or without concomitant disease or pregnancy, the risk of nicotine replacement in a smoking cessation program should be weighed against the hazard of continued smoking and the likelihood of achieving cessation of smoking without nicotine replacement. Treatment with HABITROL chewing gum should be discontinued if symptoms of nicotine overdosage appear. Mild intoxication produces nausea, vomiting, abdominal pain, diarrhoea, headache, sweating, and pallor (see "Overdosage"). Doses of nicotine that are tolerated by adult smokers during treatment can produce severe symptoms of poisoning in small children and may prove fatal (see "Overdosage"). HABITROL chewing gum must be kept out of reach of children at all times. Occasional smokers are not expected to benefit from the use of HABITROL. Dependent smokers with a recent myocardial infarction, unstable or worsening angina pectoris including Prinzmetal's angina, severe cardiac arrhythmias, uncontrolled hypertension or recent cerebrovascular accident should be encouraged to stop smoking with non-pharmacological interventions (such as counselling). If this fails, HABITROL may be considered but as data on safety in these patient groups are limited, initiation should only be under close medical supervision. HABITROL should be used with caution in patients with: severe hypertension, stable angina pectoris, cerebrovascular disease, occlusive peripheral arterial disease, heart failure, hyperthyroidism or pheochromocytoma, moderate to severe hepatic and/or severe renal impairment, active peptic ulcer. Smokers with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated because catecholamine release can affect carbohydrate metabolism and vasoconstriction may delay or reduce insulin absorption. Swallowed nicotine may exacerbate symptoms in subjects suffering from active oesophagitis, gastritis or peptic ulcer. Avoid use of HABITROL Chewing Gum if oral or pharyngeal inflammation is present. There is the possibility that, as with other gums, HABITROL chewing gum may stick to dentures, dental caps or partial bridges and may damage dental work.
No animal studies have been undertaken on HABITROL chewing gum. The toxicity of nicotine as a constituent of tobacco has been well documented. Acute toxic effects include convulsions, cardiac insufficiency, and paralysis of the respiratory system. At high doses in cats and dogs, nicotine has been shown to potentiate histamine-induced peptic ulcer. Nicotine has no geneotoxic activity in most of the mutagenicity test systems. The well-known carcinogenicity of tobacco smoking is mainly caused by pyrolysis products. Application of nicotine chewing gum, however, avoids the high temperature required for the formation of these carcinogenic products. Reproductive toxicity studies with nicotine in several animal species have demonstrated non-specific retardation of foetal growth. Studies in rats produced evidence of decreased fertility, prolonged pregnancy, and behavioural disorders in the offspring. In mice the offspring of animals exposed to very high doses of nicotine showed skeletal defects in the peripheral parts of the limbs. Overall, there are no clear cut grounds for believing that nicotine at the concentrations reached by treatment with nicotine gum has any teratogenic potential and/or inhibitory effects on fertility. All excipients used in HABITROL chewing gum are of food or pharmaceutical grade.
In pregnant women, complete cessation of tobacco consumption should always be recommended without nicotine replacement therapy (NRT). However, for women unable to quit on their own, NRT may be recommended to assist a quit attempt. Nicotine is harmful to the foetus. However, the risk for the foetus is probably less than to be expected with continued smoking due to: Lower maximal plasma concentrations compared to inhaled nicotine, resulting in a nicotine exposure less or not more than associated with smoking. No exposure to polycyclic hydrocarbons and carbon monoxide. As nicotine does pass to the foetus, the decision to use NRT should be made as early on in pregnancy as possible with the aim of discontinuing after use for two to three months. If NRT is used during pregnancy, HABITROL chewing gum should preferably be used while pregnant as they usually provide a lower daily dose of nicotine than patches. However, if the woman suffers from nausea and/or vomiting, the patch may be preferred but should be removed before going to bed.
Nicotine is excreted in breast milk in quantities that may affect the child even in therapeutic doses. Like smoking, nicotine replacement therapy should be avoided during breast-feeding. However HABITROL chewing gum may be used if necessary. Women should breastfeed just before they use the product to allow time between NRT use and feeding to be as long as possible.
Data on the use of NRT in treating adolescents under the age of 18 years are limited. NRT should only be used in adolescents 12 to 17 years after consultation with a healthcare professional and use should be restricted to 12 weeks. If treatment is required for longer than 12 weeks, this should be discussed with a healthcare professional. Do not use in children under 12 years.
There is no evidence or particular risk associated with driving or operating machinery if HABITROL chewing gum is taken according to the recommended dose. However smoking cessation can cause behavioural changes.
In principle, HABITROL chewing gum can cause adverse reactions similar to those associated with nicotine administered by smoking. The most common side effects are dizziness, headaches and insomnia. These could also be withdrawal symptoms associated with giving up smoking and could be the result of too little nicotine. Nicotine from chewing gum may sometimes cause a slight irritation of the mouth and throat and increase salivation at the start of treatment. Excessive swallowing of dissolved nicotine may, at first, cause hiccupping. Those people with a tendency to indigestion may suffer initially from minor indigestion or heartburn. Slower chewing will usually overcome this problem. Excessive consumption of chewing gum by people who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches. Less common side effects include palpitations, redness and rashes. Individuals who are liquorice-sensitive, along with those who chew more HABITROL Liquorice chewing gum than is recommended, may experience symptoms of water retention, headache, vertigo, increased urination, increased blood pressure and general weakness.
No clinically relevant interactions between NRT and other drugs have definitely been established. However nicotine may enhance the haemodynamic effects of adenosine. Smoking but not nicotine is associated with increased CYP1A2, and possibly CYP1A1, activity. After cessation of smoking there may be reduced clearance of substrates for these enzymes and increased plasma levels of some medicinal products. This is of potential clinical importance in products with a narrow therapeutic window e.g. theophylline, ropinirole, clozapine and olanzapine. Cessation of smoking, with or without NRT, may alter the individual's response to concomitant medication and may require adjustment of dose. In particular, anticonvulsants may require special monitoring and/or dosage adjustment. Dose reduction may be required for: caffeine, oestrogens, imipramine, lignocaine, oxazepam, pentazocine, theophylline, warfarin, possibly due to reversal of hepatic enzyme induction on smoking cessation insulin, possibly due to increase in subcutaneous absorption on smoking cessation adrenergic antagonists (e.g. prazosin, labetalol), possibly due to reduction in circulating catecholamines on smoking cessation Dose increase may be required for: adrenergic agonists (e.g. isoprenaline, phenylephrine), possibly due to reduction in circulating catecholamines on smoking cessation Smoking may lead to reduced analgesic effects of opioids (e.g. dextropropoxyphene, pentazocine), reduced diuretic response to furosemide, reduced effect of beta-adrenergic blockers (e.g. propranolol) on blood pressure and heart rate decrease and reduced responder rates in ulcer healing with H2- antagonists. Both smoking and nicotine may raise the blood levels of cortisol and catecholamines. Dosages of nifedipine, adrenergic antagonists and adrenergic agonists may need to be adjusted.
In overdose, symptoms corresponding to heavy smoking may be seen. General symptoms of nicotine poisoning include: pallor, sweating, burning throat, salivation, nausea, vomiting, abdominal cramps, diarrhoea, headache, dizziness, hearing and vision disturbances, tremor, mental confusion, muscle weakness, palpitations, dilated pupils, tachycardia, cardiac arrhythmias, dyspnoea, circulatory disturbance, convulsions, prostration, absence of neurological reaction, respiratory failure. Lethal doses may produce convulsions, and death follows as a result of peripheral or central respiratory paralysis or, less frequently, cardiac failure. The acute lethal oral dose is approximately 0.5-0.75 mg per kg body weight, corresponding in an adult to 40-60 mg. Doses of nicotine that are tolerated by adult smokers during treatment can produce severe symptoms of poisoning in small children and may prove fatal. If poisoning is suspected in a child, a doctor must be consulted immediately. Overdose with HABITROL chewing gum could occur if many pieces are chewed simultaneously. Risk of overdose is small as nausea and vomiting usually occurs at an early stage. Risk of poisoning by swallowing the gum is small. Since the release of nicotine from the gum is slow, very little nicotine is absorbed from the stomach and intestine. Any that is absorbed will be inactivated by the liver.
In the event of overdose or suspected overdose, seek immediate medical advice or contact the Poisons Information Centre (Telephone 0800 764 766) Vomiting should be induced with syrup of ipecacuanha or gastric lavage carried out (wide bore tube). A suspension of activated charcoal should then be passed through the tube and left in the stomach. Artificial respiration with oxygen should be instituted if needed and continued for as long as necessary. Other therapy, including treatment of shock, is purely symptomatic.
Store below 25oC. Medicines should be kept out of the reach of children.
General Sale Medicine.
Boxes containing 96 pieces of gum (8 blister platforms, each containing 12 pieces of gum).
HABITROL chewing gum contains nicotine, chewing gum base (containing butylated hydroxytoluene), calcium carbonate, carnauba wax, gelatin, glycerol, mannitol, menthol, polacrilin, sodium bicarbonate, sodium carbonate anhydrous, sorbitol, talc, titanium dioxide, water - purified, xylitol. Classic HABITROL chewing gum contains maltitol solution. Fruit, Mint and Liquorice HABITROL chewing gums contain saccharin, saccharin sodium, acesulfame potassium. Flavours: Fruit - fruit flavour. Mint - eucalyptus oil, peppermint oil. Liquorice - eucalyptus oil, anise oil, liquorice root extract. Classic - fruit flavour. Each gum contains sorbitol, xylitol and mannitol with a combined total of 0.4g per piece. For the 2mg strength, this is equivalent to 8g per maximum dose of 20 pieces. For the 4mg strength, this is equivalent to 4g per maximum dose of 10 pieces. Please note that products containing these ingredients may have a laxative effect or cause diarrhoea. Each piece of gum also contains 11.5mg (0.5mmol) sodium which should be taken into account by those on a low sodium diet. For the 2mg strength, this is equivalent to 230mg (10mmol) sodium per maximum dose of 20 pieces. For the 4mg strength, this is equivalent to 115mg (5mmol) sodium per maximum dose of 10 pieces
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22 May 2009 (r) Registered Trademark