HABITROL® & HABITROL® MINT Nicotine Chewing Gum 2 mg, 4 mg

Presentation:

HABITROL 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 two flavours, original (tutti-sweet) and mint.

Uses:

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.

Pharmacokinetics:

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 of the 2 mg gum after a single dose is approximately 4.8 nanograms per ml and following steady state administration is approximately 14 nanograms per ml (average plasma concentration of nicotine when smoking a cigarette is 15-30 nanograms per ml). For a chewing gum of 4 mg gum, it has been calculated that a maximum plasma concentration of approximately 10 nanograms per ml is reached after approximately 30 minutes. Nicotine is eliminated mainly via hepatic metabolism; small amounts of nicotine are eliminated in unchanged form via the kidneys. The plasma half-life is approximately three hours. Nicotine crosses the blood-brain barrier, the placenta, and is detectable in breast milk.

Indications:

HABITROL treatment is indicated for the relief of nicotine withdrawal symptoms, in nicotine dependency as an aid to smoking cessation.

Dosage and Administration:

Users should stop smoking completely during treatment with HABITROL gum. One piece of HABITROL gum to be chewed when the user feels the urge to smoke. Normally, 8-12 pieces per day, up to a maximum of 25 pieces per day for the 2 mg gum and 15 pieces for the 4 mg gum.

Directions for Use:

1. One piece of gum should be chewed until the taste becomes strong.

2. The chewing gum should be rested between the gum and cheek.

3. When the taste fades, chewing should commence again.

4. 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 they have stopped using the product. The characteristics of chewing gum as a pharmaceutical form are such that individually different nicotine levels can result in the blood. Therefore, dosage frequency should be adjusted according to individual requirements within the stated maximum limit.

Concomitant use of acidic beverages such as coffee or soda may interfere with the buccal absorption of nicotine. Acidic beverages should be avoided for 15 minutes prior to chewing the gum.

CHILDREN: Not to be used by children.

Contraindications:

HABITROL gum should not be used by non-smokers or people under 18 years of age. Furthermore, people should not use the gum and smoke concomitantly. Use is contra-indicated during pregnancy and lactation, acute myocardial infarction, unstable or worsening angina pectoris, severe cardiac arrhythmias, and recent cerebrovascular accident.

Warnings and Precautions:

Swallowed nicotine may exacerbate symptoms in subjects suffering from active oesophagitis, oral and pharyngeal inflammation, gastritis or peptic ulcer. Use with caution in patients with hypertension, stable angina pectoris, cerebrovascular disease, occlusive peripheral arterial disease, heart failure, hyperthyroidism, diabetes mellitus, and renal or hepatic impairment. Counselling may help smokers to quit. Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in small children and may prove fatal (see 'Overdosage').

Mutagenicity / Carcinogenicity / Reproduction Toxicity

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.

Pregnancy and Lactation:

In common with medical advice on stopping smoking in these situations, HABITROL gum is contra-indicated in pregnant women and during breast feeding.

Effects on Ability to Drive or Use Machines:

There is no evidence or particular risk associated with driving or operating machinery if HABITROL Chewing Gum is ataken according to the recommended dose.

Adverse Effects:

In principle, HABITROL gum can cause adverse reactions similar to those associated with nicotine administered by smoking. Nicotine from gum may sometimes cause a slight irritation of the throat and increase salivation at the start of treatment. Excessive swallowing of dissolved nicotine may, at first, cause hiccuping. Those with a tendency to indigestion may suffer initially from minor indigestion or heartburn. Slower chewing will usually overcome this problem. Excessive consumption of gum by subjects who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.

Interactions:

Drug Interactions: No information is available on interactions between HABITROL gum and other medicines.

Smoking Cessation:

This is different in the case of smoking where interactions with other medications may occur due to a multitude of other substances contained in the smoke. Presumably due to the polycylic aromatic hydrocarbons contained in the smoke, the metabolism of different medicinal products may be speeded up by enzyme induction e.g. caffeine, theophylline, paracetamol, phenylbutazone, pentazocine, lidocaine, benzodiazepines, imipramine, warfarin, oestrogen and vitamin B12. Upon smoking cessation it may be expected that the hitherto increased metabolism of these medicinal products is slowed down or normalised. Unaltered dosage of the products may result in an increase in their blood concentration.

Therefore when prescribing HABITROL a possible dose adjustment should be considered in patients treated with the above mentioned medicinal products. Other reported effects of smoking include a reduction of the analgesic effects of propoxyphene, reduced diuretic response to frusemide, change in the pharmacological effect of propranolol and altered responder rates in ulcer healing with H2-antagonists. Smoking and nicotine may raise the blood levels of cortisol and catecholamines. Dose adjustment of nifedipine, adrenergic agonists or adrenergic antagonists may be necessary. Increased subcutaneous absorption of insulin which occurs upon smoking cessation may necessitate a reduction in insulin dose.

Overdosage:

In overdose, symptoms corresponding to heavy smoking may be seen. The acute lethal oral dose of nicotine is about 0.5 - 0.75 mg per kg body weight, corresponding in an adult to 40 - 60 mg. Even small quantities of nicotine are dangerous in children, and may result in severe symptoms of poisoning which may prove fatal. If poisoning is suspected in a child, a doctor must be consulted immediately. Overdose with HABITROL gum may only occur if many pieces are chewed simultaneously. Risk of overdose is small as nausea or vomiting usually occurs at an early stage. Risk of poisoning by swallowing the gum is small. Since the release of nicotine from gum is slow, very little nicotine is absorbed from the stomach and intestine, and if any is, it will be inactivated in the liver.

General symptoms of nicotine poisoning include: weakness, perspiration, salivation, throat burn, nausea, diarrhoea, abdominal pain, hearing and visual disturbances, headache, tachycardia, and cardiac arrhythmia, dyspnoea, prostration, circulatory collapse, coma and terminal convulsions.

Treatment of overdosage: In the event of overdosage, 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.

Pharmaceutical Precautions:

Store below 25ºC. Medicines should be kept out of the reach of children.

Boxes containing 96 pieces of gum (8 blister platforms, each containing 12 pieces of gum).

Further Information:

List of Excipients: HABITROL Chewing Gum Gum base, calcium carbonate, sorbitol, glycerin, sodium carbonate, sodium bicarbonate, amberlite, menthol, fruit flavour, butylated hydroxytoluene, acesulfame potassium, saccharin, sodium saccharin, talc, carnauba wax.

HABITROL Mint Chewing Gum Fruit flavour is replaced by peppermint and eucalyptus.

HABITROL gum is sugar-free