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This guide provides general information about nicotine and specific information about the NICORETTE Inhaler treatment. Please read all of it carefully, before you start using the NICORETTE Inhaler. Do not throw this guide away nor the carton as you may need to read them again. If you have any questions or want more information, consult your doctor or pharmacist or call the NICORETTE Inhaler Call It Quits counselling and support line at 1-866-311-5606.
You have taken the most important step of all: deciding to quit. Now that you've put your mind to it, your strength and willpower combined with the proper use of NICORETTE Inhaler can help you conquer the cravings and make your habit a thing of the past. Read on to find out how the NICORETTE Inhaler can help you do just that.
How the NICORETTE Inhaler can help you?
The NICORETTE Inhaler can help you stop smoking by reducing your urge to smoke. The NICORETTE Inhaler can calm the craving for a cigarette and satisfy the hand-to-mouth ritual of the smoker. Although it may be an effective aid, the Inhaler is only part of your stop smoking program. Your chances of quitting smoking depend on how much you want to quit, how addicted you are to nicotine, and how closely you follow a stop smoking program. Success in quitting with nicotine replacement therapy (such as the NICORETTE Inhaler) usually involves behavioral change. People who use the NICORETTE Inhaler with a comprehensive behavioral smoking cessation program are more successful in quitting smoking. Such a program can include support groups, counselling or specific behavior-altering techniques. In order to use this product, you must be at least 18 years of age.
Understanding your smoking habit
Many of the cigarettes you smoke are little more than “habit” cigarettes; you've gotten into the habit of having them at certain times, like:
with morning coffee
while talking on the phone
while driving your car
when under stress
while having a drink with friends
The other cigarettes you smoke are cigarettes your body feels it “needs”. Nicotine is a chemical your body has come to like and depend on. When you smoke, nicotine is released into your bloodstream, “topping up” its supply. After a while, your blood levels of nicotine decrease until you feel a craving telling you to “top up” again.
How does the NICORETTE Inhaler work?
The NICORETTE Inhaler is designed to help you quit smoking cigarettes. It replaces some of the nicotine you crave when you stop smoking, and helps to relieve symptoms of nicotine withdrawal such as irritability, frustration, anger, anxiety, difficulty concentrating and restlessness. For many people, smoking is the most difficult habit to break. Smokers repeat the hand-to-mouth ritual approximately 200 times a day (73,000 times a year). While the importance of this effect in quitting smoking is, as yet, unknown, the NICORETTE Inhaler can reduce the craving to smoke, while also providing the comfort of the hand-to-mouth ritual.
Set a Quit Day
Your chances of quitting smoking increase dramatically when you set a Quit Day for yourself. Your Quit Day shouldn't be too far in the future, nor should it be a particularly stressful day. Before your Quit Day, go over all your reasons for wanting to quit, and try to imagine yourself leading a cigarette-free life. When your Quit Day arrives, stop smoking completely and begin your NICORETTE Inhaler treatment. And throughout it all, remember to take it one day at a time—every day without a cigarette makes you a winner.
How do I use the NICORETTE Inhaler?
(See package insert for illustrations.)
Remove the mouthpiece from the plastic wrap. Align marks and separate the two parts of the mouthpiece.
Take out the cartridge tray. Peel back the foil and take out one cartridge. Press the cartridge firmly into the bottom of the mouthpiece until the seal breaks.
Replace the top on the mouthpiece. Align the marks to close. Press down firmly to break the top foil seal of the cartridge. Twist to misalign marks and secure.
Place the tapered end of the Inhaler in your mouth and inhale deeply into the back of your throat or puff in short breaths. As you inhale or puff through the mouthpiece, nicotine turns into a vapor and is absorbed through the lining of your mouth and throat and not in your lungs. Use longer and more often at first to help control cigarette cravings. Use the Inhaler at room temperature (15-30°C). Cold temperatures reduce the amount of nicotine you inhale.
After about 20 minutes of frequent continuous puffing, nicotine in the cartridge is used up (the nicotine content may last longer if you use the Inhaler less intensively).
Try different schedules to help control cravings. Puffing on the Inhaler for 5 minutes at a time will give you enough nicotine for 4 uses. Puffing on the Inhaler for 10 minutes at a time will give you enough nicotine for 2 uses. In a few days you'll find what works best for you and know when nicotine in cartridges is used up.
When the cartridge is empty, take off the top of the mouthpiece and throw the used cartridge away, out of reach of children and pets.
Clean the mouthpiece regularly with soap and water.
Avoid drinking acidic beverages such as coffee, tea, soft drinks, alcohol or citrus juices when using the NICORETTE Inhaler. They can prevent it from working properly.
When should I use the NICORETTE Inhaler?
The NICORETTE Inhaler has a flexible dosing system that may be used whenever you feel an urge to smoke. Use the NICORETTE Inhaler longer and more often at first to help control cigarette cravings. The dose of nicotine from one puff of the Inhaler is much less than from one puff of a cigarette. The nicotine in each cartridge is used up after about 20 minutes of frequent continuous puffing. Try different schedules to help control cravings and use the Inhaler at times when you most crave a cigarette. After you have tried it a few times you will develop the technique which most suits you and gives the best results.
The most successful quitters have learned to use an average of 6 cartridges a day. The dose is based on the individual, so you decide how many cartridges are required to reduce your cravings. For the first 3 to 12 weeks of treatment, you should use at least 6 cartridges per day. Do not use more than 12 cartridges in one day. As your body adjusts to not smoking, you can either stop using the Inhaler or slowly reduce the number of cartridges used each day over the next 6 to 12 weeks.
How long should I use the NICORETTE Inhaler?
It is important that you use the NICORETTE Inhaler long enough to help you overcome your dependence on cigarettes. Normally this period will be 3 months. After that, for the next 6 to 12 weeks, the dosage is gradually reduced by using fewer cartridges daily. Use of the NICORETTE Inhaler beyond 6 months is not recommended (see Table 1).Table 1: NICORETTE Inhaler Recommended Dosing
|Treatment||Duration||Recommended # of Cartridges per Day|
|Initial treatment||up to 12 weeks||6–12 cartridges|
|Gradual reduction (if needed)||6–12 weeks||reduce gradually when daily use is reduced to 1–2 cartridges, stop using Inhaler|
Can I smoke while using the NICORETTE Inhaler?
Do not smoke, chew tobacco, use snuff or any other Nicotine Replacement Therapy products while using the NICORETTE Inhaler because you may overdose on nicotine. Signs of a nicotine overdose include bad headaches, dizziness, upset stomach, drooling, vomiting, cold sweat, blurred vision, difficulty hearing, mental confusion, weakness and fainting. If you experience any of these symptoms, consult your doctor, or local Poison Control Center immediately.
What are the possible side effects for Nicorette inhaler of the NICORETTE Inhaler?
Like all drugs, the NICORETTE Inhaler can cause side effects. Many people experience mild irritation of the mouth or throat, and cough when they first use the NICORETTE Inhaler. Stomach upset may occur. In clinical studies, the frequency of cough and mouth or throat irritation declined with the continued use of the NICORETTE Inhaler.
Who should not use the NICORETTE Inhaler?
If you have any of these conditions, you should consult your doctor or pharmacist before using this product:
Heart problems (recent heart attack, irregular heartbeat, severe or worsening heart pain)
Stomach problems or ulcers
High blood pressure
Allergies to drugs
Diabetes requiring insulin
Kidney or liver disease
Wheezing, asthma or chronic lung problems
Treatment for poor circulation
Treatment for circulation disorders of the brain
Are there any special concerns for women?
Women should take adequate precautions to avoid becoming pregnant while using the NICORETTE Inhaler. Do not use if you are pregnant (or think you may be pregnant) or nursing unless your doctor tells you to do so. Nicotine in any form can cause harm to your unborn baby. Only you and your doctor can decide if the benefits of using the NICORETTE Inhaler to stop smoking outweigh the risk of using this medication.
What about the Inhaler and other medications?
Tell your doctor or pharmacist about any medications you are taking—the dosages may need to be changed. Check with your doctor or pharmacist before taking any new medicine while using the NICORETTE Inhaler.
How should I store the NICORETTE Inhaler?
When not in use always store mouthpiece and cartridges in the plastic case, out of reach of children and pets. Store cartridges at room temperature (15-30°C) and protect from light and humidity. If you keep cartridges in the car, be careful since car interiors can heat up quickly.
Keep the NICORETTE Inhaler out of the reach of children and pets. This product is not child resistant. The NICORETTE Inhaler can cause serious illness in children and pets—even in very small amounts. If a child chews or swallows NICORETTE Inhaler cartridges, call a doctor or Poison Control Center. After a cartridge is used, throw it away out of the reach of children and pets. Even used cartridges contain enough nicotine to seriously harm children and pets.
Staying smoke free
Take up an activity that might have been difficult—if not impossible—to do while you smoked. Join a health club, or start exercising at home. It can make you feel even better about yourself for quitting. Some other helpful tips:
Try to avoid alcohol, coffee and other beverages you associate with smoking.
Keep your hands occupied by playing with a pencil, paper clip, stress ball, etc.
Instead of smoking after meals, try brushing your teeth or going for a walk.
Try to avoid people or situations you associated with smoking—at least for a little while.
Each month, on the anniversary of your Quit Day, plan a special celebration.
You may also need additional help. This is nothing to be ashamed of, and your doctor or pharmacist will be able to recommend a self-help group or support program in your area.
Coping with relapse
If you do relapse, don't feel embarrassed or ashamed. Most people who successfully quit smoking do so after several attempts.
Most relapses occur within the first week or within the first three months after quitting, especially during situations you used to associate with smoking, like stress or when drinking alcohol. Knowing that these situations can be difficult can help you prepare for them or, better yet, avoid them in the first place. It's important to have the support of friends and family.
Information for the Patient
Nicotine is the active ingredient in Nicorette Inhaler (nicotine inhalation system). Nicorette Inhaler releases 4 mg of nicotine in the form of vapor when air is inhaled through the inhaler. Clinical studies have shown that nicotine replacement from nicotine containing products can help people give up smoking by relief of abstinence symptoms associated with smoking cessation.
The cardiovascular effects of nicotine include peripheral vasoconstriction, tachycardia, and elevated blood pressure. Acute and chronic tolerance to nicotine develops from smoking tobacco or ingesting nicotine preparations. Acute tolerance (a reduction in response for a given dose) develops rapidly (less than 1 hour), but not at the same rate for different physiologic effects (skin temperature, heart rate, subjective effects). Withdrawal symptoms such as cigarette craving can be reduced in most individuals by plasma nicotine levels lower than those achieved from smoking.
Withdrawal from nicotine in addicted individuals can be characterized by craving, nervousness, restlessness, irritability, mood lability, anxiety, drowsiness, sleep disturbances, impaired concentration, increased appetite, minor somatic complaints (headache, myalgia, constipation, fatigue), and weight gain. Nicotine toxicity is characterized by nausea, salivation, abdominal pain, vomiting, diarrhea, diaphoresis, flushing, dizziness, disturbed hearing and vision, confusion, weakness, palpitations, prostration, altered respiration and hypotension.
The major fraction of the nicotine in Nicorette Inhaler is deposited in the oral cavity. Continuous, rapid inhalation over 20 minutes releases up to 40% (4 mg) of the nicotine from each cartridge and about 50% of the released nicotine is systemically available, i.e. about 2 mg. Absorption of nicotine through the buccal mucosa is slow and does not produce the high and rapid nicotine plasma concentrations seen with cigarette smoking. Self-administration (ad lib. at clinical use) typically produces nicotine plasma levels of 6-8 ng/mL, which are only about 1/3 of those achieved with cigarette smoking. The plasma levels following clinical use correspond to once hourly chewing of Nicorette chewing gum 2 mg. One puff of 50 mL contains approximately 15 µg of nicotine. Maximal plasma concentrations are reached within 15 minutes after forced inhalation for 20 minutes.
Steady state plasma levels of approximately 20-25 ng/mL are achieved with continuous, rapid inhalations during 20 minutes per hour for 12 hours at ambient room temperature in a laboratory setting. The release of nicotine from the Nicorette Inhaler is temperature dependent. Average peak plasma nicotine concentrations achieved after forced inhalation were 22.5 ng/mL at 20°C, 29.7 ng/mL at 30°C and 34.0 ng/mL at 40°C.
The therapeutic blood concentrations of nicotine, i.e. the blood levels which relieve craving, are individual, based on the patient's nicotine dependence.
The volume of distribution following i.v. administration of nicotine is approximately 2 to 3 L/kg and the half-life ranges from 1 to 2 hours. The major eliminating organ is the liver, and average plasma clearance is about 1.2 L/min; the kidney and lung also metabolize nicotine. More than 20 metabolites of nicotine have been identified, all of which are believed to be less active than nicotine. The primary metabolite of nicotine is cotinine, which has a half-life of 15 to 20 hours and reaches concentrations that exceed those of nicotine by 10-fold. The plasma protein binding of nicotine is less than 5%. Other diseases or concomitant use of other drugs would not be expected to have a significant effect on nicotine kinetics. The primary urinary metabolites are cotinine (15% of the dose) and trans-3-hydroxycotinine (45% of the dose). About 10% of the nicotine is excreted unchanged in the urine. As much as 30% may be excreted in the urine with high urine flow rates and acidification below pH 5.
There are no differences in nicotine kinetics between men and women.
Pharmacokinetic differences due to age have not been identified.
Severe renal impairment would be expected to affect the clearance of nicotine and its metabolites. In smoking patients undergoing hemodialysis, elevated nicotine levels have been seen.
Nicorette Inhaler (nicotine inhalation system) is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms. Nicorette Inhaler provides the smoker with adequate amounts of nicotine to reduce the urge to smoke, and may provide some degree of comfort by providing a hand-to-mouth ritual similar to smoking, although the importance of such an effect in smoking cessation is, as yet, unknown. Nicorette Inhaler treatment should be used as part of a comprehensive behavioral smoking-cessation program.
Physicians should anticipate that the pharmacokinetics of certain concomitant medications may be altered by smoking cessation with or without nicotine replacement. Smoking is associated with increased CYP1A2 activity. Upon smoking cessation, reduced clearance of substrates for this enzyme may occur. This may lead to an increase in plasma levels for some medicinal products. Of potential clinical importance are products with a narrow therapeutic window, such as theophylline, tacrine and clozapine.
Upon smoking cessation, the plasma concentration of other medications, such as imipramine, olanzapine, clomipramine and fluvoxamine, which are partially metabolized by CYP1A2, may also be increased. However, data that supports this occurrence is not available, and its possible clinical significance is unknown.
The pharmacokinetics of nicotine have not been studied in the elderly or in patients with renal or hepatic impairment; however, given that nicotine is extensively metabolized and that its total systemic clearance is dependent on liver blood flow, some influence of hepatic impairment on drug kinetics (reduced clearance) should be anticipated. Only severe renal impairment would be expected to affect the clearance of nicotine or its metabolites from the circulation.
One hundred and thirty-two patients over the age of 60 participated in clinical trials of Nicorette Inhaler therapy. Nicorette Inhaler appeared to be as effective in this age group as in younger smokers. The initial dose in elderly patients may have to be adjusted because their concomitant diseases may increase risk.
Nicorette Inhaler has not been specifically studied in asthma or chronic obstructive pulmonary disease. Nicotine is an airway irritant and might cause bronchospasm. Nicorette Inhaler should be used with caution in patients with bronchospastic disease. Other forms of nicotine replacement might be preferable in patients with severe bronchospastic airway disease.
Nicorette Inhaler therapy should be used with caution in patients with hyperthyroidism pheochromocytoma, or insulin-dependent diabetes since nicotine causes the release of catecholamines by the adrenal medulla.
The patient should stop smoking completely when initiating Nicorette Inhaler therapy (nicotine inhalation system) (see Dosage). Patients should be informed that they should not continue to smoke while using Nicorette Inhaler, because they may experience adverse effects due to peak nicotine levels higher than those experienced from smoking alone. If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the Nicorette Inhaler dose should be reduced or treatment discontinued (see Warnings). The use of Nicorette Inhaler beyond 6 months by patients who stop smoking has not been studied and is not recommended.
A separate User Guide is included in the package of Nicorette Inhaler (see Information for the Patient). It contains important information on how to use and dispose of Nicorette Inhaler. Patients should be encouraged to ask questions to ensure they understand the instructions. Patients must be advised to keep both used and unused cartridges as well as the plastic Nicorette Inhaler out of the reach of children and pets.
Nicorette Inhaler therapy is likely to have a low abuse potential based on differences between it and cigarettes in three characteristics commonly considered important in contributing to abuse: much slower absorption causing a slower rise in blood nicotine levels, lower blood levels of nicotine and over time the amount of use/day declines. Nicorette Inhaler does not produce arterial concentrations similar to cigarettes.
The use of the inhaler beyond 6 months has not been evaluated in clinical trials and is not recommended. To minimize the risk of dependence, patients should be encouraged to withdraw gradually from Nicorette Inhaler therapy after 3 months of usage (see Dosage). If necessary, dose reduction can be achieved by gradual reduction of the dose over a 6 to 12 week period.
Nicorette Inhaler (nicotine inhalation system) consists of a mouthpiece and a plastic cartridge delivering 4 mg of nicotine from a porous polyethylene plug containing 10 mg nicotine. Nicotine is the active ingredient. Inactive components of the product are menthol, ethanol, and a porous plug which are pharmacologically inactive. Store at room temperature (15-30°C). Protect cartridges from light and humidity.
The use of Nicorette Inhaler (nicotine inhalation system) is contraindicated in the following:
Patients with hypersensitivity or allergy to nicotine or to menthol. Patients with acute hypersensitivity reactions should discontinue use of Nicorette Inhaler and should be advised of the possibility of acute hypersensitivity reactions to other forms of nicotine, including cigarettes;
Non-smokers or occasional smokers;
Persons under 18 years of age (see Warnings);
Pregnant women or nursing mothers (see Warnings); and
Patients during the immediate post-myocardial infarction period, patients with life-threatening arrhythmias, patients with severe or worsening angina pectoris and patients who have had a recent cerebral vascular accident (see Warnings).
Nicotine delays healing in peptic ulcer disease; therefore, Nicorette Inhaler therapy should be used with caution in patients with active peptic ulcers and only when the benefits of including nicotine replacement in a smoking-cessation program are considered to outweigh the risks.
The safety of Nicorette Inhaler therapy in nursing infants has not been examined. Nicotine passes freely into breast milk; the milk to plasma ratio averages 2.9. Nicotine is absorbed orally (see Contraindications). Nicotine concentrations in milk can be expected to be lower with Nicorette Inhaler when used as recommended than with cigarette smoking, as plasma nicotine concentrations are generally reduced with nicotine replacement. The risk of exposure of the infant to nicotine from Nicorette Inhaler therapy should be weighed against the risk associated with the infant's exposure to nicotine from continued smoking by the mother (passive smoke exposure and contamination of breast milk with other components of tobacco smoke).
The risks of nicotine replacement in patients with certain cardiovascular and peripheral vascular diseases should be weighed against the benefits of including nicotine replacement in a smoking cessation program for them. Specifically, patients with coronary heart disease (history of myocardial infarction and/or angina pectoris), serious cardiac arrhythmias, or vasospastic diseases (Buerger's disease, Prinzmetal's variant angina) should be carefully screened and evaluated before nicotine replacement is recommended.
Palpitations have been reported occasionally with the use of Nicorette Inhaler as well as with other nicotine replacement therapies. No serious cardiovascular events were reported in clinical studies with Nicorette Inhaler, but if such symptoms occur, its use should be discontinued.
Nicotine from any source can be toxic and addictive. For any smoker, with or without concomitant disease, 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.
Tobacco smoke, which has been shown to be harmful to the fetus, contains nicotine, hydrogen cyanide, and carbon monoxide. The Nicorette Inhaler does not deliver hydrogen cyanide and carbon monoxide. However, nicotine has been shown in animal studies to cause fetal harm. It is therefore presumed that Nicorette Inhaler can cause fetal harm when administered to a pregnant woman. The effect of nicotine delivery by Nicorette Inhaler has not been examined in pregnancy (see Contraindications). Therefore, pregnant smokers should be encouraged to attempt cessation using educational and behavioral interventions before using pharmacological approaches.
Women of child-bearing potential should be advised to take adequate precautions to avoid becoming pregnant while using the Nicorette Inhaler.
Nicorette Inhaler therapy should be used with caution in these patients and only when the benefits of including nicotine replacement in a smoking-cessation program outweigh the risks.
Nicorette Inhaler is not to be used by persons under 18 years of age. The use of Nicorette Inhaler in children and adolescents who smoke has not been evaluated (see Contraindications). However, no specific medical risk is known or expected in nicotine dependent adolescents. Nicorette Inhaler should be used for the treatment of tobacco dependence in the older adolescent only if the potential benefit justifies the potential risk.
The amounts of nicotine that are tolerated by adult smokers can cause severe poisoning if a child or pet swallows, chews or sucks on the nicotine cartridge. The risk of poisoning also exists if a child sucks on an inhaler containing the nicotine cartridge. Therefore, patients should be cautioned to keep both the used and unused Nicorette Inhaler (nicotine inhalation system) out of the reach of children and pets.
All components of the Nicorette Inhaler system should also be kept out of the reach of children and pets to avoid accidental swallowing and choking.
Nicorette Inhaler (nicotine inhalation system) and the placebo were both associated with local irritant side effects occurring most often in the early stages of treatment. The most frequent complaints from local side effects were cough, irritation in throat, pharyngitis, stomatitis and rhinitis. Overall, these complaints were rated as mild. Coughing was reported by 27% in the active group and by 8% in the placebo group, irritation in the throat was reported by 24% active versus 7% placebo, pharyngitis by 15% active versus 8% placebo, stomatitis by 15% active and 8% placebo, and rhinitis by 18% active and 13% placebo (see Table 1). The frequency of cough, and mouth and throat irritation declined with continued use of Nicorette Inhaler.
Symptoms of withdrawal were common in both active and placebo groups. Common withdrawal symptoms seen in over 3% of patients on active drug included dizziness, anxiety, sleep disorder and depression.
A complete overview of spontaneous adverse drug event reports from the market since the introduction of the Nicorette Inhaler in many countries worldwide has not revealed any change in the adverse drug event profile nor the incidence of adverse drug events.
Adverse Event Inhaler Treatment Groups Nicorette Inhaler (% )
Systemic Effects Headache 190 (26) 143 (20) Dyspepsia 100 (14) 54 (8) Nausea 72 (10) 47 (7) Chest Pain 35 (5) 20 (3) Diarrhea 31 (4) 19 (3) Flatulence 31 (4) 17 (2) Vomiting 16 (2) 5 (1) Dyspnea 14 (2) 10 (1) Hiccup 14 (2) 1 (0.1) Thirst 12 (2) 6 (1) Local Effects Coughing 199 (27) 62 (8) Throat Irritation 178 (24) 51 (7) Pharyngitis 111 (15) 59 (8) Stomatitis 110 (15) 56 (8) Rhinitis 135 (18) 90 (13) Sinusitis 57 (8) 50 (7) Mouth Dry 53 (7) 45 (6) Local Paresthesia 33 (4) 6 (1) Gingival Irritation 13 (2) 7 (1)
Signs and symptoms of an overdose from a Nicorette Inhaler (nicotine inhalation system) are expected to be the same as those of acute nicotine poisoning, including: pallor, cold sweat, nausea, salivation, vomiting, abdominal pain, diarrhea, flushing, palpitations, headache, dizziness, disturbed hearing and vision, tremor, mental confusion and weakness. Prostration, hypotension, and respiratory failure may ensue with large overdoses. Lethal doses of nicotine produce convulsions quickly and death follows as a result of peripheral or central respiratory paralysis or, less frequently, cardiac failure. The acute, minimal, oral lethal dose of nicotine in human adults is believed to be 40 to 60 mg (<1 mg/kg). Much lower doses have been reported to be toxic in children. The effects of using several cartridges in rapid succession are unknown. One cartridge of Nicorette Inhaler contains 10 mg nicotine, of which, approximately 4 mg is delivered nicotine. It is unlikely that an excessive nicotine overdose will occur via inhalation, but should such an overdose occur, the signs would be that of acute nicotine poisoning.
Nicorette Inhaler should be stopped immediately if the patient shows signs of overdosage and the patient should seek immediate medical care by contacting a physician or local poison-control centre. Persons ingesting nicotine cartridges should be referred to a health care facility for management. Due to the possibility of nicotine-induced seizures, activated charcoal should be administered. In unconscious patients with a secure airway, instill activated charcoal via a nasogastric tube. Repeated doses of activated charcoal should be administered as long as the cartridge remains in the gastrointestinal tract since it will continue to release nicotine for many hours. The Nicorette Inhaler cartridges can be identified with a radiogram. A saline cathartic or sorbitol added to the first dose of activated charcoal may speed gastrointestinal passage of the cartridge.
Other supportive measures include diazepam or barbiturates for seizures, atropine for excessive bronchial secretions or diarrhea, respiratory support for respiratory failure, and vigorous fluid support for hypotension and cardiovascular collapse.
Most patients will need to gradually discontinue the use of Nicorette Inhaler after the initial treatment period. Gradual reduction of the dose may begin after 12 weeks of initial treatment and may last for up to 12 weeks. Recommended strategies for discontinuing use include suggesting to patients that they use the product less frequently, keeping a tally of daily usage, trying to meet a steadily reducing target or setting a planned quit date for stopping use of the product. Some patients may not require gradual reduction of dosage and may abruptly stop treatment successfully. The safe use of this product for longer than 6 months has not been established.
Smoking cessation should be accompanied by a behavioral support program.
For best results, patients should be encouraged to use at least 6 cartridges per day at least for the first 3 to 6 weeks of treatment. In clinical trials, the average daily dose was >6 cartridges for patients who successfully quit smoking. Additional doses may be needed to control the urge to smoke with a maximum of 12 cartridges daily for up to 12 weeks. Regular use of Nicorette Inhaler during the first week of treatment may help patients adapt to the irritant effects of the product.
Dosage can be adjusted in those patients with signs or symptoms of nicotine withdrawal or excess. The symptoms of nicotine withdrawal overlap those of nicotine excess. Since patients using the Nicorette Inhaler may also smoke intermittently, it is sometimes difficult to determine if they are experiencing nicotine withdrawal or nicotine excess. Controlled clinical trials of nicotine products suggest that palpitations, nausea and sweating are more often symptoms of nicotine excess, whereas anxiety, nervousness and irritability are more often symptoms of nicotine withdrawal.
In order to ensure optimal efficacy and safety of the Nicorette Inhaler, patients should be advised to use the Nicorette Inhaler only at room temperature (15-30°C).
After using the Nicorette Inhaler, carefully separate the mouthpiece and remove the used cartridge. The used cartridge should be disposed of immediately in such a way as to prevent its access by children or pets (see Information for the Patient leaflet for further directions on handling and disposal). The mouthpiece is reusable and should be cleaned regularly with soap and water.