Nicotine Replacement Therapy

Nicotine is the chief alkaloid in tobacco products and the ingredient that makes cigarettes addictive.

Nicotine replacement therapy (NRT) products deliver a controlled amount of nicotine without the tar, carbon monoxide, and other toxins found in cigarette smoke. Nicotine gum, lozenges, and skin patches are available over the counter as stop-smoking aids. Nicotine nasal spray is available only on prescription.

All of these products reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking. The nasal spray is licensed as an aid to smoking cessation for the relief of nicotine withdrawal symptoms, and should be used as part of a comprehensive behavioural smoking cessation program.

Nicotine replacement is only part of a complete stop-smoking program. All of these products work best alongside counselling, a support plan, or other behaviour change techniques.

These warnings apply to all nicotine replacement products unless a particular form is named. Always check the label of the product you are using. The symptoms that mean you should stop using a product are listed in the Nicotine side effects section below.

Do not keep smoking

• Stop smoking completely on the day you start treatment.
• Do not smoke or use any other tobacco or nicotine product during treatment — nicotine overdose can occur.
• Use only one nicotine product at a time, unless a healthcare provider has told you otherwise.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, only use nicotine replacement on the advice of your health care provider.
• Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine.
• These medicines are believed to be safer than smoking, but the risks to your child from them are not fully known.
• Nicotine passes freely into breast milk.

Ask a doctor before use if you have

• heart disease, a recent heart attack, or an irregular heartbeat. Nicotine can increase your heart rate
• high blood pressure not controlled with medication. Nicotine can increase your blood pressure
• a stomach ulcer or diabetes
• a history of seizures
• a sodium-restricted diet (gum and lozenges only)
• an allergy to adhesive tape, or skin problems that make rashes more likely (patch only)

Ask a doctor or pharmacist before use if you are

• using a non-nicotine stop smoking drug
• taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted

Keep out of reach of children and pets

• Used and unused gum, lozenges, patches, and spray bottles all hold enough nicotine to make a child or pet sick, and can be fatal.
• Wrap used gum or lozenges in paper and throw them in the trash.
• Fold used patches sticky sides together and put them back in the pouch.
• Replace the cap on empty spray bottles. Even empty bottles contain enough nicotine to seriously harm children and pets.
• In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Children and teenagers

• If you are under 18, ask a doctor before use. No studies have been done to show whether these products work in this age group.
• Nicotine nasal spray is not recommended for children or adolescents, because its safety and effectiveness have not been evaluated in them.
• These products are not for sale to people under 18, and proof of age is required.

Extra warnings for the skin patch

• Remove the patch at bedtime if you get vivid dreams or other sleep disturbances.
• Remove the patch before any MRI scan, to avoid possible burns.
• Do not wear more than one patch at a time, and do not cut a patch into smaller pieces.

Extra warnings for the nasal spray

• Tell your doctor if you have chronic nasal problems (nasal allergies, inflammation, sinusitis, or nasal polyps), heart problems, high blood pressure, stomach ulcers or heartburn, wheezing or asthma, an overactive thyroid, diabetes requiring insulin, kidney or liver disease, or drug allergies.
• Tell your doctor about every medicine you take, as doses may need to be changed, and check before starting any new medicine.
• The spray can be habit-forming. Use it only for as long as you need it to stop smoking, as directed by your doctor. The chance of becoming dependent on it rises if you use it for longer than 6 months.
• Do not use it if you are allergic to nicotine or to any ingredient in the product.
• It is not recommended in severe reactive airway disease, during labour and delivery, or in children and teenagers.
• It generally should not be used in the period straight after a heart attack, or if you have serious arrhythmias or severe or worsening angina.

Ingredients to be aware of

• 4 mg lozenges contain 5.1 mg of phenylalanine per lozenge. Check the label if you have phenylketonuria (PKU).
• Each lozenge also contains 17 mg of sodium and 1 g of mannitol.
• Each 4 mg piece of gum contains 94 mg of calcium and 13 mg of sodium.

Get emergency medical help if you have signs of an allergic reaction to nicotine: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using any nicotine product and speak to a doctor if you get symptoms of an allergic reaction, such as difficulty breathing or a rash.

Stop use and ask a doctor if you develop:

• an irregular heartbeat or palpitations occur
• symptoms of nicotine overdose, such as nausea, vomiting, dizziness, diarrhea, weakness, and a rapid heartbeat
• symptoms of an allergic reaction, such as difficulty breathing or a rash.

And for particular forms:

• Gum: mouth, teeth, or jaw problems occur
• Lozenge: mouth problems occur, or persistent indigestion or a severe sore throat occurs
• Patch: skin redness caused by the patch does not go away after four days, or your skin swells, or you get a rash

Common side effects of gum and lozenges

Nicotine gum and lozenges can occasionally cause:

• mouth or throat irritation
• hiccups
• heartburn, nausea, or other stomach upset
• headaches
• dizziness.

These are more likely if you use pieces one straight after another, or if you chew or swallow a lozenge instead of letting it dissolve.

Common side effects of the skin patch

Skin reactions are the most common problem. Stop using the patch and ask a doctor if redness does not go away after four days, your skin swells, or you get a rash.

Vivid dreams and other sleep disturbances also occur. If they do, you can remove the patch at bedtime and apply a new one in the morning.

Common side effects of the nasal spray

During the first week or so, most people experience the following side effects:

• hot, peppery feeling at the back of the throat or nose
• sneezing
• coughing
• watery eyes
• runny nose.

Wait 5 minutes before driving. Be sure to use regularly for the first week to help adjust to the side effects. Side effects will lessen for most people in a few days. Don't stop using the Nasal Spray. If side effects do not lessen after a week, call your doctor.

In clinical trials, nasal irritation affected nearly all patients (94%) in the first 2 days and most (81%) at 3 weeks, becoming milder with continued use.

Some of what you feel after quitting is nicotine withdrawal rather than an effect of the product. Nicotine replacement reduces these symptoms but may not eliminate them entirely. Withdrawal symptoms may include:

• unexpected craving or urges for cigarettes
• anxiety, irritability, restlessness, mood changes, nervousness
• drowsiness
• trouble concentrating
• increased appetite and weight gain
• headaches, muscular pain, constipation, fatigue.

Withdrawal symptoms can begin almost at once after you stop smoking and are normally at their strongest during the first three or four days. Your smoker's cough may get worse before it improves.

Palpitations, nausea, and sweating are more often symptoms of too much nicotine, whereas anxiety, nervousness, and irritability are more often symptoms of nicotine withdrawal.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Start using your nicotine product on your quit day, and stop smoking completely. Read the User's Guide or self-help guide that comes in the pack for complete directions. It is important to complete treatment. If you feel you need to use the product for a longer period to keep from smoking, talk to your health care provider.

Choosing your starting strength (gum and lozenges)

• If you smoke your first cigarette more than 30 minutes after waking up, use the 2 mg gum or lozenge.
• If you smoke your first cigarette within 30 minutes of waking up, use the 4 mg gum or lozenge.

Nicotine gum

• Nicotine gum is a medicine and must be used a certain way to get the best results
• Chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.
• Repeat this process until most of the tingle is gone (about 30 minutes)
• Do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
• To improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
• if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
• Do not use more than 24 pieces a day
• It is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

Nicotine lozenges

• Nicotine lozenge is a medicine and must be used a certain way to get the best results
• Place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge.
• You may feel a warm or tingling sensation
• Occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes)
• Do not eat or drink 15 minutes before using or while the lozenge is in your mouth
• To improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks
• Do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects
• Do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
• It is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

The lozenge is designed to deliver nicotine through the lining of your mouth, not through your stomach, which is why swallowing should be kept to a minimum. The User's Guide notes that most people get used to the taste after a day or two.

Nicotine skin patch (transdermal system)

Choose your starting step based on how much you smoke:

• Apply one new patch every 24 hours on skin that is dry, clean and hairless
• Remove backing from patch and immediately press onto skin. Hold for 10 seconds.
• Wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.
• The used patch should be removed and a new one applied to a different skin site at the same time each day
• If you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning
• Do not wear more than one patch at a time
• Do not cut patch in half or into smaller pieces
• Do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours
• To avoid possible burns, remove patch before undergoing any MRI (magnetic resonance imaging) procedures
• It is important to complete treatment. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

Patches are supplied in child-resistant pouches. Do not use if the individual pouch is open or torn.

Nicotine nasal spray (prescription)

Each actuation of the spray delivers about 0.5 mg of nicotine. One dose is 1 mg of nicotine (two sprays, one in each nostril).

• Use as directed by your doctor. Treatment is usually started at 1 or 2 doses per hour and adjusted by your doctor.
• Using at least 8 doses per day is recommended, because less is unlikely to be effective. But do not use more than 5 times an hour or 40 times in 24 hours.
• The recommended duration of treatment is 3 months, and use beyond 6 months is not recommended.
• Stop smoking completely during the Nicotrol NS treatment program.

Prime pump (before first use): Get a tissue or paper towel. Hold the bottle. Press up onto the bottom with your thumb. Pump into tissue until you see a fine spray (6 to 8 times). Throw the tissue away.

Follow directions exactly:

• Blow your nose if it is not clear.
• Tilt your head back slightly.
• Insert the tip of bottle into your nostril as far as is comfortable.
• Breathe in through your mouth.
• Spray once in each nostril. Do not sniff or inhale while spraying.
• If your nose runs, gently sniff to keep the Nasal Spray in your nose. Wait 2 or 3 minutes before blowing your nose.
• Place the cap back on the bottle after use.
• If you don't use the Nasal Spray for 24 hours, prime in a tissue 1 or 2 times.

Avoid contact with skin, eyes, and mouth. If the bottle breaks, wear rubber gloves, wipe up with a paper towel, and wash surfaces thoroughly. Do not let nicotine come in contact with your skin, mouth, or eyes. If it does, rinse with plain water immediately. Nicotine overdose can occur when nicotine is absorbed through the skin.

The leaflet advises waiting 5 minutes before driving after using the spray, because of the peppery, watery-eyed effects most people get in the first week.

Nicotine gum, lozenges, and nasal spray are used as needed, so you are not likely to miss a dose. Do not take extra to make up for a missed dose, and do not exceed the daily maximum for your product (24 pieces of gum, 20 lozenges, or 40 doses of nasal spray).

If you forget to change your patch, apply a new one as soon as you remember and go back to your usual once-daily schedule. Do not wear more than one patch at a time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. The amount of nicotine in a used or unused lozenge, piece of gum, or patch can be fatal to a child or pet who chews, sucks or swallows it. Even an empty nasal spray bottle contains enough nicotine to seriously harm children and pets. Suspected nicotine poisoning in a child should be treated as a medical emergency.

Symptoms of nicotine overdose listed on the patient labelling include nausea, vomiting, dizziness, diarrhea, weakness, and rapid heartbeat. The nasal spray leaflet lists bad headaches, dizziness, upset stomach, drooling, vomiting, diarrhea, cold sweat, a weak and irregular pulse, blurred vision, hearing difficulties, mental confusion, and weakness and fainting.

• Do not eat or drink anything in the 15 minutes before using gum or a lozenge, or while it is in your mouth.
• Do not chew one piece of gum straight after another, or use more than one lozenge at a time — this can cause hiccups, heartburn, or nausea.
• Do not sniff, swallow, or inhale as you use the nasal spray, and take care not to spray your eyes.
• Do not cut a patch, wear more than one, or leave one on for longer than 24 hours.

Ask a doctor or pharmacist before using any nicotine product if you are:

• using a non-nicotine stop smoking drug (such as bupropion or varenicline)
• taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted

Quitting smoking itself, with or without nicotine replacement, changes how your body handles several medicines, because tobacco smoke induces liver enzymes. The Nicotrol NS prescribing information lists these:

For the nasal spray specifically, absorption is slightly reduced and delayed in people with a cold or rhinitis, and using a nasal decongestant spray such as xylometazoline delays it further.

This list is not complete. Other drugs may interact with nicotine, including prescription and over-the-counter medicines, vitamins, and herbal products.

• Gum: store at 20–25°C (68–77°F) and protect from light. Wrap used pieces of gum in paper and throw away in the trash.
• Lozenges: store at 20–25°C (68–77°F). Keep the vial tightly closed and protect from light. If you need to remove a lozenge, wrap it in paper and throw away in the trash.
• Patches: store at 20–25°C (68–77°F). Save the pouch to use for patch disposal, and dispose of used patches by folding the sticky ends together and putting them in the pouch.
• Nasal spray: store at room temperature, 15–30°C (59–86°F), out of reach of children. Dispose of used bottles with their child-resistant caps in place, where children and pets cannot reach them.

Keep both used and unused nicotine products out of the reach of children and pets.