Nicotine, Inhalation

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KEY POINTS

• This medicine is inhaled by mouth to help you stop smoking. Use it exactly as directed.
• You must stop smoking completely when you start using this medicine, and you must not smoke while using the medicine. Smoking while using this medicine may cause an overdose of nicotine with unpleasant side effects.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: smoking deterrent

Generic and brand names: nicotine inhalation; Nicotrol Inhaler

What is this medicine used for?

This product is used to help you stop smoking. It provides relief from the symptoms of nicotine withdrawal you feel when you first stop smoking and helps lessen the urge to smoke.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Asthma, COPD, or other lung disease
• Diabetes
• Gastric reflux disease (GERD)
• Heart disease or a recent heart attack
• High blood pressure
• Liver or kidney disease
• Pheochromocytoma (tumor of the adrenal gland)
• Thyroid problems
• Ulcers

Tell your healthcare provider if you continue to smoke, chew tobacco, use snuff, or use other products that contain nicotine.

Females of childbearing age: Tell your healthcare provider if you are pregnant or breast-feeding. Nicotine from any source can harm the baby. Do not become pregnant while using this medicine. If you become pregnant, contact your healthcare provider. This treatment is not recommended during pregnancy or while breast-feeding. If you are pregnant or breast-feeding, do not use this medicine unless your healthcare provider approves. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine.

How do I use it?

You must stop smoking completely when you start using this medicine, and you must not smoke while using the medicine. Smoking while using this medicine may cause an overdose of nicotine with unpleasant side effects.

If you have tried to stop smoking using another form of nicotine replacement therapy and have not had any success, ask your healthcare provider if this medicine is right for you. Do not use this medicine with any other form of nicotine, because you may overdose.

Use this medicine exactly as your healthcare provider prescribes. Do not use more or use it longer than prescribed. An instruction sheet is included in the package of this medicine. Read the information carefully. Ask your healthcare provider or pharmacist about anything you do not understand.

Check the label on the medicine for directions about your specific dose. Large amounts of nicotine can cause nausea, vomiting, diarrhea, cold sweats, and severe side effects that can affect your hearing, vision, mental state, and breathing. Also, an overdose may cause convulsions and even death. Follow your healthcare provider's directions exactly.

Check with your healthcare provider before using this medicine in children under age 18.

Begin using this medicine on your quit day. Carefully read and follow the directions that come in the package of medicine for how to use this medicine. Use the number of cartridges your healthcare provider prescribes. The number of cartridges you need depends on the number of cigarettes you smoked before you began this treatment. Usually you will need at least 6 cartridges a day for the first 3 to 6 weeks of treatment. Each cartridge lasts for about 20 minutes of constant puffing. Do not use more than 16 cartridges each day unless directed to do so by your healthcare provider.

You may gradually reduce the number of cartridges you use each day until your craving for nicotine is gone.

Follow directions in the medicine package for how to care for the mouthpiece and safely store the medicine.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, diarrhea, stomach pain, cold sweat, headache, dizziness, trouble seeing or hearing, confusion, restlessness, fast or irregular heartbeat, chest pain, drooling, coma.

What should I watch out for?

Caution: Nicotine can poison children and pets. Keep used and unused nicotine in a safe place out of the reach of children. Dispose of the medicine safely.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

When you stop smoking, there may be a change in how certain medicines work for you. Talk to your healthcare provider if you are taking medicine that reduces the chance of blood clots, bronchodilators, or diabetes medicines.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Signs of nicotine overdose (pale skin, cold sweats, nausea, increased saliva, vomiting, diarrhea, severe headache, dizziness, confusion, weakness, very slow or very fast heartbeat, irregular heartbeat, severe nervousness, trouble breathing, trouble seeing or hearing, seizures).

Other: Mild irritation of the mouth, throat, and nose; runny nose; cough; mild nausea; change in sense of taste; mild headache; back pain; hiccups.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Also, when you stop smoking and start using any nicotine replacement products, the dosage of some medicines you may have been taking may need adjustment. Talk to your healthcare provider if you are taking:

• Adenosine (Adenocard)
• Alpha blockers such as doxazosin (Cardura), prazosin (Minipress), and terazosin
• Antianxiety medicines such as chlordiazepoxide, diazepam (Valium), and oxazepam
• Antiarrhythmic medicines (to treat irregular heartbeat) such as flecainide and mexiletine
• Antidepressants such as amitriptyline, desipramine (Norpramin), fluvoxamine (Luvox), imipramine (Tofranil), and nortriptyline (Pamelor)
• Antipsychotic medicines such as clozapine (Clozaril, FazaClo) and olanzapine (Zyprexa)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Caffeine in food, drinks, or medicines
• Cancer medicines such as erlotinib (Tarceva) and irinotecan (Camptosar)
• Cimetidine (Tagamet)
• Decongestants such as oxymetazoline (Afrin, Dristan), phenylephrine (Neo-Synephrine, Sudafed PE), and pseudoephedrine (Sudafed)
• Doxepin (Silenor)
• Furosemide (Lasix)
• Insulin
• Medicines to treat breathing or lung problems such as aminophylline and theophylline
• Migraine medicines such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar), and methylergonovine
• Other medicines or products to help you stop smoking
• Pentazocine (Talwin)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Varenicline (Chantix)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.