In the U.S.—

• Smoking cessation adjunct

Nicotine ( NIK-oh-teen) , in an inhaler, is used to help you stop smoking. It is used for up to 6 months as part of a stop-smoking program. This program may include counseling, education, specific behavior change techniques, or support groups.

With the inhaler, nicotine is inhaled through the mouth and is absorbed in the mouth and throat, but not in the lungs. Eight to ten puffs on the inhaler provide about the same amount of nicotine as one puff on an average cigarette. This nicotine takes the place of the nicotine that you would otherwise get from smoking. In this way, the withdrawal effects of not smoking are less severe. Then, as your body adjusts to not smoking, the use of the nicotine inhaler is decreased gradually over several weeks. Finally, use is stopped altogether.

This medicine is available only with your doctor's prescription, in the following dosage form:

Inhalation
• Cartridges for inhalation (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For nicotine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to nicotine or to menthol. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Nicotine, whether from smoking or from the inhaler, is not recommended during pregnancy. Studies in animals have shown that nicotine can cause harmful effects in the fetus.

Breast-feeding—Nicotine passes into breast milk and may cause unwanted effects in the baby. It may be necessary for you to stop breast-feeding during treatment.

Children—Small amounts of nicotine can cause poisoning in children. Even used nicotine inhaler cartridges contain enough nicotine to cause serious harm in children. Also, the cartridges are small enough that they can cause choking if they are swallowed.

Older adults—This medicine has been tested in a limited number of patients 60 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using the nicotine inhaler, it is especially important that your health care professional know if you are taking any of the following medicines:

• Theophylline (e.g., Theo-Dur) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Norpramin], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—Stopping smoking may change the effects of these medicines; the amount of medicine you need to take may change

• Asthma or other breathing problems or
• Heart or blood vessel disease or
• High blood pressure or
• Liver disease or
• Overactive thyroid or
• Pheochromocytoma or
• Stomach ulcer or
• Type 1 diabetes mellitus (sugar diabetes)—Nicotine may make the condition worse

The nicotine inhaler usually comes with patient directions. Read the directions carefully before using this medicine.

The nicotine inhaler should be used at or above room temperature (60 °F [16 °C]). Cold temperatures decrease the amount of nicotine you inhale.

It is important to participate in a stop-smoking program during treatment. This may make it easier for you to stop smoking.

To decrease the risk of becoming dependent on the nicotine inhaler, your doctor may instruct you to stop treatment gradually. This may be done by keeping track of, and steadily reducing, use of the nicotine inhaler or by setting a planned date for stopping use of the inhaler.

Dosing—

The dose of nicotine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of nicotine. If your dose is different, do not change it unless your doctor tells you to do so.

• For cartridge for inhalation dosage form:
  • To help you stop smoking:
    • Adults and older teenagers—At first, the dose is 6 to 16 cartridges per day for up to twelve weeks. Then the dose is gradually reduced over a period of up to twelve weeks.
    • Children—Use and dose must be determined by your doctor.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Do not smoke during treatment with the nicotine inhaler because of the risk of nicotine overdose.

Do not use the nicotine inhaler for longer than 6 months if you have stopped smoking because continuing use of nicotine in any form can be harmful and addictive.

Nicotine should not be used in pregnancy. If there is a possibility you might become pregnant, you may want to use some type of birth control. If you think you may have become pregnant, stop taking this medicine immediately and check with your doctor.

Nicotine products must be kept out of the reach of children and pets. Even used nicotine inhaler cartridges contain enough nicotine to cause serious harm in children. If a child chews on or swallows a cartridge, contact your doctor or poison control center at once.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Less common
  • Fast or irregular heartbeat;  fever with or without chills;  headache;  nausea with or without vomiting;  runny nose;  shortness of breath, tightness in chest, trouble in breathing, or wheezing;  skin rash, itching, or hives;  tearing of eyes 
  
  

• Symptoms of overdose
  • Abdominal or stomach pain;  cold sweat ;  confusion;  convulsions (seizures);  disturbed hearing and vision;  drooling;  extreme exhaustion;  pale skin;  slow heartbeat;  tremors 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Coughing;  indigestion;  mouth and throat irritation;  stuffy nose 
  
  

• Less common
  • Anxiety;  back pain;  change in taste;  diarrhea;  dizziness;  feeling of burning, numbness, tightness, tingling, warmth or heat;  feelings of drug dependence ;  flu-like symptoms;  general pain;  hiccups;  mental depression ;  pain in jaw and neck;  pain in muscles;  passing of gas;  problems with teeth;  trouble in sleeping;  unusual tiredness or weakness 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.