Pronunciation:

NIK-oh-teen

Brand Names:

• Nicotrol
• Nicorette Inhaler

Dosage Forms:

• Device

Classifications:

Therapeutic—

Smoking Cessation Agent

Pharmacologic—

Cholinergic System

Uses of This Medicine:

Nicotine inhaler is used to help you stop smoking. Nicotine is absorbed in the mouth and throat and enters the blood stream. This replaces the nicotine you would get from smoking and makes the withdrawal effects from not smoking less severe. The amount of nicotine is decreased over time until use is stopped.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of inhaled nicotine in the pediatric population. Safety and efficacy have not been established. Small amounts of nicotine can cause serious unwanted effects in children, and the inhaler contains enough nicotine to cause problems, including used cartridges.

Older adults—

Although appropriate studies on the relationship of age to the effects of inhaled nicotine have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving inhaled nicotine.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

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 taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Tegafur

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (severe chest pain) or
• Asthma or
• Breathing problems or
• Buerger disease (circulation problem) or
• Diabetes (insulin-dependent) or
• Heart rhythm problems (eg, arrhythmia) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Pheochromocytoma (adrenal problem) or
• Raynaud disease (circulation problem) or
• Stomach ulcer or
• Tachycardia (fast heart rate)—Use with caution. May make these conditions worse.

• Heart attack, history of or
• Heart or blood vessel disease—Use with caution. May cause side effects to become worse.

• Kidney disease, severe or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine should come with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

You should stop smoking completely before you start using this medicine. Do not use any tobacco products during therapy. If you continue to smoke with the inhaler, you may have serious unwanted effects from nicotine.

It is also important to use a stop-smoking program that may include education, counseling, and psychological support. This may make it easier for you to stop smoking.

To use:

• The inhaler comes with a plastic mouthpiece and cartridges (small tubes) of nicotine. The cartridges are inserted into the mouthpiece.
• Use the inhaler at a room temperature above 60 degrees F.
• After inserting the cartridge, inhale or puff through the mouthpiece. The cartridge will last about 20 minutes with active puffing.
• When the cartridge is empty, take it out of the mouthpiece. Throw it away where children and pets cannot reach it.
• The mouthpiece can be reused. Wash it regularly with soap and water. Store it in the original plastic storage case.

Dosing—

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral inhalation dosage form (cartridge):
  • To help you stop smoking:
    • Adults—At first, use 6 cartridges per day. Your doctor may adjust the dose based on the number of cigarettes you smoke per day or based on how well you tolerate the medicine. However, the total dose is usually not more than 16 cartridges per day. Your dose will be gradually reduced before stopping treatment completely.
    • Children—Use is not recommended.

Storage—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

When the cartridge is empty, take it out of the mouthpiece. Throw it away where children and pets cannot reach it.

The mouthpiece can be reused. Wash it regularly with soap and water. Store it in the original plastic storage case.

Precautions While Using This Medicine:

Do not smoke or use any tobacco products with the inhaler. If you continue to smoke or chew tobacco, you may have serious unwanted effects from nicotine. Call your doctor right away if you have dizziness, headaches, an upset stomach, drooling, vomiting, diarrhea, cold sweats, blurred vision, trouble hearing, confusion, fainting, or weakness.

Do not use any other nicotine products with the inhaler. This includes nicotine patches, lozenges, or gum. You may have serious unwanted effects if you use more than one nicotine product.

Pregnant women should only use this medicine as directed by a doctor. Cigarette smoke can seriously harm your child. Try to stop smoking without using medicine. The risks to your child from this medicine are not fully known.

Nicotine products must be kept out of the reach of children and pets. Small amounts of nicotine can cause serious unwanted effects in children, and a used cartridge may contain enough nicotine to cause problems. If the cartridge is touched by a child, contact your doctor or poison control center at once.

During the first week, your mouth or throat may feel irritated. Do not stop using the medicine. If you continue to use the inhaler, you should adjust to these effects. If the irritation does not get better after several weeks, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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 immediately 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

skin rash, itching, or hives

tearing of the eyes

tightness in the chest

trouble breathing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Cold sweat

confusion

convulsions (seizures)

diarrhea

dizziness

drooling

hearing and vision changes

nausea and vomiting

pale skin

stomach pain

tremors

weakness

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

coughing

heartburn

indigestion

mouth and throat irritation

stomach discomfort, upset, or pain

stuffy nose

Less common

Anxiety

back pain

change in taste

depression

diarrhea

dizziness

feeling of burning, numbness, tightness, tingling, warmth, or heat

hiccups

muscle pain

pain in the jaw and neck

passing of gas

teeth problems

trouble sleeping

unusual tiredness or weakness

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.