Nicotrol (Inhalation)

Nicotine inhaler is used to help you stop smoking. Nicotine is taken in through the mouth and throat and goes into the bloodstream. This replaces the nicotine you would get from smoking and reduces the withdrawal effects from not smoking. The amount of nicotine is decreased over time until you stop using it.

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

Do not smoke or use any tobacco products with the inhaler. If you keep smoking or chewing tobacco, you may experience serious unwanted effects from nicotine. Call your doctor immediately 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 face 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 greatly harm your child. Try to stop smoking without using medicine. The risks to your child from this medicine are not completely understood.

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 have enough nicotine to cause problems. If a child touches the cartridge, contact your doctor or poison control center immediately.

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

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

In deciding to use a medicine, you and your doctor must consider the risks and benefits of the medicine. For this medicine, think about the following:

Allergies

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

Pediatric

Appropriate studies have not been performed on how inhaled nicotine affects children. Safety and effectiveness 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.

Geriatric

Although appropriate studies on the effects of inhaled nicotine in older adults have not been done, there have been no specific problems documented for this age group. However, older patients are more likely to have age-related kidney, liver, or heart issues, which may require caution and a dose adjustment for patients using inhaled nicotine.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. An alternative to this medication should be prescribed, or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Certain medicines should not be used together at all, but in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to change the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when using this medicine. The following interactions have been highlighted based on their potential importance and are not necessarily all-inclusive.

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

• Tegafur

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Angina (severe chest pain) or
• Asthma or
• Breathing problems or
• Buerger disease (circulation problem) or
• Diabetes (insulin-dependent) or
• Heart rhythm problems (e.g., 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 worsen these conditions.

• History of heart attack or
• Heart or blood vessel disease—Use with caution. May worsen side effects.

• Severe kidney disease or
• Liver disease—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

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.

In the U.S.

• Nicotrol

In Canada

• Nicorette Inhaler

Available Dosage Forms:

• Device

Therapeutic Class: Smoking Cessation Agent

Pharmacologic Class: Cholinergic System

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.

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