Pronunciation:

NIK-oh-teen pol-a-KRIL-ex

Brand Names:

• Commit
• Nicorelief
• Nicorette
• Basic Care Mini Nicotine Polacrilex Lozenge - Mint
• Equate Mini Nicotine Lozenge - Fast Dissolving - Mint
• Exact Nicotine Lozenge - Mint
• Good Sense Nicotine Polacrilex Lozenge - Mint
• Life Brand Nicotine Lozenge Mini - Mint
• Life Brand Nicotine Lozenge - Mint
• Nic-Assist - Mint
• Quit Nicotine Gum - Mint

Dosage Forms:

• Gum
• Lozenge/Troche

Classifications:

Therapeutic—

Smoking Cessation Agent

Pharmacologic—

Cholinergic System

Uses of This Medicine:

Nicotine oral chewing gum and lozenges are used to help you stop smoking. Nicotine is absorbed from the gum or lozenge in the mouth 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 without a prescription, but proof of age (18 years or older) is required.

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 oral nicotine in the pediatric population. Safety and efficacy have not been established. Small amounts of nicotine can cause serious unwanted effects in children, and lozenges or gum contain enough nicotine to cause problems, including used pieces.

Older adults—

No information is available on the relationship of age to the effects of oral nicotine in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Diabetes or
• Heart or blood vessel disease or
• Hypertension (high blood pressure), uncontrolled or
• Irritation of mouth or throat or
• Loose dental fillings (gum only) or
• Stomach ulcer—Use with caution. May make these conditions worse.

• Phenylketonuria (metabolic disorder)—Some of the lozenges contain phenylalanine, which may make this condition worse.

Proper Use of This Medicine:

Use this medicine exactly as directed in the dosing section on the label. Ask your doctor or pharmacist if you have any questions.

This medicine comes with a patient instruction booklet. Read and follow these instructions carefully.

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.

Begin using this medicine on your "quit" day, even if you are not able to stop smoking immediately.

Chewing gum:

• If you have the urge to smoke, slowly chew one piece of gum until you notice a peppery taste or feel a slight tingling in your mouth.
• Stop chewing and place (“park”) the gum between your cheek and gum. When the taste or tingling is almost gone, slowly chew the gum again until you taste it.
• Continue chewing and “parking” the gum for about 30 minutes to get the full dose.
• Do not chew too fast or chew more than one piece at a time.
• Do not drink acidic beverages, such as citrus fruit juices, coffee, soft drinks, or tea within 15 minutes before or while chewing a piece of gum.
• As your urge to smoke becomes less frequent, gradually reduce the pieces of gum used. Follow the dosing instructions on the label.

Lozenges:

• Do not eat or drink for 15 minutes before using a lozenge.
• If you have the urge to smoke, slowly suck one lozenge until it dissolves.
• Do not bite or chew the lozenge like hard candy. Do not swallow the lozenge. Try not to swallow most of the dissolved medicine.
• Do not use more than one lozenge at a time or many lozenges one after another.
• As your urge to smoke becomes less frequent, gradually reduce the number of lozenges used. Follow the dosing instructions on the label.

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.

• To help you stop smoking:
  • For oral dosage form (gum):
    • Adults and teenagers 18 years or older—The dose will be provided on the label and is based on the number of cigarettes you smoke per day. Do not chew more than one piece (2 milligrams (mg) or 4 mg) at a time. Do not use more than 24 pieces of gum per day. The amount of nicotine is decreased over time when you use fewer pieces. If you need to use the gum for a longer period of time than recommended on the label, talk to your doctor.
    • Children—Use is not recommended.
  • For oral dosage form (lozenge):
    • Adults and teenagers 18 years or older—The dose will be provided on the label and is based on the number of cigarettes you smoke per day. Do not use more than one lozenge (2 milligrams (mg) or 4 mg) at a time. Do not use more than 5 lozenges in 6 hours or more than 20 lozenges per day. The amount of nicotine is decreased over time when you use fewer pieces. If you need to use the lozenges for a longer period of time than recommended on the label, talk to your doctor.
    • Children—Use is not recommended.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.

Wrap used pieces of gum in paper and throw them away in the trash. If you remove a lozenge before it dissolves, wrap it in paper and throw it away in the trash. Make sure the gum or lozenge is out of the reach of children and pets.

Precautions While Using This Medicine:

It is important to finish the program completely. If you need to use oral nicotine for a longer period of time, talk to your doctor.

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. Although this medicine is believed to be safer than smoking, 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 used gum or lozenges may contain enough nicotine to cause problems. If the gum or lozenges are swallowed, contact your doctor or poison control center at once.

If the chewing gum sticks to your dental work or causes loose fillings, check with your medical doctor or dentist.

This medicine contains sodium. Talk to your doctor if you are on a sodium-restricted diet.

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

Blurred vision

dizziness

headache

nervousness

pounding in the ears

Rare

Fast or irregular heartbeat

hives, itching, rash, redness, or swelling of the skin

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

Symptoms of overdose

Dizziness

fast heartbeat

nausea or vomiting

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

Mouth sores, blisters, or irritation

nausea or vomiting

sore throat

Less common

Acid or sour stomach

belching

diarrhea

dizziness

heartburn

hiccups

mouth, tooth, jaw, or neck pain

problems with teeth

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.