Nicotine (Oral, Oromucosal)

Nicotine oral chewing gum and lozenges help you quit smoking. Nicotine is absorbed in your mouth from the gum or lozenge and goes into your bloodstream. This replaces the nicotine you would get from smoking and reduces the withdrawal symptoms from not smoking. The amount of nicotine is gradually decreased until you stop using it.

You can get this medicine without a prescription, but you need to show proof of age (18 years or older).

It is important to complete the entire program. If you need to use oral nicotine for longer, speak with your doctor.

Pregnant women should only use this medicine if directed by a doctor. Cigarette smoke can seriously harm your child. Try to quit smoking without using medicine. While this medicine is thought to be safer than smoking, the risks to your child from this medicine are not fully understood.

Nicotine products must be kept away from children and pets. Even small amounts of nicotine can cause serious side effects in children, and used gum or lozenges may have enough nicotine to cause issues. If the gum or lozenges are swallowed, contact your doctor or poison control center immediately.

If the chewing gum sticks to your dental work or causes loose fillings, consult 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 you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use this medicine, you and your doctor need to weigh the risks against the benefits. Here are some important points to consider:

Allergies

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

Pediatric

There have not been appropriate studies on how oral nicotine affects children. Its safety and effectiveness have not been established. Even small amounts of nicotine can cause serious side effects in children, and lozenges or gum have enough nicotine to cause issues, including used pieces.

Geriatric

There is no information available on how oral nicotine affects older patients.

Breast Feeding

There are no adequate studies on the risks to infants when women use this medication while breastfeeding. Weigh the potential benefits against the potential risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together despite possible interactions. If this is the case, your doctor might need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around mealtime or with certain foods due to potential interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, 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. This may worsen these conditions.

• Phenylketonuria (metabolic disorder)—Some lozenges contain phenylalanine, which may worsen this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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. 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.

In the U.S.

• Commit
• Nicorelief
• Nicorette

In Canada

• 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

Available Dosage Forms:

• Gum
• Lozenge/Troche

Therapeutic Class: Smoking Cessation Agent

Pharmacologic Class: Cholinergic System

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.

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