Commit

Brand name:

Commit, Nicorelief, Nicorette.

Nicotine oral chewing gum and lozenges are used in nicotine replacement therapy.

This replaces the nicotine you would get from smoking as it is absorbed from the gum or lozenge in the mouth and enters the blood stream.

The withdrawal effects from not smoking less severe when taking this drug. The amount of nicotine is slowly tapered until use is completely stopped.

This drug does not require a prescription but age verification of 18 years or older is required.

Before taking this drug, the risks and benefits for your body should be discussed with your healthcare provider.

Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies in the pediatric population on the relationship of age to the effects of oral nicotine have not been performed while safety and efficacy have not been established.

Nicotine lozenges or gum contain adequate nicotine to cause problems in children. No data is available regarding the correlation of age to the effects of oral nicotine in geriatric patients.

Adverse effects have been reported in animal studies but studies in pregnant women or animals are still inadequate. Infant risk is still undetermined when using this medication during breastfeeding.

Discuss with your healthcare professional about the risks and benefits of this drug before breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other prescription or non-prescription drugs. Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects.

Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as diabetes, cardiovascular disease, hypertension, irritation of mouth or throat, loose dental fillings, stomach ulcer, or phenylketonuria.

This drug must be taken exactly as directed by your healthcare professional. To prevent any side effects, take this drug exactly as directed on the label or as prescribed by your healthcare professional.

Follow the instructions on the label or as directed by your healthcare professional. To aid in your smoking cessation, you will be advised to use a stop-smoking program that may include education, counseling, and psychological support.

Use this drug immediately even if you still cannot totally stop smoking. If the urge to smoke arises, slowly chew one piece of gum until you notice a peppery taste or feel a slight tingling in your mouth.

Place the gum between your cheek and gum and slowly chew the gum again when the taste or tingling is almost gone until you taste it again. Continue chewing and the gum for about 30 minutes to get the full dose.

Refrain from chewing the gum too fast or chew more than one piece at a time, or drink acidic beverages, such as citrus fruit juices, coffee, soft drinks, or tea within 15 minutes before or while chewing a piece of gum.

Avoid eating or drinking for 15 minutes before using a lozenge and slowly suck one lozenge until it dissolves if you get an urge to smoke. Refrain from chewing or swallowing the lozenge.

Consume only one lozenge at a time. The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed.

The dosage of this drug you take depends on the medical problem for which you are using this drug. Adults and teenagers 18 years or older are dosed based on the number of cigarettes they smoke per day.

Do not chew more than one piece at a time. The dose must not exceed 24 pieces of gum per day. Use in children is not recommended.

Adults and teenagers 18 years or older are dosed based on the number of cigarettes they smoke per day. Do not use more than one lozenge at a time.

The dose must not exceed 5 lozenges in 6 hours or more than 20 lozenges per day. Use in children is not recommended.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children.

Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

Finish the program completely to ensure smoking cessation. Consult with your healthcare provider if you need to use oral nicotine for a longer period of time.

Use this drug in pregnant women only under the advice of a healthcare professional. The risks of this drug to your child are still unknown.

This drug must be kept out of the reach of children and pets as small amounts of nicotine can cause serious unwanted effects in children.

Contact your healthcare professional or poison control center immediately if the gum or lozenges are swallowed.

Check with your health care professional or dentist if the chewing gum sticks to your dental work or causes loose fillings.

Seek advice from your healthcare professional if you are on a sodium-restricted diet.

Consult with your healthcare professional before taking any other prescription or nonprescription drugs, and herbal or vitamin supplements.

Side effects may vary for each individual and prompt medical attention should be given if they occur.

Consult with your healthcare professional immediately if you experience symptoms of:

• blurred vision
• dizziness
• headache
• nervousness
• pounding in the ears
• fast or irregular heartbeat
• hives
• itching
• rash
• redness
• swelling of the skin
• symptoms of overdose such as dizziness
• fast heartbeat
• nausea or vomiting
• weakness

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear.

Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional.

Report any side effects to the FDA hotline at 1-800-FDA-1088.