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|Commit

NICOTINE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Commit
• NicoDerm CQ
• Nicorette
• Nicotrol

In Canada—

• Habitrol
• Nicoderm
• Nicorette
• Nicorette Plus
• Nicotrol
• Prostep

Generic name product may be available in the U.S.

Category

• Smoking cessation adjunct

Description

Nicotine (NIK-o-teen), in a flavored chewing gum, a lozenge, or a skin patch, is used to help you stop smoking. It is used for up to 12 weeks as part of a stop-smoking program. This program may include education, counseling, and psychological support.

As you chew nicotine gum or suck on the nicotine lozenge, nicotine passes through the lining of your mouth and into your blood stream. When you wear a nicotine patch, nicotine passes through your skin into your blood stream. This nicotine takes the place of nicotine that you would otherwise get from smoking. In this way, the withdrawal effects of not smoking are less severe. Then, as your body adjusts to not smoking, the use of the nicotine gum is decreased gradually until use is stopped altogether. For most brands of patches, the strength of the patch you use will be decreased over a few weeks until use is stopped. If you are using the brand of patch that is available in only one strength, use is stopped after the treatment period indicated on the label.

Children, pregnant women, and nonsmokers should not use nicotine gum or patches because of harmful effects.

Nicotine gum or lozenge is available without a prescription. Some nicotine patches are available without a prescription. Nicotine is available in the following dosage forms:

• Oral
• Chewing gum (U.S. and Canada)
• Lozenge (U.S.)

• Topical
• Transdermal (stick-on) skin patch (U.S. and Canada)

Before Using This Medicine

If you are using this medicine without a prescription, carefully read and follow any precautions on the label. For nicotine gum, lozenges, and patches, the following should be considered:

Allergies—Tell your healthcare professional if you have ever had any unusual or allergic reaction to nicotine. Also tell your healthcare professional if you are allergic to any other substances, such as foods, preservatives, or dyes. If you plan to use the nicotine patches, tell your healthcare professional if you have ever had a rash or irritation from adhesive tape or bandages.

Pregnancy—Nicotine, whether from smoking or from the gum, lozenges, or patches, is not recommended during pregnancy. Studies in humans show that miscarriages have occurred in pregnant women using nicotine replacement products. In addition, studies in animals have shown that nicotine can cause harmful effects in the fetus.

Breast-feeding—Nicotine passes into breast milk. It may be necessary for you to stop breast-feeding during treatment.

Children—Small amounts of nicotine can cause serious harm in children. Even nicotine patches that have been used still contain enough nicotine to cause problems in children. Although there is no specific information comparing use of nicotine in teenagers with use in other age groups, this medicine is not expected to cause different side effects or problems in nicotine-dependent teenagers than it does in adults.

Older adults—Nicotine gum, lozenges, and patches have been used in a limited number of patients 60 years of age or older, and have not been shown to cause different side effects or problems in older people than in younger adults.

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 healthcare professional may want to change the dose, or other precautions may be necessary. When you are using nicotine gum or patches, it is especially important that your healthcare professional know if you are taking any of the following:

• Aminophylline (e.g., Phyllocontin) or
• Insulin or
• Labetalol (e.g., Trandate) or
• Oxtriphylline (e.g., Choledyl) or
• Prazosin (e.g., Minipress) or
• Propoxyphene (e.g., Darvon) or
• Propranolol (e.g., Inderal) or
• Theophylline (e.g., Slo-Phyllin, Theo-Dur)—Stopping smoking may increase the effects of these medicines; the amount of medicine you need to take may change

• Isoproterenol (e.g., Isuprel) or
• Phenylephrine (e.g., Neo-Synephrine)—Stopping smoking may decrease the effects of these medicines; the amount of medicine you need to take may change

Other medical problems—The presence of other medical problems may affect the use of nicotine gum or patches. Make sure you tell your healthcare professional if you have any other medical problems, especially:

• Dental problems (with gum only) or
• Diabetes, type 1 (sugar diabetes) or
• Heart or blood vessel disease or
• High blood pressure or
• Inflammation of mouth or throat (with gum only) or
• Irritated skin (with patches only) or
• Overactive thyroid or
• Pheochromocytoma (PCC) or
• Stomach ulcer or
• Stroke, recent or
• Temporomandibular (jaw) joint disorder (TMJ) (with gum only)—Nicotine may make the condition worse

Proper Use of This Medicine

For patients using the chewing gum :

• Nicotine gum usually comes with patient directions. Read the directions carefully before using this medicine .
• Use nicotine gum exactly as directed on the label . Remember that it is also important to participate in a stop-smoking program during treatment. This may make it easier for you to stop smoking.
• When you feel the urge to smoke, chew one piece of gum very slowly until you taste it or feel a slight tingling in your mouth. Stop chewing, and place (“park”) the chewing gum between your cheek and gum until the taste or tingling is almost gone. Then chew slowly until you taste it again. Continue chewing and stopping (“parking”) in this way for about 30 minutes in order to get the full dose of nicotine.
• Do not chew too fast , do not chew more than one piece at a time, and do not chew more than one piece of gum within an hour. To do so may cause unpleasant side effects or an overdose. Also, slower chewing will reduce the possibility of belching.
• You should 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 . The acid will prevent the nicotine from being released from the gum.
• As your urge to smoke becomes less frequent, gradually reduce the number of pieces of gum you chew each day until you are chewing three to six pieces a day. This may be possible within 2 to 3 months.
• Remember to carry nicotine gum with you at all times in case you feel the sudden urge to smoke. One cigarette may be enough to start you on the smoking habit again.
• Using hard sugarless candy between doses of gum may help to relieve any nicotine cravings you may have between doses of gum.

For patients using the lozenge :

• Nicotine lozenges usually come with patient directions. Read the directions carefully before using this medicine .
• Use nicotine lozenges exactly as directed on the label . Remember that it is also important to participate in a stop-smoking program during treatment. This may make it easier for you to stop smoking.
• Do not eat or drink for 15 minutes before using a nicotine lozenge.
• When you feel the urge to smoke, suck one lozenge slowly until it dissolves. Do not bite or chew the lozenge like a hard candy. Do not swallow the lozenge.
• As your urge to smoke becomes less frequent, gradually reduce the number of lozenges you use each day until you are using three to six lozenges a day. This should be possible within 12 weeks.
• Remember to carry nicotine lozenges with you at all times in case you feel the sudden urge to smoke. One cigarette may be enough to start you on the smoking habit again.

For patients using the transdermal system (skin patch) :

• Nicotine patches usually come with patient instructions. Read them carefully before using this medicine. Nicotine patches will work only if applied correctly .
• Remember that it is also important to participate in a stop-smoking program during treatment . This may make it easier for you to stop smoking.
• Do not remove the patch from its sealed pouch until you are ready to put it on your skin . The patch may not work as well if it is unwrapped too soon.
• Do not try to trim or cut the adhesive patch to adjust the dosage . Check with your healthcare professional if you think the medicine is not working as it should.
• Apply the patch to a clean, dry area of skin on your upper arm, chest, or back. Choose an area that is not very oily, has little or no hair, and is free of scars, cuts, burns, or any other skin irritations.
• Press the patch firmly in place with the palm of your hand for about 10 seconds. Make sure there is good contact with your skin, especially around the edges of the patch.
• The patch should stay in place even when you are showering, bathing, or swimming. Apply a new patch if one falls off.
• Rinse your hands with plain water after you have finished applying the patch to your skin . Nicotine on your hands could get into your eyes and nose and cause stinging, redness, or more serious problems. Using soap to wash your hands will increase the amount of nicotine that passes through your skin .
• After 16 or 24 hours, depending on which product you are using, remove the patch. Choose a different place on your skin to apply the next patch. Do not put a new patch in the same place for at least 1 week. Do not leave the patch on for more than 24 hours . It will not work as well after that time and it may irritate your skin.
• After removing a used patch, fold the patch in half with the sticky sides together. Place the folded, used patch in its protective pouch or in aluminum foil. Make sure to dispose of it out of the reach of children and pets.
• Try to change the patch at the same time each day. If you want to change the time when you put on your patch, just remove the patch you are wearing and put on a new patch. After that, apply a fresh patch at the new time each day.
• Nicotine patches should be removed from the skin during strenuous exercise. If a patch is left on, too much nicotine may pass through your skin into your blood stream.
• If you are using a 24-hour patch and begin having unusual dreams or disturbed sleep, you may take the patch off before going to bed and put a new one on after you wake up the next morning.

Dosing—The dose of nicotine will be different for different patients. Follow your healthcare professional"s orders or the directions on the label . The following information includes only the average doses of nicotine. If your dose is different, do not change it unless your healthcare professional tells you to do so.

• For the oral dosage form (chewing gum):
  • To help you stop smoking:
    • Adults and teenagers—The usual dose is one piece of chewing gum every one to two hours for six weeks, one piece of chewing gum every two to four hours for three weeks, then one piece of chewing gum every four to eight hours for three weeks. You should not chew more than 24 pieces of gum a day.
    • Children—Use and dose must be determined by your healthcare professional.
• For the oral dosage form (lozenge):
  • To help you stop smoking:
    • Adults and teenagers—The usual dose is suck slowly one lozenge until it dissolves every one to two hours for six weeks, suck one lozenge every two to four hours for three weeks, then suck one lozenge every four to eight hours for three weeks. You should not use more than 20 lozenges a day.
    • Children—Use and dose must be determined by your healthcare professional.
• For the transdermal (stick-on) skin patch:
  • To help you stop smoking:
    • Adults and teenagers—The dose you receive will be based on your body weight, how often you have the urge to smoke, and the brand and strength of the patch you use. This dose will be provided on the package label.
    • Children—Use and dose must be determined by your healthcare professional.

Storage—To store this medicine:

• Keep out of the reach of children because even small doses of nicotine can cause serious harm in children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children and pets.

Precautions While Using This Medicine

Do not smoke during treatment with nicotine gum, lozenges, or patches because of the risk of nicotine overdose.

Nicotine should not be used in pregnancy . If there is a possibility you might become pregnant, you may want to use some type of birth control. If you think you may have become pregnant, stop using this medicine immediately and check with your healthcare professional.

Nicotine products must be kept out of the reach of children and pets . Even nicotine patches that have been used still contain enough nicotine to cause problems in children. If a child chews or swallows one or more pieces of nicotine gum or lozenges, contact your healthcare professional or poison control center at once. If a child puts on a nicotine patch or plays with a patch that is out of the sealed pouch, take it away from the child and contact your healthcare professional or poison control center at once.

For patients using the chewing gum :

• Do not chew more than 24 pieces of gum a day . Chewing too many pieces may be harmful because of the risk of overdose.
• Do not use nicotine gum for longer than 12 weeks . To do so may result in physical dependence on the nicotine. If you feel the need to continue using the gum after 12 weeks, contact your healthcare professional.
• If the gum sticks to your dental work, stop using it and check with your medical healthcare professional or dentist . Dentures or other dental work may be damaged because nicotine gum is stickier and harder to chew than ordinary gum.

For patients using the lozenges :

• Do not use more than 20 lozenges a day . Sucking too many pieces may be harmful because of the risk of overdose.
• Do not use nicotine lozenges for longer than 12 weeks . If you feel the need to continue using the lozenges after 12 weeks, contact your healthcare professional.

For patients using the transdermal system (skin patch) :

• Mild itching, burning, or tingling may occur when the patch is first applied, and should go away within 24 hours. After a patch is removed, the skin underneath it may be red. It should not remain red for more than a day. If you get a skin rash from the patch, or if the skin becomes swollen or very red, call your healthcare professional . Do not put on a new patch. If you become allergic to the nicotine in the patch, you could get sick from using cigarettes or other products that contain nicotine.
• Do not use nicotine patches for longer than 12 weeks if you have stopped smoking. If you feel the need to continue using nicotine patches after 12 weeks, contact your healthcare professional.

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.

Other 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. However, check with your healthcare professional if any of the following side effects continue or are bothersome:

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

Revised: 04/21/2003

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