Nicotine, Transdermal

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KEY POINTS

• These adhesive patches are used to help you stop smoking. Use it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: smoking deterrent

Generic and brand names: nicotine, transdermal; Habitrol; NicoDerm-CQ

What is this medicine used for?

These adhesive patches are designed to help you stop smoking by releasing nicotine that is absorbed through the skin. As your body becomes used to smaller amounts of nicotine in your system, your addiction to nicotine is reduced. Using this medicine with behavior modification and counseling increases the likelihood you can quit smoking.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to adhesive tape
• Asthma or other breathing problems that you take medicine to control
• Depression that you take medicine to control
• Diabetes
• Gastric reflux disease (GERD)
• Heart disease, an irregular heartbeat, or a recent heart attack
• High blood pressure
• Liver or kidney disease
• Pheochromocytoma (tumor of the adrenal gland)
• Skin disease
• Seizures
• Thyroid problems
• Ulcers

Tell your healthcare provider if you continue to smoke, chew tobacco, use snuff, or use other products that contain nicotine.

Females of childbearing age: Tell your healthcare provider if you are pregnant or breast-feeding. Nicotine from any source can harm the baby. Do not become pregnant while using this medicine. If you become pregnant, contact your healthcare provider. This treatment is not recommended during pregnancy or while breast-feeding. If you are pregnant or breast-feeding, do not use this medicine unless your healthcare provider approves. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine.

How do I use it?

If you have tried to stop smoking using another form of nicotine replacement therapy and have not had any success, ask your healthcare provider if this medicine is right for you.

Use this medicine exactly as your healthcare provider prescribes. If your healthcare provider has not given you specific instructions, follow the directions that come with the medicine package. An instruction sheet is included in the package of this medicine. Do not use more or use it longer than prescribed. Ask your healthcare provider or pharmacist about anything you do not understand.

Begin using this medicine on your quit day. Check the label on the medicine for directions about your specific dose. This medicine comes in 3 strengths, and is a 3-step program. The dose is based upon how many cigarettes you smoke a day. If you smoke 11 or more cigarettes a day start with the 21 mg patch (step 1), followed by step 2 and step 3. If you smoke 10 or less cigarettes a day start with the 14 mg patch (step 2), followed by step 3. Follow the directions that come with the medicine package carefully.

Check with your healthcare provider before using this medicine in children under age 18.

Wash your hands before and after applying the patch. Apply a patch once a day to clean, dry skin on your upper body or outer surface of the upper arm, or a place on the body as described on the instructions included in the medicine package. Choose a spot with no hair or broken skin. Make sure your skin is free of lotion or soap. Save the pouch for disposing of the patch after use.

You may wear the patch for 16 to 24 hours. If you have cigarette cravings when you wake up, wear for 24 hours. If you have vivid dreams or trouble sleeping, you may remove the patch at bedtime and apply a new patch the following morning. The patch should be applied at approximately the same time each day.

Remove the patch after 24 hours and apply a new patch in a different spot. Do not reuse the same spot for at least one week. Do not leave the patch on for more than 24 hours, because it may irritate your skin and loses strength after 24 hours.

Apply the patch right after removing it from the protective pouch to prevent loss of nicotine by evaporation. Make sure all the edges of the patch are firmly attached. Press the patch firmly against your skin with the palm of your hand for about 10 seconds. Do not wear more than 1 patch at a time and do not cut patches.

After removing a used patch, fold it over and put it in the pouch from which you have removed a new patch. Dispose of the patch safely away from children and pets.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, diarrhea, stomach pain, cold sweat, headache, dizziness, trouble seeing or hearing, confusion, restlessness, fast or irregular heartbeat, chest pain, drooling, coma.

What should I watch out for?

Caution: Nicotine can poison children and pets. Keep used and unused nicotine in a safe place out of the reach of children. Dispose of the medicine safely.

Stop using this medicine and contact your healthcare provider if you have:

• A skin rash or redness caused by the patch that does not go away after 4 days, or your skin swells
• Fast or irregular heartbeat
• Symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness, and fast heartbeat

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine. The patch may need to be removed before certain tests or procedures such as MRIs.

When you stop smoking, there may be a change in how certain medicines work for you. Talk to your healthcare provider if you are taking medicine that reduces the chance of blood clots, bronchodilators, or diabetes medicines.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Signs nicotine overdose (pale skin, cold sweats, nausea, increased saliva, vomiting, diarrhea, severe headache, dizziness, confusion, weakness, very slow or very fast heartbeat, irregular heartbeat, severe nervousness, trouble breathing, trouble seeing or hearing, seizures); skin irritation, redness, or swelling under the patch that does not go away.

Other: Mild skin irritation, redness, or swelling under the patch; trouble sleeping; mild nervousness; strange dreams.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Also, when you stop smoking and start using any nicotine replacement products, the dosage of some medicines you may have been taking may need adjustment. Talk to your healthcare provider if you are taking:

• Adenosine (Adenocard)
• Alpha blockers such as doxazosin (Cardura), prazosin (Minipress), and terazosin
• Antianxiety medicines such as chlordiazepoxide, diazepam (Valium), and oxazepam
• Antiarrhythmic medicines (to treat irregular heartbeat) such as flecainide and mexiletine
• Antidepressants such as amitriptyline, desipramine (Norpramin), fluvoxamine (Luvox), imipramine (Tofranil), and nortriptyline (Pamelor)
• Antipsychotic medicines such as clozapine (Clozaril, FazaClo) and olanzapine (Zyprexa)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Caffeine in food, drinks, or medicines
• Cancer medicines such as erlotinib (Tarceva) and irinotecan (Camptosar)
• Cimetidine (Tagamet)
• Decongestants such as oxymetazoline (Afrin, Dristan), phenylephrine (Neo-Synephrine, Sudafed PE), and pseudoephedrine (Sudafed)
• Doxepin (Silenor)
• Furosemide (Lasix)
• Insulin
• Medicines to treat breathing or lung problems such as aminophylline and theophylline
• Migraine medicines such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar), and methylergonovine
• Other medicines or products to help you stop smoking
• Pentazocine (Talwin)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Varenicline (Chantix)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Leave the patch in its sealed wrapper until you are ready to put it on.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.