What is the most important information I should know about nicotine?

Do not use this medication if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

You may not be able to use certain forms of this medicine if you have medical conditions that could interfere with use. Ongoing nasal or sinus problems (such as allergies, nasal polyps, or sinusitis) could affect safe use of the nasal spray form of nicotine. Mouth or dental problems may affect safe use of nicotine gum or lozenges. A skin condition may affect safe use of nicotine transdermal patches. Talk with your doctor about the best form of nicotine for you to use.

Do not smoke while you are using nicotine. Stop smoking as soon as your treatment begins. Smoking while using this medication can be dangerous.

What is nicotine?

Nicotine is the primary ingredient in tobacco products.

Nicotine in medical products is used to aid in smoking cessation. Using a controlled amount of nicotine helps reduce nicotine withdrawal symptoms when you quit smoking.

Nicotine may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before using nicotine?

You may not be able to use certain forms of this medicine if you have medical conditions that could interfere with use. Ongoing nasal or sinus problems (such as allergies, nasal polyps, or sinusitis) could affect safe use of the nasal spray form of nicotine. Mouth or dental problems may affect safe use of nicotine gum or lozenges. A skin condition may affect safe use of nicotine transdermal patches. Talk with your doctor about the best form of nicotine for you to use.

Before using this medication, tell your doctor if you have:

• heart disease, an irregular heartbeat, high blood pressure or chest pain;
• a jaw condition called TMJ (temporomandibular joint) disease;
• an overactive thyroid;
• diabetes;
• pheochromocytoma (tumor of the adrenal gland);
• liver or kidney disease;
• a stomach ulcer; or
• asthma or chronic pulmonary disease.

You may not be able to use nicotine, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

Nicotine oral lozenges may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

Nicotine can cause harm to an unborn baby. Do not use nicotine if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication.

Nicotine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take nicotine?

Use nicotine exactly as it was prescribed for you. Do not use the medication in larger amounts or for longer than recommended by your doctor.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To use the patches:

• Choose a different place on your body to wear the patch each time you put on a new one. Do not use the same skin area twice within 7 days.
• Apply the patch to clean, dry, and hairless skin on the outer part of your upper arm or on your chest. Remove the patch after 24 hours and replace it with a new one.
• If you are using Nicotrol patches, apply a new patch each morning and remove it at bedtime. Do not wear the patch while you are sleeping. If you are using Nicoderm CQ, you may wear the patch for 16 or 24 hours. If you crave cigarettes when you wake up, you may wear the patch for 24 hours. Do not wear the patch at night if you have vivid dreams or trouble sleeping.

To use the chewing gum or oral lozenges:

• Place a piece of gum or a lozenge in your mouth.
• Chew the gum slowly several times and stop chewing when you notice a tingling sensation or a peppery taste in the mouth. “Park” the gum between your cheek and gum and leave it there until the taste or tinging sensation is almost gone. Then slowly chew a few more times until the taste or sensation returns. Park the gum again in a different place in your mouth. Chewing too much or too quickly can cause too much nicotine to be released from the gum and you may have side effects such as nausea, hiccups, or stomach problems. Remove the gum after 30 minutes, or when the taste or tingle no longer return when you chew the gum.
• Allow the lozenge to dissolve slowly without chewing or swallowing. You may notice a warm or tingling sensation in your mouth. Move the lozenge from one side of your mouth to the other while it is dissolving.
• Do not eat or drink for 15 minutes before using the gum or lozenge and while the medicine is in your mouth.

To use the nasal spray:

• Blow nose if it is not clear. Tilt head back slightly. Insert the tip of bottle into your nostril as far as comfortable. Spray once in each nostril. Do not sniff, swallow, or inhale while spraying. If your nose runs, gently sniff to keep the medicine in. Wait 2 or 3 minutes before blowing your nose. Do not use more of the medication than is directed.
• Recap the bottle after each use. If you don’t use the nasal spray for 24 hours, prime the pump by spraying several sprays into a tissue 1, then throw the tissue away.
• Do not get nicotine spray into your eyes or mouth or on your skin. If this does occur, rinse the area with water.

To use the inhaler:

• Inhale deeply or puff in short breaths. As you inhale through the mouthpiece, nicotine turns into a vapor and is absorbed into the mouth and throat. Nicotine in cartridges is used up after about 20 minutes of active puffing.

Keep used and unused nicotine patches or gum out of the reach of children and pets to prevent poisoning. Used bottles of nasal spray should be thrown away with their child-resistant caps in place.

Store nicotine products at room temperature away from moisture, heat, and direct sunlight.

What happens if I miss a dose?

Since nicotine is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it.

Symptoms of a nicotine overdose may include nausea; vomiting; diarrhea; stomach pain; cold sweat; headache; dizziness; problems with hearing or vision; confusion; uneven heartbeats; chest pain; seizures; and death.

What should I avoid while taking nicotine?

Do not smoke while you are using nicotine. Stop smoking as soon as your treatment begins. Smoking while using this medication can be dangerous.

What are the possible side effects of nicotine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using nicotine and call your doctor at once if you have any of these serious side effects:

• seizures; or
• chest pain or uneven heartbeats.

Continue using nicotine and talk with your doctor if you have any of these less serious side effects:

• dizziness;
• belching or hiccups;
• stomach upset or nausea;
• mouth or throat soreness;
• dry or watering mouth;
• watering eyes;
• headache;
• runny or stuffy nose (when using the nasal spray);
• white patches or sores inside your mouth or on your lips (when using the inhaler);
• constipation;
• sneezing and coughing;
• changes in taste; or
• redness, itching, or burning where the patch is worn.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.