Nicotrol

DRUG DESCRIPTION

NICOTROL® Inhaler (nicotine inhalation system) consists of a mouthpiece and a plastic cartridge delivering 4 mg of nicotine from a porous plug containing 10 mg nicotine. The cartridge is inserted into the mouthpiece prior to use. Nicotine is a tertiary amine composed of a pyridine and a pyrrolidine ring. It is a colorless to pale yellow, freely water-soluble, strongly alkaline, oily, volatile, hygroscopic liquid obtained from the tobacco plant. Nicotine has a characteristic pungent odor and turns brown on exposure to air or light. Of its two stereoisomers, S(-)nicotine is the more active. It is the prevalent form in tobacco, and is the form in the NICOTROL (nicotine inhalation system) Inhaler. The free alkaloid is absorbed rapidly through skin, mucous membranes, and the respiratory tract.

Chemical Name: S-3-(1-methyl-2-pyrrolidinyl) pyridine
Molecular Formula: C10H14N2
Molecular Weight: 162.23
Ionization Constants: pKa1 = 7.84, pKa2 = 3.04 at 15°C
Octanol-Water Partition Coefficient: 15:1 at pH 7

 NICOTROL - nicotine Structural Formula Illustration

Nicotine is the active ingredient; inactive components of the product are menthol and a porous plug which are pharmacologically inactive. Nicotine is released when air is inhaled through the Inhaler.

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.

Less serious side effects may include:

  • dizziness;
  • belching or hiccups;
  • stomach upset or nausea;
  • mouth or throat soreness;
  • dry or watering...

Read All Potential Side Effects and See Pictures of Nicotrol »

What are the precautions when taking nicotine inhalation system (Nicotrol)?

Before using this product, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as menthol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled/worsening chest pain, recent heart attack, irregular heartbeat (serious arrhythmias).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel disease (e.g., Raynaud's disease, stroke), breathing problems (e.g., asthma, emphysema), diabetes, heart disease (e.g., chest pain, heart...

Read All Potential Precautions of Nicotrol »


Nicotrol Consumer (continued)

SIDE EFFECTS: Headache, nausea, mouth/tooth/throat pain, cough, runny/stuffy nose, change in taste, heartburn, hiccups, sweating, or diarrhea may occur. Common nicotine withdrawal symptoms can occur when you stop smoking and include dizziness, anxiety, depression, or trouble sleeping, among others. If any of these withdrawal symptoms or side effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Serious side effects are more likely if you continue to smoke while using this product. Do not smoke while you are using this medication.

Stop using this medication and tell your doctor immediately if any of these unlikely but serious side effects occur: severe dizziness, mental/mood changes (e.g., irritability, trouble sleeping, vivid dreams), numbness/tingling in hands/feet, swelling hands/ankles/feet.

Stop using this medication and seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, confusion, severe headache, fast/irregular/pounding heartbeat, slurred speech, weakness on one side of the body.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as menthol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled/worsening chest pain, recent heart attack, irregular heartbeat (serious arrhythmias).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel disease (e.g., Raynaud's disease, stroke), breathing problems (e.g., asthma, emphysema), diabetes, heart disease (e.g., chest pain, heart attack), high blood pressure, liver disease, severe kidney disease, stomach/intestinal sores (peptic ulcers), certain adrenal problem (pheochromocytoma), overactive thyroid (hyperthyroidism).

Nicotine and smoking may harm an unborn baby. If you are pregnant, try to stop smoking without using a nicotine replacement product if possible. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Nicotine from smoking and from this medication passes into breast milk and could have undesirable effects on a nursing infant. Smoking near an infant can also harm the infant. Consult your doctor before breast-feeding.


Nicotrol Patient Information Including Side Effects

Brand Names: Commit, Commit Cappuccino, Commit Cherry, Habitrol, Leader Nicotine Polacrilex, Nicoderm C-Q, Nicoderm C-Q Clear, Nicorelief, Nicorette, Nicorette Cinnamon Surge, Nicorette Fruit Chill, Nicorette Mint, Nicotrol Inhaler, Nicotrol NS

Generic Name: nicotine (oral/patches/nasal) (Pronunciation: NIK oh teen)

  • What is nicotine (Nicotrol)?
  • What are the possible side effects of nicotine?
  • What is the most important information I should know about nicotine?
  • What should I discuss with my healthcare provider before using nicotine?
  • How should I take nicotine?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking nicotine?
  • What other drugs will affect nicotine?
  • Where can I get more information?

What is nicotine (Nicotrol)?

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 other purposes not listed in this medication guide.

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.

Less serious side effects may include:

  • 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.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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. Nasal or sinus problems (allergies, nasal polyps, 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.

The nicotine transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

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