Nicotrol

What is Nicotrol used for?

Nicotrol is used to treat nicotine withdrawal. It is used to curb the craving to smoke.

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 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

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.

Before taking Nicotrol, tell your doctor:

• If you are allergic to Nicotrol; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Chest pain or pressure, a heartbeat that does not feel normal, or a recent heart attack.
• If you still smoke, chew tobacco, or use other products that have nicotine while using Nicotrol.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Nicotrol with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Nicotrol?

• Tell all of your health care providers that you take Nicotrol. This includes your doctors, nurses, pharmacists, and dentists.
• Get counseling to help you quit smoking.
• Do not use more than told. Unsafe side effects may happen.
• Tell your doctor if you are taking another drug to help you stop smoking.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Nicotrol affects you.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• When you stop smoking, other drugs may be affected. Talk with your doctor.
• Tell your doctor if you have not been able to quit smoking after using Nicotrol for as long as it says to use it.
• This medicine may cause harm or be deadly if used or swallowed by children or pets. If a child uses Nicotrol or if Nicotrol is swallowed by a child or pet, call a doctor or poison control center right away.
• If you are 65 or older, use Nicotrol with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Nicotrol, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Nicotrol best taken?

Use Nicotrol as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For breathing in only.
• Keep out of your eyes.
• Clean the mouthpiece often with soap and water.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

What are the side effects of Nicotrol that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Mood changes.
• Feeling confused.
• Chest pain or pressure, a fast heartbeat, or an abnormal heartbeat.
• A burning, numbness, or tingling feeling that is not normal.
• Dizziness.
• Upset stomach or throwing up.
• Diarrhea.
• Drooling.
• Shakiness.
• Feeling tired or weak.
• Cold sweats.
• Blurred eyesight.
• Change in hearing.

What are some other side effects of Nicotrol?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Trouble sleeping.
• Bad dreams.
• Feeling nervous and excitable.
• Headache.
• Joint pain.
• Back pain.
• Irritation where Nicotrol is used.
• Flu-like signs.
• Gas.
• Cough.
• Runny nose.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Nicotrol?

• Store at room temperature.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

• NDC 0009-5400-01
• Nicotrol® Inhaler
  (nicotine inhalation
  system)
• 10 mg/cartridge
  (4 mg delivered)
• Rx only
• FOR ORAL INHALATION USE ONLY
  KEEP OUT OF THE REACH OF CHILDREN
• 168 Cartridges
  5 Mouthpieces, 1 Plastic Case

SRC: NLM .