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Nicotrol

"As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration today proposed a new rule that would extend the agency's tobacco authority to cover addi"...

Nicotrol

NICOTROL® INHALER
(NICOTINE INHALATION SYSTEM) 10 MG PER CARTRIDGE
(4 MG DELIVERED)

An Aid to Help You Stop Smoking

PATIENT INFORMATION

Read and follow carefully.

If you have questions or want more information, ask your doctor or pharmacist.

  1. NICOTROL (nicotine inhalation system) Inhaler helps you quit smoking by reducing your urge to smoke. Success in quitting with nicotine replacement therapy (such as NICOTROL (nicotine inhalation system) Inhaler) usually involves behavior change.
    • Your doctor may adjust the number of Inhaler cartridges during the first few weeks. As your body adjusts to not smoking, your doctor will either tell you to stop using the Inhaler or slowly reduce the dose.
    • People who use Nicotrol (nicotine inhalation system) Inhaler with a comprehensive behavioral smoking cessation program are more successful in quitting smoking. This program can include support groups, counseling or specific behavior change techniques.
  2. Side Effects: Many people experience mild irritation of the mouth or throat and cough when they first use the Nicotrol (nicotine inhalation system) Inhaler. Most people get used to these effects in a short time. Stomach upset may also occur.
  3. Because you are already addicted to the nicotine in cigarettes, it is possible to stay dependent on the lower dose of nicotine found in the Nicotrol (nicotine inhalation system) Inhaler. It is important to use the Inhaler for only as long as directed by your doctor to overcome your nicotine addiction and smoking habit.

NICOTROL (nicotine inhalation system) Inhaler Contents

 NICOTROL Inhaler Contents - Illustration

WARNINGS : Read before using NICOTROL (nicotine inhalation system) Inhaler

Commit yourself - NO SMOKING! For the NICOTROL (nicotine inhalation system) Inhaler to help, you must be firmly committed to quitting! Stop smoking as soon as you start using the Inhaler. Do not smoke or use any other tobacco products at any time while using the NICOTROL Inhaler.

Nicotine overdose can occur. If symptoms of overdose occur, call a doctor or Poison Control Center immediately. Overdose symptoms include: bad headaches, dizziness, upset stomach, drooling, vomiting, diarrhea, cold sweat, blurred vision, hearing difficulties, mental confusion, weakness and fainting.

 Commit yourself - Illustration

Keep out of reach of children and pets. The NICOTROL (nicotine inhalation system) Inhaler can cause serious illness in children and pets - even in very small amounts. If a child chews on or swallows NICOTROL (nicotine inhalation system) Inhaler cartridges, call a doctor or Poison Control Center. After a cartridge is used, throw away out of reach of children and pets. Even used cartridges contain enough nicotine to seriously harm children and pets.

The NICOTROL (nicotine inhalation system) Inhaler is a child resistant product. Please read carefully the instructions regarding how to open, close and lock.

 Keep out of reach of children and pets - Illustration

Tell your doctor if you have:

  • heart problems (recent heart attack, irregular heartbeat, severe or worsening heart pain)
  • stomach ulcers
  • overactive thyroid
  • high blood pressure
  • allergies to drugs
  • diabetes requiring insulin
  • kidney or liver disease
  • wheezing or asthma

  • Tell your doctor about any medicines you are taking– the dosages may need to be changed. Check with your doctor before taking any new medicine while using NICOTROL (nicotine inhalation system) Inhaler.

 Tell your doctor about any medicines you are taking - Illustration

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Oonly use this medicine on the advice of your health care provider - Illustration

  • Follow doctor's directions.
  • Stop smoking completely during the NICOTROL (nicotine inhalation system) Inhaler treatment program.

 Remove mouthpiece from plastic wrap - Illustration

  • Remove mouthpiece from plastic wrap.
  • Push the top and bottom together and turn the two pieces to line up the markings.
  • Pull the top and bottom apart.

 Peel back to release 1 cartridge - Illustration

  • Take out cartridge tray.
  • Peel back to release 1 cartridge.
  • Insert cartridge into Inhaler.
  • Push hard on the cartridge until it pops down into place.

 Line up the markings again and push the two pieces back together - Illustration

  • Line up the markings again and push the two pieces back together so they fit tight.
  • Turn the top and bottom pieces so the markings do not line up and it is locked again.
  • Store cartridges in plastic case when not in use.

 Inhale deeply into back of throat - Illustration

  • Inhale deeply into back of throat or puff in short breaths.
  • As you inhale or puff through the mouthpiece, nicotine turns into a vapor and is absorbed into your mouth and throat.
  • Use Inhaler longer and more often at first to help control cigarette cravings.

 Nicotine in cartridges is used up after about 20 minutes - Illustration

  • Nicotine in cartridges is used up after about 20 minutes of active puffing.
  • Try different schedules to help control cravings. Puffing on the Inhaler for 5 min. at a time will give you enough nicotine for 4 uses. In a few days you'll find what works best and know when nicotine in cartridges is used up.
  • Use Inhaler at room temperature (above 60°F), cold temperatures reduce amount of nicotine you inhale.

 When cartridge is empty, take off top of mouthpiece - Illustration

  • When cartridge is empty, take off top of mouthpiece.
  • Throw used cartridge away, out of reach of children and pets.
  • When not in use keep the mouthpiece in the locked position and always store mouthpiece and cartridges in plastic case, out of reach of children and pets.

Read and Follow

  • Side Effects: You may experience mild irritation of the mouth or throat and cough when you first use the Nicotrol (nicotine inhalation system) Inhaler. You should get used to these effects in a short time. Stomach upset may also occur.
  • Do not use more than 16 cartridges each day unless directed to do so by your doctor.
  • Do not use longer than 6 months.
  • Store cartridges at room temperature, not to exceed 77°F (25°C).
  • If you keep cartridges in car, be careful: interiors heat up quickly.
  • Protect from light.
  • Clean mouthpiece regularly with soap and water.

QUESTIONS? Call 1-888-642-6876

Last reviewed on RxList: 3/18/2009
This monograph has been modified to include the generic and brand name in many instances.

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Nicotrol - User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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