Nicotrol Inhaler

(Nicotine)

The active ingredient in Nicotrol Inhaler is nicotine. Nicotrol Inhaler provides nicotine without the harmful chemicals in cigarette smoke and other nicotine-containing products. This is helpful for people who experience sudden or intense nicotine cravings and need rapid craving relief when quitting smoking.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Nicotrol Inhaler. However, the following is a synopsis of the general guidelines for the use of Nicotrol Inhaler:

• The inhaler consists of a reusable mouthpiece and replaceable nicotine cartridges. Insert one cartridge into the mouthpiece before use. Puff on the mouthpiece using shallow, frequent puffs. Do not inhale deeply into the lungs. Each cartridge delivers nicotine over about 20 minutes of active puffing.
• Use enough cartridges each day to control cigarette cravings and nicotine withdrawal symptoms. Gradually reduce the number of cartridges used per day over time as cravings improve. Do not use more than 16 cartridges in one day or as directed by your healthcare professional.
• Used cartridges should be disposed of safely and kept out of the reach of children.
• Avoid eating or drinking acidic beverages just before or during use, as this may reduce nicotine absorption.

Some mild or common side effects of Nicotrol Inhaler include:

• Throat irritation.
• Mouth soreness or irritation.
• Coughing.
• Runny nose.
• Hiccups.
• Heartburn.
• Upset stomach or nausea.

Some individuals may experience serious side effects while using Nicotrol Inhaler. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Chest pain or pressure.
• Irregular heartbeat or changes in heart rate.
• Signs of a heart attack, such as chest pain, cold sweat, or back pain.
• Severe dizziness or fainting.
• Signs of an allergic reaction, including swelling of the face, lips, tongue, or throat.

These are not all of the possible side effects of Nicotrol Inhaler. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Nicotrol Inhaler, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Heart disease, including a previous heart attack or angina.
• High blood pressure or hypertension.
• Irregular heartbeat.
• Liver disease.
• Overactive thyroid.
• Pheochromocytoma.
• Diabetes.
• Stomach ulcers.

• Allergic to nicotine or any component of the inhaler system.
• Are non-smokers or do not currently use tobacco products.

Nicotrol Inhaler begins to relieve cigarette cravings within minutes of use. While it is not as fast-acting as a nicotine nasal spray, repeated puffing can provide enough nicotine to reduce withdrawal symptoms and support smoking cessation throughout the day.

When Nicotrol Inhaler is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Bupropion, which has been studied with nicotine replacement therapy and may increase the chance of side effects such as high blood pressure.
• Other nicotine replacement therapy products may increase the risk of excess nicotine exposure.

Nicotrol Inhaler is available as a reusable oral inhaler mouthpiece and individual nicotine cartridges that deliver a controlled dose of nicotine. Each cartridge contains 10 mg of nicotine, but only 4 mg are actually delivered.

Nicotrol Inhaler should be stored at room temperature, away from the reach of children or pets.

Nicotrol Inhaler was manufactured by Pfizer and has been discontinued.

Nicotrol Inhaler is a brand-name nicotine inhalation system. There is no generic version currently available.

Nicotrol Inhaler should be discontinued gradually. As nicotine cravings decrease, the number of cartridges used each day should be reduced over time. Gradual tapering helps prevent nicotine withdrawal symptoms. A healthcare provider can help create a step-down plan that supports long-term smoking cessation and wellness.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. Smoking during pregnancy carries serious risks, and your healthcare provider will determine whether nicotine replacement therapy is appropriate.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. Nicotine can pass into breast milk, and a healthcare professional can help weigh the risks and benefits of treatment during breastfeeding.