Nicotrol NS (Nasal)

Nicotine nasal spray is used to help you stop smoking. Nicotine is taken in through the nose and goes into the bloodstream. This replaces the nicotine you would get from smoking and reduces the withdrawal symptoms from not smoking. The amount of nicotine is lowered over time until you stop using it.

This medicine is available only with your doctor's prescription.

Do not smoke or use any tobacco products with the nasal spray. If you keep smoking or chewing tobacco, you may experience serious unwanted effects from nicotine. Call your doctor immediately if you have dizziness, headaches, an upset stomach, drooling, vomiting, diarrhea, cold sweats, blurred vision, trouble hearing, confusion, fainting, or weakness.

Do not use any other nicotine products with the nasal spray. This includes nicotine patches, lozenges, or gum. You may have serious unwanted effects if you use more than one nicotine product.

Pregnant women should only use this medicine as directed by a doctor. Cigarette smoke can seriously harm your child. Try to stop smoking without using medicine. The risks to your child from this medicine are not fully known.

Nicotine products must be kept out of the reach of children and pets. Small amounts of nicotine can cause serious unwanted effects in children, and a used bottle may contain enough nicotine to cause problems. If a child touches the spray bottle, contact your doctor or poison control center immediately.

During the first week, you may feel a hot, peppery sensation in your throat or nose, cough, have a runny nose, sneeze, or have watery eyes. Do not stop using the medicine. If you continue to use the nasal spray, you should get used to these effects. If these effects do not lessen after several weeks, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you must consider the risks of taking it compared to the benefits it may provide. This is a decision you and your doctor will make together. For this medicine, the following should be thought about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Appropriate studies have not been performed on how nicotine nasal spray affects children. Safety and effectiveness have not been established. Small amounts of nicotine can cause serious unwanted effects in children, and the nasal spray has enough nicotine to cause problems, including used bottles.

Geriatric

While appropriate studies on how nicotine nasal spray affects older adults have not been done, no specific problems have been documented for this age group so far. However, older patients may have age-related kidney, liver, or heart issues, which may require caution and a dose adjustment for those using nicotine nasal spray.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. An alternative to this medication should be prescribed, or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there could be an interaction. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. When taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are based on their potential significance and may not include all possibilities.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Tegafur

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken close to mealtimes or with certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Angina (severe chest pain) or
• Asthma or
• Breathing problems or
• Buerger disease (circulation problem) or
• Diabetes (insulin-dependent) or
• Heart rhythm problems (e.g., arrhythmia) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Pheochromocytoma (adrenal problem) or
• Raynaud disease (circulation problem) or
• Stomach ulcer or
• Tachycardia (fast heart rate)—Use with caution. May worsen these conditions.

• History of heart attack or
• Heart or blood vessel disease—Use with caution. May worsen side effects.

• Severe kidney disease or
• Liver disease—Use with caution. Effects may be increased due to slower removal of the medicine from the body.

• Chronic nasal allergies or
• Nasal polyps or
• Chronic rhinitis (runny nose) or
• Chronic sinusitis—Use is not recommended due to potential nasal irritation.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Shortness of breath
• Swelling of the gums, mouth, or tongue
• Tightness in the chest
• Tingling in the arms, legs, hands, or feet

Less common

• Burning, tingling, or prickly sensations in the nose, mouth, or head
• Confusion
• Difficulty with swallowing
• Dryness or pain in the throat
• Fast or irregular heartbeat
• Muscle pain
• Nasal blister or sore
• Numbness of the nose or mouth

Rare

• Difficulty speaking
• Loss of memory
• Migraine headache
• Pinpoint red or purple spots on skin
• Skin rash
• Swelling of the feet or lower legs
• Wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Cold sweat
• Confusion
• Convulsions (seizures)
• Diarrhea
• Dizziness
• Drooling
• Hearing and vision changes
• Nausea and vomiting
• Pale skin
• Stomach pain
• Tremors
• Weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain
• Constipation
• Cough
• Headache
• Hot, peppery feeling in the back of the throat or nose
• Indigestion
• Nausea
• Runny nose
• Sneezing
• Watery eyes

Less common

• Acne
• Change in sense of smell or taste
• Dryness, burning, itching, or irritation of the eyes
• Earache
• Flushing of the face
• Hoarseness
• Itching
• Menstrual disorder
• Nosebleed
• Passing of gas
• Sinus problems
• Soreness of the teeth and gums
• Stomach pain
• Stuffy nose

Rare

• Changes in vision
• Diarrhea
• Dry mouth
• Hiccups
• Increased amount of sputum

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Nicotrol NS

Available Dosage Forms:

• Spray

Therapeutic Class: Smoking Cessation Agent

Pharmacologic Class: Cholinergic System

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine should come with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

You should stop smoking completely before you start using this medicine. Do not use any tobacco products during therapy. If you continue to smoke with the nasal spray, you may have serious unwanted effects from nicotine.

It is also important to use a stop-smoking program that may include education, counseling, and psychological support. This may make it easier for you to stop smoking.

This medicine should only be used in the nose. Do not get it on your skin, or in the mouth, eyes, or ears. If the spray gets on these areas, rinse the affected area immediately and only with water.

To use:

• Prime the spray before using it the first time.
• Hold a tissue or paper towel over the tip. Pump the bottle 6 to 8 times until medicine sprays out.
• If you do not use the medicine for 24 hours or longer, prime the spray again by pumping 1 or 2 times.
• Tilt your head back slightly. Breathe through your mouth. Spray once in each nostril. Do not sniff, swallow, or inhale the spray.
• If your nose runs after using the spray, sniff gently. You can blow your nose after 2 or 3 minutes.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For the nasal dosage form (spray):To help you stop smoking: Adults—At first, 1 spray in each nostril (1 milligram (mg)). The dose may be repeated 1 to 4 times during the same hour if needed. Your doctor may adjust the dose based on the number of cigarettes you smoke per day or based on how well you tolerate the medicine. However, the total dose is usually not more than 40 mg per day (40 sprays in each nostril). Your dose will be gradually reduced before stopping treatment completely. Children—Use is not recommended.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

When the bottle is empty, replace the cap and throw it away. Make sure it is out of the reach of children and pets.

If the spray bottle breaks or medicine leaks out of the bottle, wear rubber gloves to wipe up the spill. Wash the area completely using a paper towel. Nicotine can be absorbed through your skin and may cause serious unwanted effects.

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