Nicotrol NS

Generic Name: nicotine (Nasal route)

NIK-oh-teen

Commonly used brand name(s):

In the U.S.

• Nicotrol NS

Available Dosage Forms:

• Spray

Therapeutic Class: Smoking Cessation Agent

Pharmacologic Class: Cholinergic

Uses For Nicotrol NS

Nicotine in a nasal spray is used to help you stop smoking. It is used for up to 6 months as part of a stop-smoking program. This program may include counseling, education, or psychological support.

With the nasal spray, nicotine is inhaled through your nose and passes into your blood stream. This nicotine takes the place of the nicotine you would otherwise get from smoking. In this way, the withdrawal effects of not smoking are less severe. Then, as your body adjusts to not smoking, the use of nicotine nasal spray is decreased gradually over several weeks. Finally, use is stopped altogether.

Children, pregnant women, and nonsmokers should not use nicotine nasal spray because of harmful effects.

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

Before Using Nicotrol NS

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

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

Pediatric

Because of nicotine nasal spray's toxicity, use in children is not recommended.

Geriatric

Although appropriate studies on the relationship of age to the effects of nicotine nasal spray have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving nicotine nasal spray.

Pregnancy

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Clozapine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergies or
• Common cold or
• Nose polyps or
• Rhinitis or
• Sinusitis—Nicotine nasal spray may not work properly.

• Asthma or other breathing problems or
• Heart attack, history of or
• Heart or blood vessel disease or
• Heart rhythm problems or
• Hypertension (high blood pressure) or
• Overactive thyroid or
• Pheochromocytoma (an adrenal problem) or
• Stomach ulcer or
• Type 1 diabetes (sugar diabetes)—Use with caution. Nicotine may make these conditions worse.

• Drug abuse or
• Drug dependence—Dependence may be more likely to develop.

• Kidney disease or
• Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of Nicotrol NS

Nicotine nasal spray usually comes with patient directions. Read the directions carefully before using this medicine. Ask your doctor if you have any questions.

You should stop smoking completely before you start using this medicine. If you continue to smoke during treatment, you may have an increased risk of nicotine overdose.

Use this medicine exactly as directed by your doctor. Remember that it is also important to participate in a stop-smoking program during treatment. This may make it easier for you to stop smoking.

To use the nasal spray:

• Tilt your head back slightly as you spray this medicine to your nose. Be careful not to sniff, swallow, or inhale this medicine.

Use of nicotine nasal spray may be gradually reduced by using only one half of a dose at a time or skipping doses by not using the spray every hour. You may also keep track of the number of doses and use fewer each day, or set a date to stop using nicotine nasal spray.

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 spray dosage form:
  • To help you stop smoking:
    • Adults—At first, 1 or 2 sprays (0.5 to 1 milligram [mg]) into each nostril every hour. The dose should then be adjusted based on the number of cigarettes you smoked each day before beginning treatment with the nasal spray and the side effects the nasal spray causes. Your doctor may increase your dose as needed. However, the total dose is usually not more than 80 sprays (40 mg).
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

Precautions While Using Nicotrol NS

Nicotine nasal spray should not be used by people who do not smoke because they can become addicted to nicotine.

Nicotine should not be used in pregnancy. If there is a possibility you might become pregnant, you may want to use some type of birth control. If you think you may have become pregnant, stop using this medicine immediately and check with your doctor.

During the first week of use, you may have a hot, peppery feeling in the back of your throat or nose; coughing; runny nose; sneezing; or watery eyes. Do not stop using this medicine. If you continue to use nicotine nasal spray regularly, you should adjust to these effects. If these effects do not lessen after 1 week, check with your doctor.

Avoid contact with the skin, mouth, eyes, and ears . If even a small amount of nicotine nasal spray comes into contact with the skin, mouth, eyes, or ears, the affected area should be immediately rinsed with water only.

Do not use nicotine nasal spray for longer than 6 months. This may result in physical dependence on the nicotine.

Nicotine products must be kept out of the reach of children and pets. Even very small amounts of nicotine may cause poisoning in children. If a child uses nicotine nasal spray, contact your doctor or poison control center at once.

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.

Nicotrol NS Side Effects

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:

• Feelings of dependence
• joint pain
• shortness of breath
• swelling of the gums, mouth, or tongue
• tightness in the chest
• tingling in the arms, legs, hands, or feet

• 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

• Blood-containing blisters on the skin
• difficulty with speaking
• loss of memory
• migraine headache
• skin rash
• swelling of the feet or lower legs
• wheezing

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

• Cold sweat
• convulsions (seizures)
• disturbed hearing and vision
• dizziness
• drooling
• pale skin
• slow heartbeat
• tremors
• unusual tiredness or weakness
• vomiting

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:

• Back pain
• constipation
• cough
• headache
• hot, peppery feeling in the back of the throat or nose
• indigestion
• nausea
• runny nose
• sneezing
• watery eyes

• Abdominal or stomach pain
• acne
• change in sense of smell or taste
• dryness, burning, itching, or irritation of the eyes
• earache
• flushing of the face
• hoarseness
• itching
• menstrual problems
• nosebleed
• passing of gas
• sinus problems
• soreness of the teeth and gums
• stuffy nose

• Changes in vision
• diarrhea
• dryness of the 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.

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