Nicotine-nasal

Name: Nicotine-nasal

How to use

Read the Patient Information Leaflet provided by your pharmacist before you start using your nicotine nasal spray and each time you get a refill. Follow all the directions for use carefully. If you have any questions, consult your doctor or pharmacist.It is very important to stop smoking completely while using this nicotine product. Tilt your head back and use 1 spray in each nostril or as directed by your doctor. Do not sniff, swallow, or inhale through the nose as you use the spray. Follow all instructions and learn proper technique for use.When you quit smoking, start using your nicotine nasal spray whenever you crave a cigarette, using 2 to 4 sprays per hour. Usually, you will use at least 8 doses (16 sprays) each day when you first start or as directed by your doctor. Do not use more than 40 doses total (80 sprays) in a day. Your doctor may direct you to use this product on a regular schedule as well as at times when you have the urge to smoke. Regular use during the first week can help your body get used to the medication and decrease side effects such as nose irritation. The best dose for you is the dose that decreases the urge to smoke without side effects from too much nicotine. Follow your doctor's orders carefully. Your dose will need to be adjusted to your needs, including smoking history and medical condition.If this drug touches the skin, lips, mouth, or ears, rinse the affected area immediately with water. Do not use soap. If this medication gets into your eyes, flush your eyes with clear water for 20 minutes. Discard used containers with the child-resistant cap on and away from the reach of children and pets.After you have stopped smoking and you have reached the best dose and schedule for you, continue at that dose. Usually, after about 8 weeks, your doctor will help you gradually reduce your dose until you are no longer smoking and no longer need nicotine replacement. Treatment for longer than 6 months is usually not recommended, but consult your doctor.This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as tobacco cravings, nervousness, irritability, headache) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.Tell your doctor if you have not been able to quit smoking after using this product for 4 weeks. Some smokers are unsuccessful the first time they try to quit. You may need to stop using this product and try again later. Many people who cannot quit the first time are successful the next time.

Overdose

This product may be harmful if swallowed. If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: confusion, drooling, seizure, slow/shallow breathing, hearing problems.

Notes

Do not share this medication with others.

Commonly used brand name(s)

In the U.S.

  • Nicotrol NS

Available Dosage Forms:

  • Spray

Therapeutic Class: Smoking Cessation Agent

Pharmacologic Class: Cholinergic

Before Using nicotine

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 nicotine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to nicotine 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

Appropriate studies have not been performed on the relationship of age to the effects of nicotine nasal spray in the pediatric population. Safety and efficacy have not been established. Small amounts of nicotine can cause serious unwanted effects in children, and the nasal spray contains enough nicotine to cause problems, including used bottles.

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

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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 nicotine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking nicotine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

  • Tegafur

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 nicotine. Make sure you 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 (eg, 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 make these conditions worse.
  • Heart attack, history of or
  • Heart or blood vessel disease—Use with caution. May cause side effects to become worse.
  • Kidney disease, severe or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Nasal allergies, chronic or
  • Nasal polyps or
  • Rhinitis (runny nose), chronic or
  • Sinusitis, chronic—Use is not recommended due to potential for nasal irritation.

nicotine 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:

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.

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