Recommended Topic Related To:

Nicotrol NS

"Dec. 14, 2012 -- Smokers who take Chantix to stop smoking may be at higher risk for heart attacks and strokes compared to those who don't take the drug, the FDA says. But the increased risk is small and should be weighed against the risks of cont"...

Nicotrol NS

Nicotrol NS

Nicotrol NS Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Nicotrol NS (nicotine) Nasal Spray 10 mg/mL is the primary ingredient in tobacco products and is used to aid in smoking cessation for the relief of nicotine withdrawal symptoms. Nicotrol NS therapy should be used as a part of a comprehensive behavioral smoking cessation program. Common side effects include chest tightness, indigestion, tingling in limbs, constipation, nasal or mouth sores, nasal congestion, sinus irritation, eye irritation, changes in sense of smell or taste, sore throat, numbness of the nose or mouth, burning of the nose or eyes, earache, facial flushing, or hoarseness.

The dose of Nicotrol NS is individualized on the basis of each patient's nicotine dependence and the occurrence of symptoms of nicotine excess. One dose is 1 mg of nicotine (2 sprays, one in each nostril). Nicotrol NS may interact with cold or allergy medication that contains phenylephrine, antidepressants, insulin, asthma medications, labetalol, oxazepam, pentazocine, prazosin, propranolol, theophylline, or varenicline or other non-nicotine smoking cessation products. Tell your doctor all medications and supplements you use. The harmful effects of cigarette smoking on maternal and fetal health are clearly established. Nicotrol NS should be used during pregnancy only if the likelihood of smoking cessation justifies the potential risk of using it by the pregnant patient, who might continue to smoke. Nicotine passes into breast milk. Caution should be exercised when Nicotrol NS is administered to nursing mothers. Consult your doctor before breastfeeding.

Our Nicotrol NS (nicotine) Nasal Spray 10 mg/mL Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Nicotrol NS in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • blisters inside your mouth;
  • fast or pounding heartbeats, fluttering in your chest;
  • extreme weakness or dizziness;
  • severe nausea and vomiting; or
  • bronchospasm (wheezing, tightness in your chest, trouble breathing).

Less serious side effects may include:

  • mild dizziness;
  • dry mouth, upset stomach, burping, or hiccups;
  • muscle or joint pain;
  • mouth or throat soreness;
  • changes in taste; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nicotrol NS (Nicotine Nasal Spray) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Nicotrol NS FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Assessment of adverse events in the 730 patients who participated in controlled clinical trials is complicated by the occurrence of signs and symptoms of nicotine withdrawal in some patients and nicotine excess in others. The incidence of adverse events is confounded by the many minor complaints that smokers commonly have, by continued smoking by many patients and the local irritation from both active drug and the pepper placebo. No serious adverse events were reported during the trials.

Common Smoker's Complaints

Common complaints experienced by the smokers in the study (users of both active and placebo spray) include: chest tightness, dyspepsia, paraesthesia (tingling) in limbs, constipation, and stomatitis.

Tobacco Withdrawal Symptoms

Symptoms of tobacco withdrawal were frequent in users of both active and placebo sprays. Common withdrawal symptoms seen in over 5% of patients included: anxiety, irritability, restlessness, cravings, dizziness, impaired concentration, weight increase, emotional lability, somnolence and fatigue, increased sweating, and insomnia. Less frequently seen probable withdrawal symptoms (under 5%) included: confusion, depression, apathy, tremor, increased appetite, incoordination and increased dreaming.

Anxiety, irritability, restlessness and tobacco cravings occurred about equally in both groups, while other symptoms tended to be slightly more common on placebo spray.

Effects of the Spray

NICOTROL NS (nicotine nasal spray) and the pepper-containing placebo were both associated with irritant side effects on the nasopharyngeal and ocular tissues. During the first 2 days of treatment, nasal irritation was reported by nearly all (94%) of the patients, the majority of whom rated it as either moderate or severe. Both the frequency and severity of nasal irritation declined with continued use of NICOTROL NS (nicotine nasal spray) but was still experienced by most (81%) of the patients after 3 weeks of treatment, with most patients rating it as moderate or mild.

Other common side-effects for both active and placebo groups were: runny nose, throat irritation, watering eyes, sneezing, and coughing.

The following local events were reported somewhat more commonly for active than for placebo spray: nasal congestion, subjective comments related to the taste or use of the dosage form, sinus irritation, transient epistaxis, eye irritation, transient changes in sense of smell, pharyngitis, paraethesias of the nose, mouth or head, numbness of the nose, or mouth, burning of the nose or eyes, earache, facial flushing, transient changes in sense of taste, hoarseness, nasal ulcer or blister.

Effects of Nicotine

Feelings of dependence on the spray were reported by more patients on active spray than placebo. Drug-like effects such as calming were also more frequent on active spray. (See Drug Abuse And Dependence).

Other Adverse Effects

Adverse events which could not be classified and listed above and which were reported by > 1% of patients on active spray are listed in the following table:

Adverse Events Not Attributable to Intercurrent Illness

Adverse Event Active Placebo
HEADACHE 18% 15%
BACK PAIN 6% 4%
DYSPNEA 5% 6%
NAUSEA 5% 5%
ARTHRALGIA 5% 1%
MENSTRUAL DISORDER 4% 4%
PALPITATION 4% 4%
FLATULENCE 4% 3%
TOOTH DISORDER 4% 1%
GUM PROBLEMS 4% 1%
MYALGIA 3% 4%
ABDOMINAL PAIN 3% 3%
CONFUSION 3% 3%
ACNE 3% 1%
DYSMENORRHEA 3% 0%
PRURITUS 2% 3%

Adverse events reported with a frequency of < 1% among active spray users are listed below:

Body as a Whole:edema peripheral, pain, numbness, allergy

Gastrointestinal: dry mouth, hiccup, diarrhea

Hematologic: purpura Neurological: aphasia, amnesia, migraine, numbness

Respiratory: bronchitis, bronchospasm, sputum increased

Skin and appendages: rash, purpura Special Senses: vision abnormal

Drug Abuse And Dependence

NICOTROL NS has a dependence potential intermediate between other nicotine-based therapies and cigarettes. This is the result of differences between cigarettes, NICOTROL NS, nicotine gum and nicotine patches in pharmacokinetic and dosing characteristics commonly associated with abuse and dependence. NICOTROL NS is distinct from other nicotine-based smoking cessation therapies in its greater speed of onset, greater capacity for self-titration of dose, and frequent and rapid fluctuations in plasma nicotine concentration.

Dependence on nicotine nasal spray occurred in the clinical trials. Feelings of dependency on the spray were reported by 32% of active spray users and 13% of placebo spray users. Such dependence may represent transference of tobacco-related nicotine dependence to NICOTROL NS (nicotine nasal spray) .

Fifteen to 20% of patients used the active spray for longer periods than recommended (6 months to 1 year) and 5% used the spray at a higher dose than recommended. Some of these patients experienced anxiety about stopping the spray and some reported craving for the spray rather than for cigarettes.

Read the entire FDA prescribing information for Nicotrol NS (Nicotine Nasal Spray) »

A A A

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.


Smoking Cessation

Get tips, treatments, & motivation.

Related Drugs
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations