NICOTROL® NS (nicotine nasal spray) 10 mg/mL
NICOTROL NS (nicotine nasal spray) is indicated as an aid to 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.
Important Safety Information
Use of NICOTROL NS is contraindicated in patients with known hypersensitivity
or allergy to nicotine, menthol or to any component of the product.
The safety and efficacy of the continued use of NICOTROL NS for periods
longer than 6 months have not been adequately studied and such use is not
recommended.
The patient must stop smoking completely before using NICOTROL NS.
Because nicotine is addictive, patient dependency upon NICOTROL NS is
possible. It is important the patient use it only for as long as needed to
overcome a smoking habit.
Prior to starting NICOTROL NS, the patient must inform the healthcare
professional of all medications he or she is taking. Certain concomitant
medications may require a dosage adjustment.
A special note about children and pets. NICOTROL NS can cause serious
illness in children and pets—even in very small amounts. If a child or pet uses
or ingests NICOTROL NS, immediately call a doctor or call your regional poison
center.
Adverse reactions. The patient may experience mild to moderate nasal
irritation when treating with NICOTROL NS. In clinical trials, other common side
effects were: runny nose, throat irritation, watering eyes, sneezing, and
coughing. 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.
Pregnancy and nursing. The specific effects of NICOTROL NS treatment on
fetal development and nursing infants are unknown. Therefore, pregnant and
nursing smokers should be encouraged to attempt cessation using educational
and behavioral interventions before using pharmacological approaches.
Asthma, bronchospasm and reactive airway disease. Use of NICOTROL NS
is not recommended in patients with known chronic nasal disorders (eg, allergy,
rhinitis, nasal polyps and sinusitis), asthma, bronchospasm, and severe reactive
airway disease.
Cardiovascular or peripheral vascular diseases. NICOTROL NS should be
used with caution in patients with cardiovascular and peripheral vascular
diseases, specifically coronary heart disease, serious cardiac arrhythmias, or
vasospastic diseases. In these situations, the potential risks of using NICOTROL
NS should be discussed with the patient.