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Nicotrol NS

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Nicotrol NS

Side Effects
Interactions

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 Nicotrol NS (nicotine nasal spray) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

The extent of absorption and peak plasma concentration is slightly reduced in patients with the common cold/rhinitis. In addition, the time to peak concentration is prolonged. The use of a nasal vasoconstrictor such as xylometazoline in patients with rhinitis will further prolong the time to peak (See Pharmacokinetics). Smoking cessation, with or without nicotine replacement, may alter the pharmacokinetics of certain concomitant medications.

May Require a Decrease in Dose at Cessation of Smoking Possible Mechanism
Acetaminophen, caffeine, imipramine, oxazepam, pentazocine, propranolol, or other beta-blockers, theophylline Deinduction of hepatic enzymes on smoking cessation.
Insulin Increase of subcutaneous insulin absorption with smoking cessation.
Adrenergic antagonists (e.g. prazosin, labetalol) Decrease in circulating catecholamines with smoking cessation.
May Require a Decrease in Dose at Cessation of Smoking Possible Mechanism
Adrenergic agonists (e.g. isoproterenol, phenylephrine) Decrease in circulating catecholamines with smoking cessation.

Read the Nicotrol NS Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 3/10/2009
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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