Nicotine (nasal)

Nicotine (nasal)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Overview

Nicotine (nasal) is a that is FDA approved for the {{{indicationType}}} of . Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Nicotine (nasal) FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Nicotine (nasal) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Nicotine (nasal) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Nicotine (nasal) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Nicotine (nasal) in pediatric patients.

Non–Guideline-Supported Use

Contraindications

• Use of NICOTROL NS therapy is contraindicated in patients with known hypersensitivity or allergy to nicotine or to any component of the product.

Warnings

• Nicotine from any source can be toxic and addictive. Smoking causes lung disease, cancer, and heart disease and may adversely affect pregnant women or the fetus. For any smoker, with or without concomitant disease or pregnancy, the risk of nicotine replacement in a smoking cessation program should be weighed against the hazard of continued smoking, and the likelihood of achieving cessation of smoking without nicotine replacement.

• Pregnancy, Warning

• Tobacco smoke, which has been shown to be harmful to the fetus, contains nicotine, hydrogen cyanide, and carbon monoxide. Nicotine has been shown in animal studies to cause fetal harm. It is therefore presumed that NICOTROL NS can cause fetal harm when administered to a pregnant woman. The effect of nicotine delivery by NICOTROL NS has not been examined in pregnancy (See PRECAUTIONS). Therefore, pregnant smokers should be encouraged to attempt cessation using educational and behavioral interventions before using pharmacological approaches. If NICOTROL NS is used during pregnancy, or if the patient becomes pregnant while using it, the patient should be apprised of the potential hazard to the fetus.

• Safety Note Concerning Children

• The amounts of nicotine that are tolerated by adult smokers can produce symptoms of poisoning and could prove fatal if NICOTROL NS is used or ingested by children or pets. A full bottle of NICOTROL NS contains 100 mg of nicotine, some of which will still be in the bottle when it is discarded. Therefore, patients should be cautioned to keep both used and unused containers of NICOTROL NS out of the reach of children and pets.

Precautions

• The patient should be urged to stop smoking completely when initiating NICOTROL NS therapy (SeeDOSAGE AND ADMINISTRATION). Patients should be informed that if they continue to smoke while using the product, they may experience adverse effects due to peak nicotine levels higher than those experienced from smoking alone. If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the treatment should be discontinued (See WARNINGS). Physicians should anticipate that concomitant medications may need dosage adjustment

• Sustained use (beyond 6 months) of NICOTROL NS by patients who stop smoking is not recommended and should be discouraged .

• Use of NICOTROL NS is not recommended in patients with known chronic nasal disorders (e.g. allergy, rhinitis, nasal polyps and sinusitis) since such use has not been adequately studied.

• Asthma, Bronchospasm and Reactive Airway Disease

• Exacerbation of bronchospasm in patients with pre-existing asthma has been reported. Use of NICOTROL NS in patients with severe reactive airway disease is not recommended.

• Effect of NICOTROL NS on the Nasal Mucosa

• Topical application of either nicotine or tobacco products is irritating to the nasal mucosa and physicians should consider both the risks and benefits to the patient before initiating or continuing NICOTROL NS therapy.

• The effect of NICOTROL NS on the nasal mucosa was studied in 39 cigarette smokers who used NICOTROL NS for 1 month. When compared to baseline, random biopsies taken after four weeks of treatment revealed 1 patient with persistence of pre-existing dysplasia and 1 patient with a newly found dysplasia. In both, dysplasia was not seen after a recovery period of eight weeks.

• Forty-two patients who used NICOTROL NS for more than 6 months underwent follow-up ear, nose and throat examinations 1 to 3 months after discontinuing the use of the spray. Many reported local irritant effects of the spray during spray use, but none showed persistent mucosal injury that the examining physician could attribute to use of the product.

• The clinical significance of these findings is not known, but extended use of the product beyond six months is not recommended.

• Cardiovascular or Peripheral Vascular Diseases

• The risks of nicotine replacement in patients with cardiovascular and peripheral vascular diseases should be weighed against the benefits of including nicotine replacement in a smoking cessation program for them. Specifically, patients with coronary heart disease (history of myocardial infarction and/or angina pectoris), serious cardiac arrhythmias, or vasospastic diseases (Buerger's disease, Prinzmetal's variant angina and Raynaud's phenomena) should be evaluated carefully before nicotine replacement is prescribed.

• Tachycardia occurring in association with nicotine replacement therapy has been reported. No serious cardiovascular events were reported in clinical studies with NICOTROL NS, but if symptoms occur, its use should be discontinued.

• NICOTROL NS generally should not be used in patients during the immediate postmyocardial infarction period, nor in patients with serious arrhythmias, or with severe or worsening angina.

• Renal or Hepatic Insufficiency

• The pharmacokinetics of nicotine have not been studied in the elderly or in patients with renal or hepatic impairment. However, given that nicotine is extensively metabolized and that its total system clearance is dependent on liver blood flow, some influence of hepatic impairment on drug kinetics (reduced clearance) should be anticipated. Only severe renal impairment would be expected to affect the clearance of nicotine or its metabolites from the circulation (See PHARMACOKINETICS).

• Endocrine Diseases

• NICOTROL NS therapy should be used with caution in patients with hyperthyroidism, pheochromocytoma or insulin-dependent diabetes, since nicotine causes the release of catecholamines by the adrenal medulla.

• Peptic Ulcer Disease

• Nicotine delays healing in peptic ulcer disease; therefore, NICOTROL NS therapy should be used with caution in patients with active peptic ulcers and only when the benefits of including nicotine replacement in a smoking cessation program outweigh the risks.

• Accelerated Hypertension

• Nicotine therapy constitutes a risk factor for development of malignant hypertension in patients with accelerated hypertension; therefore, NICOTROL NS therapy should be used with caution in these patients and only when the benefits of including nicotine replacement in a smoking cessation program outweigh the risks.

Adverse Reactions

Clinical Trials Experience

• 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 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 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

table02

• 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

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Nicotine (nasal) in the drug label.

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.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category D

• The harmful effects of cigarette smoking on maternal and fetal health are clearly established. These include low birth weight, an increased risk of spontaneous abortion, and increased perinatal mortality. The specific effects of NICOTROL NS on fetal development are unknown. Therefore pregnant smokers should be encouraged to attempt cessation using educational and behavioral interventions before using pharmacological approaches.

• Spontaneous abortion during nicotine replacement therapy has been reported; as with smoking, nicotine as a contributing factor cannot be excluded.

• 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.

• Teratogenicity

• Animal Studies

• Nicotine was shown to produce skeletal abnormalities in the offspring of mice when toxic doses were given to the dams (25 mg/kg IP or SC).

• Human Studies

• Nicotine teratogenicity has not been studied in humans except as a component of cigarette smoke (each cigarette smoked delivers about 1 mg of nicotine). It has not been possible to conclude whether cigarette smoking is teratogenic to humans.

• Other Effects

• Animal Studies

• A nicotine bolus (up to 2 mg/kg) to pregnant rhesus monkeys caused acidosis, hypercarbia, and hypotension (fetal and maternal concentrations were about 20 times those achieved after smoking one cigarette in 5 minutes). Fetal breathing movements were reduced in the fetal lamb after intravenous injection of 0.25 mg/kg nicotine to the ewe (equivalent to smoking 1 cigarette every 20 seconds for 5 minutes). Uterine blood flow was reduced about 30% after infusion of 0.1 µg/kg/min nicotine to pregnant rhesus monkeys (equivalent to smoking about six cigarettes every minute for 20 minutes).

• Human Experience

• Cigarette smoking during pregnancy is associated with an increased risk of spontaneous abortion, low birth weight infants and perinatal mortality. Nicotine and carbon monoxide are considered the most likely mediators of these outcomes. The effects of cigarette smoking on fetal cardiovascular parameters have been studied near term. Cigarettes increased fetal aortic blood flow and heart rate and decreased uterine blood flow and fetal breathing movements. NICOTROL NS has not been studied in pregnant women.

Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nicotine (nasal) in women who are pregnant.

Labor and Delivery

• NICOTROL NS is not recommended for use during labor and delivery. The effect of nicotine on a mother or the fetus during labor is unknown.

Nursing Mothers

• Caution should be exercised when NICOTROL NS is administered to nursing mothers. The safety of NICOTROL NS therapy in nursing infants has not been examined. Nicotine passes freely into breast milk; the milk to plasma ratio averages 2.9. Nicotine is absorbed orally. An infant has the ability to clear nicotine by hepatic first-pass clearance; however, the efficiency of removal is probably lowest at birth. Nicotine concentrations in milk can be expected to be lower with NICOTROL NS when used as recommended than with cigarette smoking, as maternal plasma nicotine concentrations are generally reduced with nicotine replacement. The risk of exposure of the infant to nicotine from NICOTROL NS therapy should be weighed against the risks associated with the infant's exposure to nicotine from continued smoking by the mother (passive smoke exposure and contamination of breast milk with other components of tobacco smoke) and from NICOTROL NS alone, or in combination with continued smoking.

Pediatric Use

• NICOTROL NS therapy is not recommended for use in the pediatric population because its safety and effectiveness in children and adolescents who smoke have not been evaluated.

Geriatic Use

• Clinical studies of NICOTROL NS did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects. Other reports on clinical experience have not identified differences between older and younger patients. In general, dosage selection for an elderly patient should be cautious, usually starting at the low end of the dosage range reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease.

Gender

There is no FDA guidance on the use of Nicotine (nasal) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Nicotine (nasal) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Nicotine (nasal) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Nicotine (nasal) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Nicotine (nasal) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Nicotine (nasal) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Nasal

Monitoring

There is limited information regarding Monitoring of Nicotine (nasal) in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Nicotine (nasal) in the drug label.

Overdosage

• The oral LD50 for nicotine is >5 mg/kg in dogs and >24 mg/kg in rodents. Death is due to respiratory paralysis. The oral minimum acute lethal dose for nicotine in adult humans is reported to be 40 to 60 mg (<1 mg/kg). A full bottle of NICOTROL NS contains 100 mg of nicotine.

• NICOTROL NS would be expected to be irritating if sprayed in the eyes, mouth or ears. Eye exposure should be treated with copious irrigation with water for 20 minutes. Large oral nicotine ingestions cause vomiting, and the consequences of an overdose will vary; should this occur, patients should contact their physician immediately. For additional emergency information, call your regional poison center.

• Signs and Symptoms of Nicotine Toxicity

• Signs and symptoms of an overdose of NICOTROL NS would be expected to be the same as those of acute nicotine poisoning including: pallor, cold sweat, nausea, salivation, vomiting, abdominal pain, diarrhea, headache, dizziness, disturbed hearing and vision, tremor, mental confusion, and weakness. Prostration, hypotension, and respiratory failure may ensue with large overdoses. Lethal doses produce convulsions quickly and death follows as a result of peripheral or central respiratory paralysis or, less frequently, cardiac failure.

• Overdose from Ingestion

• If emesis has not occurred, it should be induced in conscious patients with a suitable emetic followed by an appropriate dose of activated charcoal. In unconscious patients with a secure airway, instill activated charcoal via a nasogastric tube. A saline cathartic or sorbitol may be added to the first dose of activated charcoal.

• Management of Nicotine Poisoning

• Other supportive measures include diazepam or barbiturates for seizures, atropine for excessive bronchial secretions or diarrhea, respiratory support for respiratory failure, and vigorous fluid support for hypotension and cardiovascular collapse.

Pharmacology

There is limited information regarding Nicotine (nasal) Pharmacology in the drug label.

Mechanism of Action

• Nicotine, the chief alkaloid in tobacco products, binds stereo-selectively to nicotinic-cholinergic receptors at the autonomic ganglia, in the adrenal medulla, at neuromuscular junctions, and in the brain. Two types of central nervous system effects are believed to be the basis of nicotine's positively reinforcing properties. A stimulating effect is exerted mainly in the cortex via the locus ceruleus and a reward effect is exerted in the limbic system. At low doses, the stimulant effects predominate while at high doses the reward effects predominate. Intermittent intravenous administration of nicotine activates neurohormonal pathways, releasing acetylcholine, norepinephrine, dopamine, serotonin, vasopressin, beta-endorphin, growth hormone, and ACTH.

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

• The cardiovascular effects of nicotine include peripheral vasoconstriction, tachycardia, and elevated blood pressure. Acute and chronic tolerance to nicotine develops from smoking tobacco or ingesting nicotine preparations. Acute tolerance (a reduction in response for a given dose) develops rapidly (less than 1 hour), but not at the same rate for different physiologic effects (skin temperature, heart rate, subjective effects). Withdrawal symptoms such as cigarette craving can be reduced in most individuals by plasma nicotine levels lower than those from smoking.

• Withdrawal from nicotine in addicted individuals can be characterized by craving, nervousness, restlessness, irritability, mood lability, anxiety, drowsiness, sleep disturbances, impaired concentration, increased appetite, minor somatic complaints (headache, myalgia, constipation, fatigue), and weight gain. Nicotine toxicity is characterized by nausea, abdominal pain, vomiting, diarrhea, diaphoresis, flushing, dizziness, disturbed hearing and vision, confusion, weakness, palpitations, altered respiration and hypotension.

• Both smoking and nicotine can increase circulating cortisol and catecholamines, and tolerance does not develop to the catecholamine-releasing effects of nicotine. Changes in the response to a concomitantly administered adrenergic agonist or antagonist should be watched for when nicotine intake is altered during NICOTROL NS therapy and/or smoking cessation

Pharmacokinetics

• Each actuation of NICOTROL NS delivers a metered 50 microliter spray containing approximately 0.5 mg of nicotine. One dose is considered 1 mg of nicotine (2 sprays, one in each nostril).

• Absorption

• Following administration of 2 sprays of NICOTROL NS approximately 53% ± 16% (Mean ± SD) enters the systemic circulation. No significant difference in rate or extent of absorption could be seen due to the deposition of nicotine on different parts of the nasal mucosa. Plasma concentrations of nicotine obtained from 1 dose (1 mg nicotine) of NICOTROL NS rise rapidly, reaching maximum venous concentrations of 2–12 ng/mL in 4–15 minutes. The apparent absorption half-life of nicotine is approximately 3 minutes. There is wide variation among subjects in their plasma nicotine concentrations from the spray. As a result, after a 1 mg dose of spray approximately 20% of the subjects reached peak nicotine concentrations similar to those seen after smoking one cigarette (7–17 ng/mL) (See DRUG ABUSE AND DEPENDENCE Section). Figure 1 below plots the mean and 5th and 95th percentile nicotine concentrations after a 1 mg single dose of the nasal spray (n=30).

Distribution

The volume of distribution following IV administration of nicotine is approximately 2 to 3 L/kg. Plasma protein binding of nicotine is <5%. Therefore, changes in nicotine binding from use of concomitant drugs or alterations of plasma proteins by disease states would not be expected to have significant effects on nicotine kinetics.

Metabolism

More than 20 metabolites of nicotine have been identified, all of which are less active than the parent compound. The primary urinary metabolites are cotinine (15% of the dose) and trans-3-hydroxycotinine (45% of the dose). Cotinine has a half-life of 15 to 20 hours and concentrations that exceed nicotine by 10-fold. The major site for the metabolism of nicotine is the liver. The kidney and lung are also sites of nicotine metabolism.

Elimination

About 10% of the nicotine absorbed is excreted unchanged in the urine. This may be increased to up to 30% with high urine flow rates and urinary acidification below pH 5. The average plasma clearance is about 1.2 L/min in a healthy adult smoker. The apparent elimination half-life of nicotine from NICOTROL NS is 1 to 2 hours.

Pharmacokinetic Model

The data were well described by a two-compartment model with first-order input.

Based on individual fits (N=18) the following parameters were derived after the administration of a 1 mg dose: Absorption rate constant (Ka) = 14.4 ± 7.3 hr-1 (Mean ± SD), Elimination rate constant (Ke) = 0.60 ± 0.53 hr-1, Distribution rate constants (K12) = 4.84 ± 2.57 hr-1, (K21) = 4.35 ± 2.30 hr-1, Volume of distribution over fraction absorbed (V/F) = 2.73 ± 0.82 L/kg in 8 female and 10 male adults weighing 76 ± 15 kg.

Gender Differences

• Intersubject variability (50% coefficient of variation) among the pharmacokinetic parameters (AUC, Cmax and Clearance/kg) were observed for both genders. There were no differences between females or males in the kinetics of NICOTROL NS.

• Drug/Drug Interactions

• The extent of absorption is slightly reduced (approximately 10%) in patients with the common cold/rhinitis. In patients with rhinitis the peak plasma concentration is reduced by approximately 20% (concentrations are lower by 1.5 ng/mL on average) and the time to peak concentration prolonged by approximately 30% (delayed by 7 minutes on average). The use of a nasal vasoconstrictor such as xylometazoline in patients with rhinitis will further prolong the time to peak by approximately 40% (delayed by 15 minutes on average), but the peak plasma concentration remains on average the same as those with rhinitis.

Nonclinical Toxicology

• Carcinogenesis, Mutagenesis, Impairment Of Fertility

• Nicotine itself does not appear to be a carcinogen in laboratory animals. However, nicotine and its metabolites increased the incidences of tumors in the cheek pouches of hamsters and forestomach of F344 rats, respectively, when given in combination with tumor-initiators. One study, which could not be replicated, suggested that cotinine, the primary metabolite of nicotine, may cause lymphoreticular sarcoma in the large intestine of rats.

• Neither nicotine nor cotinine were mutagenic in the Ames salmonella test. Nicotine induced repairable DNA damage in an E. coli test system. Nicotine was shown to be genotoxic in a test system using Chinese hamster ovary cells. In rats and rabbits, implantation can be delayed or inhibited by a reduction in DNA synthesis that appears to be caused by nicotine. Studies have shown a decrease in litter size in rats treated with nicotine during gestation.

Clinical Studies

There is limited information regarding Clinical Studies of Nicotine (nasal) in the drug label.

How Supplied

There is limited information regarding Nicotine (nasal) How Supplied in the drug label.

Storage

There is limited information regarding Nicotine (nasal) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

• A patient instruction sheet is included in the package of NICOTROL NS dispensed to the patient. Patients should be encouraged to read the instruction sheet carefully and to ask their physician and pharmacist about the proper use of the product.

• It should be explained to patients that they are likely to experience nasal irritation, which may become less bothersome with continued use.

• Patients must be advised to keep both used and unused containers out of the reach of children and pets.

Precautions with Alcohol

• Alcohol-Nicotine (nasal) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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