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Drug overview for NICOTROL NS (nicotine):
Generic name: NICOTINE (NICK-oh-teen)
Drug class: Smoking Deterrents - Nicotinic or Bupropion (NDRI)-Type
Therapeutic class: Chemical Dependency, Agents to Treat
Nicotine, a naturally occurring autonomic drug, is a ganglionic (nicotinic) cholinergic-receptor agonist.
No enhanced Uses information available for this drug.
Generic name: NICOTINE (NICK-oh-teen)
Drug class: Smoking Deterrents - Nicotinic or Bupropion (NDRI)-Type
Therapeutic class: Chemical Dependency, Agents to Treat
Nicotine, a naturally occurring autonomic drug, is a ganglionic (nicotinic) cholinergic-receptor agonist.
No enhanced Uses information available for this drug.
DRUG IMAGES
NICOTROL NS 10 MG/ML SPRAY
The following indications for NICOTROL NS (nicotine) have been approved by the FDA:
Indications:
Smoking cessation
Professional Synonyms:
Smoking cessation assistance
Indications:
Smoking cessation
Professional Synonyms:
Smoking cessation assistance
The following dosing information is available for NICOTROL NS (nicotine):
Therapy with buccal (chewing gum, lozenge) nicotine polacrilex may be useful as a temporary substitute for smoking and, when used in conjunction with other therapies, may be beneficial in overcoming manifestations of nicotine withdrawal. Unlike nicotine transdermal systems or intranasal spray, but like orally inhaled nicotine using a smokeless cigarette-like inhaler, buccal nicotine polacrilex can provide a substitute oral activity during cigarette withdrawal. In addition, buccal administration of nicotine has the potential advantage of allowing smokers to control the amount and timing of dosing, thus allowing the patient to self-titrate dosage to an appropriate level and to use acute (''rescue'') dosing to combat acute craving episodes.
By comparison, transdermal systems potentially may provide some advantages over buccal nicotine polacrilex, such as a reduction in symptoms of craving, ease of administration, absence of local oral adverse effects, fewer adverse GI effects, less frequent dosing leading to better compliance, the absence of reinforcement of addictive behavior obtained from frequent self-administration of nicotine, and effectiveness across diverse settings and populations and when used with a variety of psychosocial interventions.
Nicotine oral inhalers provide a method of replacement that most closely mimics the behaviors (i.e., handling and inhalation through the mouth) of cigarette smoking, although clinical experience suggests that this mode of administration contributes at most only marginally to efficacy compared with buccal nicotine polacrilex or intranasal nicotine. In addition, the cigarette shape and more obvious use of the oral inhaler may carry some stigma in certain patients. Likewise, use of the nasal inhaler may carry some stigma in certain patients, and initially is locally very irritating.
Any of these forms of nicotine provides an alternative source of the drug that is devoid of tars, carbon monoxide, and respiratory irritants and that may help reduce withdrawal symptoms associated with nicotine dependence. Some data suggest that withdrawal symptoms unrelieved with transdermal nicotine therapy alone may respond to combined therapy with transdermal nicotine and buccal nicotine polacrilex. Some clinicians state that there are insufficient data from well-designed studies to recommend one method of smoking cessation therapy (e.g., transdermal nicotine systems, nicotine gum) over another.
Selection of an appropriate form of nicotine replacement should be individualized based on factors such as cost, insurance coverage, adherence, comorbid conditions, and specific warnings and contraindications.
Dosage of nicotine polacrilex is expressed in terms of nicotine. Dosage of nicotine polacrilex should be individualized by the patient after careful instruction and, unless self-administered without supervision, should be assessed periodically by the clinician. Supervised or unsupervised (self-medication) nicotine polacrilex therapy can be initiated with either the 2- or 4-mg (of nicotine) gum or lozenge, but should be individualized depending on the patient's degree of nicotine dependence.
Transdermal systems of nicotine are applied only once daily; after the prescribed duration of daily use (e.g., 16 or 24 hours), the system in use is removed and discarded and a new system is applied at a different site. The Nicotrol(R) transdermal system is designed to provide systemic nicotine delivery of nicotine over 16 hours; this system is applied daily after awakening and removed before retiring. Patients should be instructed not to use the same Nicotrol(R) transdermal system for longer than 16 hours.
The duration of daily use for NicoDerm(R) CQ(R) is 16-24 hours; patients who crave a cigarette upon awakening should wear this transdermal system for 24 hours. Patients who experience vivid dreams or other disturbances of sleep with application of NicoDerm(R) CQ(R) for 24 hours should remove the transdermal system after about 16 hours of application, before retiring. Patients should be instructed not to use the same NicoDerm(R) CQ(R) transdermal system for longer than 24 hours.
The metered pump of nicotine nasal solution delivers a metered 50-mcL spray that contains 0.5 mg of the drug per actuation. The commercially available pump containing 100 mg (10 mg/mL) of nicotine delivers approximately 200 sprays (i.e., 100 doses).
A 1-mg dose of nicotine is delivered by administering 1 spray of the nasal solution via the metered pump into each nostril (i.e., 2 sprays total). The dosage of nicotine nasal spray should be individualized depending on the patient's dependence on nicotine and whether symptoms of excessive intake of nicotine occur. Therapy with the nasal spray usually is initiated in adults with 1-mg doses administered once or twice per hour.
This initial dosage may be increased according to patient tolerance and response to a maximum of five 1-mg doses per hour to administer a maximum hourly dose of 5 mg and daily dose of 40 mg (i.e., 80 sprays). To achieve optimal therapeutic results, patients should be encouraged to administer at least the minimum recommended dosage of 8 mg daily since lower dosages are unlikely to be effective. Use of the spray regularly during the first week of therapy may allow adaptation to the irritant effect of nicotine nasal spray.
Nicotine dosage with the nasal spray can then be adjusted in patients with manifestations of nicotine withdrawal or excessive intake of nicotine, recognizing that some symptoms of excessive intake (as might occur in patients who continue to smoke) may be similar to those of nicotine withdrawal. In clinical studies of nicotine replacement therapy, excessive intake of nicotine appeared to be more often manifested by palpitations, nausea, and sweating and those of nicotine withdrawal by anxiety, nervousness, and irritability. When nicotine withdrawal was experienced most strongly, nicotine nasal spray was used liberally, up to the maximum dosage recommended of 40 mg daily in some heavy smokers, by patients who achieved cessation of smoking in clinical studies.
Once an appropriate dosage has been established, the manufacturer recommends continuation of therapy with nicotine nasal spray at that dosage for up to 8 weeks in patients who have abstained successfully from smoking. Therapy should then be discontinued sometime over the subsequent 4-6 weeks. An optimal schedule of tapering the dosage to discontinuance was not identified in clinical studies; therapy simply was discontinued by many patients at their last clinic visit.
The manufacturer recommends several strategies that patients can use to discontinue therapy with nicotine nasal spray including halving each dose (i.e., to 1 spray (0.5 mg)) administered, reducing the frequency of use, tallying daily administration, targeting a steady reduction in dosage, skipping a dose by deviating from hourly administration, or setting a date for discontinuance of therapy. Therapy can be discontinued abruptly in some patients, although gradual reduction of the dosage may be preferable in others. Continued therapy with nicotine nasal spray beyond 12-14 weeks has not been shown to improve outcome, and safety of use beyond 6 months has not been established.
Complete abstinence is the goal of therapy with nicotine nasal spray. If patients have not stopped smoking after 4 weeks of therapy with nicotine nasal spray, such therapy probably should be discontinued. Unsuccessful patients should be counseled and probably should receive a break from smoking cessation therapy before another attempt is tried.
Such patients may benefit from adjunctive interventions to enhance the possibility of success on the next attempt. Another attempt to quit smoking should be encouraged by a more favorable context.
Nicotine oral inhaler cartridges labeled as containing 10 mg of nicotine deliver a maximum of approximately 4 mg total with repeated inhalation.
Initial dosage of nicotine via oral inhalation should be individualized. Patients may self-titrate the orally inhaled dosage to the level of nicotine replacement they require. In clinical studies, most successful patients used between 6-16 cartridges daily.
Patients generally increased their daily nicotine dosage from the first to the second week of oral inhalation therapy, and then subsequently decreased their daily consumption somewhat but not substantially over the next 4 weeks. The recommended duration of therapy is 3 months, after which patients may be weaned from oral inhalation therapy by gradual reduction of the daily dosage over 6-12 weeks. Safety and efficacy of oral inhalation therapy have not been established beyond 6 months and therefore such prolonged use is not recommended by the manufacturer.
For optimal results, patients should be instructed to use at least 6 cartridges daily at least for the initial 3-6 weeks of nicotine oral inhalation therapy, with the likelihood of success increasing with daily doses exceeding this amount. Additional daily doses may be required to control the urge to smoke, but the manufacturer recommends that daily consumption not exceed 16 nicotine cartridges (about 64 mg of delivered nicotine) for up to 12 weeks. Dosage should be adjusted if manifestations of nicotine withdrawal or excess develop.
Initial treatment generally should continue for about 12 weeks, after which oral inhalation therapy may be gradually withdrawn.
After completion of a course (generally up to 12 weeks) of nicotine oral inhalation therapy, most patients require a gradual reduction in daily cartridge consumption, although abrupt discontinuance may be possible in some patients. Gradual dosage reduction may extend over 6-12 weeks. Recommended strategies for discontinuing therapy include recommending that the patient decrease the frequency of daily use of the oral inhaler, keep a tally of daily usage, try to meet a steadily reducing target, or set a planned quit date for discontinuing oral inhalation therapy.
Nicotine oral inhalation therapy provides the smoker with adequate amounts of nicotine to reduce the urge to smoke, and may provide some degree of comfort by providing a hand-to-mouth ritual similar to smoking. The goal of nicotine oral inhaler therapy is complete abstinence from cigarette smoking. If the patient is unable to stop smoking completely by the fourth week of oral inhalation therapy, the manufacturer states that treatment probably should be discontinued.
Patients who fail to quit on any attempt may benefit from interventions to improve their chances with subsequent attempts. After an unsuccessful attempt, the patient should be counseled and probably should be given a treatment break before another attempt. Once conditions are more favorable, a new attempt at smoking cessation using orally inhaled or another form of nicotine replacement therapy can be initiated.
The manufacturers state that treatment of acute overdosage with nicotine polacrilex gum or transdermal systems, nasal solutions, or oral inhaler cartridges of nicotine generally involves symptomatic and supportive care and should include measures that are used for the treatment of acute nicotine intoxication; there is no specific antidote for nicotine intoxication. Cases of oral ingestion of transdermal systems or oral inhaler cartridges of nicotine should be treated in a health-care facility. If vomiting has not occurred following acute ingestion of an overdose, the stomach should be emptied immediately by inducing emesis or by gastric lavage.
If the patient is comatose, having seizures, or lacks the gag reflex, gastric lavage with a wide-bore tube may be performed if an endotracheal tube with cuff inflated is in place to prevent aspiration of gastric contents. Because acute nicotine intoxication can result in seizures, activated charcoal should be administered following gastric lavage and/or emesis to decrease absorption of nicotine. If a transdermal system or oral inhaler cartridge has been ingested, activated charcoal should be administered repeatedly for as long as the system or cartridge remains in the GI tract because nicotine release from the system or cartridge will continue for many hours.
Administration of a saline cathartic or sorbitol may be used to increase GI transit of the gum, transdermal system, or oral inhaler cartridge or of the activated charcoal. Vigorous fluid support and/or other appropriate therapy should be instituted if hypotension and/or cardiovascular collapse occur. Seizures usually may be controlled by IV administration of a benzodiazepine (e.g., diazepam) or short-acting barbiturate.
Atropine may be given for bradycardia, excessive bronchial secretions, or diarrhea. Assisted pulmonary ventilation may be necessary for the management of respiratory paralysis following severe nicotine intoxication.
If signs or symptoms of acute nicotine intoxication occur in patients receiving transdermal nicotine therapy, the transdermal system should be removed promptly and immediate medical care sought. The skin may be flushed with water to remove nicotine and then dried, but soap should not be used because it reportedly may increase dermal absorption of the drug. It should be kept in mind that systemic absorption of nicotine from a transdermal system will continue for several hours after removal of the system because of the presence of a skin depot of the drug.
If the nasal solution of nicotine is sprayed inadvertently into the eye, the affected eye(s) should be treated with copious irrigation (e.g., with water) for 20 minutes. Irritation also can result from inadvertent exposure of the oral mucosa or inner ear to the nasal spray.
Although the risk of excessive overdosage following oral inhalation of nicotine from inhaler cartridges that deliver about 4 mg of drug is low in adult smokers, if manifestations of acute nicotine intoxication occur following oral inhalation of the drug, a clinician or poison control center should be contacted immediately for emergency information. The possibility that severe, potentially fatal overdosage could occur following oral inhalation of nicotine in a child should be considered.
By comparison, transdermal systems potentially may provide some advantages over buccal nicotine polacrilex, such as a reduction in symptoms of craving, ease of administration, absence of local oral adverse effects, fewer adverse GI effects, less frequent dosing leading to better compliance, the absence of reinforcement of addictive behavior obtained from frequent self-administration of nicotine, and effectiveness across diverse settings and populations and when used with a variety of psychosocial interventions.
Nicotine oral inhalers provide a method of replacement that most closely mimics the behaviors (i.e., handling and inhalation through the mouth) of cigarette smoking, although clinical experience suggests that this mode of administration contributes at most only marginally to efficacy compared with buccal nicotine polacrilex or intranasal nicotine. In addition, the cigarette shape and more obvious use of the oral inhaler may carry some stigma in certain patients. Likewise, use of the nasal inhaler may carry some stigma in certain patients, and initially is locally very irritating.
Any of these forms of nicotine provides an alternative source of the drug that is devoid of tars, carbon monoxide, and respiratory irritants and that may help reduce withdrawal symptoms associated with nicotine dependence. Some data suggest that withdrawal symptoms unrelieved with transdermal nicotine therapy alone may respond to combined therapy with transdermal nicotine and buccal nicotine polacrilex. Some clinicians state that there are insufficient data from well-designed studies to recommend one method of smoking cessation therapy (e.g., transdermal nicotine systems, nicotine gum) over another.
Selection of an appropriate form of nicotine replacement should be individualized based on factors such as cost, insurance coverage, adherence, comorbid conditions, and specific warnings and contraindications.
Dosage of nicotine polacrilex is expressed in terms of nicotine. Dosage of nicotine polacrilex should be individualized by the patient after careful instruction and, unless self-administered without supervision, should be assessed periodically by the clinician. Supervised or unsupervised (self-medication) nicotine polacrilex therapy can be initiated with either the 2- or 4-mg (of nicotine) gum or lozenge, but should be individualized depending on the patient's degree of nicotine dependence.
Transdermal systems of nicotine are applied only once daily; after the prescribed duration of daily use (e.g., 16 or 24 hours), the system in use is removed and discarded and a new system is applied at a different site. The Nicotrol(R) transdermal system is designed to provide systemic nicotine delivery of nicotine over 16 hours; this system is applied daily after awakening and removed before retiring. Patients should be instructed not to use the same Nicotrol(R) transdermal system for longer than 16 hours.
The duration of daily use for NicoDerm(R) CQ(R) is 16-24 hours; patients who crave a cigarette upon awakening should wear this transdermal system for 24 hours. Patients who experience vivid dreams or other disturbances of sleep with application of NicoDerm(R) CQ(R) for 24 hours should remove the transdermal system after about 16 hours of application, before retiring. Patients should be instructed not to use the same NicoDerm(R) CQ(R) transdermal system for longer than 24 hours.
The metered pump of nicotine nasal solution delivers a metered 50-mcL spray that contains 0.5 mg of the drug per actuation. The commercially available pump containing 100 mg (10 mg/mL) of nicotine delivers approximately 200 sprays (i.e., 100 doses).
A 1-mg dose of nicotine is delivered by administering 1 spray of the nasal solution via the metered pump into each nostril (i.e., 2 sprays total). The dosage of nicotine nasal spray should be individualized depending on the patient's dependence on nicotine and whether symptoms of excessive intake of nicotine occur. Therapy with the nasal spray usually is initiated in adults with 1-mg doses administered once or twice per hour.
This initial dosage may be increased according to patient tolerance and response to a maximum of five 1-mg doses per hour to administer a maximum hourly dose of 5 mg and daily dose of 40 mg (i.e., 80 sprays). To achieve optimal therapeutic results, patients should be encouraged to administer at least the minimum recommended dosage of 8 mg daily since lower dosages are unlikely to be effective. Use of the spray regularly during the first week of therapy may allow adaptation to the irritant effect of nicotine nasal spray.
Nicotine dosage with the nasal spray can then be adjusted in patients with manifestations of nicotine withdrawal or excessive intake of nicotine, recognizing that some symptoms of excessive intake (as might occur in patients who continue to smoke) may be similar to those of nicotine withdrawal. In clinical studies of nicotine replacement therapy, excessive intake of nicotine appeared to be more often manifested by palpitations, nausea, and sweating and those of nicotine withdrawal by anxiety, nervousness, and irritability. When nicotine withdrawal was experienced most strongly, nicotine nasal spray was used liberally, up to the maximum dosage recommended of 40 mg daily in some heavy smokers, by patients who achieved cessation of smoking in clinical studies.
Once an appropriate dosage has been established, the manufacturer recommends continuation of therapy with nicotine nasal spray at that dosage for up to 8 weeks in patients who have abstained successfully from smoking. Therapy should then be discontinued sometime over the subsequent 4-6 weeks. An optimal schedule of tapering the dosage to discontinuance was not identified in clinical studies; therapy simply was discontinued by many patients at their last clinic visit.
The manufacturer recommends several strategies that patients can use to discontinue therapy with nicotine nasal spray including halving each dose (i.e., to 1 spray (0.5 mg)) administered, reducing the frequency of use, tallying daily administration, targeting a steady reduction in dosage, skipping a dose by deviating from hourly administration, or setting a date for discontinuance of therapy. Therapy can be discontinued abruptly in some patients, although gradual reduction of the dosage may be preferable in others. Continued therapy with nicotine nasal spray beyond 12-14 weeks has not been shown to improve outcome, and safety of use beyond 6 months has not been established.
Complete abstinence is the goal of therapy with nicotine nasal spray. If patients have not stopped smoking after 4 weeks of therapy with nicotine nasal spray, such therapy probably should be discontinued. Unsuccessful patients should be counseled and probably should receive a break from smoking cessation therapy before another attempt is tried.
Such patients may benefit from adjunctive interventions to enhance the possibility of success on the next attempt. Another attempt to quit smoking should be encouraged by a more favorable context.
Nicotine oral inhaler cartridges labeled as containing 10 mg of nicotine deliver a maximum of approximately 4 mg total with repeated inhalation.
Initial dosage of nicotine via oral inhalation should be individualized. Patients may self-titrate the orally inhaled dosage to the level of nicotine replacement they require. In clinical studies, most successful patients used between 6-16 cartridges daily.
Patients generally increased their daily nicotine dosage from the first to the second week of oral inhalation therapy, and then subsequently decreased their daily consumption somewhat but not substantially over the next 4 weeks. The recommended duration of therapy is 3 months, after which patients may be weaned from oral inhalation therapy by gradual reduction of the daily dosage over 6-12 weeks. Safety and efficacy of oral inhalation therapy have not been established beyond 6 months and therefore such prolonged use is not recommended by the manufacturer.
For optimal results, patients should be instructed to use at least 6 cartridges daily at least for the initial 3-6 weeks of nicotine oral inhalation therapy, with the likelihood of success increasing with daily doses exceeding this amount. Additional daily doses may be required to control the urge to smoke, but the manufacturer recommends that daily consumption not exceed 16 nicotine cartridges (about 64 mg of delivered nicotine) for up to 12 weeks. Dosage should be adjusted if manifestations of nicotine withdrawal or excess develop.
Initial treatment generally should continue for about 12 weeks, after which oral inhalation therapy may be gradually withdrawn.
After completion of a course (generally up to 12 weeks) of nicotine oral inhalation therapy, most patients require a gradual reduction in daily cartridge consumption, although abrupt discontinuance may be possible in some patients. Gradual dosage reduction may extend over 6-12 weeks. Recommended strategies for discontinuing therapy include recommending that the patient decrease the frequency of daily use of the oral inhaler, keep a tally of daily usage, try to meet a steadily reducing target, or set a planned quit date for discontinuing oral inhalation therapy.
Nicotine oral inhalation therapy provides the smoker with adequate amounts of nicotine to reduce the urge to smoke, and may provide some degree of comfort by providing a hand-to-mouth ritual similar to smoking. The goal of nicotine oral inhaler therapy is complete abstinence from cigarette smoking. If the patient is unable to stop smoking completely by the fourth week of oral inhalation therapy, the manufacturer states that treatment probably should be discontinued.
Patients who fail to quit on any attempt may benefit from interventions to improve their chances with subsequent attempts. After an unsuccessful attempt, the patient should be counseled and probably should be given a treatment break before another attempt. Once conditions are more favorable, a new attempt at smoking cessation using orally inhaled or another form of nicotine replacement therapy can be initiated.
The manufacturers state that treatment of acute overdosage with nicotine polacrilex gum or transdermal systems, nasal solutions, or oral inhaler cartridges of nicotine generally involves symptomatic and supportive care and should include measures that are used for the treatment of acute nicotine intoxication; there is no specific antidote for nicotine intoxication. Cases of oral ingestion of transdermal systems or oral inhaler cartridges of nicotine should be treated in a health-care facility. If vomiting has not occurred following acute ingestion of an overdose, the stomach should be emptied immediately by inducing emesis or by gastric lavage.
If the patient is comatose, having seizures, or lacks the gag reflex, gastric lavage with a wide-bore tube may be performed if an endotracheal tube with cuff inflated is in place to prevent aspiration of gastric contents. Because acute nicotine intoxication can result in seizures, activated charcoal should be administered following gastric lavage and/or emesis to decrease absorption of nicotine. If a transdermal system or oral inhaler cartridge has been ingested, activated charcoal should be administered repeatedly for as long as the system or cartridge remains in the GI tract because nicotine release from the system or cartridge will continue for many hours.
Administration of a saline cathartic or sorbitol may be used to increase GI transit of the gum, transdermal system, or oral inhaler cartridge or of the activated charcoal. Vigorous fluid support and/or other appropriate therapy should be instituted if hypotension and/or cardiovascular collapse occur. Seizures usually may be controlled by IV administration of a benzodiazepine (e.g., diazepam) or short-acting barbiturate.
Atropine may be given for bradycardia, excessive bronchial secretions, or diarrhea. Assisted pulmonary ventilation may be necessary for the management of respiratory paralysis following severe nicotine intoxication.
If signs or symptoms of acute nicotine intoxication occur in patients receiving transdermal nicotine therapy, the transdermal system should be removed promptly and immediate medical care sought. The skin may be flushed with water to remove nicotine and then dried, but soap should not be used because it reportedly may increase dermal absorption of the drug. It should be kept in mind that systemic absorption of nicotine from a transdermal system will continue for several hours after removal of the system because of the presence of a skin depot of the drug.
If the nasal solution of nicotine is sprayed inadvertently into the eye, the affected eye(s) should be treated with copious irrigation (e.g., with water) for 20 minutes. Irritation also can result from inadvertent exposure of the oral mucosa or inner ear to the nasal spray.
Although the risk of excessive overdosage following oral inhalation of nicotine from inhaler cartridges that deliver about 4 mg of drug is low in adult smokers, if manifestations of acute nicotine intoxication occur following oral inhalation of the drug, a clinician or poison control center should be contacted immediately for emergency information. The possibility that severe, potentially fatal overdosage could occur following oral inhalation of nicotine in a child should be considered.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| NICOTROL NS 10 MG/ML SPRAY | Maintenance | Adults spray 1 spray (0.5 mg) in each nostril by intranasal route as directed up to 5 times per hour and not more than 40 times per day |
No generic dosing information available.
The following drug interaction information is available for NICOTROL NS (nicotine):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for NICOTROL NS (nicotine):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Temporomandibular joint disorder |
There are 8 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| 30 day risk period post-myocardial infarction |
| Acute myocardial infarction |
| Angina |
| Buerger's disease |
| Life-threatening cardiac arrhythmias |
| Raynaud's phenomenon |
| Severe uncontrolled hypertension |
| Unstable angina pectoris |
There are 8 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Disease of liver |
| Esophagitis |
| Hyperthyroidism |
| Peptic ulcer |
| Pharyngitis |
| Pheochromocytoma |
| Prinzmetal angina |
| Type 1 diabetes mellitus |
The following adverse reaction information is available for NICOTROL NS (nicotine):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 8 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Palpitations |
| Rare/Very Rare |
|---|
|
Anaphylaxis Aphasia Bronchospastic pulmonary disease Memory impairment Purpura Seizure disorder Visual changes |
There are 42 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Cough Drug dependence Dysgeusia Earache Epistaxis Eye tearing Flushing Lesion of nasal mucosa Nasal congestion Nasal passage irritation Ocular irritation Ocular pain Paresthesia Parosmia Rhinitis Sneezing Sore throat |
Abdominal pain with cramps Acne vulgaris Acute cognitive impairment Arthralgia Back pain Dysmenorrhea Dyspnea Flatulence Gingival disorders Headache disorder Menstrual disorder Myalgia Nausea Pruritus of skin Tooth disorder |
| Rare/Very Rare |
|---|
|
Bronchitis Chest pain Diarrhea Dysphagia Hiccups Increased sputum Migraine Peripheral edema Skin rash Xerostomia |
The following precautions are available for NICOTROL NS (nicotine):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Nicotine may cause fetal harm when administered to pregnant women. Although the exact mechanism has not been determined, cigarette smoking during pregnancy has been associated with fetal growth retardation, an increased risk of spontaneous abortion, and increased perinatal mortality. Substantial evidence indicates that decreased birthweight in neonates born to women who smoke is in part caused by a direct vasoconstrictive effect of nicotine on uterine vasculature resulting in fetal hypoxia; the effects of carbon monoxide in cigarette smoke also have been implicated.
Rapid IV infusion of nicotine (up to 2 mg/kg) in pregnant rhesus monkeys caused acidosis, hypercarbia, and hypotension (fetal and maternal nicotine concentrations were about 20 times those achieved after smoking one cigarette in 5 minutes). Reduction of fetal respiratory movement was observed in the fetal lamb after IV injection of nicotine in the ewe at a dose equivalent to smoking one cigarette every 20 seconds for 5 minutes (0.25 mg/kg). In pregnant rhesus monkeys, IV infusion of nicotine at a dosage of 0.2
mg/kg over 20 minutes (equivalent to smoking 120 cigarettes over 20 minutes) reduced uterine blood flow by about 30%. Spontaneous abortion rates may be higher in women who smoke and the frequency appears to be related directly to the number of cigarettes smoked. Although a direct causal relationship has not been established, at least one spontaneous abortion reportedly occurred during nicotine polacrilex therapy.
Nicotine has produced skeletal abnormalities in the progeny of mice given the drug subcutaneously or intraperitoneally at a dose known to be toxic to the dams (25 mg/kg). Studies in rats and monkeys using nicotine doses similar to those associated with cigarette smoking have not revealed evidence of teratogenicity. The teratogenic potential of cigarette smoking or nicotine in humans has not been clearly established.
Although several studies suggest that tobacco smoke has transplacental carcinogenic effects, the role of nicotine in the transplacental effects of tobacco smoke has not been fully elucidated. Cigarette smoking and use of nicotine polacrilex gum during the latter stage of pregnancy have both been associated with decreased fetal breathing movement, possibly resulting from a nicotine-induced decrease in placental perfusion; increased fetal total aortic blood flow and heart rate and decreased uterine blood flow also have been noted. Nicotine polacrilex (administered as one or two 2- or 4-mg pieces of gum delivering 1-4 mg of nicotine) reportedly had less effect on these parameters than cigarette smoking.
However, in a limited study of pregnant (e.g., between 24-36 weeks of gestation) women who continued to smoke at least 10 cigarettes daily for 5 days or who discontinued smoking and began taking nicotine polacrilex gum for 5 days at a dosage of at least 6 pieces of 2-mg gum (up to 30 pieces) daily chewed at a rate not to exceed 2 pieces hourly, there were no differences between the groups in changes in maternal or fetal hemodynamic measurements (e.g., maternal heart rate and mean arterial pressure, fetal heart rate, uterine resistance index, umbilical resistance index). The maternal serum cotinine concentration after 5 days was decreased with nicotine polacrilex gum but did not change with continuance of smoking. Peak and trough maternal serum nicotine concentrations after 5 days were lower with nicotine polacrilex gum than with continuance of smoking.
Spontaneous abortion has been reported during nicotine replacement therapy; as with smoking, nicotine as a contributing factor cannot be ruled out. The effects of nicotine delivered by a transdermal system have been studied in a limited number of pregnant women. In pregnant (e.g., between 27-38 weeks of gestation) smokers who did not smoke cigarettes during the study, application for 6 hours of a transdermal system that delivered nicotine at a rate of 21 mg/24 hours did not result in changes in measures of fetal well-being (e.g., biophysical profiles, heart rate, umbilical artery Doppler examination, uterine activity) nor were maternal vital signs affected adversely.
The effects of nicotine delivered intranasally have not been studied in pregnant women. Some clinicians have suggested that the risk to the fetus may be less with nicotine replacement therapy than with cigarette smoking because plasma nicotine concentrations with nicotine polacrilex or transdermal or intranasal nicotine therapy usually are similar to or lower than those produced by cigarette smoking and neither mother nor fetus is exposed to carbon monoxide or other hazardous substances in cigarette smoke. Women who do not stop smoking on their own early in pregnancy are likely to be highly nicotine dependent.
Smoking cessation programs consisting of behavioral and educational rather than pharmacologic interventions should be tried in pregnant women before nicotine polacrilex or transdermal, intranasal, or orally inhaled nicotine therapy is considered. Therapy with nicotine polacrilex or transdermal, intranasal, or orally inhaled nicotine should be used during pregnancy only if the increased likelihood of smoking cessation, with its potential benefits, justifies the potential risk to the fetus and patient of nicotine replacement and possible continued smoking. The USPHS guideline makes no recommendations regarding the use of nicotine replacement therapy in pregnant women because of inconclusive evidence of efficacy and the possibility of an increased risk of adverse fetal effects; however, it should be considered that smoking exposes pregnant women to not only nicotine, but to other harmful chemicals that may cause injury to the woman and fetus.
Although smoking cessation prior to conception or early in pregnancy is most beneficial, health benefits result from cessation at anytime; therefore, efforts to encourage smoking cessation should persist for women who continue smoking after conception. Postpartum follow-up of women who stop smoking during pregnancy is important since there is a high rate of relapse during the postpartum period, even for women who maintained total abstinence for 6 months or longer during pregnancy. Relapse may be decreased by continued emphasis on the relationship between maternal smoking and poor health outcomes (e.g., sudden infant death syndrome, respiratory infections, asthma, middle ear disease) in infants and children.
Rapid IV infusion of nicotine (up to 2 mg/kg) in pregnant rhesus monkeys caused acidosis, hypercarbia, and hypotension (fetal and maternal nicotine concentrations were about 20 times those achieved after smoking one cigarette in 5 minutes). Reduction of fetal respiratory movement was observed in the fetal lamb after IV injection of nicotine in the ewe at a dose equivalent to smoking one cigarette every 20 seconds for 5 minutes (0.25 mg/kg). In pregnant rhesus monkeys, IV infusion of nicotine at a dosage of 0.2
mg/kg over 20 minutes (equivalent to smoking 120 cigarettes over 20 minutes) reduced uterine blood flow by about 30%. Spontaneous abortion rates may be higher in women who smoke and the frequency appears to be related directly to the number of cigarettes smoked. Although a direct causal relationship has not been established, at least one spontaneous abortion reportedly occurred during nicotine polacrilex therapy.
Nicotine has produced skeletal abnormalities in the progeny of mice given the drug subcutaneously or intraperitoneally at a dose known to be toxic to the dams (25 mg/kg). Studies in rats and monkeys using nicotine doses similar to those associated with cigarette smoking have not revealed evidence of teratogenicity. The teratogenic potential of cigarette smoking or nicotine in humans has not been clearly established.
Although several studies suggest that tobacco smoke has transplacental carcinogenic effects, the role of nicotine in the transplacental effects of tobacco smoke has not been fully elucidated. Cigarette smoking and use of nicotine polacrilex gum during the latter stage of pregnancy have both been associated with decreased fetal breathing movement, possibly resulting from a nicotine-induced decrease in placental perfusion; increased fetal total aortic blood flow and heart rate and decreased uterine blood flow also have been noted. Nicotine polacrilex (administered as one or two 2- or 4-mg pieces of gum delivering 1-4 mg of nicotine) reportedly had less effect on these parameters than cigarette smoking.
However, in a limited study of pregnant (e.g., between 24-36 weeks of gestation) women who continued to smoke at least 10 cigarettes daily for 5 days or who discontinued smoking and began taking nicotine polacrilex gum for 5 days at a dosage of at least 6 pieces of 2-mg gum (up to 30 pieces) daily chewed at a rate not to exceed 2 pieces hourly, there were no differences between the groups in changes in maternal or fetal hemodynamic measurements (e.g., maternal heart rate and mean arterial pressure, fetal heart rate, uterine resistance index, umbilical resistance index). The maternal serum cotinine concentration after 5 days was decreased with nicotine polacrilex gum but did not change with continuance of smoking. Peak and trough maternal serum nicotine concentrations after 5 days were lower with nicotine polacrilex gum than with continuance of smoking.
Spontaneous abortion has been reported during nicotine replacement therapy; as with smoking, nicotine as a contributing factor cannot be ruled out. The effects of nicotine delivered by a transdermal system have been studied in a limited number of pregnant women. In pregnant (e.g., between 27-38 weeks of gestation) smokers who did not smoke cigarettes during the study, application for 6 hours of a transdermal system that delivered nicotine at a rate of 21 mg/24 hours did not result in changes in measures of fetal well-being (e.g., biophysical profiles, heart rate, umbilical artery Doppler examination, uterine activity) nor were maternal vital signs affected adversely.
The effects of nicotine delivered intranasally have not been studied in pregnant women. Some clinicians have suggested that the risk to the fetus may be less with nicotine replacement therapy than with cigarette smoking because plasma nicotine concentrations with nicotine polacrilex or transdermal or intranasal nicotine therapy usually are similar to or lower than those produced by cigarette smoking and neither mother nor fetus is exposed to carbon monoxide or other hazardous substances in cigarette smoke. Women who do not stop smoking on their own early in pregnancy are likely to be highly nicotine dependent.
Smoking cessation programs consisting of behavioral and educational rather than pharmacologic interventions should be tried in pregnant women before nicotine polacrilex or transdermal, intranasal, or orally inhaled nicotine therapy is considered. Therapy with nicotine polacrilex or transdermal, intranasal, or orally inhaled nicotine should be used during pregnancy only if the increased likelihood of smoking cessation, with its potential benefits, justifies the potential risk to the fetus and patient of nicotine replacement and possible continued smoking. The USPHS guideline makes no recommendations regarding the use of nicotine replacement therapy in pregnant women because of inconclusive evidence of efficacy and the possibility of an increased risk of adverse fetal effects; however, it should be considered that smoking exposes pregnant women to not only nicotine, but to other harmful chemicals that may cause injury to the woman and fetus.
Although smoking cessation prior to conception or early in pregnancy is most beneficial, health benefits result from cessation at anytime; therefore, efforts to encourage smoking cessation should persist for women who continue smoking after conception. Postpartum follow-up of women who stop smoking during pregnancy is important since there is a high rate of relapse during the postpartum period, even for women who maintained total abstinence for 6 months or longer during pregnancy. Relapse may be decreased by continued emphasis on the relationship between maternal smoking and poor health outcomes (e.g., sudden infant death syndrome, respiratory infections, asthma, middle ear disease) in infants and children.
Nicotine is distributed into milk in a milk to plasma ratio averaging 2.9. Proper use of nicotine polacrilex preparations or transdermal, intranasal, or orally inhaled nicotine would be expected to produce lower concentrations of nicotine in milk than would cigarette smoking because of lower maternal plasma nicotine concentrations with nicotine replacement therapy.
Although some clearance of orally absorbed nicotine in infants will occur through first-pass metabolism in the liver, the efficiency of nicotine removal probably is lowest at birth. The safety of nicotine replacement therapy in infants who are breast-feeding has not been evaluated. Whether to use nicotine polacrilex or transdermal, intranasal, or orally inhaled nicotine in a nursing woman should be based on comparison of the risks associated with exposure of the infant to nicotine and other tobacco contaminants in the breast milk as well as those of passive exposure to tobacco smoke from continued smoking by the mother, and those associated with use of such nicotine replacement therapy alone or concomitantly with continued smoking.
Although some clearance of orally absorbed nicotine in infants will occur through first-pass metabolism in the liver, the efficiency of nicotine removal probably is lowest at birth. The safety of nicotine replacement therapy in infants who are breast-feeding has not been evaluated. Whether to use nicotine polacrilex or transdermal, intranasal, or orally inhaled nicotine in a nursing woman should be based on comparison of the risks associated with exposure of the infant to nicotine and other tobacco contaminants in the breast milk as well as those of passive exposure to tobacco smoke from continued smoking by the mother, and those associated with use of such nicotine replacement therapy alone or concomitantly with continued smoking.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for NICOTROL NS (nicotine):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for NICOTROL NS (nicotine)'s list of indications:
| Smoking cessation | |
| F17 | Nicotine dependence |
| F17.2 | Nicotine dependence |
| F17.20 | Nicotine dependence, unspecified |
| F17.200 | Nicotine dependence, unspecified, uncomplicated |
| F17.201 | Nicotine dependence, unspecified, in remission |
| F17.203 | Nicotine dependence unspecified, with withdrawal |
| F17.208 | Nicotine dependence, unspecified, with other nicotine-induced disorders |
| F17.209 | Nicotine dependence, unspecified, with unspecified nicotine-induced disorders |
| F17.21 | Nicotine dependence, cigarettes |
| F17.210 | Nicotine dependence, cigarettes, uncomplicated |
| F17.211 | Nicotine dependence, cigarettes, in remission |
| F17.213 | Nicotine dependence, cigarettes, with withdrawal |
| F17.218 | Nicotine dependence, cigarettes, with other nicotine-induced disorders |
| F17.219 | Nicotine dependence, cigarettes, with unspecified nicotine-induced disorders |
| O99.33 | Tobacco use disorder complicating pregnancy, childbirth, and the puerperium |
| O99.330 | Smoking (tobacco) complicating pregnancy, unspecified trimester |
| O99.331 | Smoking (tobacco) complicating pregnancy, first trimester |
| O99.332 | Smoking (tobacco) complicating pregnancy, second trimester |
| O99.333 | Smoking (tobacco) complicating pregnancy, third trimester |
| O99.334 | Smoking (tobacco) complicating childbirth |
| O99.335 | Smoking (tobacco) complicating the puerperium |
| Z87.891 | Personal history of nicotine dependence |
Formulary Reference Tool