(nik oh TEEN)
Smoking cessation: Treatment to aid smoking cessation for the relief of nicotine withdrawal symptoms (including nicotine craving)
Hypersensitivity to nicotine or any component of the formulation.
OTC labeling: Nicorette lozenge: When used for self-medication, do not use if you are allergic to soya.
Tobacco cessation (patients should be advised to completely stop smoking upon initiation of therapy):
Gum: Chew 1 piece of gum when urge to smoke occurs. If strong or frequent cravings are present after 1 piece of gum, may use a second piece within the hour (do not continuously use one piece after the other). Patients who smoke their first cigarette within 30 minutes of waking should use the 4 mg strength; otherwise the 2 mg strength is recommended. Use according to the following 12-week dosing schedule:
Weeks 1 to 6: Chew 1 piece of gum every 1 to 2 hours (maximum: 24 pieces/day); to increase chances of quitting, chew at least 9 pieces/day during the first 6 weeks
Weeks 7 to 9: Chew 1 piece of gum every 2 to 4 hours (maximum: 24 pieces/day)
Weeks 10 to 12: Chew 1 piece of gum every 4 to 8 hours (maximum: 24 pieces/day)
Inhalation: Oral: Initial: Usually 6 to 16 cartridges per day; best effect was achieved by frequent continuous puffing (20 minutes); maximum: 16 cartridges/day; recommended duration of treatment is 3 months, after which patients may be weaned from the inhaler by gradual reduction of the daily dose over 6 to 12 weeks. Use beyond 6 months is not recommended (has not been studied).
Lozenge: Oral: 1 lozenge when urge to smoke occurs; do not use more than 1 lozenge at a time. Patients who smoke their first cigarette within 30 minutes of waking should use the 4 mg strength; otherwise the 2 mg strength is recommended. Use according to the following 12-week dosing schedule:
Weeks 1 to 6: 1 lozenge every 1 to 2 hours (maximum: 5 lozenges every 6 hours; 20 lozenges/day); to increase chances of quitting, use at least 9 lozenges/day during the first 6 weeks
Weeks 7 to 9: 1 lozenge every 2 to 4 hours (maximum: 5 lozenges every 6 hours; 20 lozenges/day)
Weeks 10 to 12: 1 lozenge every 4 to 8 hours (maximum: 5 lozenges every 6 hours; 20 lozenges/day)
Nasal: Spray: 1 to 2 doses/hour (each dose [2 sprays, one in each nostril] contains 1 mg of nicotine); do not exceed more than 5 doses (10 sprays) per hour [maximum: 40 mg/day (80 sprays)] or 3 months of treatment. Note: For best results, use at least the recommended minimum of 8 doses per day (less is unlikely to be effective).
Transdermal patch: Topical: Note: Adjustment may be required during initial treatment (move to higher dose if experiencing withdrawal symptoms; lower dose if side effects are experienced).
Patients smoking >10 cigarettes/day: Begin with step 1 (21 mg/day) for 6 weeks, followed by step 2 (14 mg/day) for 2 weeks; finish with step 3 (7 mg/day) for 2 weeks
Patients smoking ≤10 cigarettes/day: Begin with step 2 (14 mg/day) for 6 weeks, followed by step 3 (7 mg/day) for 2 weeks
Refer to adult dosing.
There are no dosage adjustments provided in the manufacturers labeling (has not been studied). Only severe renal impairment should affect clearance of nicotine or its metabolites from circulation.
There are no dosage adjustments provided in the manufacturers labeling (has not been studied); because total system clearance of nicotine is dependent on hepatic blood flow, anticipate reduced clearance.
Gum: Chew slowly until it tingles, then place gum between cheek and gum until tingle is gone; repeat process until most of tingle is gone (~30 minutes). Do not eat or drink 15 minutes before using or while the gum is in mouth.
Lozenge: Do not chew or swallow; allow to dissolve slowly (~20 to 30 minutes); minimize swallowing and occasionally move lozenge from one side of the mouth to the other until completely dissolved. Do not eat or drink 15 minutes before using or while lozenge is in mouth.
Nasal spray: Prime pump prior to first use (pump 6 to 8 times until fine spray appears) or if it has not been used for 24 hours (pump 1 to 2 times). Blow nose prior to use. Tilt head back slightly and insert tip of bottle into nostril. Breathe through mouth and spray once in each nostril. Do not sniff, swallow, or inhale through the nose during administration. After administration, wait 2 to 3 minutes before blowing nose.
Oral Inhalation: Insert cartridge into inhaler and push hard until it pops into place. Replace mouthpiece and twist the top and bottom so that markings do not line up. Inhale deeply into the back of the throat or puff in short breaths. Nicotine in cartridge is used up after about 20 minutes of active puffing. Clean mouthpiece regularly with soap and water.
Transdermal patch: Apply new patch to nonhairy, clean, dry skin on the upper body or upper outer arm; each patch should be applied to a different site. Apply immediately after removing backing from patch; press onto skin for ~10 seconds. Patch may be worn for 16 or 24 hours. If cigarette cravings occur upon awakening, wear for 24 hours; if vivid dreams or other sleep disturbances occur, remove the patch at bedtime and apply a new patch in the morning. Do not cut patch; causes rapid evaporation, rendering the patch useless. Do not wear more than 1 patch at a time; do not leave patch on for more than 24 hours (may irritate skin). Wash hands after applying or removing patch. Discard patches by folding adhesive ends together, replace in pouch and dispose of properly in trash.
Hazardous agent; use appropriate precautions for handling and disposal (EPA, P-listed).
Some products may contain phenylalanine and/or sodium.
Store at room temperature.
NicoDerm CQ: Dispose of used patches by folding sticky ends together; place in pouch and discard.
Nicorette gum, Nicorette lozenge and mini lozenge, Nicotrol: Protect from light. Wrap used pieces of gum in paper and discard.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Gum, Mouth/Throat, as polacrilex:
Nicorelief: 2 mg (50 ea, 110 ea)
Nicorelief: 2 mg (50 ea, 110 ea) [mint flavor]
Nicorelief: 4 mg (50 ea, 110 ea) [contains fd&c yellow #10 (quinoline yellow)]
Nicorelief: 4 mg (50 ea, 110 ea) [contains fd&c yellow #10 (quinoline yellow); mint flavor]
Nicorette: 2 mg (170 ea, 200 ea) [original flavor]
Nicorette: 2 mg (190 ea) [contains menthol; fresh mint flavor]
Nicorette: 2 mg (20 ea, 40 ea, 100 ea, 160 ea, 190 ea) [contains menthol; fruit flavor]
Nicorette: 2 mg (110 ea, 170 ea) [contains menthol; mint flavor]
Nicorette: 2 mg (40 ea [DSC]) [contains menthol, polysorbate 80]
Nicorette: 2 mg (20 ea, 100 ea, 160 ea, 190 ea) [contains menthol, polysorbate 80; cinnamon flavor]
Nicorette: 2 mg (20 ea, 100 ea, 160 ea, 190 ea) [contains menthol, polysorbate 80; mint flavor]
Nicorette: 4 mg (60 ea [DSC], 170 ea, 200 ea) [contains fd&c yellow #10 (quinoline yellow); original flavor]
Nicorette: 4 mg (100 ea, 160 ea, 190 ea) [contains fd&c yellow #10 (quinoline yellow), menthol, polysorbate 80; cinnamon flavor]
Nicorette: 4 mg (100 ea, 190 ea) [contains fd&c yellow #10 aluminum lake, menthol; fresh mint flavor]
Nicorette: 4 mg (20 ea, 40 ea, 100 ea, 160 ea, 190 ea) [contains fd&c yellow #10 aluminum lake, menthol; fruit flavor]
Nicorette: 4 mg (110 ea, 170 ea) [contains fd&c yellow #10 aluminum lake, menthol; mint flavor]
Nicorette: 4 mg (40 ea [DSC]) [contains fd&c yellow #10 aluminum lake, menthol, polysorbate 80]
Nicorette: 4 mg (20 ea, 100 ea, 160 ea, 190 ea) [contains fd&c yellow #10 aluminum lake, menthol, polysorbate 80; mint flavor]
Nicorette Starter Kit: 2 mg (110 ea) [original flavor]
Nicorette Starter Kit: 2 mg (100 ea) [contains menthol]
Nicorette Starter Kit: 4 mg (110 ea) [contains fd&c yellow #10 aluminum lake; original flavor]
Thrive: 2 mg (100 ea, 110 ea) [contains saccharin sodium]
Thrive: 4 mg (100 ea, 110 ea) [contains fd&c blue #2 (indigotine), saccharin sodium]
Generic: 2 mg (20 ea, 40 ea, 50 ea, 100 ea, 110 ea); 4 mg (20 ea, 40 ea, 50 ea, 100 ea, 110 ea)
Inhaler, Inhalation:
Nicotrol: 10 mg (168 ea) [contains menthol]
Kit, Transdermal:
Generic: 21-14-7 MG/24HR, 21-14-7 mg/24 hr
Lozenge, Mouth/Throat, as polacrilex:
NICOrelief: 2 mg (72 ea [DSC]); 4 mg (72 ea [DSC]) [contains aspartame]
Nicorette: 2 mg (72 ea, 81 ea) [cherry flavor]
Nicorette: 2 mg (108 ea) [contains aspartame]
Nicorette: 2 mg (24 ea, 27 ea, 72 ea, 81 ea, 168 ea) [contains aspartame, soy protein; mint flavor]
Nicorette: 4 mg (72 ea, 81 ea) [cherry flavor]
Nicorette: 4 mg (108 ea) [contains aspartame]
Nicorette: 4 mg (24 ea, 72 ea, 81 ea, 168 ea) [contains aspartame, soy protein; mint flavor]
Nicorette Mini: 2 mg (81 ea, 135 ea); 4 mg (81 ea, 135 ea)
Generic: 2 mg (24 ea, 27 ea, 72 ea [DSC]); 4 mg (24 ea, 27 ea, 72 ea [DSC])
Patch 24 Hour, Transdermal:
Nicoderm CQ: 7 mg/24 hr (14 ea); 14 mg/24 hr (14 ea, 21 ea); 21 mg/24 hr (7 ea, 14 ea, 21 ea)
Nicotine Step 3: 7 mg/24 hr (14 ea)
Nicotine Step 2: 14 mg/24 hr (14 ea)
Nicotine Step 1: 21 mg/24 hr (14 ea)
Generic: 7 mg/24 hr (1 ea, 7 ea, 14 ea); 14 mg/24 hr (1 ea, 7 ea, 14 ea); 21 mg/24 hr (1 ea, 7 ea, 14 ea, 28 ea)
Solution, Nasal:
Nicotrol NS: 10 mg/mL (10 mL)
Adenosine: Nicotine may enhance the AV-blocking effect of Adenosine. Nicotine may enhance the tachycardic effect of Adenosine. Monitor therapy
Cimetidine: May increase the serum concentration of Nicotine. Monitor therapy
Varenicline: May enhance the adverse/toxic effect of Nicotine. Monitor therapy
Signs and symptoms of nicotine toxicity (eg, severe headache, dizziness, mental confusion, disturbed hearing and vision, abdominal pain; rapid, weak and irregular pulse; salivation, nausea, vomiting, diarrhea, cold sweat, weakness)
Nasal spray/inhaler:
>10%:
Central nervous system: Headache (18% to 26%)
Gastrointestinal: Inhaler: Mouth/throat irritation (66%), dyspepsia (18%)
Respiratory: Inhaler: Cough (32%), rhinitis (23%)
1% to 10%:
Dermatologic: Acne (3%)
Endocrine & metabolic: Dysmenorrhea (3%)
Gastrointestinal: Flatulence (4%), gum problems (4%), diarrhea, hiccup, nausea, taste disturbance, tooth abrasions
Neuromuscular & skeletal: Back pain (6%), arthralgia (5%), jaw/neck pain
Respiratory: Nasal burning (nasal spray), sinusitis
Miscellaneous: Withdrawal symptoms
<1% (Limited to important or life-threatening): Allergy, amnesia, aphasia, bronchitis, bronchospasm, edema, migraine, numbness, pain, purpura, rash, sputum increased, vision abnormalities, xerostomia
Adverse events previously reported in prescription labeling for chewing gum, lozenge, and/or transdermal systems. Frequency not defined; may be product or dose specific:
Central nervous system: Concentration impaired, depression, dizziness, headache, insomnia, nervousness, pain
Gastrointestinal: Aphthous stomatitis, constipation, cough, diarrhea, dyspepsia, flatulence, gingival bleeding, glossitis, hiccups, jaw pain, nausea, salivation increased, stomatitis, taste perversion, tooth abrasions, ulcerative stomatitis, xerostomia
Dermatologic: Rash
Local: Application site reaction, local edema, local erythema
Neuromuscular & skeletal: Arthralgia, myalgia, paresthesia
Respiratory: Cough, sinusitis
Miscellaneous: Allergic reaction, diaphoresis
Disease-related concerns:
- Cardiovascular disease: Nicotine can increase heart rate and blood pressure. The risk versus the benefits should be weighed in patients with cardiovascular or peripheral vascular diseases, specifically patients with a history of myocardial infarction and/or angina pectoris, serious cardiac arrhythmias, or vasospastic diseases (Buerger disease, Prinzmetal variant angina, Raynaud phenomena); use caution in patients with angina, hypertension, or recent MI. Discontinue use if irregular heartbeat or palpitations occur. Use caution in patients with accelerated hypertension due to the risk of malignant hypertension. Generally, avoid use during the immediate postmyocardial infarction period, in patients with serious arrhythmias, or with severe or worsening angina.
- Diabetes: Use with caution in patients with insulin-dependent diabetes.
- Gastrointestinal disease: Use with caution in patients with active peptic ulcer disease; healing may be delayed.
- Hepatic impairment: Use with caution in patients with severe hepatic impairment; effects on metabolism unknown.
- Hyperthyroidism: Use with caution in patients with hyperthyroidism.
- Pheochromocytoma: Use with caution in patients with pheochromocytoma.
- Renal impairment: Use with caution in patients with severe renal impairment; effects on elimination unknown.
Dosage form specific issues:
- Chewing gum: OTC labeling: When used for self-medication, consult a health care provider before use in patients on a sodium-restricted diet and in patients with a history of seizures. Discontinue use and consult a health care provider if mouth, teeth, or jaw problems occur.
- Inhaler: Use with caution in patients with bronchospastic disease (eg, asthma, chronic pulmonary disease); may cause bronchospasm due to potential airway irritation; other forms of nicotine replacement may be preferred in patients with severe bronchospastic airway disease. Sustained use (beyond 6 months) by patients who quit smoking is not recommended.
- Lozenge: OTC labeling: When used for self-medication, consult a health care provider before use in patients on a sodium-restricted diet and in patients with a history of seizures. Discontinue use and consult a health care provider if mouth problems, persistent indigestion, or severe sore throat occurs.
- Nasal spray: Use of nasal product is not recommended with chronic nasal disorders (eg, allergy, rhinitis, nasal polyps, and sinusitis). Exacerbations of bronchospasm has been reported in patients with preexisting asthma; use in patients with severe reactive airway disease is not recommended. Nasal mucosa irritation may occur. Sustained use (beyond 6 months) by patients who quit smoking is not recommended.
- Transdermal patch: May contain conducting metal (eg, aluminum); remove patch prior to MRI. OTC labeling: When used for self-medication, consult a health care provider before use in patients who have an allergy to adhesive tape or who have skin problems. Discontinue use and contact a health care provider if skin redness caused by the patch does not resolve after 4 days or if inflammation or rash occurs. If vivid dreams or other sleep disturbances occur, remove the patch at bedtime and apply another patch in the morning.
Special handling:
- Hazardous agent: Use appropriate precautions for handling and disposal (EPA, P-listed).
Other warnings/precautions:
- Appropriate use: Urge patients to stop smoking completely when initiating therapy.
- OTC labeling: When used for self-medication, discontinue use and contact a health care provider if symptoms of nicotine overdose (eg, nausea, vomiting, dizziness, diarrhea, weakness, rapid heartbeat) or an allergic reaction (eg, difficulty breathing, rash) occurs.
D (RX products)
Adverse events have been observed in animal reproduction studies. Nicotine crosses the placenta (HHS 2014). Maternal smoking is associated with birth defects (HHS 2014; Hachshaw 2011); the incidence of birth defects following nicotine replacement therapy may be similar (limited data) (Dhalwani 2015). Nicotine exposure via cigarette smoke may cause increased ectopic pregnancy, low birth weight, increased risk of spontaneous abortion, increased perinatal mortality; increased aortic blood flow, increased heart rate, decreased uterine blood flow, and decreased breathing have been reported in the fetus. Smoking during pregnancy is associated with sudden infant death syndrome (SIDS), an increased risk of asthma, infantile colic, and childhood obesity (ACOG 2010; HHS 2014). Women who are pregnant should be encouraged not to smoke. The use of nicotine replacement products to aid in smoking cessation has not been adequately studied in pregnant women (amount of nicotine exposure is varied). Nonpharmacologic treatments are recommended. If the benefits of nicotine replacement therapy outweigh the unknown risks, it should be done under close supervision (ACOG, 2010).
Nicotine, a naturally occurring alkaloid, 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 CNS effects are believed to be the basis of nicotines 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.
Buccal mucosa, transdermal: Slow; Intranasal: ~ 53%; Inhaler: <5% reaches the lower respiratory tract
2 to 3 L/kg (Svensson, 1987)
Hepatic (major), kidney, and lung; >20 metabolites (primarily metabolites are to cotinine (1/5 as active) and trans-3-hydroxycotinine)
Urine (~10% as unchanged)
Intranasal: More closely approximate the time course of plasma nicotine levels observed after cigarette smoking than other dosage forms (Svensson, 1987)
Serum: Transdermal: ~2 to 8 hours (Bannon, 1989; DeVeaugh-Geiss, 2010); Intranasal: 4 to 15 minutes; Oral inhalation: ≤15 minutes; Gum: ~30 minutes (Svensson, 1987)
Transdermal: ~4 hours (Bannon, 1989); Nasal spray: 1 to 2 hours; Inhaler: 1 to 2 hours
5% to 20% (Svensson, 1987)
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?
- Patient may experience insomnia, nightmares, joint pain, tingling of mouth, gingival changes, rhinitis, rhinorrhea, cough, or watery eyes. Have patient report immediately to prescriber severe anxiety, mood changes, confusion, angina, tachycardia, arrhythmia, burning or numbness feeling, severe dizziness, severe headache, nausea, vomiting, diarrhea, tremors, severe loss of strength and energy, nasal sores, pharyngitis, severe mouth pain or irritation, jaw pain, or severe skin irritation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.