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Nicotine: Drug information

Nicotine: Drug information
(For additional information see "Nicotine: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • FT Nicotine [OTC];
  • Habitrol [OTC];
  • Nicoderm CQ [OTC];
  • Nicorette Mini [OTC];
  • Nicorette Starter Kit [OTC];
  • Nicorette [OTC];
  • Nicotine Mini [OTC];
  • Nicotine Step 1 [OTC];
  • Nicotine Step 2 [OTC];
  • Nicotine Step 3 [OTC];
  • Nicotrol;
  • Nicotrol NS;
  • Thrive [OTC]
Pharmacologic Category
  • Smoking Cessation Aid
Dosing: Adult
Smoking cessation

Smoking cessation (patients should completely stop smoking upon initiation of therapy): Note: Extended duration therapy (>12 weeks) of nicotine cessation products is often used to ensure patient does not return to smoking (Ref).

Gum: Oral: 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 treatment: 6 to 16 cartridges/day (at least 6 cartridges/day for the first 3 to 6 weeks) for up to 12 weeks; maximum: 16 cartridges/day. Note: Best effect achieved with frequent continuous puffing (20 minutes). Use beyond 6 months is not recommended (has not been studied). If patient is unable to stop smoking by the fourth week of therapy, consider discontinuation.

Discontinuation of therapy: After initial treatment, gradually reduce daily dose over 6 to 12 weeks. Some patients may not require gradual reduction of dosage and may stop treatment abruptly.

Lozenge: Oral: 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: Initial: 1 to 2 doses/hour (each dose [2 sprays, one in each nostril] contains 1 mg of nicotine); adjust dose as needed based on patient response; 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). Use beyond 6 months is not recommended (has not been studied). If patient is unable to stop smoking by the fourth week of therapy, consider discontinuation.

Discontinuation of therapy: Discontinue over 4 to 6 weeks. Some patients may not require gradual reduction of dosage and may stop treatment abruptly.

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.

Dosing: Kidney Impairment: Adult

There are no specific dosage adjustments provided in the manufacturer's labeling. However, nicotine clearance is decreased in moderate to severe renal impairment; consider dose reduction.

Dosing: Hepatic Impairment: Adult

There are no specific dosage adjustments provided in the manufacturer's labeling. However, nicotine clearance is decreased in moderate to severe hepatic impairment; consider dose reduction.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Nasal spray/inhaler:

>10%:

Central nervous system: Headache (18% to 26%)

Gastrointestinal: Oral irritation (≤66%), dyspepsia (18%)

Respiratory: Nasal discomfort (94%), throat irritation (≤66%), cough (32%), rhinitis (23%)

1% to 10%:

Central nervous system: Pain (>3%), paresthesia (>3%), withdrawal syndrome (>3%)

Dermatologic: Acne vulgaris (3%)

Gastrointestinal: Flatulence (4%), gingival disease (4%), diarrhea (>3%), dysgeusia (>3%), hiccups (>3%), nausea (>3%)

Genitourinary: Dysmenorrhea (3%)

Neuromuscular & skeletal: Back pain (6%), arthralgia (5%), jaw pain (>3%), neck pain (>3%)

Respiratory: Flu-like symptoms (>3%), sinusitis (>3%)

Miscellaneous: Fever (>3%)

<1%: Amnesia, aphasia, bronchospasm, hypersensitivity reaction, increased bronchial secretions, migraine, nonthrombocytopenic purpura, numbness, peripheral edema, skin rash, visual disturbance, xerostomia

Frequency not defined:

Central nervous system: Altered sense of smell, facial paresthesia

Dermatologic: Burning sensation of the nose, facial flushing

Gastrointestinal: Oral paresthesia

Ophthalmic: Burning sensation of eyes, eye irritation, watery eyes

Otic: Otalgia

Respiratory: Epistaxis, hoarseness, nasal congestion, nasal mucosa ulcer, pharyngitis, rhinorrhea, sneezing

Postmarketing: Anaphylaxis, chest pain, dysphagia

Adverse events reported for chewing gum, lozenge, and/or transdermal systems were reported in prescription labeling. Frequency not defined; may be product- or dose-specific:

Cardiovascular: Cardiac arrhythmia, increased blood pressure, palpitations

Central nervous system: Abnormal dreams, sleep disturbance

Dermatologic: Erythema of skin, skin rash

Gastrointestinal: Dyspepsia, heartburn, hiccups, oral irritation, sore throat

Hypersensitivity: Hypersensitivity reaction

Local: Application site reaction, localized edema

Neuromuscular & skeletal: Jaw pain

Contraindications

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.

Warnings/Precautions

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.

• Gastrointestinal disease: Use with caution in patients with esophagitis or active gastric or peptic ulcer disease; healing may be delayed.

• Hepatic impairment: Nicotine clearance is decreased in patients with moderate to severe hepatic impairment; use with caution. Monitor for adverse effects; consider dose reduction.

• Renal impairment: Nicotine clearance is decreased in patients with moderate to severe renal impairment; use with caution. Monitor for adverse effects; consider dose reduction.

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 have 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.

• Phenylalanine: Some products may contain phenylalanine.

• 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.

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.

Dosage Forms Considerations

Nicotrol NS contains approximately 200 sprays.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gum, Mouth/Throat, as polacrilex:

Nicorette: 2 mg (170 ea, 200 ea) [original flavor]

Nicorette: 2 mg (20 ea, 100 ea, 160 ea) [contains menthol; fruit flavor]

Nicorette: 2 mg (170 ea) [contains menthol; mint flavor]

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) [contains menthol, polysorbate 80; mint flavor]

Nicorette: 2 mg (100 ea, 160 ea) [contains menthol, polysorbate 80; spearmint flavor]

Nicorette: 4 mg (20 ea, 100 ea, 160 ea) [contains menthol, polysorbate 80, quinoline (d&c yellow #10) aluminum lake; mint flavor]

Nicorette: 4 mg (100 ea, 160 ea) [contains menthol, polysorbate 80, quinoline yellow (d&c yellow #10); cinnamon flavor]

Nicorette: 4 mg (100 ea) [contains menthol, quinoline (d&c yellow #10) aluminum lake; fresh mint flavor]

Nicorette: 4 mg (20 ea, 100 ea, 160 ea) [contains menthol, quinoline (d&c yellow #10) aluminum lake; fruit flavor]

Nicorette: 4 mg (170 ea) [contains menthol, quinoline (d&c yellow #10) aluminum lake; mint flavor]

Nicorette: 4 mg (100 ea) [contains menthol, quinoline (d&c yellow #10) aluminum lake; spearmint flavor]

Nicorette: 4 mg (170 ea, 200 ea) [contains quinoline yellow (d&c yellow #10); original 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 quinoline (d&c yellow #10) aluminum lake; original flavor]

Thrive: 2 mg (100 ea) [contains 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: 7 mg/24 hr (14s) & 14 mg/24 hr (14s) & 21 mg/24 hr (28s)

Lozenge, Mouth/Throat, as polacrilex:

FT Nicotine: 2 mg (24 ea); 4 mg (24 ea) [gluten free; contains aspartame]

Nicorette: 2 mg (20 ea)

Nicorette: 2 mg (24 ea) [contains aspartame; mint flavor]

Nicorette: 2 mg (24 ea, 72 ea) [contains aspartame, soy protein; mint flavor]

Nicorette: 4 mg (20 ea) [mint flavor]

Nicorette: 4 mg (24 ea, 72 ea) [contains aspartame, soy protein; mint flavor]

Nicorette Mini: 2 mg (20 ea, 81 ea, 135 ea)

Nicorette Mini: 2 mg (27 ea) [mint flavor]

Nicorette Mini: 4 mg (20 ea, 81 ea)

Nicotine Mini: 2 mg (24 ea) [contains aspartame]

Nicotine Mini: 2 mg (27 ea) [contains aspartame; mint flavor]

Nicotine Mini: 4 mg (24 ea, 27 ea) [contains aspartame]

Generic: 2 mg (24 ea, 27 ea); 4 mg (24 ea, 27 ea)

Patch 24 Hour, Transdermal:

Habitrol: 21 mg/24 hr (7 ea, 14 ea)

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 (1 ea, 7 ea, 14 ea)

Nicotine Step 2: 14 mg/24 hr (1 ea, 7 ea, 14 ea)

Nicotine Step 1: 21 mg/24 hr (1 ea, 7 ea, 14 ea, 28 ea)

Generic: 7 mg/24 hr (7 ea, 14 ea); 14 mg/24 hr (7 ea, 14 ea, 28 ea); 21 mg/24 hr (7 ea, 14 ea, 28 ea)

Solution, Nasal:

Nicotrol NS: 10 mg/mL (10 mL)

Generic Equivalent Available: US

May be product dependent

Pricing: US

Gum (Nicorette Mouth/Throat)

2 mg (per each): $0.45

4 mg (per each): $0.51

Gum (Nicorette Starter Kit Mouth/Throat)

2 mg (per each): $0.51

4 mg (per each): $0.46

Gum (Nicotine Polacrilex Mouth/Throat)

2 mg (per each): $0.28 - $0.40

4 mg (per each): $0.27 - $0.42

Gum (Thrive Mouth/Throat)

2 mg (per each): $0.42

Inhalation (Nicotrol Inhalation)

10 mg (per each): $3.62

Kit (Nicotine Transdermal)

21-14-7 mg/24 hrs (per each): $1.83

Lozenge (Nicorette Mini Mouth/Throat)

2 mg (per each): $0.60

4 mg (per each): $0.55

Lozenge (Nicorette Mouth/Throat)

2 mg (per each): $0.46

4 mg (per each): $0.46

Lozenge (Nicotine Polacrilex Mouth/Throat)

2 mg (per each): $0.43 - $0.49

4 mg (per each): $0.43 - $0.49

Patch, 24-hour (Habitrol Transdermal)

21 mg/24 hrs (per each): $2.52

Patch, 24-hour (Nicoderm CQ Transdermal)

7 mg/24 hrs (per each): $1.71

14 mg/24 hrs (per each): $1.71

21 mg/24 hrs (per each): $1.71

Patch, 24-hour (Nicotine Transdermal)

7 mg/24 hrs (per each): $2.39 - $2.52

14 mg/24 hrs (per each): $2.39 - $2.52

21 mg/24 hrs (per each): $2.13 - $2.14

Solution (Nicotrol NS Nasal)

10 mg/mL (per mL): $16.11

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

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 between cheek and gum (~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); avoid excessive priming. 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. Avoid contact with skin, eyes, and mouth (nicotine overdose can occur when nicotine is absorbed through the skin).

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. Do not inhale into the lungs like a cigarette. 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 Drugs Handling Considerations

Hazardous agent; use appropriate precautions for handling and disposal (EPA, P-listed). Note: The EPA is amending the P075 listing for nicotine to exclude over-the-counter (OTC) nicotine patches, gums, and lozenges; when the rule is finalized, OTC nicotine products will no longer be considered hazardous waste when discarded (refer to Docket No. EPA-HQ-RCRA-2007-0932).

Use: Labeled Indications

Smoking cessation: Treatment to aid smoking cessation for the relief of nicotine withdrawal symptoms (including nicotine craving)

Medication Safety Issues
Sound-alike/look-alike issues:

NicoDerm may be confused with Nitroderm

Nicorette may be confused with Nordette

Other safety concerns:

Transdermal patch may contain conducting metal (eg, aluminum); remove patch prior to MRI.

Metabolism/Transport Effects

Substrate of CYP1A2 (minor), CYP2A6 (minor), CYP2B6 (minor), CYP2C19 (minor), CYP2C9 (minor), CYP2D6 (minor), CYP2E1 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Adenosine: Nicotine may enhance the AV-blocking effect of Adenosine. Nicotine may enhance the tachycardic effect of Adenosine. Risk C: Monitor therapy

Methysergide: Nicotine may enhance the vasoconstricting effect of Methysergide. Risk C: Monitor therapy

Varenicline (Systemic): May enhance the adverse/toxic effect of Nicotine. Risk C: Monitor therapy

Food Interactions

Lozenge: Acidic foods/beverages decrease absorption of nicotine.

Pregnancy Considerations

Nicotine crosses the placenta (ACOG 2020).

Adverse pregnancy outcomes are associated with nicotine exposure from maternal cigarette smoking. Adverse fetal/neonatal effects include fetal growth restriction, low birth weight, orofacial clefts, increased perinatal mortality, and sudden infant death syndrome. Adverse effects in children exposed to nicotine in utero include asthma, bone fractures, childhood obesity, infantile colic, and respiratory infections. Maternal tobacco use during pregnancy is also associated with increased risks of abruptio placentae, ectopic pregnancy, preterm delivery, placenta previa, preterm prelabor rupture of membranes, and decreased maternal thyroid function. Most information related to pregnancy outcomes is from studies of maternal cigarette smoking. However, exposure to nicotine during pregnancy in any form, including secondhand smoke, is associated with adverse events. Benefits to smoking cessation occur at any time during pregnancy. The risk of fetal growth restriction is decreased the earlier in gestation that smoking cessation occurs. The most benefits to the mother and fetus are observed when smoking is stopped <15 weeks' gestation (ACOG 2020).

Based on available data, pregnancy outcomes are similar following maternal nicotine replacement therapy (NRT) when compared to cigarette smoking (Claire 2020; Taylor 2021).

Due to pregnancy-induced physiologic changes, some pharmacokinetic properties of nicotine may be altered. The clearance of nicotine (either from smoking or use of NRT) is increased during pregnancy due in part to increased CYP450 metabolism. Nicotine levels are decreased (Baraona 2017; Claire 2020; Hickson 2019; Taghavi 2018).

All pregnant patients should be screened for nicotine use, regardless of form (cigarettes, e-cigarettes, hookahs, snus, vaping products, as well as lozenges, patches, and gum). Cessation of intake is recommended, and interventions should be individualized (ACOG 2020). The benefit of tobacco smoking cessation for pregnant patients is well documented; behavioral interventions are effective and recommended. Information related to pharmacotherapy interventions in pregnancy is limited and insufficient to make specific recommendations (USPSTF [Krist 2021]). When behavioral counseling is insufficient, the severity of maternal tobacco dependance should be considered along with the known risks of smoking and possible risks of the pharmacologic intervention (ACOG 2020; USPSTF [Krist 2021]). NRT is the most studied pharmacologic intervention in pregnant patients. Although use of NRT decreases maternal and fetal exposure to the additional toxic chemicals found in cigarettes, studies in pregnant patients have inconsistent or inconclusive outcomes, with some showing adverse events or lack of efficacy (ACOG 2020; Baraona 2017; Claire 2020). If used, NRT during pregnancy should be done under close medical supervision in patients with a clear resolve to quit smoking (ACOG 2020).

Breastfeeding Considerations

Nicotine and cotinine are present in breast milk (Ilett 2003).

The amount of nicotine in breast milk following maternal use of nicotine replacement products varies. In one study, breast milk concentrations of nicotine following either maternal use of the 21 mg/day patch or smoking ~17 cigarettes/day were similar; milk concentrations decreased when lower doses of the nicotine patch were used (Ilett 2003).

Cotinine can be detected in the serum of breastfed infants following maternal use of nicotine replacement therapy (Ilett 2003). Hepatic clearance of nicotine in the newborn is lowest at birth.

Nicotine and cotinine are also present in the breast milk of mothers who smoke cigarettes and cotinine can be detected in the urine of breastfed infants (Dahlström 2008).

Nicotine replacement therapy (NRT) is considered compatible with breastfeeding (ABM [Reece-Stremtan 2015]; Sachs 2013). The amount of nicotine received from the replacement product should be less than that received from smoking. Use of short-acting products (gum, lozenges) is preferred (Sachs 2013). Avoiding use of short-acting NRT immediately prior to breastfeeding may decrease nicotine concentrations in breast milk (Grangé 2020).

Dietary Considerations

Some products may contain phenylalanine and/or sodium.

Monitoring Parameters

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)

Mechanism of Action

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 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.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action:

Intranasal: More closely approximate the time course of plasma nicotine levels observed after cigarette smoking than other dosage forms (Svensson 1987).

Inhalation: Immediate (Olsson Gisleskog 2021).

Absorption:

Buccal mucosa, transdermal: Slow.

Intranasal: ~53%.

Inhaler: <5% reaches the lower respiratory tract.

Ingestion: ~30% to 40% (Olsson Gisleskog 2021).

Distribution: 2 to ~4 L/kg (Olsson Gisleskog 2021; Svensson 1987).

Protein binding: 5% to 20% (Svensson 1987).

Metabolism: Hepatic (major), kidney, and lung; >20 metabolites (primary metabolites are cotinine and trans-3-hydroxycotinine).

Half-life elimination: Transdermal: ~4 hours (Bannon 1989); Intranasal: 1 to 2 hours; IV: 4.5 hours (Olsson Gisleskog 2021); Oral inhalation: 1 to 2 hours.

Time to peak, serum: Transdermal: ~2 to 8 hours (Bannon 1989; DeVeaugh-Geiss 2010); Intranasal: 10 to 20 minutes; Oral inhalation: ≤15 minutes; Gum: ~30 minutes (Svensson 1987).

Excretion: Urine (~10% as unchanged).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Nicorette | Nicotinell | Niquitin mint;
  • (AR) Argentina: Nicorette | Nicotinell | Nicotinell Fruit | Nicotinell Six Pack | Nicotinell Tin Case | Niquitin | Niux;
  • (AT) Austria: Nicorette | Nicotinell | Nicotrol | Niquitin clear | Niquitin mini;
  • (AU) Australia: Amcal nicotine | Chemists own nicotine | Guardian nicotine patches | Herron Nicaway | Iquit | Medihealth nicotine | Nicabate | Nicabate cq | Nicabate cq soft mint | Nicabate Pre-Quit | Nicorette | Nicorette cooldrops | Nicorette freshdrops | Nicorette Quickmist | Nicotine | Pharmacy care nicotine | Quitx | Quitx nicotine | Your pharmacy nicotine;
  • (BE) Belgium: Nicopatch | Nicorette | Nicotinell | Niquitin;
  • (BG) Bulgaria: Nicorette | Nicorette berrymint | Nicorette freshmint | Nicotinell;
  • (BR) Brazil: Nicolan | Nicorette | Nicotinell | Niquitin;
  • (CH) Switzerland: Nicorette | Nicorette Invisi | Nicostop mepha | Nicotinell;
  • (CL) Chile: Nicorette | Nicotinell;
  • (CN) China: Nicorette | Nicotinell | Niquitin cq;
  • (CO) Colombia: Nicoless | Nicorette | Niquitin;
  • (CZ) Czech Republic: Nicorette | Nicorette icemint | Nicotinell | Niquitin | Niquitin clear | Niquitin cq | Niquitin mini;
  • (DE) Germany: Nicopass Laktritz | Nicopass Mint | Nicopatch | Nicorette | Nicotin beta | Nicotinell | Nikofrenon | Niquitin;
  • (DK) Denmark: Nicorette classic | Nicorette Fruitmint | Nicovel mint;
  • (EE) Estonia: Nicorette | Nicorette coolmint | Nicotinell | Niquitin mini | Niquitin mint;
  • (EG) Egypt: Nicotinell;
  • (ES) Spain: Nicokern | Nicorette | Nicorette clear | Nicorette freshfruit | Nicorette ice mint | Nicorette mint | Nicorette parches | Nicorette supermint | Nicotinell | Nicotrol | Niquitin | Quitt;
  • (FI) Finland: Nicolan elan | Nicopatch | Nicorette | Nicotinell | Nicover;
  • (FR) France: Nicopass | Nicopatch | Nicopatchlib | Nicorette | Nicoretteskin | Nicorettespray | Nicotine eg | Nicotinell | Nicotinell classic | Nicotinell menthe | Niquitin | Niquitin clear | Niquitin Menthe Fraiche | Niquitinminis;
  • (GB) United Kingdom: Nicabate | Nicassist | Nicorette | Nicorette cools | Nicorette Fruitfusion | Nicotinell | Niquitin | Niquitin cq | Niquitin minis;
  • (GR) Greece: Nicopass | Nicopatch | Nicorette | Nicotinell;
  • (HK) Hong Kong: Nicorette | Nicotinell | Niquitin;
  • (HR) Croatia: Nicorette | Nicorette freshmint | Nicorette invisipatch | Niquitin cq;
  • (HU) Hungary: Nicopass | Nicorette | Nicotinell | Niquitin | Niquitin clear | Niquitin cq;
  • (ID) Indonesia: Nicotinell;
  • (IE) Ireland: Nicochew | Nicopass | Nicorette | Nicotinell | Niquitin | Niquitin cq;
  • (IL) Israel: Nicorette | Nicotinell | Niquitin cq;
  • (IN) India: 2baconil | Kwitz | Niclonz | Nicochew | Nicogum | Nicorette | Nicotex | Nicotex chew gum | Nicotinell | Nixit | Nosmok | Nulife | Smoke free;
  • (IS) Iceland: Nicorette;
  • (IT) Italy: Nicodose | Nicopatch | Nicorette | Nicorette mint | Nicorette Quickmist | Nicotinell | Nicotinell Mint | Niquitin cq | Niquitin mini | Niquitinact;
  • (JO) Jordan: Clear Assiquit | Nicorette | Nicotinell Mint;
  • (JP) Japan: Ciganon cq | Nicorette | Nicorette aventis | Nicorette pfizer | Nicotinell | Nicotinell tts;
  • (KR) Korea, Republic of: Exoderm | Exodus | Nico a | Nico free | Nicoderm | Nicoless | Nicomagic | Nicoman | Nicopatch | Nicorette | Nicorette Invisi | Nicostop | Nicotinel-tts | Nicotinell;
  • (KW) Kuwait: Nicorette | Nicotinell;
  • (LB) Lebanon: Nicotinell | Niquitin;
  • (LT) Lithuania: Nicopass | Nicorette | Nicorette coolmint | Nicotinell | Niquitin;
  • (LU) Luxembourg: Nicorette | Nicotinell | Niquitin;
  • (LV) Latvia: Nicopass | Nicorette | Nicorette coolmint | Nicotinell | Niquitin;
  • (MA) Morocco: Nicopass | Nicopatch | Smoke-end ln;
  • (MX) Mexico: Nicolan | Nicorette | Nicotinell | Nicotinell tts | Niquitin;
  • (MY) Malaysia: Nicorette | Nicotinell | Niquitin;
  • (NL) Netherlands: Etos nicotine | Nicopass | Nicopatch | Nicorette | Nicotine | Nicotinell | Nicotinell classic | Nicotinell classic kauwgom | Nicotinell Mint | Niqero | Niquitin clear | Niquitin menthol;
  • (NO) Norway: Nicorette | Nicotinell | Nicotinell peppermint | Nicovel | Zonnic;
  • (NZ) New Zealand: Habitrol | Nicabate | Nicorette | Nicotine | Nicotinell | Nicotrol;
  • (PE) Peru: Nicotinell;
  • (PH) Philippines: Nicotinell | Nosmok;
  • (PL) Poland: Niccorex lemon | Niccorex mint | Nicorette | Nicorette classic | Nicorette freshfruit | Nicorette freshmint | Nicorette Fruit | Nicorette Icy White | Nicotinell | Niquitin | Niquitin menthol | Niquitin przezroczysty;
  • (PR) Puerto Rico: Commit | Habitrol | Nicoderm | Nicoderm cq | Nicorelief | Nicorette | Nicotine | Nicotine Transdermal System | Nicotrol | Thrive;
  • (PT) Portugal: Nicopatch | Nicorette | Nicotina Actavis | Nicotinell | Niquitin | Niquitin menta;
  • (QA) Qatar: Nicorette Inhalator | Nicotinell Regular Strength | Nicotinell TTS 10 | Nicotinell TTS 20 | Nicotinell TTS 30 | Niquitin;
  • (RO) Romania: Nicorette | Nicorette clear | Nicorette freshfruit | Nicorette icemint | Nicorette mint | Niquitin clear;
  • (RU) Russian Federation: Nicorette | Nicorette Fresh fruits | Nicorette freshmint | Nicorette frosty mint | Nicotinell | Niquitin | Niquitin mini;
  • (SA) Saudi Arabia: Nicorette | Nicotinell | Niquitin;
  • (SE) Sweden: Nicolan Mint | Nicorette | Nicorette Citrus | Nicorette frukt | Nicorette Fruktmint | Nicorette fruktmint | Nicorette Mentolmint | Nicorette mint | Nicorette Novum | Nicorette pepparmint | Nicorette Spicemint | Nicotinell | Nicotinell Fruit | Nicotinell Lakrits | Nicotinell Mint | Nicotinell Peppermint | Nicotinell spearmint | Nicotinell Tropisk frukt | Nicovel | Nikotin frukt abece | Nikotin frukt apofri | Nikotin mint abece | Nikotin mint apofri | Nikotugg | Niquitin | Niquitin clear | Niquitin mentolmint | Niquitin mint | Zonnic mint | Zonnic pepparmint;
  • (SG) Singapore: Nicorette | Nicotinell;
  • (SI) Slovenia: Nicorette;
  • (SK) Slovakia: Nicorette | Nicorette icemint | Nicorette mint | Nicotinell | Nicotinell Fruit | Nicotinell Mint | Niquitin | Niquitin clear | Niquitin cq | Niquitin mini;
  • (TH) Thailand: Nicomild | Nicorette | Nicotinell;
  • (TN) Tunisia: Nicopass | Nicopatch | Nicotinell;
  • (TR) Turkey: Nicorette Invisi | Nicotinell | Niquitin;
  • (TW) Taiwan: Exodus | Nicodin | Nicorette | Nicotinell | Niquitin | Smokfree Nicotine;
  • (UA) Ukraine: Nicorette | Nicorette fresh mint | Nicorette ice mint;
  • (UG) Uganda: Nosmok;
  • (UY) Uruguay: Nicorette | Nicotinell;
  • (VE) Venezuela, Bolivarian Republic of: Nicorette;
  • (ZA) South Africa: Nicorette | Nicorette freshfruit | Nicorette freshmint | Nicotinell
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