Dosing & Uses
Dosage Forms and Strengths
oral inhaler
- 10mg/cartridge (4 mg delivered)
Smoking Cessation
Indicated to reduce withdrawal symptoms during smoking cessation
Best effect observed with frequent, continuous puffing over 20 minute periods throughout the day
6 or more cartridges/day PRN [4 mg/cartridge]; do not exceed 16 cartridges/day
Use at least 6 cartridges/day for the first 3-6 weeks for improved success at quiting
Administration
Before initiating nicotine replacement reatment, patient must have desire to stop smoking
Most effective as part of comprehensive smoking cessation plan
See product user's guides for details
Not recommended
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- cabotegravir
nicotine inhaled will decrease the level or effect of cabotegravir by increasing metabolism. Contraindicated. Cabotegravir is metabolized by UGT1A1 and UGT1A9. Strong UGT1A1 or UGT1A9 inducers decrease cabotegravir systemic exposure, thereby increasing potential for loss of virologic response.
Serious - Use Alternative (0)
Monitor Closely (6)
- adenosine
nicotine inhaled increases effects of adenosine by unknown mechanism. Use Caution/Monitor. Adenosine associated tachycardia and chest pain.
- cimetidine
cimetidine increases levels of nicotine inhaled by decreasing renal clearance. Use Caution/Monitor.
- esketamine intranasal
esketamine intranasal, nicotine inhaled. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .
- green tea
green tea, nicotine inhaled. Other (see comment). Use Caution/Monitor. Comment: Green tea may include caffeine. Caffeine is a CNS-stimulant and additive effects may be seen when coadministered with other CNS stimulants. Caffeine should be avoided or used cautiously.
- solriamfetol
nicotine inhaled and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.
- varenicline
varenicline increases toxicity of nicotine inhaled by Other (see comment). Use Caution/Monitor. Comment: Varenicline is a partial agonist at the nicotinic Ach receptor; concomitant use with nicotine replacement therapy may increase adverse effects.
Minor (5)
- bupropion
bupropion, nicotine inhaled. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypertension.
- dihydroergotamine
dihydroergotamine, nicotine inhaled. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Additive vasospasm.
- dihydroergotamine intranasal
dihydroergotamine intranasal, nicotine inhaled. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Additive vasospasm.
- niacin
nicotine inhaled increases effects of niacin by pharmacodynamic synergism. Minor/Significance Unknown.
- rose hips
nicotine inhaled decreases levels of rose hips by increasing elimination. Minor/Significance Unknown.
Adverse Effects
>10%
Mouth/throat irritation (66%)
Cough (32%)
Headache (18-26%)
Rhinitis (23%)
Dyspepsia (18%)
1-10%
Back pain (6%)
Arthralgia (5%)
Flatulence (4%)
Gum problems (4%)
Acne (3%)
Dysmenorrhea (3%)
<1%
Nicotine withdrawal (irritability, dizziness, headache, insomnia)
Hiccups
N/V
Anorexia
Diarrhea
Increased salivation
Cardiac dysrhythmia (rare)
Hypertension (rare)
Tachyarrhythmia (rare)
Immune hypersensitivity reaction (rare)
Warnings
Contraindications
Hypersensitivity to nicotine or components
Cautions
Nicotine from any source can be toxic and addictive
Patient should be urged to stop smoking completely when initiating therapy; patients should be informed that if they continue to smoke while using the product, they may experience adverse effects due to peak nicotine levels higher than those experienced from smoking alone
If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the treatment should be discontinued; physicians should anticipate that concomitant medications may need dosage adjustment
Sustained use (beyond 6 months) by patients who stop smoking is not recommended and should be discouraged
Care should be taken not to spray the eyes while administering therapy
Exacerbation of bronchospasm in patients with pre-existing asthma reported; use in patients with severe reactive airway disease is not recommended; use is associated with irritant effects with no significant impairment in nasal condition
Topical application of either nicotine or tobacco products is irritating to the nasal mucosa and physicians should consider both risks and benefits to patient before initiating or continuing therapy
Therapy should be used with caution in patients with hyperthyroidism, pheochromocytoma, or insulin-dependent diabetes, since nicotine causes release of catecholamines by the adrenal medulla
Nicotine delays healing in peptic ulcer disease; therefore, therapy should be used with caution in patients with esophagitis, active gastric or peptic ulcers and only when benefits of including nicotine replacement in a smoking cessation program outweigh risks
Nicotine therapy constitutes a risk factor for development of malignant hypertension in patients with accelerated hypertension; therefore, therapy should be used with caution in these patients and only when benefits of including nicotine replacement in a smoking cessation program outweigh risks
Cardiovascular or peripheral vascular diseases
- The risks of nicotine replacement in patients with cardiovascular and peripheral vascular diseases should be weighed against benefits of including nicotine replacement in a smoking cessation program for them; specifically, patients with coronary heart disease (history of myocardial infarction and/or angina pectoris), serious cardiac arrhythmias, or vasospastic diseases (Buerger’s disease, Prinzmetal's variant angina and Raynaud’s phenomena) should be evaluated carefully before nicotine replacement is prescribed
- Tachycardia occurring in association with nicotine replacement therapy has reported; no serious cardiovascular events were reported in clinical studies but if symptoms occur, its use should be discontinued.
- This drug generally should not be used in patients during immediate postmyocardial infarction period, nor in patients with serious arrhythmias, or with severe or worsening angina
Renal or hepatic insufficiency
- Pharmacokinetic studies in patients with moderate to severe renal impairment or moderate to severe hepatic impairment have shown decreased nicotine clearance
- The pharmacokinetics of nicotine not studied in the elderly; given that nicotine is extensively metabolized and that its total system clearance is dependent on liver blood flow, some influence of hepatic impairment on drug kinetics (reduced clearance with potential for increased adverse effects) are anticipated
- Moderate and severe renal impairment would be expected to affect the clearance of nicotine or its metabolites from circulation; consider dose reduction and monitoring patients for adverse events (such as nausea or dizziness) associated with elevated levels of nicotine
Pregnancy & Lactation
Pregnancy
Harmful effects of cigarette smoking on maternal and fetal health are clearly established; these include low birth weight, an increased risk of spontaneous abortion,and increased perinatal mortality
Specific effects on fetal development are unknown; therefore pregnant smokers should be encouraged to attempt cessation using educational and behavioral interventions before using pharmacological approaches
Spontaneous abortion during nicotine replacement therapy reported; as with smoking, nicotine as a contributing factor cannot be excluded
This drug should be used during pregnancy only if likelihood of smoking cessation justifies potential risk of using it by pregnant patient, who might continue to smoke
Nicotine teratogenicity has not been studied in humans except as a component of cigarette smoke (each cigarette smoked delivers about 1 mg of nicotine); it has not been possible to conclude whether cigarette smoking is teratogenic to humans.
Animal data
- Nicotine was shown to produce skeletal abnormalities in offspring of mice when toxic doses were given to dams (25 mg/kg IP or SC)
- A nicotine bolus (up to 2 mg/kg) to pregnant rhesus monkeys caused acidosis, hypercarbia, and hypotension (fetal and maternal concentrations were about 20 times those achieved after smoking one cigarette in 5 minutes)
- Fetal breathing movements were reduced in fetal lamb after intravenous injection of 0.25 mg/kg nicotine to ewe (equivalent to smoking 1 cigarette every 20 seconds for 5 minutes); uterine blood flow was reduced about 30% after infusion of 0.1 μg/kg/min nicotine to pregnant rhesus monkeys (equivalent to smoking about six cigarettes every minute for 20 minutes
Lactation
Caution should be exercised when therapy is administered to nursing mothers; safety of therapy in nursing infants has not been examined; nicotine passes freely into breast milk; the milk-to-plasma ratio averages 2.9; nicotine is absorbed orally
An infant has the ability to clear nicotine by hepatic first-pass clearance; however, efficiency of removal is probably lowest at birth; nicotine concentrations in milk can be expected to be lower with this drug when used as recommended than with cigarette smoking, as maternal plasma nicotine concentrations are generally reduced with nicotine replacement
The risk of exposure of infant to nicotine from therapy should be weighed against risks associated with infant’s exposure to nicotine from continued smoking by the mother (passive smoke exposure and contamination of breast milk with other components of tobacco smoke) and from this drug alone, or in combination with continued smoking
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Agonist at nicotinic receptors; potent ganglionic and central nervous stimulant
Absorption
Peak plasma time: 15 minutes
Distribution
Protein binding: <5%
Vd: 2-3 L/kg
Metabolism
Metabolism: liver (some renal, lung)
Metabolites: over 20, less active
Elimination
Clearance: 1.2 L/min
Excretion: urine (30%)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Nicotrol inhalation - | 10 mg solution |  | |
| nicotine transdermal - | 21 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 21 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 21 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 7 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 21 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 21 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 14 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 21-14-7 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 7 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 7 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 14 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 14 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 14 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 21 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 21 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 14 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 7 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 21 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 14 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 7 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 21 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 21 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 14 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 7 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 21 mg/24 hr transdermal system |  | |
| nicotine transdermal - | 21 mg/24 hr transdermal system |  | |
| Nicoderm CQ transdermal - | 21 mg/24 hr transdermal system |  | |
| Nicoderm CQ transdermal - | 14 mg/24 hr transdermal system |  | |
| Nicoderm CQ transdermal - | 21 mg/24 hr transdermal system |  | |
| Nicoderm CQ transdermal - | 7 mg/24 hr transdermal system |  | |
| Nicoderm CQ transdermal - | 7 mg/24 hr transdermal system | | |
| Nicoderm CQ transdermal - | 21 mg/24 hr transdermal system |  | |
| Nicotrol NS nasal - | 10 mg/mL liquid |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
nicotine transdermal
NICOTINE PATCH - TRANSDERMAL
(NICK-oh-teen)
COMMON BRAND NAME(S): Habitrol, Nicoderm CQ, Nicotrol
USES: This medication can help you quit smoking by replacing the nicotine in cigarettes. The nicotine in tobacco is an important part of cigarette addiction. When you stop smoking, your nicotine levels drop quickly. This drop can cause withdrawal symptoms such as craving tobacco, nervousness, irritability, headache, weight gain, and difficulty concentrating.Stopping smoking is hard and your chance of success is best when you are ready and have made a commitment to quit. Nicotine replacement products are part of a total stop-smoking program that includes behavior change, counseling, and support. Smoking causes lung disease, cancer, and heart disease. Stopping smoking is one of the most important things you can do to improve your health and live longer.
HOW TO USE: If you are using the over-the-counter product, read all directions on the product package before using this medication. If your doctor has prescribed this medication, read the Patient Information Leaflet if available from your pharmacist before you start using this product and each time you get a refill. Make sure you understand how to apply a new patch and dispose of the used product. If you have any questions, ask your doctor or pharmacist.Start this medication on your quit (smoking) day. The patch should be applied to a clean, dry, non-hairy area on the trunk or upper arm. Check the manufacturer's instruction sheet for recommended areas to place the patch. If necessary, clip hair from the site before applying the patch. Do not shave the area. Remove the patch from the package, peel off the protective strip, and immediately apply the patch to the skin. Press firmly for 10 to 20 seconds to make sure the patch stays in place. Be sure the edges are held firmly to the skin. Wash your hands with plain water after applying the patch. Do not use soap.The best dose for you is the dose that decreases the urge to smoke without side effects from too much nicotine. If your doctor has prescribed this medication, follow your doctor's orders carefully. Your dose will need to be adjusted to your needs, including smoking history and medical condition.Different brands of nicotine patches have different amounts of nicotine and different instructions for how long to leave the patch on the skin (such as for 24 hours or only while awake). Consult your doctor or pharmacist about which brand of patch to use. If you wake up craving cigarettes, the 24-hour patch may be best. If the patch causes vivid dreams or interferes with sleep, you may need to wear the patch only while awake (16 hours each day).Do not apply the patch to red/cut/irritated skin or over other skin products (such as makeup, lotions, powders). Do not use the patch if the individual pouch is open or damaged or if the patch is cut, torn, or damaged. Apply the patch to a different area on your body each time to avoid irritation. Wait at least a week before using the same application site. Apply a new patch if your patch falls off.Do not wear a patch for more than 24 hours. Do not wear more than 1 patch at a time. After removing each patch, fold it in half so it sticks to itself, and discard in the trash away from children and pets.Use a new patch each day, applying it at the same time each day to help you remember, usually when you wake up. After several weeks, you will gradually lower your dose (strength of patch) until you no longer need nicotine replacement. It is important to complete the treatment with this medication (8 to 10 weeks). If after the treatment period, you still feel the need to use this medication to prevent you from smoking, talk to your doctor.If you suddenly stop using this medication, you may have withdrawal symptoms (such as tobacco cravings, nervousness, irritability, headache). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used nicotine for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.Tell your doctor if you have not been able to quit smoking after using this product for 4 weeks. Some smokers are unsuccessful the first time they try to quit. You may need to stop using this product and try again later. Many people who cannot quit the first time are successful the next time.
SIDE EFFECTS: Mild itching, redness, burning, and stinging at the application site may occur. Stop using this product and tell your doctor if redness caused by the patch does not go away after 4 days. Nausea, dizziness, flushing, heartburn, or headache may also occur. Common nicotine withdrawal symptoms can occur when you stop smoking and include dizziness, anxiety, depression, or trouble sleeping, among others. If any of these withdrawal symptoms or side effects last or get worse, tell your doctor or pharmacist promptly.If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Serious side effects are more likely if you continue to smoke while using this product.Stop using this medication and tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as irritability, trouble sleeping, vivid dreams), numbness/tingling in hands/feet, swelling hands/ankles/feet.Stop using this medication and get medical help right away if you have any very serious side effects, including: chest pain, confusion, severe headache, fast/irregular/pounding heartbeat, trouble speaking, weakness on one side of the body.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to nicotine; or to adhesive tape; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel disease (such as Raynaud's disease, stroke), diabetes, heart disease (such as chest pain, heart attack, irregular heartbeat), high blood pressure, liver disease, kidney disease, esophagus problems (such as esophagitis), stomach/intestinal sores (peptic ulcers), certain adrenal problem (pheochromocytoma), overactive thyroid (hyperthyroidism), seizures, skin problems (such as eczema, contact dermatitis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).If you are going to have an MRI test, tell testing personnel that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI. Ask your doctor whether you will need to remove your patch before the test and apply a new patch afterward, and how to do so properly.Strenuous exercise may raise your skin temperature and increase the amount of nicotine absorbed through the skin. Talk with your doctor about the effects of exercise on this medication.Avoid exposing the skin under the patch to direct heat sources such as heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, or prolonged direct sunlight while wearing your patch. Heat sources may cause more drug to be released into your body, increasing the chance of side effects.Nicotine and smoking may harm an unborn baby. If you are pregnant, try to stop smoking without using a nicotine replacement product if possible. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.Nicotine from smoking and from this medication passes into breast milk and could have undesirable effects on a nursing infant. Smoking near an infant can also harm the infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Stopping smoking can change the way the liver removes certain drugs from the body (including acetaminophen, caffeine, insulin, oxazepam, pentazocine, propoxyphene, propranolol, theophylline, tricyclic antidepressants such as amitriptyline/imipramine, "water pills"/diuretics such as furosemide). Tell all your doctors and pharmacists that you are quitting smoking.
OVERDOSE: This medication patch may be harmful if chewed or swallowed. If someone has overdosed, remove the patch if possible. For serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: confusion, drooling, seizure, slow/shallow breathing, hearing problems.
NOTES: If your doctor has prescribed this medication for you, do not share it with others.
MISSED DOSE: If you forget to change your patch on time, change it as soon as you remember. You can change your next patch 24 hours later or go back to your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store in original packaging at room temperature away from light and moisture. Do not store in the bathroom. Keep patches in the sealed protective pouch until ready to use. Apply patch immediately after removing from pouch. Do not use if the pouch is damaged, cut, or opened ahead of time. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed (See How to Use section).
Information last revised August 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
