nicotine gum (OTC)

Brand and Other Names:Nicorette Gum
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

gum

  • 2mg
  • 4mg

Smoking Cessation

Weeks 1-6: 1 piece of gum q1-2hr; ches at least 9 pieces per day during the first 6 weeks to increase chances of quiting

Weeks 7-9: 1 piece of gum q2-4hr

Weeks 10-12: 1 piece of gum q4-8hr

<25 cigarettes/day: Initiate with 2 mg

≥25 cigarettes/day: Initiate with 4 mg

For strong/frequent cravings, may use second piece within 1 hour

Safety and efficacy not established

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Adverse Effects

Frequency Not Defined

Increased blood pressure

Tachycardia

Dizziness

Insomnia

Irritability

Anorexia

Dyspepsia

Hiccups

Increased salivation

Indigestion

Nausea

Vomiting

Cough

Dental

  • May loosen inlays/fillings
  • Stick to dentures
  • Damage to oral mucosa & teeth
  • Temporal mandibular joint dysfunction and pain with excessive chewing
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Warnings

Contraindications

Hypersensitivity drug or excipients, including soya

Cautions

Weigh benefits versus risk in patients with cardiovascular or peripheral vascular disease, including angina pectoris, vasospastic disease, or serious cardiac arrhythmias, hypertension; discontinue use if irregular heartbeat or palpitations occur

Monitor for adverse effects and consider dose reduction in hepatic or renal impairment as clearance may be reduced

Patient should discontinue use and contact healthcare professional if symptoms of nicotine overdose occur, including dizziness, nausea, vomiting, diarrhea, or rapid heartbeat

Poisoning/fatality may occur in children if inhaled, ingested, or buccally absorbed

Continuously chewing gum increases nicotine release leading to increased adverse effects (see administration instructions)

Stop use if oral blistering occurs

If teeth, mouth, or jaw problems occur, discontinue use and talk to healthcare provider

May delay healing of esophagitis or active gastric or peptic ulcer disease

Use caution in patients with insulin-dependent diabetes

Use caution in patients on sodium restricted diet or with history of seizures

Use caution in hyperthyroidism or pheochromocytoma

Stop use and ask a doctor if symptoms of an allergic reaction occur, such as, difficulty breathing or rash

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Pregnancy & Lactation

Pregnancy category: D; tobacco smoke known to cause low birth weight, spontaneous abortion, increased perinatal mortality, decreased placental perfusion; however, nicotine replacement is believed to be safer during pregnancy than smoking

Lactation: nicotine and metabolite (cotinine) pass into breast milk up to hr after maternal smoking; risk of exposure of infant to 2nd hand smoke may be more detrimental than nicotine replacement; nicotine may increase infant heart rate

Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

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.

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Pharmacology

Mechanism of Action

Transdermal nicotine systemically absorbed; binds to nicotine receptors; reduces withdrawal symptoms, including nicotine craving, associated with smoking cessation

Pharmacokinetics

Peak Plasma Level: Dependent on chewing vigor and duration

Trough Plasma Level: trough serum level 1 hr after smoking 1 cigarette/hr about 2x that of 2 mg gum

Elimination Half-Life: 30-120 min

Metabolism: Liver via oxidation

Excretion: (renal; pH dependent, increased with acidic urine) 10-20%

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Administration

Administration

There are no significant safety concerns associated with using more than 1 nonprescription nicotine replacement therapies (OTC NRT) at the same time or at the same time as another nicotine-containing product—including a cigarette

Patients using an OTC NRT while trying to quit smoking but slip up and have a cigarette, should not stop using the NRT, but keep using the OTC NRT and keep trying to quit

NRT users should still pick a day to quit smoking, and begin using the OTC NRT product on their "quit" day, even if they aren't immediately able to stop smoking

It is important for patients to complete the full program, but some patients may need to use the NRT for a longer period of time to keep from smoking

Nicotine is bound to an ion exchange resin (polacrilex) and released only during chewing

Delay use until at least 15 minutes after consuming food or liquids

Concurrent consumption of acidic beverages (eg, coffee, cola) significantly decreases nicotine absorption

Instruct patient to not chew nicotine gum as regular gum; begin chewing slowly until feels tingling or peppery taste in mouth; THEN

Move gum between to inside cheek (ie, between patient’s teeth & cheek) until tingling subsides

Repeat chewing until tingling appears & subsides until tingling doesn’t come back (then that piece of gum is finished)

Before using this product, instruct the patient to read the enclosed user's guide for complete directions and other important information

To improve the chances of quitting, chew at least 9 pieces/day for the first 6 weeks

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Nicotrol inhalation
-
10 mg solution
Nicotrol NS nasal
-
10 mg/mL liquid
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
-
14 mg/24 hr transdermal system
nicotine transdermal
-
7 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
-
21 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 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
-
14 mg/24 hr transdermal system
nicotine transdermal
-
7 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
nicotine transdermal
-
14 mg/24 hr transdermal system
nicotine transdermal
-
7 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

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Select a drug:
Patient Education
nicotine inhalation

NICOTINE INHALER - ORAL INHALATION

(NICK-oh-teen)

COMMON BRAND NAME(S): 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. Using the inhaler can replace the hand-to-mouth habit of smoking.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: Read the Patient Information Leaflet provided by your pharmacist before you start using your nicotine inhaler and each time you get a refill. Follow all the directions for use carefully. If you have any questions, consult your doctor or pharmacist.It is very important to stop smoking completely while using this nicotine product. Insert a cartridge into the mouthpiece and inhale the medication by quickly puffing on the mouthpiece for four 5-minute sessions or continually for about 20 minutes. Although using the inhaler is like smoking a cigarette, you do not need to inhale deeply as you would a cigarette for the medicine to work. The medicine works in the mouth and throat, not in the lungs.Avoid acidic food and drink (e.g., citrus fruit, coffee, juices, carbonated drinks) for 15 minutes before inhaling this medication.After using the inhaler for a total of 20 minutes, remove the used cartridge and throw it away out of reach of children and pets. The mouthpiece is reusable. Clean with soap and water.When you quit smoking, start using a nicotine cartridge whenever you crave a cigarette. Usually, you will use at least 6 cartridges each day for the first 3 to 6 weeks or as directed by your doctor. Do not use more than 16 cartridges in a day. Your doctor may direct you to use this product on a regular schedule as well as at times when you have the urge to smoke. Regular use can help your body get used to the medication and decrease side effects such as sore throat. The best dose for you is the dose that decreases the urge to smoke without side effects from too much nicotine. Follow your doctor's orders carefully. Your dose will need to be adjusted to your needs, including smoking history and medical condition.After you have stopped smoking and you have reached the best dose and schedule for you, continue at that dose. Usually, after about 3 months, your doctor will help you gradually reduce your dose until you are no longer smoking and no longer need nicotine replacement.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: Headache, nausea, mouth/tooth/throat pain, cough, runny/stuffy nose, change in taste, heartburn, hiccups, sweating, or diarrhea may 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 persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because 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. Do not smoke while you are using this medication.Stop using this medication and tell your doctor right away if you have any serious side effects, including: severe dizziness, mental/mood changes (e.g., 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), 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 it; or if you have any other allergies. This product may contain inactive ingredients (such as menthol), 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 (e.g., Raynaud's disease, stroke), breathing problems (e.g., asthma, emphysema), diabetes, heart disease (e.g., 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.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).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.Some products that may interact with this drug include: medications for high blood pressure (including beta blockers such as labetalol, prazosin), bronchodilators/decongestants (e.g., isoproterenol, phenylephrine).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: If someone has overdosed and has 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: Do not share this medication with others.

MISSED DOSE: If you are using this on a regular schedule and you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.This medication will not work well if it is too cold. Keep the medication in an inside pocket or warm area during cold weather.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. Consult your pharmacist or local waste disposal company.

Information last revised July 2021. Copyright(c) 2021 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.

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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.