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
nicotine transdermal
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21 mg/24 hr transdermal system
nicotine transdermal
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21 mg/24 hr transdermal system
nicotine transdermal
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21 mg/24 hr transdermal system
nicotine transdermal
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14 mg/24 hr transdermal system
nicotine transdermal
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7 mg/24 hr transdermal system
nicotine transdermal
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14 mg/24 hr transdermal system
nicotine transdermal
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14 mg/24 hr transdermal system
nicotine transdermal
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7 mg/24 hr transdermal system
nicotine transdermal
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14 mg/24 hr transdermal system
nicotine transdermal
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14 mg/24 hr transdermal system
nicotine transdermal
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21-14-7 mg/24 hr transdermal system
nicotine transdermal
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7 mg/24 hr transdermal system
nicotine transdermal
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21 mg/24 hr transdermal system
nicotine transdermal
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21 mg/24 hr transdermal system
nicotine transdermal
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14 mg/24 hr transdermal system
nicotine transdermal
-
21 mg/24 hr transdermal system
nicotine transdermal
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7 mg/24 hr transdermal system
nicotine transdermal
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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
-
7 mg/24 hr transdermal system
nicotine transdermal
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21 mg/24 hr transdermal system
nicotine transdermal
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21 mg/24 hr transdermal system
nicotine transdermal
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21 mg/24 hr transdermal system
Nicotrol NS nasal
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10 mg/mL liquid
Nicoderm CQ transdermal
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21 mg/24 hr transdermal system
Nicoderm CQ transdermal
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14 mg/24 hr transdermal system
Nicoderm CQ transdermal
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21 mg/24 hr transdermal system
Nicoderm CQ transdermal
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7 mg/24 hr transdermal system
Nicoderm CQ transdermal
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7 mg/24 hr transdermal system
Nicoderm CQ transdermal
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21 mg/24 hr transdermal system
Nicotrol inhalation
-
10 mg solution

Copyright © 2010 First DataBank, Inc.

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Patient Handout

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Patient Education
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 provided by 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, consult 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.Some products that may interact with this drug include: medications for high blood pressure (including beta blockers such as labetalol, prazosin), bronchodilators/decongestants (such as 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: 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 April 2022. Copyright(c) 2022 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.