Nicotine 4mg Mint Gum 110s
It is used to treat nicotine withdrawal.It is used to curb the craving to smoke.
Drug Class
Smoking cessation aid
Pharmacologic Class
Nicotinic acetylcholine receptor agonist
Pregnancy Category
Category D
FDA Approved
Jan 1984
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nicotine gum is a medicine that helps people stop smoking by giving them a small, controlled amount of nicotine. This helps reduce the cravings and withdrawal symptoms you get when you stop smoking, making it easier to quit.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, follow your doctor's instructions and read all the information provided. This product is available in two different doses, which are determined by when you have your first cigarette of the day. If you smoke your first cigarette within 30 minutes of waking up, you will use one dose; if you smoke your first cigarette more than 30 minutes after waking up, you will use the other dose. If you are unsure about which dose to use, consult your pharmacist or doctor.
Using the Gum
1. Use the gum immediately after opening the package.
2. Do not swallow the gum. Instead, chew it slowly until you experience a tingling or peppery sensation in your mouth.
3. Once you feel the tingling or peppery sensation, place the gum between your cheek and gum.
4. When the sensation is gone, chew the gum slowly again and then place it between your cheek and gum at a different site.
5. Repeat this process for about 30 minutes or until the tingling or peppery sensation is no longer present.
6. Avoid eating or drinking within 15 minutes before using the gum or while you are using it.
7. If needed, you can use a second piece of gum within an hour, but do not use two pieces at the same time.
Storing and Disposing of Your Medication
Store the gum at room temperature, protected from light.
After using the gum, wrap it in paper before throwing it away.
What to Do If You Miss a Dose
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not use two doses at the same time or take extra doses.
To use this medication effectively, follow your doctor's instructions and read all the information provided. This product is available in two different doses, which are determined by when you have your first cigarette of the day. If you smoke your first cigarette within 30 minutes of waking up, you will use one dose; if you smoke your first cigarette more than 30 minutes after waking up, you will use the other dose. If you are unsure about which dose to use, consult your pharmacist or doctor.
Using the Gum
1. Use the gum immediately after opening the package.
2. Do not swallow the gum. Instead, chew it slowly until you experience a tingling or peppery sensation in your mouth.
3. Once you feel the tingling or peppery sensation, place the gum between your cheek and gum.
4. When the sensation is gone, chew the gum slowly again and then place it between your cheek and gum at a different site.
5. Repeat this process for about 30 minutes or until the tingling or peppery sensation is no longer present.
6. Avoid eating or drinking within 15 minutes before using the gum or while you are using it.
7. If needed, you can use a second piece of gum within an hour, but do not use two pieces at the same time.
Storing and Disposing of Your Medication
Store the gum at room temperature, protected from light.
After using the gum, wrap it in paper before throwing it away.
What to Do If You Miss a Dose
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Chew the gum slowly until you feel a tingling sensation or a peppery taste. Then, 'park' the gum between your cheek and gum. Let it sit there until the tingling or taste fades. Then, chew it again slowly until the tingling returns, and park it again. Repeat this process for about 30 minutes.
- Do not chew the gum too fast or swallow it, as this can lead to too much nicotine being absorbed quickly, causing side effects like hiccups, heartburn, or nausea.
- Avoid eating or drinking anything (especially acidic beverages like coffee, soda, or juice) for 15 minutes before and during chewing the gum, as this can reduce nicotine absorption.
- Follow the dosing schedule carefully and gradually reduce the number of pieces you use over 12 weeks.
- Combine with behavioral support programs for best results.
Available Forms & Alternatives
Available Strengths:
- Nicotine Gum 2mg Mint Refill 50's
- Nicotine Gum 4mg Starter Kit 110's
- Nicotine Polacr 4mg Mint Gum 40's
- Nicotine Polacr 4mg Mintgum 100s
- Nicotine Polacr 2mg Gum 40's
- Nicotine Pol 2mg Mint Gum 100s
- Nicotine Polacr 4mg Cinn Gum 100's
- Nicotine Polacr 4mg Orig Gum 50's
- Nicotine Polacr 2mg Gum Orig 50s
- Nicotine Pol 2mg Original Gum
- Nicotine Polacr 4mg Mint Loz 72's
- Nicotine Polacrilex 4mg Gum 100's
- Nicotine Pol 4mg Orig Gum
- Nicotine TD 7mg/24h Patch 14s
- Nicotine Polacrilex 4mg Chewing Gum
- Nicotine Polacrilex 2mg Chewing Gum
- Nicotine 14mg/24h Patch 14s
- Nicotine 21mg/24h Patch 28s
- Nicotine 21mg/24h Patch 14s
- Nicotine TD 21mg/24h Patch 7s
- Nicotine TD 14mg/24h Patch 7s
- Nicotine SF 2mg Cinn Gum 100's
- Nicotine Lozenge 4mg Mint
- Nicotine 2mg Original Gum 20s
- Nicotine 2mg Mint Lozenge 81s
- Nicotine 4mg Mint Gum 110s
- Nicotine 4mg Mint Gum 20s
- Nicotine TD 7mg/24h Patch 7s
- Nicotine 2mg SF Fruit Gum 100s
- Nicotine TD 21mg/24h Patch 14s
- Nicotine Pol 4mg Mint Lozenges
- Nicotine TD 14mg/24h Patch 28's
- Nicotine Pol 2mg Mint Loz 72s
- Nicotine Polacr 4mg Mint Loz 72s
- Nicotine Pol 2mg Mint Gum 110s
- Nicotine 2mg Mini Mint Loz 72s
- Nicotine 4mg Mini Mint Loz 72s
- Nicotine Pol 4mg Mint Gum
- Nicotine Mini Mint 2mg Loz 81s
Dosing & Administration
Adult Dosing
Standard Dose:
For individuals who smoke their first cigarette within 30 minutes of waking: 4 mg gum. Weeks 1-6: 1 piece every 1-2 hours. Weeks 7-9: 1 piece every 2-4 hours. Weeks 10-12: 1 piece every 4-8 hours. Max 20 pieces/day.
Dose Range:
1 - 20 mg
Condition-Specific Dosing:
smoking_cessation_initial:
1 piece every 1-2 hours for 6 weeks
smoking_cessation_taper_1:
1 piece every 2-4 hours for 3 weeks
smoking_cessation_taper_2:
1 piece every 4-8 hours for 3 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (generally not recommended for individuals under 18 without medical supervision)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, use with caution
Moderate:
No specific adjustment, use with caution
Severe:
No specific adjustment, use with caution due to potential for increased nicotine levels
Dialysis:
Considerations: Nicotine is not significantly removed by dialysis. Use with caution.
Hepatic Impairment:
Mild:
No specific adjustment, use with caution
Moderate:
No specific adjustment, use with caution
Severe:
No specific adjustment, use with caution due to potential for increased nicotine levels
Pharmacology
Mechanism of Action
Nicotine acts as an agonist at nicotinic acetylcholine receptors in the central and peripheral nervous systems. In smoking cessation, it replaces the nicotine from tobacco, reducing withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating, cravings) and the urge to smoke.
Pharmacokinetics
Absorption:
Bioavailability:
30-50% (variable due to chewing technique and swallowing)
Tmax:
15-30 minutes (buccal absorption)
FoodEffect:
Acidic beverages (e.g., coffee, soda, juice) can decrease buccal absorption of nicotine. Avoid eating or drinking for 15 minutes before and during chewing.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
<5%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 2 hours (nicotine); 19 hours (cotinine)
Clearance:
Approximately 1.2 L/min
ExcretionRoute:
Renal (pH-dependent)
Unchanged:
10-30% (dependent on urine pH)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of chewing)
PeakEffect:
15-30 minutes
DurationOfAction:
Variable, related to chewing frequency and individual metabolism, but effects on craving reduction can last longer than plasma half-life.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Mood changes
Confusion
Chest pain or pressure
Fast or abnormal heartbeat
Abnormal sensations, such as burning, numbness, or tingling
Dizziness, tiredness, or weakness
Diarrhea, stomach upset, or vomiting
Drooling
Shakiness
Sore throat
Mouth, teeth, or jaw problems
Cold sweats
Blurred vision
Changes in hearing
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Sleep disturbances
Bad dreams
Feeling nervous or excitable
Headache
Joint pain
Back pain
Irritation at the site of administration
Mouth tingling
* Gum changes
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Mood changes
Confusion
Chest pain or pressure
Fast or abnormal heartbeat
Abnormal sensations, such as burning, numbness, or tingling
Dizziness, tiredness, or weakness
Diarrhea, stomach upset, or vomiting
Drooling
Shakiness
Sore throat
Mouth, teeth, or jaw problems
Cold sweats
Blurred vision
Changes in hearing
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Sleep disturbances
Bad dreams
Feeling nervous or excitable
Headache
Joint pain
Back pain
Irritation at the site of administration
Mouth tingling
* Gum changes
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe nausea or vomiting
- Dizziness or lightheadedness
- Headache that is severe or persistent
- Cold sweat
- Confusion
- Weakness
- Blurred vision
- Hearing problems
- Rapid or irregular heartbeat
- Seizures (rare, indicates severe overdose)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have to this medication, its components, or other substances, including foods, drugs, or products. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, such as:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
Your nicotine use, including smoking, chewing tobacco, or using other nicotine products, while taking this medication
If you have temporomandibular joint (TMJ) disease
* If you are under 18 years of age, as this medication is not recommended for children without consulting a doctor
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have to this medication, its components, or other substances, including foods, drugs, or products. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, such as:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
Your nicotine use, including smoking, chewing tobacco, or using other nicotine products, while taking this medication
If you have temporomandibular joint (TMJ) disease
* If you are under 18 years of age, as this medication is not recommended for children without consulting a doctor
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To increase your chances of quitting smoking, consider seeking counseling to help you overcome nicotine addiction.
To minimize the risk of adverse effects, do not exceed the recommended dosage. Taking more than prescribed can lead to unsafe side effects. If you are using another medication to aid in smoking cessation, be sure to inform your doctor.
When attempting to quit smoking, even with the assistance of medications like this one, you may experience symptoms of nicotine withdrawal. These symptoms can vary, so it is crucial to report any adverse effects to your doctor.
Until you are familiar with how this medication affects you, avoid operating a vehicle or engaging in activities that require alertness. Additionally, be aware that quitting smoking can alter the effectiveness of other medications you are taking, so consult with your doctor to discuss any potential interactions.
If you have not been able to quit smoking after using this medication for the recommended duration, inform your doctor. It is also important to note that chewing gum can potentially cause problems with dental work, such as loose teeth or dental implants.
If you are following a low-sodium or sodium-free diet, consult with your doctor before using this medication, as some products may contain sodium.
This medication can be hazardous or even fatal if ingested by children or pets. If a child uses this medication or if it is accidentally ingested by a child or pet, immediately contact a doctor or a poison control center.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects. Furthermore, if you are pregnant or become pregnant while taking this medication, inform your doctor promptly, as it may pose a risk to the unborn baby. If you are breastfeeding, discuss the potential risks to your baby with your doctor.
To minimize the risk of adverse effects, do not exceed the recommended dosage. Taking more than prescribed can lead to unsafe side effects. If you are using another medication to aid in smoking cessation, be sure to inform your doctor.
When attempting to quit smoking, even with the assistance of medications like this one, you may experience symptoms of nicotine withdrawal. These symptoms can vary, so it is crucial to report any adverse effects to your doctor.
Until you are familiar with how this medication affects you, avoid operating a vehicle or engaging in activities that require alertness. Additionally, be aware that quitting smoking can alter the effectiveness of other medications you are taking, so consult with your doctor to discuss any potential interactions.
If you have not been able to quit smoking after using this medication for the recommended duration, inform your doctor. It is also important to note that chewing gum can potentially cause problems with dental work, such as loose teeth or dental implants.
If you are following a low-sodium or sodium-free diet, consult with your doctor before using this medication, as some products may contain sodium.
This medication can be hazardous or even fatal if ingested by children or pets. If a child uses this medication or if it is accidentally ingested by a child or pet, immediately contact a doctor or a poison control center.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects. Furthermore, if you are pregnant or become pregnant while taking this medication, inform your doctor promptly, as it may pose a risk to the unborn baby. If you are breastfeeding, discuss the potential risks to your baby with your doctor.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Headache
- Hiccups
- Increased salivation
- Abdominal pain
- Cold sweat
- Pallor
- Palpitations
- Weakness
- Tremors
- Confusion
- Convulsions (severe cases)
- Respiratory depression (severe cases)
What to Do:
If you suspect an overdose, stop using the gum immediately and seek emergency medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US).
Drug Interactions
Moderate Interactions
- Adenosine (nicotine may increase heart rate and blood pressure, potentially reducing adenosine's effectiveness)
- Beta-blockers (nicotine may reduce their hypotensive effects)
- Insulin (nicotine may cause an increase in blood glucose, requiring insulin dose adjustment)
- Theophylline (smoking cessation may increase theophylline levels due to reduced metabolism)
- Caffeine (smoking cessation may increase caffeine levels due to reduced metabolism)
- Flecainide (smoking cessation may increase flecainide levels due to reduced metabolism)
- Imipramine (smoking cessation may increase imipramine levels due to reduced metabolism)
- Olanzapine (smoking cessation may increase olanzapine levels due to reduced metabolism)
- Clozapine (smoking cessation may increase clozapine levels due to reduced metabolism)
- Ropinirole (smoking cessation may increase ropinirole levels due to reduced metabolism)
Monitoring
Baseline Monitoring
Smoking history and dependence level
Rationale: To determine appropriate nicotine gum strength (2mg vs 4mg) and initial dosing schedule.
Timing: Prior to initiation of therapy
Cardiovascular status (e.g., recent MI, unstable angina, severe arrhythmias)
Rationale: Nicotine can have cardiovascular effects; caution is advised in patients with pre-existing cardiovascular disease.
Timing: Prior to initiation of therapy
Dental/oral health
Rationale: Gum can stick to dentures or dental work, and can cause jaw pain.
Timing: Prior to initiation of therapy
Routine Monitoring
Adherence to chewing instructions
Frequency: At each follow-up visit (e.g., weekly initially, then bi-weekly)
Target: Proper chewing technique (chew-park method)
Action Threshold: Improper use may lead to inadequate nicotine delivery or excessive side effects; re-educate patient.
Smoking cessation progress
Frequency: At each follow-up visit
Target: Reduction or cessation of smoking
Action Threshold: Lack of progress may indicate need for dose adjustment, combination NRT, or alternative therapies.
Side effects (e.g., nausea, hiccups, jaw pain, dyspepsia, throat irritation)
Frequency: At each follow-up visit
Target: Minimal to tolerable side effects
Action Threshold: Persistent or severe side effects may require dose reduction, change in chewing technique, or discontinuation.
Symptoms of nicotine overdose (e.g., nausea, vomiting, dizziness, headache, palpitations)
Frequency: At each follow-up visit
Target: Absence of overdose symptoms
Action Threshold: Presence of symptoms requires immediate reduction in nicotine intake and medical evaluation.
Symptom Monitoring
- Nausea
- Vomiting
- Hiccups
- Jaw pain
- Dyspepsia
- Throat irritation
- Dizziness
- Headache
- Palpitations
- Cold sweat
- Confusion
- Weakness
- Seizures (rare, severe overdose)
Special Patient Groups
Pregnancy
Category D. Nicotine crosses the placenta and can harm the fetus. Smoking during pregnancy is highly detrimental. While behavioral therapy is the first-line treatment for smoking cessation in pregnant women, if NRT is considered necessary, the benefits of quitting smoking must outweigh the risks of nicotine exposure. Intermittent NRT (like gum) is generally preferred over continuous forms (like patches) to minimize continuous fetal exposure. Use the lowest effective dose for the shortest duration.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on organogenesis and increased risk of miscarriage.
Second Trimester:
Potential for adverse effects on fetal growth and development.
Third Trimester:
Potential for adverse effects on fetal growth, premature birth, and neurodevelopmental issues.
Lactation
L3 (Moderately Safe). Nicotine is excreted into breast milk and can be harmful to the infant. However, the risks of continued maternal smoking are greater than the risks of nicotine from NRT. If NRT is used, advise mothers to use the gum immediately after breastfeeding to allow time for nicotine levels to decrease before the next feeding. Consider using the lowest effective dose and limiting exposure.
Infant Risk:
Infant exposure to nicotine via breast milk can lead to irritability, restlessness, poor feeding, and potential long-term developmental effects. Cotinine, an active metabolite, also passes into breast milk.
Pediatric Use
Nicotine gum is not indicated for smoking cessation in individuals under 18 years of age without specific medical supervision. Safety and efficacy have not been established in this population.
Geriatric Use
No specific dose adjustments are generally required for elderly patients. However, caution should be exercised due to potential for increased sensitivity to nicotine's effects, especially cardiovascular effects. Monitor for side effects and adjust dose as needed.
Clinical Information
Clinical Pearls
- Proper chewing technique ('chew-park' method) is crucial for effective nicotine delivery and to minimize side effects like hiccups or stomach upset.
- Avoid acidic beverages (e.g., coffee, soda, juice) for 15 minutes before and during gum use, as they can impair nicotine absorption.
- Nicotine gum can be used as part of a combination NRT regimen (e.g., with a nicotine patch) for patients with high nicotine dependence or severe withdrawal symptoms.
- The 4mg strength is typically recommended for individuals who smoke their first cigarette within 30 minutes of waking, indicating higher nicotine dependence.
- Encourage patients to set a quit date and seek behavioral counseling or support groups to maximize success rates.
Alternative Therapies
- Nicotine patch
- Nicotine lozenge
- Nicotine inhaler
- Nicotine nasal spray
- Bupropion SR (Zyban, Wellbutrin SR)
- Varenicline (Chantix)
- Behavioral counseling and support programs (e.g., Quitline)
Cost & Coverage
Average Cost:
$40 - $70 per 110 pieces
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans, sometimes as a preventative benefit. Coverage tier varies (e.g., Tier 1 or 2 for generics).
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.